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Day 19 Linda Gross v. Ethicon: Medicine and Marketing

Dr. Miles Murphy, urologist, Ethicon consultant

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

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.

D19 lassoo your physicians who have the ability to drive businessRecruiting

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.”

D19 aaron kirkimo med affairs felt tier 2 and 3 docs less skilled lack the skil lset to use the trocar huge

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

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.”

D19 surgeon in training put both trocars thru the bladder of patient lucente to ciarocca

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.

D19 ethicon brought in docs with low skill set if we dont train them our competition will

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.

D19 marianne kaminski dir prof education could the preceptors influence yes they could

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

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 AuthorD19 asking vince lucente to be the author on literature already written

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 OpinionD19 what murphy had done in prep for the case saying he read arnaud deposition he signed it

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

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

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:

D19 devliery of products to meet revenue projections 2

Email from Piet Hinoul, Ethicon Med Dir

Email from Piet Hinoul, Ethicon Med Dir

Slater shows mesh curled to Dr. Murphy

Slater shows mesh curled to Dr. Murphy

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

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

14 Comments

  1. Carmel Berry says:

    Dysparunia following mesh placement. !! Yet in 2006 my specialist still couldnt ‘understand’ why I had such problems. They must have hidden it well.

  2. Melynda says:

    Speechless, yet again.

  3. MarieAnn says:

    I was in my 40s, in great shape, rode my bike several times a week, was a practicing nurse, had a loving, intimate relationship with my wonderful husband, three awesome kids. Life was good. Fall of 2009, all that changed when I was implanted with the unsafe prolift device for a low bladder, could hardly move my right leg when I awoke from anesthesia. After things went really wrong at 8 wks post-op, severe pain, couldn’t urinate, erosion into vaginal canal. The prolift trained doctor said he had to talk with the gynecare rep, he didn’t know why I was in such pain!? DUH!! Now he was the doctor and he was asking a sales person how to treat a patient? I wish I could put one in his private parts, without anesthesia! This is all just crap! If I’d just seen a picture of that prolift, I would have run! They are idiots to think that belongs in a woman’s pelvis! I could hardly walk, felt like something was holding my legs back, like sitting on glass. Just pure torture! I’ve had 6 extra surgeries, punctured bladder, stent in ureter, 4 units of blood, almost died with major removal of infected mesh arms deep in groins. Had Many repairs, painful procedures that are very hard to recover from and yes, many indwelling catheters! Will this ever end? All this suffering so greedy people could line their pockets with blood money. I will never be the same.

  4. Jim says:

    What a crock, they screwed up now they don’t to for their mistake.

  5. Linda Dodson says:

    What I wouldn’t give to post ALL of my 27-page complaint letter to the FDA, dated February 22, 2007, and the follow-up investigation conducted by the FDA. The FDA spent about a week at Ehticon, conducting their investigation as a result of my complaint letter. I have a copy of the investigative report and Ethicon was cited.

    Quoting directly from my letter to the FDA against Ethicon, “I am alleging that Ethicon, Inc. has violated their own Code of Ethics in their statements of “It is our fundamental responsibility to place the well-being of the patient first by appropriately balancing risks and benefits and to ensure that the best interests of patients and physicians who use our products receive utmost consideration. It is our responsibility to help ensure access to our products to our products in the communities where we develop them. It is our responsibility to apply Credo-based values and judgment regarding the design, conduct, analysis and interpretation of clinical studies and results. It is our responsibility to ensure all Company-based, medically relevant product information is fair and balanced, accurate and comprehensive, to enable well-informed risk-benefit assessments about our products. It is our responsibility to understand differences in values across cultures and to adapt our behaviors in keeping with our ethical concerns”. Ethicon has failed me as a consumer, and I am a victim of their products failure to meet its performance standards, and they have lied to me and I continue to suffer both physically and mentally from their medical device and their unethical conduct.

