Description
In failure-to-warn pharmaceutical litigation, drug manufacturers often assert "impossibility" preemption, which requires showing that it is impossible to comply with both the state and the federal labeling requirements. In Wyeth v. Levine, 555 U.S. 555 (2009), the Supreme Court required manufacturers of name-brand drugs to show that the FDA would have rejected labeling plaintiffs argue should have been present for on-label uses.
Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) held that impossibility preemption is a question law and described the high burden that pharmaceutical manufacturers must meet to win on an impossibility-preemption defense. The case, however, shows that the "presumption against preemption" is dead and courts’ scope of review is limited.
Both plaintiff and defense counsel must understand the latest interpretations of and strategies for using or defeating this powerful preemption defense.
Listen as this experienced panel discusses preemption in the context of pharmaceutical litigation.
Presented By
Mr. Masslon joined Washington Legal Foundation 2020 after having served as Assistant Solicitor General for the State of West Virginia, where he regularly practiced before both state and federal appellate courts. He also acquired invaluable experience while clerking for judges on the U.S. District Court for the Western District of Pennsylvania and the Superior Court of Pennsylvania. Mr. Masslon graduated magna cum laude from Clemson University, where he majored in Economics. Following additional graduate study in Economics, he went on to receive a J.D. and an L.L.M. in Taxation from Georgetown University Law Center.
Mr. Wool represents clients in toxic tort, pharmaceutical and medical device litigation. He has been intricately involved in the several major litigations. Mr. Wool was appointed to the Plaintiff’s Steering Committee in multi-district litigation (MDL) 2642, In Re Fluoroquinolone Products Liability Litigation, by the Honorable John R. Tunheim to represent thousands of plaintiffs suffering from permanent and debilitating peripheral neuropathy. Additionally, he served a critical role in MDL 2741, In Re Roundup Products Liability Litigation, successfully arguing against the first motion to dismiss filed anywhere in the country setting the stage for continued litigation. Mr. Wool has extensive knowledge and experience in every step of the litigation process from drafting complaints, to organizing multi-district litigation and arguing dispositive motions in federal court.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Wednesday, July 21, 2021
- schedule
1:00 p.m. ET./10:00 a.m. PT
- Federal statutes regulating drugs and devices
- Overview of preemption
- Types of preemption
- How asserted
- Implied preemption under Food, Drug and Cosmetic Act
- Wyeth v. Levine
- Merck v. Albrecht
- Mutual Pharmaceutical v. Bartlett
- PLIVA v. Mensing
The panel will review these and other issues:
- Is there a heightened evidentiary standard for preemption cases
- What cases are "Levine-like"?
- What kind of discovery is relevant to and permitted in connection with deciding preemption?
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