united states district court southern district ......2021/01/15 · no. cv 11-01230 rs, 2014 wl...

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF FLORIDA

IN RE: ZANTAC (RANITIDINE)

PRODUCTS LIABILITY

LITIGATION

_______________________________/

MDL NO. 2924

20-MD-2924

JUDGE ROBIN L. ROSENBERG

MAGISTRATE JUDGE BRUCE E. REINHART

THIS DOCUMENT RELATES TO:

Ralph Dudley v. GlaxoSmithKline, et al. 9:20-cv-81056-RLR

Kalmeta Salvatore v. GlaxoSmithKline, et al. 9:20-cv-81059-RLR

Allen Brittner v. GlaxoSmithKline, et al. 9:20-cv-81061-RLR

John Cash v. GlaxoSmithKline, et al. 9:20-cv-81065-RLR

Jose Flores v. GlaxoSmithKline, et al. 9:20-cv-81068-RLR

Joseph Gregory Jr. v. GlaxoSmithKline, et al. 9:20-cv-81072-RLR

Roy Williams v. GlaxoSmithKline, et al. 9:20-cv-81073-RLR

Mark Hernandez v. GlaxoSmithKline, et al. 9:20-cv-81074-RLR

Michael White v. GlaxoSmithKline, et al. 9:20-cv-81075-RLR

Ryan Ortega v. GlaxoSmithKline, et al. 9:20-cv-81077-RLR

Oliver Reynolds v. GlaxoSmithKline, et al. 9:20-cv-81078-RLR

Grag Amelino v. GlaxoSmithKline, et al. 9:20-cv-81087-RLR

Matthew Yedlin v. GlaxoSmithKline, et al. 9:20-cv-81089-RLR

Armando Becerril v. GlaxoSmithKline, et al. 9:20-cv-81090-RLR

Lynn Smith v. GlaxoSmithKline, et al. 9:20-cv-81092-RLR

Chris Ives v. GlaxoSmithKline, et al. 9:20-cv-81093-RLR

James Newton v. GlaxoSmithKline, et al. 9:20-cv-81094-RLR

Michael Jerde v. GlaxoSmithKline, et al. 9:20-cv-81096-RLR

Albert Muesse v. GlaxoSmithKline, et al. 9:20-cv-81097-RLR

Reha Ray Karaoz v. GlaxoSmithKline, et al. 9:20-cv-81098-RLR

Greg Knell v. GlaxoSmithKline, et al. 9:20-cv-81099-RLR

Austin Barnes v. GlaxoSmithKline, et al. 9:20-cv-81104-RLR

Michael Caratti v. GlaxoSmithKline, et al. 9:20-cv-81105-RLR

Brian Elias v. GlaxoSmithKline, et al. 9:20-cv-81106-RLR

Marc Friedland v. GlaxoSmithKline, et al. 9:20-cv-81107-RLR

Marc Mitchell v. GlaxoSmithKline, et al. 9:20-cv-81109-RLR

Mark Morrison v. GlaxoSmithKline, et al. 9:20-cv-81110-RLR

Dwight Norman v. GlaxoSmithKline, et al. 9:20-cv-81112-RLR

Brian Wilbur v. GlaxoSmithKline, et al. 9:20-cv-81118-RLR

Velo Wright Jr. v. GlaxoSmithKline, et al. 9:20-cv-81119-RLR

Case 9:20-md-02924-RLR Document 2569 Entered on FLSD Docket 01/15/2021 of 30

Claudia Masouredis v. GlaxoSmithKline, et al. 9:20-cv-81121-RLR

Lolita Mills v. GlaxoSmithKline, et al. 9:20-cv-81122-RLR

Gary Campbell v. GlaxoSmithKline, et al. 9:20-cv-81142-RLR

John Geurin v. GlaxoSmithKline, et al. 9:20-cv-81143-RLR

Carbajal, et al. v. GlaxoSmithKline, et al. 9:20-cv-81144-RLR

Joseph Gigliello v. GlaxoSmithKline, et al. 9:20-cv-81145-RLR

James Goetz v. GlaxoSmithKline, et al. 9:20-cv-81152-RLR

Steven Brodie v. GlaxoSmithKline, et al. 9:20-cv-81153-RLR

Henry D. Harbaugh v. GlaxoSmithKline, et al. 9:20-cv-81154-RLR

John Russell v. GlaxoSmithKline, et al. 9:20-cv-81157-RLR

Gilbert Astruc v. GlaxoSmithKline, et al. 9:20-cv-81216-RLR

MOTION TO REMAND CASES TO CALIFORNIA STATE COURT

The above-captioned Plaintiffs, by and through undersigned counsel, move this Court to

remand forty-one cases removed from California state court pursuant to 28 U.S.C. § 1447(c).

This Motion is filed with leave of Court pursuant to the Court’s January 11, 2021 Order (Doc.

2535).


i

TABLE OF CONTENTS

Page

TABLE OF CONTENTS ................................................................................................................. i

TABLE OF AUTHORITIES .......................................................................................................... ii

INTRODUCTION .......................................................................................................................... 1

BACKGROUND ............................................................................................................................ 4

LEGAL STANDARD ..................................................................................................................... 4

ARGUMENT .................................................................................................................................. 6

I. The Drug Company Defendants Have Not Proven, with Clear and Convincing

Evidence, that Plaintiffs’ Negligence Claims Against the California Retailers Are

Impossible ......................................................................................................................... 6

A. Plaintiffs State a Colorable, if Not Plausible, Claim of Negligence Against the

California Retailer Defendants .................................................................................. 6

B. This Court Recently Held that Pleading a Negligence Claim Against a Retailer

Would Be Possible .................................................................................................... 9

C. Defendants’ Attempt to Reconstitute Plaintiffs’ Claims Solely Around Testing for a

Latent Defect Fails Because Plaintiffs Allege Actual and Constructive Knowledge

of the Defect ............................................................................................................ 10

II. The Drug Company Defendants Have Not Established that Plaintiffs’ Strict Liability

Claims Are, by Clear and Convincing Evidence, Impossible Based on a Defense of

Preemption ...................................................................................................................... 13

A. The Drug Company Defendants Cannot Establish Fraudulent Joinder of Plaintiffs’

Strict Liability Claims Based on a Preemption Defense Because the Court Lacks

Independent Jurisdiction to Consider the Merits of the Defense ............................ 14

B. The Drug Company Defendants Have Not Demonstrated, with Clear and

Convincing Evidence, that Plaintiffs’ Strict Liability Manufacturing Defect Claims

Are Impossible ........................................................................................................ 18

CONCLUSION ............................................................................................................................. 20

REQUEST FOR HEARING ......................................................................................................... 21

CERTIFICATION PURSUANT TO LOCAL RULE 7.1(A)(3) .................................................. 21


ii

TABLE OF AUTHORITIES

Page(s)

Cases

A.S. v. Pfizer, Inc.,

No. 1:13-CV-00524-LJO, 2013 WL 2384320 (E.D. Cal. May 30, 2013) .......................... 16, 17

Ambriz v. CVS Pharmacy, Inc.,

No. 19-CV-1391, 2020 WL 1660018 (E.D. Cal. Apr. 3, 2020) ........................................... 7, 12

Armstrong v. McKesson Corp.,

No. C, 13-03113 WHA, 2013 WL 4516668 (N.D. Cal. Aug. 23, 2013) ............................ 16, 17

Arriaga v. CitiCapital Commercial Corp.,

85 Cal. Rptr. 3d 143 (Ct. App. 2008) ....................................................................................... 19

Barker v. Lull Eng’g Co.,

573 P.2d 443 (Cal. 1978) .......................................................................................................... 19

Brush v. Bayside Orthopaedics, Inc.,

No. 8:14-CV-2163-T-36EAJ, 2014 WL 5426643 (M.D. Fla. Oct. 22, 2014) .......................... 18

Buck v. McKesson Corp.,

No. 13CV2541 JLS (RBB), 2014 WL 12514793

(S.D. Cal. July 29, 2014)..................................................................................................... 15, 17

Cabral v. Ralphs Grocery Co.,

248 P.3d 1170 (Cal. 2011) .......................................................................................................... 8

Caouette v. Bristol-Myers Squibb Co.,

No. C-12-1814 EMC, 2012 WL 3283858 (N.D. Cal. Aug. 10, 2012)...................................... 16

Catlett v. McKesson Corp.,


Celeste v. Merck, Sharp & Dohme Corp.,

No. 14CV360 AJB MDD, 2014 WL 2739025 (S.D. Cal. June 17, 2014) ................................ 15

Chicago, Rock Island & Pacific Ry. Co. v. Schwyhart,

227 U.S. 184 (1913) .................................................................................................................... 5

Cotton v. Mass. Mut. Life Ins. Co.,

402 F.3d 1267 (11th Cir. 2005) .......................................................................................... 15, 18

Coyle v. Historic Mission Inn Corp.,

234 Cal. Rptr. 3d 330 (Ct. App. 2018) ..................................................................................... 12


iii

Crowe v. Coleman,

113 F.3d 1536 (11th Cir. 1997) ........................................................................................ 5, 6, 12

D.A. ex rel. Wilson v. McKesson Corp.,

No. 1:13-CV-01700-LJO, 2014 WL 202738 (E.D. Cal. Jan. 17, 2014) ............................. 15, 17

Dodich v. Pfizer Inc.,

No. C 18-02764 WHA, 2018 WL 3584484 (N.D. Cal. July 26, 2018) .............................. 15, 17

Eddy v. Stowe,

185 P. 1024 (Cal. Ct. App. 1919) ....................................................................................... 12, 13

Emana v. McKesson Corp.,


Ferrari v. Nat. Partners, Inc.,

No. 15-CV-04787, 2016 WL 4440242 (N.D. Cal. Aug. 23, 2016) ............................................ 7

Florence v. Crescent Res., LLC,

484 F.3d 1293 (11th Cir. 2007) ................................................................................................ 17

Franchise Tax Bd. of State of Cal. v. Constr. Laborers Vacation Tr. for S. California,

463 U.S. 1 (1983) ...................................................................................................................... 14

Fransas v. Brenntag N. Am. Inc.,

No. 9:17-CV-80058, 2017 WL 9292098 (S.D. Fla. Mar. 10, 2017)..................................... 6, 11

Garrett v. Howmedica Osteonics Corp.,

153 Cal. Rptr. 3d 693 (Ct. App. 2013) ..................................................................................... 19

Garza v. Endo Pharm.,

No. CV 12-1585-CAS OPX, 2012 WL 5267897 (C.D. Cal. Oct. 24, 2012) .............................. 8

Geisse v. Bayer HealthCare Pharm. Inc.,

No. 17-CV-07026-JD, 2019 WL 1239854 (N.D. Cal. Mar. 18, 2019) ............................... 15, 18

Grancare, LLC v. Thrower by & through Mills,

889 F.3d 543 (9th Cir. 2018) .................................................................................................... 15

Hatherley v. Pfizer, Inc.,

No. CIV. 2:13-00719 WBS, 2013 WL 3354458 (E.D. Cal. July 3, 2013) ......................... 16, 17

Henderson v. Washington Nat. Ins. Co.,

454 F.3d 1278 (11th Cir. 2006) ............................................................................................ 5, 17

Hensley-Maclean v. Safeway, Inc.,

No. CV 11-01230 RS, 2014 WL 1364906 (N.D. Cal. Apr. 7, 2014) ................................... 8, 12


iv

Hermosillo v. McKesson Corp.,


Hughes v. Mylan Inc.,

No. CIV.A. 11-5543, 2011 WL 5075133 (E.D. Pa. Oct. 25, 2011).......................................... 16

Hunter v. Philip Morris USA,

582 F.3d 1039 (9th Cir. 2009) .................................................................................................. 15

In re Abilify (Aripiprazole) Prod. Liab. Litig.,

No. 3:16MD2734, 2018 WL 6258903, at *6 (N.D. Fla. Nov. 8, 2018) ................ 3, 5, 14, 15, 18

In re Avandia Mktg., Sales Practices & Prod. Liab. Litig.,

624 F. Supp. 2d 396 (E.D. Pa. 2009) .................................................................................. 16, 17

In re Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet I”),

889 F. Supp. 2d 931 (E.D. Ky. 2012) ................................................................................. 16, 17

In re Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet II”),

106 F. Supp. 3d 849 (E.D. Ky. 2015) ................................................................................. 16, 17

In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prod. Liab. Litig.,

905 F. Supp. 2d 644 (E.D. Pa. 2012) .................................................................................. 16, 17

In re Lipitor (Atorvastatin Calcium) Mktg. Sales Practices & Prod. Liab. Litig.,

No. 2:14-MN-2502-RMG, 2016 WL 7373887 (D.S.C. July 14, 2016) .............................. 16, 17

In Re Plavix Prod. Liab. & Mktg. Litig.,

No. 3:13-CV-03610-FLW, 2014 WL 4954654 (D.N.J. Oct. 1, 2014)................................ 16, 17

In re Zoloft (Sertraline Hydrochloride) Prod. Liab. Litig.,

No. 12-MD-2342, 2013 WL 6050627 (E.D. Pa. Nov. 14, 2013) ....................................... 16, 17

In re: Zantac (Ranitidine) Prods. Liab. Litig.,

No. 20-MD-2924, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020) ............................................... 9

In re: Zantac (Ranitidine) Prods. Liab. Litig.,

No. 20-MD-2924, 2020 WL 7864585 (S.D. Fla. Dec. 31, 2020) ............................................... 9

J.E. v. Smithkline Beecham Corp.,

No. CV 13-04897-KAW, 2014 WL 11369807 (N.D. Cal. Jan. 27, 2014) ......................... 15, 17

J.F. ex rel. Moore v. McKesson Corp.,

No. 1:13-CV-01699-LJO, 2014 WL 202737 (E.D. Cal. Jan. 17, 2014) ............................. 15, 17

J.K.B. by Bennett v. Pfizer, Inc.,

No. CV1305043MMMJCGX, 2013 WL 12129385 (C.D. Cal. Nov. 4, 2013)................... 16, 17


v

J.P. ex rel. Plummer v. McKesson Corp.,

No. 2:13-CV-02207-TLN, 2014 WL 3890326 (E.D. Cal. Aug. 7, 2014)........................... 15, 17

Kemp v. Int’l Bus. Machines Corp.,

109 F.3d 708 (11th Cir. 1997) .................................................................................................. 14

LAOSD Asbestos Cases,

248 Cal. Rptr. 3d 219 (Ct. App. 2019) ................................................................................. 7, 10

Lueck v. McKesson Corp.,


Mathis v. Pfizer Inc.,

No. SACV1801256AGAFMX, 2018 WL 5291933 (C.D. Cal. Oct. 22, 2018) .................. 15, 17

Pacheco de Perez v. AT&T Co.,

139 F.3d 1368 (11th Cir. 1998) .................................................................................................. 6

Parks v. The New York Times Co.,

308 F.2d 474 (5th Cir. 1962) ...................................................................................................... 5

Pike v. Frank G. Hough Co.,

467 P.2d 229 (Cal. 1970) ............................................................................................................ 7

Rentz v. McKesson Corp.,

No. CV 12-4399 PSG (EX), 2012 WL 12888362 (C.D. Cal. Aug. 7, 2012) ............................ 16

Robinson v. Pfizer Inc.,

No. 4:16-CV-439 (CEJ), 2016 WL 1721143 (E.D. Mo. Apr. 29, 2016) .................................. 17

Rodriguez v. Inglewood Unified Sch. Dist.,

230 Cal. Rptr. 823 (Ct. App. 1986)............................................................................................. 7

Romo v. McKesson Corp.,

No. CV 12-2036 PSG (EX), 2013 WL 12131188 (C.D. Cal. Feb. 20, 2013) .......................... 16

Scimone v. Carnival Corp.,

720 F.3d 876 (11th Cir. 2013) .................................................................................................... 5

Seo v. All-Makes Overhead Doors,

119 Cal. Rptr. 2d 160 (Ct. App. 2002) ....................................................................................... 7

Smith v. Amylin Pharm., LLC,

No. 13CV1236 AJB MDD, 2013 WL 3467442 (S.D. Cal. July 10, 2013) .............................. 16

Spiers v. McKesson Corp.,



vi

Steel Co. v. Citizens for a Better Env’t,

523 U.S. 83 (1998) ...................................................................................................................... 6

Stillwell v. Allstate Ins. Co.,

663 F.3d 1329 (11th Cir. 2011) .......................................................................................... 4, 5, 6

Strawbridge v. Curtiss,

7 U.S. 267 (1806) ........................................................................................................................ 4

Taha v. Pfizer, Inc.,

No. CV1302577MWFFFMX, 2013 WL 12142560 (C.D. Cal. July 1, 2013) .................... 16, 17

Travis v. McKesson Corp.,


Trees v. Pfizer Inc.,

No. CV 2:16-0334-RMG, 2016 WL 11540619 (D.S.C. Aug. 18, 2016) ............................ 15, 17

Triggs v. John Crump Toyota, Inc.,

154 F.3d 1284 (11th Cir. 1998) .................................................................................................. 5

Univ. of S. Alabama v. Am. Tobacco Co.,

168 F.3d 405 (11th Cir. 1999) .................................................................................................... 6

Vandermark v. Ford Motor Co.,

391 P.2d 168 (Cal. 1964) .......................................................................................................... 19

W.W. v. McKesson Corp.,

No. SACV131649AGDFMX, 2014 WL 12577143 (C.D. Cal. Jan. 31, 2014) .................. 15, 17

Zachman v. Johnson & Johnson,

No. 15-CV-04285-RS, 2015 WL 7717190 (N.D. Cal. Nov. 30, 2015) .................................... 15

Zaremba v. Orthopedics, Inc.,

No. 8:14-CV-1016-T-33TGW, 2014 WL 3057400 (M.D. Fla. July 7, 2014) .................... 13, 18

Statutes

28 U.S.C. § 1441 ............................................................................................................................. 4

28 U.S.C. § 1447 ..................................................................................................................... 2, 1, 3

Cal. Civ. Code § 1714 ................................................................................................................... 12

Other Authorities

Judicial Council of California Civil Jury Instruction 1221 ....................................................... 7, 11

Fla. Std. Jury Instr. (Civ.) 601.4 ................................................................................................... 11


1

INTRODUCTION

In June 2020, the Drug Company Defendants1 improperly removed the above-captioned

cases from California state court, claiming federal subject matter jurisdiction when none existed.

Pursuant to 28 U.S.C. § 1447(c), Plaintiffs request that these cases be remanded back to

California state court before any further prejudice attends these Plaintiffs.

As set forth in their complaints, Plaintiffs are California citizens and originally filed their

cases in California state court, naming at least one California Retailer Defendant2 and at least one

Drug Company Defendant, thus complete diversity does not exist between the parties.

Notwithstanding this lack of complete diversity, the Drug Company Defendants removed the

cases to federal court, claiming that the citizenship of the California Retailer Defendants should

be ignored for jurisdictional purposes because of the heavily disfavored doctrine of fraudulent

joinder. Under the doctrine, the Court can ignore the citizenship of the diversity-destroying

California Retailer Defendants only if Drug Company Defendants prove, with clear and

convincing evidence and all factual and legal uncertainties going against them, that it would be

impossible to bring any claim against the California Retailer Defendants. If even a single claim

is colorable, remand must occur.

Plaintiffs allege three causes of action against the California Retailer Defendants: (1)

negligence, (2) strict liability - failure to warn, and (3) strict liability - manufacturing defect. The

Drug Company Defendants have failed to meet—and cannot meet—their heavy burden of

proving that each and every cause of action is, by clear and convincing evidence, impossible.

Regarding negligence, Plaintiffs specifically allege that the California Retailer Defendants

were negligent by failing to limit ranitidine’s exposure to heat during the transport, storage, and

stocking of ranitidine products. These failures, in turn, led to the accumulation of N-nitroso-

dimethylamine (“NDMA”) in the ranitidine products that substantially contributed to each

1 “Drug Company Defendants” collectively refers to Defendants GlaxoSmithKline, LLC, Boehringer Ingelheim

Pharmaceuticals, Inc., Boehringer Ingelheim USA Corp., Pfizer, Inc., Sanofi US Services Inc., and Sanofi-Aventis

U.S. LLC. 2 “California Retailer Defendants” collectively refers to Defendants Safeway, Inc., Safeway Health, Inc., The Vons

Companies, Inc., Kaiser Permanente International, and Grocery Outlet.


2

Plaintiff’s development of cancer. California law has long recognized that the seller of a good

must take reasonable precautions to ensure the products they sell do not pose an unreasonable

risk to the consumer. This is settled law that is enshrined in California’s model jury instructions

and significant caselaw. Indeed, the possibility of this type of negligence claim was recently

acknowledged by this Court in its recent motions to dismiss rulings. This finding of possibility,

in and of itself, demands remand.

Notwithstanding, the Drug Company Defendants argue that this negligence claim is

impossible because the only way the California Retailer Defendants could have known about the

need to avoid exposure to heat would have been to conduct extensive drug testing. This

argument, however, misrepresents the allegations and confuses the law. Factually, the

complaints allege that California Retailer Defendants knew or should have known that exposing

ranitidine to heat could cause NDMA formation because this fact had been well documented for

decades. Thus, the premise of the Drug Company Defendants’ argument is, factually, false.

Legally, whether the California Retailer Defendants were “negligent” will turn on whether the

defendant acted as a reasonably prudent person would under like circumstances. This inquiry

looks at what the California Retailer Defendants knew or should have known and balances that

against the burden of protecting against the risk. If, as Plaintiffs allege, the California Retailer

Defendants knew or should have known that exposing ranitidine to heat would lead to NDMA

formation, then they could be negligent by failing to prevent their ranitidine products from being

exposed to heat. Under California law, such a claim is not only possible, it is plausible.

Therefore, because the Drug Company Defendants fail to prove impossibility for the negligence

claim, the Court need not reach the strict liability claims; there would be a least one possible

claim against the California Retailer Defendants in each lawsuit, requiring remand.

For Plaintiffs’ strict liability claims, the Drug Company Defendants argue that they are

“impossible” pursuant to federal preemption. However, as discussed below, in the context of a

motion to remand, this Court cannot address the merits of a preemption defense. There is a

jurisdictional bar—an impossibility preemption affirmative defense cannot, itself, establish


3

fraudulent joinder because the Court must have independent jurisdiction, in the first place, to

adjudicate preemption. This was recently observed by the Hon. M. Casey Rodgers in the

neighboring In re Abilify (Aripiprazole) Prod. Liab. Litig. MDL in the Northern District of

Florida. No. 3:16MD2734, 2018 WL 6258903, at *6 (N.D. Fla. Nov. 8, 2018). There, Judge

Rodgers held, in the context of a remand motion for cases removed from California state court,

“that, without any independent grounds for federal jurisdiction over Plaintiffs’ claims, [the court]

lacks subject matter jurisdiction to assess the merits of [a] potential conflict preemption defense.”

Id. This holding is supported by a mountain of unanimous authority from thirty-five different

federal courts across the United States, including seven other MDLs. The Drug Company

Defendants cannot, as a matter of law, establish fraudulent joinder of Plaintiffs’ strict liability

claims by arguing that the state claim is preempted.

Finally, with regard to Plaintiffs’ manufacturing defect claim, the Drug Company

Defendants argue that Plaintiffs’ claim against the California Retailer Defendants is impossible

because they did not manufacture the ranitidine at issue. This is a misstatement of California

law. In California, a manufacturing defect is not limited to errors in the manufacturing process,

but refers to any defect in the product that renders it different from its intended design. Here,

Plaintiffs allege that the California Retailer Defendants caused their ranitidine products to

develop a “manufacturing defect” by letting their products accumulate unsafe levels of NDMA

during transport and storage. Under this theory, California law recognizes a strict liability

manufacturing defect claim. That the California Retailer Defendants did not literally

“manufacture” the pills is irrelevant.

The Drug Company Defendants have failed to prove, with clear and convincing evidence

and all factual and legal uncertainties going against them, that it would be impossible for the

Plaintiffs to bring any claim against a California Retailer Defendant. Accordingly, there is no

fraudulent joinder and, thus, no subject matter jurisdiction over these cases. Pursuant to 28

U.S.C. § 1447(c), Plaintiffs respectfully request this Court remand these cases.


4

BACKGROUND

These forty-one cases were originally filed over eight months ago in California state court.

Specifically, on May 11, 2020, thirty-nine of the underlying lawsuits were filed in California

Superior Court, Alameda County (the “Alameda Cases”) and on June 10, 2020, Plaintiffs Mills

(9:20-cv-81122-RLR) and Masouredis (9:20-cv-81121-RLR) filed lawsuits in California

Superior Court, San Francisco County (“San Francisco Cases”). On June 15, 2020, the Drug

Company Defendants removed the Alameda Cases to the Northern District of California and

they removed the San Francisco cases on June 23, 2020.

While these cases were pending before the Northern District of California, Plaintiffs filed

motions to remand. However, after the cases were transferred to the MDL, those motions were

denied without prejudice on July 22, 2020 pursuant to Pretrial Order # 24.

On July 27, 2020, Plaintiffs moved for leave to refile a motion to remand. (Doc. 1205.)

The motion was denied, without prejudice, on August 7, 2020. (Doc. 1394). After denying two

more requests for leave to file a motion to remand without prejudice, (Docs. 1607 & 2229), on

January 11, 2021, this Court gave leave to Plaintiffs to file a motion to remand by January 15,

2021. (Doc. 2535).

While these removed cases were waiting for their opportunity to seek remand, the Parties

met and conferred and agreed that these California Plaintiffs would not need to adopt the Master

Pleadings, submit short form complaints, or provide any Census Plus Forms unless this Court

denied Plaintiffs’ anticipated motion to remand. Exh. 1 at 1.3

LEGAL STANDARD

An action filed in state court may be removed to federal court based upon diversity or

federal question jurisdiction. 28 U.S.C. § 1441(a). “When a case is removed based on diversity

jurisdiction,” like here, “the case must be remanded to state court if there is not complete

diversity between the parties[.]” Stillwell v. Allstate Ins. Co., 663 F.3d 1329, 1332 (11th Cir.

2011) (emphasis added) (citing Strawbridge v. Curtiss, 7 U.S. 267, 267 (1806)). This is because,

3 All cited exhibits are attached to the Declaration of R. Brent Wisner filed concurrently with this motion.


5

without complete diversity, the Court lacks subject matter jurisdiction over the lawsuit.

“As a general proposition, a plaintiff, as ‘master of the complaint,’ is free to structure his

case in a manner that falls short of the requirements for diversity jurisdiction, including by

properly joining a diversity-destroying defendant.” In re Abilify (Aripiprazole) Prod. Liab.

Litig., No. 3:16MD2734, 2018 WL 6258903, at *1 (N.D. Fla. Nov. 8, 2018) (citing Scimone v.

Carnival Corp., 720 F.3d 876, 882 (11th Cir. 2013)). Indeed, a plaintiff’s motive in naming a

non-diverse defendant is irrelevant. Triggs v. John Crump Toyota, Inc., 154 F.3d 1284, 1291

(11th Cir. 1998) (quoting Chicago, Rock Island & Pacific Ry. Co. v. Schwyhart, 227 U.S. 184

(1913)). The “plaintiff has the right to select the forum, to elect whether to sue joint tortfeasors

and to prosecute his own suit in his own way to a final determination.” Crowe v. Coleman, 113

F.3d 1536, 1538 (11th Cir. 1997) (quoting Parks v. The New York Times Co., 308 F.2d 474, 478

(5th Cir. 1962)). Here, the Drug Company Defendants concede, as they must, that there is not

complete diversity between the Plaintiffs and the California Retailer Defendants because they are

all citizens of the State of California. Instead, the Drug Company Defendants invoke the

doctrine of fraudulent joinder. Notice of Removal, ¶¶ 4-7.4 Under the doctrine, the Court can

“ignore the presence of the non-diverse defendant” and retain subject matter jurisdiction,

provided the removing party proves that the non-diverse defendant was fraudulently joined.

Henderson v. Washington Nat. Ins. Co., 454 F.3d 1278, 1281 (11th Cir. 2006). The removing

parties here, i.e., the Drug Company Defendants, have not met this heavy burden.

