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Defense Wraps in Huskey V. Ethicon, Cross on Million$ of Company Friends

Dr. Christina Pramudji, female urologist, Houston

Dr. Christina Pramudji, female urologist, Houston

Dr. Christina Pramudji, MD was the witness called by Ethicon as the defense wraps up its case in the second week of this product liability case, Huskey v Ethicon.

The Houston- based urogynecologist was chosen by Ethicon (Johnson & Johnson) to do a physical exam on plaintiff Jo Husky to determine her mesh-related injuries.

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

Mrs. Huskey’s claim is she’s continued to experience chronic pelvic pain since 2011. It began five months following the implant of a TVT-O (transvaginal tape obturator) to treat stress urinary incontinence (SUI).

With a girlish voice and her hair back in a ponytail, Dr. Pramudji’s appearance belied her credentials – a board certified urologist with a subspecialty in Pelvic Floor Medicine and Reconstructive Surgery who’s performed more than 900 obturator sling procedures.

Her sling of choice – Ethicon’s TVT-O (transvaginal obturator).

For her enthusiasm, the doctor has been paid $75-thousand in recent years to consult with Ethicon and teach other doctors how to implant the polypropylene medical device.

A: “I feel like I have an obligation to teach other doctor how to do it properly and safely,” said Dr. Pramudji.

 

EXPERT WITNESS

Jones during Linda Gross trial, Feb. 2013

Jones during Linda Gross trial, Feb. 2013

As is customary by both sides, after certifying her as an expert it was established that Dr. Pramudji charged $600 an hour for her work here and $700 an hour for a deposition or court testimony. She’s put roughly 100 hours into this case.

Much of the afternoon was spent with J&J attorney Christy Jones leading a choreographed Q and A with the doctor.

The doctor said pelvic pain and dyspareunia (painful sex) is very common in post-menopausal women, even without a medical device implant. A failure of the sphincter around the urethra to squeeze shut can affect up to 50 percent of older women.

The burch (sutures) and pubovaginal sling (using the patient’s tissue) have fallen out of favor because they represent major surgery, said Dr. Pramudji.

But there is a known downside to mesh slings such as the TVT and TVT-O, she admitted – the 3 R’s – mesh exposure, erosion and extrusion.

 

PAIN PRE-EXISTED TVT-O

The defense attempted to establish that Mrs. Huskey had complained of pelvic pain to her primary care doctor prior to her TVT-O surgery in February 2011. The discomfort was so bad she had gone to the emergency room in November 2010 where the doctor found a solid mass in one ovary.

Following two partial removal surgeries, Mr. Huskey complained of pelvic pain particularly on her left lateral side where one doctor had yanked on the sling to try to remove it. The same doctor performed an exam using a speculum, which escalated her pain creating a spasm on the pelvic floor.

Yes, she reported a muscle spasm syndrome. That’s where it hurts. That is where she is tender on examination. This is what’s causing her discomfort,” said Dr. Pramaduji adding the area is far away from where she had her implant surgery.

“We don’t know what caused it, it happened well after she was done with the sling so I can’t link those two together in any way.”

“Do you have any opinion whether or not the TVT-O she received caused the muscle spasms she is currently experiencing?”

“No, it did not.”

Regardless of her undiagnosed pelvic pain, the doctor added Huskey was a perfect candidate for the TVT-O and the IFU (instructions for use) were sufficient.

 

Fidelma Fitzpatrick, Motley Rice

Fidelma Fitzpatrick, Motley Rice

CROSS EXAM- ETHICON’S MILLION PLUS FRIENDS

In the afternoon on cross examination, the attorney for Huskey, Fidelma Fitzpatrick (Motley Rice) shot out of the gate.

Dr. Pramudji agreed the pelvic pain noted in the emergency room visit turned out not to be gynecologic but was gastrointestinal in origin.

Why put a TVT in a patient with pelvic pain of unknown origin? Do you think it would be better to know the origin especially when it’s an elective procedure?

“No, I think it was an appropriate decision.”

“Would you agree, you don’t want it to be put it in the body unless you can say it’s not possible it could be the TVT or TVT-O?

“It’s clear there is no correlation.”

 

ETHICON PREPARATION

Even though Dr. Pramudji said she had spent about 100 hour reading documents to get ready to testify for the trial, as of last April, when Fitzpatrick conducted her deposition, she had put about 50 hours in.

“You spent more time getting ready with lawyers from Ethicon for this jury than to read her medical research!” she accused.

“Your examination of Mrs. Huskey wasn’t independently done was it? It was done for Ethicon they paid you?

“That’s correct.

“They paid for your opinion

“They paid me to give my opinion, not to give a certain opinion.

“They paid you in excess of $60,000 for your opinion in this case?

“Correct.

“About $600 of that was earned in time dong the exam of Mrs. Huskey?

