Fosamax Jawbone Death Trial Goes to the Jury

Manhattan, NYIt may not necessarily be a headache medication on trial, but the outcome could be a headache for pharmaceutical giant Merck as it works to complete a multi-billion dollar merger with Schering-Plough. At issue is Fosamax, a drug that has been taken by millions of women to offset bone loss associated with menopause. The allegation is that it also causes osteonecrosis, or death of the jaw among other Fosamax side effects. A lawsuit litigated since August 12 has just gone to the jury and everyone is watching.

The plaintiff in the case is a 71-year-old retired deputy sheriff from Fort Walton Beach, Florida. Shirley Boles took the drug from 1997 to 2006. In 2002 her problems began after having a tooth extracted. Boles is now regularly plagued with infections that drain through open wounds in her chin.

Osteonecrosis is the breaking-down, or 'death' of the jawbone. The gums have been known to fall away, exposing jawbone tissue that has all the appearance of being moth-eaten.

Boles' lawsuit is but one of a flurry of federal and state lawsuits estimated in the range of 900 to more than 1200 pending cases involving the Fosamax drug that was first approved in 1995 by the US Food and Drug Administration (FDA) for the treatment of bone loss of osteoporosis associated with menopause. Two years later Fosamax was approved for the treatment of osteoporosis itself and the drug soon became one of the most popular drugs in the country.

The plaintiff accused Merck of putting patients at risk by over promoting Fosamax and by not warning doctors about the potential for jawbone disintegration.

Merck claimed it became aware of the problem in 2003.

On September 2nd the presiding judged asked the jury to decide several questions: Was Merck negligent in formulating Fosamax? Did the company fail to warn Mrs. Boles' doctor of a known risk? Is Fosamax a defective product? And, if the jury answers yes to any of those questions, did that circumstance legally cause Mrs. Boles' jawbone problems?

According to the New York Times Fosamax lost 50 percent of its previous market share in 2008. Even so, Fosamax had global sales of $1.5 billion last year, with 2.6 million prescriptions in the US alone. That figure is down from 15 million the previous year.

Although there have been anecdotal cases and animal studies published in medical journals, Merck notes the absence of any clinical study rigorously proving, or dismissing the link between bisphosphonates and osteonecrosis. In 2004 the FDA acknowledged the risk nonetheless and requested that manufacturers update their labels.