Mistrial Declared in FOSAMAX® (alendronate sodium) New Jersey State Court Trial

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Monday, March 18, 2013 2:07 pm EDT

Dateline:

WHITEHOUSE STATION, N.J.

Public Company Information:

NYSE:
MRK

Merck, known outside the United States and Canada as MSD, today said a mistrial was declared by Judge Carol E. Higbee of the Superior Court for Atlantic County, N.J., in the Su v. Merck case.

One week after opening statements were given, the plaintiff suffered a serious health complication unrelated to her use of FOSAMAX. As a result of her inability to proceed with the trial, Judge Higbee declared a mistrial.

The plaintiff alleged that she used FOSAMAX and that she sustained a femur fracture. No decision has been made as to when the case may be re-tried. 

Merck is represented in the case by Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada, PLLC, Ridgeland, Miss.; Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum, LLP, Chicago, Ill.; and Eileen Oakes Muskett of Fox Rothschild LLP, Atlantic City, N.J.

Status of Litigation

This is the eighth FOSAMAX case to go to trial and the first case to be tried where the plaintiff alleges she sustained a femur fracture in association with the use of FOSAMAX.  All of the earlier 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 in Boles v. Merck and has filed a post-trial motion for judgment as a matter of law in Scheinberg 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.  

The next trial involving claims of a femur fracture in association with the use of FOSAMAX, Glynn v. Merck, is scheduled to begin April 8, 2013, in the U.S. District Court for the District of New Jersey.

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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