Another woman just filed a lawsuit against the maker of Fosamax (alendronate) over a femur fracture she suffered while on the osteoporosis medication. The South Carolina woman is being represented by the national law firm, Parker Waichman LLP. This new lawsuit was filed on June 29th in the Superior Court of New Jersey, Atlantic County Law Division (Docket No. L-456712), and names Merck Sharp & Dohme Corp. and Merck & Co., Inc. as defendants.
The complaint states that the woman began treatment with Fosamax in December 2005 and suffered a right subtrochanteric femur fracture in July 2010. The lawsuit alleges that the femur fracture was a result of taking Fosamax for years and cites serious consequences that include severe mental and physical pain and suffering, permanent injuries, emotional distress, economic loss due to medical expenses, and living-related expenses due to a new lifestyle. Among other things the lawsuit seeks compensatory, statutory, and punitive damages.
Merck won approval for Fosamax in 1995; the drug is intended to treat bone loss due to osteoporosis and osteopenia. According to the lawsuit, the bisphosphonate drug actually increases the risk of fractures by inhibiting bone turnover and enabling secondary mineralization. This mineralization allegedly causes the bones to become more brittle and vulnerable to breaks.
The lawsuit also claims that the Merck knew, or should have known, about this defect, yet continued to market Fosamax without warning consumers. Meanwhile, the U.S. Food & Drug Administration (FDA) has warned that Fosamax and other bisphosphonates, such as Actonel or Boniva, may increase risks for atypical femur fractures in patients taking the medication to treat osteoporosis. An atypical femur fracture—which manifests as a subtrochanteric or diaphyseal fracture—may occur during normal everyday activities with little or no trauma.
The Archives of Internal Medicine recently published a study comparing patients with atypical versus “classic” femur fractures, reporting that 82 percent of patients in the atypical fracture category had taken bisphosphonates. The FDA has also recently published research about the risks and benefits of bisphosphonate therapy. According to their review of over 2,300 postmenopausal women, the agency stated that there was little reason to use Fosamax and its sister drugs for more than five years. The data was published in the New England Journal of Medicine this May.
This is not the first lawsuit concerning Fosamax and not the first lawsuit filed on behalf of a patient by Parker Waichman LLP. In fact, the national law firm recently filed several other, similar, lawsuits on behalf of women who took Fosamax and subsequently suffered fractures. The lawsuits name Merck Sharp & Dohme Corp., Merck & Co., Inc., and other potential manufacturers as defendants. We also recently wrote that another lawsuit, also filed by Parker Waichman LLP, in which a Maryland woman claimed that Merck’s Fosamax caused her double thigh fractures.
Another recent study of adverse event reports involving Fosamax and other bisphosphonates found that the risk of esophageal cancer associated with these drugs might be higher than first thought. Last summer, the FDA issued a Drug Safety Communication to update the public on its ongoing review of the possible association between oral bisphosphonate drugs and an increased risk of esophageal cancer. At that time, the agency noted that the two studies it reviewed had reached conflicting conclusions and, while the FDA said it believed the benefits of bisphosphonates continued to outweigh their risks, it acknowledged that further study of the issue was needed. Its safety review is ongoing.