Mixed Result in Federal Trial Involving FOSAMAX® (alendronate sodium)

Publish Date:

Tuesday, February 5, 2013 12:54 pm EST

Category:

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.

About Merck

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 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.

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:

www.merck.com/product/usa/pi_circulars/f/FOSAMAX/FOSAMAX_pi.pdf

www.merck.com/product/usa/pi_circulars/f/FOSAMAX/FOSAMAX_mg.pdf

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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