For more than a decade, Merck has been defending itself against claims its osteoporosis drug Fosamax caused patients to suffer “atypical femoral fractures," even taking its fight to the Supreme Court, where it eked out a win. Now, after that SCOTUS fight, the company has prevailed against 500 Fosamax lawsuits.
In a Wednesday ruling, a federal judge in New Jersey tossed hundreds of Fosamax cases, siding with Merck's argument that federal law preempted the state-law injury claims, Reuters reports.
In the long-running legal battle, Merck has argued that it tried to add the fracture warning to Fosamax's label but that the FDA rejected the addition. Because FDA labels amount to federal law, the company shouldn't be liable under state laws for failing to warn of the drug's risks, the company has said.
This week, U.S. Judge Freda Wolfson agreed, tossing more than 500 injury claims on the drug that won its original FDA approval in 1995, according to Reuters.
The development followed a 2019 win for Merck—and the larger biopharma industry—at the U.S. Supreme Court. In that unanimous decision, the justices said a judge, not a jury, should rule on a company's preemption defense, according to law firm Jones Day. The issue should be treated as a legal question rather than a factual one as well, the justices said.
In doing so, SCOTUS rejected an appeals court's ruling that manufacturers must convince a jury of their preemption defense.
Ahead of that decision, Merck's Fosamax headache had played out for years. Back in 2013, for instance, the company lost a "bellwether" trial related to one injury lawsuit. Also in 2013, the company agreed to a proposed $28 million settlement to resolve certain Fosamax suits, Reuters reported at the time.