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Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX & reg; (alendronate sodium)

Tue, 10/04/2011 - 5:24am
Merck

WHITEHOUSE STATION, N.J., Oct. 3, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, today said a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

"We believe the company acted properly," said Chilton Varner of King & Spalding LLP, outside counsel for Merck. "Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body's ability to heal."

Today's verdict marks the fourth time a jury has found in Merck's favor on a plaintiff's product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.

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, and that FOSAMAX is a safe and effective medication as described in the product labeling that was properly designed and did not cause the plaintiff's dental and jaw problems. 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 is pleased with the jury's verdict," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. "We have now won four of the first five cases that have been tried to verdict. We continue to believe that FOSAMAX is a safe and effective medication and the company provided appropriate and timely information about FOSAMAX to consumers and to the medical, scientific and regulatory communities."

U. S. District Judge John F. Keenan presided over the trial. Merck is represented by Chilton Varner of King & Spalding LLP in Atlanta, Andrew Goldman of Goldman Ismail Tomaselli Brennan & Baum LLP in Chicago and Stephen Marshall of Venable LLP in Baltimore.

Status of Litigation

This is the fifth case regarding FOSAMAX® (alendronate sodium) to go to trial. Merck won three of the first four. The first three trials were conducted as part of the federal multidistrict litigation proceedings before Judge Keenan. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck in May 2010. The second case to be tried to a verdict, 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 was later reduced by Judge Keenan and which Merck intends to appeal after the damages portion of the case is retried. The third case to be tried to a verdict, Graves v. Merck, resulted in a defense verdict for Merck in November 2010. The fourth 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 June 30, 2011, approximately 1,650 cases, which include approximately 2,050 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. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years duration. 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. 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. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon. New or unusual hip, thigh or groin pain should be evaluated, as atypical femoral (thigh bone) fractures have been reported in patients taking bisphosphonates, including FOSAMAX.

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 and connect with us on Twitter, Facebook and YouTube.

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. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to 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 2010 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).

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