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Fosamax Class Action Ruling Expected to Result in Many More Dead Jaw Syndrome Lawsuits Against Merck

Jan 9, 2008 | Parker Waichman LLP

Fosamax patients concerned that they are at risk for Osteonecrosis of the Jaw (ONJ) will have to file individual lawsuits against Fosamax maker Merck if they want to force the company to pay for medical monitoring for the condition, also known as Dead Jaw Syndrome.   That’s because a federal judge has refused to grant class action status to a group of Fosamax lawsuit plaintiffs in Pennsylvania, Florida and Louisiana who wanted Merck to establish a Fosamax medical monitoring fund.  Because of the judge’s decision in this matter, it is expected that the number of Fosamax Dead Jaw Syndrome lawsuits currently making their way through the courts is likely to explode.

Fosamax, a popular osteoporosis drug, has been reviewed by the Food & Drug Administration (FDA) over a number of safety issues.  One of the most serious is its association with ONJ or Dead Jaw Syndrome.  In July 2005, the FDA had Merck update the Fosamax label to include a warning on this condition.  ONJ is a disorder 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.

Earlier this week, the FDA warned that Fosamax had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain.  The agency advised doctors and patients to be aware of this side effect, and to discontinue Fosamax use should it occur. In October, the FDA announced it would be conducting a safety review of Fosamax and other osteoporosis drugs in its class, known as bisphosphonates, after a study published last May in the New England Journal of Medicine found that patients taking these drugs had high rates of atrial fibrillation.

In a ruling dated last Thursday, U.S. District Judge John Keenan denied motions to approve classes of current and former users of the popular drug in Pennsylvania, Florida and Louisiana who have not been diagnosed with Dead Jaw Syndrome. "The court finds that class-treatment of these claims is inappropriate because they present too many individual questions of fact particular to each class member's claim," Keenan wrote in a 41-page ruling.

Had the motion for class action status been approved, current and former Fosamax users could have sued Merck for the costs of medical monitoring as a group, under one complaint.   But now, they will have to seek Fosamax medical monitoring in individual lawsuits.   Because of Judge Keenan’s ruling, it is now estimated that the number of Fosamax cases in federal and state courts would increase to 1,500 to 2,000 by the end of the year from roughly 460 now.  The first federal Fosamax cases are expected to go to trial at the end of the year,

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