Douglas E. Penner,Esq. Goodman, Allen Donnelly PLLC

Jacque L Mitchell, BSN, CPHRM, Risk Manager Sentara

Larry Reback, J.D., ARM, Managing Principal, Integro Insurance Brokers

Attendees will: ◦ Understand the increase in medical mass tort claims and

their impact. ◦ Understand the claims process and role of the attorney, risk

manager and insurance carrier in handing these claims. ◦ Identify processes that need to be in place to ensure that

medical information needed and requested is handled appropriately.

◦ Understand the claims process and role of the attorney, risk manager and insurance carrier in handing these claims.

What is a class action?

◦ May also be called “representative action”

◦ Type of lawsuit where one side is a large group of people represented by one person: the class representative

How does a class action lawsuit work?

◦ In federal court, governed by Federal Rule of Civil Procedure 23

◦ No statutory procedure for

class actions in Virginia

4 Prerequisites for Class Actions:

◦ Numerosity: class must be so numerous that joinder of all members is impracticable;

◦ Commonality: must be questions of law or fact common to all of the class members;

◦ Typicality: claims of the class representative must be typical of claims of the class; AND

◦ Adequate representative: class representative(s) will fairly and adequately protect the interests of the class

Class action must also fit within one of these types: ◦ Type 1: individual class members bringing

separate actions would create a risk of prejudice to other potential class members or the opposing party

◦ Type 2: lawsuit seeks injunctive or declaratory relief based on defendant(s) treating the whole class alike

◦ Type 3: common questions of law or fact predominate over any questions that only affect individual members, and class action is superior to any other method of adjudicating the controversy

Case is not a class action until court certifies it as a class action. Court must also define the class and the class claims and issues, and must appoint class counsel.

In a Type 3 case, court must provide

individual notice to class members. A class action can only be settled or

dismissed with court approval, and court will get feedback from class members.

Shareholder securities class actions ◦ Investors in Enron stock filed suits

against Enron Corp., individual officers & directors, Enron’s accountant Arthur Anderson, and others alleging that Enron engaged in fraud

Court ultimately approved a $7.2 billion settlement

◦ Investors in World Com stock brought suit against World Com and individual employees for fraud

Ultimately settled for $6.2 billion

◦ Investors in AOL Time Warner stock sued the company for fraud

Ultimately settled for $2.5 billion

Silicone breast implants ◦ After years of litigation alleging that women suffered

autoimmune disease from silicone breast implants, 3 major manufacturers (Corning, Baxter, Bristol-Meyers Squibb/MEC, 3M) settled class action litigation for around $3.4 billion At the time (1994), it was the largest

class action lawsuit in history.

Exxon Valdez oil spill ◦ Class action was filed on behalf of approx. 32,000 people, including entire small coastal

communities, following Exxon Valdez supertanker running aground in 1989

Initial verdict of approx. $5 billion ultimately reduced to around $500 million after a series of appeals

What is a mass tort action?

◦ Also involves a large number of claims, but each plaintiff has an individual claim

◦ Plaintiffs may be located in different places, but share a common injury or damage

◦ Mass torts may be consolidated into multidistrict litigation – this is a special federal legal procedure by which cases can be consolidated and sent to a single court for all pretrial proceedings and discovery

Mass torts would not be suitable for class treatment. For example, negative effects of a defective drug or medical device will result in different injuries to different plaintiffs.

Mass tort cases do not have to be certified.

Mass tort cases are very complex and lack the clear structure of a class action. Variations in claims can make it difficult to determine settlements and compensation.

◦ A failed class action (i.e., a putative class action that the court does not certify) may proceed as a mass tort case

◦ Examples of mass tort actions:

Product liability

Defective drugs & medical devices

Large antitrust claims against businesses

Large scale disasters (e.g., plane crashes, plant explosions)

Really began to emerge in 1980s Various factors contributed to the rise of

these claims, including: ◦ Mass marketing of products, which increases the

population’s exposure ◦ Weaknesses in regulatory processes (e.g., medical

devices were not subject to FDA review until 1976) ◦ Evolution of plaintiff’s law firms and advertising

facilitates the filing of claims ◦ Development of product liability law gave victims the opportunity to sue common defendants

New England Compound Center (NECC) meningitis outbreak ◦ 2012 fungal meningitis outbreak was worst case

of contaminated pharmaceuticals in U.S. history

◦ More than 750 cases in 20 states linked to contaminated batches of methylprednisolone acetate compounded and distributed by NECC

◦ In RE New England Compound Pharmacy, Inc. Products Liability Litigation, 13-MD-2419-RWZ (D.Mass.) was consolidated action in federal court

◦ In May 2015, Judge approved NECC’s Joint Chapter 11 Bankruptcy Plan, which included a settlement fund estimated at more than $200 million to compensate victims who were exposed to tainted epidural steroid injections and other contaminated drugs.