To establish fraudulent joinder, “the removing party has the burden of proving by clear and

convincing evidence that … there is no possibility the plaintiff can establish a cause of action

against the resident defendant[.]” Stillwell, 663 F.3d at 1332 (emphasis added) (quoting Crowe,

113 F.3d at 1538).5 The Court must “construe removal statutes strictly” and resolve “all doubts

4 To facilitate ease of reference, all citations to a “complaint” or “notice of removal” will be to the complaint and

notice of removal filed in Ralph Dudley v. GlaxoSmithKline, et al., 9:20-cv-81056-RLR, found at docket number 1.

A copy of those documents are attached as Exhibits 1 and 2 to the Declaration of R. Brent Wisner. 5 Fraudulent joinder can also be established if the removing party can prove that the plaintiff “has fraudulently pled

jurisdictional facts to bring the resident defendant into state court.” Stillwell, 663 F.3d at 1332. However, there is

no claim of actual fraud raised in any Notice of Removal and, thus, it does not form the basis for any removal.


6

about jurisdiction … in favor of remand to state court.” Univ. of S. Alabama v. Am. Tobacco

Co., 168 F.3d 405, 411 (11th Cir. 1999) (emphasis added, citations omitted). This burden is,

intentionally, “a heavy one.” Fransas v. Brenntag N. Am. Inc., No. 9:17-CV-80058, 2017 WL

9292098, at *2 (S.D. Fla. Mar. 10, 2017) (J. Rosenberg). “A presumption in favor of remand is

necessary because if a federal court reaches the merits of a pending motion in a removed case

where subject matter jurisdiction may be lacking it deprives a state court of its right under the

Constitution to resolve controversies in its own courts” and “‘offends fundamental principles of

separation of powers[.]”” Univ. of S. Alabama, 168 F.3d at 411 (quoting Steel Co. v. Citizens for

a Better Env’t, 523 U.S. 83, 94 (1998)). Moreover, “strict construction of removal statutes also

prevents ‘exposing the plaintiff to the possibility that he will win a final judgment in federal

court, only to have it determined that the court lacked jurisdiction on removal[.]” Crowe, 113

F.3d at 1538 (quotation omitted).

And, in assessing whether a claim is “possible,” the Court cannot use federal pleading

standards. Stillwell, 663 F.3d at 1334. Unlike the plausibility standard in federal

court,“[n]othing in [Eleventh Circuit] precedents concerning fraudulent joinder requires anything

more than conclusory allegations[.]” Id. In considering the allegations and legal theories, “[t]he

district court must evaluate factual allegations in the light most favorable to the plaintiff and

resolve any uncertainties about the applicable law in the plaintiff’s favor.” Id. (emphasis

added). “Where a plaintiff states even a colorable claim against the resident defendant, joinder is

proper and the case should be remanded” for lack of subject matter jurisdiction. Pacheco de

Perez v. AT&T Co., 139 F.3d 1368, 1380 (11th Cir. 1998).

ARGUMENT

I. The Drug Company Defendants Have Not Proven, with Clear and Convincing

Evidence, that Plaintiffs’ Negligence Claims Against the California Retailers Are

Impossible

A. Plaintiffs State a Colorable, if Not Plausible, Claim of Negligence Against the

California Retailer Defendants

In each underlying complaint, the Plaintiffs allege negligence against the California


7

Retailer Defendants under California law. Thus, to keep these cases in federal court, the Drug

Company Defendants bear the burden of proving, with clear and convincing evidence—and with

all factual and legal doubts resolved in Plaintiffs’ favor—that a negligence claim against the

California Retailer Defendants is impossible. The Drug Company Defendants have not even

come close to meeting this heavy burden.

In California, a “seller is negligent if it fails to use the amount of care in … selling the

products that a reasonably careful … seller would use in similar circumstances to avoid exposing

others to a foreseeable risk of harm.” LAOSD Asbestos Cases, 248 Cal. Rptr. 3d 219, 223 (Ct.

App. 2019), review denied (Cal. Aug. 21, 2019) (citing Judicial Council of California Civil Jury

Instruction 1221 regarding negligence under products lability). To state a negligence claim

against the seller of a good under California law, a plaintiff must prove:

1. That [the Supplier] … supplied …. the [product];

2. That [the Supplier] was negligent in …supplying… the [product];

3. That [the plaintiff] was harmed; and

4. That [the Supplier]’s negligence was a substantial factor in causing [the

plaintiff]’s harm.

Judicial Council of California Jury Instruction 1221 (Negligence – Essential Factual Elements).

“[I]n determining whether [the defendant] used reasonable care, [the factfinder] should balance

what [defendant] knew or should have known about the likelihood and severity of potential harm

from the product against the burden of taking safety measures to reduce or avoid harm.” Id.; see

Pike v. Frank G. Hough Co., 467 P.2d 229, 232 (Cal. 1970).

This duty to exercise reasonable care for the welfare of customers while selling products

stems from a long-recognized “special relationship” between the “supplier of good and buyer or

user” enshrined in California common law. Seo v. All-Makes Overhead Doors, 119 Cal. Rptr. 2d

160, 167 (Ct. App. 2002) (quoting Rodriguez v. Inglewood Unified Sch. Dist., 230 Cal. Rptr.

823, 825 (Ct. App. 1986)). Negligence against a retailer is a well-established theory of liability

under California law. See Ambriz v. CVS Pharmacy, Inc., No. 19-CV-1391, 2020 WL 1660018,

at *4 (E.D. Cal. Apr. 3, 2020); Ferrari v. Nat. Partners, Inc., No. 15-CV-04787, 2016 WL


8

4440242, at *9 (N.D. Cal. Aug. 23, 2016); Hensley-Maclean v. Safeway, Inc., No. CV 11-01230

RS, 2014 WL 1364906, at *3 (N.D. Cal. Apr. 7, 2014) (“Safeway has not pointed to any

statutory provision limiting its general duty of care[.]”); see Cabral v. Ralphs Grocery Co., 248

P.3d 1170, 1175 (Cal. 2011); see also Garza v. Endo Pharm., No. CV 12-1585-CAS OPX, 2012

WL 5267897, at *2 (C.D. Cal. Oct. 24, 2012) (noting that plaintiff “could potentially state a

claim against defendant CVS for negligence[.]”).

Here, Plaintiffs allege each element of a negligence claim. Specifically, Plaintiffs allege

that the California Retailer Defendants “had a duty to ensure that the Ranitidine-Containing

Drugs supplied to Plaintiff were stored, handled, and dispensed in a safe manner[.]” Complaint, ¶

283. Plaintiffs allege that the California Retailer Defendants “breached their duty to Plaintiff by

failing to properly store the Ranitidine-Containing Drugs supplied to Plaintiff, leading to

dangerous levels of NDMA accumulating in the drugs that harmed Plaintiff.” Complaint, ¶ 287.

The underlying complaints explain:

Defendants acted below the standard of care by storing and dispensing Ranitidine-

Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs

were safe for human use by, for example, consulting the available medical literature

evidencing the potential human health dangers associated with the storage of

Ranitidine-Containing Drugs and the formation of NDMA within Ranitidine-

Containing drugs when the drugs are stored at particular temperatures.

Complaint, ¶ 287. Indeed, the underlying complaints state that “[b]ased on the public scientific

information available starting in 1982 (or earlier), the Defendants knew or should have known

that NDMA could form in ranitidine by exposure to heat and/or over time in storage” and that

“[e]arly studies, including the one conducted by GSK in the early 1980s, demonstrated that

NDMA formed when ranitidine was exposed to heat.” Complaint, ¶¶ 180, 144. Because of this

“[e]xtensive data” showing “that exposure to heat in storage conditions leads to the systematic

breakdown of the ranitidine molecule into NDMA, accumulating over time in the finished

product[,]” the underlying complaints assert that “[n]othing prevented any Defendant from, on its

own, taking action to prevent accumulation of NDMA in ranitidine drugs by ensuring cold


9

storage and transport.” Complaint, ¶¶ 286, 171 see also Complaint, ¶ 288 (“Defendants knew or

should have known that storage of Ranitidine-Containing Drug can lead to the formation of

dangerous levels of carcinogenic NDMA in the drugs.”). And, in fact, the underlying complaints

specifically allege that the California Retailer Defendants “failed to adhere to and/or follow its

established practices and procedures in storing the Ranitidine-Containing Drugs” that were

ingested by the Plaintiffs. Complaint, ¶ 289. Thus, “[a]s a direct and proximate result of

Defendants’ improper storage practices of the Ranitidine-Containing Drugs, Plaintiff was

exposed to dangerous levels of NDMA which caused Plaintiff’s cancer.” Complaint, ¶ 290.

These allegations, with all factual or legal uncertainties read in a light most favorable to the

Plaintiffs, state a colorable claim for negligence against the California Retailer Defendants. The

risk of NDMA accumulation is alleged to have been known or knowable and a jury could

conclude that a “reasonably careful” seller should have used more care in the storage, transport,

and stocking of the ranitidine products they sold.

B. This Court Recently Held that Pleading a Negligence Claim Against a Retailer

Would Be Possible

Recently, this Court confirmed that bringing a negligence claim against a retailer for

negligent storage and transport could be possible:

With respect to the “heating” theory—that the [Retailer] Defendants should be

held liable for storing ranitidine at an elevated temperature prohibited by both

federal law and state law—the Plaintiffs have leave in an amended complaint to

plead this theory because, at this juncture, the Court is not prepared to conclude it

would be futile for the Plaintiffs to so plead[.]

In re: Zantac (Ranitidine) Prods. Liab. Litig., No. 20-MD-2924, 2020 WL 7864585, at *18 (S.D.

Fla. Dec. 31, 2020). This ruling was focused on the MDL’s Master Pleadings, where the MDL

Plaintiffs did not allege a heating theory of negligence. See In re: Zantac (Ranitidine) Prods.

Liab. Litig., No. 20-MD-2924, 2020 WL 7864213, at *19 (S.D. Fla. Dec. 31, 2020) (“[T]o the

extent that it is Plaintiffs’ intent to hold Defendants liable for storing ranitidine products under

the wrong conditions, such a theory is not pled.”). This contrasts with the complaints here,


10

which specifically allege negligence regarding heating against the California Retailer

Defendants.6 See Complaint, ¶¶ 283-91. And, while the Court delineated various issues that

needed to be addressed in an amended pleading to satisfy the plausibility standard in federal

court, the issue here, i.e., impossibility, was decided. Defendants argued that amendment would

be futile, i.e., impossible, and the Court rejected that argument; holding, instead, that pleading a

negligence claim against a retailer might be possible. Thus, for the purposes of a fraudulent

joinder analysis, the Drug Company Defendants have not met their heavy burden of proving

impossibility. In fact, they have already lost this argument in this Court.

C. Defendants’ Attempt to Reconstitute Plaintiffs’ Claims Solely Around Testing

for a Latent Defect Fails Because Plaintiffs Allege Actual and Constructive

Knowledge of the Defect

Retailers in California, like any other seller of a good, must take reasonable care in selling

their products to avoid foreseeable harm to their customers. LAOSD Asbestos Cases, 248 Cal.

Rptr. at 223 (A “seller is negligent if it fails to use the amount of care in … selling the products

that a reasonably careful … seller would use in similar circumstances to avoid exposing others to

a foreseeable risk of harm.”). The Drug Company Defendants try to reconstitute Plaintiffs’

negligence claim around testing for “unforeseeable risks” or “latent defects,” arguing that “a

seller of a product does not have a duty to investigate or test products stocked on its shelves for

unforeseen risks[.]” Notice of Removal, ¶ 36 (emphasis added). But, the premise of this

argument, i.e., that the risk of NDMA formation was unforeseen or unforeseeable, is false. The

underlying complaints clearly allege that “[b]ased on the public scientific information available

starting in 1983 (or earlier), the Defendants knew or should have known that NDMA could form

in ranitidine by exposure to heat [.]” Complaint, ¶ 180. In other words, the complaints

specifically allege that the risk was foreseen and/or foreseeable. Nowhere do the complaints

suggest that testing was the only way the California Retailer Defendants could know NDMA

would form. When such allegations are considered in a light most favorable to Plaintiffs—as

6 These forty-one cases are not subject to the master pleadings, nor have they adopted the master pleadings.


11

they must—the Defendant Drug Company Defendants’ argument falls apart.

In fact, alleging that a retailer should have known of the risk is generally sufficient to state

a possible negligence claim for the purposes of defeating fraudulent joinder. In Fransas v.

Brenntag N. Am. Inc., this Court directly addressed this issue. 2017 WL 9292098, at *2. There,

a plaintiff asserted a negligence claim under Florida law—negligence law that is almost identical

to California7—against a well-known Florida retailer, Publix, and several other manufacturers

and distributors of talcum powder. Id. Like here, the Fransas plaintiff alleged that the talcum

powder was contaminated (asbestos) and that the contamination substantially contributed to the

development of cancer (mesothelioma). Id. The defendants removed the case from Florida state

court to the Southern District of Florida, arguing that the negligence claim against Publix was

impossible and, thus, fraudulently joined. Id. To support this claim, Publix submitted a

declaration indicating that it had no knowledge of the asbestos contamination, did not test the

product, and simply sold the product in the exact way it was received. Id., at *3. The plaintiff

did not refute this fact, but pointed to allegations that Publix should have known of the risk. 8 Id.

Thus, this Court ruled that, “[v]iewed in the light most favorable to Plaintiffs … combined with

the remaining unrefuted allegations in Plaintiffs’ Complaint are sufficient to establish a

possibility that Plaintiffs may state a claim for negligence against Publix under Florida law[.]”

Id., at *4. This Court then remanded the case. Id.

The same analysis applies here. Plaintiffs allege that the California Retailer Defendants

knew or should have known that exposing ranitidine products to heat could cause NDMA

formation, and they allege facts about that information as being publicly available. See, e.g.,

Complaint 1, ¶ 288. Assuming those allegations are true—as this Court must—if the California

Retailer Defendants allowed their ranitidine products to be exposed to heat and then sold that

7 Compare Fla. Std. Jury Instr. (Civ.) 601.4 with Jud. Council of Cal. Civil Jury Inst. 1221. 8 Incidentally, on these facts, Plaintiffs’ claims against the California Retailer Defendants in these cases present an

even stronger case for negligence than the plaintiff in Fransas against Publix. In Fransas, Publix claimed (and the

plaintiff did not refute) that the talcum powder “products were not altered by Publix prior to sale of the products to

consumers[.]” 2017 WL 9292098, at *3. Here, Plaintiffs allege that the California Retailer Defendants, through

negligent storage and transport, contributed to ranitidine breaking down into NDMA and thus caused the

contamination. See Complaint, ¶¶ 286-89.


12

ranitidine to the Plaintiffs, there is a possible, if not plausible, claim of negligence. And, if

negligence is possible, then there is no fraudulent joinder. Remand must issue.

To the extent the Drug Company Defendants are arguing that it would be unreasonable for

the California Retailer Defendants to have known about the risk of exposing ranitidine to heat,

such an argument is factually and legally insufficient. Legally, this argument goes to the merits

of Plaintiffs’ claim and, thus, cannot form the basis for removal. Crowe, 113 F.3d at 1542.

There is no dispute, under California law, that a retailer owes a duty of care to their customers to

exercise reasonable care in storing and transporting the products they sell. Cal. Civ. Code §

1714(a) (“Everyone is responsible, not only for the result of his or her willful acts, but also for an

injury occasioned to another by his or her want of ordinary care or skill in the management of his

or her property or person[.]”); see CVS Pharmacy, Inc., 2020 WL 1660018, at *4; Safeway, Inc.,

2014 WL 1364906, at *3. And, “whether [the defendant] used reasonable care,” involves

balancing “what [the defendant] knew or should have known about the likelihood and severity of

potential harm from the product against the burden of taking safety measures to reduce or avoid

harm.” Judicial Council of California Jury Instruction 1221. These questions are, by their

nature, fact- and case-specific. “This is because ‘[e]ach case presents different conditions and

situations. What would be ordinary care in one case might be negligence in another.’” Coyle v.

Historic Mission Inn Corp., 234 Cal. Rptr. 3d 330, 340 (Ct. App. 2018), reh’g denied (July 9,

2018), review denied (Sept. 19, 2018) (quoting Eddy v. Stowe, 185 P. 1024, 1027 (Cal. Ct. App.

1919)). More importantly, they are questions for a jury. And, in the context of a fraudulent

joinder analysis, they are questions that must be answered in favor of remand.

Factually, this argument fails as well. The premise of the Drug Company Defendants’

argument—that testing was the only way the California Retailer Defendants could have known

to avoid exposing the ranitidine to heat during transport and storage—is contrary to the

underlying complaints. For example, Plaintiffs allege that “[t]he risk of creating NDMA by

exposing ranitidine to heat has been well-known and documented.” Complaint, ¶ 144; see also

Complaint, ¶¶ 180, 286 (alleging that ranitidine breaking down into NDMA after exposure to


13

heat was well known for decades). In fact, the ranitidine warning label directly cautions against

exposure to heat. The over-the-counter box for Zantac states “avoid excessive heat” and to store

the drug below 77⸰F. Exh. 4 at 1. This has been on the box since, at least, 1998. Id. Similar

warnings exist on the prescription Zantac label, requiring storage below 86⸰F. Exh. 5 at 2. It is

entirely possible—indeed, likely—that in transporting and storing ranitidine throughout

California, where temperatures routinely exceed 90⸰F, excessive heat exposure occurred; heat

exposure that could have been avoided had the California Retailer Defendants used temperature-

controlled transport systems. Any argument that the California Retailer Defendants needed to

conduct exhaustive testing is nothing more than a red herring. They just needed to read the label

of the product they sold.

The Drug Company Defendants’ attempt to reconstitute and narrow Plaintiffs’ alleged

negligence regarding transport and storage into one about extensive testing for unknown risks is

unavailing. It contradicts the allegations in the complaints and impermissibly delves into the

merits of Plaintiffs’ claims. It surely does not satisfy the Drug Company Defendants’ heavy

burden of proving impossibility.

II. The Drug Company Defendants Have Not Established that Plaintiffs’ Strict Liability

Claims Are, by Clear and Convincing Evidence, Impossible Based on a Defense of

Preemption

The Court only needs to consider Plaintiffs’ strict liability claims if the Drug Company

Defendants have proven, with clear and convincing evidence, that negligence against the

California Retailer Defendants is impossible. E.g., Zaremba v. Orthopedics, Inc., No. 8:14-CV-

1016-T-33TGW, 2014 WL 3057400, at *3 (M.D. Fla. July 7, 2014) (refusing to consider

preemption defense as basis for fraudulent joinder because other claims were possible). If the

Court concludes that the Drug Company Defendants have met this heavy burden regarding the

negligence claim, then the Court will still need to determine if the Drug Company Defendants

have also proven that the strict liability claims alleged in twenty-seven complaints are also

impossible under California law.


14

The Drug Company Defendants make one argument as to why Plaintiffs’ strict lability

claims are impossible: they argue the claims are preempted by federal law. Notice of Removal,

¶¶ 23-35. This defense is based on a supposed “conflict” between state and federal law, i.e., that

it is impossible for the California Retailer Defendants’ to comply with California law without

also violating federal law. Mensing, 564 U.S. at 624. This Court has analyzed the merits of a

similar preemption challenge—to the extent claims are premised on labeling or design defects—

in ruling on the first round of the Retailers’ Motions to Dismiss based on preemption. Plaintiffs

will not repeat any argument raised in that briefing. Instead, Plaintiffs focus on two issues.

A. The Drug Company Defendants Cannot Establish Fraudulent Joinder of

Plaintiffs’ Strict Liability Claims Based on a Preemption Defense Because the

Court Lacks Independent Jurisdiction to Consider the Merits of the Defense

A preemption defense cannot, as a matter of law, form the basis for fraudulent joinder

because the Court must have federal jurisdiction before deciding the merits of a preemption

defense. See Kemp v. Int’l Bus. Machines Corp., 109 F.3d 708, 714 (11th Cir. 1997) (“Without

any basis for federal jurisdiction over a case, a federal court cannot decide a preemption

defense.”); see also Franchise Tax Bd. of State of Cal. v. Constr. Laborers Vacation Tr. for S.

California, 463 U.S. 1, 2 (1983) (A case “may not be removed on the basis of a federal defense,

including the defense of pre-emption, even if the defense is anticipated in the complaint and both

parties admit that the defense is the only question truly at issue.”).

The Hon. M. Casey Rodgers in the Northern District of Florida9 recently confirmed this

jurisdictional rule in the Eleventh Circuit. In re Abilify, 2018 WL 6258903, at *5-6. There, like

here, the drug company defendants10 argued, in the context of fraudulent joinder, that the

California defendant’s claims were preempted because they had “no authority ‘to initiate a

design, manufacturing, or label change’ for the brand name drugs they distribute.” Id., at *5-6.

9 Judge Rodgers currently presides over two MDLs, In re: Abilify (Aripiprazole) Products Liability Litigation, 3:16-

md-2734 (N.D. Fla.) and In re: 3M Combat Arms Earplug Products Liability Litigation, 3:19-md-2885 (N.D. Fla.),

where over 210,000 cases are pending. 10 Defense Co-Lead Anand Agneshwar was in leadership in the Abilify MDL and was responsible for the removal of

the Abilify cases from California state court. He also filed the opposition to remand in the Abilify MDL. It is worth

noting that despite losing this exact issue two years ago, Mr. Agneshwar repeated these arguments here.


15

Judge Rodgers, however, could not address the merits of the defense (no matter how

compelling11) because “in conflict preemption cases where a federal court otherwise lacks

subject matter jurisdiction over the dispute, the case must be remanded and the preemption

argument must be decided by the state court.” Id., at *5. She explained that even though the

preemption defense “is framed within the context of fraudulent joinder, it nonetheless remains a

substantive defense that goes to the merits of Plaintiffs’ state law claims” and, thus, “must be

decided by a court with competent jurisdiction.” Id., at *6 (quoting Cotton v. Mass. Mut. Life

Ins. Co., 402 F.3d 1267, 1292 (11th Cir. 2005). And, because impossibility preemption was the

only basis for arguing fraudulent joinder of the strict lability claims, just like here, Judge Rodgers

“lack[ed] subject matter jurisdiction to assess the merits of [the California defendant]’s potential

conflict preemption defense … which means the issue cannot provide a basis for a finding that

[the California defendant] was fraudulently joined.” Id.

Judge Rodgers’ jurisdictional holding is supported by a deluge of unanimous case law.

Thirty-five federal courts (including the Ninth Circuit Court of Appeals, where this case was

removed) have looked at this exact issue and each court concluded that a Mensing preemption

defense does not provide a basis for removal due to fraudulent joinder.12 This case law includes

11 See, e.g., In re Abilify, 2018 WL 6258903, at *5 (“This argument [preemption] is not without conceptual and,

frankly, practical appeal. … If the preemption issue were properly before the Court for a determination on the

merits, these authorities might well be considered persuasive.”). 12 See, e.g., Hunter v. Philip Morris USA, 582 F.3d 1039, 1045 (9th Cir. 2009); Grancare, LLC v. Thrower by &

through Mills, 889 F.3d 543, 549 (9th Cir. 2018) (Interpreting Hunter as holding that “an

implied preemption affirmative defense was not a permissible ground for finding fraudulent joinder[.]”); Geisse v.

Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *3 (N.D. Cal. Mar. 18, 2019)

(“[P]reemption goes to the merits of the plaintiff’s case and entails a degree of analysis that does not render a state

law claim obviously barred or frivolous for fraudulent joinder purposes.”); Mathis v. Pfizer Inc., No.

SACV1801256AGAFMX, 2018 WL 5291933, at *3 (C.D. Cal. Oct. 22, 2018); Dodich v. Pfizer Inc., No. C 18-

02764 WHA, 2018 WL 3584484, at *3 (N.D. Cal. July 26, 2018); Trees v. Pfizer Inc., No. CV 2:16-0334-RMG,

2016 WL 11540619, at *9 (D.S.C. Aug. 18, 2016); Zachman v. Johnson & Johnson, No. 15-CV-04285-RS, 2015

WL 7717190, at *3 (N.D. Cal. Nov. 30, 2015); J.P. ex rel. Plummer v. McKesson Corp., No. 2:13-CV-02207-TLN,

2014 WL 3890326, at *5 (E.D. Cal. Aug. 7, 2014); Buck v. McKesson Corp., No. 13CV2541 JLS (RBB), 2014 WL

12514793, at *4 (S.D. Cal. July 29, 2014); Celeste v. Merck, Sharp & Dohme Corp., No. 14CV360 AJB MDD, 2014

WL 2739025, at *6 (S.D. Cal. June 17, 2014); W.W. v. McKesson Corp., No. SACV131649AGDFMX, 2014 WL

12577143, at *3 (C.D. Cal. Jan. 31, 2014); J.E. v. Smithkline Beecham Corp., No. CV 13-04897-KAW, 2014 WL

11369807, at *3 (N.D. Cal. Jan. 27, 2014); J.F. ex rel. Moore v. McKesson Corp., No. 1:13-CV-01699-LJO, 2014

WL 202737, at *10 (E.D. Cal. Jan. 17, 2014) (“[I]t is inappropriate to determine whether Plaintiffs' claims against

McKesson are preempted by federal law.”); D.A. ex rel. Wilson v. McKesson Corp., No. 1:13-CV-01700-LJO, 2014


16

seven decisions (including Judge Rodgers’) from MDL courts throughout the country. See In re

Darvocet, Darvon & Propoxyphene Prod. Liab. Litig. (“Darvocet I”), 889 F. Supp. 2d 931, 934

(E.D. Ky. 2012) (“Preemption is a federal defense that goes to the merits of a claim. As such, it

does not support a finding of fraudulent joinder.”); In re Darvocet, Darvon & Propoxyphene

Prod. Liab. Litig. (“Darvocet II”), 106 F. Supp. 3d 849, 855 (E.D. Ky. 2015) (“[I]t would be

inappropriate for the Court to analyze whether the claims against McKesson are preempted by

federal law at this stage in the proceedings.”); In re Diet Drugs (Phentermine, Fenfluramine,

Dexfenfluramine) Prod. Liab. Litig., 905 F. Supp. 2d 644, 647 (E.D. Pa. 2012) (“[A] federal

preemption defense to support their assertion that McKesson has been fraudulently joined

fails.”); In re Lipitor (Atorvastatin Calcium) Mktg. Sales Practices & Prod. Liab. Litig., No.

2:14-MN-2502-RMG, 2016 WL 7373887, at *6 (D.S.C. July 14, 2016); In re Zoloft (Sertraline

Hydrochloride) Prod. Liab. Litig., No. 12-MD-2342, 2013 WL 6050627, at *2 (E.D. Pa. Nov.

14, 2013) (“A preemption defense goes to the merits of a plaintiff’s case and does not overcome

the strong presumption against removal jurisdiction[.]”); In Re Plavix Prod. Liab. & Mktg. Litig.,

No. 3:13-CV-03610-FLW, 2014 WL 4954654, at *8 (D.N.J. Oct. 1, 2014); In re Avandia Mktg.,

Sales Practices & Prod. Liab. Litig., 624 F. Supp. 2d 396, 420 (E.D. Pa. 2009) (rejecting

preemption as a ground for fraudulent joinder).

Importantly, no court has ever found fraudulent joinder because a Mensing preemption

WL 202738, at *10 (E.D. Cal. Jan. 17, 2014); J.K.B. by Bennett v. Pfizer, Inc., No. CV1305043MMMJCGX, 2013

WL 12129385, at *6 (C.D. Cal. Nov. 4, 2013); Spiers v. McKesson Corp., No. C 13-03046 WHA, 2013 WL

4671231, at *2 (N.D. Cal. Aug. 29, 2013); Travis v. McKesson Corp., No. C 13-03099 WHA, 2013 WL 5737946, at

*2 (N.D. Cal. Aug. 26, 2013); Armstrong v. McKesson Corp., No. C 13-03113 WHA, 2013 WL 4516668, at *2

(N.D. Cal. Aug. 23, 2013); Catlett v. McKesson Corp., No. C 13-03067 WHA, 2013 WL 4516732, at *2 (N.D. Cal.

Aug. 23, 2013); Emana v. McKesson Corp., No. C 13-03157 WHA, 2013 WL 4426257, at *2 (N.D. Cal. Aug. 14,

2013); Lueck v. McKesson Corp., No. C 13-03167 WHA, 2013 WL 4427111, at *2 (N.D. Cal. Aug. 14, 2013);

Hermosillo v. McKesson Corp., No. C 13-03169 WHA, 2013 WL 4427828, at *2 (N.D. Cal. Aug. 14, 2013); Smith

v. Amylin Pharm., LLC, No. 13CV1236 AJB MDD, 2013 WL 3467442, at *4 (S.D. Cal. July 10, 2013); Hatherley v.

