United States: The Ripples Of The Fosamax Reversal

Last Updated: March 15 2019
Article by Eric Alexander

If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court's creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA's rejection of the same proposed label, FDA's statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA's pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosamax decisions out of the District of New Jersey, which we touted not too subtly. Then the Third Circuit reversed, essentially holding that summary judgment cannot be granted for defendants under a Levine analysis because juries have to decide whether the clear evidence bar was met. We sharpened our proverbial pens to decry the reasoning of that decision, its impact on litigation, and its invitation for juries to second-guess FDA.

We have, of course, tracked the appeal of Fosamax to the Supreme Court, including the amicus brief of the Solicitor General and the oral argument. The Solicitor's brief advocated that judges should decide preemption under Levine when interpreting the scope of an agency decision is required for the decision. Drawing on the Administrative Procedures Act, the brief argued that "[n]o sound reason exists for treating the meaning and effect of an FDA administrative determination differently" than other federal agency decisions, which are questions of law. Drawing on Supreme Court authority in the patent context, the brief reasoned that "[t]o the extent extrinsic evidence may sometimes be relevant in litigation between private parties to determine the meaning and effect of FDA's agency action, the court's evaluation of such subsidiary facts does not alter the ultimate legal character of the inquiry or the court's exclusive authority to resolve it." Cases are not exactly on hold while the Supreme Court mulls over what to do with the Fosamax appeal, so we were intrigued by the question certified on appeal in Rinder v. Merck Sharpe & Dohme Corp., — N.E. 3d –, 2019 IL App. (1st) 171969 (Ill. App. Jan. 23, 2019):

Under [Levine] federal law preempts state-law failure to warn claims related to the use of a prescription drug if there is "clear evidence" that the FDA would not permit the manufacturer to include the plaintiff's requested warning in the drug's labeling. Is the question whether the defendant has presented the necessary "clear evidence" one for resolution by the court or jury?

We will skip over the underlying facts of the case, but we can say there are multiple FDA decisions to be interpreted, it was pretty to clear to us that FDA would have rejected the label plaintiff wanted when they wanted it, and the plaintiff's arguments seemed to hinge on after-the-fact evidence of causation. But here is where we come back to Fosamax. Although most published decisions involved the court deciding whether there was the clear evidence in the record required by Levine, the court identified Fosamax as the only relevant federal circuit decision and proceeded to follow it in rejected each of defendant's arguments for why the court should decide the issue and find it was impossible to the defendant to have the label that plaintiff wanted. In essence, the Rinder court ruled that "the issue presented by the [Levine] inquiry is simply a particular application of the task juries regularly perform in tort cases, determining what the evidence shows probably would have happened if the allegedly wrongful conduct had not occurred." Therefore, substantive Illinois law would require a jury to consider the defense of conflict preemption and summary judgment would be impossible in cases where plaintiff could come up with some arguments against defendant's urged interpretation of the FDA's decisions. Until Fosamax is reversed or at least rejected by other circuit courts, this is the sort of facile decision we will keep seeing.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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