    I DO NOT BELIEVE that Ethicon followed through in upholding their own code of ethics. As I have stated many times, IT IS ALL ABOUT GREED AND $$$$$. Very sad that so many women have been butchered by synthetic mesh material. I believe the FDA is just as guilty as the manufacturer’s of these ineffective and NO scientific evidence that they are safe and effective products.

    • Betty says:

      I agree 100%. I had asked if we could sue the FDA. Not a very good option from what I was told. They are just as responsible and bought out by “special interests” as well. Just disgusting.

  6. Betty says:

    I really hope the jury can see the significance of Dr. Murphy’s so called “expertise”. That he could go over documents that showed differences in what he thinks he knows and just disregard them – shows that he is arrogant, and feels his knowledge is superior. He admits that this product could cause a lifetime of harm, yet doesn’t see a big problem with that either. To say that erosion is an easily fixed problem, just use estrogen cream is an insult to anyone of us thousands who have been injured and eroded. His testimony flies in the face of the defence attorneys earlier questions trying to pinpoint the problem on Linda. She should have known these complications could happen, in spite of the fact that Dr. Murphy considers them minor. What a crock, indeed!

  7. Linda Dodson says:

    More information cited in my letter to the FDA, dated February 22, 2007 that supports, in my opinion, that the FDA DID NOT do their job in protecting the consumer.

    “As a consumer and private citizen, who can I trust to ensure the responsible regulatory agency is going to perform their job in protecting me and other innocent people from harmful medical devices? The consumer cannot rely on the overzealous manufacturers, sales representatives, physicians, and hospitals to protect us, because they are making money and increasing their revenue and allowing innocent people to suffer, both physically and mentally from harmful medical devices that should be banned from the market.”

    “After reading my complaint, you will have a better understanding why I have concluded the FDA cannot and must not rely on any manufacturer that sells these same and/or similar synthetic mesh materials for its intended use in women’s pelvic floor area’s for pelvic organ prolapse problems. I have provided you with clear evidence, of at least one company that has violated the FDA’s regulation of unethical business practices on reporting of adverse events. Based on this evidence, I would not rely upon Ethicon to act responsibly by issuing their own recall of their product due to their own evidence of deception in reporting adverse events.”

    “The FDA must investigate and take into consideration from whom and what factors would be considered for determining whether or not the synthetic mesh material has a malfunction and/or improper or inadequate design within the device family, and it fails to perform in accordance with the manufacturers labeling and marketing for it’s intended use? Will it be suggestions of any statement of words, design, device or any combination thereof, or the extent to which the labeling or advertising fails to reveal material facts in relationship to relevant warnings, precautions, side effects and any contraindications when a reasonable consumer reading the manufacturers labeling is misleading to the true use, safety and effectiveness of the manufacturers medical device? What is the precise definition of mesh erosion? how do you categorize and define “Serious injury” when a patient presents with very serious health problems, and have to have repeated surgeries in order to maintain bodily function, as a result of mesh erosion? Will it be defined as to the size of the mesh erosion? Will it be defined as to how many trips the patient goes to the physicians’ office to have mesh excised? Will it be defined as to how many women have had mesh erode into the bladder, urethra, bowel area and/or any other body part that separates from the initial surgical placement of the mesh material? Also please take into consideration the number of fistulas as women are presenting with. I am providing you with clear evidence from Ethicon and their contradiction of fistulas on what is printed on their brochure, titled “Get the Facts, Be Informed, Make Your Best Decision”, and their web site http://www.gynecare and what they have reported on some of their adverse events reports submitted to the FDA.”

  8. Linda Dodson says:

    Continued…..I’m on a roll and still outraged to this day about what Ethicon knew and when they knew. In my opinion, from the very beginning.

