N.J. verdict could affect many bone-drug suits

February 13, 2011|By Jacqueline L. Urgo, Inquirer Staff Writer

ATLANTIC CITY - What Merck & Co. knew about risks associated with its popular osteoporosis drug Fosamax and when are the crux of a product-liability trial under way to determine whether the pharmaceutical giant is liable for a Montgomery County woman's painful jawbone loss.

Alison Rosenberg, 67, of Wyncote, never had osteonecrosis, in which bones decay and die, contend lawyers for Merck, based in Hunterdon County, N.J.

Company representatives say that her oral health problems and use of steroids to treat various conditions led to the degeneration and that it was unrelated to Fosamax use.

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Neither Rosenberg, who used the drug between 1999 and 2006, nor her physician, Debra Somers of Philadelphia, was aware of concerns that the Food and Drug Administration expressed to Merck in 2004 about the possible connection between osteonecrosis of the jaw and oral bisphosphonates such as Fosamax, according to the lawsuit.

Rosenberg's lawyers assert that Merck continued to market and distribute Fosamax without changing its warning label. The lawsuit says the drug caused the eventual death of a portion of Rosenberg's jawbone after a tooth extraction in March 2005. She underwent outpatient surgery five times at the Hospital of the University of Pennsylvania to file, scrape, and drill away the bone and is in chronic pain, her lawyers said.

The trial, before Judge Carol B. Higbee in Atlantic County Superior Court, is the fourth involving such claims and could help guide settlements in nearly 1,200 similar lawsuits involving Fosamax. The case wrapped up Thursday; jury deliberations are to resume Monday.

After FDA approval in 1995, Merck sold the drug alendronate sodium under the name Fosamax, saying it would increase bone density in postmenopausal women. The drug also has been prescribed to men.

According to Rosenberg's lawyers, studies published as early as 2000 showed that oral bisphosphonates could increase the risk of osteonecrosis of the jaw - known as ONJ or "jaw death" - in addition to joint pain, constipation, and diarrhea.

In her closing argument Wednesday, Merck's lawyer, Christy D. Jones, said the company had done everything it could to inform health-care providers about all possible side effects in a timely manner.

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