Federal MDL Court Rules Plaintiff’s Failure to Warn Claim Pre-empted in FOSAMAX® (alendronate sodium) Bellwether Case
June 27, 2013 8:21 am ET
WHITEHOUSE STATION, N.J., June 27, 2013 – Merck, known as MSD outside the United States and Canada, today said that the U.S. District Court for the District of New Jersey found that a plaintiff’s failure to warn claim is pre-empted by federal law.
In a post-trial ruling issued in the Glynn v. Merck case, Judge Joel A. Pisano found that “pre-emption is warranted, because there is clear evidence that the FDA would not have approved a change to the Precautions section of the FOSAMAX label prior to Mrs. Glynn’s fracture.”
The post-trial ruling occurred after a jury returned a unanimous verdict in favor of Merck. In the case, the plaintiff had claimed she used FOSAMAX and subsequently suffered an atypical femur fracture.
“We are pleased with the Court’s pre-emption decision,” 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. We remain confident in the efficacy and safety profile of FOSAMAX, and will continue to always act in the best interest of patients.”
FOSAMAX was approved as a safe and effective medication by the U.S. Food and Drug Administration in September 1995 and is still approved today for multiple indications, including the treatment and prevention of osteoporosis in postmenopausal women.
Merck is represented by Chilton Varner and Andrew Bayman, both of King & Spalding LLP in Atlanta; Stephen Marshall of Venable LLP in Baltimore; and by Karen Confoy of Fox Rothschild LLP, in Princeton, N.J.
Status of Litigation
Glynn v. Merck is the ninth FOSAMAX case to go to trial and the second case to be tried where the plaintiff alleged she sustained a femur fracture in association with the use of FOSAMAX. The first case alleging a femur fracture injury resulted in a mistrial. All of the seven other 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 March 31, 2013, approximately 4,990 cases, which include approximately 5,585 plaintiff groups, had been filed and were pending against Merck in either federal or state court. In approximately 1,210 of these cases, plaintiffs allege that they sustained a jaw-related injury, while the plaintiffs in the approximately 3,780 other cases allege that they sustained a femur fracture and/or other bone-related injuries.
About FOSAMAX (alendronate sodium)
FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. The optimal duration of use has not been determined. The safety and effectiveness of FOSAMAX for the treatment of osteoporosis are based on clinical data of four years’ duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low risk for fracture should be considered for drug discontinuation after three to five years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
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 (ONJ), 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.
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.
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:
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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