Term: 2018
Docket: 17-290
Merck Sharp & Dohme Corp. v. Albrecht
- Pro
17-290 MERCK SHARP & DOHME CORP. V. ALBRECHT DECISION BELOW: 852 F.3d 268 JUSTICE ALITO TOOK NO PART. October 26, 2018 JUSTICE ALITO IS NO LONGER RECUSED. CERT. GRANTED 6/28/2018 QUESTION PRESENTED: In Wyeth v. Levine, 555 U.S. 555 (2009), this Court held that the FDA's approval of a drug label does not, standing alone, insulate the manufacturer from failure-to-warn liability under state tort law. At the same time, the Court recognized that if "the FDA would not have approved" the label demanded by state law, then the manufacturer could invoke an "impossibility'' preemption defense. Id. at 571. In this case, it was "undisputed" that (i) "the FDA was aware of the possible link" between petitioner's drug and the risk at issue; (ii) petitioner "submitted a comprehensive safety update to the FDA reporting . . . numerous studies" finding "such an association"; (iii) petitioner "proposed warning language" about this risk, but the FDA "rejected" it; (iv) the FDA stated that the "conflicting nature of the literature d[id] not provide a clear path forward” and that it needed "more time" to consider "the issue of a precaution"; and (v) only later, after a report from a task force, did the FDA become "confident” that an association "potentially'' existed. Pet.App.59a-60a. The Third Circuit nonetheless held that a jury could find that petitioner had not shown by "clear and convincing evidence" that the FDA would have rejected a warning label of the type that respondents claim state law required. See Pet.App.37a, 56a-57a. The question presented is: Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning? LOWER COURT CASE NUMBER: 14-1900
In the case of Merck Sharp & Dohme Corp. v. Albrecht, the U.S Supreme Court ruled in favor of pharmaceutical company Merck, stating that only a federal court can decide whether FDA regulations preempt state law claims under "impossibility preemption". The plaintiffs had alleged that Merck failed to warn them about potential risks associated with its osteoporosis drug Fosamax. However, evidence showed that Merck had attempted to update their warning labels but were rejected by the FDA due to insufficient proof at the time. The ruling clarified when a drug manufacturer is exempt from state-law failure-to-warn claims and emphasized it's not enough for a company merely to show they informed regulators about an adverse event; instead, they must demonstrate 'clear evidence' that regulators would have rejected any attempt by them to revise their product warnings.
In the dissenting opinion for MERCK SHARP & DOHME CORP. v. ALBRECHT, Justice Alito, joined by Chief Justice Roberts and Justice Kavanaugh, argued that the majority's decision was based on an incorrect interpretation of 'clear evidence'. They contended that federal law preempts state-law failure-to-warn claims if there is clear evidence that FDA would not have approved a change to the drug’s label; however, they disagreed with how 'clear evidence' should be defined. The dissenting justices believed it should mean proof beyond reasonable doubt rather than just substantial evidence as interpreted by the majority. Furthermore, they opined this question of preemption is primarily legal in nature and thus falls within judges’ expertise rather than juries’. They also expressed concern about practical implications of leaving such determinations to juries which could result in inconsistent outcomes across different cases involving identical facts.
