Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX® (alendronate sodium)
October 3, 2011 10:54 am ET
WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.
“We believe the company acted properly,” said Chilton Varner of King & Spalding LLP, outside counsel for Merck. “Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body’s ability to heal.”
Today’s verdict marks the fourth time a jury has found in Merck’s favor on a plaintiff’s product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.
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, and that FOSAMAX is a safe and effective medication as described in the product labeling that was properly designed and did not cause the plaintiff’s dental and jaw problems. 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 is pleased with the jury’s verdict,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. “We have now won four of the first five cases that have been tried to verdict. We continue to believe that FOSAMAX is a safe and effective medication and the company provided appropriate and timely information about FOSAMAX to consumers and to the medical, scientific and regulatory communities.”
U. S. District Judge John F. Keenan presided over the trial. Merck is represented by Chilton Varner of King & Spalding LLP in Atlanta, Andrew Goldman of Goldman Ismail Tomaselli Brennan & Baum LLP in Chicago and Stephen Marshall of Venable LLP in Baltimore.
Status of Litigation
This is the fifth case regarding FOSAMAX® (alendronate sodium) to go to trial. Merck won three of the first four. The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge Keenan. 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 was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried. The third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010. The fourth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.
As of June 30, 2011, approximately 1,650 cases, which include approximately 2,050 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. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. 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, including FOSAMAX. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. New or unusual hip, thigh or groin pain should be evaluated, as atypical femoral (thigh bone) fractures have been reported in patients taking bisphosphonates, including FOSAMAX.
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The Prescribing information and Medication Guide for FOSAMAX® are attached and are available at:
FOSAMAX® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
Pam Eisele, 908-423-5042
Carol Ferguson, 908-423-4465