J&J’s Prosima Pelvic Mesh – A Game Changer?
MND, September 24, 2015 ~ On this Day Four of the Cavness v Ethicon (Carol Cavness v. Kowalczyk et al., case # DC-14-04220) trial being heard before Judge Ken Molberg in a Dallas courtroom, William Gage, an attorney for Ethicon, had to do damage control to the testimony by an expert for the Plaintiff, Dr. Peggy Pence Wednesday.
THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THE LIVE FEED IN THE COURTROOM.
Dr. Pence is often called into testify for the injured in these cases because her expertise is in how to bring drugs and devices to market, and presumably, how not to.
Dr. Pence was calm, pleasant and concise in her language, often speaking to the jury directly to further dissect a point about U.S. Food and Drug Administration (FDA) regulations.
One day earlier, (See Day Three) Dr. Pence had outlined how there were two “no-go” points in bringing the Prosima to the market. Dr Marcus Carey, an Australian doctor, had sold the intellectual property rights to the company for millions if his study met certain benchmarks for safety and efficacy. It did not.
THE MARCUS STUDY
Under cross examination by attorney William Gage, for Defendant J&J, documents from the day earlier were revisited. Mr Gage would attempt to tell the rest of the story on the successes of Prosima.
In the Carey study, conducted by the doctor who would benefit from a positive outcome, after examining 95 patients who had been implanted with a prototype Prosima, its objective success rate (exam of the women to determine an anatomic fix) was 92 or 86 percent at 6 and 12 months, Mr. Gage pointed out.
Dr. Pence interjected that is correct but does not take into account the many patients were lost in follow-up. Gage moved to strike that comment as nonresponsive. Sustained, said Judge Molberg. (One has to wonder if jurors make a special mental note to remember the nugget of any objection).
Dr Pence had told jurors the day earlier that when a woman does not follow-up in a study, it generally indicates she is not having a good outcome. Gage continued.
The subjective success rate (filling out a questionnaire) was 91 and 86% at 6 and 12 months, he stated. Doctors in the study were concerned the “procedure would not provide enough support even with the vaginal support device,” was one of the key comments within the study among doctors who used the Prosima prototype.
That wasn’t an issue was it, asked and stated Mr. Gage at the same time. Can you answer that?
I can’t answer yes or no, Dr. Pence said.
(In sort of a mixed message to the jury, Mr. Gage told jurors Ms Cavness had a posterior colporrhaphy or native tissue repair in addition to the Prosima.)
Dr. Carey made some changes to the prototype Prosima during the course of the study. He made alterations in shape and to the procedure as he was moving toward completion of his study “Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device,” M. Carey, M. Slack, P. Higgs, Feb. 2008. See it here.
You weren’t critical of that, asked Mr. Gage referring to the alterations made to the Prosima.
“All accurate data is good data,” Dr. Pence reminded Gage with a smile.
Mr. Gage continued with the good news about the Prosima prototype outcomes.
Sexual dysfunction was reported by 58% of the women before the Prosima. After the implant was in the body for 12-months, that number declined to 23%. That’s more than a 100 percent improvement in sexual dysfunction! he asked and stated at the same time.
Going deep into the data, Mr. Gage questioned Dr. Pence’s statement that a lack of follow-up in study participants indicates a failure. Remember the Prosima data showed 15 women not examined last 12 months were considered objective failures creating a failure rate at 28.4%. If they had returned the failure rate would be 12.6%, insisted Mr. Gage.
“Don’t you think the jury should have heard that,” Gage asked rather aggressively.
Dr. Pence would not be shaken. She exudes confidence without being arrogant.
“The key when you are doing clinical trials, you have to look at the overall and include those who are lost to follow up,” she replied calmly turning to the jury. “As I said yesterday, the data speaks for itself.”
PROSIMA – A GAME CHANGER
The concept of the Prosima pelvic floor mesh was intended to be an improvement over the Prolift mesh, a large amount of polypropylene mesh with arms that would anchor deep in a woman’s pelvis. Prosima offered less mesh than the Prolift and less dissection. The concept didn’t turn out as expected.
Mr. Gage reminded the jury Ethicon could have marketed Prosima once it got FDA clearance in 2007. You can market it the next day, he said. Ethicon chose not to market it once it got FDA 510(k) approval. In fact, Prosima was held back from launch after it received FDA clearance. ( It was finally marketed in January 2010).
Didn’t that show the company was being careful, he the expert witness Pence.
Gage: “Ethicon went above and beyond the standard of the industry by conducting a study on live woman and waiting for a couple of years before marketing, wouldn’t you agree with that?”
Pence: “I’d say they complied with the standard at the time and it was a good thing to require study.”
Clearly, Pence said, they had disappointing results in the Marcus study and as a result, bad results would impact its acceptance in the market. That’s why they didn’t launch, she said firmly.
Mr. Gage showed company emails that showed the Prosima was being well received in the medical community. “Some preliminaruy results from doctors that have used Prosima have been very favorable and the results have looked good,” said an inner office email. Dr. Ahmet Bedestani, board certified female pelvic medicine surgeon from Louisiana, who was glowing in his praise.
“Prosima represents my central thought process. I cannot have this product fail. I have become identified by this and believe me there are many who would like nothing more than this product to not do well. …”I believe in my bones that this technology represents a quantum leap forward for the patients. 40% of my Bussiness [sic] is redos of other peoples surgery and let me just say it is scary out there. Prosima is a game changer and it is my mission to make sure everyone knows it.”