Pfizer, Inc., No. CIV. 2:13-00719 WBS, 2013 WL 3354458, at *6 (E.D. Cal. July 3, 2013); Taha v. Pfizer, Inc., No.

CV1302577MWFFFMX, 2013 WL 12142560, at *3 (C.D. Cal. July 1, 2013); A.S. v. Pfizer, Inc., No. 1:13-CV-

00524-LJO, 2013 WL 2384320, at *9 (E.D. Cal. May 30, 2013); Romo v. McKesson Corp., No. CV 12-2036 PSG

(EX), 2013 WL 12131188, at *9 (C.D. Cal. Feb. 20, 2013); Caouette v. Bristol-Myers Squibb Co., No. C-12-1814

EMC, 2012 WL 3283858, at *4 (N.D. Cal. Aug. 10, 2012); Rentz v. McKesson Corp., No. CV 12-4399 PSG (EX),

2012 WL 12888362, at *4 (C.D. Cal. Aug. 7, 2012); Hughes v. Mylan Inc., No. CIV.A. 11-5543, 2011 WL 5075133,

at *6 (E.D. Pa. Oct. 25, 2011) (“Mensing merely provides a framework for the state court to adjudicate Plaintiffs’

claim; it is not a hook that lands these cases in federal court.”).


17

defense rendered a claim impossible. Indeed, these Drug Company Defendants, represented by

these same attorneys, have specifically litigated and lost this exact issue over twenty-five times

and, each time, lost.13 Pfizer, in particular, has a history of recycling lost arguments. E.g.,

Robinson v. Pfizer Inc., No. 4:16-CV-439 (CEJ), 2016 WL 1721143, at *4 (E.D. Mo. Apr. 29,

2016) (“In light of these repeated admonishments and remands to state court for six years,

defendant can no longer argue that its asserted basis for seeking removal to federal court in these

circumstances is objectively reasonable … plaintiffs are entitled to just costs and actual expenses

because defendant lacked an objectively reasonable basis for seeking removal.”).14

The Eleventh Circuit has, in rare circumstances, pondered the merits of an affirmative

defense (never preemption) in consideration of fraudulent joinder; but, even there, the Eleventh

Circuit expressly refused to rule on the merits of the defense and, instead, ordered remand so the

state court could decide the issue. See, e.g., Florence v. Crescent Res., LLC, 484 F.3d 1293,

1298 (11th Cir. 2007) (considering whether state statute barred claims and concluding the issue

should be remanded and decided by the state court); Henderson v. Washington Nat. Ins. Co., 454

13 GSK: W.W., 2014 WL 12577143, at *3; J.E, 2014 WL 11369807, at *3; J.F., 2014 WL 202737, at *10; D.A.,

2014 WL 202738, at *10; Spiers, 2013 WL 4671231, at *2; Travis, 2013 WL 5737946, at *2; Armstrong, 2013 WL

4516668, at *2; Emana, 2013 WL 4426257, at *2; Lueck, 2013 WL 4427111, at *2; Catlett, 2013 WL 4516732, at

*2; Hermosillo, 2013 WL 4427828, at *2; D.A., 2014 WL 202738, at *10; J.P., 2014 WL 3890326, at *5; Buck,

2014 WL 12514793, at *4; see also In re Avandia, 624 F. Supp. 2d at 420. Pfizer: Mathis, 2018 WL 5291933, at

*3; Dodich, 2018 WL 3584484, at *3; Trees, 2016 WL 11540619, at *9; In re Lipitor, 2016 WL 7373887, at *6; In

re Zoloft, 2013 WL 6050627, at *2; J.K.B. 2013 WL 12129385, at *6; Hatherley, 2013 WL 3354458, at *6; Taha,

2013 WL 12142560, at *3; A.S., 2013 WL 2384320, at *9; In re Diet Drugs, 905 F. Supp. 2d at 648. Sanofi: In Re

Plavix, 2014 WL 4954654, at *8. 14 Co-lead defense counsel, Mark S. Cheffo, was involved with the Robinson case. Mr. Cheffo has a well-

documented history of repeatedly using preemption to assert fraudulent joinder of a California defendant to avoid

state court jurisdiction and, each time, losing. In 2012, he removed cases from California state court and had them

transferred to the Darvocet MDL, arguing that the California defendants were fraudulently joined. The court

rejected that argument, holding that “[p]reemption is a federal defense that goes to the merits of a claim. As such, it

does not support a finding of fraudulent joinder.” In re Darvocet I, 889 F. Supp. 2d at 934. Six months later, he

removed even more cases from California state court into the Zoloft MDL using the same arguments. Again, he lost.

In re Zoloft, 2013 WL 6050627, at *2. Undeterred, he attempted to make this argument again, in the Darvocet MDL

and the Court rejected it: “it would be inappropriate for the Court to analyze whether the claims against McKesson

are preempted by federal law at this stage in the proceedings, and the Court reiterates its previous conclusion that the

defendants’ preemption argument does not support a finding of fraudulent joinder. The Court has previously

addressed and rejected the defendants’ fraudulent joinder arguments … and will not reconsider them here.”

Darvocet II, 106 F. Supp. 3d at 855. Then, in 2016, in the Lipitor litigation, Mr. Cheffo removed cases from

California and, again an MDL court rejected it: In re Lipitor, 2016 WL 7373887, at *6. Considering Mr. Cheffo’s

repeated use of an argument that he has lost multiple times in other MDLs, it raises the question of whether this

removal, using the same failed argument, was made in good faith.


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F.3d 1278, 1284 (11th Cir. 2006) (considering whether plaintiff pleaded fraudulent concealment

in a case where parties agreed the statue of limitations had expired and concluding that the

district court erred for not remanding the case because allowing “a federal court to interpose its

judgment would fall short of the scrupulous respect for the institutional equilibrium between the

federal and state judiciaries that our federal system demands.”); see also Brush v. Bayside

Orthopaedics, Inc., No. 8:14-CV-2163-T-36EAJ, 2014 WL 5426643, at *4 (M.D. Fla. Oct. 22,

2014) (discussing the merits of a Mensing preemption and concluding it “is a determination best

left to State Court.” (quoting Zaremba, 2014 WL 3057400, at *3 n.2)). Indeed, Plaintiffs have

not found, and the Drug Company Defendants have not cited, a single case in which the Eleventh

Circuit (or any Circuit) allowed consideration of a preemption defense in the context of

fraudulent joinder. “To the contrary, the Eleventh Circuit has emphasized that conflict

preemption ‘is a substantive issue that must be decided by a court with competent jurisdiction.’”

In re Abilify, 2018 WL 6258903, at *6 (quoting Cotton, 402 F.3d at 1292).

The law is overwhelming and unanimous15—asserting a preemption defense does not

render a claim impossible for fraudulent joinder purposes, specifically in the context of a motion

to remand. Absent independent jurisdiction over the case, the Court cannot consider the merits

of the Defendant Drug Company’s preemption defense and therefore remand is required.

B. The Drug Company Defendants Have Not Demonstrated, with Clear and

Convincing Evidence, that Plaintiffs’ Strict Liability Manufacturing Defect

Claims Are Impossible

In the context of Plaintiffs’ manufacturing defect claim, even if the Court entertained

Defendant’s “preemption” argument, it still fails. The Drug Company Defendants argue that

Plaintiffs’ manufacturing defect claims against the California Retailer Defendants are

15 In their Notice of Removal, the Drug Company Defendants argue that this jurisdictional bar is unsettled, citing an

appeal to the Ninth Circuit in Geisse v. Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at

*2-3 (N.D. Cal. Mar. 18, 2019). Notice of Removal, ¶ 32. In Geisse, the district court ruled, consistent with the

unanimous authority, that “preemption goes to the merits of the plaintiff's case and entails a degree of analysis that

does not render a state law claim obviously barred or frivolous for fraudulent joinder purposes.” Id., at *3. And,

while the defendant appealed this ruling, as noted by the Drug Company Defendants, the defendant ultimately

abandoned the appeal. See No. 19-15783, at Docs. 57-59 (9th Cir.).


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“preempted” because “the Retailer Defendants could not have altered the manufacturing of

Zantac.” Notice of Removal, ¶ 29. But, the California Retailer Defendants are not being sued

for the literal manufacturing process of the ranitidine product; they are being sued for their role

in creating a “manufacturing defect” through their “[f]ailure to implement procedures that would

reduce or eliminate NDMA levels in Ranitidine-Containing Drugs” and “[f]ailure to implement

appropriate handling instructions and storage conditions for the drug.” Complaint, ¶¶ 217(c)-(d).

In California, “retailers engaged in the business of distributing goods to the public are

strictly liable in tort for personal injuries caused by defects in those goods.” Arriaga v.

CitiCapital Commercial Corp., 85 Cal. Rptr. 3d 143, 149 (Ct. App. 2008) (citing Vandermark v.

Ford Motor Co., 391 P.2d 168, 171 (Cal. 1964)). To bring a manufacturing defect claim against

a retailer, a plaintiff must prove: (1) that the defendant sold the product, (2) that the product

contained a manufacturing defect when it left defendants’ possession, (3) that the plaintiff was

harmed, and (4) that the product was a substantial factor in causing plaintiff’s harm. Judicial

Council of California Civil Jury Instruction 1201 (Strict Liability—Manufacturing Defect—

Essential Factual Elements). The term “manufacturing defect” is not limited to defects caused in

the manufacturing process. Rather, “[a] product has a manufacturing defect if it differs from the

manufacturer’s intended result or from other ostensibly identical units of the same product line.”

Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr. 3d 693, 706 (Ct. App. 2013) (citing

Barker v. Lull Eng’g Co., 573 P.2d 443, 454 (Cal. 1978)).

Here, Plaintiffs allege the California Retailer Defendants failed “to implement procedures

that would reduce or eliminate NDMA levels in Ranitidine-Containing Drugs” and “implement

appropriate handling instructions and storage conditions for the drug” which resulted in the

ranitidine products being “defective with respect to their manufacture,” because “Defendants

deviated materially from their … handling, and storage specifications[.]” Complaint, ¶¶ 215,

217(c), 217(d). And, Plaintiffs allege this improper “storage, and handling posed an

unreasonable risk of harm to Plaintiff.” Complaint, ¶ 215. These allegations, when combined

with other allegations explaining that NDMA forms during “transport and storage, and especially


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when exposed to heat … accumulating over time in the finished product,” Complaint, ¶ 149, and

that “[n]othing prevented any Defendant from, on its own, taking actions to prevent

accumulation of NDMA in ranitidine drugs by ensuring cooled storage and transport[,]”

Complaint, ¶ 171, state a possible manufacturing defect claim against the California Retailer

Defendants. These allegations outline a theory of “manufacturing defect” liability whereby the

California Retailer Defendants failed to properly store and transport the ranitidine products

which, in turn, led to the accumulation of NDMA in the finished product—a manufacturing

defect—that contributed to each Plaintiffs’ cancer.

Under this theory, the Drug Company Defendants’ preemption argument, i.e., that “the

Retailer Defendants could not have altered the manufacturing of Zantac[,]” is irrelevant. This

claim is not based on whether the California Retailer Defendants actually manufactured the

product, it is based on whether the California Retailer Defendants created a manufacturing defect

in improperly transporting and storing the ranitidine products. And, nothing in the Drug

Company Defendants’ notices of removal suggests or otherwise challenges the ability of the

California Retailer Defendants, under federal law, to take precautions consistent with the

labeling to reduce NDMA accumulation. Thus, the Drug Company Defendants cannot prove by

clear and convincing evidence that a manufacturing defect claim under California law is

impossible based upon a preemption defense.

CONCLUSION

The Drug Company Defendants have failed to meet their heavy burden of demonstrating,

by clear and convincing evidence—with all factual and legal uncertainties resolving in Plaintiffs’

favor—that Plaintiffs’ claims against the California Retailer Defendants are impossible under

California law. As this Court lacks subject matter jurisdiction, Plaintiffs respectfully request the

Court enter an order remanding these cases to their respective California state courts.16

16 The Mills (9:20-cv-81122-RLR) and Masouredis (9:20-cv-81121-RLR) cases should be remanded to California

Superior Court, County of San Francisco. All other cases should be remanded to California Superior Court, County

of Alameda.


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REQUEST FOR HEARING

Pursuant to Local Rule 7.1(b)(2), Plaintiffs respectfully request oral argument on this

motion to respond to any questions or concerns the Court may regarding the legal and factual

issues underpinning this Motion. A hearing would also give any the Court an opportunity to

organize and discuss this Motion’s effect on the overall MDL, if any, and provide a platform for

the Parties to address any issues that may arise between now and the Court’s ruling.

CERTIFICATION PURSUANT TO LOCAL RULE 7.1(A)(3)

Pursuant to Local Rule 7.1(a)(3), undersigned Counsel on behalf of Plaintiffs, conferred with

all parties or non-parties who may be affected by the relief sought in this motion in a good faith effort

to resolve the issues raised in the motion and has been unable to do so.

DATED: January 15, 2021 Respectfully submitted,

/s/ R. Brent Wisner

R. Brent Wisner, Esq.

[email protected]

BAUM, HEDLUND, ARISTEI, &

GOLDMAN, P.C.

10940 Wilshire Blvd., 17th Floor

Los Angeles, CA 90024

Telephone: (310) 207-3233

Facsimile: (310) 820-7444

/s/ Jennifer A. Moore

Jennifer A. Moore, Esq.

[email protected]

MOORE LAW GROUP, PLLC

1473 South 4th Street

Louisville, KY 40208

Telephone: (502) 717-4080

Facsimile: (502) 717-4086

Attorneys for Plaintiffs


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CERTIFICATE OF SERVICE

I hereby certify that on this 15th day of January, 2021, I filed the foregoing MOTION

TO REMAND CASES TO CALIFORNIA STATE COURT electronically through the

CM/ECF system, which will send notice of filing to all CM/ECF participants.

Dated: January 15, 2021 BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C.

/s/ R. Brent Wisner


[email protected]



Telephone: (310) 207-3233

Facsimile: (310) 820-7444

Counsel for Plaintiffs


mailto:[email protected]

1




PRODUCTS LIABILITY

LITIGATION

_______________________________/

MDL NO. 2924

20-MD-2924


































Case 9:20-md-02924-RLR Document 2569-1 Entered on FLSD Docket 01/15/2021 Page 1 of 5

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DECLARATION OF R. BRENT WISNER IN SUPPORT OF MOTION TO REMAND

I, R. Brent Wisner, do hereby declare and state:

1. I am an attorney licensed to practice in the State of California and District of

Columbia. I am admitted to practice before this Court pro hac vice and pursuant to Pretrial

Order # 1. I am a Shareholder with the law firm of Baum, Hedlund, Aristei & Goldman, P.C.,

and counsel of record for several Plaintiffs in the above-captioned actions. I make this

declaration based on my personal knowledge and, if called as a witness, I could and would testify

competently to these matters.

2. In each of the above-captioned complaints, a negligence claim is alleged against one

or more of the following defendants, collectively referred to as the California Retailer

Defendants in the accompanying motion and memorandum of law: Safeway, Inc., Safeway

Health, Inc., The Vons Companies, Inc., Kaiser Permanente International, and Grocery Outlet.

3. In the following lawsuits, a strict liability claim is alleged against one of more of the

California Retailer Defendants:








3






















4. Attached as Exhibit 1 is a fair and accurate copy of the complaint filed in California

Superior Court, Alameda County on May 11, 2020 in Ralph Dudley v. GlaxoSmithKline, et al.,

9:20-cv-81056-RLR. To the best of my knowledge, this Complaint contains exemplar

allegations of all forty-one Plaintiffs’ negligence and strict liability claims against the California

Retailer Defendants.

5. Attached as Exhibit 2 is a fair and accurate copy of the Notice of Removal filed in

Ralph Dudley v. GlaxoSmithKline, et al, 9:20-cv-81056-RLR. To the best of my knowledge, this

Notice contains exemplar arguments concerning the grounds for the removal of the above-

captioned cases from California State Court.

6. Attached as Exhibit 3 is a fair and accurate copy of an email exchange between

myself, Jennifer Moore, and Joseph Petrosinelli memorializing an agreement regarding whether

the Plaintiffs would need to file short form complaints and census plus forms prior to a ruling on

a motion to remand.


4

7. Attached as Exhibit 4 is a fair and accurate copy of the over-the-counter packaging

from a Zantac product approved by the U.S. Food and Drug Administration (“FDA”) in 1998.

This document was obtained from the FDA’s website. Please note, the document has been

highlighted to note identify the portion relevant to this Motion.

8. Attached as Exhibit 5 is a fair and accurate copy of the prescription drug label for

Zantac, approved by the FDA in 1985. This document was obtained from the FDA’s website.

Please note, the document has been highlighted to identify the portion relevant to this Motion.

I declare under penalty of perjury that the foregoing is true and correct.

Executed on the 15th of January, 2021 at Tiburon, California.

/s/ R. Brent Wisner



5

CERTIFICATE OF SERVICE

I hereby certify that on this 15th day of January, 2021, I filed the foregoing

DECLARATION OF R. BRENT WISNER IN SUPPORT OF MOTION TO REMAND

electronically through the CM/ECF system, which will send notice of filing to all CM/ECF

participants.

Dated: January 15, 2021 BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C.

/s/ R. Brent Wisner


[email protected]



Telephone: (310) 207-3233

Facsimile: (310) 820-7444

Counsel for Plaintiffs


mailto:[email protected]

EXHIBIT 1

Case 9:20-md-02924-RLR Document 2569-2 Entered on FLSD Docket 01/15/2021 Page 1 of61

005

)

• r Jennifer A. Moore (SBN 206779)

[email protected] 2 MOORE LAW GROUP, PLLC

1473 South 4th Street 3 Louisville, KY 40208

4 Tel: (502) 717-4080 Fax: (502) 717-4086

5

6 Attorney for Plaintiff

• I IIIIII IIIII IIIII IIIII IIIII IIIII IIIII IIIII IIII IIII 22692143

,..~rrir •~-\ ~.°" Jt .t.J...t~, .i.!!:J D ALAMEDA COUNTY

MAY I l 202)

~~E!~:~OUR~

~puty

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SUPERIOR COURT FOR THE ST ATE OF CALIFORNIA COUNTY OF ALAMEDA

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RALPH DUDLEY

Plaintiff,

V.

GlaxoSmithKline, LLC; GlaxoSmithKline, plc; Boehringer lngelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Boehringer lngelheim Corporation; Pfizer, Inc.; Sanofi US Services, Inc.; Sanofi S.A.; Sanofi-Aventis U.S. LLC; The Vons Companies, Inc.; and DOES 1 through 100 inclusive,

Defendants.

Case No.

RG2006167 152 COMPLAINT .

DEMAND :FOR JURY TRIAL

1 COMPLAINT

L Case 4:20-cv-03913-DMR Document 1-1 Filed 06/15/20 Page 6 of 91Case 9:20-md-02924-RLR Document 2569-2 Entered on FLSD Docket 01/15/2021 Page 2 of61

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TABLE OF CONTENTS

Page

TABLE OF CONTENTS ........................................................................................................................ 2

INTRODUCTION .................................................................................................................................. 4

PARTIES ................................................................................................................................................ 5

I. Plaintiff ........................................................................................................................... 5

II. Defendants ...................................................................................................................... 7

A. Manufacturer Defendants .................................................................................... 7

B. Retailer Defendants ........................................................................................... 10

C. Doe Defendants ................................................................................................. 11

JURISDICTION AND VENUE ........................................................................................................... 12

FACTUAL ALLEGATIONS ............................................................................................................... 13

I. Regulatory History of Ranitidine-Containing Drugs .................................................... 13

II. Recalls and the FDA’s Ban ........................................................................................... 16

III. Dangers of NDMA ........................................................................................................ 20

IV. How Ranitidine Transforms into NDMA Within the Human Body ............................. 25

A. Formation of NDMA in the Environment of the Human Stomach .................. 26

B. Formation of NDMA in the Other Organs of Human Body ............................. 32

C. Formation of NDMA by Exposure to Heat and/or Time .................................. 34

D. Evidence Also Directly Links Ranitidine Exposure to Cancer ......................... 36

V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing Drugs. ............................................................................................................................ 37

VI. Defendants Knew or Should Have Known of the NDMA Risk ................................... 38

VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants) ....... 42

VIII. Equitable Tolling/Estoppel ........................................................................................... 43

CAUSES OF ACTION ......................................................................................................................... 44

COUNT I: STRICT PRODUCTS LIABILITY – FAILURE TO WARN .............................. 44

COUNT II: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT ............... 47


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COUNT III: NEGLIGENCE – FAILURE TO WARN ............................................................ 49

COUNT IV: NEGLIGENT PRODUCT DESIGN ................................................................... 52

COUNT V: NEGLIGENT MANUFACTURING .................................................................... 55

COUNT VI: NEGLIGENT MISREPRESENTATION ............................................................ 56

COUNT VII: NEGLIGENCE ................................................................................................... 58

JURY TRIAL DEMAND ..................................................................................................................... 59

PRAYER FOR RELIEF ....................................................................................................................... 59


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INTRODUCTION

1. This is a personal injury action for damages relating to Defendants’ design,

manufacture, sale, marketing, advertising, promotion, testing, labeling, packaging, handling,

distribution, and storage of ranitidine-containing drugs including the brand name, Zantac, and its

various generic forms (“Ranitidine-Containing Drugs,” unless specifically identified).

2. Plaintiff brings this action for personal injuries suffered as a result of ingesting the

defective and unreasonably dangerous Ranitidine-Containing Drugs and developing various cancers

and their sequelae as a result of this ingestion.

3. As more particularly set forth herein, Plaintiff maintains that the Ranitidine-

Containing Drugs he ingested are defective, dangerous to human health, unfit and unsuitable to be

advertised, marketed, and sold in the United States, were manufactured improperly, and lacked

proper warnings of the dangers associated with their use.

4. N-Nitrosodimethylamine (“NDMA”) is a potent carcinogen. Discovered as a

byproduct in manufacturing rocket fuel in the early 1900s, today, its only use is to induce tumors in

animals as part of laboratory experiments. Its only function is to cause cancer. It has no business

being in a human body.

5. Zantac, the popular antacid medication that was used by millions of people every day,

leads to the production of staggering amounts of NDMA. The U.S. Food and Drug Administration’s

(“FDA”) allowable daily limit of NDMA is 96 ng (nanograms) and yet, in a single dose of Zantac,

researchers are discovering over 3 million ng.

6. These recent revelations by independent researchers have caused widespread recalls of

Zantac and its generic forms both domestically and internationally, including the domestic recall by

the current owner and controller of Zantac new drug applications (“NDA”). Recently, on April 1,

2020, the FDA ordered the immediate recall of all Ranitidine-Containing Drugs sold in the United

States citing unacceptable and unpreventable levels of NDMA accumulation.

7. The high levels of NDMA observed in Ranitidine-Containing Drugs is a function of

the ranitidine molecule: (1) the way it breaks down in the human digestive system; (2) the way it

interacts with various enzymes in the human body; (3) the way it breaks down when exposed to heat,


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in particular, during transport and storage; and (4) the way the molecule naturally degrades, over

time, into NDMA. As it stands, ingestion of Ranitidine-Containing Drugs leads to real-world levels

NDMA exposure that are proven to cause cancer.

8. This lawsuit seeks to hold Defendants responsible for defective design, manufacturing,

sale, marketing, advertising, promotion, testing, labeling, packaging, handling, distribution, and

storage that caused Plaintiff’s severe injuries.

PARTIES

I. Plaintiff

9. Plaintiff resides in California and is a citizen of California and no other state.

10. Plaintiff started consuming brand name over-the-counter Ranitidine-Containing Drugs

in approximately 1995 until approximately 2020.

11. As a direct and proximate result of consuming carcinogenic Ranitidine-Containing

Drugs, Plaintiff was diagnosed with prostate cancer.

12. Based on prevailing scientific evidence, exposure to Ranitidine-Containing Drugs (and

the attendant NDMA) can cause prostate cancer in humans.

13. Had any Defendant warned Plaintiff that Ranitidine-Containing Drugs could lead to

exposure to NDMA or, in turn, cancer, Plaintiff would not have taken Ranitidine-Containing Drugs.

14. Plaintiff is informed and believes and based thereon alleges that as a direct and

proximate result of Plaintiff’s use of and/or exposure to Ranitidine-Containing Drugs supplied and

distributed by Defendants herein, Plaintiff suffered significant harm, conscious pain and suffering,

physical injury and bodily impairment including, but not limited to cancer, other permanent physical

deficits, permanent bodily impairment and other sequelae. Plaintiff’s injuries required

hospitalizations, in-patient surgeries, medication treatments, and other therapies to address the

adverse physical effects and damage caused by Plaintiff’s use of and/or exposure to Ranitidine-

Containing Drugs.

15. As a direct and proximate result of the wrongful conduct, acts, omissions, fraudulent

concealments, fraudulent misrepresentations, and fraudulent business practices by Defendants and

DOES 1 through 100, inclusive, Plaintiff used and/or was exposed to Ranitidine-Containing Drugs


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and were diagnosed with serious health injuries including prostate cancer.

16. As a result of using and/or being exposed to Defendants’ Ranitidine-Containing

Drugs, Plaintiff has been permanently and severely injured, having suffered serious consequences

from Ranitidine-Containing Drugs.

17. As a further direct and proximate result of defects in Ranitidine-Containing Drugs and

the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff

suffered severe mental and physical pain and have and will sustain permanent injuries and emotional

distress, along with economic loss due to medical expenses and living-related expenses as a result of

lifestyle changes.

18. As a further direct and proximate result of defects in Ranitidine-Containing Drugs and

the wrongful conduct, acts, omissions, and fraudulent misrepresentations of Defendants, Plaintiff

required extensive emergency medical treatment, health care, attention and services, thereby

incurring medical, incidental, and service expenses pertaining to emergency medical treatments and

procedures undertaken in efforts to maintain and/or save Plaintiff.

19. Plaintiff is an individual who suffered damages as a result of injuries resulting from

Plaintiff’s use and/or exposure to Ranitidine-Containing Drugs and is authorized to bring an action

for the causes of actions alleged herein including, but not limited to, injuries and damages sustained

by Plaintiff, resulting from Plaintiff’s use and/or exposure to Ranitidine-Containing Drugs. Said

injuries and damages sustained by Plaintiff were caused or substantially contributed to by the

wrongful conduct of Defendants and DOES 1 through 100, inclusive.

20. The product warnings for Ranitidine-Containing Drugs in effect during the time period

Plaintiff used and/or were exposed to Ranitidine-Containing Drugs were vague, incomplete or

otherwise inadequate, both substantively and graphically, to alert consumers to the severe health risks

associated with Ranitidine-Containing Drugs use and/or exposure.

21. The Defendants and DOES 1 through 100, and each of them, inclusive, did not

provide adequate warnings to consumers including Plaintiff and the general public about the

increased risk of serious adverse events that are described herein.

22. Had Plaintiff been adequately warned of the potential life-threatening side effects of


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the Defendants’ and DOES 1 through 100, and each of them, inclusive, Ranitidine-Containing Drugs,

Plaintiff would not have purchased, used or been exposed to Ranitidine-Containing Drugs.

23. By reason of the foregoing, Plaintiff developed serious and dangerous side effects

including prostate cancer and other cancers, related sequelae, physical pain and suffering, mental

anguish, and loss of enjoyment of life. By reason of the foregoing, Plaintiff suffered economic losses

and special damages including, but not limited to, loss of earning and medical expenses. Plaintiff’s

general and special damages are in excess of the jurisdictional limits of the Court.

24. Plaintiff has reviewed his potential legal claims and causes of action against the

Defendants and have intentionally chosen only to pursue claims based on state law. Any reference to

any federal agency, regulation or rule is stated solely as background information and does not raise a

federal question. Plaintiff has chosen to only pursue claims based on state law and are not making

any claims which raise federal questions. Accordingly, Plaintiff contends that California State

jurisdiction and venue is proper.

