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US high court to hear Merck appeal in pharmaceutical warning label dispute

by Glenn Hess
December 31, 2018 | A version of this story appeared in Volume 97, Issue 1

Chemical structure of alendronate sodium.

The US Supreme Court will hear arguments on Jan. 7 in a case that could have major implications for when drug makers may be protected from consumer claims alleging injury.

The justices will consider a case involving hundreds of state-based liability lawsuits accusing Merck & Co. of failing to adequately warn of the risk of fractures associated with its osteoporosis drug Fosamax (alendronate sodium).

In 2008, Merck gave the US Food and Drug Administration data that suggested Fosamax might be linked to certain bone fractures, but the agency rejected the company’s proposal to add a warning label to the medication. After reviewing new research, FDA in 2010 ordered the company to include a warning on its product label. But more than 500 patients claimed that their injuries occurred before then and Merck should have warned them sooner.

The drug maker contends that FDA’s initial rejection of its proposed warning label should preempt the lawsuits. In 2014, a federal court in New Jersey sided with Merck on its federal preemption defense.

But in 2017, the 3rd US Circuit Court of Appeals in Philadelphia allowed the claims to go to trial. The appeals court said that a “reasonable jury” could conclude that FDA had objected only to Merck’s phrasing of the proposed warning label and might have approved “a properly worded warning” about Fosamax.

Merck’s appeal of that ruling is the matter now before the Supreme Court.


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