The Launch of Prolift Pelvic Mesh – What the Company Knew
Budke Day Three –
The old adage is you don’t want to know how laws and sausage are made. As this trial is showing, that might extend to medical devices too.
In this third day of the defective product/ medical malpractice trial of Budke v. Ethicon, Dr. Becky Simpson, the plaintiffs continued to show the jury of 15 how a medical device is brought to market, despite the doubts about it safety and efficacy.
Attorneys for the Budke family are Adam Slater (Mazie Slater Katz and Freeman), Ben Anderson (Anderson Law) and Amy Gunn (Simon Law PC).
As she has many times before, Ethicon is represented by Christy Jones. Ethicon is the medical device division of Johnson & Johnson.
Scientist/ surgeon and Ethicon consultant, Axel Arnaud was presented to the jury in Camdenton, Missouri on videotape in the morning.
Thank you Mesh Warrior Foundation for the Injured for coverage support. A full transcript is available with a subscription to Mesh News Desk! Mesh-injured receive complimentary copies.
Dr. Arnaud was project leader of the team that brought the Prolift to market in March 2005. The Prolift was not perfect – it caused mesh erosions and scar plate formation which encouraged shrinkage of the mesh, chronic pain and infection as tissues contract and nerves are encapsulated.
Still cadaver clinics had shown the mesh was safe and effective. Anatomically at least, the tools packaged with the Prolift worked to deliver the plastic mesh adequately to the cadavers.
Prolift would be the largest mesh the company made used to hold up falling pelvic organs known as prolapse. Made of polypropylene it consisted of a body and six arms that would anchor permanently into a woman’s pelvic floor.
The Prolift System was the same mesh implanted in plaintiff Joan Budke. Her family contends it potentiated the infection which led to her death 16 months later.
For some reason removal of problematic mesh, as there was with Joan Budke, was never studied by the company, nor was the innovative kit itself studied complete with large stainless steel trocars or hooks and a cannula to thread the mesh into place through incisions in the vagina. No one in this case so far has been able to answer why the kit as a whole was never studied.
Arnaud, along with eight French scientists who made up the TVM group for Ethicon, knew mesh erosion was rather common – in about 5 to 15% of the implants. Not a problem he said. In most of the cases the treatment is just a resection of the small erosion, put in a couple of sutures in. “It’s a very minor secondary procedure,” he said.
What is important Arnaud said, is “not to have an excessive fibrotic reaction that is going to dramatically increase the retraction of the mesh. This is fortunately very unusual…..”
Arnaud said he was proud of his participation in the TVM project.
Despite the fact that the Prolift had launched, that didn’t stop the TVM group from continuing to seek improvements.
A June 2, 2006 minutes of experts concluded “Unmet needs continue to exist.”
French scientist Michel Cosson, the most experienced doctor on the use of polypropylene implants in women wrote in an email “Polypropylene mesh might not be improvable in terms of shrinkage. We may need a completely new material.”
By 2006, the Lightning Project used a different mesh, the UltraPro, not the Gynemesh PS with the hope that the new mesh would be partially absorbed by the body. The UltraPro was considered the most promising mesh for pelvic floor repair. Larger pore mesh, like the UltraPro, decreased fibrotic bridging and shrinkage leading to better tissue ingrowth.
Appearing to the jurors via videotape deposition was Scott Jones, a project director at Ethicon. Inside the company it was thought the latest innovation Prolift M+, made with Ultrapro, would have a lower complication rate. See 510K) fda document here.
Jones said, “We thought it might be more compliant with the vaginal tissue. It was a larger pore size and the mesh was more flexible and it moved more naturally. The vagina is a dynamic area and the mesh would accommodate that movement. The hope was that mesh might offer some different benefits.”
Had Ethicon offered training on how to handle a mesh erosion or exposure to manage erosions? “I don’t believe we’ve done that,” answered Jones.
Slater- Was removal difficult?
Jones – “I’d say it was a complicated procedure.”
