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Regulatory Focus™ > News Articles > 2019 > 5 > SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

Posted 20 May 2019 | By Zachary Brennan 

SCOTUS Says Judge, Not Jury, Should Decide Merck Drug Labeling Case

In cases where state failure-to-warn claims should be dismissed as pre-empted by federal law, the Supreme Court on Monday unanimously ruled that judges, rather than juries, are better equipped to evaluate the nature and scope of an agency’s, such as the US Food and Drug Administration (FDA), determination.

While ruling that a lower court should re-assess its decision on the Merck case related to the labeling for a drug’s side effects, the majority opinion also noted: “[W]e assume—but do not decide—that, as was true of the warning at issue in Wyeth, 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."

Justice Clarence Thomas also wrote in a concurring opinion: “Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law.”

In addition to ruling that this question of pre-emption is one for a judge to decide, the opinion from the Supreme Court also held that “clear evidence” should be defined as “evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.”


The opinions are related to a case where more than 500 individuals, who took the osteoporosis drug Fosamax (alendronic acid) and suffered atypical femoral fractures from 1999 to 2010, sued Merck seeking damages because state law imposed upon Merck a legal duty to warn them and their doctors about the risk of the fractures. Merck, however, argued that respondents’ state law failure-to-warn claims should be dismissed because they are pre-empted by federal law.

The company defended itself because it proposed adding a warning to Fosamax’s label related to the risk of stress fractures, but FDA rejected that proposal because the company’s use of the term “stress fractures” may be considered a more minor type of fracture than what some patients were seeing and what was being reported in the literature.

A warning about “atypical femoral fractures” did not appear on the Fosamax label until 2011, when FDA ordered that change based on its own analyses. The label now refers to fractures as “atypical” five times, but does not use the term “stress fracture.”


Justice Thomas added that FDA’s complete response letter related to Merck’s prior approval supplement application to add certain language regarding fractures to the Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label “was not a final agency action with the force of law, so it cannot be ‘Law’ with pre-emptive effect. Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypothetical agency action is not ‘Law.’”

Thomas also noted how Merck added atypical femoral fractures to the Adverse Reactions section through FDA’s “changes being effected” process, which also could have enabled Merck to add language to the Warnings and Precautions section, but Merck did not do so. “If it had, it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfy both sets of duties,” Thomas wrote.

Justice Samuel Alito, joined by Chief Justice John Roberts and Justice Brett Kavanaugh, also offered a concurring opinion but raised concerns with the court’s opinion because its discussion of the law and the facts “may be misleading on remand.

“A reader of the Court’s opinion will inevitably be left with the impression that, once the FDA rejected Merck’s proposed warning in 2009, neither the FDA nor Merck took any other actions related to atypical femoral fractures ‘until 2011,’…But that is simply not true. While Merck’s 2008 proposal was pending, the FDA remained in contact with Merck about the issue of atypical femoral fractures, which Merck, at the time, labeled as a type of stress fracture."

An internal Merck memorandum also describes a phone call in which an FDA official allegedly told Merck that “[t]he conflicting nature of the literature does not provide a clear path forward, and more time will be need[ed] for FDA to formulate a formal opinion on the issue of a precaution around these data.

“Thus, for years the FDA was: aware of this issue, communicating with drug manufacturers, studying all relevant information, and instructing healthcare professionals and patients alike to continue to use Fosamax as directed. For this reason, the FDA itself, speaking through the Solicitor General, takes the position that the FDA’s decision not to require a label change prior to October 2010 reflected the FDA’s “determin[ation]” that a new warning “should [not] be included in the labeling of the drug,” the justices wrote.


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