Tlogo CVNHANKS TO COURTROOM VIEW NETWORK FOR PROVIDING A LIVE FEED TO Carol Cavness v. Kowalczyk et al., case # DC-14-04220, in its fifth day in a Dallas courtroom.

MND, September 25, 2015 ~ Carol Cavness sued Ethicon in 2014 after having a Prosima polypropylene mesh device implanted transvaginally two years earlier to treat pelvic organ prolapse (POP).

The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Three of those cases have yielded jury awards ranging from $1.2 to $11.1 million. Other cases filed against Ethicon, a division of Johnson & Johnson, have beeen quietly settled, though the healthcare giant has offered no large settlements in this mass tort. J&J is facing about 35,000 product liability filings over pelvic mesh, more than any of the other six manufacturers.

So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.

Prolene Mesh

Prolene Mesh

Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint.   Instead the company called the mesh “safe and effective” in its marketing efforts.

“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.

Cavness is seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages will also be allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.

The Plaintiff’s complaint says Dr. Teresa Kowalczyk was negligent in the care and treatment of her patient and failed to disclose the risks associated with the medical device. But what did the doctor actually know about the risks?

Dr. Kowalczyk, implanting physician

Dr. Kowalczyk, implanting physician

THE IMPLANT PHYSICIAN

Dr Teresa Kowalczyk was the Ob/Gyn who implanted Carol Cavness with the Prosima mesh on April 24, 2012. Jurors will have to decide if her failure to care for the patient was due to being ill-informed about the dangers of mesh or whether she practiced poorly.

Originally from Poland, she works in the underserved area of Greenville, Texas about 50 miles northeast of Dallas. Both Dr. Kowalczyk and her hospital, Hunt Regional Medical Center, are being sued by the Plaintiff for the care she received.

Dr. Kowalczyk began using the Prosima mesh in 2010. Previously she had used some mesh for pelvic organ repair made by American Medical Systems but generally she had rejected most meshes, instead relying on native tissue repair.

She appeared nervous. Her answers were precise and complete and spoken with a slight accent.

Prosima prototype

Prosima prototype

Sometime in 2010, the doctor met the sales rep for Ethicon products, Paul Quartz. She trusted him. They met once or twice a week. Sometimes he would bring lunch to the office. He got to know her staff.  He seemed to know about the Prosima Pelvic Floor Repair System.  Dr. Kowalczyk liked what she heard. Prosima didn’t have the long arms of the Prolift Pelvic mesh used for POP, it didn’t use trocars, stainless steel tubes to pass the mesh into place, and it was a much smaller mesh.

Dr. Kowalczyk liked to read all of the materials herself, she said and she didn’t remember if the sales rep was in the operating room when she implanted Ms. Cavness.  

David Matthews, Attorney for Cavness

David Matthews, Attorney for Cavness

Plaintiff attny. Matthews: “Is Paul Quartz why you first started using Prosima?”

Dr. K: “Yes. He said it was softer and promoted quick recovery.  He said any problems would be a technique issue, that any problems with Prosima are rare.”

Matthews: “Did he ever tell you the FDA was questioning Ethicon about the safety of Prosima?”

I don’t recall, she said. On cross examination, Dr. Kowalczyk said some practices don’t let the sales reps in. She tries to be nice to them.

Sales rep Quartz wanted to get the word out in Greenville so he prepared the invitations sent out to the community for a meet-and-greet luncheon to learn about the Prosima and other gynecological issues with Dr. Kowalczyk hosting the get-together.

“All surgical procedures involve risks,” said the brochure.

To encourage her acceptance of the Prosima, Paul Quartz gave Dr. K a study authored by Halina Zyczynski, at the University of Pittsburgh. One-Year Clinical outcomes After Prolapse Surgery with nonanchored mesh and vaginal support devices, Here,  which concluded “vaginal support, pelvic symptoms and sexual function improved at one year….” but the co-authors included David Robinson, and others working for Ethicon, directly or indirectly, as part of the Prosima Study Investigators.

The study says under “Performance” the inflammation is transient and that the mesh remained soft and pliable.

That was not what the FDA had concluded a year earlier. In a Safety Communication, the agency said a posterior repair with mesh did not represent added benefit to native tissue repair, and complications with POP (pelvic organ prolapse) mesh were “not rare.” Dr. Kowalczyk did not know that.

