Merck is finally free from liability in more than 500 lawsuits related to the safety of its osteoporosis drug Fosamax, ending a 14-year saga.
The New Jersey federal district court dismissed the cases in an opinion filed this week – after allegations that Merck failed to warn patients about the fracture risks of the drug.
Merck has fought lawsuits surrounding Fosamax for years related to allegations that it failed to warn consumers of possible “atypical femoral fractures” after taking the drug. But Merck maintained that the FDA would not allow the pharmaceutical industry to add a warning about potential fractures to its label.
Merck won related cases dismissed in 2013 after late U.S. District Judge Joel Pisano ruled in favor of the pharmaceutical industry. Four years later, the decision was eventually overturned by the 3rd Court of Appeal.
Two years and a writ of certiorari later, the Supreme Court heard Merck’s case and overturned the judgment of the appeals court, ordering it to reconsider its decision. This decision allowed the lawsuits against Merck to go to trial.
At the heart of the legal battle between Merck and the plaintiffs is a legal principle in federal-state relations called preemption, which allows federal law to prevail over state law. And in this case, since the FDA would not have approved a Fosamax label warning that state law required, Merck’s attorneys argued that the drugmakers should not be blamed or punished. for failing to comply with this state law. And the judge agreed.
In the 87-page ruling, Chief District Judge Freda Wilson agreed with Merck, writing:
The Court finds that the defendant [Merck] fully informed the FDA of the rationale for its proposed warning, which was adequate under state law and encompassed the harm plaintiffs here allege. The FDA, in turn, informed the respondent that it would not approve the Fosamax label change to include this warning in the CRL. Because the basis of the FDA’s rejection was insufficient evidence of a causal link between Fosamax and atypical femoral fractures, the Court is satisfied that the evidence is clear and compelling that the Agency would not have endorsed a warning made differently, no matter how the defendant attempted to submit a. Plaintiffs’ claims of failure to warn of state law are therefore anticipated and defendant’s motion for summary judgment is GRANTED.
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