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December 28, 2015 Practice Points

District Court Disposes of MDL with Impossibility Preemption Ruling

By M. Joseph Winebrenner

On November 9, 2015, the U.S. District Court for the Southern District of California granted a sweeping motion for summary judgment on impossibility preemption grounds, ending a two-year multidistrict litigation (MDL) in resounding favor of the defendants. See In re Incretin-Based Therapies Prods. Liab. Litig., No. 13-md-2452, 2015 U.S. Dist. LEXIS 152763 (S.D. Cal. Nov. 9, 2015).

In Incretin, the MDL plaintiffs alleged that manufacturers of four anti-diabetic medications (Januvia, Janumet, Byetta, and Victoza) failed to warn that their respective products could cause pancreatic cancer. The defendants moved for summary judgment on impossibility preemption grounds. Impossibility preemption can be found in the context of name-brand pharmaceuticals only where there is “clear evidence that the FDA [Food and Drug Administration] would not have approved a change to [the] label.” Wyeth v. Levine, 555 U.S. 555, 571 (2009).

The court granted the defendants’ motion, concluding that there was “clear evidence” that the FDA would not have approved the labeling change that the plaintiffs contended should have been made. In so concluding, the court relied upon the following previous actions by the FDA, among others:

  • In 2009, the FDA reviewed its adverse-event database for incidents of pancreatic cancer, concluding there was “little inference for risk” based on the review and that a causal association was indeterminate.
  • In February 2014, the FDA published an assessment of pancreatic safety in the New England Journal of Medicine, concluding that “assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer . . . are inconsistent with the current data.”
  • In March 2014, the FDA responded to a citizen petition to withdraw Victoza from the market, concluding that “[a]ny causal association between exposure to Victoza and pancreatic cancer is indeterminate at this time,” and based on its findings recommended no change to the labeling.
  • In September 2014 and since, the FDA repeatedly reviewed pancreatic safety concerns of Victoza and other similar drugs in relation to new medications and expanded indications. The FDA at no time required reference to the risk of pancreatic cancer in the label.

Given this record, the court concluded that there was clear evidence that the FDA would “have rejected a pancreatic cancer label change, having found on more than one occasion that scientific evidence did not support such a reference.” Id. at *89.

The plaintiffs made several arguments in an attempt to avoid summary judgment, all of which were unavailing. The court rejected their contention that preemption could be found only where the FDA had previously rejected, expressly, the proposed labeling change at issue. The court likewise rejected the arguments that preemption could not be found because (1) the FDA actions underlying the defendants’ preemption argument were not “official” FDA actions, and (2) the FDA’s conclusion of an “indeterminate” risk was not a final conclusion, but rather was the agency’s current assessment in an ongoing investigation. Id. at **97, 102–03 (“The potential for the FDA to reach a different conclusion in the future in light of new scientific evidence or developments does not preclude a finding of preemption now. . . . Because the Court is required to analyze conflict preemption in the context of the current record, the FDA’s ongoing review does not undermine the FDA’s current conclusions.”). Finally, the court rejected the plaintiffs’ argument that preemption could not be found because the defendants had allegedly failed to disclose data supportive of a causal connection. The court declined to consider this argument, concluding that it was a de facto allegation of fraud-on-the-FDA preempted by Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). Moreover, as the court reasoned, “[w]hat the FDA considers in evaluating a safety signal is best left to the discretion of the FDA and not subject to challenge as part of a preemption analysis.” Id. at *111.

The Incretin decision is the latest installment on impossibility preemption in the context of name-brand pharmaceuticals, and represents a significant victory for manufacturers. The court’s order dealt a significant blow to plaintiffs, who had litigated the cases for more than two years before the docket was wiped clean on summary judgment. The decision proves that preemption is not dead, even with regard to name-brand prescription drugs, and under the right facts can provide a sweeping defense that can aid manufacturers in both litigation and settlement negotiations. Accordingly, defendants once again can, and should, consider preemption as a viable defense in failure-to-warn litigation.

M. Joseph Winebrenner, Faegre Baker Daniels LLP, Minneapolis, MN

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