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Bone decay results in $10.5 million verdict by federal jury

A federal jury in New York weathered Hurricane Sandy to award a plaintiff almost $10.5 million after she developed necrosis of the jaw from taking Zometa.

Barbara Davids was diagnosed with metastatic breast cancer and was prescribed Zometa to help prevent fractured or broken bones, said her attorney, John J. Vecchione of Valad & Vecchione in Fairfax, Va.

But after taking the drug for one and half years Davids developed necrosis of the jaw, or bone decay, with dead bones literally falling out of her mouth, he said.

The suit was one of hundreds filed in an MDL against Novartis Pharmaceuticals, the maker of Zometa.

A month-long trial interrupted by “Superstorm Sandy” resulted in a verdict that included $10 million in punitive damages and was the second plaintiffs’ victory this year, Vecchione said.

The Zometa cases present a challenge because the drug is still on the market, Vecchione acknowledged.

“Novartis takes the position that these plaintiffs have cancer and tries to argue that they don’t deserve to be warned” about the dangers of the drug, Vecchione said. “Juries need to understand that individuals are in charge of their own health care decisions and [Novartis] can’t make the decision for them.”

Bruce J. Berger, a partner at Hollingsworth in Washington, who represented Novartis at trial, did not immediately return a call requesting comment on the case.

A company spokesperson said the company is “reviewing our appellate options.”

“We are disappointed and disagree with the jury’s verdict,” the spokesperson, Julie Masow, added.

Damning emails

Davids took 16 doses of Zometa over an 18-month period, Vecchione said, in order to reduce skeletal related events, or SREs, that are common in cancer patients.

At first, she suffered from pain and swelling that would not go away. Then her teeth began to fall out, followed by pieces of bone that “smelled like death,” Vecchione said.

Davids could not have dental implants because invasive surgery is no longer an option after taking Zometa for a certain length of time. She was able to undergo an operation to relive some of her pain but has permanent numbness on the left side of her face, Vecchione said.

She filed suit in February 2006, alleging failure to warn.

Zometa contains bisphosphonate, which is intended to strengthen bones. But although medical studies indicated in early 2003 that there was a link between Zometa and osteonecrosis of the jaw, the company failed to update the drug’s labels until 2005, Davids claimed.

Both Davids and her son took the stand at trial. Vecchione called 17 other witnesses, including Davids’ physicians, the two doctors who discovered the link between Zometa and jaw necrosis, and Novartis employees.

Vecchione also introduced some particularly damning evidence against the drug manufacturer: emails that indicated that Novartis tried to block a report connecting Zometa to jaw decay.

In one email, Novartis executive director of marketing Stefano Fratarcangeli instructed another employee to find an oncologist to contact the co-author of the study and have him or her “make the case that there is no scientific rational [sic] that link bisphosphonate to osteonecrosis.”

In another email, he described the report as “quite damaging.”

Storm interrupts trial

Trial began on Oct. 12 and took 12 days, Vecchione said. But the jury didn’t reach a verdict until Nov. 2 because of a break for Columbus Day and an interruption caused by Hurricane Sandy.

Both sides had their hotel power knocked out and the courthouse’s phone service and website went down.

Even when the parties returned to the courtroom, it was unclear if the jurors would be able to make it back in, given the power outages, gas shortages and dangerous driving conditions caused by the storm.

The defense moved for a mistrial due to the storm and the conditions, but U.S. District Court Judge Arthur D. Spatt denied the motion and 11 of the 12 jurors returned for deliberations.

Vecchione said he did not ask the jury for a specific dollar amount and also declined to provide any sort of formula for damages. The remaining jurors deliberated for just a few hours before returning a unanimous verdict of $450,000 in compensatory damages –$350,000 for past damages and $100,000 for the future – and $10 million in punitive damages.

After the verdict was read, the defense indicated it plans to file a motion to reduce the punitive damages, which were awarded under New Jersey law. That state caps punitives at five times the compensatory total, which would reduce the $10 million to roughly $2.7 million.

A similar result occurred in 2010, when a North Carolina jury awarded a Zometa plaintiff $13 million but the verdict was reduced under the state’s damages cap to less than $2 million.

Of the eight Zometa cases that have been tried to a verdict, the parties have split the results, with four plaintiffs’ victories and four defense wins. Vecchione, a member of the plaintiffs’ steering committee for the MDL, noted that two of the juries have also awarded punitive damages and three of the four verdicts have been more than $1 million.

With the approximately 400 MDL cases now being sent back to the jurisdictions where they were originally filed, Vecchione said he is looking forward to the coming trials.

“I think you can draw some conclusions [about the strength of the plaintiffs’ cases] from the speed and the unanimity of the [Davids] verdict,” he said.

Plaintiff’s attorneys: John J. Vecchione of Valad & Vecchione in Fairfax, Va.; John J. Beins of Beins, Goldberg & Hennessey in Chevy Chase, Md.

Defense attorneys: Bruce J. Berger and Robert E. Johnson of Hollingsworth in Washington; Jacqueline Bushwack of Rivkin Radler in Uniondale, N.Y.

The case: Davids v. Novartis Pharmaceuticals Corp.; Nov. 2, 2012; U.S. District Court for the Eastern District of New York; U.S. District Court Judge Arthur D. Spatt.


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