Day 19 Linda Gross v. Ethicon: Medicine and Marketing

Dr. Miles Murphy, urologist, Ethicon consultant

Mesh Medical Device News Desk, February 7, 2013 ~ On this Day 19 of the Linda Gross v. Ethicon trial, the importance of marketing to Ethicon was made clear through internal documents. First, second and third tiers of doctors were brought in for training and not everyone was "getting it," that is how to use the innovative trocars to pierce the groin and deliver the polypropylene mesh to a woman's pelvic floor.

That didn't slow the march toward a 2005 launch of the Prolift.

In this Day 19, Dr. Miles Murphy was brought to the stand for a third day to be questioned by plaintiff attorney, Adam Slater. Dr. Murphy, 43, is a urogynecologist who, in 2004, formed the Institute for Female Pelvic Medicine with Dr. Vincent R. Lucente, who is credited as being the first doctor to ever use a Prolift mesh and procedure in the U.S.

Dr. Vincent R. Lucente, first doc to use Prolift

Marketing Money and Medicine

Through a series of emails from inside the company, Slater showed Dr. Murphy and the jury the importance of marketing.

Though he had his own private practice, Dr. Murphy was involved with Ethicon, a division of Johnson & Johnson, as an instructor to other doctors in various mesh techniques. He could not remember specifically if he had ever taught the Prolift technique, usually done with a cadaver over a weekend session with recruited doctors as the audience.

The commercialization of Prolift in March 2005 (without FDA approval or notification) was important even up to the level of Dr. Piet Hinoul, Medical Affairs Director WorldWide for Ethicon.

Recruiting

The sales representative would be charged with "targeting" the doctors who would be the best candidates to "drive business."

Sales reps had to sell not only to physicians but to hospitals and facilities that would be users. The sales team was encouraged to follow up with sales calls and even go into the operating room with doctors.

"Be available" said the professional education. 'Recruiting is the main responsibility of the rep," said a Power Point presentation with a cowboy lassoing icon.

In an October 7, 2004 email, Giselle Bonet of marketing announced there were additional funds for Gynemesh preceptorships. Doctors like Miles Murphy were "preceptors," recruited to share their knowledge, train and influence other doctors to use the new device.

Sales was told to recruit three physicians to be preceptors all in preparation of "a successful launch of our next generation pelvic floor product in Q1."

In an email written by Dr. Hinoul, to "Dear Friends" within the company, it refers to the "take away messages" from two meetings he attended with other doctors. He felt the "commercial spin" should focus on both the non-mesh users as well as Prolift users... to grow the market."

But the problem was the lower tier doctors were not learning as fast as Tier One top docs recruited to attend these learning sessions. In a company email, they felt the lower tier docs both don't have the "skill set to use the trocar/cannula system of Prolift. They felt that the lower tier docs both don't have the anatomic knowledge or the surgical skills to use these tools. Consequently they opt for the devices that allow them to more comfortably work in areas that they have at least a modicum of anatomic knowledge/comfort."

Prolift, Medtech Marketing

Doctors liked the sound of "tension-free" even though, as one company email said, "despite the fact that most do not understand it." Tension-free was a marketing "concept" that the company "owned."

Slater to Murphy: "Despite the fact that most doctors are not taking to it? Couldn't that cause a lifetime of pain and dyspareunia?"

Dr. Murphy: 'It's possible."

In fact in one instance, a doctor in training in Lucente's office put both trocars through the bladder during pelvic prolapse surgery. Dr. Vincent Lucente, an early recruit of Ethicon, said in an email to Research & Development's Scott Ciarocca "Missed the F*kin urethers by millimeters $%&* try and imagine how pissed off I was!"

He writes in the same email "surgeon selection is key to keep the complication rate down."

Training was not going entirely well. The Tier One doctors were not confident that doctors with a lower skill set would be successful in implanting Prolift. In an email by Tim Sweatt June 27, 2006, one month before Linda Gross had her implant.

Writing to Giselle Bonet (marketing) about "Training Needs" he writes he would like to see a cadaver lab in the morning for slings and one in the afternoon for Prolift. "Too often we send surgeons to train on Prolift who in reality should only use Gynemesh at this time, but they want to train and if we don't our competition will train them."

The skill set would involve multiple arms in the pre-cut Prolift implanted with trocar tools versus the flat sheet of Gynemesh PS that had previously been used.

Marianne Kaminski, Dir. Professional Ed. Ethicon

Slater showed the jury a videotaped deposition clip of the Director of Professional Education at Ethicon, Marianne Kaminski.

“Could the preceptors influence, yes they could," she said in response to a question.

Teaching Tools

Slater and Murphy

Doctors and preceptors would be trained using citations of scientific articles. Slater asked Dr. Murphy if was important that the presentation be "fair and balanced?", in other words presenting both sides of the procedure and product.

