UPDATE: March 22, 2017
In a 3-0 decision, the 3rd Circuit Court of Appeals in Philadelphia held that plaintiffs may proceed to trial on their failure-to-warn claims, and that a lower court erred in finding the claims were pre-empted by federal law. The case is In re: Fosamax (Alendronate Sodium) Products Liability Litigation, 3rd Circuit Court of Appeals, No. 14-1900. The claims accuse Merck & Co of failing to adequately warn about the risks of thigh bone fractures associated with Fosamax. Plaintiffs claim to suffer atypical femur fracture from long-term use, and that Merck knew about this risk for over 10 years before warning about it in January 2011.
Merck’s label change occurred four months after an outside task force hired by the FDA published a report associating Fosamax with femur fractures. In March 2014, U.D. District Judge Joel Pisano in Trenton, New Jersey, dismissed all claims by plaintiffs injured before September 14, 2010, the date of the task force report.
Judge Pisanao, who retired from the bench in 2015, cited a 2009 U.S. Supreme Court decision that state law-based failure-to-warn claims were pre-empted when there was “clear evidence” that the FDA would not have approved a warning that plaintiffs requested. Writing for the appeals court,Judge Julio Fuentes found enough evidence for a reasonable jury to conclude that the FDA would have approved “a properly-worded warning” about Fosamax, “or at the very least, to conclude that the odds of FDA rejection were less than highly probable.” Judge Fuentes also wrote that a jury could also find that doctors would not have prescribed Fosamax had Merck properly warned of the risk of femur fractures on the label.