Fosamax® Trial Ends in Verdict for Plaintiff – Merck to Pay $8 Million

Merck to Pay $8 million in Damages in Fosamax® Jury Trial

July 28 2010 — A New York jury awarded Shirley Boles, of Fort Walton Beach, FL, $8 million in compensatory damages from her case against Merck & Co, which alleged the osteoporosis drug Fosamax caused her jaw osteonecrosis. This was the second lawsuit against Merck for Ms. Boles–the first ended in a mistrial.

Ms. Boles first sued Merck in 2006, claiming she had suffered from jaw decay (osteonecrosis) due to Fosamax, a drug she had taken from 1997 to 2006. Her jaw problem developed after having a tooth extraction in 2002, which left her with ongoing medical problems and infections in her gums. Her first lawsuit against Merck ended in a mistrial in 2009.

The Boles’ trial was Merck’s first of nearly 900 lawsuits claiming that Fosamax caused osteonecrosis. In a prepared statement, Merck said they would challenge the verdict; that the verdict in favor of Boles was contrary to the evidence presented at trial.

Fosamax & All Bisphosphonates Under Watchful Eye

Fosamax belongs to a class of drugs called “bisphosphonates,” which are designed to reduce bone loss that can occur with menopause and aging. Bisphosphonates work by slowing down the bone resorption process while bone formation continues unaffected by the drug. After FDA approval of Fosamax in 1995, dentists and oral surgeons began reporting a connection between bisphosphonates and osteonecrosis starting in 2001. As research of the drugs long-term effects continued, other serious issues came to light.

In 2010, the American Academy of Orthopaedic Surgeons presented research that suggested long-term use of Fosamax or other bisphosphonates could increase the risk of hip fractures in post-menopausal women. The FDA has also issued a notice of safety review of all bisphosphonate drugs after cardiologists warned of chronic irregular heartbeat in long-term patients.

With the increase in reports of potential side effects and additional research bringing to light potential long-term issues with the entire drug class, it might be easy to assume that the drugs are dangerous. Dr. Melvin Rosenwasser, chief of orthopedic trauma surgery at Columbia University Medical Center, says the drugs are helpful in the early years of use, but more research is needed.

“These are good drugs. They strengthen bone and protect from fractures for a while,” says Dr. Rosenwasser. “But, in some people they can become harmful after a period of time.”