Statement on FOSAMAX® (alendronate sodium) Product Liability Trial

Publish Date:

Tuesday, April 9, 2013 8:30 am EDT

Category:

WHITEHOUSE STATION, N.J., April 9, 2013 – Merck, known as MSD outside the United States and Canada, will vigorously defend itself in a jury trial set to begin today in the U.S. District Court for the District of New Jersey. In Glynn v. Merck, the plaintiff alleges she used FOSAMAX and sustained an atypical femur fracture. 

Merck believes the evidence will show that FOSAMAX did not cause the plaintiff’s fracture as she claims and that the company provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities.

“Unfortunately, the plaintiff had medical conditions and risk factors that cause people to have fractures,” said Chilton Varner, outside counsel for Merck. “The evidence will show that the plaintiff was at risk of sustaining a fragility fracture and that FOSAMAX significantly reduced, but could not eliminate that risk.”

Additionally, Merck believes the evidence will show that the plaintiff did not sustain an atypical femur fracture, that FOSAMAX did not cause plaintiff’s fracture, and that the company 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 approved today for multiple indications, including the treatment and prevention of osteoporosis in postmenopausal women.      

Judge Joel A. Pisano will preside over the trial. Merck is represented by Chilton Varner and Andrew Bayman, both of King & Spalding LLP in Atlanta, Ga., and by Karen Confoy of Fox Rothschild LLP, Princeton, N.J.

Status of Litigation

This is the ninth FOSAMAX case to go to trial and the second case to be tried where the plaintiff alleges she sustained a femur fracture in association with the use of FOSAMAX. The first case alleging a femur fracture injury resulted in a mistrial. All of the seven other trials – five federal and two New Jersey state cases – involved allegations associated with jaw-related problems. Merck won five of those seven prior trials. Among the two losses, the company is appealing the jury verdict inBoles v. Merckand has filed a post-trial motion for judgment as a matter of law inScheinberg v. Merck.

As of Dec. 31, 2012, approximately 4,560 cases, which include approximately 5,140 plaintiff groups, had been filed and were pending against Merck in either federal or state court. In approximately 1,230 of these cases, plaintiffs allege that they sustained a jaw-related injury, while the plaintiffs in the approximately 3,330 other cases allege that they sustained a femur fracture and/or other bone-related injuries.

About FOSAMAX (alendronate sodium)

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 4 years’ duration. 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 States and 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 2012 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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