WASHINGTON (CN) – Juries should not resolve questions about federal pre-emption in drug-labeling litigation, the mostly unanimous Supreme Court ruled Monday, saying such issues must be resolved by judges.
The case stems from Doris Albrecht’s lawsuit against Merck regarding the osteoporosis drug Fosamax. Vying to present a class of Fosamax users who broke their femurs between 1999 and 2010, Albrecht says Merck had a legal duty to warn them about this side effect known as atypical femoral fractures.
Though Merck argued that failure-to-warn claims are pre-empted by federal law, the Third Circuit found that such questions must be resolved by juries.
The Supreme Court disagreed and vacated that judgment Monday, with five of the justices joining the lead opinion by Justice Stephen Breyer in full.
“Judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination,” Breyer wrote. “Judges are experienced in ‘the construction of written instruments,’ such as those normally produced by a federal agency to memorialize its considered judgments.”
The court released the ruling a full decade after deciding in Wyeth v. Levine that failure-to-warn claims under state state law are pre-empted if there is “clear evidence” that the Food and Drug Administration would not have approved a change to the drug’s label.
Breyer clarified today that the term clear evidence “is 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.”
While Justices Clarence Thomas, Ruth Bader Ginsburg, Sonia Sotomayor, Elena Kagan, and Neil Gorsuch joined in Breyer’s opinion, Chief Justice Roberts and Justice Brett Kavanaugh joined an opinion concurring in judgment by Justice Samuel Alito.
Justice Thomas filed a separate concurring opinion.
Though Fosamax was approved by the Food and Drug Administration for sale in 1995, the FDA only in 2011 required that Merck change the label to warn about the risk of atypical femoral fractures.
Merck applauded the Supreme Court on Monday for reinstating the initial decision in its favor by the U.S. District Court.
“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,” Merck said.
The company also noted that the FDA supported its position in this case, through the solicitor general.
Merck is represented by Jones Day, and Albrecht is represented by Kellogg Hansen. The firms Viles & Beckman in Fort Myers, Florida, and Cellino & Barnes in Buffalo, New York, represent Fosamax users as well.