Mixed Result in Federal Trial Involving FOSAMAX® (alendronate sodium)
February 5, 2013 12:54 pm ET
Jury Finds Product Not Defectively Designed
Jury Awards Plaintiff $285,000 on Failure to Warn
WHITEHOUSE STATION, N.J., Feb. 5, 2013 – Merck, known outside the United States and Canada as MSD, today said a jury in the U.S. District Court for the Southern District of New York returned a mixed verdict in theScheinberg v. Merckcase. After a three-week trial, the jury found that FOSAMAX was not defectively designed and awarded the plaintiff $285,000 on the failure-to-warn claim.
“We disagree with the jury’s verdict on the failure-to-warn claim. Merck provided appropriate warnings, and the plaintiff was at increased risk for dental and jaw problems regardless of whether she was taking FOSAMAX,” said Chilton Varner of King & Spalding LLP, outside counsel for Merck. “She had a long history of severe periodontal disease.”
The plaintiff in this case alleged she used FOSAMAX and suffered delayed healing and osteonecrosis of the jaw following a tooth extraction.
During the trial, Merck produced evidence showing that the plaintiff had severe periodontal disease that can cause people to develop jaw and dental problems, regardless of whether they were taking FOSAMAX.
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.
FOSAMAX was approved as a safe and effective medication by the U.S. Food and Drug Administration in September 1995 and is approved for multiple indications, including the treatment and prevention of osteoporosis in postmenopausal women.
Judge John F. Keenan presided over the trial. Merck is represented by Chilton Varner and Andrew Bayman, both of King & Spalding LLP in Atlanta, Ga.
Status of Litigation
This is the seventh FOSAMAX case to go to trial. The others included four federal cases and two New Jersey state cases. Merck has won five of the seven trials.
As of Sept. 30, 2012, approximately 4,005 cases, which include approximately 4,580 plaintiff groups, had been filed and were pending against Merck in either federal or state court.
About FOSAMAX (alendronate sodium)
FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. FOSAMAX should not be used in patients who have 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. Dosing instructions should be followed and 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. Atypical femur fractures have been reported in patients taking bisphosphonates.
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Forward Looking Statement
This statement includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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The Prescribing information and Medication Guide for FOSAMAX® (alendronate sodium) 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.
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