II. Defendants

A. Manufacturer Defendants

25. Defendant, Boehringer Ingelheim Pharmaceuticals, Inc., is a Delaware corporation

with its principal place of business located at 900 Ridgebury Road, Ridgefield, Connecticut 06877.

Boehringer Ingelheim Pharmaceuticals, Inc. is a citizen of Connecticut and Delaware, and not of any

other state. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of the German company

Boehringer Ingelheim Corporation. Boehringer Ingelheim Pharmaceuticals, Inc. owned and

controlled the NDAs for over-the-counter (“OTC”) Zantac between December 2006 and January

2017, and manufactured and distributed the drug in the United States during that period. At all

relevant times, Boehringer Ingelheim Pharmaceuticals, Inc. has conducted business and derived

substantial revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac

within the State of California and Alameda County.

26. Defendant, Boehringer Ingelheim USA Corporation, is a Delaware corporation with

its principal place of business located in at 900 Ridgebury Rd., Ridgebury, Connecticut 06877.

Boehringer Ingelheim USA Corporation is a citizen of Delaware and Connecticut and is not a citizen


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of any other state. At all relevant times, Boehringer Ingelheim USA Corporation has conducted

business and derived substantial revenue from its manufacturing, advertising, distributing, selling,

and marketing of Zantac within the State of California and Alameda County.

27. Defendant, Boehringer Ingelheim Corporation, is a German multinational

pharmaceutical corporation with its principal place of business located at Matthias Reinig 55216,

Ingelheim, Germany. Boehringer Ingelheim Corporation is the parent company of Defendants,

Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation. At all

relevant times, Boehringer Ingelheim Corporation has conducted business and derived substantial

revenue from its manufacturing, advertising, distributing, selling, and marketing of Zantac within the

State of California and Alameda County.

28. Collectively, Defendants, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer

Ingelheim USA Corporation, and Boehringer Ingelheim Corporation, shall be referred to as

“Boehringer.”

29. Defendant, GlaxoSmithKline, LLC, is a Delaware limited liability company with its

principal place of business located at 5 Crescent Drive, Philadelphia, Pennsylvania, 19112 and Five

Moore Drive, Research Triangle, North Carolina, 27709. GSK is a citizen of Delaware. GSK is a

wholly owned subsidiary of GlaxoSmithKline, plc, which is its sole member. At all relevant times,

GSK has conducted business and derived substantial revenue from its manufacturing, advertising,

distributing, selling, and marketing of Zantac within the State of California and Alameda County.

30. Defendant, GlaxoSmithKline, plc, is a foreign entity and a citizen of the United

Kingdom, and is not a citizen of any state in the United States. GlaxoSmithKline, plc is the

successor-in-interest to the companies that initially developed, patented, and commercialized the

molecule known as ranitidine. Ranitidine was initially developed by Allen & Hanburys Ltd., which

was a subsidiary of Glaxo Labs Ltd. Allen & Hanburys Ltd. was awarded Patent No. 4,128,658 by

the U.S. Patent and Trademark Office in December 1978, which covered the ranitidine molecule. In

1983, the FDA granted approval to Glaxo Holdings, Ltd. to sell Zantac in the United States. Glaxo

Holdings, Ltd. was later absorbed into Glaxo Wellcome, PLC. And then, in 2000, GlaxoSmithKline,

plc and GSK were created by the merger of Glaxo Wellcome and SmithKline Beecham. At all


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relevant times, GlaxoSmithKline, plc has conducted business and derived substantial revenue from its

manufacturing, advertising, distributing, selling, and marketing of Zantac within the State of

California and Alameda County.

31. Collectively, Defendants GlaxoSmithKline, LLC and GlaxoSmithKline, plc, shall be

referred to as “GSK.” GSK, and its predecessors, have controlled the prescription Zantac NDAs

since 1983.

32. Defendant, Pfizer, Inc. (“Pfizer”), is a Delaware corporation with its principal place of

business located at 235 East 42nd Street, New York, New York 10017. Pfizer is a citizen of

Delaware and New York and is not a citizen of any other state. In 1993, Glaxo Wellcome, plc

formed a joint venture with Warner-Lambert, Inc. to develop and obtain OTC approval for Zantac. In

1995, NDA 20-520 Zantac OTC 75 mg tablets were approved. In 1998, NDA 20-745 OTC Zantac

75 mg effervescent tablets were approved. Also, in 1998, Warner-Lambert and Glaxo Wellcome

ended their joint venture, with Warner-Lambert retaining control over the OTC NDA for Zantac and

the Zantac trademark in the United States and Glaxo Wellcome retaining control over the Zantac

trademark internationally.1 In 2000, Pfizer acquired Warner-Lambert and maintained control over

the Zantac OTC NDA until December 2006. At all relevant times, Pfizer has conducted business and

derived substantial revenue from its manufacturing, advertising, distributing, selling, and marketing

of Zantac within the State of California and Alameda County.

33. Defendant, Sanofi US Services, Inc., is a Delaware corporation with its principal place

of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807, and is a wholly owned

subsidiary of Sanofi S.A. Sanofi is a citizen of Delaware and New Jersey and is not a citizen of any

other state. Sanofi controlled the NDA for OTC Zantac starting in January 2017 through the present

and manufactured and distributed the drug in the United States during that period. Sanofi voluntarily

recalled all brand name OTC Zantac on October 18, 2019. At all relevant times, Sanofi has conducted

1 See Warner-Lambert and Glaxo End A Venture on Ulcer Drug Zantac, WALL STREET JOURNAL (Aug. 4, 1998), available at https://www.wsj.com/articles/SB902188417685803000.


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business and derived substantial revenue from its manufacturing, advertising, distributing, selling,

and marketing of Zantac within the State of California and Alameda County.

34. Defendant, Sanofi S.A., is a French multinational pharmaceutical company

headquartered in Paris, France, with its principal place of business located at 54, Rue La Boetie, in

the 8th arrondissement. Defendant, Sanofi S.A., changed its name to Sanofi in May 2011. As of 2013,

Sanofi S.A. was the world’s fifth largest pharmaceutical company by prescription sales. At all

relevant times, Sanofi S.A. has conducted business and derived substantial revenue from its



35. Defendant, Sanofi-Aventis U.S. LLC, was and is a Delaware limited liability company

with its principal place of business located at 55 Corporate Drive, Bridgewater, New Jersey 08807.

Sanofi-Aventis U.S. LLC is a citizen of Delaware and New Jersey and is not a citizen of any other

state. Sanofi-Aventis US LLC is a wholly owned subsidiary of Sanofi S.A. At all relevant times,

Sanofi-Aventis U.S. LLC has conducted business and derived substantial revenue from its



36. Collectively, Defendants Sanofi US Services, Inc., Sanofi S.A., and Sanofi-Aventis

U.S. LLC, shall be referred to as “Sanofi.”

37. Defendants, Boehringer, GSK, Pfizer, and Sanofi, shall be referred to collectively as

the “Manufacturer Defendants.”

B. Retailer Defendants

38. The Vons Companies, Inc. (“Vons”) is a Michigan Corporation with its headquarters

and principal place of business located at 11555 Dublin Canyon Rd., Pleasanton, California 94588.

Vons is a wholly owned subsidiary of Albertsons Companies, Inc. Vons is a citizen of California and

Delaware and is not a citizen of any other state. At all relevant times, Vons has conducted business

and derived substantial revenue from its advertising, selling, and marketing of Ranitidine-Containing

Drugs within the State of California and Alameda County. Specifically, Vons supplied Plaintiff with

the Ranitidine-Containing Drugs which caused Plaintiff’s injuries.


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C. Doe Defendants

39. The true names and/or capacities, whether individual, corporate, partnership,

associate, governmental, or otherwise, of Defendants DOES 1 through 100, inclusive, and each of

them, are unknown to Plaintiff at this time, who therefore sues said Defendants by such fictitious

names. Plaintiff is informed and believes, and thereon alleges, that each Defendant designated herein

as a DOE caused injuries and damages proximately thereby to Plaintiff as hereinafter alleged; and

that each DOE Defendant is liable to the Plaintiff for the acts and omissions alleged herein below,

and the resulting injuries to Plaintiff, and damages sustained by Plaintiff. Plaintiff will amend this

Complaint to allege the true names and capacities of said DOE Defendants when that same is

ascertained.

40. Plaintiff is informed and believes, and thereon alleges, that at all times herein

mentioned, each of the Defendants and each of the DOE Defendants was the agent, servant,

employee and/or joint venturer of the other co-Defendants and other DOE Defendants, and each of

them, and at all said times, each Defendants and each DOE Defendant was acting in the full course,

scope and authority of said agency, service, employment and/or joint venture.

41. Plaintiff is informed and believes and alleges that at all times mentioned herein,

Defendants and DOES 1 through 100, inclusive, and each of them, were also known as, formerly

known as and/or were the successors and/or predecessors in interest/business/product line/or a

portion thereof, assigns, a parent, a subsidiary (wholly or partially owned by, or the whole or partial

owner), affiliate, partner, co-venturer, merged company, alter egos, agents, equitable trustees and/or

fiduciaries of and/or were members in an entity or entities engaged in the funding, researching,

studying, manufacturing, fabricating, designing, developing, labeling, assembling, distributing,

supplying, leasing, buying, offering for sale, selling, inspecting, servicing, contracting others for

marketing, warranting, rebranding, manufacturing for others, packaging and advertising of

Ranitidine-Containing Drugs. Defendants and DOES 1 through 100, inclusive, and each of them, are

liable for the acts, omissions and tortious conduct of its successors and/or predecessors in

interest/business/product line/or a portion thereof, assigns, parent, subsidiary, affiliate, partner, co-

venturer, merged company, alter ego, agent, equitable trustee, fiduciary and/or its alternate entities in


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that Defendants and DOES 1 through 100, inclusive, and each of them, enjoy the goodwill originally

attached to each such alternate entity, acquired the assets or product line (or portion thereof), and in

that there has been a virtual destruction of Plaintiff’s remedy against each such alternate entity, and

that each such Defendants has the ability to assume the risk spreading role of each such alternate

entity.

42. Plaintiff is informed and believes, and thereon alleges, that at all times herein

mentioned, that Defendants and DOES 1 through 100, inclusive, and each of them, were and are

corporations organized and existing under the laws of the State of California or the laws of some state

or foreign jurisdiction; that each of the said Defendants and DOE Defendants were and are authorized

to do and are doing business in the States of California and Missouri and regularly conducted

business in these States and in Alameda County.

43. Upon information and belief, at relevant times, Defendants and DOES 1 through 100,

and each of them, inclusive, were engaged in the business of researching, developing, designing,

licensing, manufacturing, distributing, selling, marketing, and/or introducing into interstate

commerce and into the State of California, including in Alameda County, either directly or indirectly

through third parties or related entities, Ranitidine-Containing Drugs.

44. At relevant times, Defendants and DOES 1 through 100, inclusive, and each of them,

conducted regular and sustained business and engaged in substantial commerce and business activity

in the State of California, which included but was not limited to selling, marketing and distributing

Ranitidine-Containing Drugs in the State of California and Alameda County.

45. At all relevant times, Defendants and DOES 1 through 100, inclusive, and each of

them, expected or should have expected that their acts would have consequences within the United

States of America including the State of California and including Alameda County, said Defendants

derived and derive substantial revenue therefrom.

JURISDICTION AND VENUE

46. This Court has jurisdiction over this action pursuant to the California Constitution

Article VI, Section 10, which grants the Superior Court “original jurisdiction in all causes except

those given by statute to other trial courts.” The Statutes under which this action is brought do not


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specify any other basis for jurisdiction.

47. This Court has personal jurisdiction over each Defendant insofar as each Defendant is

authorized and licensed to conduct business in the State of California, a resident of the State of

California, maintains and carries on systematic and continuous contacts in the State of California,

regularly transacts business within the State of California, and regularly avails itself of the benefits of

the State of California.

48. Additionally, Defendants caused tortious injury by acts and omissions in this judicial

jurisdiction and caused tortious injury in this jurisdiction by acts and omissions outside this

jurisdiction while regularly doing and soliciting business, engaging in a persistent course of conduct,

and deriving substantial revenue from goods used or consumed and services rendered in this

jurisdiction.

49. Venue is proper in this Court pursuant to California Code of Civil Procedure Section

395(a) in that the headquarters and principal place of business of Defendant The Vons Companies,

Inc. is in Alameda County, California.

50. Plaintiff seeks relief that is within the jurisdictional limits of the Court.

FACTUAL ALLEGATIONS

I. Regulatory History of Ranitidine-Containing Drugs

51. Defendants marketed and sold Ranitidine-Containing Drugs under the brand name

“Zantac” or its generic version by either prescription or OTC. Defendants sold Ranitidine-

Containing Drugs in the following forms: injection, syrup, and/or tablets and capsules.

52. Zantac (ranitidine) was originally discovered and developed by scientist John

Bradshaw on behalf of GSK2 in 1976.

53. The drug belongs to a class of medications called histamine H2-receptor antagonists

(or H2 blockers), which decrease the amount of acid produced by cells in the lining of the stomach.

2 Dr. Bradshaw was working for Glaxo Inc. at the time. Glaxo Inc. later merged with the Wellcome Foundation in 1995 to become Glaxo Wellcome plc. Then, in 2000, Glaxo Wellcome plc merged with SmithKline Beecham plc to form GlaxoSmithKline plc one of the defendants in this MDL. For the purposes of this PIMC, these entities will be referred to as GSK.


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Other drugs within this class include cimetidine (Tagamet), famotidine (Pepcid), and nizatidine

(Tazac).

54. Cimetidine (Tagamet), discovered and developed by Smith, Kline and French3, was

the first H2 blocker to be developed and is the prototypical histamine H2 receptor antagonist from

which the later members of the class were developed. Indeed, Zantac was specifically developed by

GSK in response to the success of cimetidine.

55. Zantac was approved by the FDA, pursuant to the New Drug Application (“NDA”)

process in 1983 (NDA 18-703) and, quickly, became one of GSK’s most successful products, being

the first prescription drug in history to reach $1 billion in sales, which in the pharmaceutical industry

is referred to as a “Blockbuster.”

56. In 1993, GSK entered into a joint venture with Pfizer4 to develop an OTC version of

Zantac. That joint venture led to FDA approval of an OTC version of Zantac in 1995. Zantac OTC

was approved through an NDA process (NDA 20-520).

57. In 1997, GSK’s patent on the original prescription Zantac drug expired, and generic

Ranitidine-Containing Drugs entered the market. Despite generic entry, however, brand name

prescription and OTC Zantac continued to be sold. Although sales of brand-name Zantac declined as

a result of generic and alternative products, Ranitidine-Containing Drug sales remained strong over

time. As recently as 2018, Zantac was one of the top 10 antacid tablet brands in the United States,

with sales of Zantac 150 totaling $128.9 million—a 3.1% increase from the previous year.

58. In 1998, the joint venture between GSK and Pfizer dissolved. As part of the

separation, GSK retained the rights to sell all forms of Zantac internationally and prescription Zantac

in the U.S., while Pfizer retained the rights to sell OTC Zantac domestically and retained ownership

over the Zantac trademark under a trademark licensing agreement. Under this agreement, GSK

3 Smith, Kline and French later merged with the Beecham Group in 1989 to form SmithKline Beecham plc. And, as discussed above, SmithKline Beecham plc was merged into GSK in 2000. 4 The joint venture was between Glaxo Wellcome plc and Warner–Lambert, Inc. Warner-Lambert was later acquired by Pfizer, Inc. in 2000. For the purposes of this PIMC, Warner-Lambert will be referred to as Pfizer.


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retained control and responsibility over the prescription Zantac NDAs and Pfizer retained control and

responsibility over the OTC Zantac NDAs; however, Pfizer was required to obtain approval from

GSK prior to making any product or trademark improvements or changes.

59. In October 2000, Pfizer obtained full rights to OTC Zantac in the United States and

Canada from GSK pursuant to a divestiture and transfer agreement. As part of this agreement, GSK

divested all domestic Zantac OTC assets to Pfizer including all trademark rights and removed the

restrictions on Pfizer’s ability to seek product line extensions or the approval for higher doses of OTC

Zantac. GSK retained the right to exclusive use of the Zantac name for any prescription ranitidine-

containing product in the US.

60. In October 2003, Pfizer submitted NDA 21-698 for approval to market OTC Zantac

150 mg. The FDA approved NDA 21-698 OTC Zantac 150 mg on August 31, 2004.

61. In 2006, Pfizer through a divestiture agreement, transferred all assets pertaining to its

Zantac OTC line of products, including the rights to sell and market all formulations of OTC Zantac

in the United States and Canada, as well as all intellectual property, research and development, and

customer and supply contracts to Boehringer Ingelheim Pharmaceuticals, Inc. As part of this deal,

Boehringer obtained control and responsibility over all of the Zantac OTC NDAs.

62. In 2009, GSK ceased marketing prescription Zantac in the U.S. and abandoned the

Zantac prescription NDA. Although, according to GSK’s recent annual report (2019), GSK claims to

have “discontinued making and selling prescription Zantac tablets in 2017 … in the U.S.”5

63. In 2016, Boehringer sold the rights of OTC Zantac to Sanofi US Services, Inc.

pursuant to an asset swap agreement As part of this deal, Sanofi obtained control and responsibility

over the OTC NDAs and currently retains that control and responsibility.

64. To date, the FDA has approved numerous generic manufacturers for the sale of

prescription and OTC Ranitidine-Containing Drugs through an Abbreviated New Drug Application

(“ANDA”) process.

5 GlaxoSmithKline, plc, Annual Report at 37 (2019), available at https://www.gsk.com/media/5894/annual-report.pdf


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II. Recalls and the FDA’s Ban

65. On September 9, 2019, pharmacy and testing laboratory Valisure LLC and

ValisureRX LLC (collectively, “Valisure”) filed a Citizen Petition calling for the recall of all

ranitidine-containing drugs due to exceedingly high levels of NDMA found in ranitidine pills. FDA

and European regulators started reviewing the safety of ranitidine with specific focus on the presence

of NDMA.6 This triggered a cascade of recalls by the makers and retailers of Ranitidine-Containing

Drugs.

66. On September 13, 2019, the FDA’s Director for Drug Evaluation and Research, Dr.

Janet Woodcock, issued a statement that some ranitidine medicines may contain NDMA.

67. On September 24, 2019, generic manufacturer Sandoz Inc. voluntarily recalled all of

its ranitidine-containing drugs due to concerns of a “nitrosamine impurity, N-nitrosodimethylamine

(NDMA), which was found in the recalled medicine.”7

68. On September 26, 2019, Walgreens, Walmart, and Rite-Aid and Apotex Corp.—

makers of generic OTC ranitidine—voluntarily recalled all ranitidine-containing drugs and removed

the drugs from the shelves.8 Apotex issued a statement, noting that “Apotex has learned from the

U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines

including brand and generic formulations of ranitidine regardless of the manufacturer, contain a

nitrosamine impurity called N-nitrosodimethylamine (NDMA)[.]”9

69. On September 28, 2019, CVS Health Corp. stated that it would stop selling Zantac and

its own generic ranitidine-containing drugs out of concern that it might contain a carcinogen.

6 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine; https://www.ema.europa.eu/en/news/ema-review-ranitidine-medicines-following-detection-ndma. 7 https://www.fda.gov/news-events/press-announcements/fda-announces-voluntary-recall-sandoz-ranitidine-capsules-following-detection-impurity. 8 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. 9 https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and.


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70. On October 2, 2019, the FDA ordered testing on Zantac and specified a protocol to be

used that did not involve the use of heat.10

71. On October 8, 2019, GSK voluntarily recalled all Zantac and ranitidine-containing

drugs internationally.11 As part of the recall, GSK publicly acknowledged that unacceptable levels of

NDMA were discovered in Zantac and noted that “GSK is continuing with investigations into the

potential source of the NDMA.”12

72. On October 23, 2019, Dr. Reddy’s Laboratories Ltd and Sanofi voluntarily recalled all

of their ranitidine-containing drugs.13

73. On October 28, 2019, Perrigo Company plc, Novitium Pharma LLC, and Lannet

Company Inc., voluntarily recalled all their ranitidine-containing drugs from the market.14

74. On November 1, 2019, the FDA announced the results of recent testing, finding

“unacceptable levels” of NDMA in ranitidine-containing drugs, and requested that drug makers begin

to voluntarily recall their ranitidine-containing drugs.15

75. Between November 1, 2019 and February 27, 2020, the following ranitidine makers

recalled their drugs from the market, citing NDMA concerns: Aurobindo Pharma USA, Amneal

Pharmaceuticals, LLC, American Health Packaging, Golden State Medical Supply, Precision Dose

Inc., Glenmark Pharmaceutical Inc., Appco Pharma LLC, and Northwind Pharmaceuticals.16

10 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine 11 https://www.gov.uk/government/news/zantac-mhra-drug-alert-issued-as-glaxosmithkline-recalls-all-unexpired-stock 12 Justin George Varghese, GSK recalls popular heartburn drug Zantac globally after cancer scare, Reuters (Oct. 8, 2019), available at https://www.reuters.com/article/us-gsk-heartburn-zantac/gsk-recalls-popular-heartburn-drug-zantac-globally-after-cancer-scare-idUSKBN1WN1SL. 13 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine. 14 Id. 15 https://www.fda.gov/drugs/drug-safety-and-availability/laboratory-tests-ranitidine. 16 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine.


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76. On January 2, 2020, research laboratory, Emery Pharma, submitted a Citizen Petition

to the FDA, showing that NDMA accumulates in ranitidine at unsafe rates when exposed to heat

levels that would occur during transport and storage.

77. Emery’s Citizen Petition outlined its substantial concern that Ranitidine is a time- and

temperature-sensitive pharmaceutical product that develops a known carcinogen, NDMA, when

exposed to heat, a common occurrence during shipping, handling, and storage. In addition to

warning about this condition, Emery requested agency directives to manufacturers and distributors to

ship Ranitidine-Containing Drugs in temperature-controlled vehicles.

78. In response,17 on April 1, 2020, the FDA recounted that a recall is an “effective

methods [sic.] of removing or correcting defective FDA-regulated products . . . particularly when

those products present a danger to health.”18 The FDA sought the voluntary consent of

manufacturers to accept the recall “to protect the public health from products that present a risk of

injury.”19 The FDA found that the recall of all Ranitidine-Containing Drugs and public warning of

the recall was necessary because the “product being recalled presents a serious health risk.”20 The

FDA therefore sent Information Requests to all applicants and pending applicants of Ranitidine-

Containing Drugs “requesting a market withdrawal.”21

79. The FDA found its stability testing raised concerns that NDMA levels in some

ranitidine drugs stored at room temperature can increase with time to unacceptable levels. Other

testing conducted by FDA revealed a correlation between NDMA levels and expiration date. The

FDA’s testing eroded the agency’s confidence that any ranitidine product could remain stable through

its labeled expiration date. Consequently, the FDA was compelled to order the drugs off the market.

17 Letter of Janet Woodcock, Docket No. FDA-2020-P-0042 (April 1, 2020), available at https://emerypharma.com/wp-content/uploads/2020/04/FDA-2020-P-0042-CP-Response-4-1-2020.pdf. 18 Id., citing 21 CFR 7.40(a). 19 Id. 20 Id. 21 Id., fn. 43.


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The FDA’s decision to ban the drug rendered moot Emery’s request for temperature-controlled sales

conditions.

80. The FDA therefore issued a public statement requesting the immediate removal of all

Ranitidine-Containing Drugs from the market due to the risk to public health.22 “The agency has

determined that the impurity in some ranitidine drugs increases over time and when stored at higher

than room temperatures and may result in consumer exposure to unacceptable levels of this

impurity.” Based upon its own testing and evaluation, the FDA concluded that “NDMA levels

increase in ranitidine even under normal storage conditions and NDMA has been found to increase

significantly in samples stored at higher temperatures, including temperatures the product may be

exposed to during distribution and handling by consumers.”

81. The FDA’s reaction to the NDMA crisis involving ranitidine has come under attack.

Over 43 different countries and jurisdictions took action to restrict or ban ranitidine-containing drugs

before the FDA took any action.23 Indeed, despite being notified of the problem by Valisure in June

2019, the FDA left the drug on the market for nearly an entire year, during which time countless

more individuals were exposed to a carcinogen against their will.

82. The FDA’s reaction to the NDMA crisis involving ranitidine has come under attack.

Over 43 different countries and jurisdictions took action to restrict or ban ranitidine-containing drugs

before the FDA took any action.24

22 Press Release, FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, U.S. Food and Drug Administration (April 1, 2020), available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market 23 Margaret Newkirk and Susan Berfield, FDA recalls are always voluntary and sometimes haphazard—and the agency doesn’t want more authority to protect consumers, Bloomberg Businessweek (Dec. 3, 2019), available at https://www.bloomberg.com/graphics/2019-voluntary-drug-recalls-zantac/. 24 Margaret Newkirk and Susan Berfield, FDA recalls are always voluntary and sometimes haphazard—and the agency doesn’t want more authority to protect consumers, Bloomberg Businessweek (Dec. 3, 2019), available at https://www.bloomberg.com/graphics/2019-voluntary-drug-recalls-zantac/.


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III. Dangers of NDMA

83. According to the U.S. Environmental Protection Agency (“EPA”), “NDMA is a

semivolatile organic chemical that forms in both industrial and natural processes.”25 It is one of the

simplest members of a class of N-nitrosamines, a family of potent carcinogens. The dangers that

NDMA poses to human health have long been recognized. A news article published in 1979 noted

that “NDMA has caused cancer in nearly every laboratory animal tested so far.”26 NDMA is no

longer produced or commercially used in the United States, except for research, such as a tumor

initiator in animal bioassays. In other words, the only use for NDMA today is to cause cancer in

laboratory animals.

84. Both the EPA and the International Agency for Research on Cancer (“IARC”) have

classified NDMA as a probable human carcinogen.27

85. The American Conference of Governmental Industrial Hygienists classifies NDMA as

a confirmed animal carcinogen.28

86. The U.S. Department of Health and Human Services (“DHHS”) states that NDMA is

reasonably anticipated to be a human carcinogen.29 This classification is based upon DHHS’s

25 United States Environmental Protection Agency, Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA) (Nov. 2017), https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf (last visited Apr. 15, 2020). 26 Jane Brody, Bottoms Up: Alcohol in moderation can extend life, The Globe and Mail (CANADA) (Oct. 11, 1979); see Rudy Platiel, Anger grows as officials unable to trace poison in reserve’s water, The Globe and Mail (CANADA) (Jan. 6, 1990) (reporting that residents of Six Nations Indian Reserve “have been advised not to drink, cook or wash in the water because testing has found high levels of N-nitrosodimethylamine (NDMA), an industrial byproduct chemical that has been linked to cancer”); Kyrtopoulos et al, DNA adducts in humans after exposure to methylating agents, 405 MUT. RES. 135 (1998) (noting that “chronic exposure of rats to very low doses of NDMA gives rise predominantly to liver tumors, including tumors of the liver cells (hepatocellular carcinomas), bile ducts, blood vessels and Kupffer cells”). 27 See EPA Technical Fact Sheet, supra; International Agency for Research on Cancer (IARC) - Summaries & Evaluations, N-NITROSODIMETHYLAMINE (1978), http://www.inchem.org/documents/iarc/vol17/n-nitrosodimethylamine.html (last visited Apr. 15, 2020). 28 https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf. 29 Id. at 3.


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findings that NDMA caused tumors in numerous species of experimental animals, at several different

tissue sites, and by several routes of exposure, with tumors occurring primarily in the liver,

respiratory tract, kidney, and blood vessels.30

87. The FDA considers NDMA a chemical that “could cause cancer” in humans.31

88. The World Health Organization (“WHO”) states that there is “conclusive evidence

that NDMA is a potent carcinogen” and that there is “clear evidence of carcinogenicity.”32

89. As early as 1980, consumer products containing unsafe levels of NDMA and other

nitrosamines have been recalled by manufacturers, either voluntarily or at the direction of the FDA.

90. Most recently, beginning in the summer of 2018, there have been recalls of several

generic drugs used to treat high blood pressure and heart failure—Valsartan, Losartan, and

Irbesartan—because the medications contained nitrosamine impurities that do not meet the FDA’s

safety standards.

