Case No. 17-290, 3d Cir.
Preview by Samuel E. Meredith, Senior Online Editor
Merck was initiated by over 500 people who used an osteoporosis medication known as Fosamax. The plaintiffs claim that Fosamax caused them to experience “an atypical femoral fracture,” and that the drug manufacturer did not properly warn them that such fractures were among the possible side effects of the medicine. Brief for Respondents at 7, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. filed Nov. 14, 2018).
In response to these allegations, Merck has argued that it is immune from state law failure-to-warn claims. In support of this assertion, Merck cites Wyeth v. Levine, in which the Court held that drug manufacturers are immune from state law failure-to-warn claims in situations where there is “clear evidence” that it is “impossible . . . to comply with both federal and state [warning label] requirements.” 555 U.S. 555, 571–73 (2009).
Merck moved for summary judgment based on this impossibility defense ahead of the first trial in the consolidated litigation. The district court did not rule on the motion before the first trial but eventually granted the motion after the jury in the first trial entered a verdict in favor of Merck.
The Third Circuit then reversed the district court’s ruling, explaining that Merck “ha[d] not carried its burden” under “[t]he Wyeth ‘clear evidence’ standard.” In re Fosamax Alendronate Sodium Prods. Liab. Litig., 852 F.3d 268, 271 (3d Cir. 2017).
Before the Court, Merck argues that it has demonstrated sufficient evidence of impossibility by showing that its attempts to publish warnings about the fractures were denied by the FDA. See Brief for Petitioner at 7–16, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. filed Sept. 13, 2018). In response, the plaintiffs argue that the FDA rejected Merck’s proposals because they contained inaccurate information and not because of any objection to warnings about the fractures as a general matter. See Brief for Respondents at 35–40, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. filed Nov. 14, 2018).
In addition to these disputes about the factual record, the litigants in Merck also disagree about who should ultimately be responsible for deciding whether a drug manufacturer has presented enough evidence to qualify for the impossibility defense. While Merck contends that the impossibility defense presents a legal question fit for a judge, the plaintiffs aver that impossibility is a factual issue for juries to decide. In any event, both parties agree that the Court may decide whether summary judgment was proper in this case without addressing this question.