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Merck loses retrial of Fosamax/ONJ case
By DrBicuspid Staff

June 28, 2010 -- Merck has been ordered to pay $8 million in compensatory damages to a 72-year-old woman who claimed the company's bisphosphonate drug Fosamax caused her to develop osteonecrosis of the jaw (ONJ) and related dental problems.

Shirley Boles' original lawsuit ended in a mistrial last September. But on June 25, a jury in New York found in favor of Boles, calling Fosamax -- routinely used to treat osteoporosis -- "defectively designed" and "unreasonably dangerous," according to news reports.

Merck stated in a June 28 press release that it believes the awarding of compensatory damages was unjustified and excessive.

"We disagree with the jury's verdict. We believe the jury verdict was a result of plaintiff's counsel's inflammatory and prejudicial remarks," said Paul Strain of the Venable law firm, outside counsel for Merck, in the release. "The plaintiff was at increased risk for dental and jaw problems even if she was not taking Fosamax."

Boles testified that she used Fosamax from 1997 to 2006 and that she suffered various jaw problems and complications following two tooth extractions in June 2002, including a several-day hospitalization in 2004 to treat her condition.

During the trial, Merck produced evidence showing that the plaintiff had medical problems that cause people to develop jaw problems, regardless of whether they were taking Fosamax. She had significant periodontal disease and a history of smoking up to a pack of cigarettes a day, Merck said.

In addition, Merck said it presented evidence that it acted responsibly in researching and developing Fosamax as well as monitoring the medicine since it has been on the market. The company's clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with Fosamax. Merck also presented evidence that it provided appropriate and timely information about Fosamax to the medical, scientific, and regulatory communities and consumers.

"Both the finding and the amount of the compensatory damages are against the weight of the evidence," said Bruce Kuhlik, executive vice president and general counsel of Merck, in the release. "We believe the evidence showed that Fosamax did not cause the plaintiff's injury and that it is a safe and effective medication that was properly designed. While this is not the outcome we had hoped for, we remain fully committed to defending these cases."

Merck is currently facing more than 1,000 similar lawsuits. Boles' was one of three so-called bellwether cases being heard in federal court in Manhattan. One case was thrown out last year, and a jury found in favor of Merck in another case in May. A fourth is set to go to trial in federal court in November.

Copyright © 2010 DrBicuspid.com

Merck triumphs in 2nd Fosamax trial, May 5, 2010

U.S. lawsuit over Merck's Fosamax dismissed, November 23, 2009

Merck lawsuit over Fosamax ends in mistrial, September 11, 2009

Merck denies Fosamax caused woman's ONJ, August 11, 2009

Merck faces bellwether Fosamax lawsuit, August 10, 2009


Last Updated 6/28/2010 10:02:34 AM

4 comments so far ...
6/30/2010 2:03:22 PM
dr.s
Biggest BULL in the history of lawsuits.....i have been an oral surgeon for 4 years and yet to see a case of ONJ that is complex to treat due to bisphosphonate only... relevant medical history is the major factor for ONJ, not BIS...
everyone watch out, next time you have a patient needing an ext, you should recommend RCT and cut the tooth flush with the gumline and allow it to ex-foliate with time...of course many patients will not want to pay $$$$ for RCT and core for a NON-FUNCTIONAL tooth, they will tell you that they are welling to take the risk of ONJ, DO NOT TRUST them.
good luck to all.
6/30/2010 2:39:09 PM
Dr. Dan
I couldn't agree with dr. s more. Perhaps Merck should retaliate by taking the drug off the market. History is full of verdicts in favor of the plaintiffs even the overwellming body of evidence vindicates the defendants. It is all about the big bad corporations and what they did to the little people. How many times have drugs been brought to the public only to find side effects many years later?

Even though my son is a lawyer, what the legal profession is doing "in defense of the public good" makes me sick. Lawyers are advertising (soliciting) for clients to join class action law suits. The latest in our area involves asbestos and mesothelioma. It is time to for the law profession to police itself and get rid of the ambulance chasers and the fear mongers.
6/30/2010 3:30:05 PM
jawsurgn
I disagree with Dr. Dan and Dr. S.  I have been an OMS for 20 years and unfortunately have seen and treated many oral and IV BRONJ cases.  They are difficult to arrest and are devostating to patients.  Smoking, DM, chemo, poor hygiene, steroids and other immunocompromising factors are not the only reason why patients have this problem.  Physicians are keeping patients on these drugs for years and are not monitoring them.  One case I treated, the lady was on Fosamax for 18 years!  Studies are showing that many times the patient can be treated with oral meds for a year and go off for at least one, if not more, years without sacrificing bone density.  This might cut down on the number of growing cases.  Last study I read said it occurs in 1:1000 cases in those on oral meds.  The AAOMS protocol should be followed for now until research shows us how we can better treat our patients.
7/12/2010 6:22:46 AM
belle
I too have seen a few cases of ONJ and am only a GP (I saw them in residency). A side note on lawyers.....I was recently in need of a lawyer for a personal matter and I went to Angie's list....hmmm...they don't list lawyers! So doctors can get ripped on "the list" and not lawyers. UGH!
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