In a 3-0 ruling, the 3rd US Circuit Court of Appeals in Philadelphia restored the claims of several hundreds of plaintiffs against Merck for their osteoporosis drug Fosamax, according to Reuters. The plaintiffs claim the company didn’t adequately warn of the risk of thigh bone fractures that the drug may carry. Trials can now proceed on failure-to-warn claims, which a lower court originally found to be pre-empted by federal law.
Fosamax has been prescribed to post-menopausal women since 1995. It is a bisphosphonate intended to increase bone density by slowing resorption, a process which causes bones to break down. Typical side effects include abdominal pain, heartburn, constipation, diarrhea, upset stomach, and nausea. However, plaintiffs claim that long term use has also contributed to atypical femur fractures. In addition, they claim that Merck knew about safety issues with the drug for up to a decade before finally putting a warning label on it in 2011.
Additional controversy surrounds the warning. It came just four months after an independent task force hired by the FDA associated Fosamax with bone fractures. The task force’s report came out in September of 2010, and that also happens to be the cutoff date Judge Joel Pisano used to initially dismiss plaintiffs’ claims against Merck. In so doing, he stated it would be unlikely the FDA would have approved the warning they had sought before then.
The Appeals court found evidence that an FDA rejection of additional safety warnings for Fosamax would have been “less than highly probable.” They also concluded that a jury could potentially find that doctors would not have prescribed the drug if they were fully aware of its risks.
Merck has said they are reviewing their options and are “confident” in Fosamax’s safety and effectiveness. However, this is not the first time the drug has been associated with deteriorating bone mass in the body. Merck offered a $27.7 million settlement in December of 2013 to plaintiffs claiming Fosamax contributed to osteonecrosis of the jaw.
Fosamax is not the only bone spur plaguing Merck. Plaintiffs have claimed that the corporation downplayed safety concerns with their NuvaRing intrauterine contraceptive device and it also agreed to pay $23 million to end litigation over their Vioxx drug.
Fractures that happen as a result of low bone density can be life altering for people at an advanced age. They contribute to disability in post-menopausal women and can cause a loss of independence and increase the risk of premature death. Drugs intended to increase bone density can help but may carry much larger dangers. Discuss all medication options and side effects with your medical professional before making a decision that could have a substantial impact on your quality of life.