91. The no-observed-adverse-effect level (“NOAEL”) is the level of exposure at which

there is no biologically or significant increase in the frequency or severity of any adverse effects of

the chemical. Due to NDMA’s ability to affect DNA at a microscopic level, there is no NOAEL for

NDMA. This means any amount of NDMA exposure increases risk.

92. That said, the FDA has set an acceptable daily intake (“ADI”) level for NDMA at 96

nanograms. This means, according to the FDA, consumption of 96 nanograms of NDMA a day

would increase the risk of developing cancer by 0.001% over the course of a lifetime. That risk

increases as the level of NDMA exposure increases. However, any level above 96 nanograms is

30 https://www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf. 31 https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine 32 World Health Organization, Guidelines for Drinking Water Quality, N-Nitrosodimethylamine (NDMA) (3rd ed. 2008), available at https://www.who.int/water_sanitation_health/dwq/ chemicals/ndmasummary_2ndadd.pdf.


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considered unacceptable.33 For example, tobacco smoke also contains NDMA. One filtered cigarette

contains between 5 to 43 nanograms of NDMA.

93. In mouse studies examining the carcinogenicity of NDMA through oral

administration, animals exposed to NDMA developed cancer in the kidney, bladder, liver, and lung.

In comparable rat studies, similar cancers were observed in the liver, kidney, pancreas, and lung. In

comparable hamster studies, similar cancers were observed in the liver, pancreas, and stomach. In

comparable Guinea-pig studies, similar cancers were observed in the liver and lung. In comparable

rabbit studies, similar cancers were observed in the liver and lung.

94. In other long-term animal studies in mice and rats utilizing different routes of

exposures—inhalation, subcutaneous injection, and intraperitoneal (abdomen injection)—cancer was

observed in the lung, liver, kidney, nasal cavity, and stomach.

95. Prior to the agency’s ban on Ranitidine-Containing Drugs, the FDA considered the

drug as category B for birth defects, meaning it was considered safe to take during pregnancy.

However, in animal experiments, for those animals exposed to NDMA during pregnancy, the

offspring had elevated rates of cancer in the liver and kidneys.

96. NDMA is, itself, a very small molecule. This allows it to freely pass through all areas

of the body, including the blood-brain and placental barrier. This is particularly concerning as

ranitidine has been marketed for pregnant women and young children for years.

97. In addition, NDMA breaks down into various derivative molecules that, themselves,

are associated with causing cancer. In animal studies, derivatives of NDMA induced cancer in the

stomach and intestine (including colon).

98. Research shows that lower levels of NDMA, i.e., 40 ng, are fully metabolized in the

liver, but high doses enter the body’s general circulation.

99. Numerous in vitro studies confirm that NDMA is a mutagen—causing mutations in

human and animal cells.

33 https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan.


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100. Overall, the animal data demonstrates that NDMA is carcinogenic in all animal

species tested: mice, rats, Syrian golden, Chinese and European hamsters, guinea-pigs, rabbits,

ducks, mastomys, fish, newts, and frogs.

101. Pursuant to the EPA cancer guidelines, “tumors observed in animals are generally

assumed to indicate that an agent may produce tumors in humans.”34

102. In addition to the overwhelming animal data linking NDMA to cancer, there are

numerous human epidemiological studies exploring the effects of dietary exposure to various cancers.

And, while these studies (several discussed below) consistently show increased risks of various

cancers, the exposure levels considered in these studies are a very small fraction—as little as 1

millionth—the exposures noted in a single Zantac capsule, i.e., 0.191 ng/day (dietary) v. 304,500

ng/day (Zantac).

103. In a 1995 epidemiological case-control study looking at NDMA dietary exposure with

220 cases, researchers observed a statistically significant 700% increased risk of gastric cancer in

persons exposed to more than 0.51 ng/day.35


746 cases, researchers observed statistically significant elevated rates of gastric cancer in persons

exposed to more than 0.191 ng/day.36

105. In another 1995 epidemiological case-control study looking at, in part, the effects of

dietary consumption on cancer, researchers observed a statistically significant elevated risk of

developing aerodigestive cancer after being exposed to NDMA at .179 ng/day.37

106. In a 1999 epidemiological cohort study looking at NDMA dietary exposure with 189

cases and a follow up of 24 years, researchers noted that “N-nitroso compounds are potent

34 See https://www3.epa.gov/airtoxics/cancer_guidelines_final_3-25-05.pdf. 35 Pobel, et al., Nitrosamine, nitrate and nitrite in relation to gastric cancer: a case-control study in Marseille, France, 11 EUROP. J. EPIDEMIOL. 67–73 (1995). 36 La Vecchia, et al., Nitrosamine intake and gastric cancer risk, 4 EUROP. J. CANCER. PREV. 469–474 (1995). 37 Rogers, et al., Consumption of nitrate, nitrite, and nitrosodimethylamine and the risk of upper aerodigestive tract cancer, 5 CANCER EPIDEMIOL. BIOMARKERS PREV. 29–36 (1995).


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carcinogens” and that dietary exposure to NDMA more than doubled the risk of developing

colorectal cancer.38

107. In a 2000 epidemiological cohort study looking at occupational exposure of workers in

the rubber industry, researchers observed significant increased risks for NDMA exposure for

esophagus, oral cavity, pharynx, prostate, and brain cancer.39

108. In a 2011 epidemiological cohort study looking at NDMA dietary exposure with 3,268

cases and a follow up of 11.4 years, researchers concluded that “[d]ietary NDMA intake was

significantly associated with increased cancer risk in men and women” for all cancers, and that

“NDMA was associated with increased risk of gastrointestinal cancers” including rectal cancers.40


2,481 cases, researchers found a statistically significant elevated association between NDMA

exposure and colorectal cancer.41

110. In addition to studies demonstrating that NDMA directly causes cancer, research

shows that exposure to NDMA (1) can exacerbate existing but dormant cancers (i.e., not malignant),

(2) promote otherwise “initiated cancer cells” to develop into cancerous tumors; and (3) reduce the

ability of the body to combat cancer. Thus, in addition to NDMA being a direct cause of cancer

itself, NDMA can also be a contributing factor to a cancer injury caused by some other source.

111. NDMA is also known to be genotoxic—meaning, it can cause DNA damage in human

cells. Indeed, multiple studies demonstrate that NDMA is genotoxic both in vivo and in vitro.

However, recent studies have shown that the ability of NDMA to cause mutations in cells is affected

38 Knekt, et al., Risk of Colorectal and Other Gastro-Intestinal Cancers after Exposure to Nitrate, Nitrite and N-nitroso Compounds: A Follow-Up Study, 80 INT. J. CANCER 852–856 (1999) 39 Straif, et al., Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers, 57 OCCUP ENVIRON MED 180–187 (2000). 40 Loh, et al., N-nitroso compounds and cancer incidence: the European Prospective Investigation into Cancer and Nutrition (EPIC)–Norfolk Study, 93 AM J CLIN NUTR. 1053–61 (2011). 41 Zhu, et al., Dietary N-nitroso compounds and risk of colorectal cancer: a case-control study in Newfoundland and Labrador and Ontario, Canada, 111 BR J NUTR. 6, 1109–1117 (2014).


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by the presence of enzymes typically found in living humans, suggesting that “humans may be

especially sensitive to the carcinogenicity of NDMA.”42

IV. How Ranitidine Transforms into NDMA Within the Human Body

112. The ranitidine molecule, itself, contains the constituent molecules to form NDMA.

See Figure 1.

113. Specifically, the O=N (Nitroso) on one side of the ranitidine molecule can combine

with the H3C-N-CH3 (DMA) on the other side to form NDMA. The NDMA forms out of the

ranitidine molecule itself.

114. The formation of NDMA by the reaction of DMA and a nitroso source (such as a

nitrite) is well characterized in the scientific literature and has been identified as a concern for

contamination of the American water supply.43 Indeed, in 2003, alarming levels of NDMA in

drinking water processed by wastewater treatment plants was specifically linked to the presence of

ranitidine.44

42 World Health Organization, Guidelines for Drinking Water Quality, N-Nitrosodimethylamine (NDMA) (3rd ed. 2008), available at https://www.who.int/water_sanitation_health/dwq/ chemicals/ndmasummary_2ndadd.pdf. 43 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989). 44 Mitch, et al., N-Nitrosodimethylamine (NDMA) as a Drinking Water Contaminant: A Review, 20 ENV. ENG. SCI. 5, 389-404 (2003).


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115. Ranitidine leads to NDMA exposure by: (1) formation of NDMA in the human

stomach; (2) formation of NDMA due to an enzymatic reaction throughout the human body; and (3)

formation of NDMA due to heat and/or time.

A. Formation of NDMA in the Environment of the Human Stomach

116. When the ranitidine molecule is exposed to the acidic environment of the stomach,

particularly when accompanied by nitrites (a chemical commonly found in heartburn-inducing

foods), the Nitroso molecule (0=N) and the DMA molecule (H3C-N-CH3) break off and reform as

NDMA.

117. In 1981, Dr. Silvio de Flora, an Italian researcher from the University of Genoa,

published the results of experiments he conducted on ranitidine in the well-known journal, The

Lancet. When ranitidine was exposed to human gastric fluid in combination with nitrites, his

experiment showed “toxic and mutagenic effects[.]”45 Dr. de Flora hypothesized that these

mutagenic effects could have been caused by the “formation of more than one nitroso derivative

[which includes NDMA] under our experimental conditions.” Id. Dr. de Flora cautioned that, in the

context of ranitidine ingestion, “it would seem prudent to … suggest[] a diet low in nitrates and

nitrites, by asking patients not to take these at times close to (or with) meals[.]”46 Id.

118. GSK knew of Dr. de Flora’s publication because, two weeks later, GSK responded in

The Lancet, claiming that the levels of nitrite needed to induce the production of nitroso derivatives

(i.e., NDMA) were not likely to be experienced by people in the real world.47

45 De Flora, Cimetidine, Ranitidine and Their Mutagenic Nitroso Derivatives, THE LANCET 993-994 (Oct. 31, 1981). 46 This admonition came two years before the FDA’s approved Zantac in 1983. Notwithstanding, in 1998 GSK applied for and obtained an indication for OTC Zantac “[f]or the prevention of meal-induced heartburn at a dose of 75 mg taken 30 to 60 minutes prior to a meal.” See https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/ 20520s1_Zantac.pdf. So, GSK specifically invited patients to take Zantac shortly before eating heartburn-inducing food. 47 R. T., Brittain, et al, Safety of Ranitidine, THE LANCET (Nov. 14, 1981).


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119. In its submission to the FDA, GSK explained that the level of nitrite present would be

unrealistic and, thus, these results had no “practical clinical significance”48:

120. Around this same time—before Zantac was approved by the FDA—GSK conducted

another study to examine, among other things, how long-term use of ranitidine could affect the levels

of nitrite in the human stomach.49 Remarkably, in the study that was presented to the FDA, GSK

admitted that ranitidine use caused the proliferation of bacteria in the human stomach that are known

to convert nitrates to nitrites, which leads to elevated levels of nitrite in the stomach environment.

GSK acknowledged this could increase the risk of developing NDMA and, in turn, cancer, but then

dismissed this risk because people were only expected to use ranitidine-containing drugs for a short-

term period:

48 Excerpted from the Summary Basis of Approval submitted to the FDA to obtain approval of Zantac in the early 1980s. This document was obtained through a Freedom of Information Act request to the FDA. 49 The results of this study are discussed in the Summary Basis of Approval, obtained from the FDA.


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121. GSK knew—and indeed specifically admitted—that ranitidine could react with nitrite

in the human stomach to form NDMA and, at the same time, that long-term use of ranitidine could

lead to elevated levels of nitrite in the human stomach.

122. In response to Dr. de Flora’s findings, in 1982, GSK conducted a clinical study

specifically investigating gastric contents in human patients.50 The study, in part, specifically

measured the levels of N-Nitroso compounds in human gastric fluid. GSK indicated that there were

no elevated levels, and even published the results of this study five years later, in 1987. The study,

however, was rigged. It did not use gold-standard mass spectrometry to test for NDMA, but instead,

used a process that could not measure N-nitrosamines efficiently. And worse, in the testing it did do,

GSK refused to test gastric samples that contained ranitidine in them out of concern that samples with

ranitidine would contain “high concentrations of N-nitroso compounds being recorded.” Id. So, GSK

did not test for NDMA in any gastric fluid that contained ranitidine.

123. In 1983, the same year Zantac obtained approval from the FDA, seven researchers

from the University of Genoa published a study discussing ranitidine and its genotoxic effects (ability

to harm DNA).51 The researchers concluded “it appears that reaction of ranitidine with excess

sodium nitrite under acid conditions gives rise to a nitroso-derivative (or derivatives) [like NDMA]

capable of inducing DNA damage in mammalian cells.” Id.

124. Then, again in 1983, Dr. de Flora, along with four other researchers, published their

complete findings.52 The results “confirm our preliminary findings on the formation of genotoxic

derivatives from nitrite and ranitidine[.]” Id. Again, the authors noted that, “the widespread clinical

use [of ranitidine] and the possibility of a long-term maintenance therapy suggest the prudent

adoption of some simple measures, such as a diet low in nitrates and nitrites or the prescription of

these anti-ulcer drugs at a suitable interval from meals.” Id. This admonition carries weight

50 Thomas, et al., Effects of one year’s treatment with ranitidine and of truncal vagotomy on gastric contents, 6 GUT. Vol. 28, 726-738 (1987). 51 Maura, et al., DNA Damage Induced by Nitrosated Ranitidine in Cultured Mammalian Cells, 18 TOX. LTTRS. 97-102 (1983). 52 De Flora, et al., Genotoxicity of nitrosated ranitidine, 4 CARCINOGENESIS 3, 255-260 (1983).


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considering GSK’s studies indicate that long-term ranitidine consumption, itself, leads to elevated

levels of nitrites in the human gut.

125. The high instability of the ranitidine molecule was elucidated in scientific studies

investigating ranitidine as a source of NDMA in drinking water and specific mechanisms for the

breakdown of ranitidine were proposed.53 These studies underscore the instability of the NDMA

group on the ranitidine molecule and its ability to form NDMA in the environment of water treatment

plants which supply many American cities with water.

126. In 2016, researchers at Stanford University conducted an experiment on healthy

volunteers (Stanford Study).54 They measured the NDMA in urine of healthy individuals over the

course of 24 hours, administered one dose of ranitidine, and then measured the NDMA in the urine of

the same individuals for another 24 hours. On average, the level of NDMA increased by 400 times,

to approximately 47,000 nanograms. The only change during that 24-hour period was the

consumption of ranitidine. This study directly demonstrated that unsafe levels of NDMA are formed

in the human body as a result of ranitidine ingestion. The scientists further explained that humans do

not typically excrete NDMA in their urine, so that the observed 47,000 nanograms likely only

captured 1/100 of the actual NDMA levels in the human body.

127. These studies did not appreciate the full extent of NDMA formation risk from

ranitidine; specifically, the added danger of this drug having not only a labile DMA group but also a

readily available nitroso source in its nitrite group on the opposite terminus of the molecule. Recent

testing reveals that NDMA levels in ranitidine batches are so high that the nitroso for NDMA likely

comes from no other source than the ranitidine molecule itself.

128. Valisure is an online pharmacy that also runs an analytical laboratory that is ISO

17025 accredited by the International Organization for Standardization (“ISO”) – an accreditation

recognizing the laboratories technical competence for regulatory. Valisure’s mission is to help

53 Le Roux, et al., NDMA Formation by Chloramination of Ranitidine: Kinetics and Mechanism, 46 Environ. Sci. Technol. 20, 11095-11103 (2012). 54 Zeng, et al., Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine, 37 CARCINOGENESIS 625-634 (2016).


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ensure the safety, quality, and consistency of medications and supplements in the market. In

response to rising concerns about counterfeit medications, generics, and overseas manufacturing,

Valisure developed proprietary analytical technologies that it uses in addition to FDA standard assays

to test every batch of every medication it dispenses.

129. In its September 9, 2019 Citizen’s Petition to the FDA, Valisure disclosed as part of

its testing of Zantac, and other ranitidine-containing drugs that in every lot tested there were

exceedingly high levels of NDMA discovered. Valisure’s ISO 17025 accredited laboratory used FDA

recommended GC/MS headspace analysis method FY19-005-DPA8 for the determination of NDMA

levels. As per the FDA protocol, this method was validated to a lower limit of detection of 25 ng.55

The results of Valisure’s testing show levels of NDMA well above 2 million ng per 150 mg Zantac

tablet, shown below in Table 1.

Table 1 – Ranitidine Samples Tested by Valisure Laboratory Using GC/MS Protocol

150 mg Tablets or equivalent Lot # NDMA per tablet (ng)

Reference Powder* 125619 2,472,531

Zantac, Brand OTC 18M498M 2,511,469

Zantac (mint), Brand OTC 18H546 2,834,798

Wal-Zan, Walgreens 79L800819A 2,444,046

Wal-Zan (mint), Walgreens 8ME2640 2,635,006

Ranitidine, CVS 9BE2773 2,520,311

Zantac (mint), CVS 9AE2864 3,267,968

Ranitidine, Equate 9BE2772 2,479,872

Ranitidine (mint), Equate 8ME2642 2,805,259

Ranitidine, Strides 77024060A 2,951,649

55 US Food and Drug Administration. (updated 01/25/2019). Combined N-Nitrosodimethlyamine (NDMA) and N-Nitrosodiethylamine (NDEA) Impurity Assay, FY19-005-DPA-S.


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130. Valisure’s testing shows, on average, 2,692,291 ng of NDMA in a 150 mg Zantac

tablet. Considering the FDA’s permissible limit is 96 ng, this would put the level of NDMA at

28,000 times the legal limit. By way of comparison, a person would need to smoke at least 6,200

cigarettes to achieve the same levels of NDMA found in one 150 mg dose of Zantac.

131. Valisure, however, was concerned that the extremely high levels of NDMA observed

in its testing were a product of the modest oven heating parameter of 130 °C in the FDA

recommended GC/MS protocol. So, Valisure developed a low temperature GC/MS method that

could still detect NDMA but would only subject samples to 37 °C, the average temperature of the

human body. This method was validated to a lower limit of detection of 100 ng.

132. Valisure tested ranitidine tablets by themselves and in conditions simulating the

human stomach. Industry standard “Simulated Gastric Fluid” (“SGF” 50 mM potassium chloride, 85

mM hydrochloric acid adjusted to pH 1.2 with 1.25 g pepsin per liter) and “Simulated Intestinal

Fluid” (“SIF” 50 mM potassium chloride, 50 mM potassium phosphate monobasic adjusted to pH 6.8

with hydrochloric acid and sodium hydroxide) were used alone and in combination with various

concentrations of nitrite, which is commonly ingested in foods like processed meats and is elevated in

the stomach by antacid drugs. The inclusion of nitrite in gastric fluid testing is commonplace and

helps simulate the environment of a human stomach.

133. Indeed, Zantac was specifically advertised to be used when consuming foods

containing high levels of nitrates, like tacos, pizza, etc.56

134. The results of Valisure’s tests on ranitidine tablets in biologically relevant conditions

demonstrate significant NDMA formation under simulated gastric conditions with nitrite present (see

Table 2).

Table 2 – Valisure Biologically Relevant Tests for NDMA Formation

Ranitidine Tablet Studies NDMA (ng/mL) NDMA per tablet (ng)

Tablet without Solvent Not Detected Not Detected

56 See, e.g., https://www.ispot.tv/ad/dY7n/zantac-family-taco-night; https://youtu.be/jzS2kuB5_wg; https://youtu.be/Z3QMwkSUlEg; https://youtu.be/qvh9gyWqQns.


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Table 2 – Valisure Biologically Relevant Tests for NDMA Formation

Tablet Not Detected Not Detected

Simulated Gastric Fluid (“SGF”) Not Detected Not Detected

Simulated Intestinal Fluid Not Detected Not Detected

SGF with 10 mM Sodium Nitrite Not Detected Not Detected

SGF with 25 mM Sodium Nitrite 236 23,600

SGF with 50 mM Sodium Nitrite 3,045 304,500

135. Under biologically relevant conditions, when nitrites are present, high levels of

NDMA are found in one dose of 150 mg Zantac, ranging between 245 and 3,100 times above the

FDA-allowable limit. One would need to smoke over 500 cigarettes to achieve the same levels of

NDMA found in one dose of 150 mg Zantac at the 25 nanogram level (over 7,000 for the 50

nanogram level).

136. When the scientific data is assessed overall, the literature demonstrates that the

ingestion of ranitidine in the presence of human-relevant levels of nitrite in the stomach—a substance

that is commonly found in foods that induce heartburn and that is known to be elevated in people

taking ranitidine for longer than a month—the ranitidine molecule breaks down into levels of NDMA

that would dramatically increase a person’s risk of developing cancer.

B. Formation of NDMA in the Other Organs of Human Body

137. In addition to the gastric fluid mechanisms investigated in the scientific literature,

Valisure identified a possible enzymatic mechanism for the liberation of ranitidine’s DMA group via

the human enzyme dimethylarginine dimethylaminohydrolase (“DDAH”), which can occur in other

tissues and organs separate from the stomach.

138. Liberated DMA can lead to the formation of NDMA when exposed to nitrite present

on the ranitidine molecule, nitrite freely circulating in the body, or other potential pathways,

particularly in weak acidic conditions such as that in the kidney or bladder. The original scientific

paper detailing the discovery of the DDAH enzyme in 1989 specifically comments on the propensity

of DMA to form NDMA: “This report also provides a useful knowledge for an understanding of the


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endogenous source of dimethylamine as a precursor of a potent carcinogen, dimethylnitrosamine

[NDMA].”57

139. In Figure 2, below, computational modelling demonstrates that ranitidine (shown in

green) can readily bind to the DDAH-1 enzyme (shown as a cross-section in grey) in a manner

similar to the natural substrate of DDAH-1 known as asymmetric dimethylarginine (“ADMA,”

shown in blue).

140. These results indicate that the enzyme DDAH-1 increases formation of NDMA in the

human body when ranitidine is present; therefore, the expression of the DDAH-1 gene is useful for

identifying organs most susceptible to this action.

141. Figure 3 below, derived from the National Center for Biotechnology Information,

illustrates the expression of the DDAH-1 gene in various tissues in the human body.

57 Ogawa, et al., Purification and properties of a new enzyme, NG, NG-dimethylarginine dimethylaminohydrolase, from rat kidney, 264 J. BIO. CHEM. 17, 10205-10209 (1989).


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142. DDAH-1 is most strongly expressed in the kidneys but also broadly distributed

throughout the body, such as in the liver, prostate, stomach, bladder, brain, colon, and prostate. This

offers both a general mechanism for NDMA formation in the human body from ranitidine and

specifically raises concern for the effects of NDMA on numerous organs, including the bladder.

143. The possible enzymatic reaction of ranitidine to DDAH-1, or other enzymes, suggests

that high levels of NDMA can form throughout the human body. Indeed, ranitidine metabolizes and

circulates throughout the human body, crossing the placental and blood-brain barrier, within 1-2

hours. When the ranitidine interacts with the DDAH-1 enzyme in various organs throughout the

body, it breaks down into NDMA. This observation is validated by the Stanford study.

C. Formation of NDMA by Exposure to Heat and/or Time

144. The risk of creating NDMA by exposing ranitidine to heat has been well-known and

documented. Early studies, including the one conducted by GSK in the early 1980s, demonstrated

that NDMA formed when ranitidine was exposed to heat. This point was underscored in the Valisure

petition, which specifically developed a detection protocol that did not use heat.

145. In response to Valisure, on October 2, 2019, the FDA recommended that researchers

use the LC-HRMS protocol for detecting NDMA in ranitidine because the “testing method does not

use elevated temperatures” and has been proven capable of detecting NDMA.


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146. On January 2, 2020, Emery Pharma, an FDA-certified pharmaceutical testing

laboratory, conducted a series of tests on ranitidine using the FDA-recommended LC-HRMS

protocol. The researchers exposed ranitidine to 70 ⸰C for varying periods of time. The results

showed that increasing levels of NDMA formed based on exposure to heat. The following diagram

reveals how NDMA accumulates over time when exposed to 70 ⸰C:

147. The researchers cautioned:

NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer. Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.

148. Indeed, the FDA’s recent testing confirms that NDMA levels increase in ranitidine

even under normal storage conditions, and NDMA has been found to increase significantly in


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samples stored at higher temperatures, including temperatures to which ranitidine may be exposed

during distribution and handling by consumers.58

149. The results of this data demonstrate that in normal transport and storage, and

especially when exposed to heat, the ranitidine molecule systematically breaks down into NDMA,

accumulating over time in the finished product. Considering ranitidine-containing drugs have an

approved shelf life of 36 months, the possibility of the drug accumulating dangerously high levels of

NDMA prior to consumption is very real—a point underscored by the FDA’s swift removal of the

product from the market.

D. Evidence Also Directly Links Ranitidine Exposure to Cancer

150. In addition to numerous epidemiology studies examining how NDMA causes cancer

in humans, researchers have also specifically looked at ranitidine and found an association with

cancer.

151. One epidemiology study, published in 2004, showed that men taking either ranitidine

or cimetidine (Tagamet) had increased risks of bladder cancer.59

152. In one epidemiology study specifically designed to look at breast cancer, ranitidine

was shown to more than double the risk of breast cancer, an effect that was even more pronounced in

those with specific gene mutations.60

153. In another comprehensive epidemiological study looking at various cancer risks and

H2 blockers, including ranitidine, the data showed that ranitidine consumption increased the risk of

prostate, lung, esophageal, pancreatic, and kidney cancer. Of particular note, the study indicated that

people under the age of 60 that took ranitidine were five times more likely to contract prostate cancer.

58 Press Release, FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, U.S. Food and Drug Administration (April 1, 2020), available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market 59 D. Michaud, et al, Peptic Ulcer Disease and the Risk of Bladder Cancer in a Prospective Study of Male Health Professionals, 13 CANCER EPI. BIOMARK. & PREV. 250–254, 252 (Feb. 2004). 60 Robert W. Mathes, et al, Relationship between histamine2-receptor antagonist medications and

risk of invasive breast cancer, 17 CANCER EPI. BIOMARKERS & PREVENTION 1, 67-72 (2008).


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154. A study published in 2018, demonstrated an increased risk of liver cancer associated

with use of ranitidine in comparison with other histamine type 2 receptor antagonists (H2RAs) in the

class. The purpose of the study was to determine whether there was an increased risk of liver cancer

associated with proton pump inhibitors, a different class of medications indicated for the treatment of

GERD. This finding is particularly notable as the authors adjusted for variables and, more

significantly, did not study or consider long term use of H2RAs or the possibility of a dose dependent

increase in risk.61

155. In 2018, a study found an increased risk in hepatocellular carcinoma associated with

use of H2RAs.62 The authors were evaluating the risk of cancer in association with proton pump

inhibitors and looked at H2RAs as a confounder. The study only considered use of H2RAs within one

year of cancer diagnosis and still found an increased odds ratio associated with use of H2RAs and

hepatocellular carcinoma, a type of liver cancer.

156. A number of other studies have been published over the years showing an increased

risk of various cancers associated with use of ranitidine and/or H2RAs.63 However it is especially

noteworthy that Memorial Sloan Kettering, in conjunction with various researchers, plan to publish a

study specifically looking at ranitidine users and cancer risks in the Journal of the American Medical

Association (“JAMA”). The article was accepted and is set for publication.

V. Defendants Made False Statements in the Labeling of Their Ranitidine-Containing Drugs.

157. A manufacturer is required to give adequate directions for the use of a pharmaceutical

61 Kim Tu Tran,, et al., Proton pump inhibitor and histamine‐2 receptor antagonist use and risk of liver cancer in two population‐based studies, 48 ALIMENTARY PHARMA & THERAP 1, 55-64 (2018). 62 Shao, Y‐HJ, et al., Association between proton pump inhibitors and the risk of hepatocellular carcinoma, 48 ALIMENTARY PHARMA & THERAP 4, 460-468 (2018). 63 Robert W. Mathes, et al., Relationship between histamine2-receptor antagonist medications and risk of invasive breast cancer, 17 CANCER EPID. & PREV BIOMARKERS 1, 67-72 (2008); see also Ahn, Jeong Soo, et al., Acid suppressive drugs and gastric cancer: a meta-analysis of observational studies, 19 WORLD J. GASTROENTEROLOGY 16, 2560 (2013); Lai, Shih-Wei, et al., Use of proton pump inhibitors correlates with increased risk of pancreatic cancer: a case-control study in Taiwan, 46 KUWAIT MED J. 1, 44-48 (2014); Poulsen et al., Proton Pump Inhibitors and risk of gastric cancer – a population based cohort study, 100 BRITISH J CANCER 1503-1507 (2009); E Wennerström, Acid-suppressing therapies and subsite-specific risk of stomach cancer, 116 BRITISH J CANCER 9, 1234-1238 (2017).


