Federal law preempts the claims of plaintiffs alleging they were not adequately warned of the risk of pancreatic cancer from incretin-based drugs, several drugmakers said in court papers filed in federal multidistrict litigation.
Defendants Novo Nordisk, Inc., Merck Sharp & Dohme Corp., Eli Lilly and Company and Amylin Pharmaceuticals, LLC, said federal law preempts the plaintiffs’ failure-to-warn theories because “there is clear evidence that the Food and Drug Administration .. would refuse to approve the plaintiff’s proposed warning.”
The U.S. Supreme Court held in Wyeth v. Levine that federal law does not preempt state-law failure-to-warn claims over pharmaceuticals “’absent clear evidence that FDA would not have approved’” changes in the labeling instructions. The defendant drugmakers argue that these incretin cases are an example of clear evidence that the FDA would not have approved changes to proposed warnings.
“The clear evidence is that, here and now, FDA would not approve pancreatic-cancer labeling for these products,” the defendants said in court papers. “Therefore, federal law preempts plaintiffs’ failure-to-warn claims.”
The FDA concluded that scientific data did not support reasonable evidence of a causal association between the mediations and pancreatic cancer earlier this year, the defendants said. For example, the FDA rejected a public citizen petition asking for incretin-based Victoza to be withdrawn from the market because of the allegedly increased risk of pancreatic cancer, the drugmakers said. FDA employees also authored an article in the New England Journal of Medicine about regulators’ year-long evaluation of the possible association between pancreatic cancer and incretin-based drugs.
The incretin-based drugs at issue are Byetta, Januvia, Janumet and Victoza. Incretin-based drugs treat type-2 diabetes by increasing incretin hormones, which lower blood sugar by stimulating the production of insulin.
The MDL is pending in the Southern District of California.
Amaris Elliott-Engel contributes to law.com.