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Jury Awards Plaintiff $10.4 Million For Injuries, Punitive Damages Linked To Novartis' Zometa

CENTRAL ISLIP, N.Y. - (Mealey's) A New York federal jury on Nov. 2 found Novartis Pharmaceuticals Corp. liable for a woman's osteonecrosis of the jaw (ONJ) and awarded her $10.45 million, according to the parties (Barbara Davids v. Novartis Pharmaceuticals Corporation, No. 2:06-431, E.D. N.Y.).

The jury in the U.S. District Court for the Eastern District of New York awarded Barbara Davids $350,000 for past damages, $100,000 for future damages and $10 million in punitive damages, a plaintiff's source told Mealey Publications.

In a Nov. 5 statement, a Novartis spokesperson said, "We are disappointed and disagree with the jury's verdict. We are reviewing our appellate options."

Fosamax, Zometa Use

In 2001, Davids was diagnosed with stage 1 breast cancer. Later that year, Davids' primary care physician prescribed Fosamax, an oral bisphosphonate drug, to treat Davids' osteoporosis.

In 2003, Davids' cancer metastasized to her bones, and she was prescribed Femara. Later that year, she was treated with Zometa, an intravenous bisphosphonate drug made by Novartis.

In 2006, Davids sued Novartis in the District Court. Her case was transferred into the Aredia/Zometa multidistrict litigation and was remanded in 2011.

As of April, her claims were for strict liability, negligent manufacture, negligent failure to warn and breach of express and implied warranty.

Novartis' Defense

According to a September pretrial order, Novartis argued that the warnings about Zometa's adverse side effects were adequate and that it did not have to warn Davids' oncologist. It also denied that any failure to warn caused Davids' injuries.

Instead, Novartis said, Davids' ONJ was spontaneous and possibly related to extensive dental treatment prior to her starting Zometa.

In addition, the defendants argued that Davids' claims are barred by the learned intermediary doctrine. Novartis also denied that there was any manufacturing or design defect.

Month-Long Trial

The trial began Oct. 4.

Davids' expert witnesses were Wayne A. Ray, Ph.D.; Suzanne Parisian, M.D.; James Vogel, M.D.; Robert E. Marx, D.D.S.; and Richard A. Kraut, D.D.S. Novartis' experts were Janet Arrowsmith, M.D.; Kenneth Fleisher, D.D.S.; Arthur Goldberg, M.D.; Theresa Guise, M.D.; Mitchell Levine, M.D.; Allan Lipton, M.D.; Graham Russell, M.D., Ph.D.; and Stuart Super, D.M.D.

Judge Arthur D. Spatt presided.

Concurrent Fosamax Claim

Davids has also sued Merck & Co. Inc., the manufacturer of Fosamax, in the Southern District of New York, where the Fosamax multidistrict litigation is located.

Davids is represented by Bart T. Valad and John J. Vecchione of Valad & Vecchione in Fairfax, Va., Terrence J. Sweeney of New York and Deborah N. Misir of Lally & Misir in Mineola, N.Y. Novartis is represented by Anne Marla Friedman, Bruce J. Berger, Katharine R. Latimer and Robert E. Johnston of Hollingsworth in Washington, D.C., and Jesse J. Graham and David Richman of Rivkin Radler in Uniondale, N.Y.

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