Zometa Jaw Decay Verdict Upheld, Judge Blasts Novartis for Cover-Up

A federal judge has rejected an attempt by Novartis to overturn the verdict in a Zometa jaw decay lawsuit, highlighting evidence that suggests the drug maker’s employees intentionally covered up medical evidence of the bone drug’s side effects. 

Novartis was trying to obtain a new trial in a product liability lawsuit brought by the family of Rita Fussman, who alleged that the company failed to adequately warn consumers that side effects of Zometa could cause a condition known as osteonecrosis of the jaw (ONJ), where the jaw bone decays and dies.

A year ago, a North Carolina  jury awarded Fussman’s estate $13 million in compensatory and punitive damages, finding that the company intentionally withheld vital safety information from consumers.

U.S. District Judge James Beaty rejected Novartis’ attempt to overturn the award, saying that the jury in the case had sufficient evidence to rule that Novartis could be subjected to punitive damages for intentionally misleading consumers by trying to conceal evidence of Zometa ONJ. Judge Beaty said that the jury was presented with “clear and convincing evidence” that Novartis managers intentionally initiated a cover-up of Zometa side effects, and then tried to subvert medical inquiries into the drug. Judge Beaty said that the evidence pointed to the knowledge and approval of the cover-up by high-ranking Novartis officials.

The case was the first bellwether trial in the federal Zometa jaw decay litigation, which involves hundreds of lawsuits that have been consolidated along with similar claims involving Aredia, another chemotherapy drug, as part of a multidistrict litigation (MDL) in the U.S. District Court in Nashville. The case was seen as a test case for how juries would weigh expert testimony, evidence and arguments in future Zometa ONJ lawsuits.

One of the more damaging pieces of evidence presented during the trial was an internal email from a marketing executive that seemed to suggest the company suppressed a report outlining a number of cases where Zometa was linked to ONJ.

Novartis began warning doctors of the potential for jaw damage in 2005, but the lawsuit alleged that Novartis knew about the link much earlier, potentially as early as the 1980s. Fussman began taking Zometa in 2001.

Due to tort reform laws, Fussman’s estate only received $1.3 million of the $13 million jury award. Fussman herself died in 2009 of breast cancer.

Aredia (pamidronate disodium) and Zometa (zoledronic acid) are treatments used to reduce bone complications associated with multiple myeloma and bone metastases from solid tumors. Both belong to a class of drugs known as bisphosphonates, which have been associated with an increased risk of ONJ.