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Day 18: Linda Gross v. Ethicon Surgeon Says Prolift Warnings Were Adequate

Ethicon attorney, Christy Jones

Ethicon attorney, Christy Jones

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!

Dr. Miles Murphy, urogynecologist

Dr. Miles Murphy, urogynecologist

CLARIFICATIONS

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.

Prolift procedure, edited Courtesy: Courtroom View Network

Prolift procedure, edited Courtesy: Courtroom View Network

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?”

Murphy: “No.”

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

Dr. Miles Murphy, Urogynecologist testifying for Ethicon

Dr. Miles Murphy, Urogynecologist testifying for Ethicon

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.

D18  does prolift causedyspareunia assoc w 17 percent denovo dyspareunia rateDYSPAREUNIA RATE 

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.”

 

MESH EXPOSURE

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.”

D18 prolift adequately warned in IFU in 2006

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?

Murphy: “Absolutely.”

Adam Slater in court

Adam Slater in court this pm

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.

Dr. Vincent R. Lucente MD

Dr. Vincent R. Lucente MD

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.

D18 dr murphy 2 day 2Slater asked if that brought into question the credibility of his testimony.

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.

D18 doc asking for advice in sexualy active women HUGe

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.

D18  scare the daylights out of surgeons if they see these complications. huge

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.”

RETRACTION/CONTRACTION

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.

D18  michel cosson 2 yr before launchsays erosion a problem

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.

D18 lightning project charger fast upgrade of the productLIGHTENING PROJECT

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.  Here is the 12-page letter the group sent to the FDA.

 

19 Comments

  1. Carmel Berry says:

    Thanks again Jane… I would love to read the letter you mention in the last paragraph. The link seems to be broken.

    • Jane Akre says:

      The link is fixed now I believe… please check and let me know thank you!!

      • Hi Jane,

        I didn’t have any problem opening the 12 page letter, which I am now getting ready to read. I read the rest of the article, and I am flabbergasted by the testimony of Dr. Miles Murphy. He truly showed what a FOOL he is. I am actually glad that he testified this way; it served to show the jury how incompetent he really is.

    • Donna says:

      My doctor placed the Prolift in me in 2006 and in 2007 used the TVT because the Prolift failed to correct my problems. Double trouble; two procedures and more problems than prior procedure status. Was told the pain during intercourse..plus depression and anxiety….was due to menopause.

      Lost my job in 2012 due to chronic pain from the mesh. One surgery to remove the mesh which resulted in sepsis. Three other doctors for opinions and physical therapy which resulted in more pain. Finally applied for Social Security disability which was approved in April 2013. My monthly allowance for SSD does not cover half of of my monthly wages and the great benefits I lost. Just call me “emotional” for what J&J and doctor greed did to me. No big deal? Right? So upset from what I read about day 18.

      • Jane Akre says:

        Donna- tell us what you have done for yourself medically. How have you addressed the pain? Have you found a doctor who can help and who suggests a full removal? Can he/she do that removal and how do you know? Are there other satisfied patients? Many patients are becoming proactive and taking the next step to wellness. Would you like to talk to patient advocates? jane a.

        • Donna says:

          The doctor who removed part of the mesh in 2010 said it is deeply embedded and was very difficult to remove. The doctor who did the Prolift and TVT had an assistant who warned me I was going to a doctor who was a butcher yet this practice continued to tell me the mesh was not my issue and menopause was my problem.

          After being so sick from the removal surgery, I do not want to risk having the same result from another attempt to remove more mesh. My body has been through to much in the last couple of years. In 2009 I lost 12 inches of my colon. At that time I was going through treatments for breast cancer. Now I wonder if the colon problem was related to the mesh? I would think the doctor would have seen the mesh during the operation? I also had a fistula from my bladder to my intestines.

          My present doctor put me on Elavil and a diazepam suppository for sleep and pain. The next step is a visit to a pelvic pain specialist. I rather not be on pain medication which will result in more complications with my bowels. I was in the hospital twice since my colon surgery

          for bowel obstructions. I want my life back. What would you suggest for helping me with my pain? The spasms hit me like child birth contractions and I have chronic UTIs. My pelvic area feels hot with inflammation and tight like a rubber band. I feel bloated most days. Appreciate any advice.

          • Betty says:

            Hi Donna,

            I’m sorry that you’re another victim of this horrible product. Watch out on the valium (diazepam) – new studies are showing it causes memory loss when used long-term. For very severe bladder/urethra/bowel pain and spasms try B&O (belladonna & opium), it is the only medicine that I’ve found that actually removed this extreme pain. I’m sad to say this, but miralax and linzess seems to be the only products that keep the bowels moving, . Linzess is a relatively new product on the market, but it does help with BM’s. I was told – whatever you do, don’t strain. Trying to get a Dr. to listen to this issue was next to impossible. I couldn’t go without straining. The linzess and miralax have helped to bring that back to almost normal. The bottom 8″ of my colon don’t seem to be working at all and so I get “constipated” with very soft stools. Also, hyomax a very old drug (and inexpensive), works well with bladder/bowel spasms. Another non-drug way to help with severe ECP (excruciating crotch pain) is to take a condom and fill it with 50/50 mixture of alcohol to water, tie it off, double wrap it and put it in a plastic ziplock (in case it breaks) pop it in the freezer. I have several of these in my freezer and they actually work pretty well. Wrap them in 3 sheets of paper towel and set in your underware. They last around 1-3 hours. (and help with clitoral pain). I hope this helps! God Bless

          • Kim says:

            Donna I would like to ask you some personal question via my email. I am struggling with pelvic issues and I need surgery. Please email me so we can talk. I would really like and need to talk to you.

