Day 18: Linda Gross v. Ethicon Surgeon Says Prolift Warnings Were Adequate
February 6, 2013 ~ On this Day 18 of the Linda Gross v. Ethicon trial, the defense team brought Dr. Miles Murphy, 42, to the stand for a second day. His testimony actually started Tuesday afternoon when attorneys for Linda Gross concluded her case.
Dr. Murphy is a urogynecologist practicing in Pennsylvania. He has worked for Ethicon as a consultant and in training other doctors in the use of Prolift mesh, the product Ms. Gross was implanted with in July 2006.
Thanks to Courtroom View Network for access to this trial!
Christy Jones of Butler, Snow first established that Dr. Murphy was not there to discuss Linda Gross specifically. He affirmed that even though his testimony directly related to the product used on Ms. Gross in July 2006.
Dr. Murphy then went through some rather graphic slides of a Prolift procedure. (Any image shown here has been edited.)
Unlike the animation he showed the jury yesterday to explain the difference between the various prolapse surgeries and abdominal versus vaginal procedures, these images showed the cannulas or tubes inserted into the body to deliver the mesh via trocars, or a hollow metal instruments that plunge into groin tissue just outside the vagina.
At one point the doctor in the Ethicon training film is shown rocking the tools back and forth in the essentially blind procedure that places the Prolift, using the instruments to feel the correct placement.
Jones asked if this so called “blind procedure” is dangerous to the woman?
Murphy: ” I would respond there are sections of the procedure that, for lack of a better term, are “blind.” That doesn’t mean the surgeon shouldn’t know at all times where the device is and where the surrounding anatomy is.”
Jones: ‘Is there anything unusual about the Prolift procedure?”
When the mesh was shown pulled out of the buttocks Jones asked if there was any roping or folding of the mesh apparent?
Dr. Murphy said there was no “roping” and in fact, he said he had never heard of that term, (roping is a term made up for this….he began to say).
DATA in 2006
Showing slides of the data comparing native tissue repair with a mesh repair, Dr. Murphy said “There seemed to be evidence that mesh repair would provide a more durable anatomic repair.”
Prolift had higher anatomic cure rates, he said. And when compared to native tissue repair, Dr. Murphy said mesh is much more likely to provide a lasting repair. In a study by Altman, the anatomic cure of 90% with mesh was compared to the 55% with native tissue repair, something Dr. Murphy called statistically significant.
Dr. Murphy also refuted the “clean-contaminated” theory of placing mesh transvaginally.
“Theoretically it might be but that has not been proven in studies I know,” he told Christy Jones.
Looking at the rate of dyspareunia, or pelvic pain associated with sex, Jones showed Dr. Murphy a study, Does Prolift cause Dyspareunia?”
Unfortunately the doctor said all sorts of pelvic surgery can result in pelvic pain. He pointed to a several different types of repair, that resulted in similar dyspareunia rates post-op ranging from 14 to 19% when comparing native tissue with mesh repairs.
It tells us there is no different rate of dyspareunia with any type of reconstructive surgery, said the urogynecologist.
Jones: ” Is dyspareunia a risk associated with any prolapse surgery? Is pelvic pain a risk assoc with any surgery to repair prolapse?
Murphy: ” Unfortunately it is.”
Murphy said a patient experiencing mesh exposure or erosion may be unaware or asymptomatic. As a treatment, you can use estrogen cream or trim the mesh he suggested.
Jones: ” Could it take more than one procedure to remove the mesh?
Murphy: “After excising most mesh you never have to go in again; maybe twice unless they were diabetic”
Jones: ” What is your guess as to the average exposure rate?
Murphy: “As I mentioned before I’m part of a systematic review group that did a large review of all of the studies. They came up with a range of about zero to 25% with an average of 10 percent erosion rate.”
Jones: “In 2006, was that information about erosion in the IFU?
Murphy: “It was.”
IFU, Instructions For Use
Christy Jones asked if he feels the IFU for Prolift in 2005 was adequate in its warning to doctors about the adverse events associated with Prolift?
A failure-to-warn is one important issue in this defective product case.
The IFU includes the risks of Prolift, Dr. Murphy agreed. Besides he says, a urologist shouldn’t rely solely on the IFU.