    “Based upon my own findings, after reading the published literature, you are going to be very challenged to fina a “Medical Professional” who you can rely uppon for the most accurate and truthful opinions with truthful clinical findings. There are too many published reports with varying degrees of opinion on the use, safety and effectives of mesh material. Also, you must take into consideration the relationship a physician may have in promoting one companies mesh material over another company, and if there is a conflict of interest with the physician and the companies’ product they use.”

    “The first person I would contact is Dr. Joel S. Lippman, former vice president at two Johnson & Johnson subsidiaries, including Ethicon, Inc. Dr. Lippman has filed a lawsuit alleging he was unlawfully terminated on May 15, 2006 because he repeatedly complained about product safety problems and urged several to be recalled or not launched. I would suggest googling Dr. Lippman’s name and read some of the articles that have been published about his termination from Ethicon and his allegations.”

    “Dr. Lippman was Ethicon’s Chief Medical Officer, and if I’m not mistaken, he was directly responsible for the synthetic mesh materials.

    “There are several doctors’ who have claimed recognition as leaders in this field. One is Dr. Vincent Lucente. You can do a google search, and you’ll find a lot of information about him. Look for the news article that was published on April 28, 2003, “GYNECARE Introduces First and Only Polypropylene Mesh Indicated Specifically for Pelvic Floor Repair”. It states “GYNECARE, the women’s health division of Ethicon, Inc., has introduced GYNECARE GYNEMESH PS, the first polypropylene mesh support material for female pelvic floor repair. The lightweight material offers permanent yet soft and supple support in a variety of applications including, cystocele, recetocele, and vaginal suspension”. Please notice the word “Permanent” support. It further states “Women are living longer and outliving their tissue,” said Vicent Lucente, M.D., a urogynecologist at St. Luke’s Hospital, Allentown, PA. The challenge has been that never before have we had a material that was designed to combine permanent support with the softness and pliability needed in vaginal reconstructive surgery. I beliee that GYNEMESH PS offers the pelvic floor surgeon an excellent combination of these qualities.” I have Gynemesh PS in me and it did not offer “permanent support.” This article was published in 2003, and I wonder if Dr. Lucente still stands by his opinion of “Permanent support”?

    I also, at that time of my research, came across a report written by the FDA that stated their system was broken. In response to this, I wrote in my letter to the FDA “I do applaud the FDA in recognizing your system is broken and taking the necessary action to correct it, and as stated in the report, “It’s going to take years to develop a new system that’s more in line with new technology.” However, in the mean time, when you are faced with a complaint that rings to your attention some serious questions on the continued use, safety and effectiveness of a medical device, and the serious health hazard risk it poses to the general population (women), how do you plan on responding to it?”

    The FDA continued to ignore this problem and after the 2008 Notification to Hospital’s and Doctor’s, who were already aware of this problem, I sat down and it took me over a week to compile, from their own database of adverse events, a fifty plus page document, listing the manufacturer’s, number of events and outcomes, etc., and it took them until July 2011 to come up with a plan of action.

    After speaking at the FDA meeting in September 2011, I had a Doctor from the FDA meeting come up to me after the meeting on Friday evening that after receiving that fifty something page email that they took it to their superiors and a team was formed to study what I brought to their attention. This person said if it had not been for that email they would not be having the meeting that week.

    I know that there have been a lot of people that have been very pro-active in getting the FDA’s attention, and I applaud each and everyone that has taken a stand to stand up for the rights of the consumer. IF not for everyone working together a a collective group, we would not be where we are today.

    When I first began my journey after having synthetic mesh placed in my body, without my full knowledge and consent, I had no idea just how BIG the problems were. My research took many month’s and a lot of time away from my family and grandchildren. I did all this research in pain. I told my family if I died for them to please have an autopsy performed on me. I did have the cystocele mesh removed and I continue to have problems with the rectocele. Due to health problems, I have had to cancel to trips to CA to see Dr. Raz. I am having a colonoscopy on Monday and if my Gastro Dr cannot find anything, then I plan on making and keeping my next appointment with Dr. Raz. My sweet sister, Brenda Jones, had surgery at UCLA and Dr. Raz performed it. She had nothing but incredible things to say about him and his staff.

