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BROOKLYN, N.Y. (Mealey's) A New York federal jury in the first federal Zometa trial found May 25 that the plaintiff did not prove by a preponderance of evidence that the Novartis Pharmaceuticals Corp. drug caused a decedent's osteonecrosis of the jaw (ONJ) (Karlene Hogan, et al. v. Novartis Pharmaceuticals Corporation, No. 1:06-cv-260, E.D. N.Y.).
Karlene Hogan alleged that Zometa, an injection bisphosphonate drug prescribed to patients with metastasizing cancer to prevent bone damage, caused ONJ in her husband, Timothy Hogan. The jury in the U.S. District Court for the Eastern District of New York found insufficient evidence that it did.
Having answered "no" to the first question, the jury did not reach questions about whether Zometa's warning was inadequate compared to what manufacturer defendant Novartis knew or should have know at the time Hogan took the drug and whether inadequate warning caused Hogan's ONJ.
In March 2003, Hogan, of Rhode Island, was prescribed Zometa injections to prevent bone loss during cancer treatment. In December 2003, he had eight teeth extracted.
In July 2004, an X-ray found a nonhealing lesion and soft tissue mass in an area of Hogan's jaw where teeth had been extracted. Necrotic tissue was removed, and Hogan was diagnosed with ONJ.
Hogan died of cancer in 2005. His widow, Karlene Hogan, sued Novartis in the District Court.
The case was transferred to the Aredia/Zometa multidistrict litigation in the Middle District of Tennessee for pretrial proceedings before being remanded to the Eastern District of New York. Defense counsel said it is the first federal Zometa case to go to trial.
The case went to trial on claims of failure to warn - strict liability and/or negligence under Rhode Island law and on Novartis' duty to warn Timothy Hogan of the ONJ risk. Karlene Hogan also claimed breach of implied warranty of merchantability under Rhode Island law.
The trial began May 16. The jury was charged on May 25 and deliberated less than five hours before returning its verdict, according to defense counsel.
"We are pleased with the jury's verdict and believe that Zometa is an effective option for patients with bone metastases," Novartis said in a press statement.
[Editor's Note: Full coverage will be in the June 2 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 #28-110602-008V. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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