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Jurors Deliberate The Future of Merck's Fosamax

Posted by Jane Akre
Thursday, September 03, 2009 5:10 PM EST
Category: Protecting Your Family
Tags: Osteoporosis, Fractures, Jaw Necrosis, Jaw Death, National Osteoporosis Foundation,

Jurors deliberate the future of Fosamax to determine if it causes jaw necrosis and whether Merck adequately warned doctors about that side effect.

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IMAGE SOURCE: © Fosamax Web site

Fosamax, the osteoporosis drug, is on trial.

Jurors have begun deliberations on whether the drug contributed to a jawbone killing condition known as osteonecrosis .

The case is just the first among about 900 federal and state cases pending against Merck over Fosamax. The Wall Street Journal reports the company has set aside $42 million for its defense.

In this instance, Shirley Boles, a 71-year-old Florida woman, says that taking Fosamax for nine years, caused her debilitating condition. Merck overpromotes Fosamax and does not include warning to doctors about the potential for osteonecrosis, lawyers for the plaintiff say.

Osteonecrosis can be worsened during dental surgery causing the gums to fall away and exposing bone.

In Boles case, her problem developed after she had a tooth extracted, reports the New York Times. She developed infections that had to drain through open wounds in her chin.

Merck says there is no proof of that and Ms. Boles had other health problems.

The case is being heard in United States District Court in Manhattan and began last month. Several hundred other lawsuits have been consolidated in that court.

The jury of three men and five women has been asked to answer several questions: Did Merck fail to warn her doctor about the drug risks? Was Merck negligent in formulating Fosamax and is it defective? Did her particular circumstance cause Ms. Boles problem?

Punitive damages have been ruled out by the judge as there is no indication of malice.

Fosamax belongs to a class of drugs known ad bisphosphonates, that interfere with the normal cycle of bone erosion and reabsorption that rebuilds new bone throughout a woman’s lifetime. They can slow the formation of building new bone tissue, Judge Keenan wrote in an opinion last July, the New York Times reports.

The drug was approved by the Food and Drug Administration in 1995 and according to a report in the journal Osteoporosis International in 2007, 55 million bisphosphonates prescriptions are written in the U.S. each year.

An FDA review in 2004 agreed osteonecrosis could apply to the class of drugs as a whole, and asked manufacturers to add that information to their label. Bisphosphonates include Boniva, Actonel, and Reclast, among others.

The outcome of this trial will be watched closely by pharmaceutical companies, the public and Wall Street analysts.

Fosamax generated about $1.55 billion in sales last year, about half from the previous year. #


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