Fosamax Fracture Lawsuits Dismissed Again, After Judge Rules FDA Rejected Label Warning Change

The FDA rejected an effort by Merck to add new Fosamax fracture label warnings in 2009, a federal judge determined.

Following a lengthy litigation and appeals process, a U.S. District Judge has issued a ruling that will once again result in the dismissal of several hundred Fosamax lawsuits filed against Merck for failing to warn about a fracture risk associated with their osteoporosis drug, determining that the FDA would have rejected any warning before 2010.

Fosamax (alendronate) was introduced by Merck in 1995, as a prescription medication to strengthen bones and avoid bone fractutes associated with osteoporosis. However, after side effects of Fosamax were linked to an increased of severe, atypical femur fractures, which may occur with little or no trauma after long-term use of the medication, the FDA required a warning update in October 2010.

During the subsequent years, hundreds of former users filed lawsuits against the drug maker, alleging that it ignored signs associated with the increased fracture risk, and the importance of taking “drug holidays” when using the medication long-term.

In 2014, U.S. District Judge Joel Pisano granted Merck’s motion for summary judgment, dismissing all Fosamax fracture claims involving injuries that occurred before the FDA label update, finding that the claims were pre-empted by federal law.

During a lengthy appeals process, the Third Circuit Court of Appeals vacated that order in March 2017, and Merck pursued the claim to the U.S. Supreme Court.

In a ruling issued in May 2019, the Supreme Court outlined the standard for a federal preemption defense in drug warning claims, indicating that it is a question for a judge, not a jury, to determine that there is “clear evidence” federal regulators were fully informed about the justifications for adding a warning, and the FDA, in turn, informed the drug maker the agency would not approve a label change to include that warning. Therefore, hundreds of cases were reinstated and returned back to the U.S. District Court for a ruling based on the guidance of this opinion.

On Wednesday, Chief U.S. District Judge Freda Wolfson of the U.S. District Court of New Jersey issued an opinion (PDF), ruling that Merck had provided clear evidence that the U.S. Food and Drug Administration (FDA) would have rejected the warning plaintiffs say was missing from the Fosamax label.

Judge Wolfson determined that Merck had provided evidence, including emails, safety updates and a specific request to change the label. However, in 2009 the FDA sent a “complete response letter” rejecting a requested label change, saying the change wasn’t justified by the data available at that time. This triggered Merck’s protection from liability through federal preemption laws, according to the ruling.

“Based on clear and convincing evidence, the Court finds that Defendant fully informed the FDA of the justifications for its proposed warning, which was adequate under state law and encompassed the injury Plaintiffs allege here,” Judge Wolfson stated in the ruling. “Because the basis for 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 convincing that the Agency would not have approved a differently worded warning no matter how Defendant attempted to submit one.”

The ruling effectively ends the litigation for a second time, but it is unclear whether plaintiffs have any remaining avenue to appeal the decision on new grounds.