Merck sign Merck headquarters in New Jersey. Photo: Shutterstock

Updated at 3:23 p.m.

In a win for Big Pharma, the U.S. Supreme Court on Monday remanded a class of failure-to-warn tort claims against drug manufacturer Merck to the U.S. Court of Appeals for the Third Circuit for determination by judges, not juries.

The court was unanimous on the result in Merck Sharp & Dohme v. Albrecht, and Justice Stephen Breyer wrote the opinion for the court. He was joined in an unusual lineup by Justices Clarence Thomas, Ruth Bader Ginsburg, Sonia Sotomayor, Elena Kagan and Neil Gorsuch. Thomas filed a separate concurrence, as did Justice Samuel Alito Jr., joined by Chief Justice John Roberts Jr. and Justice Brett Kavanaugh. The Alito concurrence agreed with the result, but not the reasoning.

At issue in the case was whether state-law failure-to-warn suits against Merck were preempted by federal law when the U.S. Food and Drug Administration rejected Merck’s effort to warn about the risk of osteoporosis drug Fosamax, and whether it was up to juries to determine why the FDA rejected Merck’s proposed warnings.

At the end of a complex description of the Fosamax litigation, Breyer wrote, “The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination.”

The ruling may also have the effect of steering more tort claims filed against drug labeling to federal courts rather than state courts. An amicus brief filed in the case by the Pharmaceutical Research and Manufacturers of America told the court, “The burdens of product liability litigation are already substantial for life sciences companies, and a regime that permits these companies to be held liable under state law for failure to include warnings expressly deemed inappropriate or unwarranted by the FDA would greatly compound that liability in a manner that both is unfair and could deter innovation.”

Brian Wolfman, professor at Georgetown University Law Center, countered the notion that the decision was a sure win for Merck.

“Under today’s decision, plaintiffs will continue to be able to pursue the vast majority of state-law damages claims alleging that a drug manufacturer failed to warn of hazards associated with the drug,” Wolfman said in a piece at the Public Citizen blog. “That is, preemption will rarely be a barrier to state-law failure-to-warn claims leveled against the manufacturers of prescription drugs.”

Dorsey & Whitney partner Creighton Magid said of the decision Monday, “With today’s opinion, the Supreme Court made it clear that determinations of whether federal law would have allowed changes to existing warnings is a question of law to be determined by a judge, rather than a question of fact to be decided by a jury.” Magid added, “It makes sense for judges to make these calls, rather than trying to provide individual juries with seminars on regulatory and administrative law.”

Washington Legal Foundation senior counsel Cory Andrews remarked, “Today’s decision will ensure that complex legal questions involving federal preemption are decided by federal judges, not lay juries.”

The ruling was a win for Jones Day partner Shay Dvoretzky, who represented Merck. He argued that because of the FDA’s refusal of added label warnings, Merck could not be liable under state law.

Merck said in a statement it was “pleased with the Supreme Court’s decision to confirm Merck’s position that the question of preemption should be decided by a Judge, thereby reversing the decision of the Third Circuit.” The statement added: “The FDA itself, through the Solicitor General, has supported Merck’s position. Merck remains fully committed to defending these cases going forward and will continue to present evidence that it acted appropriately at all times in regard to the potential risk of atypical femur fractures.”

David Frederick, partner at Kellogg, Hansen, Todd, Figel & Frederick, represented the more than 500 plaintiffs who claimed that Merck did not give adequate warning that Fosamax can increase the likelihood of bone fractures.

“This opinion protects access to justice for injured patients. It reaffirms Wyeth [v. Levine], which ensured patients can hold drug companies accountable when they fail to warn about side effects, and it provides the clarification the Third Circuit requested,” Frederick said in a statement. “Further, the opinion makes clear that preemption can be established only by a formal FDA action prohibiting the manufacturer from changing its warning label to add any adequate warning under state law.”


Read more:

Merck Asks SCOTUS to Reject ‘Unduly High Hurdles’ in Federal Pre-emption Cases

SG Urges SCOTUS to Review ‘Clear Evidence’ Ruling in Fosamax Case