On January 7, 2019, the Supreme Court of the United States (SCOTUS) heard oral arguments about who has the final say in warnings labels on pharmaceuticals. The case, Merck v. Albrecht, presents the question to SCOTUS of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempts to change the warning label that were rejected by the United States Food and Drug Administration (FDA).
In June 2008, the FDA informed Merck that it was made aware of reports regarding fractures in patients using bisphosphonate drugs such as Fosamax. Three months later, in September 2008, Merck submitted three prior approval supplements (PAS) for its three Fosamax products, each application supported with evidence regarding femoral fractures.
Several months later, in May 2009, the FDA issued a Complete Response Letter telling Merck that the Agency could not approve the applications in their present form. This led Merck to updating the Adverse Reactions section of the drug’s labeling using the FDA’s recommended text, but also withdrawing its three pending PAS and submitting new Changes Being Effected (CBE) supplements.
Nothing was done on either side until March 2010, when the FDA issued a safety announcement stating that the data at that time did not show “a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures,” but that the Agency was working with a task force to gather additional information.
Roughly six months later, in September 2010, the task force identified such an association and one month later, the FDA announced that it would require bisphosphonate manufacturers to modify their labeling to include information regarding the risk of such fractures in the Warnings and Precautions sections. Shortly after that announcement, the FDA approved the labeling change for Fosamax submitted by Merck.
As one might imagine, hundreds of lawsuits poured in against Merck, alleging that they sustained femoral fractures by taking Fosamax and that Merck had essentially failed to provide adequate warnings on its label. Initially a federal court sided with Merck, but in March 2017, a Pennsylvania appeals court found that a “reasonable jury” could conclude that Merck could have revised the Warnings and Precautions on the label prior to September 2010 and the FDA prevented such a revision.
Oral Arguments at the Supreme Court
During oral arguments at SCOTUS, it seemed as though Merck may pull out a win. Justice Stephen Breyer told David C. Frederick, who was arguing on behalf of Fosamax users, that it seemed to him that Merck couldn’t have changed Fosamax’s warnings. He said it seemed that the FDA initially thought that it was “more dangerous” to “put the risk in the label than … to leave it out.”
Only two of the court’s nine justices, Elena Kagan and Sonia Sotomayor, said anything during arguments that suggested they are inclined to rule against Merck. Sotomayor told Merck attorney Shay Dvoretzky that the company never gave the FDA “proper language” and “never gave them what your scientists told you to give them.” Justice Ruth Bader Ginsburg was absent from the argument, but has reportedly read the briefs and oral arguments and may participate in the decision.
Amicus Curiae Arguments
As is typical in most SCOTUS cases, there are strong feelings on each side. Lawyers for the Trump Administration argue that “because FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting [Merck’s] impossibility-preemption defense.” The lawyers are also arguing that when the FDA declines to approve a drug labeling change, the “interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve, not factual questions for a jury.”
Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) also argue that by allowing companies to be held liable under state law for a failure to include warnings that were deemed inappropriate or unwarranted by the FDA “would greatly compound that liability in a manner that both is unfair and could deter innovation.”
However, nearly two dozen state attorneys general argue the other side of the coin, that Merck’s argument involves Congress’ careful balance between federal and state regulatory authority, in an area typically handled by the states. “States have long regulated in the area of drug labeling. The duty to warn patients and physicians about emerging safety risks predates—by decades—the advent of federal regulation of drugs,” the attorneys argue.