DRUG, DEVICE AND BIOTECHNOLOGY SECTION

www.thefederation.org

Volume 3, Issue 1 Spring 2015

What’s Inside

Upcoming FDCC Events What’s New in the Field 2015 Annual FDCC Meeting Topic Spotlight A Social Experiment: 2015 Outlook for FDA’s Social Media Policy

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In the News

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Welcome New Member ……………………….….. 12

DDB Membership ………………………………..…. 13

Upcoming FDCC Events

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04/13/2015 - 07/16/2015

Local Meeting Projects Various Locations: See here for details

05/13/2015

Joint Law Firm Management Conference Location: The Conrad Chicago

06/08/2015

FDCC Deposition Boot Camp-New Orleans Location: Phelps Dunbar LLP

07/25/2015

2015 Annual Meeting-Banff Location: Fairmont Banff Springs

See more information inside

09/28/2015 Corporate Counsel Symposium

Location: The Ritz Carlton New Orleans

10/21/2015 Insurance Industry Symposium Location: New York Athletic Club

Volume 3, Issue 1

Spring 2015

What’s New In The Field?

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FDA Wants Genetic Products Evaluated for Environmental Hazards April 5, 2015—Drugmakers seeking approval of genetically engineered products must begin submitting an assessment with their applications that evaluates whether they would be harmful if released into the environment.. Read more …

Ebola Vaccines Will Enter Phase III Soon April 3, 2015—Two Ebola vaccines are set to enter Phase III testing in West Africa soon. While there is not an official start date, the National Institute of Allergy and Infectious Diseases says talks to take the trial from Liberia to neighboring countries that have more than one active Ebola case are ongoing. Read more…

FDA Explains How Companies Can Modify a Drug Safety Assurance Plan April 2015—A new guidance document issued by the FDA explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Read more…

FDA Releases Final Guidance on Reprocessing of Reusable Medical Devices March 12, 2015—The FDA announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection. Read more…

Volume 3, Issue 1

Spring 2015

New Chief for FDA March 2015—U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg has stepped down from her post after nearly six years, ending a tenure marked by controversy over approvals for drugs, including the prescription hydrocodone painkiller Zohydro. FDA's chief scientist Stephen Ostroff, who joined the agency in 2013, is acting commissioner until a successor is named. Read more …

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Volume 3, Issue 1

Spring 2015

Please join us in Banff, Canada for the 2015 FDCC Annual Meeting from July 25-31, 2015!

Featuring the DDB Session: “Disruption in DD&B Land”

This buzz session includes four “speed” talks on recent developments in the drug and medical device landscape. Learn about who has the right to try experimental drugs, what the legal implications of telemedicine are, the future of cy pres awards in class actions, and

the evolution of parallel claims in preemption cases

FDCC members are encouraged to make hotel reservations directly with the hotel at 800-441-1414. Be sure to mention that you are with the FDCC to receive our group rates. With the current exchange rates, room rates are very favorable, starting at $294 CN for

the Run-of-House level

For more detailed information about room types and rates, please contact the hotel. Based on availability, the FDCC rates will apply three days before and three days after the

official meeting dates of July 25-31, should you wish to extend your stay.

For more information, visit HERE

2015 FDCC Annual Meeting – Banff, Canada July 25-31, 2015

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Volume 3, Issue 1

Spring 2015

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Volume 3, Issue 1

Spring 2015

A Social Experiment: 2015 Outlook for FDA’s Social Media Policy

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Volume 3, Issue 1

Spring 2015

A Social Experiment: 2015 Outlook for FDA’s Social Media Policy

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Volume 3, Issue 1

Spring 2015

A Social Experiment: 2015 Outlook for FDA’s Social Media Policy

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Product Liability Trials To Watch In 2015 1. Pelvic Mesh Litigation—The first half of 2015 will see bellwether trials in the consolidated

pelvic mesh cases in West Virginia. A total of seven (7) MDLs have been assigned to U.S. District Judge Joseph Goodwin over transvaginal surgical mesh devices used to treat pelvic organ prolapse and stress urinary incontinence. Those MDLs contain more than 70,000 cases that are currently pending. The cases are Wise et al v. C. R. Bard Inc., Case No. 2:12-cv-01378, part of MDL 2187; and Bellew v. Ethicon Inc. et al., 2:13-cv-22473, part of MDL 2327; both in the U.S. District Court for the Southern District of West Virginia.

