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.
First and foremost, the court spends a significant amount of time dealing with the issue of whether impossibility preemption, at least in this context, is a question of law for the court or a question of fact for the jury. Id. at 18-26. While the court found no other case that directly answered the question, they did note that the U.S. Supreme Court in deciding Levine and every court to have considered the Levine clear evidence standard since have treated the issue as a question of law. Id. at 19-20. Citing things like the need for consistency on a defense “equally operative to all similarly situated plaintiffs,” and the difference between analyzing legislative facts as opposed to adjudicative facts, the court concluded that deciding the federal preemption issue was “an analytical process where legal training and experience add value and where a jury’s unique ability to test credibility is not as useful or material.” Id. at 24.
Having decided that it could decide the question, the court moved on to the substantive analysis, starting with a discussion of what the “clear evidence” standard really means. The court reasoned that “clear evidence” is something more than a preponderance but less than indisputable – meaning it is closest to a “clear and convincing” standard. Id. at 27-28. To our knowledge this equation of “clear” to “clear and convincing” is a unique finding among the courts to have considered/applied the Levine test. Does it make the standard any “clearer” to apply? Questionable. But we like the position that “clear” doesn’t mean “indisputable.”
Not only did the court define the standard, it also put a finer point on the actual question to be answered:
It should be clearly noted that the question posed by Wyeth v. Levine is NOT to second guess whether the FDA should have allowed such a CBE, NOR whether or not the FDA of its own accord should have required a label change to add such a warning. Further, the question presented is not whether or not there is admissible scientific evidence that one of these drugs causes pancreatic cancer, which is a different question.
Id. at 10-11. All valid points and all things that plaintiffs use to distract the court from the real preemption question.
So, the court answered the very specific question of whether there was “clear and convincing” evidence that the FDA would have rejected the warning plaintiffs allege should have been given. The state court answered the question affirmatively – for essentially all the same reasons the federal court did. Notably, the state court like the federal court would not consider plaintiffs’ arguments regarding information allegedly withheld from the FDA as those are preempted fraud-on-the-FDA claims. Id. at 29. The state court decision also rejected the plaintiffs’ notion that defendants were required to seek a label change and be rejected for there to be preemption:
The one piece of the puzzle arguably lacking is the fact that there was never a CBE request for a manufacturer seeking to add a pancreatic cancer warning, but plaintiffs and their advocates expect too much when they make the assumption that a manufacturer would make an insincere, factually unsound request for a CBE to add an otherwise unjustified warning . . . just to obtain a denial letter. There is no cognizable legal obligation on the defendants to do so as a predicate to invoking impossibility preemption under Wyeth.
Id. at 30-31.
As both the federal and state court decisions demonstrate, the facts of the incretin FDA story are hardly equivocal. If this set of facts and statements by the FDA didn’t warrant Levinepreemption, we aren’t sure what else other than an outright rejection of a CBE would be “clear evidence.” Fortunately, that’s not what happened here and even though the facts were incredibly favorable, the legal analysis is also defense-friendly and hopefully helpful to those of you fighting a Levine battle of your own.