Fosamax Test: The Drug May Cause ONJ. A New York jury has ordered Merck & Co. to pay $8 million, to a former Fosamax user who claimed she developed osteonecrosis of the jaw (ONJ), or dead jaw syndrome, from taking the osteoporosis drug. The award was $3 million more than plaintiff Shirley Boles had asked for in her lawsuit.
Merck has already said it plans to appeal the verdict, and has called the damage award “excessive”.
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. In 2005, the Food & Drug Administration (FDA) ordered that the label for Fosamax and other bisphosphonates be updated to include warnings about ONJ.
more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts
Since then, more than 1,200 plaintiff groups have filed 900 ‘Fosamax’ lawsuits in courts around the country. About 771, including the Boles lawsuit, were consolidated before U.S. District Judge John Keenan in New York.
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.
According to a Bloomberg report, Boles’ case originally went to trial last August, but that proceeding ended in a mistrial after the jury was unable to return a verdict. The second trial began on June 7 with jury selection.
Boles case was one of three “bellwether” trials
Boles, a retired deputy from the Okaloosa County, Florida Sheriff’s Office, testified that she began taking ‘Fosamax’ after she developed a stress fracture in her foot, and eventually developed ONJ. Her lawsuit accused Merck of knowing about the Fosamax-ONJ connection as early as 1996.
Jurors on Friday found that Fosamax is defectively designed and unreasonably dangerous and that the drug was negligently designed, her lawyer told Bloomberg.
Boles’ case was one of three “bellwether” trials scheduled by Judge Keenen in the Fosamax litigation. The first Fosamax case resulted in a Merck victory in May. The third trial is scheduled to begin in November.
Such trials are considered test cases, and often point the way to out-of-court settlements.
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