Pharmaceutical Mass Tort Cases: Key Issues from a Plaintiff Perspective

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1 Pharmaceutical Mass Tort Cases: Key Issues from a Plaintiff Perspective Anthony L. Giacomini & Mark Premo-Hopkins January 11, 2014 Tony Practices in complex commercial litigation, including multi-state class and mass actions. Represents plaintiffs in catastrophic personal injury litigation. Currently oversees the settlement phase of the firm s multi-district mass tort litigation involving a diabetes drug and the intake of the firm s other active mass tort cases. Mark Who We Are Represents hundreds of plaintiffs in multiple mass tort litigations against pharmaceutical manufacturers involving various prescription drugs. Currently serves as lead counsel for federal and state court cases in various jurisdictions involving claims against the makers of Prozac, Zoloft, Topamax, and other SSRIs. Lectures on trial tactics and SSRI birth defect litigation. For more information: 1

2 Pharmaceutical Mass Tort Basics How many cases makes a mass tort? Filed vs. Unfiled Lipitor vs. Effexor NOT a class action The Consolidation Process Federal Court MDL State Court Options Litigation by Committee Plaintiff Steering Committee Subcommittees Developing and Understanding Basic Medical Causation for Each Case Documented Proof of Use (POU) Did your client ingest/use the drug/device? At the right time? Documented Proof of Injury (POI) Is your client s injury supported by science connecting it to the drug/device? Causation problems/confounders Illicit drug use; tobacco use Diabetes; morbid obesity; age at time of injury Wrong injury (e.g., ischemic vs. hemorrhagic stroke) Consider nurse consultants 2

3 Consolidated discovery against defendant(s) by steering committee Plaintiff s initial disclosure usually covered by Plaintiff Fact Sheet Basic background and medical information about plaintiff Includes authorization for defendant to gather medical records Sometimes broken into two stages Third-party discovery Discovery in a Pharmaceutical Mass Tort Advertising/marketing firms PR/Consulting firms Third parties that publish patient education materials (e.g., Wolters Kluwer) Bellwether/Exemplar Case Selection Size of the bellwether pool Goldilocks principle Too many = difficult to manage Too few = miss major variables How to fill the pool Both sides fill half By court, based on presentations by counsel Case-specific discovery Selecting pool cases for trial Selection by court, counsel/strikes, or random 3

4 Key Legal Issues Generic vs. Brand Use PLIVA, Inc. v. Mensing, 564 U.S. ---,131 S.Ct (2011) Mutual Pharm. Co. v. Bartlett, 570 U.S. ---, 133 S.Ct (2013) Other Preemption Angles Impossibility: Wyeth v. Levine, 555 U.S. 555 (2009) Defendant must present must present clear evidence that the FDA would not have approved the labeling changes proposed by the plaintiffs May change based on state law (TX & MI) Learned Intermediary Doctrine Critical for causation You need the prescriber/treating physician to: Have seen the drug label/warnings Change his/her behavior based on the new information that should have been disclosed Experts and Importance of Daubert/Frye Generic Causation (drug/device can cause) Epidemiologist Statistical evidence shows increased risk Example: increased risk of heart attacks in diabetes patients who took the drug Medical specialists in area of relevant injuries Medical evidence supports causation May require many experts Example: birth defects embryologist; geneticist; biologist; OB/GYN; pediatric specialist 4

5 Experts and Importance of Daubert/Frye Case Specific Causation (drug/device caused in this case) Needs to be an M.D. Often relies on generic causation experts and rules out other potential causes State law matters - know your causation standard Conduct/Standard of Care Expert Expert with FDA/Industry experience to explain to the jury what the company should have known and done. Combating the FDA Defense FDA approved, how could defendant be wrong? Wyeth v. Levine [T]he manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market. Defendant violates FDA regulations DDMAC Letters FDA s inability to properly police drug companies 5

6 Trial Prep BE REALISTIC Your case is not likely to go to trial BE OPTIMISTIC! Your case is not likely to go to trial! Know Your Inventory Number of clients/cases Lack of POU Lack of POI Dual representation Statutes of Limitation Nature of injuries What does the science support? Manufacturer-specific requirements Previous settlements/releases 6

7 Know Your Inventory A robust database is a must Keep your clients information updated Keep your clients informed about what it is you will need from them And why Collect that information Early Often Accurate identifying information DOB/DOD SSN Address/phone/ Someone who will always know client s whereabouts Relationship to client/confidentiality Updated injury/health status New or worsening conditions Revisions Subsequent procedures/surgeries Death 7

8 Probate information Is there a Last Will and Testament? Get a copy Is it valid? Who are the heirs? Are heirs aware of the claim? Explain to client what it means State-specific testacy laws State-specific intestacy laws Settlements for minors Statues of Limitation Date(s) of ingestion Date(s) of implant Dates of birth/death State(s) of ingestion State(s) of implant States of birth/death Discovery Rule Tolling By agreement By statute (minors) 8

9 Insurance coverage Subrogation responsibilities Medicare (CMS; Medicaid (CMS; various state agencies and websites) New developments: Arkansas Dept. of Health and Human Servs. v. Ahlborn, 547 U.S. 268 (2006) a state Medicaid program could only recover against a personal injury recovery to the extent of the portion of the recovery allocated to repayment of medical expenses incurred as a result of the tortuous conduct. Now, as part of the very recent Bipartisan Budget Act of 2013, 202(b), the recovery can be had against the entire personal injury recovery! Veterans Private insurance Insurance coverage (continued) Specific notice (Rawlings, Ingenix, others) General inquiry Records often do not mention insurance coverage Get billing records Clients often do not remember insurance coverage Ask for wallet cards, employment records, etc. 9

10 Protection of Low Income or Needs-Based Benefits Lump sum Spend downs on qualified purchases Structured settlements Special Needs Trusts Avoid Constructive Receipt Client receipt Any sort of direction of the funds beyond a qualified investment vehicle Law firm receipt Bankruptcy Current/Active Recent past Distant past Type Chapter 13 Discharged/Completed? Terminated? Chapter 7 Pre-filing asset? Exemptions (state law)? Conversion 10

11 Keep ski tips up Watch for loose clothing Thank You! Be Careful Out There! And if you end up needing a Colorado personal injury lawyer... 11

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