Merck Challenges Verdict in Federal FOSAMAX® (alendronate sodium) Trial
WHITEHOUSE STATION, N.J., June 25, 2010 - Merck & Co., Inc. today said it is challenging the decision returned by a New York jury in the retrial of a federal FOSAMAX case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on FOSAMAX. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010.
"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 Venable LLP, outside counsel for Merck. "The plaintiff was at increased risk for dental and jaw problems even if she was not taking FOSAMAX."
Merck believes the verdict is contrary to the evidence presented at trial and that the award of compensatory damages is unjustified and excessive.
"Both the finding and the amount of the compensatory damages are against the weight of the evidence," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "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."
The plaintiff in this case alleged 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, which can result in poor wound healing.
In addition, Merck presented evidence that it acted responsibly in researching and developing FOSAMAX and in 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 to consumers.
Merck is represented by Paul Strain and Stephen Marshall of Venable LLP, Baltimore, Md.
Status of Litigation
This is a retrial of Boles v. Merck, a case that resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. The first case to reach a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010. As of March 31, 2010, approximately 1,039 cases, which include approximately 1,417 plaintiff groups, had been filed and were pending against Merck in either federal or state court.
FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. FOSAMAX should not be used in patients with certain disorders of the esophagus that delay emptying, who are unable to stand or sit upright for at least 30 minutes, who have low levels of calcium in their blood, or in patients who are allergic to FOSAMAX. Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away. Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor.
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The Prescribing information and Patient Product Information for FOSAMAX® is attached and also available at www.FOSAMAX.com.
FOSAMAX® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.