Mesh News Desk, September 22, 2015 ~ Jury selection continued for a second day in the trial of Carol Cavness v. Kowalczyk et al., case # DC-14-04220, being heard in the 95th District Court of Dallas County, Texas before Judge Ken Molberg who has presided over two other pelvic mesh cases (Batiste, Salazar) which resulted in a total of $75 million in jury awards for the mesh-injured women.
In this product liability and medical malpractice trial, Carol Cavness was implanted with the Ethicon Prosima Pelvic Floor Repair System, a polypropylene mesh used to treat pelvic organ prolapse. The Prosima was taken off the market by parent company, Johnson & Johnson in 2012.
Courtroom View Network will begin providing a live feed to Mesh News Desk (MND) Wednesday. Court watcher Joleen Chambers provided the following observations to MND.
Tuesday, the group of 60 potential jurors was honed down to a dozen and two alternates after questions posed by both sides such as – have you ever had a surgical procedure, would you consider yourself conservative, moderate or liberal and do your rent or own your home, among other questions.
Richard Capshaw asked jurors if they could use the standard to find for the Plaintiff in a civil case – “the preponderance of the evidence” rather than beyond a reasonable doubt, the standard for a criminal action.
DON’T ACCESS THE INTERNET
There was some discussion with jurors about accessing the internet before Judge Ken Molberg. He told the jurors to only consider evidence presented at trial not what they might read elsewhere. In these days of on-line news, jurors are always cautioned against accessing the internet but J&J attorney Kat Gallagher, a partner with Houston-based Beck Redden LLP, made a special point of discouraging jurors from watching the news or conducting research online. In a courtroom discussion, the Defense objected to the blog, The Mesh Warrior. Blogger Aaron Horton had attended the Linda Batiste trial in the same courtroom last year and befriended the Batiste family.
Do not allow anyone to investigate on your behalf, warned Judge Molberg. Mistrials are expensive.
Cavness is represented by Tim Goss and Richard Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, 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 Kathleen Gallagher of Beck Redden LLP. Dr. Kowalczyk is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.
A jury was finally selected after the late lunch break with an approximate even number of men and women.
Judge Molberg told the jurors that the Plaintiff will go first to present its case, followed by the Defense. A rebuttal phase will be allowed. Jurors will be allowed to take notes. Only six were willing to do so.
Carol Cavness was brought into the court after the jurors were seated. Chambers says she was nicely dressed in a dark pantsuit with stylish dark hair and small gold hoop earrings. You could tell from her face she was experiencing pain, observed Chambers.
She appeared to be able to sit and did so without any special accommodations.
PLAINTIFF OPENING- DAVID MATTHEWS
Opening arguments got underway around 4 pm with both sides given about an hour. Dave Matthews opened for Cavness. According to Chambers, Matthews told the jury that J&J had had several meetings with the U.S. Food and Drug Administration about the Prosima pelvic floor mesh to treat pelvic organ prolapse. By June 2012, the company said it would “de-commercialize” (ie no longer sell) Prosima. (See the letter Butler Snow taking four meshes off the market 2012).
Why would a company do that unless there were problems with the product, he asked. One year earlier, the FDA had issued a Safety Communication that mesh used for POP repair had complication rate that was “not rare” and that it might not be more effective than a non-mesh repair of pelvic organ prolapse (POP).” See FDA Notice here.
By January 2012, the FDA ordered three years of safety studies to be conducted by mesh makers, J&J among them. See the MND story here.
When the Prosima was lifted from the market, J&J asked the FDA to lift its requirement to study the safety of the Prosima, despite the fact the polypropylene mesh had already been permanently implanted in countless women.
The FDA agreed.
Safety studies for the Prosima were not ordered and its safety and efficacy had not been established, something Ms. Cavness doctor did not know, according to her deposition. She had already implanted 25 to 30 women with Prosima. A sales representative from Ethicon was even in the room during some surgeries.
That sales rep will be one of the witnesses called.
Mr. Matthews described the Prosima as a 4 inch by 4.5 inches piece of polypropylene with two arms that are pushed into a blind area of the pelvis. Much of it remains in Cavness’ body. The damage has been done, he said.
Matthews told jurors that Ms. Cavness was trying to keep up with the demands of her job as a Class A aviation mechanic. Juries tend to grant greater awards to women who work in demanding jobs, such as the Martha Salazar case against Boston Scientific that resulted in a $73 million verdict for Ms. Salazar last year.
Chambers say the attorney for Ethicon did not introduce herself to the jury.
DEFENDANT OPENING- KAT GALLAGHER
Kat Gallagher indicated the problems with pain Ms. Cavness experienced were due to her pelvic floor muscles giving out. Laying a foundation of doubt as to what ended Cavness in the emergency room during an episode of intense pain, she indicated previous pelvic floor problems were the cause. Pelvic organ prolapse (POP) is generally uncomfortable but not painful. The demands of her job require her to lift all the time and Ms. Cavness is working with a physical therapist to address the pain issues.
Ms. Cavness has had a partial removal of her Prosima mesh. The arms remain behind and she experiences pain UTI’s and difficulty voiding. Still she is trying to remain on the job. She sees Dr. Michael Carley, a urogynecologist at Baylor Medical Center for the pain.
Ms. Cavness shouldn’t have tried to take out the mesh, Gallagher told jurors.
FDA expert Peggy Pence should appear on the stand Wednesday. As she has in the Linda Gross case and the Budke case heard in Missouri earlier this year, Ms Pence will outline the introduction of the mesh used for pelvic meshes, Prolene. It was too stuff for the vagina insiders warned. Still it was cleared in February 2007 after J&J found a substantial equivalent already on the market, allowing the company to bypass clinical trials.
Ethicon is facing 29,000 other product liability cases consolidated in multidistrict litigation in Charleston, West Virginia and thousands more defective product cases filed by women from around the globe. The company indicates it will continue with litigation rather than to begin to offer settlement to resolve the outstanding actions. #