He has been noted in this trial as the highest paid “preceptor” or trainer for industry to spread the word and get other doctors to jump on board of the Prolift train.
Dr. Vincent Lucente received funding from Ethicon through St. Luke’s Hospital in Allentown, Pa, where he worked. Slater produced 1099 forms showing company payments to Lucente as compensation for his job – professional education, lecturing, instructing cadaver labs, meeting with physicians and instructing them on operative technique.
Slater did the math. The tally- $1,709,000 and change.
Slater – “Is it your testimony that’s the total amount?”
Lucente – “Over a 12 year period, yes.”
Not only was he chief cheerleader for Prolift, but Dr. Vincente worked extensively with marketing. Shown a chain email, Lucente, bragged to mid-level executives in marketing how he had urge the editors of a medical bulletin to physicians to remove the word “experimental” referring to pelvic organ prolapse surgery involving a mesh kit. Inclusion of the word would discourage insurance coverage and scare off patients. See a WSJ article here.
Written by Dr. Anne Weber, a mesh critic, the American College of Obstetrics and Gynecology (ACOG) bulletin published in February 2007 said, “Given the limited data and frequent changes in the marketed products…the procedures should be considered experimental and patients should consent to surgery with that understanding.”
Medical Director David Robinson said in an email shown to the jury, “Your physician needs to understand we cannot be out on the forefront on this because it will only appear too self serving. Our work remains in the background. We do not have any letter that has been sent to the green journal (ACOG Journal) nor will there be one sent by Ethicon.”
Come to the rescue – Vincent Lucente.
“I believe the best defense is a great offense,” he wrote in an email to the marketing group. “This strong undercurrent fed by the anti mesh few but influential and very outspoken needs to be faced head on. I suggest a formal written appeal to ACOG to retract the bulletin be developed (ASAP) and signed by every physician in the country.. I am not worried as much by the medical legal aspect as I am by payors who love to use the term ‘experimental’ as a reason not to pay…BIG problem.”
ACOG later revised the bulletin. Lucente took the credit to his colleagues.
“Note: no futher use of the word experimental, well this one I am taking credit for .. I led the charge on this and never thought we would get a complete “replacement” of the earlier bulletin. This is a major victory! Vince.”
On videotape, Lucente explained that when talking to editors of the ACOG, the American College of Obstetricians and Gynecologists bulletin, he just pointed out that the word ‘experimental ‘was there and it was misleading.
“I did nothing more than that.”
Slater showed another in-house email from the doctor. After a marketing director said he was doing the ‘Happy dance” with news that ‘experimental’ would be removed from the bulletin, Lucente followed up, “It may be a good idea to get an email blast out to all the sales team about this “news.” With this and the new mesh no tellin how far we can run in 2008 and beyond!””
With the jury out of the room, it was time for more “housekeeping” to keep the case on track. Both sides talked about implanting physician, Dr. Becky Simpson and the fact that she stopped using Prolift as her implant of choice one year after Ms. Budke’s surgery.
David Ball, a local lawyer for Ethicon said to mention it to the jury was simply unfair. “Mr. Slater is prone to hyperbole here,” was one of many swings he took at Slater during the day. Judge Hass said “I will allow you to introduce a portion of that… but certain pages are out… that mention the Prolift M.
Doctors like Vince Lucente were recruited to drive sales for the company. In exchange for thousands in compensation, Paul Pirisi, Ethicon’ professional education manager, coordinated the training of surgeons who would also become preceptors and recruit other doctors into the Ethicon fold.
In his videotaped deposition, Pirisi was shown a cowboy and a lasso, an image of how the system worked.
“Success or failure often comes down to recruiting which is the responsibility of the rep. target the appropriate doctors for the country “Physicians who have the ability to drive business.” You have to sell these programs to your hospitals and physicians !!!!!!”
Professional education is one of the many tools you have in your bad to help drive your business (said the message to the sales reps and doctors).
This Afternoon- Implanting Physician Becky Simpson – Was She Fully Informed on the Prolift product?