In re Fosamax: Solicitor General recommends US Supreme Court review impossibility-preemption defense

Product Liability Alert

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The Solicitor General recommended in an amicus brief that the US Supreme Court grant Merck Sharp & Dohme Corp.'s petition for a writ of certiorari to review the Third Circuit's decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017). The Third Circuit's Fosamax decision made waves in the field of FDCA preemption because it limited when an impossibility-preemption defense of state law failure-to-warn claims can be resolved on summary judgment.

The Solicitor General's recommendation, filed on May 22, substantially increases the chances that the Court will grant certiorari.

The Supreme Court last addressed the issue of impossibility preemption in the context of branded pharmaceuticals in Wyeth v. Levine, 555 U.S. 555 (2009). In Wyeth, the Court held that a pharmaceutical manufacturer could be liable for failing to warn patients on the drug label if the manufacturer could have changed its label without the prior approval of the Food and Drug Administration.Id. at 571-72. The Court then noted that such a claim could be preempted if the manufacturer could provide "clear evidence that FDA would not have approved a change to [the drug's] label."Id. at 571.

Courts since Wyeth have struggled to apply this preemption framework (including interpreting the "clear evidence" standard), and this was the issue squarely presented to the Third Circuit in Fosamax.

The Fosamax case and the Solicitor General's recommendation to grant certiorari

In 1995, FDA approved Merck's Fosamax to treat osteoporosis in postmenopausal women. Merck later sought FDA approval to add warnings to the Fosamax label to reflect studies that suggested a connection between Fosamax and an increased risk of certain "atypical" femur fractures. Merck used the Prior Approval Supplement (PAS) process – which allows labeling changes only after FDA review and approval – to suggest the label change. FDA, however, rejected Merck's PAS proposal and issued a Complete Response Letter stating that the justification for the additional warnings was "inadequate."

Despite FDA's denial of the proposed label change, more than 1,000 plaintiffs subsequently filed state-law claims against Merck, asserting that the Fosamax label failed adequately to warn of the risk of femur fractures. The cases were coordinated into an MDL for pre-trial proceedings.

Merck moved for summary judgment and asserted an impossibility-preemption defense. The district court granted the motion, but the Third Circuit reversed, holding that Wyeth's "clear evidence" requirement set a standard of proof for "how convincing the factual showing must be."  Fosamax, 852 F.3d at 285. In the Third Circuit's view, the preemption defense required "clear and convincing" evidence that FDA would have rejected the proposed warnings and that this determination is a question of fact for the jury. See id. The Third Circuit concluded that the record demonstrated a genuine issue of fact: whether FDA would have permitted a differently worded label change, or whether FDA rejected the new warnings because of an absence of evidence on the causal link between Fosamax and femoral fractures.

Merck petitioned for a writ of certiorari, and the Supreme Court requested the views of the Solicitor General. In an amicus brief filed on May 22, the Solicitor General recommended that the Court grant the writ and also offered its view of the merits. The Solicitor General disagreed with the Third Circuit that preemption is primarily a fact question. Rather, reviewing the decision of the FDA – an administrative body – and its potential impact for a preemption defense is a legal question: "[j]udges, rather than lay juries, are best suited to evaluate the scope of an agency's legal determination in light of the relevant statutory and regulatory context." Br. 14.

The Solicitor General further concluded that the Third Circuit reached the wrong substantive conclusion. Because FDA rejected Merck's proposed warning for Fosamax in a Complete Response Letter, that agency determination therefore controls and forecloses contrary state warning requirements. The Solicitor General speculated that it may be unclear whether Wyeth's demand of "clear evidence" for impossibility preemption would be a legal or factual question if no actual FDA decision existed, but he emphasized that was not the case here, where FDA had rejected Merck's proposed warning.

Even with the Solicitor General's recommendation, Fosamax is still a close case for certiorari

The Solicitor General's recommendation greatly increases the likelihood the Court will grant the writ. But the Solicitor General also admits in his brief that the decision is a close call and notes that several factors weigh against hearing the case. First, there is no circuit split on the issue of whether impossibility preemption is a fact question. Ordinarily, that would make a grant of the writ nearly impossible because the Supreme Court typically prefers to first await multiple decisions in lower courts before weighing in on an issue. Yet, in the Solicitor General's view, Fosamax does cleanly present the issue "in an MDL context in which hundreds of separate cases . . . turn on its proper resolution." Br. 22-23.

Second, Fosamax presents the preemption question in a factual scenario that likely will not exist in other cases. Typically, a predominant question in an impossibility-preemption defense is predicting whether FDA would have approved a change to the drug label if it had been requested. The Solicitor General contends that question was settled in Fosamax because Merck had requested a label change and FDA rejected that request. If the Court believes this factual background is not typical of an impossibility-preemption case, it may view any decision here as having a limited impact and therefore less worthy of a certiorari grant.

Third, the potential for certiorari is also complicated by the fact that Justice Samuel Alito recused himself from the case. That is significant for several reasons. It means there is one fewer justice to vote for certiorari (four votes are required for a grant). It also means there is an increased chance for a plurality opinion on the merits. Justice Alito's recusal is more impactful because he dissented in Wyeth and could have been expected to vote for granting certiorari to reshape the law in this area. Indeed, Justice Alito in Wyeth believed the state law failure-to-warn claims in that case were preempted as a matter of law because FDA had already approved the label in question – he would not have required the "clear evidence" of impossibility demanded by the majority and now at issue in Fosamax. Wyeth, 555 U.S. at 605-08 ("Neither the FDCA nor its implementing regulations suggest that juries may second-guess the FDA's labeling decisions.") (Alito, J., dissenting, joined by Roberts, C.J. and Scalia, J.). Had he not recused, Justice Alito likely would have advocated for a similar position here and found preemption as a matter of law.

In short, although the Solicitor General's request for a grant of certiorari typically carries great weight with the Court, it remains a close call whether the Court will grant review in this case.

Find out more about the implications of this litigation by contacting any of the authors.


1 A manufacturer may change its label without FDA approval by using the "Changes Being Effected" process. The CBE process allows a drug manufacturer to immediately implement proposed labeling changes, without prior FDA approval, based on "newly acquired information," that shows "the evidence of a causal association" that "satisfies the [relevant] standard for inclusion in the labeling." 21 C.F.R. 314.70(c)(6)(iii)(A); 314.3(b). "Newly acquired information" is defined as any "data, analyses, or other information not previously submitted to the [FDA]" that "reveal risks of a different type or greater severity or frequency previously included in submissions to FDA." Id. §314.3(b). If FDA subsequently disapproves the amended label, it may order the manufacturer to cease distribution of the newly labeled drug. 21 C.F.R. 314.70(c)(7).