Merck & Co. successfully convinced a Supreme Court judge to throw out more than 500 lawsuits late Wednesday, all alleging the multinational pharmaceutical company failed to warn users of Fosamax of the risks of developing thigh bone fractures as a side effect of the osteoporosis drug.
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U.S. District Judge Freda Wolfson in Trenton, New Jersey, stated that because the U.S. Food and Drug Administration rejected Merck’s proposal to add a warning to Fosamax’s label about the risks of fracture, federal law preempted the plaintiffs’ state-law claims.
Wednesday’s ruling marks a possible end for the more than 14 years of litigation tied to Fosamax, with Judge Wolfson’s dismissal on preemption grounds closely mirroring a ruling by now-deceased U.S. District Judge Joel Pisano in 2013 following a trial.
That ruling was overturned in 2017 by the 3rd U.S. Circuit Court of Appeals after finding that the issue of whether federal law preempted the cases presented a factual question to be decided by a jury, rather than a question of interpretation of the law by the judge.
The U.S. Supreme Court in ordered the issue be reconsidered in 2019, saying the question of federal law preempts state-law failure-to-warn claims is “a legal one for the judge, not a jury.”
Judge Wolfston noted in her 87-page ruling, that a 2009 letter by the FDA rejecting a proposed warning by Merck related to atypical femoral fractures demonstrated that the company was prevented from making the type of warning label that would have sufficed for plaintiffs.
Plaintiffs’ lawyers argued the letter did not mean the FDA would have rejected any and all warnings proposed by the drugmaker but, Wolfson said “it is clear that the agency would not have approved a differently worded warning about such a risk.”
Plaintiffs in the multidistrict litigation claim that Merck knew about the risk of suffering atypical femur fractures from long-term use of Fosamax but failed to add it to the warning label until January of 2011, only doing so after the FDA reached a new conclusion in 2010 ordering all manufacturers of bisphosphonate drugs like Fosamax to revise their warning labels after a task force investigated the matter.
In its latest quarterly report, Merck claimed it has faced a total of 3,470 product liability lawsuits involving Fosamax. Around 1,200 of those were settled in 2013 after Merck paid out more than $27 million to consumers alleging their jaw bones deteriorated due to their use of the drug.
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