Merck Statement on FOSAMAX (alendronate sodium) Product Liability Trial
WHITEHOUSE STATION, N.J., Sept. 7, 2011 – Merck, known outside the United States and Canada as MSD, will vigorously defend itself in a jury trial set to begin today in the U.S. District Court for the Southern District of New York.
Merck believes the evidence will show that FOSAMAX did not cause the plaintiff to develop dental and jaw-related problems as she claims, and the company provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities.
In Secrest v. Merck, the plaintiff alleges she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.
“Unfortunately, the plaintiff had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX,” said Chilton Varner of King & Spalding LLP, outside counsel for Merck. “She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body’s ability to heal. The evidence will show that the plaintiff would have experienced dental and jaw-related problems whether she took FOSAMAX or not.”
Additionally, the evidence will show that Merck acted responsibly in researching and developing FOSAMAX and in monitoring the medicine ever since it has been on the market. FOSAMAX was studied in clinical trials, conducted both before and following approval, involving more than 28,000 patients, including more than 17,000 treated with FOSAMAX.
FOSAMAX was approved as a safe and effective medication by the U.S. Food and Drug Administration in September 1995 and is still on the market today and approved for multiple indications, including the treatment and prevention of osteoporosis in postmenopausal women.
Judge John F. Keenan will preside over the trial. Merck is represented by Chilton Varner of King & Spalding LLP in Atlanta, Ga. and Andrew Goldman of Goldman Ismail Tomaselli Brennan & Baum LLP of Chicago, Ill.
Status of Litigation
This is the fifth FOSAMAX case 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 has since been reduced by Judge Keenan and which Merck is appealing. 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, 2010, 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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Forward Looking Statement
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