Merck Wins Another Federal FOSAMAX® (alendronate sodium) Bellwether Trial
Jury Rejects Plaintiff's Claims
WHITEHOUSE STATION, N.J., Nov. 19, 2010 - Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.
"We believe the evidence showed the company acted properly, and that FOSAMAX did not cause the plaintiff's dental and jaw problems," said Mike Brock of Covington & Burling LLP, outside counsel for Merck. "Unfortunately, the plaintiff had multiple medical conditions that can cause people to develop jaw and dental problems, regardless of whether they were taking FOSAMAX." The plaintiff in this case alleged she used FOSAMAX from 2001 to 2004 and that she suffered various jaw problems and complications following a tooth extraction in March 2003, including several surgeries to treat her condition.
At trial, 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.
"We are pleased with the jury's verdict. The company provided appropriate and timely information about FOSAMAX to consumers and the medical, scientific and regulatory communities," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "FOSAMAX is a safe and effective medicine when used in accordance with the label."
U S. District Judge John F. Keenan presided over the trial. Merck is represented by Mike Brock of Covington & Burling LLP in Washington, D.C. and Bettina Strauss of Bryan Cave LLP in St. Louis, Missouri.
Status of Litigation
This is the third FOSAMAX case to go to trial. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010. The second case to be tried to a verdict, Boles v. Merck, initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. A retrial of that case in June 2010 resulted in a plaintiff verdict, which has since been reduced by Judge Keenan and which Merck is appealing. The Graves case was selected by the MDL for a bellwether trial to replace the Flemings v. Merck case that was dismissed when the court granted Merck's motion for summary judgment. The judgment dismissing the Flemings case was affirmed on appeal by the U.S. Court of Appeals for the Second Circuit in November 2010. As of September 30, 2010, approximately 1,180 cases, which include approximately 1,560 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. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, with delayed healing, has been reported in patients taking bisphosphonates.
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