WASHINGTON: The U.S. Supreme Court agreed to hear Merck & Co’s appeal of a lower court’s ruling that revived hundreds of lawsuits accusing the company of failing to adequately warn patients of the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.
At issue in the case is whether a pharmaceutical company can be held liable for failing to warn about a health risk associated with its drug when the U.S. Food and Drug Administration rejected the company’s proposal to add a warning label to the medication about the risk.
Fosamax helps prevent and treat osteoporosis, a condition that can lead to bone fractures, in women who have gone through menopause. Conversely, it may increase the risk of fractures in the thigh bone or just below the hip joint.
Sales of Fosamax, which is also available as a generic drug, totaled $241 million in 2017, according to Merck.
Merck in 2008 submitted data to the FDA suggesting Fosamax might be linked to certain bone fractures, but the FDA rejected its proposal to add a warning label to the medication, according to court papers. After further study of the issue, the agency ordered manufacturers to revise labels to include a warning in October 2010, which Merck did the following January.
Hundreds of Fosamax users sued New Jersey-based Merck alleging the drug caused them to suffer serious thigh bone fractures and that the company failed to warn of the risk. The number of cases has swelled to more than 1,000.
Merck tried to have the cases thrown out, arguing that the FDA’s rejection of its proposed warning label should preempt the lawsuits.
A federal trial court in New Jersey sided with Merck, but in March 2017, the Philadelphia-based 3rd U.S. Circuit Court of Appeals allowed the claims to proceed to trial, saying that a jury could find that the FDA had objected only to Merck’s phrasing of the proposed warning label and might have approved “a properly worded warning” about Fosamax.
Backed by President Donald Trump’s administration, Merck asked the Supreme Court to hear the case, saying the appeals court ruling puts drug companies in an impossible position.
“Even if they cooperate with the FDA, share their safety data, and follow the agency’s direction to ‘hold off’ on adding label warnings, they still cannot escape costly, burdensome tort litigation complaining about those labels,” Merck said.
(Corrects paragraph 8 to show lower court ruling was in March 2017, instead of March 2018)