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drug such that a “layman can use a drug safely and for the purposes for which it is intended,”64 and

conform to requirements governing the appearance of the label.65

158. “Labeling” encompasses all written, printed or graphic material accompanying the

drug or device,66 and therefore broadly encompasses nearly every form of promotional activity,

including not only “package inserts” but also advertising.

159. “Most, if not all, labeling is advertising. The term “labeling” is defined in the FDCA

as including all printed matter accompanying any article. Congress did not, and we cannot, exclude

from the definition printed matter which constitutes advertising.”67

160. If a manufacturer labels a drug but omits ingredients, that renders the drug

misbranded.68

161. Because Defendants did not disclose NDMA as an ingredient in the Ranitidine-

Containing Drugs ingested by Plaintiff, the subject drugs were misbranded.

162. It is unlawful to introduce a misbranded drug into interstate commerce.69 Thus, the

Ranitidine-Containing Drugs ingested by Plaintiff were unlawfully distributed and sold.

VI. Defendants Knew or Should Have Known of the NDMA Risk

163. During the time that Defendants manufactured and sold Ranitidine-Containing Drugs

in the United States, the weight of scientific evidence showed that Ranitidine-Containing Drugs

exposed users to unsafe levels of NDMA. Defendants failed to disclose this risk to consumers on the

drug’s label—or through any other means—and Defendants failed to report these risks to the FDA.

164. Going back as far as 1981, two years before Zantac entered the market, research

showed elevated rates of NDMA, when properly tested. This was known or should have been known

by the Defendants or any other maker or distributor of ranitidine-containing drugs.

64 21 C.F.R. § 201.5. 65 21 C.F.R. § 801.15. 66 Id. 65 Fed. Reg. 14286 (March 16, 2000). 67 U.S. v. Research Labs., 126 F.2d 42, 45 (9th Cir. 1942). 68 21 C.F.R. § 201.6; 201.10. 69 21 U.S.C. § 331(a).


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165. Defendants concealed the Zantac–NDMA link from consumers in part by not

reporting it to the FDA, which relies on drug manufacturers (or others, such as those who submit

citizen petitions) to bring new information about an approved drug like Ranitidine-Containing Drugs

to the agency’s attention.

166. Manufacturers of an approved drug are required by regulation to submit an annual

report to the FDA containing, among other things, new information regarding the drug’s safety

pursuant to 21 C.F.R. § 314.81(b)(2):

The report is required to contain . . . [a] brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product. The report is also required to contain a brief description of actions the applicant has taken or intends to take as a result of this new information, for example, submit a labeling supplement, add a warning to the labeling, or initiate a new study.

167. 21 C.F.R. § 314.81(b)(2)(v) provides:

The manufacturer’s annual report also must contain copies of unpublished reports and summaries of published reports of new toxicological findings in animal studies and in vitro studies (e.g., mutagenicity) conducted by, or otherwise obtained by, the [manufacturer] concerning the ingredients in the drug product.

168. Defendants ignored these regulations and, disregarding the scientific evidence

available to them, did not report to the FDA significant new information affecting the safety or

labeling of Ranitidine-Containing Drugs.

169. Knowledge regarding the risk of NDMA in ranitidine was sufficiently available in the

publicly available scientific literature that any maker or distributor, consistent with their heightened

obligations to ensure the safety of their products, should have known about the potential NDMA risks

associated with ranitidine consumption.

170. Defendants never conducted or provided the relevant studies to the FDA, nor did they

present to the FDA with a proposed disclosure noting the link between ranitidine and NDMA.

Accordingly, because the Defendants never properly disclosed the risk to the FDA, they never

proposed any labeling or storage / transportation guidelines that would have addressed this risk.

Thus, the FDA was never able to reject any proposed warning or proposal for transport / storage.


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171. Nothing prevented any Defendant from, on its own, taking actions to prevent

accumulation of NDMA in ranitidine drugs by ensuring cooled storage and transport. Such actions

would not have required FDA approval, nor would they have violated any regulatory decisions or

laws.

172. Defendants also knew federal law requires pharmaceutical drugs to be stored,

warehoused, and distributed in accordance with current “Good Manufacturing Practices” (“GMPs”)

to ensure they meet safety, quality, purity, identity, and strength standards. See 21 U.S.C. §

351(a)(2)(B).

173. 21 C.F.R. § 211.142(b) states that the GMPs required that warehousing of drug

products shall be performed to provide for “[s]torage of drug products under appropriate conditions

of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug

products are not affected.” In other words, Defendants had a duty and were obligated to properly

store, handle, and warehouse Ranitidine-Containing Drugs.

174. Testing conducted by the FDA, which led to the agency’s ban on Ranitidine-

Containing Drugs, confirms that improper storage of Ranitidine-Containing Drugs has resulted in

extremely high levels of NDMA. FDA has also concluded that NDMA can increase in Ranitidine-

Containing Drugs even under normal storage conditions. and NDMA has been found to increase

significantly in samples stored at higher temperatures, including temperatures the product may be

exposed to during distribution and handling by consumers. FDA’s testing also showed that as

Ranitidine-Containing Drugs age the level of NDMA in the product increases.

175. FDA concluded that these defects raised the level of NDMA in Ranitidine-Containing

Drugs above the acceptable daily intake limit to the point that the drugs had to be banned.

176. In a 1981 study published by GSK, the originator of the ranitidine molecule, the

metabolites of ranitidine in urine were studied using liquid chromatography.70 Many metabolites were

listed, though there is no indication that NDMA was looked for. Plaintiff believes this was

70 Carey, et al., Determination of ranitidine and its metabolites in human urine by reversed-phase ion-pair high-performance liquid chromatography, 255 J. CHROMATOGRAPHY B: BIOMEDICAL SCI. & APPL. 1, 161-168 (1981).


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intentional—a gambit by the manufacturer to avoid detecting a carcinogen in their product. All

Defendants knew or should have known about this study and, therefore, were obligated to investigate

this issue properly. None did.

177. Indeed, in that same year, Dr. de Flora published a note in The Lancet discussing the

results of his experiments showing that ranitidine was turning into mutagenic N-nitroso compounds,

of which NDMA is one, in human gastric fluid when accompanied by nitrites – a substance

commonly found in food and in the body. GSK was aware of this as GSK specifically responded to

the note and attempted to discredit it. Defendants knew or should have known about this scientific

exchange as it was in a popular scientific journal, The Lancet. Therefore, the Defendants were

obligated to investigate this issue properly, and none did.

178. By 1987, after numerous studies raised concerns over ranitidine and cancerous nitroso

compounds (discussed previously), GSK published a clinical study specifically investigating gastric

contents in human patients and N-nitroso compounds.71 This study specifically indicated that there

were no elevated levels of N-nitroso compounds (of which NDMA is one). However, the study was

rigged to fail. It used an analytical system called a “nitrogen oxide assay” for the determination of N-

nitrosamines, which was developed for analyzing food and is a detection method that indirectly and

non-specifically measures N-nitrosamines. Furthermore, in addition to this approach being less

accurate, GSK also removed all gastric samples that contained ranitidine out of concern that samples

with ranitidine would contain “high concentrations of N-nitroso compounds being recorded.” So,

without the chemical being present in any sample, any degradation into NDMA could not, by design,

be observed. Again, this spurious test was intentional and designed to mask any potential cancer risk.

The inadequacy of this test was knowable in light of its scientific publication in 1987. All

Defendants either knew or should have known about the inadequacy of this study and should have

investigated the issue properly and/or took action to protect consumers from the NDMA risks in their

drugs. None did.

71 Thomas, et al., Effects of one year’s treatment with ranitidine and of truncal vagotomy on gastric contents, 6 GUT. Vol. 28, 726-738 (1987).


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179. In fact, upon information and belief, none of the Defendants ever used a mass

spectrometry assay to test for the presence of nitrosamines in any of the studies and trials they did in

connection with their trials associated with the ranitidine NDA. That is because when using mass

spectrometry, it requires heating of up to 130 degrees Celsius, which can result in excessive amounts

of nitrosamines being formed. Had the Defendants used a mass spectrometry assay, it would have

revealed in the finding of large amounts of NDMA, and the FDA would never have approved Zantac

as being safe.

180. Based on the public scientific information available starting in 1983 (or earlier), the

Defendants knew or should have known that NDMA could form in ranitidine by exposure to heat

and/or over time in storage. No Defendants, upon information and belief, took action to reduce this

risk through altering supply-chain conduct or warning consumers. Additionally, no Defendants took

any action to further investigate this issue notwithstanding the signal that existed in the scientific

literature.

181. There are multiple alternatives to Zantac that do not pose the same risk, such as

Cimetidine (Tagamet), Famotidine (Pepcid), Omeprazole (Prilosec), Esomeprazole (Nexium), and

Lansoprazole (Prevacid).

VII. Exemplary / Punitive Damages Allegations (Against Manufacturer Defendants)

182. Defendants’ conduct as alleged herein was done with reckless disregard for human

life, oppression, and malice. Defendants were fully aware of the safety risks of Ranitidine-

Containing Drugs, particularly the carcinogenic potential of Ranitidine-Containing Drugs as it

transforms into NDMA within the chemical environment of the human body and/or during transport

and/or storage. Nonetheless, Defendants deliberately crafted their label, marketing, and promotion to

mislead consumers.

183. This was not done by accident or through some justifiable negligence. Rather,

Defendants knew they could profit by convincing consumers that Ranitidine-Containing Drugs was

harmless to humans, and that full disclosure of the true risks of Ranitidine-Containing Drugs would

limit the amount of money Defendants would make selling the drugs. Defendants’ object was

accomplished not only through a misleading label, but through a comprehensive scheme of selective


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misleading research and testing, false advertising, and deceptive omissions as more fully alleged

throughout this pleading. Plaintiff was denied the right to make an informed decision about whether

to purchase and use Ranitidine-Containing Drugs, knowing the full risks attendant to that use. Such

conduct was done with conscious disregard of Plaintiff’s rights.

184. Accordingly, Plaintiff requests punitive damages against the Manufacturer Defendants

for the harms caused to Plaintiff.

VIII. Equitable Tolling/Estoppel

185. Plaintiff asserts all applicable statutory and common law rights and theories related to

the tolling or extension of any applicable statute of limitations, including equitable tolling, delayed

discovery, discovery rule and/or fraudulent concealment.

186. The discovery rule applies to toll the running of the statute of limitations until Plaintiff

knew, or through the exercise of reasonable care and diligence should have known, of facts that

Plaintiff had been injured, the cause of the injury, and the tortious nature of the wrongdoing that

caused the injury.

187. The nature of Plaintiff’s injuries, damages, or their causal relationship to Defendants’

conduct was not discovered, and through reasonable care and due diligence could not have been

discovered until a date within the applicable statute of limitations for filing Plaintiff’s claims.

188. The running of the statute of limitations is tolled due to equitable tolling. Defendants

are estopped from relying on any statutes of limitation or repose by virtue of their acts of fraudulent

concealment, through affirmative misrepresentations and omissions to Plaintiff and defects associated

with Ranitidine-Containing Drugs including the severity, duration, and frequency of risks and

complications. Defendants affirmatively withheld and/or misrepresented facts concerning the safety

of Ranitidine-Containing Drugs. As a result of Defendants’ misrepresentations and concealment,

Plaintiff could not have known or have learned through reasonable diligence that Plaintiff had been

exposed to the risks alleged herein and that those risks were the direct and proximate result of the

wrongful acts and/or omissions of the Defendants.

189. Given Defendants’ affirmative actions of concealment by failing to disclose this

known but non-public information about the defects – information over which the Defendants had


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exclusive control – and because Plaintiff could not reasonably have known that Ranitidine-

Containing Drugs were and are defective, Defendants are estopped from relying on any statutes of

limitations or repose that might otherwise be applicable to the claims asserted herein.

CAUSES OF ACTION

COUNT I: STRICT PRODUCTS LIABILITY – FAILURE TO WARN

(Against Manufacturer Defendants and the Retailer Defendant)

190. Plaintiff incorporates by reference each allegation set forth in preceding paragraphs as

if fully stated herein.

191. At all relevant times, Defendants engaged in the business of researching, testing,

developing, designing, manufacturing, labeling, marketing, selling, inspecting, handling, storing,

distributing, and promoting Ranitidine-Containing Drugs, which are defective and unreasonably

dangerous to consumers, including Plaintiff, because they do not contain adequate warnings or

instructions concerning the dangerous characteristics of Ranitidine-Containing Drugs and NDMA.

These actions were under the ultimate control and supervision of Defendants. At all relevant times,

Defendants registered, researched, manufactured, distributed, marketed, and sold Ranitidine-

Containing Drugs and aimed at a consumer market.

192. Defendants researched, tested, developed, designed, manufactured, labeled, marketed,

sold, inspected, handled, stored, distributed, and promoted, and otherwise released into the stream of

commerce their Ranitidine-Containing Drugs, and in the course of same, directly advertised or

marketed the products to consumers and end users, including Plaintiff, and therefore had a duty to

warn of the risks associated with the use of Ranitidine-Containing Drugs.

193. At all relevant times, Defendants had a duty to properly test, develop, design,

manufacture, inspect, package, label, market, promote, sell, handle, store, distribute, maintain,

supply, provide proper warnings, and take such steps as necessary to ensure their Ranitidine-

Containing Drugs did not cause users and consumers to suffer from unreasonable and dangerous

risks. Defendants had a continuing duty to warn Plaintiff of dangers associated with Ranitidine-

Containing Drugs. Defendants, as a manufacturer, seller, or distributor of pharmaceutical

medication, are held to the knowledge of an expert in the field.


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194. Defendants had a continuing duty to provide appropriate and accurate instructions

regarding the proper storage and handling of Ranitidine-Containing Drugs.

195. At the time of manufacture, Defendants could have provided the warnings or

instructions regarding the full and complete risks of Ranitidine-Containing Drugs because they knew

or should have known of the unreasonable risks of harm associated with the use of and/or exposure to

such products.

196. At all relevant times, Defendants failed and deliberately refused to investigate, study,

test, or promote the safety or to minimize the dangers to users and consumers of their product and to

those who would foreseeably use or be harmed by Defendants’ Ranitidine-Containing Drugs.

197. Even though Defendants knew or should have known that Ranitidine-Containing

Drugs posed a grave risk of harm, they failed to exercise reasonable care to warn of the dangerous

risks associated with use and exposure to the drugs. The dangerous propensities of their products and

the carcinogenic characteristics of NDMA as produced within the human body as a result of ingesting

Ranitidine-Containing Drugs, as described above, were known to Defendants, or scientifically

knowable to Defendants through appropriate research and testing by known methods, at the time they

distributed, supplied or sold the product, and were not known to end users and consumers, such as the

Plaintiff.

198. Defendants knew or should have known that their products created significant risks of

serious bodily harm to consumers, as alleged herein, and Defendants failed to adequately warn or

instruct consumers, i.e., the reasonably foreseeable users, of the risks of exposure to their products.

Defendants failed to warn and have wrongfully concealed information concerning the dangerous

level of NDMA in their Ranitidine-Containing Drugs and the potential for ingested Ranitidine-

Containing Drugs to transform into the carcinogenic NDMA compound, and further, have made false

and/or misleading statements concerning the safety of Ranitidine-Containing Drugs.

199. At all relevant times, Defendants’ Ranitidine-Containing Drugs reached the intended

consumers, handlers, and users or other persons coming into contact with these products, including

Plaintiff, without substantial change in their condition as designed, manufactured, sold, distributed,

labeled, and marketed by Defendants.


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200. Plaintiff was exposed to Defendants’ Ranitidine-Containing Drugs without knowledge

of their dangerous characteristics.

201. At all relevant times, Plaintiff used and/or was exposed to the use of Defendants’

Ranitidine-Containing Drugs while using them for their intended or reasonably foreseeable purposes,

without knowledge of their dangerous characteristics.

202. Plaintiff could not have reasonably discovered the defects and risks associated with

Ranitidine-Containing Drugs prior to or at the time of Plaintiff consuming Zantac. Plaintiff relied

upon the skill, superior knowledge, and judgment of Defendants to know about and disclose serious

health risks associated with using Defendants’ products.

203. Defendants knew or should have known that the minimal warnings disseminated with

their Ranitidine-Containing Drugs were inadequate, failed to communicate adequate information on

the dangers and safe use/exposure, and failed to communicate warnings and instructions that were

appropriate and adequate to render the products safe for their ordinary, intended and reasonably

foreseeable uses.

204. The information that Defendants did provide or communicate failed to contain

relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff to

avoid using the drug. Instead, Defendants disseminated information that was inaccurate, false, and

misleading, and which failed to communicate accurately or adequately the comparative severity,

duration, and extent of the risk of injuries with use of and/or exposure to Ranitidine-Containing

Drugs; continued to aggressively promote the efficacy of their products, even after they knew or

should have known of the unreasonable risks from use or exposure; and concealed, downplayed, or

otherwise suppressed, through aggressive marketing and promotion, any information or research

about the risks and dangers of ingesting Ranitidine-Containing Drugs.

205. This alleged failure to warn is not limited to the information contained on Ranitidine-

Containing Drugs’ labeling. The Defendants were able, in accord with federal law, to comply with

relevant state law by disclosing the known risks associated with Ranitidine-Containing Drugs through

other non-labeling mediums, i.e., promotion, advertisements, public service announcements, and/or

public information sources. But the Defendants did not disclose these known risks through any


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medium.

206. Had Defendants provided adequate warnings and instructions and properly disclosed

and disseminated the risks associated with their Ranitidine-Containing Drugs, Plaintiff could have

avoided the risk of developing injuries and could have obtained or used alternative medication.

However, as a result of Defendants’ concealment of the dangers posed by their Ranitidine-Containing

Drugs, Plaintiff could not have averted their injuries.

207. Defendants’ conduct, as described above, was reckless. Defendants risked the lives of

consumers and users of their products, including Plaintiff, with knowledge of the safety problems

associated with Ranitidine-Containing Drugs, and suppressed this knowledge from the general public.

Defendants made conscious decisions not to redesign, warn or inform the unsuspecting public.

Defendants’ reckless conduct warrants an award of punitive damages.

208. The Defendants’ lack of adequate warnings and instructions accompanying their

Ranitidine-Containing Drugs were a substantial factor in causing Plaintiff’s injuries.

209. As a direct and proximate result of the Defendants’ failure to provide an adequate

warning of the risks of Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and

permanent pain, suffering, disability, impairment, loss of enjoyment of life, economic loss and

damages including, but not limited to past and future medical expenses, lost income, and other

damages.

210. WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in

Plaintiff’s favor for damages, together with interest, costs herein incurred, attorneys’ fees and all such

other and further relief as this Court deems just and proper.

COUNT II: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT

(Against Manufacturer Defendants and the Retailer Defendant)



212. At all times herein mentioned, Defendants designed, manufactured, tested, marketed,

sold, handled, distributed, and stored the Ranitidine-Containing Drugs ingested by Plaintiff to

patients and physicians.


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213. At all relevant times, the medication ingested by Plaintiff were expected to and did

reach Plaintiff without a substantial change in its condition as manufactured, handled, distributed,

stored, and sold by Defendants.

214. At all relevant times, the medications ingested by Plaintiff were used in a manner that

was foreseeable and intended by Defendants.

215. The Ranitidine-Containing Drugs ingested by Plaintiff were not reasonably safe for

their intended use and were defective with respect to their manufacture, as described herein, in that

Defendants deviated materially from their design, manufacturing, handling, and storage specifications

and/or such design, manufacture, storage, and handling posed an unreasonable risk of harm to

Plaintiff.

216. The Defendants’ Ranitidine-Containing Drugs are inherently dangerous and defective,

unfit and unsafe for its intended and reasonably foreseeable uses, and do not meet or perform to the

expectations of patients and their health care providers.

217. The Ranitidine-Containing Drugs create risks to the health and safety of the patients

that are far more significant and devastating than the risks posed by other products and treatments

available to treat the corresponding medical conditions, and which far outweigh the utility of the

ranitidine-containing drugs because of Defendants’ manufacturing defects, which included but were

not limited to:

a. Failure to follow Good Manufacturing Practices;

b. Failure to adequately inspect/test the drugs during the manufacturing process;

c. Failure to implement procedures that would reduce or eliminate NDMA levels in

Ranitidine-Containing Drugs;

d. Failure to implement appropriate handling instructions and storage conditions for the

drug.

218. Defendants have intentionally and recklessly manufactured the Ranitidine-Containing

Drugs with wanton and willful disregard for the rights and health of the Plaintiff, and with malice,

placing their economic interests above the health and safety of the Plaintiff.


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219. The manufacturing defects in Defendants’ Ranitidine-Containing Drugs were

substantial factors in causing Plaintiff’s injuries

220. As a direct and proximate result of the Defendants’ defective manufacture of the

Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain,

suffering, disability, impairment, loss of enjoyment of life, economic loss and damages including, but

not limited to medical expenses, lost income, and other damages.

WHEREFORE, Plaintiff respectfully requests this Court to enter judgment in Plaintiff’s favor

for damages, together with interest, costs herein incurred, attorneys’ fees and all such other and further

relief as this Court deems just and proper.

COUNT III: NEGLIGENCE – FAILURE TO WARN

(Against Manufacturer Defendants)



222. At all relevant times, Defendants engaged in the business of testing, developing,

designing, manufacturing, marketing, selling, handling, storing, distributing, and promoting

Ranitidine-Containing Drugs. Defendants knew or by the exercise of reasonable care should have

known that their Ranitidine-Containing Drugs are not accompanied with adequate warnings or

instructions concerning the dangerous characteristics of Ranitidine-Containing Drugs and NDMA.

These actions were under the ultimate control and supervision of Defendants.

223. Defendants researched, developed, designed, tested, manufactured, inspected, labeled,

handled, stored, distributed, marketed, promoted, sold, and otherwise released into the stream of

commerce their Ranitidine-Containing Drugs, and in the course of same, directly advertised or

marketed the products to consumers and end users, including Plaintiff, and therefore had a duty to

warn of the risks associated with the use of Ranitidine-Containing Drugs.

224. At all relevant times, Defendants had a duty to properly test, develop, design,

manufacture, inspect, package, label, market, promote, sell, handle, store, distribute, maintain,

supply, provide proper warnings, and take such steps as necessary to ensure their Ranitidine-

Containing Drugs did not cause users and consumers to suffer from unreasonable and dangerous


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risks. Defendants had a continuing duty to warn Plaintiff of dangers associated with Ranitidine-

Containing Drugs. Defendants, as a manufacturer, seller, or distributor of pharmaceutical

medication, are held to the knowledge of an expert in the field.

225. Defendants had a continuing duty to provide appropriate and accurate instructions

regarding the proper storage and handling of Ranitidine-Containing Drugs.

226. At the time of manufacture, Defendants could have provided warnings or instructions

regarding the full and complete risks of Ranitidine-Containing Drugs because they knew or should

have known use of Ranitidine-Containing Drugs was dangerous, harmful and injurious when used by

Plaintiff in a reasonably foreseeable manner.

227. At all relevant times, Defendants failed and deliberately refused to investigate, study,

test, or promote the safety or to minimize the dangers to users and consumers of their product and to

those who would foreseeably use or be harmed by Defendants’ Ranitidine-Containing Drugs.

228. Defendants knew or should have known that Ranitidine-Containing Drugs posed a

grave risk of harm, but failed to exercise reasonable care to warn of the dangerous risks associated

with use and exposure to the products. The dangerous propensities of their products and the

carcinogenic characteristics of NDMA as produced within the human body as a result of ingesting

Ranitidine-Containing Drugs, as described above, were known to Defendants, or scientifically

knowable to Defendants through appropriate research and testing by known methods, at the time they

distributed, supplied or sold the product, and were not known to end users and consumers, such as the

Plaintiff.

229. Defendants further breached their duty by failing to use reasonable care to adequately

warn or instruct consumers (i.e., the reasonably foreseeable users) of the risks of exposure to their

products. Defendants failed to warn and have wrongfully concealed information concerning the

dangerous level of NDMA in their Ranitidine-Containing Drugs and the potential for ingested

Ranitidine-Containing Drugs to transform into the carcinogenic NDMA compound, and further, have

made false and/or misleading statements concerning the safety of Ranitidine-Containing Drugs.


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230. At all relevant times, Plaintiff used and/or was exposed to excessive levels of NDMA

through the use of Defendants’ Ranitidine-Containing Drugs while using them for their intended or

reasonably foreseeable purposes, without knowledge of their dangerous characteristics.

231. Defendants knew or should have known that the minimal warnings disseminated with

their Ranitidine-Containing Drugs were inadequate, failed to communicate adequate information on

the dangers and safe use/exposure, and failed to communicate warnings and instructions that were

appropriate and adequate to render the products safe for their ordinary, intended and reasonably

foreseeable uses.

232. The information that Defendants did provide or communicate failed to contain

relevant warnings, hazards, and precautions that would have enabled consumers such as Plaintiff to

avoid using the product. Instead, Defendants disseminated information that was inaccurate, false, and

misleading, and which failed to communicate accurately or adequately the comparative severity,

duration, and extent of the risk of injuries with use of and/or exposure to Ranitidine-Containing

Drugs; continued to aggressively promote the efficacy of their products, even after they knew or

should have known of the unreasonable risks from use or exposure; and concealed, downplayed, or

otherwise suppressed, through aggressive marketing and promotion, any information or research

about the risks and dangers of ingesting Ranitidine-Containing Drugs.

233. A reasonable company under the same or similar circumstance would have warned

and instructed of the dangers of Ranitidine-Containing Drugs.

234. This alleged failure to warn is not limited to the information contained on Ranitidine-

Containing Drugs’ labeling. The Defendants were able, in accord with federal law, to comply with

relevant state law by disclosing the known risks associated with Ranitidine-Containing Drugs through

other non-labeling mediums, i.e., promotion, advertisements, public service announcements, and/or

public information sources. But the Defendants did not disclose these known risks through any

medium.

235. Had Defendants provided adequate warnings and instructions and properly disclosed

and disseminated the risks associated with their Ranitidine-Containing Drugs, Plaintiff could have

avoided the risk of developing injuries and could have obtained or used alternative medication.


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However, as a result of Defendants’ concealment of the dangers posed by their Ranitidine-Containing

Drugs, Plaintiff could not have averted their injuries.

236. Defendants’ conduct, as described above, was reckless. Defendants risked the lives of

consumers and users of their products, including Plaintiff, with knowledge of the safety problems

associated with Ranitidine-Containing Drugs, and suppressed this knowledge from the general public.

Defendants made conscious decisions not to redesign, warn or inform the unsuspecting public.

Defendants’ reckless conduct warrants an award of punitive damages.

237. The Defendants’ lack of adequate warnings and instructions accompanying their

Ranitidine-Containing Drugs were a substantial factor in causing Plaintiff’s injuries.

238. As a direct and proximate result of the Defendants’ failure to provide an adequate

warning of the risks of Ranitidine-Containing Drugs, Plaintiff has been injured, sustained severe and

permanent pain, suffering, disability, impairment, loss of enjoyment of life, economic loss and

damages including, but not limited to past and future medical expenses, lost income, and other

damages.




COUNT IV: NEGLIGENT PRODUCT DESIGN




241. The Defendants knew or, by the exercise of reasonable care, should have known,

ordinary consumers such as Plaintiff would not have realized the potential risks and dangers of

Ranitidine-Containing Drugs.

242. The Defendants owed a duty to all reasonably foreseeable users to design a safe

product.


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243. The Defendants breached their duty by failing to use reasonable care in the design of

Ranitidine-Containing Drugs because the drug exposed users to unsafe levels of the carcinogen

NDMA.


Ranitidine-Containing Drugs by negligently designing the drug with an inherent susceptibility to

form NDMA.


