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Personal Injury Litigation: Federal Preemption as a Defense in Drug and Medical Device, and Pesticide Litigation

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Wednesday, July 21, 2021

Recorded event now available

or call 1-800-926-7926

This CLE course will explore the defense of federal preemption to common law personal injury claims against drug manufacturers for failure to warn, emphasizing "impossibility" preemption. The panel will discuss what is required to succeed on this defense and how "presumption against preemption" should play no role in the analysis.


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.



  1. Federal statutes regulating drugs and devices
  2. Overview of preemption
    1. Types of preemption
    2. How asserted
  3. Implied preemption under Food, Drug and Cosmetic Act
    1. Wyeth v. Levine
    2. Merck v. Albrecht
    3. Mutual Pharmaceutical v. Bartlett
    4. 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?


Masslon, John
John M. Masslon, II

Senior Litigation Counsel
Washington Legal Foundation

Mr. Masslon joined Washington Legal Foundation 2020 after having served as Assistant Solicitor General for the State of...  |  Read More

Wool, David
David J. Wool

Andrus Wagstaff

Mr. Wool represents clients in toxic tort, pharmaceutical and medical device litigation. He has been intricately...  |  Read More

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