Trial News

In Merck Sharp & Dohme Corp. v. Albrecht—a case that focuses on whether a group of plaintiffs’ state law failure-to-warn claims against Merck are preempted—oral arguments before the U.S. Supreme Court earlier this month explored the timeline of communications between the manufacturer and the FDA. (No. 17-290 (U.S. oral arg. Jan. 7, 2019)). The plaintiff respondents seemed to face an uphill battle as the Court debated how to interpret a 2009 FDA response letter in which—without clearly explaining its reason—the agency rejected a proposed change to the label for Merck’s osteoporosis drug Fosamax. In a position supported by the federal government, Merck has argued that under the impossibility preemption doctrine, the agency’s ambiguous rejection should invalidate the claims of plaintiffs who allege that they were seriously injured by that drug.

In 2008, Merck submitted a request to the FDA to update the label for Fosamax. In response to reports that the drug’s users had suffered serious “atypical femoral fractures” (AFF), Merck proposed changing the language on the label’s “Warnings and Precautions” and “Adverse Reactions” sections to warn of a risk of “stress fractures.” The FDA rejected this change to the “Warnings and Precautions” section, calling Merck’s justification “inadequate” but without clearly stating why.

In 2010, an FDA task force found evidence linking AFF with the use of biophosphonate drugs such as Fosamax. Later that year, sending different language from what Merck had originally proposed, the FDA asked Merck to update the warnings section of Fosamax’s label to reflect the AFF risk. Again, the FDA rejected additional language proposed by Merck about stress fractures, stating that the agency believed that “for most practitioners, the term ‘stress fracture’ represents a minor fracture and this would contradict the seriousness of the [AFF] associated” with biophosphonate drugs.

In 2011, after the label change, more than 1,000 patients who had taken Fosamax and suffered AFF sued Merck for its earlier failure to warn of this risk. These suits were consolidated into an MDL in federal court in New Jersey. After discovery and a bellwether trial, the district court granted Merck’s motion for summary judgment, finding that, under the Wyeth v. Levine (555 U.S. 555 (2009)) standard, the claims were preempted because there was “clear evidence” that the FDA would not have approved the warning in question.  

The Third Circuit vacated the decision, ruling that summary judgment was inappropriate because the plaintiffs had “produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk [of AFF]—or at the very least to conclude that the odds of FDA rejection were less than highly probable.” In June 2018, the Supreme Court granted certiorari.

Without focusing on the Wyeth decision or the scope of the clear evidence standard, the majority of the oral arguments examined the timeline of written and verbal communications between Merck and the FDA on the warning language and how these two parties interpreted their discussions about the AFF risk.

Washington, D.C., attorney Shay Dvoretzky, representing the defendant petitioner, stated that although the 2008 proposed label change referred to the injuries as “stress fractures,” the supporting data and materials made clear—and the FDA understood—that Merck intended to warn about the risk of a wide range of low-energy fractures, including severe fractures such as AFF. By rejecting the change, Dvoretzky argued, the FDA found that there was insufficient proof of this risk, making it impossible for Merck to move ahead with the label change.

Justices Elena Kagan and Sonia Sotomayor challenged this claim, noting that the FDA letter did not clearly state that the rejection was based on insufficient proof, and asked why Merck should escape liability for its inaction when the letter could be interpreted to mean that the FDA disagreed with the proposed terminology and the use of the term “stress fractures.” Justice Neil Gorsuch asked whether the petitioner’s position created a “moral hazard” for manufacturers that could encourage them to submit “inartfully drafted warning[s] that [they think are] reasonably calculated to be refused.”

In response, Dvoretzky argued that the FDA had been closely monitoring the AFF risks and that, regardless, the FDA understood that Merck was proposing language that covered severe breaks such as AFF. Representing the United States, Washington, D.C., attorney Malcolm Stewart supported Merck’s position, stating that “the FDA understood [Merck’s proposed “stress fracture” language] to refer more generally to any fracture that was caused without external trauma,” not only minor fractures.

Justices Kagan and Sotomayor pushed Stewart on how, under a regulatory scheme that makes manufacturers responsible for drug labels, it was acceptable that Merck did not submit a reworded proposal or update the label on its own. Stewart said that such action would have been ill advised if the government did not agree that the evidence supported a warning, citing the FDA’s concern about the “potential ill effects of over-warning.”

Washington, D.C., attorney David Frederick, representing the plaintiff respondents, emphasized that drug manufacturers bear the responsibility for label accuracy. Frederick argued that, although there might be a dispute over how the FDA understood the proposed warning language, evidence showed that Merck believed that the FDA was objecting to the terminology being used and, more important, knew that biophosphonate drugs could cause AFF. Chief Justice John Roberts and Justice Samuel Alito, however, stated doubts about what Merck should have been expected to do without clear direction from the FDA, and Justice Stephen Breyer expressed concerns about the potential dangers of over-warning and of allowing the states to set their own, different standards for required drug warnings.

The American Association for Justice filed an amicus brief in support of the plaintiff respondents, and AAJ associate general counsel Amy Brogioli described the potential impact of the Court’s ruling. “This case could reinforce positive safeguards related to drug labeling, which would help protect millions of people who rely on important medications. On the other hand, a decision in favor of Merck could make it easier for pharmaceutical defendants to pursue summary judgment on preemption grounds, blocking plaintiffs from being able to pursue their claims and have their cases heard by jurors.”

Washington, D.C., attorney Allison Zieve of Public Citizen, which also filed an amicus brief in support of the plaintiff respondents, emphasized the potential risks to public health. “Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients. Merck did not update its Fosamax labeling until ordered to do so by the FDA, which was years after Merck became aware of evidence that Fosamax was associated with a risk of atypical femoral fractures. Under Wyeth, the plaintiffs should not be barred from holding Merck accountable for its actions. If the industry is successful in using this case to undercut Wyeth, patient health and safety will suffer.”

Justice Ruth Bader Ginsburg was not present at the arguments but will participate fully in the decision.