Statement on FOSAMAX® (alendronate sodium) Product Liability Trial in New Jersey

Merck, known outside the United States and Canada as MSD, will vigorously defend itself in a jury trial set to begin today in the Superior Court for Atlantic County, New Jersey.

Merck believes the evidence will show that FOSAMAX® (alendronate sodium) did not cause the plaintiff to develop dental and jaw-related problems and that the company provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities. In Sessner v. Merck, the plaintiff alleges that she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions.

“Unfortunately, the plaintiff had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX,” said Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada PLLC, outside counsel for Merck. “The plaintiff had evidence of significant infections that required invasive dental procedures, and had conditions that inhibit the body’s ability to heal. 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 Carol E. Higbee will preside over the trial. Merck is represented by Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada PLLC in Ridgeland, Mississippi; Eileen Muskett of Fox Rothschild LLP in Atlantic City, New Jersey; and Paul Strain of Venable LLP in Baltimore, Maryland.

In a related development, the Flores v. Merck case was scheduled to be tried jointly with Sessner v. Merck, but on Feb. 27, 2012 Judge Higbee severed the Flores case from the Sessner trial. The Flores trial will be rescheduled.

Status of FOSAMAX Litigation

This is the sixth FOSAMAX case to go to trial. Merck won four of the first five trials. Four trials were conducted as part of the federal multidistrict litigation proceedings before Judge John F. Keenan in the U.S. District Court for the Southern District of New York: Maley v. Merck resulted in a defense verdict for Merck in May 2010; Boles v. Merck initially resulted in a mistrial in September 2009 after the jury was unable to reach a unanimous verdict. A retrial of that case in June 2010 resulted in a plaintiff verdict, which has since been reduced by Judge Keenan and will be retried with respect to the amount of damages in September 2012 and then appealed by Merck; Graves v. Merck resulted in a defense verdict for Merck in November 2010; Secrest v. Merck resulted in a defense verdict for Merck in October 2011. The fifth case to go to trial, Rosenberg v. Merck, which was tried in the Superior Court for Atlantic County, New Jersey, resulted in a defense verdict for Merck in February 2011.

As of Sept. 30, 2011, approximately 2,000 cases, which include approximately 2,420 plaintiff groups, had been filed and were pending against Merck in either federal or state court.

About FOSAMAX

FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. FOSAMAX should not be used in patients with 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.