A federal judge has denied a bid by Novartis -- maker of the oral bisphosphonate drugs Zometa and Aredia -- to overturn a 2010 verdict in which a jury decided Novartis failed to adequately warn consumers that using Zometa may cause osteonecrosis of the jaw (ONJ).
The ruling, issued November 21 in the U.S. District Court for the Middle District of North Carolina, came almost a year after a jury awarded $12.8 million to Rita Fussman, whose family claimed she suffered ONJ and related dental problems after being treated for breast cancer, according to a story by Pharmalot.
Novartis began warning doctors of the potential for jaw damage in 2005, but the family's lawsuit alleged that Novartis knew about the link much earlier, potentially as early as the 1980s. Fussman began taking Zometa in 2001 as part of her chemotherapy.
The jury awarded $287,000 in compensatory damages and $12.6 million in punitive damages. A punitive damages cap in North Carolina ultimately reduced the final award to $1.3 million.
But Novartis sought a new trial, arguing in part that punitive damages were awarded incorrectly, according to Pharmalot.
But in the November 21 ruling, Judge James Beaty noted North Carolina law requires that, for a plaintiff to win punitive damages, a jury must be presented with clear and convincing evidence at trial to determine that officers, directors, or managers of a company "participated in or condoned the conduct constituting the aggravating factor giving rise to punitive damage."
Beaty decided that enough evidence was presented to uphold the punitive damage award. In fact, he wrote that the jury was shown sufficient evidence to conclude a cover-up was undertaken with "the knowledge and approval of high-ranking officials."
The case is the fourth ONJ lawsuit concerning Zometa to go to trial. The first resulted in a $3.2 million verdict in October 2009; Novartis won the second one in October 2010 and the third one in May 2011.