Ranitidine-Containing Drugs by negligently designing in design and formulation, in one or more of

the following ways:

a. When placed in the stream of commerce, Defendants’ Ranitidine-Containing

Drugs were defective in design and formulation, and, consequently, dangerous

to an extent beyond that which an ordinary consumer would contemplate;

b. When placed in the stream of commerce, Defendants’ Ranitidine-Containing

Drugs were unreasonably dangerous in that they were hazardous and posed a

grave risk of cancer and other serious illnesses when used in a reasonably

anticipated manner;

c. When placed in the stream of commerce, Defendants’ Ranitidine-Containing

Drugs contained unreasonably dangerous design defects and were not

reasonably safe when used in a reasonably anticipated or intended manner;

d. Defendants did not sufficiently test, investigate, or study their Ranitidine-

Containing Drugs and, specifically, the ability for Ranitidine-Containing Drugs

to transform into the carcinogenic compound NDMA within the human body;

e. Defendants did not sufficiently test, investigate, or study their Ranitidine-

Containing Drugs and, specifically, the ability for Ranitidine-Containing Drugs

to develop increasing levels of NDMA over time under anticipated and

expected storage and handling conditions;

f. Exposure to Ranitidine-Containing Drugs presents a risk of harmful side

effects that outweigh any potential utility stemming from the use of the drug;


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g. Defendants knew or should have known at the time of marketing Ranitidine-

Containing Drugs that exposure to Ranitidine-Containing Drugs could result in

cancer and other severe illnesses and injuries;

h. Defendants did not conduct adequate post-marketing surveillance of their

Ranitidine-Containing Drugs; and

i. Defendants could have employed safer alternative designs and formulations.

For example, the Defendants could have added ascorbic acid (Vitamin C) to

each dose of Ranitidine-Containing Drugs, which is known to scavenge nitrites

and reduce the ability of the body to recombine ranitidine into NDMA.

246. The Defendants breached their duty by failing to use reasonable care by failing to use

cost effective, reasonably feasible alternative designs. there was a practical, technically feasible, and

safer alternative design that would have prevented the harm without substantially impairing the

reasonably anticipated or intended function of Defendants’ Ranitidine-Containing Drugs.

247. A reasonable company under the same or similar circumstances would have designed

a safer product.

248. Plaintiff was harmed directly and proximately by the Defendants’ failure to use

reasonable care in the design of their Ranitidine-Containing Drugs. Such harm includes significant

exposure to a known carcinogen, NDMA, which can cause or contribute the development of cancers.

249. Defendants’ defective design of Ranitidine-Containing Drugs was willful, wanton,

malicious, and conducted with reckless disregard for the health and safety of users of the Ranitidine-

Containing Drugs, including Plaintiff.

250. The defects in Defendants’ Ranitidine-Containing Drugs were substantial factors in

causing Plaintiff’s injuries.

251. As a direct and proximate result of the Defendants’ defective design of the Ranitidine-

Containing Drugs, Plaintiff has been injured, sustained severe and permanent pain, suffering,

disability, impairment, loss of enjoyment of life, economic loss and damages including, but not

limited to past and future medical expenses, lost income, and other damages.


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COUNT V: NEGLIGENT MANUFACTURING




254. At all relevant times, the Defendants manufactured, tested, marketed, sold, handled,

distributed and stored the Ranitidine-Containing Drugs that Plaintiff consumed.

255. The Defendants had a duty to exercise reasonable care, in the manufacturing, testing,

marketing, sale, handling, storing, packaging, and distribution of Ranitidine-Containing Drugs.

256. The Defendants knew or, by the exercise of reasonable care, should have known, use

of Ranitidine-Containing Drugs were carelessly manufactured, packaged was dangerous, harmful and

injurious when used by Plaintiff in a reasonably foreseeable manner.

257. The Defendants knew or, by the exercise of reasonable care, should have known,

ordinary consumers such as Plaintiff would not have realized the potential risks and dangers of

Ranitidine-Containing Drugs improperly manufactured, tested, marketed, sold, handled, distributed,

and stored.

258. Without limitation, examples of the manner in which Defendants breached their duty

to exercise reasonable care in manufacturing Ranitidine-Containing Drugs, included:

a. Failure to follow Good Manufacturing Practices;

b. Failure to adequately inspect/test the drugs during the manufacturing process;

c. Failure to implement procedures that would reduce or eliminate NDMA levels

in Ranitidine-Containing Drugs; and

d. Failure to implement appropriate handling instructions and storage conditions

for the drug.


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259. A reasonable manufacturer under the same or similar circumstances would have

implemented appropriate manufacturing procedures to better ensure the quality and safety of their

product.

260. Plaintiff was harmed directly and proximately by the Defendants’ failure to use

reasonable care in the manufacture of their Ranitidine-Containing Drugs. Such harm includes

significant exposure to a known carcinogen, NDMA, which can cause or contribute the development

of cancers.

261. Defendants’ improper manufacturing of Ranitidine-Containing Drugs was willful,

wanton, malicious, and conducted with reckless disregard for the health and safety of users of the

Ranitidine-Containing Drugs, including Plaintiff.

262. The defects in Defendants’ Ranitidine-Containing Drugs were substantial factors in

causing Plaintiff’s injuries.

263. As a direct and proximate result of the Defendants’ improper manufacturing of



not limited to past and future medical expenses, lost income, and other damages.




COUNT VI: NEGLIGENT MISREPRESENTATION




266. At all relevant times, Defendants designed, manufactured, tested (or not), packaged,

labeled, marketed, advertised, promoted, supplied, stored, handled, warehoused, distributed, sold

and/or otherwise placed Ranitidine Containing Drugs into the stream of commerce, and therefore

owed a duty of reasonable care to avoid causing harm to those that consumed Ranitidine-Containing

Drugs, such as Plaintiff.


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267. Defendants were negligent, reckless, and careless and owed a duty to Plaintiff to make

accurate and truthful representations regarding Ranitidine Containing Drugs, Defendants breached

their duty, thereby causing Plaintiff to suffer harm.

268. Defendants represented to Plaintiff via the media, advertising, website, social media,

packaging, and promotions, among other misrepresentations described herein that:

269. Ranitidine-Containing Drugs were both safe and effective for the lifetime of the

product, when in fact, the drug contains unsafe levels of NDMA far in excess of the 96 ng limit that

increases as the product ages;

270. Consumption of Ranitidine-Containing Drugs would not result in excessive amounts

of NDMA being formed in their bodies; and

271. The levels of NDMA in Ranitidine-Containing Drugs have no practical clinical

significance; and

272. Ranitidine-Containing Drugs were safe for their intended use when, in fact,

Defendants knew or should have known the products were not safe for their intended purpose.

273. These representations were false. Because of the unsafe levels of NDMA in

Ranitidine-Containing Drugs, the drug presented an unacceptable risk of causing cancer. Ranitidine-

Containing Drugs are so unsafe that the FDA was compelled to order the immediate ban of all

Ranitidine-Containing Drugs on April 1, 2020.

274. Defendants knew or should have known these representations were false and

negligently made them without regard for their truth.

275. Defendants had a duty to accurately provide this information to Plaintiff. In concealing

this information from Plaintiff, Defendants breached their duty. Defendants also gained financially

from, and as a result of their breach.

276. Defendants intended for Plaintiff to rely on these representations.

277. Each of these misrepresentations were material at the time they were made. In

particular, each of the misrepresentations concerned material facts that were essential to the analysis

undertaken by Plaintiff as to whether to purchase or consume Ranitidine Containing Drugs.


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278. Defendants have yet to correct these misrepresentations about Ranitidine-Containing

Drugs.

279. Plaintiff reasonably relied on these representations and were harmed as described

herein. Plaintiff’s reliance on Defendants’ representation was a substantial factor in causing

Plaintiff’s harms. Had Defendants told Plaintiff the truth about the safety and composition of

Ranitidine-Containing Drugs, Plaintiff would not have consumed or purchased them.

280. Defendants’ acts and omissions as described herein were committed in reckless

disregard of Plaintiff’s rights, interests, and well-being to enrich Defendants.

281. Plaintiff was injured as a direct and proximate result of Defendants’ negligent

misrepresentations regarding Ranitidine-Containing Drugs as described herein.




COUNT VII: NEGLIGENCE

(Against Retailer Defendant)

283. Plaintiff incorporates by reference every allegation set forth in preceding paragraphs

as if fully stated herein.

284. At all times relevant to this Complaint, Defendants had a duty to ensure that the

Ranitidine-Containing Drugs supplied to Plaintiff were stored, handled, and dispensed in a safe

manner.

285. In particular, Defendants had a duty to ensure that the Ranitidine-Containing Drugs

prescribed to Plaintiff were safely stored on Defendants’ premises by conducting diligent

surveillance, monitoring and inspection of storage practices.

286. As described throughout this Complaint, storage of Ranitidine-Containing Drugs can

lead to the formation of dangerous levels of NDMA within the drugs. Extensive data exists to

demonstrate that exposure to heat in storage conditions leads to the systematic breakdown of the

ranitidine molecule into NDMA, accumulating over time in the finished product. Considering

Ranitidine-Containing drugs have an approved shelf life of 36 months, the possibility of the drug


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accumulating dangerously high levels of NDMA prior to consumption is very real—a point

underscored by the FDA’s swift removal of the product from the market.

287. Defendants breached their duty to Plaintiff by failing to properly store the Ranitidine-

Containing Drugs supplied to Plaintiff, leading to dangerous levels of NDMA accumulating in the

drugs that harmed Plaintiff. Defendants acted below the standard of care by storing and dispensing

Ranitidine-Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs

were safe for human use by, for example, consulting the available medical literature evidencing the

potential human health dangers associated with the storage of Ranitidine-Containing Drugs and the

formation of NDMA within Ranitidine-Containing drugs when the drugs are stored at particular

temperatures.

288. Defendants knew or should have known that storage of Ranitidine-Containing Drugs

can lead to the formation of dangerous levels of carcinogenic NDMA in the drugs.

289. Defendants failed to adhere to and/or follow its established practices and procedures in

storing the Ranitidine-Containing Drugs supplied to Plaintiff.

290. As a direct and proximate result of Defendants’ improper storage practices of the

Ranitidine-Containing Drugs, Plaintiff was exposed to dangerous levels of NDMA which caused

Plaintiff’s cancer.

291. As a direct and proximate result of Defendants’ storage, handling and dispensing of



not limited to past and future medical expenses, and other damages.

JURY TRIAL DEMAND

292. Plaintiff demands a trial by jury on all the triable issues within this pleading.

PRAYER FOR RELIEF

293. WHEREFORE, Plaintiff requests the Court to enter judgment in Plaintiff’s favor and

against the Defendants for:

a. actual or compensatory damages in such amount to be determined at trial and as

provided by applicable law;


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b. exemplary and punitive damages sufficient to punish and deter the Defendants and

others from future wrongful practices;

c. pre-judgment and post-judgment interest;

d. costs including reasonable attorneys’ fees, court costs, and other litigation expenses;

and

e. any other relief the Court may deem just and proper.

Dated: May 11, 2020

Jennifer A. Moore, Esq. (State Bar No. 206779) [email protected] MOORE LAW GROUP, PLLC 1473 South 4th Street Louisville, KY 40208 Tel: (502) 717-4080 Fax: (502) 717-4086

Counsel for Plaintiff


EXHIBIT 2


NOTICE OF REMOVAL

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NORTHERN DISTRICT OF CALIFORNIA

DEFENDANTS’ GLAXOSMITHKLINE, LLC; BOEHRINGER INGELHEIM

PHARMACEUTICALS, INC.; BOEHRINGER INGELHEIM USA CORPORATION; PFIZER, INC.; SANOFI US SERVICES INC; AND SANOFI-AVENTIS U.S. LLC

NOTICE OF REMOVAL

Pursuant to 28 U.S.C. §§ 1332, 1441, and 1446, Defendants GlaxoSmithKline, LLC;

Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Pfizer, Inc.;

Sanofi US Services Inc.; Sanofi-Aventis U.S. LLC; (collectively, “Removing Defendants”) hereby

give notice of removal of this action, Ralph Dudley v. GlaxoSmithKline, LLC et al., Case No.

RG20061652 from the Superior Court of the State of California in and for Alameda County to the

United States District Court for the Northern District of California.

Andrew T. Bayman (pro hac vice forthcoming) Matthew J. Blaschke (SBN 281938) KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Tel: (415) 318-1212 Fax: (415) 318-1300 [email protected] [email protected] Attorneys for Defendant Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation [Additional Counsel on Signature Page]

Ralph Dudley

Plaintiff,

v.

GlaxoSmithKline, LLC; Boehringer Ingelheim Pharmaceuticals, Inc.; Boehringer Ingelheim USA Corporation; Pfizer, Inc.; Sanofi US Services Inc.; Sanofi-Aventis U.S. LLC; The Vons Companies, Inc.; and DOES 1 through 100, inclusive,

Defendants.

Case No. 3:20-cv-3913 NOTICE OF REMOVAL OF ACTION DEMAND FOR JURY TRIAL

Case 4:20-cv-03913-DMR Document 1 Filed 06/15/20 Page 1 of 19


- 2 - NOTICE OF REMOVAL

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INTRODUCTION

1. This action is one of hundreds of related lawsuits filed against manufacturers and

sellers of Zantac (ranitidine), an antacid medication, alleging that the medication causes various

cancers. On February 6, 2020, the Judicial Panel on Multidistrict Litigation (“JPML”) created a

Multidistrict Litigation (“MDL”) in the Southern District of Florida before Judge Robin Rosenberg

for pretrial coordination of cases like this one “in which plaintiffs allege that they developed cancer

as a result of NDMA formed from Zantac.” In re Zantac (Ranitidine) Prods. Liab. Litig., 2020 WL

582134, at *2 (J.P.M.L. 2020). To date, over 300 actions have been transferred to the Zantac MDL.

2. On May 11, 2020, Plaintiff filed this Complaint in the Superior Court of the State of

California in and for Alameda County against the Removing Defendants, which had manufactured

or sold Zantac over various time periods. The thrust of this Complaint—like those already pending

in the MDL—is that Plaintiff ingested over-the-counter (“OTC”) “Ranitidine-Containing Drugs,”

and as a result, developed cancer, in this case prostate cancer. Compl. ¶¶ 10-11. The Removing

Defendants are not citizens of California for diversity purposes. See id. ¶¶ 25, 26, 29, 32-33, 35. A

copy of the Complaint is attached as Exhibit A.

3. Unlike the cases in the MDL—including cases filed by these same plaintiffs’

lawyers—this Complaint also names a California-based retailer as a Defendant in an effort to

destroy diversity jurisdiction. Specifically, the Complaint includes The Vons Companies, Inc. (the

“Retailer Defendant”) as a named defendant. Id. ¶ 38. The Retailer Defendant is alleged to be a

citizen of California for diversity purposes. Id. ¶ 38.

4. As further explained below, the Retailer Defendant is fraudulently joined in this action

because—on its face—Plaintiff’s complaint fails to allege any viable cause of action against it, and

therefore its citizenship must be ignored for purposes of diversity jurisdiction.

5. First, Plaintiff cannot state any viable strict products liability claim against the

Retailer Defendant because those claims are preempted by federal law. The Retailer Defendant

lacks the legal authority under U.S. Food and Drug Administration (“FDA”) regulations to

unilaterally alter Zantac’s government-approved labeling or to manufacture the product differently.

See, e.g., Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (“If the Manufacturers had independently




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changed their labels to satisfy their state-law duty [to attach a safer label], they would have violated

federal law.”); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), MDL No. 2243,

2012 WL 181411, at *3 (D.N.J. Jan. 17, 2012) (“As a distributor of Fosamax, Watson has no power

to change Fosamax labeling. That power lies with the applicant who filed the New Drug Application

. . . seeking approval to market Fosamax.”).

6. Second, Plaintiff does not state a viable negligence claim against the Retailer

Defendant. The basis for Plaintiff’s claim is that the Retailer Defendant allegedly failed to ascertain

that the products at issue can degrade under certain conditions to form a compound called N-

nitrosodiethylamine (“NDMA”) and failed to properly store Zantac to avoid such degradation.

Compl. ¶¶ 285, 287. It is black-letter law that retailers do not have a duty to inspect or test products

in common use for defects unknown to them. See Sears, Roebuck & Co. v. Marhenke, 121 F.2d

598, 600 (9th Cir. 1941) (applying California law) (a retailer “who purchases and sells an article in

common and general use, in the usual course of trade, without knowledge of its dangerous qualities

is not under duty to exercise ordinary care to discover whether it is dangerous or not”); Valentine v.

Baxter Healthcare Corp., 68 Cal. App. 4th 1467, 1485–86 (1999) (“[I]mposition of liability for

breach of an independent duty to conduct long-term testing, where the causal link to the known

harm to plaintiff is the unknown outcome of testing that was not done, would be beyond the pale

of any California tort doctrine we can identify.”) (emphasis in original). Otherwise, every retailer

in California would have the responsibility to conduct a battery of scientific testing on all

pharmaceuticals stocked on its shelves, despite their FDA approval, in order to independently

ascertain their safety. That is not the law.

7. Because the Retailer Defendant is fraudulently joined, federal jurisdiction over this

action is proper based on complete diversity between Plaintiff and all properly joined defendants.

JURISDICTION

8. The Removing Defendants remove this action on the basis of diversity jurisdiction

pursuant to 28 U.S.C. §§ 1332, 1441, and 1446 and the doctrine of fraudulent joinder.

9. This Court has subject matter jurisdiction under 28 U.S.C. § 1332(a) because:

(1) there is complete diversity between Plaintiff and the properly joined Defendants; (2) the amount




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in controversy exceeds $75,000, exclusive of interest and costs; and (3) all other requirements for

removal have been satisfied.

BASIS FOR REMOVAL

I. There Is Complete Diversity Between Plaintiff and the Properly Joined Parties.

10. Plaintiff is a citizen of California. Id. ¶ 9.

11. The properly joined defendants are all citizens of states other than California. See id.

¶¶ 25, 26, 29, 32-33, 35.1

12. Defendant Boehringer Ingelheim Pharmaceuticals, Inc. is a corporation organized

under the laws of Delaware with its principal place of business in Ridgefield, Connecticut. Id. ¶ 25.

Boehringer Ingelheim Pharmaceuticals, Inc. is, therefore, a citizen of Delaware and Connecticut.

13. Defendant Boehringer Ingelheim USA Corporation is a corporation organized under

the laws of Delaware with its principal place of business in Ridgefield, Connecticut. Id. ¶ 26.

Boehringer Ingelheim USA Corporation is, therefore, a citizen of Delaware and Connecticut.

14. Defendant GlaxoSmithKline LLC is a limited liability company organized under the

laws of Delaware with its principal place of business in Wilmington, Delaware. Its sole member is

GlaxoSmithKline Holdings (America) Inc., a corporation organized under the laws of Delaware

with its principal place of business in Wilmington, Delaware. See Attachment to Corp. Disclosure

Statement, In re Zantac (Ranitidine) Prods. Liab. Litig., MDL No. 2924, Dkt. 43-1.

GlaxoSmithKline LLC is, therefore, a citizen of Delaware.

15. Defendant Pfizer Inc. is a corporation organized and existing under the laws of the

State of Delaware, with its principal place of business in New York, New York. Id. ¶ 32. Pfizer

Inc. is, therefore, a citizen of Delaware and New York.

16. Defendant Sanofi US Services Inc. is a corporation organized under the laws of

Delaware with its principal place of business in Bridgewater, New Jersey. Id. ¶ 33. Sanofi US

Services Inc. is, therefore, a citizen of Delaware and New Jersey.

1 Plaintiff dismissed Defendants Boehringer Ingelheim Corporation, GlaxoSmithKline, plc, and Sanofi S.A., and thus this Court need not consider their citizenship for purposes of removal. Exhibit A, at 001. In any event, Boehringer Ingelheim Corporation, GlaxoSmithKline, plc, and Sanofi S.A. are foreign entities and are not citizens of California. See Compl. ¶¶ 27, 30, 34.




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17. Defendant Sanofi-Aventis U.S. LLC is a limited liability company organized under

the laws of Delaware with its principal place of business in Bridgewater, New Jersey. Id. ¶ 35. The

sole member of Sanofi-Aventis U.S. LLC is Sanofi US Services Inc., a Delaware corporation with

its principal place of business in New Jersey. Defendant Sanofi-Aventis U.S. LLC is, is therefore,

a citizen of Delaware and New Jersey.

18. Defendants Does 1 through 100 are sued under “fictitious names.” Id. ¶ 39-45.

Therefore, their citizenship must be ignored for purposes of determining the propriety of removal.

See 28 U.S.C. § 1441(b)(1) (“In determining whether a civil action is removable on the basis of the

jurisdiction under section 1332(a) of this title, the citizenship of defendants sued under fictitious

names shall be disregarded.”).

19. Because Plaintiff is a citizen of California and the properly joined defendants are

citizens of states other than California, complete diversity exists between Plaintiff and the properly

joined defendants. See 28 U.S.C. §§ 1332, 1441.

II. The Retailer Defendant Is Fraudulently Joined

20. The Retailer Defendant is fraudulently joined, and its California citizenship should

therefore be disregarded for purposes of removal.

21. A defendant is fraudulently joined and its presence in the lawsuit is ignored for

purposes of determining diversity where there is no “possibility that a state court would find that

the complaint states a cause of action” against it. Grancare, LLC v. Thrower by & through Mills,

889 F.3d 543, 549 (9th Cir. 2018). See also Morris v. Princess Cruises, Inc., 236 F.3d 1061, 1067

(9th Cir. 2001) (a defendant is fraudulently joined “if the plaintiff fails to state a cause of action

against the resident defendant, and the failure is obvious according to the settled rules of the state”)

(citing McCabe v. Gen. Foods Corp., 811 F.2d 1336, 1339 (9th Cir. 1987)); Ritchey v. Upjohn Drug

Co., 139 F.3d 1313, 1318 (9th Cir. 1998) (same).

22. Here, the Retailer Defendant is fraudulently joined because: (1) retailers cannot

unilaterally change an FDA-approved label or alter the highly regulated manufacturing processes as

mere sellers of Ranitidine-Containing Drugs, and the claims against them are accordingly




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preempted; and (2) Plaintiff does not plead a cognizable negligence action against the Retailer

Defendant.

A. Plaintiff’s Strict Liability Claims Against the Retailer Defendant Are Preempted.

23. Plaintiff’s claims for strict products liability, under failure-to-warn and

manufacturing-defect theories, against the Retailer Defendant is preempted by federal law. As a

result, there is no “possibility that a state court would find that the complaint states a cause of action”

against the retailer. Grancare, LLC v. Thrower by & through Mills, 889 F.3d 543, 549 (9th Cir.

2018).

24. In Pliva, Inc. v. Mensing, 564 U.S. 604 (2011), the Supreme Court held that claims

involving an FDA-approved product are preempted under federal law when a defendant cannot

unilaterally satisfy state-law duties without FDA’s prior approval. Id. at 623–24 (“[W]hen a party

cannot satisfy its state duties without the Federal Government’s special permission and assistance,

which in turn is dependent on the exercise of judgment by a federal agency, that party cannot

independently satisfy those state duties for pre-emption purposes.” Id. at 623–24 (emphasis added);

see also Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 475 (2013). In Mensing, the Supreme Court

announced this preemption principle in the context of product liability actions against manufacturers

of generic drugs. Mensing, 564 U.S. at 610. The manufacturers argued that, under federal drug

regulations, they are “prevented . . . from independently changing their generic drugs’ safety labels.”

Id. at 617. Consequently, they asserted, holding them liable under state law for failure to

“adequately and safely label their products,” would directly conflict with labeling requirements

under federal law. Id. The Supreme Court agreed: Because generic manufacturers are unable to

comply with both state and federal law, state failure-to-warn claims against generic drug

manufacturers must be preempted. Id. at 618–620, 614 (“If the Manufacturers had independently

changed their labels to satisfy their state-law duty [to attach a safer label], they would have violated

federal law.”).

25. The same preemption analysis that the Supreme Court articulated in Mensing bars

claims against pharmaceutical distributors or retailers that stand even further removed than generic




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manufacturers from the ability to change drug labeling that the FDA has approved. Only the party

that submits the New Drug Application (the “NDA”) to obtain FDA approval to market a drug can

seek to change the drug’s labeling after initial approval. 21 C.F.R. § 314.71(a); id. § 314.70(a)(4)

(“The applicant must promptly revise all promotional labeling and advertising to make it consistent

with any labeling change implemented . . . .”). Here, the Retailer Defendant is not, and never was,

the holder of the Zantac NDA. Rather, it is named solely in its capacity as a retailer that sold FDA-

approved products manufactured by other parties. Therefore, the Retailer Defendant, had no

authority to unilaterally change the product’s labeling.

26. In fact, had the Retailer Defendant provided warnings about risks not included in

Zantac’s approved product labeling, it would have been breaking federal law, and would be subject

to potential civil and/or criminal penalties for “misbranding.” 21 U.S.C. §§ 333, 334. FDA

regulations on misbranding prohibit any person, including a pharmaceutical distributor, from

issuing any warning that is not consistent with the drug’s FDA-approved labeling. 21 C.F.R.

§ 201.100(d)(1). Under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the

“FDCA”), when FDA approves a drug for marketing, it also approves the drug’s labeling, including

information about the drug’s potential risks and benefits. 21 U.S.C. § 355(d).

27. The FDCA and its implementing regulations provide that a drug is misbranded if its

labeling is “false and misleading in any particular.” 21 U.S.C. § 352(a); id. § 321(n); id. § 331(a),

(b), (k); 21 C.F.R § 201.6(a). A statement about a drug’s risks would be considered “false and

misleading” if FDA has not found it to be properly substantiated. 40 Fed. Reg. 28,584 (1975) (“In

short, a drug is misbranded if its labeling makes claims that have not been properly substantiated.”).

By definition, an unapproved warning by a distributor or retailer that is inconsistent with the

approved drug labeling would not have been found to be substantiated by FDA and, thus, would

constitute misbranding.2

2 Plaintiff’s allegation that the alleged failure to warn was not limited to the Ranitidine-Containing Drugs’ labeling does not save this claim. Compl. ¶ 205. The term “labeling” under FDA regulations is broad and includes “all labels and other written, printed, or graphic matter.” 21 U.S.C. § 321(m); see also 21 C.F.R. § 1.3 (same). Thus, all materials disseminated by pharmaceutical distributors about a drug’s risks and benefits, including promotional and other materials, must be “consistent with and not contrary to . . . the approved or permitted labeling.” 21 C.F.R. § 201.100(d)(1); 73




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28. Applying this Supreme Court precedent, numerous federal courts have accordingly

held that failure-to-warn claims asserted against pharmaceutical distributors are preempted because

the distributors cannot change approved product labeling. See, e.g., In re Fosamax (Alendronate

Sodium) Prods. Liab. Litig. (No. II), MDL No. 2243, 2012 WL 181411, at *3 (D.N.J. Jan. 17, 2012)

(“As a distributor of Fosamax, Watson has no power to change Fosamax labeling. That power lies

with the applicant who filed the New Drug Application . . . seeking approval to market Fosamax.”);

Pierik v. GE Healthcare Inc., No. 1:18-cv-07733, 2019 WL 4686551, at *1 (N.D. Ill. June 18, 2019)

(“As McKesson is alleged to be a distributor rather than a manufacturer of Omniscan and

MultiHance, I cannot draw a reasonable inference that McKesson had the ability to modify the

warning labels of those drugs. Plaintiffs’ claims against McKesson are preempted . . . .”); Smith v.

GE Healthcare, Inc., No. 3:19-cv-00492, 2019 WL 4565246 (W.D. La. Sept. 4, 2019) (finding

failure-to-warn claims preempted because “McKesson has no authority to unilaterally change or

add to the Omniscan labeling” as a pharmaceutical distributor); Brazil v. Janssen Research & Dev.

LLC, 196 F. Supp. 3d 1351, 1364–65 (N.D. Ga. 2016) (“A distributor, even of a brand name drug,

has no power to change . . . labeling. That power lies with the applicant who filed the New Drug

Application.”) (citations and quotation marks omitted); In re Yasmin & Yaz Prods. Liab. Litig.,

MDL No. 2100, 2014 WL 1632149, at *6 (S.D. Ill. Apr. 24, 2014) (“Under applicable federal

regulations, generic distributors have no more authority than generic manufacturers to alter a drug’s

composition, label, or design. Accordingly, the principles announced in Mensing . . . are equally

applicable to generic distributors.”). Supreme Court precedent mandates the same result here.

