The U.S. Supreme Court on Monday handed a victory to Merck & Co – at least for now – by throwing out a lower court ruling that had revived hundreds of lawsuits accusing the company of failing to properly warn patients of debilitating thigh-bone fractures from taking its osteoporosis drug Fosamax.
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 regulators had rebuffed Merck when the company sought to add a warning to Fosamax’s label about the fracture risk.
The decision added clarity to a defense used by drug makers against product liability claims in which they argue that such litigation is preempted under federal law and the U.S. Constitution when a federal agency takes certain actions, as the Food and Drug Administration did in this case.
In a decision written by Justice Stephen Breyer, the court said that judges, not juries, must decide disputes over preemption, and that a drug manufacturer must show that it “fully informed” the FDA of the need for a warning before it was rebuffed. Lower courts now must revisit the case reflecting the Supreme Court’s guidance.
Merck’s shares traded up slightly on Monday morning, at $78.91.
Fosamax helps prevent and treat osteoporosis, a condition that can lead to bone fractures, 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.
The New Jersey-based company in 2008 submitted data to the FDA suggesting Fosamax might be linked to certain bone fractures, but the FDA denied its warning label proposal. After a task force further studied the issue, the FDA in 2010 ordered manufacturers to revise labels to include a warning, which Merck did.
The plaintiffs contend that the FDA rejected only Merck’s proposed language for the warning that focused on relatively minor stress fractures rather than the more serious fractures they suffered.
Fosamax users sued Merck in federal courts alleging the drug caused them to sustain 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.
A federal trial court in New Jersey threw out the cases, but in 2017 the 3rd Circuit allowed the claims to proceed to trial, ruling that a jury could find that the FDA had objected only to Merck’s phrasing of the proposed warning label.
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 instances in which the FDA rejected a company proposal to add a warning label to the medication about the risk.
Merck argued that because under the Constitution federal law generally trumps state law, it cannot be penalized for not taking an action that the FDA did not allow.
Merck, backed by President Donald Trump’s administration, had told the justices in a brief, “If manufacturers must face tort suits even when the FDA has made clear that no warning is necessary, they will continue to face an onslaught of troubling, coercive litigation.”
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