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TRENTON, N.J. - (Mealey's) A New Jersey federal jury on April 29 quickly found that Fosamax did not cause a plaintiff's femur fracture, the first verdict in a case in which a plaintiff claims that the osteoporosis drug weakened her thigh bone (In Re: Fosamax [Alendronate Sodium] Products Liability Litigation, MDL Docket No. 08-md-00008, Bernadette Glynn, et al. v. Merck Sharp & Dohme Corporation, No. 11-5304, D. N.J.).
According to court minutes, the jury in the U.S. District Court for the District of New Jersey found that plaintiff Bernadette Glynn "did not prove her case." The jury deliberated one hour and 20 minutes.
In an April 29 press statement, Merck said it is pleased with the 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 for Merck.
8 Years' Use
Glynn, now 58, took Fosamax from 2001 to April 2009. In April 2009, Glynn's right femur fractured and required surgical repair.
In 2011, Glynn sued Merck, alleging that Fosamax caused her atypical femur fracture (AFF) and that Merck failed to warn her doctor or her about the risk. The case was transferred into the Fosamax femur fracture multidistrict litigation in the U.S. District Court for the District of New Jersey, sometimes called "Fosamax II" because an earlier Fosamax MDL deals with claims of osteonecrosis of the jaw (ONJ).
Merck argued in a pretrial document that Fosamax did not cause Glynn's fracture and that it acted responsibly in researching, developing and monitoring the drug since it has been on the market. It noted that Fosamax remains on the market.
Other Risk Factors Claimed
In an April 9 press release, Merck said its warnings were appropriate and timely. The company said Glynn had "medical conditions and risk factors that cause people to have fractures."
Glynn was at risk for a "fragility fracture" that Fosamax reduced but could not eliminate, Merck said. In addition, Merck said Glynn did not sustain an AFF.
Glynn's case was selected for the second bellwether trial. The first trial in March ended in a mistrial after the plaintiff suffered a heart attack.
Plaintiff experts included Dr. Charles N. Cornell, an orthopedic surgeon at Weill Cornell College of Medicine in New York and a specialist in orthopedic trauma and metabolic bone disease; Dr. Michael J. Klein, a pathologist at the Hospital for Special Surgery in New York; Dr. David Madigan, a statistician at Columbia University in New York; and Cheryl Blume, Ph.D., an expert in pharmacovigilance and Food and Drug Administration regulation at her company, Pharmaceutical Development Group Inc.
The trial began April 8; the case went to the jury on April 29. Judge Joel A. Pisano presided.
The ONJ MDL is in the U.S. District Court for the Southern District of New York.
Femur Cases Dominate Litigation
Merck said there are about 3,300 Fosamax femur fracture cases and about 1,230 ONJ cases.
Glynn is represented by Paul Pennock, Edward Braniff and Jonathan Sedgh of Weitz & Luxenberg in New York and Donald Ecklund of Carella, Byrne, Cecchi, Olstein, Brody & Agnello in Roseland, N.J.
Merck is represented by Chilton Varner, Andrew T. Bayman of King & Spalding in Atlanta and Karen Confoy of Fox Rothschild in Lawrenceville, N.J.
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