29. Plaintiff’s manufacturing-defect claim against the Retailer Defendant is preempted

for the same reason as Plaintiff’s failure-to-warn claim: under federal law, the Retailer Defendant

could not have altered the manufacturing of Zantac. If the Retailer Defendant manufactured Zantac

in a different manner, it would be liable under the FDCA for the introduction into interstate

commerce of an unapproved and misbranded new drug. See 21 U.S.C. § 331(a) and (d).

Fed. Reg. 2848, 2850 n.3 (2008) (“Federal law governs not only what information must appear in labeling, but also what information may not appear.”).




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30. FDA highly regulates the manufacturing of drugs and associated processes. See

FDCA § 505; 21 U.S.C. § 355. As a result, the NDA holder must describe and disclose to FDA all

manufacturers of its products. See 21 U.S.C. § 355(b)(1)(D) (NDA must contain “a full description

of the methods used in, and the facilities and controls used for, the manufacture, processing, and

packing of such drug.”); 21 C.F.R. § 314.50(d)(i) (NDA must contain “a detailed technical

chemistry, manufacturing, and controls section,” detailing, among other things “the name and

address of the drug substance’s manufacturer” as well as “the name and address of each

manufacturer of the drug product; [and] a description of the manufacturing and packaging

procedures and in-process controls for the drug product.”). To add or change a manufacturer, the

NDA holder must accordingly submit a supplement to its NDA. See 21 C.F.R. § 314.70(a). Just as

only the NDA holder can change drug labeling, only the NDA holder has authority to submit a

supplement to its NDA to add or change a manufacturer. See 21 C.F.R. § 314.71(a) (“Only the

applicant may submit a supplement to an application.”). Manufacturing a drug out of compliance

with an approved NDA causes the product to be an unapproved new drug in violation of the FDCA.

21 U.S.C. § 331(d) (“The following acts are prohibited: . . . The introduction or delivery for

introduction into interstate commerce of any article in violation of section . . . 505 (21 U.S.C. §

355)”).

31. The Retailer Defendant was not identified in the Zantac NDA as an authorized

manufacturer of Zantac or listed and registered with FDA to manufacture Zantac. Nor did the

Retailer Defendant have the authority to designate itself as a manufacturer pursuant to an approved

NDA because none is an NDA holder. Had the Retailer Defendant nevertheless manufactured and

sold Zantac in a different manner to avoid alleged state-law liability, that would have violated the

FDCA by introducing an unapproved new drug into interstate commerce. See 21 U.S.C. § 331(d)

(“The following acts are prohibited: . . . The introduction or delivery for introduction into interstate

commerce of any article in violation of section . . . 505”). In addition, manufacturing Zantac without

appropriately registering and listing with FDA would cause the resulting product to be misbranded.

21 U.S.C. § 352(o) (A drug or device shall be deemed misbranded “[i]f it was manufactured,

prepared, propagated, compounded, or processed in an establishment not duly registered”). Both




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actions would subject retailers to civil and/or criminal penalties. See 21 U.S.C. § 333(a); 21 U.S.C.

§ 303(a)(1) (“Any person who violates a provision section 301 shall be imprisoned for not more

than one year or fined not more than $1,000, or both.”). Thus, under the settled preemption

principles articulated in Mensing, there is no “possibility that a state court would find that the

complaint states a cause of action” against the Retailer Defendant. Grancare, LLC, 889 F.3d at 549

(internal quotation marks omitted).

32. Some district courts have remanded cases where removals were based on preemption

of similar claims against distributors, though acknowledging the logic of the argument.3 These

cases are not binding, and the Court need not follow them. Indeed, this very issue is currently

pending before the United States Court of Appeals for the Ninth Circuit. See Geisse v. Bayer

HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *2–*3 (N.D. Cal. Mar. 18,

2019), appeal docketed, No. 19-15783 (9th Cir. Apr. 17, 2019).

33. Nor is the reasoning of those cases persuasive. Most invoked Hunter v. Philip Morris

USA, 582 F.3d 1039, 1044 (9th Cir. 2009), for the proposition that it is inappropriate to examine the

affirmative defense of preemption in the context of a motion to remand. But Hunter involved a

common defense that would “effectively decide[] the entire case” by barring claims against all

defendants. Id. at 1045 (internal quotation marks omitted). Not so here. Although the Removing

Defendants have a variety of dispositive defenses (including some based on different federal

preemption arguments), the claims against the Retailer Defendant is barred here for a different

3 See Geisse v. Bayer HealthCare Pharm. Inc., No. 17-CV-07026-JD, 2019 WL 1239854, at *3 (N.D. Cal. Mar. 18, 2019), appeal docketed, No. 19-15783 (9th Cir. Apr. 17, 2019) (“[P]reemption goes to the merits of the plaintiff’s case and entails a degree of analysis that does not render a state law claim obviously barred or frivolous for fraudulent joinder purposes.”); Dodich v. Pfizer Inc., No. C 18-02764 WHA, 2018 WL 3584484, at *3 (N.D. Cal. July 26, 2018) (“Although logical, neither Mensing nor Bartlett specifically dealt with distributors and defendants do not identify binding authority extending the decisions. As such, it is not manifest that plaintiff has no possible claim against McKesson under California law.”); Hatherley v. Pfizer, Inc., No. CIV 2:13-00719 WBS, 2013 WL 3354458, at *6 (E.D. Cal. July 3, 2013) (“Thus, while the argument that distributors of brand name drugs are the same as generic manufacturers may be persuasive, unless and until this rational is extended, it is not obvious that plaintiffs have no claim against McKesson under California law because of a preemption defense.”) (emphasis in original) (citations and quotation marks omitted); In re Abilify (aripiprazole) Prods. Liab. Litig., 3:16-MD-2734, 2018 WL 6258903, at *5 (N.D. Fla. Nov. 8, 2018) (noting the “conceptual, and frankly, practical appeal” of the argument).




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reason that does not apply to the Removing Defendants: the Retailer Defendant never had labeling

or manufacturing responsibility for the product, making it impossible for them to unilaterally change

the label or manufacturing of the product. Cf. id. at 1044.

34. In addition, no searching inquiry into the merits of the case is required to find that the

claims against the Retailer Defendant are preempted. Hunter, 582 F.3d at 1044 (explaining that

only a “summary inquiry [was] appropriate” to determine whether an in-state defendant was

fraudulently joined) (citations and quotation marks omitted). Here, preemption is a legal defense

that applies because of the simple and undisputed fact that the Retailer Defendant never held

regulatory authority to alter the labeling or manufacture of the product. The Court need not review

or determine any facts concerning the Retailer Defendant’s conduct or the scientific issues involved

in the litigation to assess preemption.

35. Indeed, Defendants have already successfully urged this basis for removal in the

Zantac litigation. An action was filed in Florida state court against some of the instant defendants

and a non-diverse retailer, Publix. As here, the plaintiff brought claims against all defendants for

strict products liability, and the defendants removed the case to federal court on the basis of

fraudulent joinder. Following removal, the plaintiff did not oppose defendants’ removal and,

instead, voluntarily dismissed Publix from the case. That case is now coordinated in the MDL. See

Notice of Removal, Galimidi v. Sanofi US Servs. Inc., No. 1:10-cv-24395-BB, ECF 1 (S.D. Fla.

Oct. 23, 2019); see also Notice of Voluntary Dismissal Without Prejudice as to Publix Super

Markets, Inc., In re: Zantac (Ranitidine) Prods. Liab. Litig., No. 9:20-md-2924, ECF 259 (S.D. Fla.

Mar. 6, 2020).

B. Plaintiff Fails to Plead a Cognizable Negligence Claim against the Retailer Defendant under California Law.

36. There is no possibility that Plaintiff could prevail on his negligence claim against the

Retailer Defendant under California law because a seller of a product does not have a duty to

investigate or test products stocked on its shelves for unforeseen risks.

37. The Complaint asserts that in January 2020, an FDA-certified pharmaceutical testing

laboratory called Emery Pharma conducted tests revealing that NDMA accumulates in Ranitidine-




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Containing Drugs exposed to elevated temperatures. See Compl. ¶ 147. It further alleges that

subsequent FDA testing revealed that NDMA levels could increase even under normal storage

conditions. Compl. ¶ 148.

38. The thrust of the Complaint is that the Retailer Defendant was negligent for not itself

earlier investigating and testing Ranitidine-Containing Drugs to uncover these alleged facts, and

accordingly for storing the product in conditions that allegedly led to NDMA formation. See, e.g.,

Compl. ¶ 287 (“Defendants acted below the standard of care by storing and dispensing Ranitidine-

Containing Drugs to Plaintiff without first undertaking efforts to ensure that the drugs were safe for

human use by, for example, consulting the available medical literature evidencing the potential

human health dangers associated with the storage of Ranitidine-Containing Drugs and the formation

of NDMA within Ranitidine-Containing Drugs when the drugs are stored at particular

temperatures.”).

39. Plaintiff’s claim that the Retailer Defendant should have determined that Ranitidine-

Containing Drugs degrade and form NDMA when stored at particular temperatures or lengths of

time seeks to impose a duty to investigate and test that California law does not recognize. California

law is clear that “a dealer who purchases and sells an article in common and general use, in the usual

course of trade, without knowledge of its dangerous qualities is not under duty to exercise ordinary

care to discover whether it is dangerous or not.” See Sears, Roebuck & Co. v. Marhenke, 121 F.2d

598, 600 (9th Cir. 1941) (applying California law) (emphasis added and citations omitted); see also

Tourte v. Horton Mfg. Co., 108 Cal. App. 22, 24 (1930) (affirming the holding of the Superior Court

of Alameda County that the seller of a washing machine had no duty to examine the product where

there was a latent defect unknown to the seller). Cf. Burgess v. Montgomery Ward & Co., 264 F.2d

495, 497 (10th Cir. 1959) (holding that it would be “completely unreasonable to expect the

shopkeeper to perform the inspection or test which would have revealed to an expert the defect in

the ladder rail”); Ziglar v. E. I. Du Pont De Nemours & Co., 152, 280 S.E.2d 510, 514 (N.C. App.

1981) (holding that retailer of inherently dangerous toxic substance was under no duty to detect or

remedy hidden defect); Odum v. Gulf Tire & Supply Co., 196 F. Supp. 35, 36 (N.D. Fla. 1961)

(holding that “a retailer or wholesaler is not under a duty to inspect manufactured articles of a




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complex nature for defects which are latent”); Meyer v. Rich’s Inc., 12 S.E.2d 123, 123 (Ga. App.

1940) (a seller of men’s suits had no duty to analyze the suit chemically and was therefore not liable

for buyer’s injuries caused by poisonous dye and chemicals in suit).4

40. In Sears, for example, after suffering burns from hot water leaking from a rubber hot

water bag, plaintiff sued the retailer from whom he purchased the product. 121 F.2d at 599. An

expert testified that the defect in the bag was in the faulty method of construction of the stopper and

the socket so that there was a slight leakage of water around the stopper. Id. The Ninth Circuit

explained that the question of whether or not the retailer “should have known of such defects

depends upon whether or not the vendor who sells goods manufactured by another is obligated to

inspect the goods to determine whether or not they are defective.” Id. at 600. It squarely held that

the retailer had no such duty. See id. Thus, the retailer was under no obligation to inspect the

product whether the defects “could only be discovered by such investigations as were made by the

experts, or could have been ascertained by the simple test of filling the bag with water and inverting

it after the stopper had been screwed into its socket.” Id.

41. Plaintiff’s claim here seeks to impose an even more obviously untenable duty than in

Sears. The alleged defect in the hot water bottle in Sears could have been discovered by a “simple

test.” 121 F.2d at 600. Yet here, Plaintiff’s theory would impose upon every California pharmacist

and/or retailer who sells prescription and/or over-the counter medications the obligation to conduct

their own independent, specialized testing to determine the safety of every lot of every prescription

and/or over-the-counter medication stocked on its shelves.

42. This would be a wholly unprecedented undertaking to require of every retailer in

California at pains of negligence liability. Stability testing of pharmaceutical products involves a

complex set of procedures that require considerable cost, time, and scientific expertise. Under

federal regulations, for instance, a manufacturer must submit a written protocol that includes, inter

4 Plaintiff’s conclusory and unsupported allegation that the Retailer Defendant failed to follow its own “established practices and procedures” to store the products presupposes that the Retailer owed a duty to investigate and test the products to learn that it could potentially form NDMA through certain storage conditions. Only if it had conducted such testing and investigation could formation of NDMA be a foreseeable risk of deviating from established storage practices.




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alia, sample size and test intervals based on statistical criteria for each attribute examined; storage

conditions for samples retained for testing; specific test models; testing of the drug product in the

same container-closure system as that in which the drug product is marketed; and testing of the drug

product at the time of dispensing as directed in the labeling. 21 C.F.R. § 211.166(a)(1)-(5). Such

testing must include an adequate number of batches at various storage conditions as defined in the

protocol. 21 C.F.R. § 211.166(b). Pharmaceutical companies often contract with a Contract

Manufacturing Organization (“CMO”) to conduct the stability testing. Such testing can cost

anywhere from $40,000-$60,000 per product. See PCI Synthesis, How to Know When to Toss Your

Prescription Drug or Refrigerate It (June 28, 2017), available at

https://www.pcisynthesis.com/how-to-know-when-to-toss-your-prescription-drug-or-refrigerate-

it/.

43. Yet under Plaintiff’s theory, not just the specific Retailer Defendant here but “mom

and pop” grocery or convenience stores throughout the State would be required to conduct such

detailed scientific investigations of the pharmaceutical products they sell to guarantee their safety.

Nor would Plaintiff’s novel theory be limited to storage conditions for pharmaceuticals; retailers

would have to conduct extensive testing of all of their products to discover any latent dangers and

warn against them. See, e.g., Burgess v. Montgomery Ward & Co., 264 F.2d 495, 497 (10th Cir.

1959) (“Montgomery Ward is operating a retail store, not a testing laboratory. If Montgomery Ward

were obliged to test this [allegedly defective] ladder for structural strength, so is the operator of

every retail store in the villages which dot the Kansas prairies.”). This is not the “ordinary care”

that the law demands of retailers who sell over-the-counter pharmaceuticals, or any other common

product for that matter.

44. The Complaint therefore states no cognizable claim against the Retailer Defendant

under California negligence law. The Retailer Defendant is, therefore, fraudulently joined and its

California citizenship should be disregarded for purposes of removal.

III. The Amount-in-Controversy Requirement Is Satisfied

45. Plaintiff’s claims also satisfy the amount in controversy requirement set forth in 28

U.S.C. § 1332(a).




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46. “[A] defendant’s notice of removal need include only a plausible allegation that the

amount in controversy exceeds the jurisdictional threshold.” Dart Cherokee Basin Operating Co.,

LLC v. Owens, 135 S. Ct. 547, 554 (2014). “[T]he defendant’s amount-in-controversy allegation

should be accepted when not contested by the plaintiff or questioned by the court,” and “[e]vidence

establishing the amount is required by § 1446(c)(2)(B) only when the plaintiff contests, or the court

questions, the defendant’s allegation.” Id. at 553–54.

47. Plaintiff seeks several categories of damages, including compensatory damages,

exemplary damages, and punitive damages. See Compl., Prayer for Relief ¶ 293(a)-(b).

48. The Complaint includes seven causes of action and alleges that Plaintiff’s use of

Zantac caused Plaintiff to suffer “significant harm, conscious pain and suffering, physical injury

and bodily impairment including, but not limited to cancer, other permanent physical deficits,

permanent bodily impairment and other sequelae.” Id. ¶ 14. It further asserts that Plaintiff’s injuries

required hospitalizations, in-patient surgeries, medication treatments, and other therapies to address

the adverse physical effects and damage” caused by Zantac. Id.

49. Recently, in denying remand, a court of this Circuit found that the amount in

controversy was met in a Zantac-related case similarly alleging a cancer injury and seeking

compensatory and punitive damages. There, the Court held that even applying a “conservative

estimate” the allegations “on their face” established that the amount in controversy was met. Order,

Brooks v. Sanofi, No. 2:20-cv-565, ECF 13, at 6-7 (D. Nev. Apr. 13, 2018).

50. Courts have similarly found that allegations of serious injury in products liability

actions, such as those Plaintiff makes here, support an inference that the amount-in-controversy

requirement has been met. See Mullaney v. Endogastric Sols. Inc., No. 11-62056-CIV, 2011 WL

4975904, at *2 (S.D. Fla. Oct. 19, 2011) (inferring that amount in controversy requirement was met

where plaintiff alleged that he underwent “surgical intervention that required additional life saving

medical treatment” and suffered “serious, permanent and disabling injuries”); see also Geographic

Expeditions, Inc. v. Estate of Lhotka, 599 F.3d 1102, 1107–08 (9th Cir. 2010) (“even though the

state court complaint does not specify an amount” it satisfied amount in controversy requirement

by requesting damages for, among other things, wrongful death, loss of consortium, and negligence,




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as well as funeral, medical and burial expenses); Campbell v. Bridgestone/Firestone, Inc., No.

CIVF051499-FVSDLB, 2006 WL 707291, at *2 (E.D. Cal. Mar. 17, 2006) (apparent from

complaint that amount in controversy met where plaintiffs asserted strict products liability,

negligence, and breach of warranty claims against multiple defendants and sought compensatory

damages, hospital and medical expenses, general damages, and loss of earning capacity).

51. Based on Plaintiff’s allegations, the amount in controversy exceeds $75,000,

exclusive of interest and costs.

IV. Procedural Requirements of Removal Are Satisfied

52. This Notice of Removal is timely filed pursuant to 28 U.S.C. § 1446(b). The

Removing Defendants have received a copy of, but have not yet been served with, the Complaint.

53. The Northern District of California is the federal judicial district encompassing the

Superior Court of the State of California in and for Alameda County, where this suit was originally

filed. Venue is therefore proper in this district under 28 U.S.C. §§ 84(a) and 1441(a).

54. Intradistrict Assignment. Pursuant to Civil Local Rule 3-2(c) and (d), this action

should be assigned to the Oakland or San Francisco Division, because the action arose in Alameda

County.

55. Removal pursuant to 28 U.S.C. § 1441(a) requires that “all defendants who have been

properly joined and served must join in or consent to the removal of the action.” 28 U.S.C.

§ 1446(b)(2)(A).

56. All of the Removing Defendants join in and consent to this removal.

57. No other Defendant is required to consent to this removal. On information and belief,

as of the time of filing this Notice, the Retailer Defendant has not been served with the Complaint.

Therefore, the Retailer Defendant is not required to join in or consent to the removal of this action.

See Destfino v. Reiswig, 630 F.3d 952, 957 (9th Cir. 2011) (finding an exception to the consent rules

where a defendant had not been properly served at the time of removal). Moreover, the Retailer

Defendant is fraudulently joined and therefore not required to join in the removal. See United

Computer Sys. Inc. v. AT&T Corp., 298 F.3d 756, 762 (9th Cir. 2002). The unidentified defendants




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Does 1-100 are not required to consent to removal. See Hafiz v. Greenpoint Mortg. Funding, 409

F. App’x 70, 72 (9th Cir. 2010) (nominal parties are not required to consent to removal).

58. The Removing Defendants are providing Plaintiff with written notice of the filing of

this Notice of Removal as required by 28 U.S.C. § 1446(d).

59. Pursuant to 28 U.S.C. § 1446(d), the Removing Defendants are filing a copy of this

Notice of Removal with the Clerk of the Superior Court of the State of California in and for Alameda

County.

60. Pursuant to 28 U.S.C. § 1446(a), copies of all process, pleadings, orders and other

papers filed in the state court action—as available from the state court docket or otherwise made

available to the Removing Defendants at the time of filing this Notice—are attached hereto as

Exhibit A.

61. If any question arises regarding the propriety of the removal of this action, the

Removing Defendants respectfully request the opportunity to present a brief and be heard at oral

argument in support of removal.

62. No previous application has been made for the relief requested herein.

63. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332 because this

is a civil action in which the amount in controversy exceeds $75,000, exclusive of interest and costs,

and is an action between citizens of different states.

V. Demand for Jury Trial

64. The Removing Defendants hereby demand a separate jury trial on all claims and issues

so triable.

WHEREFORE, the Removing Defendants give notice that the matter bearing Case No.

RG20061652 pending in the Superior Court of the State of California in and for Alameda County

is removed to the United States District Court for the Northern District of California, and requests

that this Court retain jurisdiction for all further proceedings in this matter.




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Dated: June 15, 2020 KING & SPALDING LLP

By: /s/ Matthew J. Blaschke________ Andrew T. Bayman (pro hac vice forthcoming) KING & SPALDING LLP 1180 Peachtree Street, Suite 1600 Atlanta, GA 30309 Tel: (404) 572-4600 Fax: (404) 572-5100 [email protected] Matthew J. Blaschke (SBN 281938) KING & SPALDING LLP 101 Second Street, Suite 2300 San Francisco, CA 94105 Tel: (415) 318-1212 Fax: (415) 318-1300 [email protected] Attorneys for Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corporation

By: /s/ Sharon D. Mayo___________

(as authorized on June 12, 2020)

Sharon D. Mayo (SBN 150469) Tommy Huynh (SBN 306222) ARNOLD & PORTER KAYE SCHOLER LLP Three Embarcadero Center, 10th Floor San Francisco, CA 94111-4024 Tel: (415) 471-3100 Fax: (415) 471-3400 [email protected] [email protected] Attorneys for Defendants Sanofi US Services Inc. and Sanofi-Aventis U.S. LLC

By: /s/ Jessica B. Rydstrom_________ (as authorized on June 12, 2020) Jessica B. Rydstrom (SBN 256600) WILLIAMS & CONNOLLY LLP




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725 12th Street NW Washington, DC 20005 Tel: (202) 434-5000 Fax: (202) 434-5029 [email protected] Attorney for Defendant Pfizer Inc.

By: /s/ Jonathan Tam______________ (as authorized on June 12, 2020) Mark S. Cheffo (pro hac vice forthcoming) DECHERT LLP 1095 Avenue of the Americas New York, NY 10036 Tel: (212) 698-3500 Fax: (212) 698-3599 [email protected] Will W. Sachse (pro hac vice forthcoming) DECHERT LLP Cira Centre, 2929 Arch Street Philadelphia, PA 19104 Tel: (215) 994-4000 Fax: (215) 994-2222 [email protected] Jonathan Tam (SBN 304143) DECHERT LLP One Bush Street, Suite 1600 San Francisco, CA 94104-4446 Tel: (415) 262-4500 Fax: (415) 262-4555 [email protected] Attorneys for Defendant GlaxoSmithKline LLC



EXHIBIT 3


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Wisner, R. Brent

From: Petrosinelli, Joe <[email protected]>Sent: Wednesday, November 11, 2020 3:43 PMTo: Jennifer Moore; Wisner, R. BrentCc: [email protected]: RE: 42 California Plaintiffs Challenging MDL Jurisdiction

Jennifer – I have spoken with our side and we are agreeable with your suggestion that these 42 clients not be required to submit CPFs or file Short Form Complaints at this time, pending the outcome of their anticipated motions to remand. I assume you agree that if their remand motions are denied, they will promptly submit CPFs and file SFCs (we can discuss an exact timetable if that occurs). Please confirm. Thanks. Joe

From: Jennifer Moore <[email protected]> Sent: Tuesday, November 10, 2020 2:41 PM To: Petrosinelli, Joe <[email protected]>; Wisner, R. Brent <[email protected]> Cc: [email protected] Subject: FW: 42 California Plaintiffs Challenging MDL Jurisdiction Joe, Thanks for returning my call yesterday. Below is the email Brent sent to LMI on 11/3/20 addressing the alleged deficiencies regarding the 42 cases we filed in California state court and stating our objections. I understand that you will discuss with your side and get back to us prior to taking any further action by the end of the week. Thanks.

Jennifer A. Moore Moore Law Group, PLLC T: (502) 717‐4080 F: (502) 717‐4086 http://www.moorelawgroup.com @MooreLawGroupKY

From: "Wisner, R. Brent" <[email protected]> Date: Tuesday, November 3, 2020 at 10:04 PM To: "Stakes, David P." <[email protected]> Cc: "Adlivankina, Valeriya" <[email protected]>, Jennifer Moore <[email protected]> Subject: 42 California Plaintiffs Challenging MDL Jurisdiction

Dear Mr. Stakes, I am writing to you on behalf of the clients listed below, represented by Baum Hedlund and Moore Law Group. LMI recently notified Baum Hedlund that these cases were allegedly delinquent in submitting Census Plus Forms pursuant to Pretrial Order # 24. It is our understanding that this notice of delinquency was prompted by the Defendants. Please note that we did not file these cases in the


2

MDL, but instead the Defendants improperly removed them to federal court. We have been waiting for leave from the Court to challenge it’s lack of jurisdiction over these cases for nearly five months. This attempt by the Defendants to impose the requirements of Pretrial Order # 24 is unfair and improper, reflecting a continued effort by these Defendants to use this federal forum to harass these Plaintiffs despite this Court lacking jurisdiction. We formally object to the Defendants’ attempt to impose PTO # 24 on these Plaintiffs. Clients: Amelino, Grag Astruc, Gilbert Barnes, Austin Becerril, Armando Brittner, Allen Brodie, Steven Campbell, Gary Caratti, Michael Carbajal, Hanna Cash, John Dudley, Ralph Elias, Brian Flores, Joes Friedland, Marc Geurin, John Gibbons, Nathan Gigliello, Joseph Goetz, James Gregory, Joseph, Jr. Harbaugh, Henry D. Hernandez, Mark Ives, Chris Jerde, Michael Karaoz, Reha Ray Knell, Greg Masouredis, Claudia Mills, Lolita Mitchell, Marc Morrison, Mark Muesse, Albert Newton, James Norman, Dwight Ortega, Ryan Reynolds, Oliver Russell, John Salvatore, Kalmeta


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Smith, Lynn White, Michael Wilbur, Brian Williams, Roy Wright, Jr., Velo Yedlin, Matthew

Thank you for all your hard work in this MDL (Val tells me you have been a great resource). Best,

R. Brent Wisner

Vice President | Senior Partner

(310) 207-3233 baumhedlund.com 10940 Wilshire Blvd, 17th Floor Los Angeles, CA 90024

CONFIDENTIALITY NOTICE -- This electronic mail message may contain confidential information belonging to the sender which is protected by the attorney-client and/or work product privilege. The information is intended only for the use of the individual(s) or entity(ies) named above. If you are not the intended recipient, you are notified that any disclosure, copying, distribution, or the taking of any action in reliance on the contents of this information is strictly prohibited. If you have received this transmission in error, please purge the received information from your system and immediately notify the sender by telephone and by return e-mail. Thank you. IRS DISCLAIMER: Communications from our firm may contain or incorporate federal tax advice. Under recently promulgated US Internal Revenue Service standards (Circular 230), we are required to inform you that only formal, written tax opinions meeting the requirements of Circular 230 may be relied upon by taxpayers for the purpose of avoiding tax-related penalties. Accordingly, this communication is not intended or written to be used, and it cannot be used, for the purpose of avoiding tax-related penalties under the Internal Revenue Code.

This message and any attachments are intended only for the addressee and may contain information that is privileged and confidential. If you have received this message in error, please do not read, use, copy, distribute, or disclose the contents of the message and any attachments. Instead, please delete the message and any attachments and notify the sender immediately. Thank you.


EXHIBIT 4


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PRODUCTS LIABILITY

LITIGATION

_______________________________/

MDL NO. 2924

20-MD-2924



































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[PROPOSED] ORDER GRANTING PLAINTIFFS’ MOTION TO REMAND CASES TO

CALIFORNIA STATE COURT

Having reviewed the Parties’ submissions, the Court finds good cause to GRANT

Plaintiffs’ Motion. The following cases are hereby immediately remanded to the Superior Court

of California for the County of Alameda:




















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Additionally, the following cases are hereby immediately remanded to the Superior

Court of California for the County of San Francisco:



DONE and ORDERED in Chambers, West Palm Beach, Florida, this ______ day of

________, 2021.

___________________________

ROBIN L. ROSENBERG

UNITED STATES DISTRICT JUDGE

Copies furnished to Counsel of Record


united states district court southern district ......2021/01/15 · no. cv 11-01230 rs, 2014 wl...

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