Merck wins another FOSAMAX® (alendronate sodium) state court trial

Merck, known outside the United States and Canada as MSD, today said a state court jury in New Jersey found in its favor in the Sessner v. Merck case, rejecting the claims of a woman who blamed her jaw-related problems on her FOSAMAX use.

“We believe the evidence showed the company acted properly, and that FOSAMAX did not cause the plaintiff’s dental and jaw problems,” said Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada PLLC, outside counsel for Merck. “Unfortunately, the plaintiff had medical conditions that can result in the development of jaw and dental problems in people, regardless of whether they were taking FOSAMAX. She had evidence of significant infections that required invasive dental procedures and had conditions that inhibit the body’s ability to heal.”

With today’s verdict, Merck won the second state court case to go to trial in the coordinated New Jersey FOSAMAX litigation. The plaintiff in this case alleged she used FOSAMAX from 2002 to 2008 and that she suffered various jaw problems and complications following the extraction of four teeth in October 2007.

At trial, 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.

“We agree with the jury’s verdict. The company provided appropriate and timely information about FOSAMAX to consumers and the medical, scientific and regulatory communities,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. “FOSAMAX is a safe and effective medicine when used in accordance with the label.”

Judge Carol E. Higbee of the Superior Court for Atlantic County, N.J., presided over the trial. Merck is represented by Christy Jones of Butler, Snow, O’Mara, Stevens & Cannada PLLC in Ridgeland, Miss.; Eileen Muskett of Fox Rothschild LLP in Atlantic City, N.J.; and Paul Strain of Venable LLP in Baltimore, Md.

Status of FOSAMAX (alendronate sodium) Litigation

This is the sixth FOSAMAX case to go to trial. Merck has now won five of the six 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, N.J., resulted in a defense verdict for Merck in February 2011.

As of Dec. 31, 2011, approximately 2,345 cases, which include approximately 2,800 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.