Statement on FOSAMAX® (alendronate sodium) Product Liability Trial in U.S. District Court
October 28, 2010 7:08 am ET
Merck will vigorously defend itself in a jury trial set to begin today in the U.S. District Court for the Southern District of New York. The company believes the evidence will show that FOSAMAX did not cause the plaintiff to develop dental and jaw-related problems as she claims and that Merck provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities.
In Graves v. Merck, the plaintiff alleges she used FOSAMAX from 2001 to 2004. The plaintiff further alleges she suffered various jaw problems and complications following a tooth extraction in March 2003, including several surgeries to treat her condition.
“Unfortunately, the plaintiff had medical problems that cause people to develop jaw problems, regardless of whether they were taking FOSAMAX,” said Mike Brock of Covington & Burling LLP, outside counsel for Merck. “She has a long history of severe rheumatoid arthritis and took a number of powerful prescription medications, including steroids, that are known to suppress the body’s immune system and inhibit the body’s ability to heal. The plaintiff also has a history of smoking a pack of cigarettes a day for more than 50 years, which can also result in poor wound healing. The evidence will show that the plaintiff would have experienced dental and jaw-related problems whether she took FOSAMAX or not.”
Judge John F. Keenan of the U.S. District Court for the District of New York will preside over the trial.
“Merck acted responsibly in researching and developing FOSAMAX and in monitoring the medicine ever since it has been on the market. Our clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with FOSAMAX,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. “The company provided appropriate and timely information about FOSAMAX to consumers and to the medical, scientific and regulatory communities.”
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.
Merck is represented by Mike Brock of Covington & Burling LLP in Washington, D.C. and Bettina Strauss of Bryan Cave LLP in St. Louis, Missouri.
Status of Litigation
This is the third FOSAMAX case to go to trial. The first case to be tried to a verdict, Maley v. Merck, resulted in a defense verdict for Merck on May 5, 2010. The second case to be tried to a verdict, Boles v. Merck, resulted in a plaintiff verdict upon a re-trial in June 2010 after the original trial in September 2009 ended in a mistrial when the jury was unable to reach a unanimous verdict. Merck is appealing the verdict in the Boles case.
As of June 30, 2010, approximately 1,092 cases, which include approximately 1,470 plaintiff groups, had been filed and were pending against Merck in either federal or state court.
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. 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.
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. 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 2009 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® is attached and is available at:
FOSAMAX® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.