2. Zoloft Litigation—Two (2) state courts are gearing up to preside over the first trials in the Zoloft birth defect litigation, which began in April. The complaints generally allege that sertraline, which Pfizer markets as Zoloft, causes potentially fatal birth defects and that Pfizer should have warned the medical community and consumers. The cases are Mia Robinson et al. vs. Wolters Kluwer Health Inc. et al., Case No. 00778, in the Philadelphia Court of Common Pleas; and Tracey Foster et al. v. Pfizer Inc. et al., Case No. 1222-CC02441-01, in the 22nd Judicial Circuit Court of Missouri.

3. Lipitor Diabetes Litigation—The first bellwether trial in the Lipitor MDL in South Carolina federal court is scheduled to begin in October 2015. The litigation consists of more than a thousand cases claiming Pfizer's cholesterol medication can cause Type 2 diabetes. U.S. District Judge Richard M. Gergel is presiding over the MDL, which the Judicial Panel on Multidistrict Litigation consolidated in February 2015. The complaints generally allege that Pfizer had not included a warning about increased glucose levels associated with Lipitor until after the U.S. Food and Drug Administration asked it to do so in 2011, based on an agency review of the drug. The case is In re: Lipitor (Atorvastatin Calcium) Marketing Sales Practices and Products Liability Litigation, MDL 2502, in the U.S. District Court for the District of South Carolina.

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First Circuit Holds That Federal Law Preempts State-Law Claims Involving a Branded Drug Label In re Celexa & Lexapro Mktg & Sales Practices Litig. (Marcus v. Forest Labs., Inc., et al.), No. 14‒1290, 2015 WL 727970 (1st Cir. Feb. 20, 2015) On February 20, 2015, the U.S. Court of Appeals for the First Circuit (the “First Circuit” or “Court”) affirmed a district court’s dismissal of a consumer fraud complaint by holding that state-law claims asserting that a branded drug label is false or misleading are impliedly preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C §§ 301 et seq. (“FDCA”). The decision in In re Celexa & Lexapro Marketing & Sales Practices Litigation applied principles from recent U.S. Supreme Court cases concluding that state-law claims challenging generic drug manufacturers’ labeling are preempted. The First Circuit’s ruling demonstrates that preemption remains a viable defense for branded drug manufacturers faced with state-law claims challenging the adequacy of drug labeling. Read more…

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Spring 2015

FDA Hears Wide Debate On Generic-Drug Warning Label Plan Drugmakers, lawyers and consumers debated the U.S. Food and Drug Administration's controversial plan to let generic-drug makers independently update their warning labels, trading divergent views on how patient safety and medication prices would be affected. The exchanges came at a daylong forum convened by the FDA to hear input on its proposal, which would effectively undo the 2011 U.S. Supreme Court decision in Pliva v. Mensing that shielded generic-drug firms from failure-to-warn liability. Read more…

CDRH Finalizes Guidance Regarding Reprocessing Reusable Medical Devices On March 17, 2015, Center for Devices and Radiological Health (CDRH) released the final guidance entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” The draft guidance was issued in May 2011 and is now being finalized on the heels of highly publicized outbreaks of hospital acquired infections associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes. In a safety alert, FDA indicated that “the complex design of duodenoscopes . . . causes challenges for cleaning and high-level disinfection [such that] effective cleaning of all areas of the duodenoscope may not be possible.” Finalizing this guidance is one of the steps FDA is taking in order “to reduce the risk of infection from reprocessed reusable devices.” Read more…

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Supreme Court Declines to Weigh in on Generic Preemption Huck v. Wyeth, Inc., 850 N.W.2d 353, 364 (Iowa 2014)