“Not at all. It is certainly important piece of information but if that’s all you relying on as a surgeon that’s a sad statement. You want to have gone to lectures, assist in surgeries, go to meetings where you talk to colleagues potentially all over the world. There are all sorts of way to gather information rather than the IFU that comes in each package,” said Dr. Murphy.
And Jones asked based upon his training and experience “Was the Prolift a safe and effective device to treat prolapse in 2006?”
Murphy: “It was.”
Jones: “Was the Prolift in 2006 an important option for women?
AFTERNOON CROSS EXAM
By the afternoon, the agreeable back and forth banter of Jones and Murphy was replaced by a contentious exchange between Adam Slater and Miles Murphy with the two often stepping on each other. Jones had already established that Dr. Murphy occasionally worked for Ethicon as a paid consultant and taught other doctors about the Prolift procedure.
Slater pushed further after establishing Dr. Murphy is at Abington Memorial Hospital where he is the chief of a section where he is the only doctor.
Dr. Murphy told the jury he is being compensated $400 an hour and $4,000 for every day he testifies.
“You reviewed documents in 2011? And you’re a consultant for Bard, Coloplast and Johnson & Johnson? Correct, Murphy said.
Slater established that Murphy and his partner Dr. Vincent R. Lucente socialized and attended parties with Ethicon executives over the past nine years.
Murphy:”What do you mean by party?”
Slater: “You don’t know what a party is?”
He and Dr. Lucente attended gatherings and had a professional relationship with the people of Ethicon. The doctor agreed.
ARE YOU CREDIBLE?
In preparation for the October 2012 report he wrote and submitted on behalf of Ethicon in the case of Linda Gross v.Ethicon, , Dr. Murphy told the jury he didn’t read company internal emails and didn’t see any taped depositions of the Medical Affairs directors or top executives for the company.
Slater: “You never looked at Charlotte Owens transcript? Do you know who she is? (former medical affairs dir. Ethicon)
Murphy: “No, not that I recall.”
Slater: “Sean O’Bryan, Scott Ciarocca?”
Murphy: “Not that I recall.”
Slater: “At the time of your deposition you had not read any depositions of anyone inside J & J or Ethicon and didn’t know what Ethicon had relied on to market Prolift?”
Murphy: “Correct. I was writing on Prolift not Medical Affairs.”
Slater: “Do you think it’s important for an expert to want to review all the important information; carefully review every single important document?”
Would you agree it’s critical for an expert to have an accurate and critical understanding of what the documents said?
Murphy: “I think the more information you have about something the better off you’re going to be.”
Slater went through a laundry list of what else Dr. Murphy did not understand or review before he formed his opinion this case – the French TVM study on mesh shrinkage; he didn’t read the Prolift Clinical Report; the design history for Prolift; the results from the different centers testing the TVM (transvaginal mesh) procedure. He didn’t read any transcripts of Ethicon employees, including two medical directors; or the underlying data on any mesh study.
At his deposition Dr. Murphy thought if something was important he assumed Slater would have provided him with the document.
NATIVE TISSUE v. PROLIFT
Slater presented Dr. Murphy with information he did know and authored in discussing the field of urogynecology with other surgeons. In November 2008, his publication compared the use of native tissue repair to mesh.
“There are uncertain tradeoffs with its use,” he wrote referring to synthetic mesh. It is “a risk that does not exist with native tissue repairs.”
Slater: “You’re saying in November 2008 it’s important for patients to know long-term data?
“Yes,” said the doctor.
Dr. Murphy agreed there is a lack of long-term data on all pelvic reconstructive surgery and he recommended patients be informed about that lapse.
JUST REMOVE THE MESH
Dyspareunia or a painful pelvic region especially during sex can be treated depending on what is causing it, Slater asked and Dr. Murphy agreed.
Slater: “When dyspareunia is caused by mesh that’s imbedded in a woman’s pelvis and the mesh is inciting that pain and the treatment to get the mesh out is not effective and not safe, that is a serious problem right?”
Murphy: ‘I would agree with you. Another form is native tissue repair and the potential for dyspareunia that does not resolve is there as well.”
Slater: “Scarring in the body will soften and not be painful over time?
Murphy: “I don’t agree with that.
Slater: “If there is scar tissue embedded in with mesh and leading to dyspareunia for many women there is no good treatment right?
Murphy: “No, you can take out the mesh.”