  2. Betty says:

    Ughhhh! Another paid insider. I’ve had several Dr.’s tell me how hard it is to get out. Several surgeries later still wondering if it is lurking around. The denial, denial, denial. I’ve met many of them. I’ve paid a hefty price for liars and hope to get my life back someday. Has he heard of the hypocratic oath?

  3. MarieAnn says:

    Would so-called Dr Murphy put the prolift in his wife or daughters? It seems clear he is in bed with Ethicon. He can’t see past the dollar signs. He is a small man. Also, I wonder what his partner thinks about being called “emotional”? I also wonder how the Prolift was sold to hospitals before it was cleared? Did the Ethicon reps bring it in their cars and into the operating rooms to “help” the surgeons implant it? What surgeon uses something that hasn’t been pre-tested in human trials and cleared as safe by the FDA??? None of this is ethical! It seems First do Harm and then we will ignore the harm done! Also, it is hell getting it out!

  4. Stephanie Brad says:

    Regarding th 12-page letter set to the FDA:

    We agree with the UPDATE’s message that mesh erosion is a potential complication of

    TVM. We do, however, feel that is quite rare that “even multiple surgeries will not resolve the

    complication.” We are unaware of any published case reports in which mesh erosion from TVM

    does not resolve after more than two returns to the operating room.

    This is insane I have erosion and I have had multiple surgeries and still have mesh causing problems, There are lots of us, I am so angry I could explode how dare they send this false information!!!

  5. Terri says:

    Wish we could select one family member of every surgeon & employee of these pharma companies to be implanted with this device including “Christy Jones” who is defending ethicon and give them absolutely no hope of ever having it removed or even treatment, no pain medications and let them live the rest of their lives with mesh in their bodies.

    I realize it’s just a dream, but what a great dream.

  6. InAz says:

    MarieAnn, yes the Reps do bring the mesh from their car into the OR for the doctor to plant.

    As I already assumed, the doctors were convinced by the Sales Rep with glorified test results that the mesh were safe. And the doctors repeated the sales pitch they learned from the Rep to the patient. Sales Rep’s job is to sell the product , so I am sure the Rep told the doctors only the positive aspect and not the probable complications that has been seen in studies. It is all about money…

  7. MarieAnn says:

    InAz, how could a hospital allow a sales rep to bring something off the street into a hospital OR and have it implanted into a patient. Where is the quality assurance department’s involvement in knowing this device is not part of approved for use stock in materials supply? Who’s to say the prolift device which was basically brought off the street is even sterile? Basically these unsafe mesh kits were sold on black market for blood money. This is all so wrong. We were innocently put under anesthesia not knowing we were to be implanted with the failed prolift all for greedy device companies and gullible doctors who can’t think for themselves and just believe the lies from device street peddlers! Lives have been lost and ruined, families have basically lost their mothers they once knew as whole, active members of society. None of this should have happened. There was no patient advocate to protect us, nobody cared enough to stop this. I’ve lost all faith in the medical doctors and the FDA who is led around by the nose by corrupt device companies. Heads need to roll!

  8. Terri says:

    Bring it from their car? Hell, there are doctors buying mesh right off eBay to save them money! Just go to eBay and search Gynecare, Kugal, Bard,TVT, Hernia patch etc. They are even selling EXPIRED mesh kits and some poor unsuspecting soul has no clue that the mesh about to be implanted in them was in god knows what kind of environment. How the hell do they sleep at night??

  9. Kathy says:

    Of course many doctors have no clue of our symptoms of failed mesh, so few want to hear them. I had zero clue that many of my problems were from mesh and thought I was falling apart until I found other mesh victims.

    Today I could hardly walk as I got out of bed. So afraid. So angry. I have never felt anger before in my life.

    Reading this doctor defend what he does for profit is terrifying.

    I remember thinking as I lay on the surgery table how weird it seemed that a rep would meet the doctor with the mesh kit . I also imagined it sitting in their car, and how unusual that seemed.

    You know, just the fact that none of us were told that removal is difficult in itself would have stopped all of us dead in our tracks. Who would implant something without plan B ?

    Can this doctor tell all of us what to do next ?

    How about a mass letter from all of us to the FDA ?

  10. Janet B says:

    When reading thru this article, I got to the email where one doc asked for advice from another because several patients who could urinate normally pre-mesh could not post-mesh surgery. My jaw dropped when I saw “Dr. Dennis Miller” mentioned as one of the docs who had patients with this issue. This was back in 2006! In 2010, I had a mesh sling put in by my local urogyn. I did not know of any complications, wasn’t warned at all. The doc who finally agreed to take it out was Dennis Miller (Milwaukee, WI). But he was very callous to me, basically called me crazy and implied that I was exaggerating my symptoms (severe pain, inability to sit, abrasive urethral pain, having to self-cath). I am LIVID that Dr. Miller obviously knew of these problems way back in 2006 according to this email. Because when I came to him desperate for help in 2010, he acted like I was the only one he’d ever seen with this problem. I have to believe between 2006 and 2010, he had many of these cases. It makes me just sick to my stomach to know that he kept implanting these devices knowing the severity of complications. And that he treated me so horribly. Yes, the manufacturers are ultimately responsible. But doctors don’t help when they belittle their patients so much. Ughh..

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