The nine justices unanimously directed the Philadelphia-based 3rd U.S. Circuit Court of Appeals to reconsider its decision allowing the lawsuits to proceed even though federal officials had rebuffed Merck when the company sought to add a warning to Fosamax’s label about the fracture risk.
At issue in the case was whether a pharmaceutical company can be held liable under state laws for failing to warn about a health risk associated with a drug in stances in which the U.S. Food and Drug Administration rejected a company proposal to add a warning label to the medication about the risk.
Fosamax helps prevent and treat osteoporosis in women who have gone through menopause. But it may increase the risk of fractures in the thigh bone or just below the hip joint, often requiring surgical intervention.
Sales of Fosamax, also available as a generic drug, totaled $209 million in 2018, according to Merck.