Merck Wins FOSAMAX® (alendronate sodium) Federal Bellwether Trial Involving
Atypical Femur Fracture Claims
WHITEHOUSE STATION, N.J. -- April 29, 2013
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 femur fracture.
“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
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 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
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 ofDec. 31, 2012, approximately4,560 cases, which include
approximately5,140 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 injuries.
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.
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Merck is known as MSD outside the United States and Canada. Through our
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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
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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
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