"Yes, that would be important," he said.

Going through one scientific paper after another, Slater showed how the company would cherry pick information and leave out the least favorable information. When a prolapse recurrence rate using native tissue showed 29-40%, for example (Olsen), the Power Point left out that that the recurrence involved not just pelvic organ prolapse (POP) repairs but also stress urinary incontinence (SUI) repairs- essentially comparing different forms of prolapse, not the ones that would be treated with Prolift.

"That's a bit of a mistake there," agreed Dr. Murphy referring to the citation.

A mesh exposure rate of 9% in the Ethicon Power Point was identified as 15.4% by a plaintiff expert in this case. "I wasn't aware of that," said Dr. Murphy. "You always want the data to be as accurate as possible."

Ethicon as Author

In order to publish, Ethicon would write articles and ask doctors to be lead authors. In an email chain dated April 2012 to Dr. Vincent Lucente, Judi Gauld, Clinical Affairs Dir. Ethicon UK asks him," We are planning on submitting the Prolift 3 year study to AUGS. Would you like to be the author on it?” In the followup email, Dr. Lucente said yes, he would be honored to be lead author.

Dr. Murphy was shown the wording from his own clinic, Institute for Female Pelvic Medicine, and how it reflected verbatim what appeared in the Prolift literature.

Dr. Lucente also began a patient registry in 2007, according to Ethicon employee Judi Gauld in her deposition. Dr. Lucente and a doctor in training went to Ethicon to obtain funding for the project. His practice partner, Dr. Murphy didn't know of the registry the time of his deposition last November.

Slater showed a graphic of the changes Ethicon's top management made to an article by Dr. Daniel Altman before publication in the New England Journal of Medicine. Dr. Altman was told that having medical devices go through a more rigorous FDA review than medical devices would slow innovation.

"In general the more data you have, the better off you're going to be," Dr. Murphy concluded.

Expert Opinion

Concluding with Dr. Murphy, Adam Slater reminded him that his opinion was an expert opinion that is supposed to be supported by evidence in the case.

Last November, Dr. Murphy signed off that he had reviewed the 600-page deposition of Dr. Axel Arnaud, a French researcher critical to the development of Prolift. But on the stand, Dr. Murphy said he spent 15 minutes giving a cursory review of the deposition.

Slater: "You couldn't point to one thing of significance to support your expert opinion right? How did that further support your opinions?"

Dr. Murphy: "It didn't change my opinion."

Ethicon attorney, Christy Jones

On Cross Examination, Christy Jones asked Dr. Murphy if it was a good thing to have industry-sponsored studies?

On one hand you get upset if there are no studies, "on the other hand you try to denigrate those studies because they are compensated to do those studies," he answered.

In terms of mesh complications, Jones asked and Dr. Murphy answered "I'd consider mesh erosion in the vast majority of cases an easily treated complication."

She established that Dr. Murphy didn't mean to trivialize the IFU as "silly," something he said the day before when he answered that most skilled surgeons rely on their experience not on the Instructions For Use.

"I didn’t mean to trivialize the IFU," he said apologetically. "I was simply trying to explain that in the hands of a surgeon as the IFU says, who are familiar with pelvic reconstructive surgery and familiar with surgical mesh, it's not a big part of what I rely on in terms of doing a procedure well. I rely on four years of medical school, four years of residency and all the training in gynecologic pelvic surgery. “

Jones: "Did you feel it necessary to spend couple thousands of hours to review each email to determine whether or not it was a safe and effective product?"

Murphy: "I did not. Because I was basing that on my extensive knowledge of medicine, surgery and procedures used to treat it. I've had very much experience in prolapse."

Jones: "Did any of the documents that counsel showed you change any of your opinions?"

Murphy: "No, they did not."

As the day concluded just after noon on Thursday, Slater came back to ask about the ultrasound procedure Dr. Murphy said he doesn't use in his practice. At the same time he reminded the jury of the more than 10,000 women who have been injured by transvaginal mesh.

Dr. Shlomo Raz

Slater: "You know Dr. Shlomo Raz who has done over 450 mesh removal surgeries, he's done it using ultrsound."

Objection, beyond the scope, said Jones.

Slater: " He he said it's clinically useless to use ultrasound" referring to an earlier testimony by Dr. Murphy. Slater continued. "Do you know sir every single time he removes mesh he did a protocol of ultrasound to see where the mesh is to guide his surgery?"

Murphy: 'No, I didn’t know that!!"

Slater: "Are you going to try and learn about that to better treat your patients?"

Objection!

Additional images from today:

Email from Piet Hinoul, Ethicon Med Dir

Slater shows mesh curled to Dr. Murphy

Dr. Murphy is leery of doing Prolift on young women who are sexually active.