Litigation

N.J. Jury Finds Novartis Didn't Fail To Warn About Jaw Risk From Aredia, Zometa Bone Drugs

NEW BRUNSWICK, N.J. -- A New Jersey state court jury on Oct. 6 found that Novartis Pharmaceuticals Corp. did not fail to provide adequate warning to a cancer patient's doctor that its bone-saving drugs Aredia and Zometa had a risk of osteonecrosis of the jaw (ONJ) (Jane Bessemer v. Novartis Pharmaceuticals Corp., MID-L-1835-08-MT, N.J. Super, Middlesex Co.).

Jane Bessemer, 73, of New Jersey, sued Novartis in the Middlesex County Superior Court.  She said she was injected with Aredia from 1999 to 2002 and with Zometa from 2002 to 2004 to prevent bone loss while she received chemotherapy for breast cancer.

Bessemer alleged that she developed ONJ as a result and had to have her jaw reconstructed using metal plates and bone screws.  She alleged that Novartis knew or should have known of the ONJ risk and failed to adequately warn her physician.

Novartis argued that the ONJ warning for both drugs was adequate and that Bessemer's jaw problem was caused by osteomyelitis.

In a 7-2 vote, the jury answered "no" to the question of whether Novartis failed to provide adequate warnings and whether it knew or should have known of the risk before Bessemer discontinued using the drugs.  The jury did not have to answer questions about whether Bessemer would have refused the drugs if she had known the risk, if the drugs were a substantial contributing factor to her jaw problems, how much Bessemer was due for pain, suffering, disability and loss of enjoyment of life and how much her husband was due for loss of consortium.

Trial began Sept. 23, and the jury began deliberations and returned its verdict on Oct. 6.

Judge Jessica R. Mayer presided.

The trial was the first in New Jersey's mass tort Zometa/Aredia docket.  As of Sept. 10, there were 129 cases pending in the state court.

[Editor's Note:  Full coverage will be in the Oct. 21 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the verdict form is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844.  Document #28-101021-006V.  For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]

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For more information, call editor Tom Moylan at 610-205-1120, or e-mail him at tom.moylan@lexisnexis.com.