Monday, October 5, 2015

J&J Wins 1st Trial Over Prosima Pelvic Mesh - Law360

J&J Wins 1st Trial Over Prosima Pelvic Mesh - Law360


Law360, Dallas (October 5, 2015, 4:10 PM ET) -- A Texas state court jury on Monday cleared Johnson & Johnson of liability in the first trial over the company's Prosima pelvic mesh device, rejecting claims the device was defectively designed and that the company didn't adequately warn consumers about the risks involved.

J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the Prosima pelvic mesh device. (Credit: AP)
In a 10-2 verdict, Dallas County District Court jurors rejected plaintiff Carol Cavness' claim that the Prosima device was defectively designed and that J&J's Ethicon Inc. unit had failed to give adequate warnings about the risks associated with the mesh device. Cavness, who had the device implanted in 2012 and says she has suffered debilitating pain and other medical problems since then, had asked jurors to award $9.56 million in actual damages and a substantial punitive damages award that would send a message to J&J about its decision to market the Prosima device.

Jurors deliberated for about seven hours following seven days of testimony.

"We're pretty shocked," David Matthews of Matthews & Associates, Cavness' attorney, said after the verdict.

Matthews said it's "sad" Johnson & Johnson took the strategy of attacking Cavness' past medical history instead of addressing her concerns about the Prosima device.

"I think they never defended the product at all," Matthews said. "I think there's a lot of information still to come to light about the Prosima."

Ethicon spokesman Matthew Johnson said in a statement Monday the jury's decision "reflects the facts in this case."

"Ethicon acted appropriately and responsibly in the research, development and marketing of the product and Prosima was not the cause of the plaintiff’s continuing medical problems," Johnson said. "We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so."

Cavness alleged after she was implanted with the mesh in 2012, she suffered debilitating pain and has spent three and a half years in and out of hospitals and undergoing multiple surgeries, along with depression and anxiety and other medical problems related to the mesh.

She argued J&J knew before it ever launched Prosima that the device was risky and carried with it the threat of permanent damage to women who were treated with it, but that the money-hungry company pushed the device to market to avoid losing ground to competitors.

"This is an epidemic," Matthews said in his closing argument. "These meshes are health care disasters. Does anyone really think this product was pulled from the market because of sales? This product was pulled because it's dangerous."

J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the device. It said Cavness' injuries are not the result of an adverse reaction to the Prosima but instead were caused by a pelvic floor disorder that was triggered by the same on-the-job injury that initially led her to seek surgery for pelvic organ prolapse.

"Mesh is not, was not and will not be the cause of her pain," said William Gage of Butler Snow LLP, an attorney for J&J. "There is no proximate cause."

After the verdict was read, several jurors said they were frustrated by the questions they had to answer. Two jurors said the jury thought they would get questions about whether Cavness had mesh remaining in her, not whether the product was defectively designed. Deliberations were heated, and around noon today, the jury thought they might not be able to come to a consensus, the jurors said.

Juror Godwin Egbobawaye said many of the jurors shed tears during deliberation out of sympathy with Cavness, but ultimately did not think she proved the Prosima device was the proximate cause of her injuries. 

The Dallas trial is the country's first involving Prosima. Other J&J pelvic mesh products have racked up a mixed verdict in state court and bellwether federal trials. The company faces tens of thousands of lawsuits in federal multidistrict litigation, and is set for several state court trials in Texas in the next six months involving its mesh products.

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