NEW YORK - (Mealey's) A New York federal jury on Feb. 5 ordered Novartis Pharmaceuticals Corp. to pay $285,000 to a plaintiff for allegedly failing to warn her or her doctor that Fosamax carries a risk of osteonecrosis of the jaw (ONJ) (In Re: Fosamax Products Liability Litigation, MDL Docket No. 1789, No. 1:06-mc-1789, Rhoda E. Scheinberg v. Merck & Co., Inc., No. 08-4119, S.D. N.Y.).
In the fifth bellwether trial in the Fosamax multidistrict litigation in the U.S. District Court for the Southern District of New York, the jury also found that Fosamax was not defectively designed.
A plaintiff's source told Mealey Publications that the jury's $285,000 failure-to-warn award was for pain and suffering. Medical expenses and lost wages were not sought.
The court previously dismissed Rhonda E. Scheinberg's punitive damages claim.
7-Year Use Of Drug
Scheinberg took Fosamax from 2000 to 2006. In 2006, she had a tooth extracted. She was later diagnosed with ONJ.
In 2008, Scheinberg sued Merck & Co. Inc. in the Southern District of New York.
Scheinberg alleged that Fosamax was defectively designed and that Merck failed to warn her or her doctor about the risk of ONJ.
Preexisting Periodontal Disease
In pretrial filings, Merck argued that Scheinberg's ONJ was caused not by Fosamax but by Scheinberg's periodontal disease, her diabetes and her use of other prescription drugs.
After Scheinberg's case finished, Merck moved for summary judgment, arguing that to prove her design defect claim, Scheinberg had to show a safer alternative design. It said the alternative design Scheinberg proposed at the end of her case - calcium and vitamin D - was presented too late in the case and was not supported by expert evidence.
Merck also argued that Scheinberg did not establish through credible testimony that Merck failed to adequately warn Scheinberg's doctor about the risk of ONJ. It said the prescribing physician testified that she knew about the risk of ONJ and prescribed it to Scheinberg anyway.
Finally, Merck argued that because the Food and Drug Administration would have rejected new warning language that Scheinberg proposed, her claim is preempted by federal law, citing the U.S. Supreme Court's decision in Wyeth v. Levine (129 S. Ct. 1187, 1198  [enhanced version available to lexis.com subscribers]). It said the FDA has determined that Fosamax can be on the market and used for its intended purposes because it is safe and effective.
Scheinberg's experts included Dr. Suzanne Parisian, Dr. Sanford Buch and Dr. Andrew Breiman. Merck's experts included Dr. Barry Gruber and Dr. Robert Glickman.
The trial began Jan. 14, and the jury began deliberating Feb. 1. Judge John F. Keenan presided.
Merck today released a statement attributed to outside defense counsel Chilton D. Varner of King & Spalding: "We disagree with the jury's verdict on the failure-to-warn claim. Merck provided appropriate warnings, and the plaintiff was at increased risk for dental and jaw problems regardless of whether she was taking FOSAMAX. She had a long history of severe periodontal disease."
Scheinberg is represented by Timothy M. O'Brien and Brandon L. Bogle of Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor in Pensacola, Fla.
Merck is represented by Andrew T. Bayman and Varner of King & Spalding in Atlanta, William J. Beausoleil and Julia R. Zousmer of Hughes, Hubbard & Reed in New York and Paul F. Strain, David J. Heubeck and Stephen E. Marshall of Venable in Baltimore.
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