A New York jury has eased the pain of Shirley Boles’ osteonecrosis of the jaw (ONJ), known as dead jaw syndrome. The jury ordered Merck & Co. to pay $8 million to the former Fosamax user who claimed she developed ONJ from taking the osteoporosis drug. Surprisingly, the award was $3 million more than plaintiff Boles mentioned in her lawsuit. Merck plans to appeal the verdict, which it called “excessive.”
ONJ results when jaw bone tissue fails to heal after minor trauma such as a tooth extraction, causing bone exposure. This can eventually lead to infection, fracture and could necessitate long-term antibiotic therapy or surgery to remove dying bone tissue. Signs and symptoms of ONJ include: a feeling of heaviness in the jaw, swelling of the gums, loose teeth, jaw pain, numbness, drainage or exposed jaw bone.
Fosamax, a bisphosphonate, is one of a number of drugs in that class used to treat osteoporosis. Others include Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa. The Food & Drug Administration (FDA) mandated that labeling for Fosamax and other bisphosphonates include ONJ warnings in 2005.
In the past five years, more than 1,200 plaintiff groups have filed 900 Fosamax lawsuits in courts across the country. Approximately 771, including the Boles suit, were consolidated before U.S. District Judge John Keenan in New York.
Boles, a retired deputy from the Okaloosa County, Florida Sheriff’s Office, testified that she started using Fosamax after a foot stress fracture and eventually developed ONJ. Her lawsuit accused Merck of knowing about the Fosamax-ONJ link as early as 1996.
On Friday, jurors found Fosamax defectively designed, unreasonably dangerous and negligently designed, her attorney told Bloomberg.
Boles’ case was one of three “bellwether” trials scheduled by Judge Keenen in the litigation. Merck won the first Fosamax case in May. The third trial is set to begin in November.
These trials are considered test cases and often induce out-of-court settlements.