Merck Wins FOSAMAX® (alendronate sodium) Federal Bellwether Trial Involving Atypical Femur Fracture Claims
April 29, 2013 4:00 pm ET
Merck, known as MSD outside the United States and Canada, today said a
jury found in its favor in the Glynn v. Merck case in the U.S.
District Court for the District of New Jersey. In the case, the
plaintiff claimed she used FOSAMAX and subsequently suffered an atypical
“We are pleased 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. “We remain
confident in the efficacy and safety profile of FOSAMAX, and will
continue to always act in the best interest of patients.”
At trial, Merck presented evidence that FOSAMAX did not cause the
plaintiff’s fracture, and that the company 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.
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.
Judge Joel A. Pisano presided over the trial. 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
This 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 Dec. 31, 2012, approximately 4,560 cases, which include
approximately 5,140 plaintiff groups, had been filed and were pending
against Merck in either federal or state court. In approximately 1,230
of these cases, plaintiffs allege that they sustained a jaw-related
injury, while the plaintiffs in the approximately 3,330 other cases
allege that they sustained a femur fracture and/or other bone-related
About FOSAMAX (alendronate sodium)
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 4 years’
duration. 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, 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
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dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
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Merck undertakes no obligation to publicly update any forward-looking
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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.
Lainie Keller, 908-423-4187
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088