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$12.8M Verdict For Jaw Injury In Aredia/Zometa Case To Be Reduced To $1.14M

WINSTON-SALEM, N.C. - (Mealey's) A North Carolina federal jury on Nov. 22 awarded $12,887,001 in an Aredia/Zometa jaw injury case, a verdict that will be reduced to $1,148,001 by North Carolina's limit on punitive damages (Herbert Fussman, et al. v. Novartis Pharmaceuticals Corporation, No. 06-149, M.D. N.C.).

A 10-person jury in the U.S. District Court for the Middle District of North Carolina found that defendant Novartis Pharmaceuticals Corp. unreasonably failed to provide an adequate warning or instruction for Aredia and Zometa, that the drugs medically caused jaw injuries to deceased plaintiff Rita Fussman and that the failure to warn was the proximate cause of Fussman's injuries.  The jury also found that Novartis breached an implied warranty of merchantability made to Fussman and that Novartis did not provide an adequate warning or instruction for the drugs to the prescribing physician.

The jury awarded $287,000 in compensatory damages and $1 to Fussman's husband, Herbert Fussman, for loss of consortium.

Finally, the jury found that Novartis was liable for punitive damages and awarded $12.6 million. 

After the jury returned its verdict, Judge James A. Beaty Jr., who presided over the 13-day trial, reduced the award pursuant to North Carolina General Statutes Section 1D-25 with final judgment to come.  The state law reduces punitive damages to three times compensatory damages or $250,000, whichever is higher.  Juries are not permitted to be told about the limitation.

The reduction would take the judgment down to $1.48 million.

Aredia and Zometa are injectable drugs prescribed to prevent fractures in cancer patients and treat osteoporosis, hypercalcemia of malignancy and pain from bone metastases.  They belong to a class of drugs known as bisphosphonates.

Rita Fussman received monthly injections of Aredia and, later, Zometa from 2001 to 2005 after breast cancer spread to her lungs and spine.  She subsequently developed bisphosphonate-related osteonecrosis of the jaw (BRONJ), a condition in which new bone fails to grow in the jaw.  

The Fussmans sued Novartis in the Middle District of North Carolina, alleging failure to warn of the risk of ONJ.  Rita Fussman subsequently died, and Herbert Fussman remains as a plaintiff.

The case was transferred to the Aredia/Zometa multidistrict litigation in the Middle District of Tennessee.  It was remanded in 2009 to the North Carolina court for trial, which began Nov. 1.

Herbert Fussman alleged that Novartis knew about the risks of Aredia and its successor, Zometa, but ignored them and failed to warn doctors and patients.  Instead, the plaintiff alleged that the defendant put false information on the drugs' label.

Dr. Robert Marx, an oral surgeon and a former outside adviser to Novartis about BRONJ, and Dr. Talib Najjar were plaintiff experts.

Novartis argued that the warning given to Rita Fussman's doctor at the time treatment began was adequate.  In addition, the company suggested that Fussman's jaw injury was consistent with osteomyelitis, a jaw bone infection.

[Editor's Note:  Full coverage will be in the Dec. 2 issue of Mealey's Emerging Drugs & Devices.  In the meantime, the verdict form is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-101202-004V.  For all of your legal news needs, please visit]

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For more information, call editor Tom Moylan at 215-988-7739, or e-mail him at