Novartis Scores Back-To-Back Jury Wins in Bone Cancer Drug Labeling Suits

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Novartis got a double dose of good news in the past week, as its trial team from Hollingsworth, Fagre Baker Daniels, Foley & Mansfield, and Stites & Harbison won back-to-back jury verdicts in Kentucky and St. Louis in cases involving the company's cancer drug, Zometa.

The two cases were transferred for trial from federal multidistrict litigation pending in the Middle District of Tennessee. Hollingsworth serves as national coordinating counsel for Novartis in litigation, which relates to Zometa and its predecessor drug, Aredia. Both drugs are prescribed to reduce the risk of bone damage as a result of metastatic cancer. There are more than 700 product liability and failure-to-warn suits pending against Novartis over the drugs in the U.S.

On Tuesday, after an eight-day trial, a jury in St. Louis federal district court delivered a verdict in favor of Novartis, finding that the company adequately warned a Missouri man's oncologist about the risk of developing a gruesome condition called osteonecrosis of the jaw from using Zometa. Plaintiff John Brodie, who died in 2008 of prostate cancer, had alleged in a March 2006 complaint that the warnings for Zometa were inadequate and that the drugs were defective as designed.

Brodie's lawyers at Osborn Law, Law Offices of Jeffrey Bogert, and Holloran White Schwartz & Gaertner claimed that ONJ was not mentioned in the "warnings" section of Zometa's 2004 label. They also alleged that both the label and letters sent to doctors in September 2004 were inadequate and confusing and "failed to mention any causal connection between Zometa and ONJ." Brodie's attorney, Daniel Osborn, did not respond to a request for comment.

Novartis countered in a motion for judgment as a matter of law that the label "contained four paragraphs of information about ONJ, the exact adverse event that Mr. Brodie claims to have suffered." Novartis also argued that, under Missouri law, Brodie couldn't prove causation since his doctor was aware of the risk of ONJ but prescribed the drug anyway. Lead Novartis trial lawyer Bruce Berger and national coordinating counsel Joe Hollingsworth and Katharine Latimer of Hollingworth couldn't immediately be reached for comment.

Meanwhile, a Bowling Green jury delivered another verdict on Wednesday for Novartis, finding that the drug company adequately warned a Bowling Green woman's oncologist about the risk of developing ONJ from using Zometa. The plaintiff, Pamela Kyle, also suffered from metastatic cancer that had spread to her bones. She sued Novartis in March 2006 alleging that the company failed to fully test Zometa before it hit the market, failed to warn doctors of the risks of the drug, and that Zometa was defective by design.

Novartis argued that Kyle had had an invasive dental procedure months after recommendations against such procedures were added to Zometa's label in March 2004 and emphasized in August 2004. The company claims that there was no evidence that Kyle's doctors would have avoided prescribing Zometa if Novartis had issued a stronger warning.

Faegre partner James O'Neal, who tried the Kyle case on behalf of Novartis, said that Aredia and Zometa are "two very good drugs" that are effective in preventing "horrible side effects of metastatic cancer."

"The jury was sensitive to the fact that we need these medications, even though they may have side effects," said O'Neal. "We showed that Novartis acted very responsibly with respect to the information as it came in." O'Neal is trying an Aredia/Zometa case for Novartis in March in North Carolina.

Novartis has been on a roll recently in the Zometa litigation, winning a summary judgment ruling in October in Atlanta federal district court and securing a dismissal in Fort Smith, Ark., federal district court in January. as its trial team from Hollingsworth, Fagre Baker Daniels, Foley & Mansfield, and Stites & Harbison won back-to-back jury verdicts in Kentucky and St. Louis in cases involving the company's cancer drug, Zometa.

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