“Would that be important for you to know,” asked Matthews. She acknowledged it would.  The IFU (Instructions for Use) contained nothing under adverse reaction that would lead a surgeon to believe chronic permanent pain could result from a Prosima implant, or that it should not be used for a Grade 3 or 4 rectocele.  She admitted the IFU admitted none of those things.

Was she adequately warned about the risks of Prosima? No, she said.

 

Pelvic organs, FDA

Pelvic organs, FDA

SURGERY SCHEDULED

Ms. Cavness had first gone to Dr. Kowalczyk on April 23, 2012 after a trip to the emergency room with abdominal cramps two days earlier. The symptoms were abrupt and had been constant for about one week. She had a Grade 3 rectocele, one step away from the most serious, where the vaginal wall next to the rectum bulges out of the vagina. It was difficult to walk, Dr. Kowalczyk noted in a follow-up visit note.

The surgeon said Ms. Cavness was in a lot of pain but she wanted to go back to work.  Surgery was suggested, but Dr. Kowalczyk said she always encourages patients to ultimately to make their own decision.  The Plaintiff was a smoker and the doctor warned her that tissues have poorer healing due to smoking.  Lifting heavy items as an aircraft mechanic represented a risk of a recurrence.

Surgery done by Dr. Kowalczyk on April 24, 2012 included a Prosima mesh to reinforce a native tissue repair for added security.  Things improved for a few weeks but by June, Ms. Cavness returned crying with lower abdominal pain worse than before surgery, she said.

The doctor suspected the symptoms could indicate interstitial cystitis, or painful bladder syndrome. She never had the testing.

Eventually Dr. Kowalczyk referred Ms. Cavness to a pain doctor.

Today, what does Dr. Kowalczyk do for a Grade 3 rectocele, she was asked under direct examination.

“I do a native tissue repair,” she said.

Kat Gallagher, attorney for J&J

Kat Gallagher, attorney for J&J

Under cross-examination, attorney Kathleen Gallagher for Ethicon asked, “You would use the Prosima today if it was available, but for the legal environment and fear of being sued, you would use it, right?”

The Defense expected an affirmative. They did not get it.

“I would not use it,” said Dr. Kowalczyk looking defiant.  

 

LIFE CARE PLAN AND MEDICAL NEEDS

Absent from most of these pelvic mesh product liability trials has been an economic forecast of what the Plaintiff will need financially and medically to live the rest of her life.   The Linda Gross case against Ethicon’s Prolift mesh yielded $11.1 million, still the highest jury award against Ethicon. It had a life care plan.

An economist was brought into Cavness v. Ethicon. Dr. Thomas Meyer projected that her job as an aircraft mechanic would result in wages lost of upward of $935,460. The Plaintiff has been trying to return to work but her pay stubs show months of lost wages due to the pain of her medical condition.

The Plaintiff has had two mesh removal surgeries and has incurred medical expenses. She would need $573,383 worth of medical care over a 25-year period with adjusted growth of 1.25% a year, plus inflation, the economist said.  That does not account for any further deterioration of her condition.

A DAUGHTER’S CONCERN 

The day ended with testimony by Ms. Cavness’ daughter, Brandy. Married with three children she lives nearby in Campbell, Texas. Brandy had witnessed her mother change from a happy, vibrant, outgoing personality who loved her work as an airline mechanic to someone who watches TV all day.  Ms. Cavness no longer enjoys yard work, remodeling, family outings, and playing with her grandchildren. The family bought her an iPad to entertain her at home.

Vaginal spotting, discharge, UTI’s and pain are part of her life today. Two mesh removal surgeries with a Dr. Carley did not resolve the issue. Neither did a surgical repair with Dr. Phillippe Zimmern of Dallas.

“It’s a struggle for her to go to work every day. To be honest I don’t know how she does it,” said Brandy who described her pain as intense as childbirth.

“She’s sad and lonely. She has to ask for help in a lot of different things… She’s a strong woman (she starts tearing up her voice breaks up).  She has to ask for help,” said Brandy.

Her mom moved in with Brandy’s family last February. Ms. Cavness and her husband have subsequently divorced. There was not a lot for them to do together anymore, said Brandy.  #