The United States Supreme Court decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground that such claims were covered under the federal preemption articulated in the landmark U.S. Supreme Court decision, Pliva v. Mensing. The plaintiff in Huck claimed that after ingesting Pliva’s generic version of Reglan (metoclopramide) she developed the neurological disorder tardive dyskinesia. Specifically, Plaintiff alleged that Pliva’s failure to update its warning label to reflect language approved by the FDA in 2004 caused her injuries, where the “updated” warning expressly included tardive dyskinesia as a possible side effect of the medication. The Iowa Supreme Court held that the preemption established in Mensing did not shield generic drug manufacturers where the manufacturer could have updated its label without violating federal law. According to the Sixth Circuit, the facts presented a narrow path around Mensing preemption—i.e., once the additional warning language was approved by the FDA in July 2004 and implemented by the brand-name manufacturers, generic drug makers like Pliva were required to update their labels accordingly. In other words, Pliva had a federal duty to match its label to Wyeth's. See 21 U.S.C. § 331(a) (prohibiting the introduction into interstate commerce any drug that is misbranded); 21 C.F.R. §§ 314.94(a)(8)(iii) (requiring generic applicant to match label of brand drug); 21 C.F.R. § 314.150(b)(10) (providing FDA may withdraw drug approval if the generic's label “is no longer consistent with that for [the brand-name]”). Because Pliva did not update its warning labels to match the brand name warning labels, the Sixth Circuit concluded that Huck’s state law negligent failure-to-warn claim was not preempted by federal labeling regulations to the extent the claim was based on Pliva’s failure to adopt the additional warning language that was approved by the FDA in 2004. Read Order …

January 2015 – April 2015

Hayes, Ashley D. Hancock Estabrook LLP.,

Syracuse, NY

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Volume 3, Issue 1

Spring 2015

Vice Chairs Joseph P.H. Babington David T. Neave Marisa A. Trasatti Michael J. Hurvitz

DDB Members

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Chair Daniel J. Herling

Board Liaison Leslie C. Packer

Adams, Robert T. Alexander, Tiffany M. Alpert, Robert L. Alverson, J. Bruce Ansnes, Terry E. Baker, Kimberly D. Bauer, Beth A. Biscan, Matthew Y. Bjorkquist, Sonia L. Boisseau, Eldon L. Bonasso, Michael Brandt, Angela B. Cahill, Brian G. Carlson, Jeffrey J. Casey, Steven F. Collins Jr., Lewis F. Collins, Richard B. Compton , J. Douglas Cooper, Robert E. Crowell, John W. D'Angelo, Christopher S. Daniels, John P. Davis, David M. DePhillips, Christopher P. Dillon, Thomas A. Drahos, Michael J. Drury Jr., William W. Durney, Peter M. Fasi II, Joseph M. Felker, Samuel L. Fiasco, William A. Fortunato, John E. Fowler, Tracy H. Fuente, Jaret J.

Gallivan, H. Mills Garofalo, Mel J. Gassler, Frank H. Godbold III, William E. Goebel, Heidi G. Governo, David M. Gulotta, James C. Haslam, Geoffrey C. Hayes, Ashley D. Hillman, Roger L. Hoover, James A. Hudson, Clark R. Hunter, C. Howard Jaroslaw, David Johnson, Andrew B. Jones, Michael W. Kaplan, Edward M. Kelley, Toyja E. Kolar, Robert D. Kreamer, J. Scott Kruse, Jeffrey A. Lawrie, Jill M. Magratten, Brooks R. Maidment, J. Scott Marks, Merton E. Martin, Sean W. Marvinney, Craig A. Mason, Wayne B. McCune, Daniel R. McGrath, Daniel W. Merten, Howard A. Miller II, Donald L. Murad, John L. Neuckranz, Thomas H.

Oldham, D. Dudley Phillips, Sandra L. Pratt, Timothy A. Reeg, Kurtis B. Rozelsky, Kurt M. Salter, Scott M. Shalhoub, Michael D. Scott, Robert E., Jr. Sinnott, John W. Smith, Laura H. Sterchi, Thomas N. Stites, Richard E. Tanenbaum, Michael A. Thompson Jr., J. Carter Todd, Monteith P. Torralbo Robert J. Vita, William E. Walsh, Michael A. Ward, Ashley W. Webster, J. Michael Wells, Adam Williams, Paul D. Wilson, Roxanne M. Wittner, Nicholas I. Woodard III, John R. Woolf, Linda S. Zuber, David A.

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Spring 2015

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Jhanelle A. Graham Associate, Semmes, Bowen & Semmes Co-editor, DDB Newsletter

Articles or defense victories to share? Email JGraham@semmes.com to be featured in

the Summer 2015 newsletter in July 2015!

Stay tuned for the new and improved Federation of Defense and Corporate Counsel Quarterly! For more information or to submit

articles, please contact:

Susan M. Popik 38 Woodhill Drive

Redwood City, CA 94061 Email: smpopik@gmail.com

Marisa A. Trasatti Principal, Semmes, Bowen & Semmes Co-editor, DDB Newsletter

Volume 3, Issue 1

Spring 2015