A federal judge has refused to overturn a verdict Zometa dead jaw lawsuit. Previously, a jury agreed that the drug maker neglected to appropriately warn about the risks connected to its bone-strengthening medications, Zometa and Aredia, such as severe jaw damage.
Oral bisphosphonates like Fosamax, Reclast, Actonel, and Boniva are taken by over 5 million Americans annually, generally by post-menopausal women to prevent or treat osteoporosis. Few studies have been conducted to assess the drugs’ long-term risks.
In 2005, the FDA ordered that the labels for bisphosphonates be updated to include warnings about osteonecrosis of the jaw, a condition also known as dead jaw syndrome. Last year, warnings were added to the “Warnings and Precautions” section regarding their association with atypical femur fractures. The FDA is currently reviewing a possible link between bisphosphonates and esophageal cancer.
US District Court Judge James Beaty also wrote that the jury was given sufficient evidence to conclude that a cover-up occurred and that cover-up was undertaken with “the knowledge and approval of high-ranking officials,” Pharmalot reported.
The ruling was issued nearly to the day one year after a jury awarded $12.8 million to Rita Fussman. Her family alleged Rita suffered jawbone damage in 2009 while suffering end-stage breast cancer; $287,000 was awarded in compensatory and $12.6 million in punitive damages, said Pharmalot. Under North Carolina law, punitive damages were reduced, bringing the final award to close to $1.3 million.
Novartis responded by requesting a new trial, claiming, among other things, that punitive damages were incorrectly awarded, said Pharmalot. The move failed and, now, executives over at Novartis are being blamed. And, since the Fussman case was the first tried in a federal multi-district litigation—and the only in which evidence was presented for punitive damages—the ruling might affect the other several hundred lawsuits against Novartis, and not in its favor, Pharmalot pointed out.
For his part, the judge’s response was vigorous. In part, Judge Beaty wrote: “… the willful and wanton conduct alleged in this case involved intentional deception and suppression of medical evidence by Novartis employees in investigating side effects and communicating with medical professionals … based on the evidence presented, the court concludes that sufficient evidence was presented to support a finding by the jury, by clear and convincing evidence, that Novartis managers intentionally concealed the risk of ONJ (osteonecrosis of the jaw), and attempted to subvert the medical inquiry regarding the risks of ONJ, all with the knowledge and approval of high-ranking officials within the company. In addition, the evidence would support the conclusion that Novartis managers took this course of action for purely financial reasons, in order to protect its marketing of bisphosphonate drugs.”
In 2010, a Tennessee federal court judge sanctioned Novartis for denying it ran direct-to-consumer Zometa ads and failing to produce those ads. The ads were discovered separately, by other lawyers in another case; Novartis “flip-flopped,” said Pharmalot, on the ads’ existence in an array of motions and was ordered to pay $50,000 in legal fees.
We recently wrote that a panel of Food & Drug Administration (FDA) advisors said that Fosamax and similar bone drugs need stronger warnings regarding duration of use because of possible long-term risks. The panel was unable to agree if use of the drugs, known as oral bisphosphonates, should be limited to five years, or how new warnings should be worded.