Gadolinium Litigation ◦ Plaintiffs claimed to have suffered substantial

injuries caused by use of gadolinium-based contrast agents in MRIs

◦ In re: Gadolinium Based Contrast Agents Products Liability Litigation, 1:08-GD-50000 (N.D. Ohio) was consolidated action in federal court, consolidating almost 1,000 cases

◦ Most settled, but some went to trial. In 2013, the jury awarded $5 million against GE Healthcare in the first to go to trial. Plaintiff had contracted nephrogenic systemic fibrosis after being injected with Omniscan.

Stöckert 3T heater-cooler lawsuits ◦ CDC and FDA issued warnings that the heater-

coolers, used to control patient temperature during cardiac procedures, were spreading nontuberculous mycobacterium (NMT)

◦ Patients have begun filing lawsuits against the manufacturer and hospitals across the country. For example, five suits have been filed by patients against WellSpan York (Pa.) Hospital, alleging that the hospital failed to protect them.

◦ A putative class action was filed in federal court in South Carolina on January 24, 2017, against the manufacturers, Livanova PLC and Sorin Group.

◦ Many more lawsuits are anticipated.

Law requires all parties involved to preserve evidence – including products – that they know or should know will become the subject of a claim or lawsuit.

Once a claim or investigation is

anticipated, a “litigation hold” will be

put into effect, directing employees to

preserve and refrain from destroying or

modifying, certain records, information,

and other potential evidence.

Sometimes a product cannot be obtained/preserved – e.g., implanted medical devices. In this case, focus on preserving medical records, photographs, surgical videos, X-rays, MRIs, CT scans, etc.

“Textbook definition” of spoliation is intentional destruction of evidence, but it can also occur when evidence is lost, altered, or cannot be produced. And, it can be either intentional or negligent. So, failure to preserve can lead to sanctions for spoliation of evidence.

Lawyers AND parties can be liable for sanctions. Sanctions can include anything from attorneys’

fees and costs incurred in moving for sanctions to the adverse inference instruction discussed below to dismissal of the case.

◦ Virginia law recognizes a spoliation inference: “where one party has within his control material evidence and does not offer it, there is [an inference] that the evidence, if it had been offered, would have been unfavorable to that party.”

What must be preserved will depend upon the claim but includes any potentially relevant evidence.

Things like medical products & devices, any output from such devices (e.g., monitoring strips), records, videos & photographs, paper, email & voicemail communications, and employee files may all be included.

Consider all possible locations of relevant information, such as: employee workspaces, warehouses, email & voicemail systems, hard drives, back-up tapes, databases, outsourced locations, and handheld devices & personal digital assistants (Blackberries, iPhones, iPads, tablet computers, etc.)

Requests for release of pathology slides and specimens ◦ Multiple requests for the same slides/tissues

(sometimes 6-8)

Requests for purchasing records – medical supplies, medications

Requests for medical records Requests for devices removed in surgery Requests for your staff to be deposed for

other than medical malpractice cases Multiple requests to preserve evidence

Most lawsuits against pharmaceutical companies allege that a person was injured or suffered serious harm from an undisclosed side effect of a prescription medication.

The laws in the United States require that the drug companies disclose all serious complications of a medicine and warn consumers about the potential risks and side-effects of a drug.

In other cases, a pharmaceutical company may promote a drug for an “off label” use. This means that the drug is used for a main purpose but may also have some incidental benefits. However, those other benefits may pose serious medical risks to the consumer.

Actos: Takeda Pharmaceuticals- Type 2 Diabetes medications. ◦ Allegations of withholding information linking the

medication to bladder cancer.

◦ 2015 settled largest number of claims in U.S. history -$2 billion for 9,000 claims

Manufactured by Bayer and Janssen

Anticoagulant, alternative to Warfarin

No antidote – considered most dangerous of anticoagulants on the market

Allegations that companies were negligent in providing accurate information on the serious side effects.

Manufactured by Pfizer

Statin for lowering cholesterol

Allegations of causing Type 2 Diabetes in women

Promoted as a safe drug and that label never carried a warning to monitor blood sugar levels until 2013 with the FDA mandate

Manufactured by GlaxoSmithKline

For nausea and vomiting linked to chemotherapy

Later used for same symptoms in pregnant females

Alleges use was promoted for treatment of morning sickness that was never approved by the FDA and led to cardiac septal defects and cleft-palate defects in infants

Paid $3 billion to settle criminal and civil allegations that included promoting Zofran for unapproved uses such as treating morning sickness.

