About 5,000 lawsuits alleging femur fractures caused by Merck’s osteoporosis drug Fosamax that had been dismissed in federal and state courts were given new life when the U.S. Court of Appeals for the Third Circuit overturned the dismissal.
The appeals court found that the District Court misapplied the U.S. Supreme Court’s 2009 ruling in Wyeth v. Levine, during which the Supreme Court held that state-law failure-to-warn claims are preempted when there is evidence that the Food and Drug Administration (FDA) would not have approved a warning label that those suing the drug company claim was necessary.
In June 2014, U.S. District Judge Joel Pisano granted a summary judgment to Merck in a lawsuit filed by Bernadette Glynn based on the FDA’s 2009 rejection of Merck’s proposed safety label revision for Fosamax that warned of the potential risk for bone fractures. Pisano then granted summary judgment on all cases stemming from injuries that occurred prior to September 2010, the date of a task force report linking Fosamax usage to femur fractures. But the appeals court said Pisano’s ruling was in error.
The “clear evidence” standard has been difficult for courts to define. In this case, the panel of judges wrote that “clear evidence” applies solely to the applicable standard of proof, and that the question of whether the FDA would have rejected a label change should be answered by a jury, and not a judge.
In 2013, in a separate legal battle, Merck agreed to pay $27 million to about 1,200 Fosamax users who sued the drug company alleging the drug caused a condition called osteonecrosis of the jaw, or ONJ.
Source: New Jersey Law Journal