December 3, 2015, Trial News
Hundreds of state law diabetes drug claims preempted
A federal district court has dismissed failure-to-warn claims in multidistrict litigation involving four drugs for the treatment of Type II diabetes, finding that the plaintiffs’ state law claims are preempted. The plaintiffs alleged that the drugmakers failed to warn about the risks of pancreatic cancer associated with the drugs—Januvia, Janumet, Byetta, and Victoza.
A federal district court has dismissed failure-to-warn claims in multidistrict litigation involving four drugs for the treatment of Type II diabetes, finding that the plaintiffs’ state law claims are preempted. The plaintiffs alleged that the drugmakers failed to warn about the risks of pancreatic cancer associated with the drugs—Januvia, Janumet, Byetta, and Victoza. The decision affects hundreds of cases in the MDL and may signal a trend that will affect other litigation, say plaintiff attorneys. (In re Incretin-Based Therapies Prods. Liab. Litig., 2015 WL 6912689 (S.D. Cal. Nov. 9, 2015).)
Judge Anthony Battaglia of the Southern District of California relied on the “clear evidence” standard set forth in the 2009 U.S. Supreme Court case Wyeth v. Levine (555 U.S. 555 (2009)). In that case, the Court considered whether a drug should have included a warning about a particular way of administering the drug to a patient. The drugmaker argued that federal law preempted the plaintiff’s claim because it could not comply with both state law and the FDA’s labeling requirements. The Court considered “whether Wyeth tried to give the warning sought by Levine and whether it had been precluded from doing so; whether the FDA or the manufacturer focused on the risks associated with [the drug’s administration]; and whether Wyeth provided the FDA with an analysis or evaluation of those risks.” The Court found that the drugmaker had not presented to the FDA a proposed warning label about the method of drug administration at issue, and the FDA had never rejected such a proposed label. Thus, the drugmaker could have provided the warning. The Court held that “absent clear evidence that the FDA would not have approved the change,” it was not impossible for the drugmaker to provide the warning without conflicting with federal law.
In the diabetes drug cases, the court found enough support in the record to establish clear evidence that the FDA would not have approved a label warning of the risks of pancreatic cancer. The judge considered several agency actions beginning in 2009 about the association between the drugs and pancreatic cancer, including a review of the FDA’s adverse event reporting system, the agency’s response to a citizen petition requesting Victoza’s removal from the market, and an evaluation of the risks published in the New England Journal of Medicine.
The plaintiffs contended that clear evidence cannot be established without the FDA’s “actual and express rejection” of a proposed warning label, and that studies did link pancreatic cancer to the drugs. The judge rejected this argument, stating that Levine does not require the FDA to have taken specific action on a proposed labeling change—rather, the clear evidence hurdle can be met if it is demonstrated that the agency would have rejected the warning.
Attorney Thomas Ayala cautioned that this opinion broadens the application of the clear evidence standard and could affect other litigation. “Defendants will likely try to expand the clear evidence exception beyond what was intended in Wyeth v. Levine. The clear evidence exception was established on what the manufacturer actually proposed for a warning and the underlying basis it provided, and then whether the FDA rejected the proposed label. What is so extraordinary about this opinion is that the judge made a finding of clear evidence without FDA proposed labeling and without the FDA having considered data and information relating to the issue, which is a critical component of making a clear evidence determination,” he said. “How can a judge accurately predict that the FDA would reject such a warning?”
“The ruling by the MDL judge represents a very aggressive application of the ‘clear evidence’ doctrine to bar plaintiffs’ state products liability claims,” said attorney Lou Bograd of the Center for Constitutional Litigation in Washington, D.C. “The judge refused to even consider significant evidence about the risk of pancreatic cancer that the defendants had but did not share with the FDA.’
Ayala noted that plaintiff attorneys need to focus on discovery and the evidentiary implications involved. “We need to have discovery of both the FDA and the company to understand the nature of the communication between them and the universe of information that the company has shared and the FDA has considered. We need to look very carefully at the record before the FDA. If an individual at the FDA drafts a response to a citizen petition, is that really a final action? It’s one person’s opinion based on limited data. And how can that opinion be admissible in court without satisfying the scrutiny applied to any other expert opinion under Rule 702 and Daubert?”