This post is from the non-Reed Smith side of the blog.
Last week we posted about the decision in In re Incretin-Based Therapies Products Liability Litigation (S.D. Cal.) dismissing plaintiffs’ failure to warn claims as preempted based on the Wyeth v. Levine “clear evidence” standard. That is “clear evidence” that the FDA would have rejected the warning sought by plaintiffs, which leads to implied preemption based on impossibility.
At that time we had heard that the judge presiding over the consolidated incretin litigation in state court in California would be issuing a similar ruling. That turned out to be correct. Here is a link to the decision, In re: Byetta Cases, Case No. JCCP 4574 (Cal. Super. Nov. 13, 2015). The ultimate conclusion is the same: the evidence demonstrates that on multiple occasions the FDA considered and rejected a causal association between incretin and pancreatic cancer and likewise concluded that the drug’s labeling did not require revision. In re: Byetta Cases, slip op. at 15-18.
We aren’t going to re-hash the impossibility preemption analysis again; we think the federal court decision handled the issue more than well enough. But, we will point out a few interesting points made in the state court decision.