    • Dawn brown says:

      I love Brenda !:) She was the one who pushed me to see Dr. Raz…. I ended up seeing Dr. Larissa Rodriguez who trained under him… I loved him but I could not take the pain any longer. I saw her 3 months sooner. Linda , thank you so much for all your hard work and dedication to mesh. Thank you for opening eyes to our pain. I pray nightly for you to get out there to Dr. Raz and have all of yours removed. What a difference it will make in you. I am feeling great.. Not my old self great yet… But working at it. This is a roller coaster ride back to health… It nearly killed me , but I am a survivor and will fight to have ALL mesh recalled or at least properly tested. Everyone should be told the side effects. Human rights

  9. Sea says:

    Frankly, I never considered my body to become a “marketing tool” for any company, doctor or hospital ….They knew the problems from the beginning ….and went ahead anyway with doctors of low grades…and yet came up with a problem solver that didn’t work either …Terrible ….

  10. D says:

    Unfortunately they didn’t care. It’s going to get worse once they lump us all together

  11. Suzette D says:

    I have suffered in silence for years. Thank you Jane for giving us a voice even if I sat at the sidelines over the years. This article hit home. Literally! I was implanted with mesh in 2010 without my knowledge or consent. Upon waking from surgery, I was told he used mesh but was made to sound minimal. For 9 months I followed everything I was told to do including pelvic floor PT at mt suggestion and desperation to be well again. Each visit the intense pain, inability to urinate, etc was noted in my chart. Mesh was never mentioned as a possible reason for the new onset of problems. At 9 months this surgeon left the practice and moved to Florida. He promised me I would always be his patient and was a phone call away. In the interim, I sought another opinion. I had been referred to none other than Dr. Murphy!!! He didn’t he do an internal exam. Instead he touched the inside of my leg with the pointed end of a cotton swab. I jumped. I would have jumped at anything in those days as my pain was so intense. His response to that was I had fibromyalgia!! He told me to dress. In disbelief, I said “I don’t like pain, but don’t you want to exam me to know where my pain is located?” He replied “meet me in his office” where he proceeded to recommend several doctors for pain management!! Several months later, a mesh commercial came on the TV. My husband said to me “that’s your problem”. I didn’t want to believe he could be right. I had convinced myself this pain was in my head but had already decided to see an old gyn that spring. She examined me and immediately attributed the pain to where the mesh was attached inside. I called the surgeon, now in Florida, several times. No call back. I pleaded with his staff…”he said I could always call”. I slowly realized, I had foolishly trusted this man with my life, I was not imagining this pain, it was very real and there are a lot of misguided medical professionals in this world. While it is not in my nature, if I could go after the surgeon who implanted me with not one BUT TWO MESHES and others like Murphy, who have injured women permanently, I would! Some how they are exempt of accountibilty. In 2013 I had a 9 hour explant surgery. Six months later, a surgery for residual pain that resulted in a pelvic floor replacement as my pelvic floor had completely eroded. Had we not pursued the pain, I would have found myself in a life threatening position. Three years later the pain continues albeit less than those first three years. I have an appointment at NYU next week to discuss repairing my bladder with my own tissue and perhaps addressing pain depending on the risks. This surgeon has come as a recommendation from Head of Urology at Johns Hopkins where my sister is a nurse, teaches and is pursuing her doctorate. No more going on my own instincts. It has taken me this long to get the courage to consider another surgery and revisit this terrible experience. It is so disheartening that mesh implants continue to this day and doctors like Murphy play god with our bodies.

    • Jane Akre says:

      Thank you Suzette. Good luck with your new appointment. I hope the doctor listens. ACell was mentioned by one doc for use to treat a bladder injury, ,,,don’t know more.

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