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Tuesday, October 5, 2010

Judge Reduces Payment in Second "Bellwether" Fosamax Case

Last June, a jury awarded $8 million to a 72-year-old woman who suffered osteonecrosis of the jaw that the jury said was associated with her use of Fosamax (alendronate sodium) oral bisphosphonate. Oral bisphosphonates like Fosamax, Actonel (risedronate sodium), Boniva (ibandronate sodium), Reclast (zoledronic acid), and others are taken to combat the loss of bone density known as osteoporosis. The drugs work by inhibiting the action of cells that normally remove bone tissue as part of the normal removal and redeposition process. In the short-term, this leads to an increase in bone tissue density, but in the long-term the effect may plateau or even decline, and side effects--such as osteonecrosis of the jaw--may increase.

However, on Monday the judge decided to reduce the verdict from $8 million to $1.5 million, saying the verdict was "excessive." Even with the reduced payment, Merck Inc. (the manufacturer of Fosamax) plans to appeal the verdict, hoping to stop the 1500+ cases against the company. After an initial verdict in the company's favor in the first Fosamax case to proceed, and this reduced verdict, the odds look good for the company in reducing its liability related to the potentially dangerous drug.

Lawyers trying to win Fosamax cases face several challenges. First, the exact mechanism that ties Fosamax to osteonecrosis of the jaw is unknown. Second, there are many competing factors that make it hard to pin necrosis on Fosamax. Most commonly, osteonecrosis of the jaw is also a complication of dental health problems or dental surgery, and may be associated with even relatively mild cases of periodontal problems or smoking. All of these were used in an attempt to dissuade a jury that Fosamax did not cause injury to the plaintiff in this case. Finally, the time frame between the use of Fosamax and osteonecrosis of the jaw can be extremely long--the average time between oral bisphosphonate use and osteonecrosis is almost five years.

However, there are many positive aspects that work in the favor of Fosamax cases. First of all, the link between bisphosphonates, includiong oral bisphosphonates like Fosamax, and osteonecrosis of the jaw is well recognized in the scientific literature. Second, the potential cause of osteonecrosis of the jaw has been an acknowledged side effect of the drug since at least 2002. Third, there is good evidence that, under the main tests used by the Supreme Court in Wyeth v. Levine (March 4, 2009), Merck did not fulfill its responsibility to actively notify the FDA and users of Fosamax about the drug's association with osteonecrosis. By its own admission, it was not by its own action, but only at the prompting of the FDA did Merck seek to update its label with the risk of ostenoecrosis.

To learn more about pharmaceutical injury litigation in this and other similar cases, please contact the personal injury lawyers at your local office of The Cochran Firm. Our lawyers have the dedication and the resources to fight for your rights.


posted by Benjamin A. Irwin at 11:21 AM

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