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First Fosamax Trial Slated For Today In Manhattan

Posted by Chrissie Cole
Tuesday, August 11, 2009 10:41 AM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, Osteoporosis, Osteonecrosis, Bisphosphonates, Fosamax

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IMAGE SOURCE: © Fosamax Web site

Pharma giant Merck & Co. will face the first of several hundred lawsuits today brought by patients who claim they suffered jaw damage from the company’s widely used drug, Fosamax for treatment of osteoporosis.

As of June 30, Merck faced 900 cases, including lawsuits with multiple patients, the company said in an August 3 regulatory filing.

Judge John Keenan will hear arguments from attorneys for Shirley Boles, 71, of Walton Beach, Florida, in federal district court in Manhattan. Her suit claims she has suffered dental and jaw problems as a result of taking Fosamax from 1997 to 2006.

Boles argued in court papers that Merck had a duty to change the drug label to warn doctors about a connection to osteonecrosis as early as the mid-1990s.

According to Bloomberg, Judge Keenan ruled out the possibility of punitive damages in the Boles trial last week. But the plaintiff’s side points out that the ruling is specific to this case only, based on the clients date of injury. Plaintiffs in other cases can still seek punitive damages.

Fosamax (alendronate), approved in the U.S. in 1995, belongs to the bisphosphonate family of drugs that also include Actonel, Boniva, Reclast and others. Bisphosphonates slow or stop reabsorption of bone. They can reduce the risk of bone fracture, and in some cases can increase bone mass in those with osteoporosis. In cancer patients, they slow bone turnover in people with cancer of the bones or multiple myeloma.

Fosamax is available in pill or liquid form. Jaw necrosis, the death of jawbone tissue, has been found in the drugs’ users and cancer patients receiving chemotherapy, according to Mahyar Etminan, a pharmacy expert for the patients.

Users of IV bisphosphonate drugs, which are not made by Merck, are more likely to contract the condition than users of the oral version, Etminan said.

“In mass litigation, all eyes are on the first trial, not only because it shows the strategy of each side, but because it is also the first indication about how jurors respond to the evidence,” said Howard Erichson, a law professor at Fordham University and an expert on civil procedure.

Later this year, two more Fosamax lawsuits are expected to go to trial, one in federal court and the other in Alabama state court.

According to a report in the journal Osteoporosis International in 2007, 55 million bisphosphonates prescriptions are written in the U.S. each year. #


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