Slater: “For some women that is virtually impossible and can be catastrophic trying to get it out, right?”
Murphy: “I don’t necessarily agree with that.”
WHAT SHOULD BE IN IFU?
Slater again tried to established what Dr. Murphy thought was important enough information to be in the Instructions for Use, or product insert. The doctor said from a legal stand point it may be important but from a medical standpoint it made no difference to him. Dr. Murphy said he made no effort to find out what importance the IFU is to other surgeons.
Since Dr. Murphy did not read internal company emails he was shown one from David Robinson, the Medical Affairs Director of Ethicon May 3, 2006. “Suzette needs Prolift help.”
In the email, a surgeon, Suzette, reminded him she attended the Prolift roundtable discussion in New Jersey in December 2005 (where surgeons are brought in to share their experiences about Prolift). She reports she had a Prolift problem – a young woman in her mid 40s who was sexually active had dyspareunia and pain after a Prolift implant.
The doctor was concerned about pain at the attachment sites. A doctor considered “experienced” enough to be invited to an Ethicon roundtable now asked,”Any advice how to proceed safely with this patient.. to relieve her pain, yet eliminate the risk of recurrent prolapse? Any advice about young, sexually active patients in the future? I’ve been a real mesh supporter thus far, but starting to have concerns in the young, sexually active population. Rethinking the role of abdominal sacrocolpopexy in these patients…”
Slater asked if patients and their doctors should be cautioned about using mesh in sexually active women.
Dr. Murphy said the risk of pain is associated with any pelvic floor repair.
ADVERSE EVENTS REPORTS
In another email document shown to the jury dated April 2004, one year before the launch of Prolift, from David Robinson the Medical Affairs Director for Ethicon, it recounted two cases of complications among patients who had received a Prolift and now could not “void” or urinate.
Another report from David Robinson, October 28, 2005 recounted at least four cases of total Prolifts resulting in patients who could not void. While Robinson hoped this would spontaneously resolve, he asked, “Has this particular problem been reported? We are going to have to look at this because the cases seem to have no common thread or any difficulty with the surgery itself. But if this starts getting reported, it is going to scare the daylights out of docs.”
Slater:” It would have been good for you to be aware of this problem before you drew your conclusions in this case?”
Murphy: ” I don’t agree with that.”
Slater: “They didn’t add that to the IFU did they?”
Murphy: “I don’t know.”
Slater asked Dr. Murphy if he was aware of patients with complications coming in to be treated by his partner, Dr. Vincent Lucente. He had removed the center of a Prolift from a Tennessee woman who was in constant pain.
“Returning for surgery is a big deal but a bad Prolift will be a disaster,” writes Dr. Lucente in an email.
You wouldn’t dispute that’s true would you, asked Slater.
Murphy: “He’s an emotional person he uses words like “disaster” pretty freely. I’d call it a complication.”
Slater showed Dr. Murphy a report by Professor Jacquetin, which was also not considered for inclusion in his final expert report.
In it the French TVM group said ultrasound showed mesh retraction and the group quantified it. The French TVM group felt mesh retraction was real.
Murphy said when mesh is pulled too tight it could be considered retraction, but he disagreed that the surface of the original implant would shrink.
And while the French TVM study cited mesh shrinkage, Dr. Murphy didn’t cite it in his expert report for the trial. He challenged Slater, “This is clearly different than my clinical experience. I see things in real life; these are ultrasounds. I don’t see that in my practice,” he said about the ultrasounds of mesh contraction.
Slater ended the day showing an Ethicon Request for Charter calling for a “Fast upgrade of Prolift System to a new mesh to retain market share.”
Ethicon planned to substitute Gynemesh PS, used in Prolift, to the Ultrapro mesh.
Ultimately, both the Prolift and the Prolift +M (Ultrapro) were removed from the market last June by Ethicon. An Ethicon spokesman said to Bloomberg:
“This is not a product recall and we continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
More Background on Dr. Murphy.
MDND previously reported on the July 2011 FDA Safety Advisory (here) that alerted the public that the risks exceeded the benefits of transvaginal mesh. It is the announcement that opened the floodgates to today’s present litigation.
Murphy and a group of surgeons took issue with that announcement. See Miles Murphy and pelvic surgeons network 12 pages, is the letter the group sent to the FDA. ###