Can't satisfy both the FDA and the State? The judge will be the judge of that.

ABSTRACT: With great power comes great responsibility; how the recent SCOTUS decision requiring prescription-drug manufacturers to prove the FDA rejected sufficient additional warnings will affect your impossibility preemption defense.

In May 2019, in a move rejecting the reasoning of the Third Circuit, the U.S. Supreme Court dove into two critical aspects of preemption analysis in Merck Sharp & Dohme Corp. v. Albrecht et al., No. 17-290, slip op. (U.S. May 20, 2019). The Court addressed who will decide whether preemption exists (a judge), and how to decide whether preemption exists where FDA action and state law conflict thereby destroying a plaintiff’s related state claims.

Specifically, the Court held a plaintiff’s claim that a drug manufacturer failed to warn pursuant to state law will fail when a judge applies a “clear evidence” standard and finds that the relevant federal and state laws “irreconcilably conflict.”

Petitioner drug manufacturer, Merck Sharp & Dohme Corporation, sought Supreme Court review of the Third Circuit’s decision to vacate and remand the lower court’s Order granting Merck’s Motion for Summary Judgment.  The Respondents, more than 500 individuals who filed individual suits which were consolidated into a multi-district litigation (MDL), were prescribed an osteoporosis drug manufactured by Merck (Fosamax) and subsequently suffered rare thigh bone breaks (referred to in litigation as “atypical femoral fractures”).  The Respondents alleged Merck breached a legal duty imposed by the state to warn of the risk of atypical femoral fractures associated with using Fosamax.  Merck countered these claims with an “impossibility preemption” defense, arguing the Respondents’ state law claims should be dismissed because conflicting federal law displaces, or preempts, the state requirement.  The Court fleshed out preemption standards set forth in an earlier Supreme Court case (Wyeth v. Levine) in an explicit attempt to aid lower courts when conducting preemption analyses, and remanded the case with these new understandings.  While the Court remanded the case, it did opine that “there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamax label.”

Under Wyeth v. Levine, 555 U.S. 555 (2009), a state-law failure-to-warn claim is preempted where there is “clear evidence” that the FDA would not have approved a change to the label.  Since Wyeth, courts have struggled to both define and apply this “clear evidence” standard.  In Merck, the Court elaborated on the clear evidence standard set out in Wyeth and held that Merck would have to show two things to trigger state law preemption: (1) Merck gave the FDA an evaluation or analysis concerning the specific dangers that would have merited the additional warning, and (2) Merck presented the would-be-state-compliant warning but was prohibited from adding said warning by the FDA.

The original Fosamax label was approved by the FDA in 1995.  The original label did not warn of the risk of atypical femoral fractures.  While the Court points to the fact that Merck scientists knew of at least a “theoretical risk” of these fractures, Merck brought the theoretical considerations to the FDA’s attention and the FDA approved a Fosamax label without requiring mention of the risk.  In 2008, Merck applied to change the Fosamax label in two ways: (1) add reference to “low-energy femoral shaft fracture” in the Adverse Reactions section of the label, and (2) provide longer discussion focused on the risk of stress fractures in the Precautions section.  The FDA approved the first addition, but rejected the second on the basis that the discussion of “stress fractures” was not sufficiently related to the risk of the specific atypical femoral fracture.  This is because atypical femoral fractures are low energy fractures that are the result of stress fractures, and have different pain symptoms and more severe repair remedies.  At that time, the FDA did however invite Merck to resubmit its application to address label change deficiencies.  Instead, Merck withdrew its application and changed the Adverse Reactions section through the “changes being effected” (CBE) process.  The CBE process is provided within the FDA regulations and permits drug manufacturers to change labels without prior FDA approval where “newly acquired information … based on reasonable evidence” warrants a new or stronger warning.  A warning about “atypical femoral fractures” appeared on the Fosamax label in 2011, after the FDA ordered a label change based on its own analysis. 

Finally, the Court reiterates the long-standing principle that the only FDA agency actions capable of answering whether preemption exists are those taken pursuant to the FDA’s congressionally delegated authority.  Where, as in Merck, the answer to preemption revolves around a question of agency disapproval, the Court unambiguously held the question of agency disapproval is a question of law for a judge to decide, not a jury.  Chatter of the role of a jury, specifically regarding factual questions about the meaning and effect of an agency decision in preemption cases, was silenced by the Court’s Opinion.  The Court unabashedly admits there are such factual questions within a preemption analysis, but held that those questions are “subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury.”  Ultimately, the Supreme Court remanded the case because the Third Circuit improperly analyzed the question of preemption as one of fact for a jury, rather than a question of law, and because the Court has now clarified how to properly apply the clear evidence standard.

What does this mean for your company?

If you, like Merck, are in the business of manufacturing drugs, you can take solace in the fact that an FDA preemption argument is in the hands of a judge.  Because the Supreme Court has now held this issue is one exclusively for the Court, it may be ruled upon during motion practice with less strife related to facts “subsumed” in this kind of complex legal analysis.  But this strategic advantage cuts both ways.  Drug-manufacturers will now have to show that the company submitted a state law required warning to the FDA.  Litigation of these issues to date has largely involved questions about what exactly the FDA rejected when disapproving label changes.  The Court makes clear that the manufacturer’s proposed label change cannot be of some broader, less threatening risk – like stress fractures – when the company has knowledge of a specific, less appeasing risk – like atypical femoral fractures.  This is to say, while the power that comes with an impossibility preemption defense can be a great litigation tool, the responsibility to fully inform and present the FDA with state-compliant warnings is equally great.