• videocam Live Webinar with Live Q&A
  • calendar_month July 10, 2026 @ 1:00 PM ET/10:00 AM PT
  • signal_cellular_alt Intermediate
  • card_travel Personal Injury & Med Mal
  • schedule 90 minutes

Personal Injury From Failure to Warn: Drug Label Litigation Under State Law and Impossibility Preemption

About the Course

Introduction

This CLE webinar will discuss the ongoing challenges with asserting the impossibility preemption defense to personal injury failure to warn claims against pharmaceutical companies after In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 22-3412 (3d Cir. Sept. 20, 2024) (reported at 118 F.4th 322), cert denied, Merck Sharp & Dohme v. Algrecht, (Case No. 24-977) (U.S. June 16, 2025).

Description

Federal preemption can be a powerful defense to state law claims that a drug maker knew or should have known about a serious risk of using its drug, but failed to disclose it in the drug's labeling, instructions, or warnings. When new evidence brings to light new side effects, and the manufacturer requests additional warnings but the FDA will not approve them, it may be impossible for the manufacturer to comply with both state and federal requirements.

Preemption due to impossibility will only be found if a court determines, as a matter of law, that the defendant drug maker fully informed the FDA of the justifications for the warning, and that the FDA informed manufacturers that it would not approve a warning required by state law. Different courts have taken slightly different approaches to analyzing these two requirements, which are deceptively simple. The key issues include: what is full disclosure, whether there were options to add the warning without FDA approval, and whether there was any chance the FDA might approve the warning. If FDA's decision not to approve the warning is ambiguous or leaves other options open to the manufacturer, then courts apply a presumption against preemption, under Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 303 (2019), on the logic that the ambiguity renders the potential conflict or impossibility merely hypothetical.

Listen as our expert panel discusses impossibility preemption after the Supreme Court's denial of certiorari to review the Third Circuit's decision about what happens when the FDA formally denies a request to add warnings without mandating any alternative.

Presented By

Josh Gardner
Partner
DLA Piper

Mr. Gardner is a first-chair trial attorney who has practiced at the intersection of law and public policy across five administrations for more than two decades in the US Department of Justice (DOJ) and private practice. He has successfully led multiple trial teams through more than a dozen bench and jury trials, including some of the most consequential cases involving the federal government. Mr. Gardner has provided strategic counsel and guidance to the White House and federal agencies in high-profile litigation and congressional investigations. He has prepared multiple witnesses for congressional testimony and represented high-level officials in numerous transcribed interviews and depositions on the Hill. Mr. Gardner has extensive experience in defending depositions on behalf of cabinet and sub-cabinet agency officials in federal court cases. He has argued dozens of dispositive and discovery motions and has extensive experience working with expert witnesses. Mr. Gardner is recognized for training and developing successful trial teams.

Christopher Gismondi
Of Counsel
DLA Piper

Mr. Gismondi is Of Counsel in the Products Liability, Mass Tort, and Class Action group at DLA Piper LLP (US). He litigates high-stakes mass tort product liability and class action lawsuits. Mr. Gismondi's practice focuses on life sciences, defending companies in mass tort and class actions where general and specific personal injuries are alleged, as well as providing broad-based risk management, litigation, and regulatory support to a wide variety of sectors (including food and beverage, healthcare, and technology). He has taken a particular interest in the rise of claims relating to neurological-based injuries, and common parlance claims of addiction that conflict with, and undermine, the medical definition of addiction. Mr. Gismondi's efforts focus on explaining complex scientific concepts to broad audiences that are not experts in the field and breaking the link of causation between the wrongdoing alleged by the plaintiff and the claimed injury. He handles cases before state and federal trial and appellate courts, arbitrators, and mediators.

Rachel A.H. Horton
Partner
DLA Piper

Ms. Horton represents pharmaceutical and medical device companies in multidistrict litigation and appeals throughout the United States. She is a high-energy litigator who regularly handles complex matters. Ms. Horton has presented oral arguments in front of federal Courts of Appeals, state and federal trial courts and arbitration panels. She was recognized with the Pennsylvania Lawyers on the Fast Track Award in 2025.

Frederick S. Longer
Member
Levin Fishbein Sedran & Berman

Mr. Longer specializes in representing individuals who have been harmed by dangerous drugs, medical devices, other defective products and antitrust violations. He has extensive experience in prosecuting individual, complex and class action litigations in both state and federal courts across the country. Mr. Longer has been involved in the resolution of several of the largest settlements involving personal injuries including the $6.75 Billion settlement involving Diet Drugs and the $4.85 Billion settlement involving Vioxx. He was part of the teams responsible for negotiating the settlements in the National Football League Players’ Concussion Litigation, MDL No. 2323, the Chinese-Manufactured Drywall Products Liability Litigation, MDL 2047, involving various suppliers and manufacturers of Chinese Drywall valued in excess of $1 Billion, and the landmark environmental settlements with DuPont and 3M in the In Re Aqueous Film-Forming Foams Products Liability Litigation, MDL No. 2873, valued in excess of $12 Billion. Mr. Longer is a frequent lecturer and has presented numerous seminars on various legal topics for professional groups.

Jimmy A. Ruck
Attorney
Kellogg Hansen Todd Figel & Frederick, PLLC

Mr. Ruck represents both plaintiffs and defendants in trial and appellate courts. At the trial level, he handles every phase of litigation, from the complaint stage to examining witnesses at trial. At the appellate level, Mr. Ruck has briefed in multiple courts of appeals and in the United States Supreme Court and successfully argued a precedent-setting victory in a federal court of appeals. He has particular experience with complex commercial disputes, securities, and antitrust litigation, representing clients in the financial, telecommunications, and technology industries.

Credit Information
  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.


  • Live Online


    On Demand

Date + Time

  • event

    Friday, July 10, 2026

  • schedule

    1:00 PM ET/10:00 AM PT

I. Overview of failure to warn claims in drug label litigation

II. Preemption defense

III. Supreme Court cases applying impossibility preemption

IV. Circuit courts' interpretation of "clear evidence" standard under Albrecht

V. Informing FDA and ambiguous FDA responses

A. Submission of incomplete post-marketing safety data 

B. Faulty analysis to support a lesser warning 

C. Intentionally triggering FDA rejection and then claiming preemption

VI. Strategies for asserting impossibility preemption

The panel will address these and other key issues:

  • Why are informal FDA communications suspect?
  • How viable is the CBE process to secure additional warnings?
  • How do courts interpret the "clear evidence" criterion?