A federal jury in Trenton has found in favor of Merck & Co. Inc. in the first suit to go to trial over claims that its osteoporosis drug Fosamax causes fractured femurs.
After an hour and 20 minutes of deliberation on Monday, jurors voted 8 to 0 that the plaintiff failed to prove by a preponderance of the evidence that her fracture was of the so-called atypical type said to be caused by the drug.
The verdict in Glynn v. Merck, Sharp & Dohme Corp., 11-cv-5304, is important because 3,330 of 4,560 pending Fosamax suits are over fractured femurs or other bone-related injuries. The rest pertain to jaw-related problems.
The drug is designed to slow bone loss and make bones more dense. But some plaintiffs say it interferes with the normal bone-healing process in such a way that microfractures are not repaired.
Atypical femur fractures are defined as near the hip or in the middle section of the long bone of the femur, with a straight, rather than uneven, fracture, and usually occurring while the subject is simply standing or walking.
Bernadette Glynn, now 58, of Cohoes, N.Y., claimed she began using the drug in 2001 and continued until 2009, when she bent over while gardening and felt a pinch in her right leg.
She later learned she fractured her femur and underwent surgery to repair it with a rod and screws.
She claimed the company failed to adequately disclose risks associated with long-term use of Fosamax.
Her suit included counts for failure to warn and defective design, both under the New Jersey Product Liability Act; negligence; negligent misrepresentation; breach of express warranty and breach of implied warrant of fitness and merchantability; and violation of the New Jersey Consumer Fraud Act. She also included a claim for loss of consortium by her husband, Richard.
The company contended that Fosamax didn’t cause Glynn’s injury, that it made the proper disclosures to the public and physicians, and that it acted responsibly in researching, developing and monitoring Fosamax.
Jurors answered "no" to the first question on the verdict sheet, which was, "did Bernadette Glynn prove by the preponderance of the evidence that she experienced an atypical femur fracture in April 2009?"
Their answer of "no" meant they did not proceed to questions on adequacy of Merck’s warning and the proper amount of compensation.
The verdict was reached after 15 days of trial before U.S. District Judge Joel Pisano.
Merck hailed the victory, which brings its record to six wins and two losses among Fosamax cases — over jaw-bone problems — tried to completion.
Bruce Kuhlik, executive vice president and general counsel of Merck, said in a statement: "The company provided appropriate and timely information about Fosamax to consumers and the medical, scientific and regulatory communities."
He added, "We remain confident in the efficacy and safety profile of Fosamax."
Merck was represented by Chilton Varner and Andrew Bayman of King & Spalding in Atlanta and Karen Confoy of Fox Rothschild in Princeton.
The lead plaintiff lawyer in the case, Paul Pennock of Weitz & Luxenberg in New York, says, "as far as the atypical fracture finding, there are appellate issues concerning the verdict sheet presentation of that question, among other issues." He declines to elaborate.
To date, two Fosamax cases have been tried before Superior Court Judge Carol Higbee in Atlantic County Superior Court. Defense verdicts were returned in both cases, in which plaintiffs linked necrosis of the jawbone to use of Fosamax.
Higbee also began a trial in another Fosamax case involving a broken femur in March. But Higbee declared a mistrial in that case March 18 after the plaintiff suffered a heart attack.
Five other Fosamax trials have been conducted to date, all in the Southern District of New York. Plaintiffs have prevailed in two.
In one, Scheinberg v. Merck, the jury awarded $285,000. In the other, Boles v. Merck, the jury awarded $8 million, but the judge reduced the award to $1.5 million. When the plaintiff sought a new damages trial, Merck settled for an undisclosed amount.
Merck introduced Fosamax in 1995, and it remains on the market. In 2005, at the recommendation of the Food and Drug Administration, the company amended its labeling to disclose risks that it can cause necrosis of the jawbone.
The labeling was changed again in 2011 after the FDA issued a safety announcement and studies linked the drug with femur fractures, exposed and rotting jawbones, fractures, gum lesions, severe jaw pain, loose teeth and secondary infections.
Suits filed in New Jersey, other than those seeking medical monitoring, were consolidated before Higbee in October 2008.