Defense on Prosima's Low Complication Rate

Thanks to Courtroom View Network for access to Cavness v. Ethicon, underway in a Dallas courtroom.

[This coverage is prepared by your editor, who has sat in the courtroom for five pelvic mesh trials (C.R. Bard, Ethicon) and has witnessed three additional trials (Boston Scientific , Ethicon) via CVN feeds. Coverage is based on collective knowledge of the issues. Your reporter is not a lawyer. Additional comments are appreciated.]

Mesh News Desk, September 30, 2015 ~ The Defense began presenting its case late Tuesday afternoon, defending Ethicon, and its parent company, Johnson & Johnson, maker of the Prosima pelvic mesh used to treat pelvic floor prolapse.

Judge Ken Molberg, 95th Judicial District, TX

The trial is now in its seventh day before Judge Ken Molberg in the 95th District Court of Dallas, Texas.

First on the stand for the defense was Dr. Teresa Kowalczyk, the physician who implanted Prosima in Ms. Cavness in April 2012.

She, along with Ethicon, are the subject of this product liability, medical malpractice trial. The Plaintiffs hope to prove the Prosima was defective in its design and manufacture and in its instructions to the physician. Without adequate information, the doctor cannot provide a true informed consent to the patient. That quandary puts the doctor between a rock and a hard place – did she practice bad medicine or is she simply a pawn of reckless and aggressive marketing by the manufacturer?

Earlier in trial, under questioning by Plaintiffs’ attorneys, Dr. Kowalczyk told the jurors she would not have used the Prosima if she had knew what she has learned as a result of this litigation.

To rebut her damaging testimony, Defense played her deposition, recorded much before this trial when, presumably, she was still in the Prosima camp. She appeared to the jury via videotape.

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

Helen Kathryn Downs of Butler Snow for J&J/ Ethicon questioned her on tape.

Dr. Kowalczyk said Ms. Cavness was in intense pain when she first visited in April 2012 and she couldn’t point to any one point of pain.

“These are the same reactions you can have with a regular pelvic repair" said the doctor, referring to a non-mesh repair.” Around three to 10 percent of patients will have complications, she said.

There is some shrinkage of the mesh, the doctor admitted, but most complications can be easily managed without large expense.

Did the jury think the doctor was credible enough to rely on her opinion? Does the jury think Ethicon is credible and transparent with its physicians? In the Plaintiffs' case, Ethicon has been shown in this trial so far to omit many known risks of its product in the IFU (Instructions for Use) that doctors rely on deciding whether to use a product or how to inform their patients about risks.

Helen Downs asked, “Did you ever feel Paul Courts II (sales rep for Ethicon) gave you false information about the Prosima? “I don’t think so,” said Dr. Kowalczyk.

Earlier in this trial, Dr. Kowalczyk told jurors she was unaware of Ethicon’s discussions that the mesh was too stiff to use in the vagina and that another mesh, the UltraPro, was being developed as an alternative.

Dr. Kowalczyk added, it was important for her to see what Ethicon said about Prosima before she used it. She was provided information about a clinical study on Prosima by a sales rep for the company which encouraged her to use the product.

WHAT DR. KOWALCZYK WASN’T TOLD

Prosima for sale on ebay, Sept 21, 2015

On cross examination, Bill Blankenship for the Plaintiff interviewed Dr. Kowalczyk.

The sales rep had told her Prosima was safer than other meshes on the market and it had fewer complications. Rep Paul Courts said it was a very good product and he was considering using it for his own wife, she said.

Bill Blankenship, Lawyer, Dallas

Blankenship: “You expect J&J to provide fair and balanced information on its products don’t you?

Dr. K: “Yes.

Blankenship: “You would expect them to tell you if it was not appropriate for a condition or there were risk; you would expect to be told?

Dr. K: “Yes.

Blankenship: “If you knew Ethicon had decided to pull Prosima from the market in February 2012 because they didn’t want to do pending FDA studies, would you tell your patient about that?

Dr. K: “Yes.

Blankenship: “If you knew they were to pull it, would you use device on Carol Cavness?

Dr. K: “No.

Blankenship: “If you knew the FDA had ordered Ethicon to further study the device or remove it from the market, would you tell Carol Cavness about it?

Dr. K: “Yes and I would not have used it, she said.

Dr. Kowalczyk said the sales rep explained the mesh product was being pulled from the market because it was too expensive to test Prosima. Prosima, along with three other pelvic meshes, were quietly removed from the market in June 2012. In doing so, Ethicon was relieved of extensive and expensive post-market testing on how the meshes were performing in its recipients.

Blankenship: “If you knew the complications would be life-altering would you use it? No. “Would you tell her? "Yes.

Blankenship: “If you knew it would result in chronic pain which is not rare, would you tell Carol about it?" "Yes. "Would you use it?" "No."

Blankenship: “If you had been told Prosima posterior mesh does not provide any added benefit compared to traditional surgery without mesh would you tell Carol?" "Yes." "Would you use it?" "No."

Blankenship: “If you knew Ethicon’s own preceptor, Vince Lucente, MD would called it a “reckless product,” would you tell Carol? “Yes. “Would you use it? “No, I would not."

Blankenship: “If you knew in 2010, the first year at you used, a clinical trial using the same mesh (Prolene PS) was stopped (Prolift study see it here) because of complications would you tell Carol?” Yes. “Would you use on Carol? “No."

