Novartis Could Pay for Alleged Zometa Dangers

(CN) - Novartis may owe punitive damages to Pennsylvanians who developed jaw bone disease after taking Zometa, a drug meant to prevent bone problems among cancer patients, a federal judge ruled.

Karen Rowland, George and Stacy Machen, and Michelle Pratt Orr claim that Zometa, a Novartis Pharmaceuticals drug prescribed to prevent cancer-related bone damage that can lead to paralysis and death, essentially has the opposite effect on patients. Their complaints were consolidated in U.S. District Court for the Western District of Pennsylvania.

Rowland and Machen took the FDA-approved drug to treat breast cancer and stage IVB Hodgkin's disease, respectively, both of which had metastasized to their bones, in September 2004 and July 2006, according to the consolidated complaint.

Zometa ultimately caused Rowland and Machen to develop osteonecrosis of the jaw, which may lead to complete loss of the jaw bone, the plaintiffs claim.

Orr similarly alleges that after a long battle with Stage II multiple myeloma, her husband John's use of Zometa since January 2003 gave him the jaw disease, until his death on Oct. 8, 2012.

The plaintiffs say Novartis had known about but chose to ignore since as early as 2002 doctors' warnings that patients treated with Zometa and a "first generation" version, Aredia, were diagnosed with osteonecrosis of the jaw.

New Jersey-based Novartis also allegedly brushed aside reports that clinical trial subjects showed symptoms of the bone disease.

The complaint says Novartis failed to warn physicians or the public about such side effects until September 2004, and has continued to market Zometa.

Dosage instructions on the drug's label that effectively constitute an overdose also worsened the severity of their side effects, the plaintiffs claim.

Noting that it operates out of New Jersey, Novartis moved to preclude Rowland and the Machens' claims for punitive damages based on a purported preclusion in that state's law for product liability suits over FDA-approved drugs where a plaintiff has not shown that the defendant "knowingly withheld or misrepresented information required to be submitted under the agency's regulations."

U.S. District Judge Mark Hornak denied the motions on Nov. 22, finding that the injury and the conduct causing it both occurred in Pennsylvania.

"NPC did conduct research regarding Zometa and make decisions on Zometa marketing, labeling, and packaging in New Jersey," Hornak wrote, abbreviating Novartis Pharmaceuticals Corp. "However, the place where the defendant engaged in certain conduct is of less significance in situations where a potential defendant might choose to conduct his activities in a state whose tort rules are favorable."

The judge later added: "While NPC may have made corporate decisions regarding Zometa in New Jersey, its liability to these plaintiffs would not be in dispute had it not marketed Zometa to them and their doctors in Pennsylvania, sold Zometa to them in Pennsylvania, and allegedly failed to warn them in Pennsylvania of Zometa's possible connection to [osteonecrosis of the jaw] ONJ."

Orr can still amend her complaint to add a claim for punitive damages since the case has not yet been set for trial, and Hornak refused to consolidate the cases for trial at this time.

The defendant's Swiss parent, Novartis International AG, reported nearly $56.7 billion in net sales for 2012.

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