Statement on FOSAMAX® (alendronate sodium) Product Liability Trial
January 14, 2013 8:30 am ET
WHITEHOUSE STATION, N.J., Jan. 14, 2013 – 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 that the company provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities.
In Scheinberg v. Merck, the plaintiff alleges she used FOSAMAX and suffered delayed healing and osteonecrosis of the jaw following a tooth extraction.
“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 severe periodontal disease. 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 and Andrew Bayman, both of King & Spalding LLP in Atlanta, Ga.
Status of Litigation
This is the seventh FOSAMAX case to go to trial, including four federal cases and two New Jersey state cases. Merck won five of the first six 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.
Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United Statesand Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
Forward Lookingf 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.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
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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