U.S. Supreme Court. (Photo: Diego M. Radzinschi/NLJ.)
Federal law preempts the claims plaintiffs are making that incretin-based drugs caused their pancreatic cancer, a group of drugmakers argued in their latest court filing on the issue. The defendants say there is no clear evidence the U.S. Food and Drug Administration would have changed the warnings given on the risks of those drugs.
Even though the U.S. Supreme Court ruled in Wyeth v. Levine that federal regulatory approval of a brand-name drug does not shield pharmaceutical companies from state tort lawsuits, now the FDA can require a labeling change if it becomes aware of new safety information that should be included in drug labeling, the drugmakers said. That was not possible at the time Levine was decided.
The Levine preemption test is if there is “’clear evidence that the FDA would not have approved’” a labeling change warning of the injury alleged by plaintiffs, the pharmaceutical companies said.
There is clear evidence that the FDA does not think that consumers or their prescribers must be warned of a causal association between incretin-based drugs and cancer in the pancreas, the drug company defendants said in court papers.
The FDA published an official statement in the New England Journal of Medicine that the current labeling for incretin-based drugs are adequate, the defendants said. The review included analyzing pancreatic cancer data from two trials involving 20,000 trials.
“FDA has recognized that incretin-based therapies are an important treatment option for patients with diabetes,” the defendants said. “Thus, when assertions were made in the scientific literature and the media about a possible causal association between the medications and pancreatic cancer, FDA acted in unprecedented fashion, launching its own comprehensive evaluation and reporting its findings, including its evaluation of the product labeling.”
Federal regulators rejected a public citizen petition to remove one incretin drug, Victoza, from the market after regulators found there is no new evidence regarding a risk of pancreatic cancer from the use of that drug, the drugmakers said. They also said the FDA approved two incretin-based therapies this past year without requiring a pancreatic cancer warning.
Sharp & Dohme Corp. is represented by Williams & Connolly LLP, Novo Nordisk by DLA Piper, Amylin Pharmaceuticals LLC by O’Melveny & Myers LLP, Eli Lilly and Company by Pepper Hamilton LLP.
Amaris Elliott-Engel contributes to law.com.