The first of hundreds of Fosamax jaw damage lawsuits is scheduled to go to trial today in a Manhattan federal courtroom. According to Bloomberg.com, the Fosamax lawsuit is the first of three so-called bellwether cases, the outcomes of which may determine if there will be out-of-court settlements in other cases.
Fosamax is one of a number of drugs used to treat osteoporosis known as bisphosphonates. Other drugs in this class include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa.
Bisphosphonates have been linked to a side effect known as Osteonecrosis of the Jaw (ONJ). Also known as Dead Jaw Syndrome, ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw.
(FDA) ordered that the label for Fosamax and other bisphosphonates be updated
In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ. Since then, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts around the country.
Plaintiffs in the lawsuits claim Merck misrepresented the drug’s safety and failed to warn doctors and patients that it might hamper blood flow to the jaw, Bloomberg.com said. They also claim that when Merck updated the label in 2005, the company still failed to adequately warn about the drug’s risks. An attorney for some plaintiffs told Bloomberg.com that Merck was the only drug company not to use the language for the warning that the FDA requested
The first Fosamax lawsuit slated for trial involves a 71-year-old Florida woman who claims to have suffered dental and jaw problems as a consequence of taking Fosamax from 1997 to 2006, Reuters said. According to the Reuters report, two other Fosamax lawsuits are scheduled to go to trial later this year, one in federal court and another in a state court in Alabama.