Story of 5

Product Liability

California Southern District Court: Manufacturers overcome state failure-to-warn claims in diabetes drug MDL

State law failure to warn claims against the manufacturers of four anti-diabetic medications alleged to cause pancreatic cancer were preempted by federal law, a federal district court in California held. These state law claims were preempted because they conflicted with federal law labeling requirements and that the manufacturers had successfully established by clear evidence that the Food and Drug Administration (FDA) would have rejected a reference to pancreatic cancer in the product labeling because the causal association between the drugs and pancreatic cancer was indeterminate (In Re: Incretin-Based Therapies Product Liability Litigation, November 9, 2015, Battaglia, A.).

Background.  This multidistrict litigation involves claims that drug makers, Merck & Co., Amylin Pharmaceuticals, LLC, Eli Lilly, Merck Sharp & Dohme Corp., and Novo Nordisk Inc., failed to warn that four prescription drugs used to treat type 2 diabetes cause or create an increased risk of pancreatic cancer. Plaintiffs are individuals with type 2 diabetes who were prescribed and consumed one or more of the prescription drugs marketed respectively as Januvia, Janumet, Byetta, and Victoza.

Plaintiffs filed state law failure-to-warn claims against the manufacturers alleging that the product labeling should have referenced a pancreatic cancer risk. The manufacturers argue that the plaintiffs’ failure-to-warn claims were not viable because they are in conflict with federal law. The manufacturers contend that conflict preemption applied because it would be impossible to reference pancreatic cancer in the drug labeling and comply with FDA labeling regulations. The manufacturers moved for summary judgment premised on conflict preemption.  The plaintiffs challenged the conflict preemption defense, seeking a cross-motion for summary judgment.

Conflict Preemption. The plaintiffs claim based on the manufacturers’ failure to warn of the risk of pancreatic cancer was preempted by federal law. A failure to warn claim is preempted by federal law where a manufacturer proves through “clear evidence” that it was impossible to comply with state and federal law because the FDA would not have approved a change to the drug label. In support of their position, the manufacturers point out seven instances where the FDA has taken a position regarding pancreatic safety: (1) the FDA’s February 2014 assessment of pancreatic safety in the New England Journal of Medicine; (2) the FDA’s rejection of a citizen petition requesting the withdrawal of Victoza; (3) the FDA’s September 2014 conclusion that a causal association between incretin mimetics and pancreatic cancer is indeterminate; and (4)–(7) the subsequent approval of other incretin-based therapies without any reference to pancreatic cancer in the product labeling. The manufacturers contend that each of these examples represents the FDA’s opinion regarding pancreatic safety and its conclusion that current information does not support a causal association between the drugs and increased risk of pancreatic cancer.  

Alternatively, the plaintiffs assert that absent an express rejection of a pancreatic cancer reference by the FDA, the manufacturers cannot establish clear evidence. Moreover, the plaintiffs argue that the FDA’s ongoing evaluation of pancreatic safety precludes preemption. Upon review of related case law and other relevant materials, the court concluded that the FDA had expressed its official opinion regarding pancreatic safety and that, based on that official opinion, the court concluded that the FDA would have rejected a pancreatic cancer labeling change. Consequently, it was determined that conflict preemption applied because it would be impossible for the manufacturers to comply with both state and federal law. Thus, the manufacturers were entitled to judgment.

The case is No. 13md2452 AJB (MDD).

Attorneys: Hunter J. Shkolnik (Napoli Bern Ripka Shkolnik & Associates, LLP) for Moses Scott. Adam Patrick O’Brien (Wells, Anderson & Race, LLC), Ana Reyes (Williams and Connolly LLP) and Dinita L. James (Gonzalez Saggio & Harlan LLP) for Merck Sharp & Dohme Corp. f/k/a Merck & Co. Inc. Amy J. Laurendeau (O’Melveny and Myers) for Amylin Pharmaceuticals, Inc. Adam Benjamin Michaels (Pepper Hamilton, LLP), Brent A. Talbot (Chaffe McCall, LLP) and David E. Stanley (Reed Smith) for Eli Lilly and Co. Vickie E. Turner (Wilson Turner Kosmo LLP) for Patheon Pharmaceuticals, Inc. Charles P. Blanchard (Chaffe McCall LLP) and Christopher M. Young (DLA Piper US) for Novo Nordisk Inc.

Companies: Merck Sharp & Dohme Corp. f/k/a Merck & Co. Inc.; Amylin Pharmaceuticals, Inc.; Eli Lilly and Co.; Patheon Pharmaceuticals, Inc.; Novo Nordisk Inc.