Viagra Lawsuits: Melanoma Skin Cancer

Prilosec Lawsuits: Kidney Complications

Taxotere Lawsuits: Permanent Hair Loss

Protonix Lawsuits: Kidney Complications

Abilify Lawsuits: Compulsive Behaviors

Lyrica Lawsuits: Birth Defects

Three areas of concern: ◦ Manufacturing defect claim- how the product was

made- is it different than the other similar products?

◦ Design defect- was there a flaw in the design (think cars- brakes and airbags) – entire line is defective or dangerous.

◦ Failing to warn the public of a known risk: (think step ladders).

Johnson and Johnson- DePuy – high failure rates for ASR, Pinnacle

Stryker Orthopaedics- loosening of implant and metallosis.

Zimmer- over its Duron Acetabular Component – bone implant does not properly attach to the bone and causes pain

Other hip manufacturers: Smith & Nephew, Biomet Inc., Wright Medical Technology, Inc. OMNI

Plaintiffs claim that long term, regular use of talc based powder contributed to the development of aggressive ovarian cancer.

J&J have two rulings awarding $55 and $72 million in two cases. Juries ruled that the manufacturer was liable for negligence, conspiracy (40 years of studies), and failure to warn consumers of the risks.

Grind up fibroids into fragments for removal through small incisions in the abdomen. No way to determine if fibroid contains uterine cancer.

If used in limited circumstances- patients must be aware of risks

1/352 women have unsuspected cancer at the time of the use of the morcellators.

J&J wanted the morcellators returned to them.

Filters are implanted in the inferior vena cava of patients with DVTs and are intended to be temporary to block dangerous blood clots from reaching a patient’s lungs.

Complications include: fracturing, migration of the filter, damage to veins, organs from perforation, bleeding and failure to prevent blood clots.

Allegations of failure to warn of risks, irresponsible design, and negligent in representation of the device.

Review release for tissue and slides ◦ Make sure someone in Risk is reviewing the

requests

◦ Multiple parties might need an agreement to share and not destroy.

◦ Know your pathology policies for retention of tissue and other specimens and products taken out

◦ Multiple requests to preserve specimens, slides with acknowledgement of receipt of Preservation Letter

Know your policy about what gets sent to Pathology – should be an exception list

Review documentation of surgery record to

ensure fate of specimen is documented correctly

Discuss with Surgery and Pathology – need to

timely open and review their mail – many requests from plaintiffs come the day of or before the surgery ◦ Review directions for release and sending products

like hip implants, filters etc.

Get to be friends with your Material Management folks: ◦ If you have a defective product, may need to pull lots

of that product from your shelves

◦ Consider voluntary reporting through the FDA ◦ Product and pharmaceutical liability cases outside your

facility: will need purchasing records by company, orders, lots, and dates of purchase

◦ Will need records of any recalls or warnings and proof

of compliance Need to have a robust system

◦ Request all correspondence including emails, invoices and updates from the company

◦ Make sure you are aware of their retention policy for the purchase records

◦ Some records will be held by in-house pharmacy.

Some records might be from commercial pharmacy in your facility where the patient bought the medications himself.

Assign an attorney to prepare staff – preferably a malpractice attorney If staff did not use product correctly or follow

directions- may come back as a claim against the hospital

Be prepared for questions about education and training on the product.

Ensure practice for reporting quality product issues is followed – report, correspondence. Make sure staff is aware of the practice

Be aware of any Maude reports made to the FDA or correspondence to the company about defective products

Plaintiffs will send letter to preserve other information: ◦ Besides everything already mentioned ◦ Medical records ◦ The product or medication that is at the

root of the claim Have a system to secure and label with

patient’s name to the product – but not on the product

Use Universal Precautions

Be able to show chain of custody

Have a process for when someone (plaintiff, manufacturer) wants to look at the product

Do not release or destroy the product

◦ Equipment software printouts – pumps, vents, bypass pumps, monitors

Keep them plugged in.

◦ Maintenance records

◦ Education records

◦ Correspondence, documents and email Litigation Hold Policy and practice for securing email and

other documents-

At minimal send everyone a “Notice to Preserve”

Use technology to place “Litigation Hold”

Reporting of claims ◦ Batch/mass tort

Reservation of Rights ◦ Need to respond?

Carrier Investigation ◦ Responding to requests for

information ◦ Litigation Guidelines

Working with your broker to enhance insurance recovery ◦ Role of Risk Management ◦ Role of coverage counsel ◦ Attorney/client privilege issue

Selection of defense counsel ◦ Duty to defend vs. non-duty to

defend Do you have to use “Panel Counsel” Rates Conflicts of interest

Effect of “other insurance” clauses ◦ What to do if there is “duplicate”

coverage Allocation between “covered”

and “uncovered” claims ◦ Negotiation strategies