Judge Refuses to Overturn $1.3 Million ONJ Verdict

A North Carolina federal judge has refused to overturn a $1.3 million verdict in an Aredia/Zometa injury case known as “dead jaw lawsuit.” Previously, a jury agreed that the drug maker, Novartis, failed to appropriately warn about the risks connected to its bone strengthening medications, such as severe jaw damage.

More than 5 million Americans use oral bisphosphonates such as Fosamax, Reclast, Actonel, and Boniva annually to treat post-menopausal osteoporosis.

There have only been a few studies conducted regarding the drug’s long-term risks. In 2005, the Food and Drug Administration (FDA) ordered that labels for bisphosphonates be updated to include warnings regarding osteonecrosis of the jaw, a condition also known as dead jaw syndrome.

In 2010, warnings were added to the “Warnings and Precautions” section, indicating association with possible femur fractures. Currently, the FDA is reviewing a possible link between bisphosphonates and esophageal cancer.

Almost to the day, one year after a jury awarded $12.8 million to Rita Fussman, the ruling was issued following a 15-day trial. Her family alleged that while suffering end-stage breast cancer, Rita developed jawbone damage in 2009, for which $287,000 was awarded in compensatory damages and $12.6 million in punitive damages.  However, under North Carolina law, the punitive damages award was reduced to $861,000. The court then entered a judgment of $1,258,083 in favor of the estate.

The jury found that Novartis Pharmaceutical Corp. unreasonably failed to provide adequate warning with respect to Aredia or Zometa, and that the drugs medically caused Fussman’s ONJ, and that Novartis’ failure to provide proper warning was the cause of Fussman’s injuries.

The jury also found that Novartis breached an implied warranty of merchanability made to Fussman.  Further, the jury also concluded that Novartis did not provide adequate warnings to the prescribing doctor, as well, finding Novartis liable for punitive damages for willful or wanton conduct.

It is clear, once again, that the huge pharmaceutical companies took this course of action purely for financial reasons, with no regard for human life.  Maybe this will serve as a warning to other pharmaceutical companies that greed does not pay. Is this justice?

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