I understand how hard it might be to even imagine getting out… but IF YOU CAN, please try to attend one or two days of Carol Caveness v. Ethicon’s Prosima. Remember, Prosimia was taken OFF THE MARKET. How will #JnJ defend from that position?
NEED TO KNOWS BEFORE YOU GO!
1) Read below article from Law360* about the details of the case.
J&J’s Ethicon Unit Defends Pelvic Mesh In Dallas Trial
By Jess Davis
Law360, Dallas (September 22, 2015, 9:29 PM ET) — Johnson & Johnson’s Ethicon Inc. unit told a Texas state court jury on Tuesday it is not responsible for injuries sustained by a woman who had the company’s Prosima pelvic mesh implant, in the country’s first trial involving the Gynecare Prosima Pelvic Floor Repair System.
In opening statements Tuesday afternoon, Ethicon told Dallas County District Court jurors that plaintiff Carol Cavness is suing the company for injuries its product did not cause, and defended the safety of its device. Cavness is seeking unspecified damages, including a punitive award, against Ethicon, which she says pushed an unsafe and defectively designed product to market despite knowing it had a high risk of complications like the years of pain she has been suffering.
Cavness’ attorney, David Matthews of Matthews & Associates, told jurors they would be the first in the country to see evidence of Ethicon’s internal development documents for the Prosima device and the warnings he said the company’s own doctors and consultants issued about the safety risks of the device. Excerpts from the documents he showed during the opening described Prosima as a “reckless product,” said “Prosima is not needed” and said the doctors had “low confidence in the data.”
“This company had multiple opportunities to stop a product they knew was dangerous but they didn’t because they pushed it for profits,” Matthews said.
He said Ethicon was told the Prosima’s plastic was too stiff for the vagina and that it was an unnecessary device because an existing surgical technique was available that achieved the same result with lower risk.
Cavness, an aircraft mechanic, was lifting a heavy object at work in April 2012 when she felt a groin strain, Matthews said. Within days, a doctor diagnosed her with pelvic organ prolapse and she had surgery to repair the prolapse with a Prosima implant, along with several other procedures.
Cavness filed suit two years after the surgery and claims that within a month of the Prosima implant, she began to have severe pain and difficulty walking. In the years since, she has had continued pain, chronic inflammation and massive scarring in the pelvis, makes weekly trips to her doctor and has developed depression and anxiety, Matthews told jurors.
Ethicon attorney Kat Gallagher of Beck Redden LLP largely steered clear of the safety of the Prosima device in her opening statement, instead concentrating on Cavness’ medical history and telling jurors the pain Cavness suffered was never caused by the Prosima mesh.
Gallagher said the pain was likely caused by “pelvic floor disorder,” a disease she was diagnosed with in May by a specialist who Cavness had not previously seen. Gallagher said an expert witness will testify that the pelvic floor disorder was triggered by the 2012 injury Cavness suffered at work.
She told jurors that though it took years to discover and that the company empathized with the pain Cavness had suffered, it was the pelvic floor disorder and not the Prosima mesh that caused her so much pain.
Gallagher did address Ethicon’s decision to pull the Prosima and other pelvic mesh devices from the market, but denied it was because they were unsafe. She said that health notices issued by the FDA about pelvic mesh scared women and made doctors fear litigation, translating to plummeting sales of the Prosima device.
Low sales figures caused by negative publicity about pelvic mesh, combined with the $4 million to $5 million cost of performing a safety study, is what made Ethicon pull the product, she said.
“This was a business decision by Ethicon in the face of what was happening,” Gallagher said. “A business decision.”
The first witness in the case will take the stand Wednesday morning.
Cavness is represented by Bill Blankenship of William F. Blankenship III PC, Tim Goss and Rich Freese of Freese & Goss PLLC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.
Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kat Gallagher of Beck Redden LLP. The doctor is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.
The case is Cavness v. Kowalczyk et al., case number DC-14-04220, in the 95th District Court of Dallas County, Texas.