WASHINGTON — The Supreme Court on Monday appeared ready to side with the drug manufacturer Merck in lawsuits alleging the company failed to warn consumers of the risks associated with its osteoporosis drug Fosamax.
In 2008, Merck proposed adding a warning label to Fosamax in an application to the Food and Drug Administration, but the FDA rejected the language. The FDA ultimately approved a warning label in 2010 following a second review. In between, however, patients taking the drug were unaware of the potential side effects of the drug, which included heightened risks of bone fractures in the thigh or below the hip joint.
More than 500 Fosamax customers have filed lawsuits against the company seeking damages for bone fractures, allegedly in response to taking the drug. A federal court tossed out the lawsuits, but the cases were revived on appeal in 2017.
On Monday, only two justices — Elena Kagan and Sonia Sotomayor — appeared sympathetic to Fosamax users, who claim the company had a legal responsibility to include the warning labels despite the FDA’s recommendation.
Kagan said the idea that Merck is “off the hook” due to the FDA was a poor argument because the company knew about the risks and “manufacturers have primary responsibility over their labels” under federal law.
The high court is asked to decide whether a drug company can be held liable for damages in civil court based on its own knowledge of a drug’s risks regardless of a federal agency’s determination.
By law, manufacturers are required to inform patients of potential adverse reactions to their drugs as soon as reasonable evidence exists.
A ruling in the case, Merck Sharp & Dohme Corp. v. Albrecht, 17-290, is expected by the end of June.