PAUL COURTS –TERRITORY ACCOUNT LEADER FOR ETHICON

Paul Courts was the sales representative who first introduced Ethicon’s Prosima mesh to Dr. Kowalczyk in 2010. The Prosima mesh was considered to be an innovation among pelvic floor meshes. It was smaller and didn’t have six anchor arms that are impossible to remove. It would substitute for the extremely large and complication-prone Prolift.

Attorney for the Plaintiff, Kevin Edwards asked whether Ethicon informed its own sales rep it was planning to decommercialize Prosima. Courts said he was contacted at some time after the implant of Ms. Cavness in April 2012.

Paul Courts II, Sales rep, Ethicon, from LinkedIn

Mr. Courts didn’t know what an FDA 522 order was (an order to study the product post-market) and he was unaware in early 2012 Ethicon’s strategic business team decided to pull the mesh from market by mid-2012.

Edwards asked the sales rep if he was present in the operating room when Ms. Cavness had her implant. Courts hesitated, then said "No."

Edwards: “Were there other occasions?" “Were there a lot?” “Yes." said Courts, referring to being present in the OR when mesh was implanted.

About Dr. Kowalczyk he said, “She wouldn’t make any decision without being 100 percent…she would ask me as much as she needed to ask me. She will go out and research and find everything she can find. She’s not one of the people you’re going to come in with, with half the information.”

Paul Courts said Dr. Kowalczyk was an extremely good surgeon, resourceful and skilled. She wanted to do what was best for her patients. She did her due diligence and would ask questions. She learned about implanting Ethicon through a company DVD and didn't go to the cadaver training. He estimated the doctor performed close to 50 Prosima implants between 2010 and 2012.

Courts was asked if there was anything in the IFU (Instructions for Use) about the permanency of this pelvic mesh and its potential for life-altering pain? Did Ethicon tell you about the cracking of Prolene? Did they tell you about the public health notification?

Courts said he had seen it but didn’t remember where. Did Ethicon give it to him? “They didn’t prevent me from having access it,” he said.

A Defense attorney asked Mr. Courts if the company hid information or was not forthcoming with information about the Prosima.

No, he said.

Dr. Jaime Sepulveda, urogynecologist for Defense

DAY 8 DEFENSE – Dr Sepulveda

Kat Gallagher, Ethicon attorney

Dr. Jaime Sepulveda, is a female pelvic medicine and reconstructive surgeon from South Florida. Originally from Puerto Rico, the doctor, in his mid-50’s, was brought to the courtroom as the second witness for the Defense in Cavness v. Ethicon. He spoke with a heavy accent that occasionally made it difficult to understand him as the camera is across the courtroom from the witness stand.

As he spoke to Ethicon attorney Kat Gallagher, he seemed pleasant and sincere.

Dr. Sepulveda and 25 other doctors started the subspecialty of urogynecology, he said, as a matter of introduction. He’s been practicing medicine for 26 years and in 1994, he opened the Miami Urogynecology Center.

Dr. Sepulveda first encountered Ethicon years ago to see sling procedures in a lab.

Rectocele, FDA

Knowing anatomy is first and foremost when doing surgical procedures and the opportunity to be trained in an Ethicon cadaver lab in France was an important part of his early education. Eventually the doctor says he started teaching for Ethicon at the cadaver labs where he was compensated at about $100,000 a year.

Kat Gallagher got the obvious question out of the way. How many hours had he spent on the case? He’s spent 150 hours, compensated at a rate of $500 an hour, or roughly $75,000.

She said to him, “I want to go through Anatomy 101. “I don’t think anyone who’s really qualified has done it."

Getting out of the witness chair, Dr. Sepulveda stood before a chart with a light pointer to show the jury the image of a rectocele, a condition where the rectum drops below the body. Pain can come on suddenly when tissues are injured by stress that then weaken causing the rectocele.

An airplane mechanic, Ms. Cavness reported lifting an 80 lb. object at work just before she went to the ER with pain in her abdominal area in April 2012.

Pain, ultimately, was the reason for her Prosima surgery.

Was Prosima the right decision, he was asked? Yes, he agreed.

Surgery with Prosima is superior to a native tissue repair alone, Dr. Sepulveda told the jury. You have a lower rate of recurrence when native tissue is reinforced with a polypropylene mesh implant, he said. That is in direct contradiction to the testimony by Dr. Michael Margolis for the Plaintiffs earlier this week. Dr. Margolis told jurors Ms Cavness' native tissue repair, the one that remains behind today, is doing fine.

Dr. Margolis also mentioned the downside of mesh that is stiff, like the Prosima. It does not adapt internally, especially in an area where there is a lot of movement. Dr Sepulveda disagreed – the mesh doesn’t shrink and cause vaginal shortening. “We haven’t seen it. Haven’t seen it in Ms. Cavness,” he said.

What about mesh degradation, one of the most common complaints about pelvic mesh. Did he see any of these issues with Ms. Cavness he was asked. " No."

Marcus Cary, MD study on Prosima prototype

Kat Gallagher asked, “Are the IFU instructions adequate when using Prosima?”

Dr. Sepulveda agreed, “Yes they are adequate.”

He held the Prosima in his hand. As to the explant surgery of the mesh, done by Dr. Carley, Dr. Sepulveda said the specimen was in multiple pieces, as we've heard.

Did Dr. Carley think he got it all? Yes, said the doctor. The idea there is mesh imbedded somewhere, that’s not true, he said, because of the length of the inserter.

After her implant, Ms. Cavness continued to have problems with pain.

“There were no issues with the mesh,” Dr. Sepulveda volunteered. #