Novartis Faces First Zometa Trial In New Jersey

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osteonecrosis1The drugmaker lost a round in court when a New Jersey state judge denied a motion for summary judgment in a lawsuit brought by a woman who claims the risks associated with the Zometa bone-strengthening drug were not disclosed properly or completely. The ruling suggests Novartis may now face a large number of trials - about 550 lawsuits are stacked up in federal court in Tennessee and 150 are queued up in New Jersey.

In reaching her conclusion, Superior Court Judge Jessica Mayer determined that Jane Bessmer, who suffered from breast cancer and was treated with two intravenous bisphosphonates - Zometa and Aredia - sufficiently argued that Novartis may have failed to warn about the risks associated with the drugs. Bisphosphonates have been linked to osteonecrosis, which is the painful death of jawbone tissue. Novartis lost a case last fall (see this) that was not part of the national litigation and the issue plagues Merck as well (see here). Bessemer now has a titanium plate where her jaw used to be.

Mayer noted there was also sufficient evidence for a jury to determine product labeling downplayed risks needed to adequately warn physicians. Novartis argued its labeling was, in fact, adequate and its duty to warn extended only to physicians, not patients directly, which is known as the learned intermediary doctrine. However, Novartis did run direct-to-consumer ads, which several Novartis employees denied in depositions. Yet Bessmer’s attorneys located several ads recently. And so Mayer also cited a breach of express warranty claim in denying the summary judgment motion. Novartis did win one significant point - Mayer ruled there will be no punitive damages.

“We think this ruling means the bulk of these cases will go forward,” says Bessemer’s attorney, John Vecchione. A Novartis spokeswoman declined to comment, citing pending litigation. The trial is scheduled for June, although that date may change.

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