“That’s correct.”

 

WARN OF RISKS?

Fitzpatrick asked if a medical device manufacturer has an obligation to disclose all of the information it has about the risks of its products?

“No I disagree. Its responsibility is to tell me about the majority of the risks possible for patient. You cannot possibly warn everyone about every risk, about everything, that’s unreasonable.”

Who should makes that decision? The medical community, said Dr. Pramudji. “If it’s not enough warning, as a medical community we will let them know you need to give us more waning.  This is not adequate.”

 

INFORMATION SHORTFALL

Fitzpatrick pointed out that every document Dr. Pramudji reviewed in preparation for forming her expert opinion was supplied by Ethicon. Yes, she agreed. But what about the documents she wasn’t shown?

aaron kirkemo“Do you know who Aaron Kirkemo is? Yes, she knew.

Had Ethicon shown her a document where Dr. Kirkemo, the former urology medical director for Ethicon, called the TVT-O a “kludgy” device.

Kludgy is an actual word. It means a clumsy or inelegant solution to a problem; a badly assembled collection of parts, hastily assembled.”

“Were you shown this document?”

“No, I haven’t seen this one.”

“And here Dr. Kirkemo says in May 14, 2010, nine months before Mrs. Huskey’s surgery he hated the obturator and wouldn’t use it. Is that relevant?

“No that’s one surgeon’s opinion.”

“You don’t think it’s relevant that the medical director doesn’t like the TVT-O”?

“No, not at all.”

Dr. Pramudji also wasn’t shown a document stating the opinions of Dr. Carl Gustav Nilsson, one of the creators of the TVT. He strongly disliked laser cut mesh. He was concerned about the efficacy of it and whether it will work as well as mechanically cut mesh.  The TVT-O is made of laser cut mesh. Portions remain behind in Mrs. Huskey’s body.

Prolene mesh

Prolene mesh

“Dr. Nilsson who authored data on the safety and efficacy of the TVT doesn’t believe it translates to the safety and efficacy of the TVT-O laser cut mesh does he?

Does it affect your opinion at all that he will not use the TVT-O?”

“No.”

 

MILLIONS OF ETHICON FRIENDS

As the day’s testimony wrapped up, Fitzpatrick carried three bulky accordion brown envelopes filled with papers, one for the plaintiff, one for the witness and one for the defense table.

The information also was not provided to the expert witness in connection with her work on this case.  It contained the compensation for “key opinion leaders” were paid to build goodwill around Ethicon products. The paper was entitled “TVT Tactics.”

In 2002 the TVT was not the Gold Standard; the burch and retropubic suspension were.

Under the chart that says “Tactics,” Ethicon planned to tip the scales in favor of the TVT, Ethicon would hold professional education events with medical societies – American Urogynecologic Society, AUA, SUFA. The expense noted was $75 million in 2002 with $50 million allocated for panel debates.

“Do you see in 2002, Ethicon had budgeted $200 million to build that goodwill with medical societies?” “Correct.”

Dr. Pramudji was not familiar with the names of AUGS board members who have been identified as deeply financially indebted to industry in the form of honorariums, consulting and teaching agreements. #

Defense documents leave court Wednesday.

Defense documents leave court Wednesday.

The trial will continue Thursday with defense expected to wrap up its case. Judge Goodwin warned if a schedule is not kept, he may have to curtail closing arguments. The jury could receive the case as soon as Thursday.#

17 Comments

  1. Dean says:

    Well done Jane great write up thank you

  2. David says:

    The paper entitled “TVT Tactics” + self-serving industry intent = diabolical scheming to exploit a profit opportunity in the human body. Or to highjack the practice of medicine and thereby “bleed it” for a one-sided manufacturer and collaborating physician (“key opinion leaders”) siphoned enrichment. With the end effect – upon inflict of this unwarranted mesh/procedural risk into clinical practice – patients harmed, and/or lifetime of safety sacrificed, who were deprived the risk-mitigated benefit potential from native repairs. An industry’s unjust gain at the patients’ expense.

  3. Kitty says:

    Nice Reporting Jane. To my understanding—Dr Parmudji is a Urologist–not or Urogynocolgist. Perhaps that is why she doesn’t recognize name from AUGS. I just cant seem to get past the studies of Masters and Johnson and their anatomy and physiology of the female sexual organs——-especially the Vagina. The more and more I see, feel and hear—I believe Women have been butchered by stuffed shirted prudes and ignoramuses.

    • Jane Akre says:

      She is a urologist and decided to specialize in female urogynecology. Then on the stand yesterday she said she was a urogynecologist. That confused me. Her website is consistent with her testimony- she is board certified in:
      Female Pelvic Medicine and Reconstructive Surgery
      Urology

      • Kitty says:

        Jane from what I got in her disposition she is a certified Urologist with sub specialty in female pelvic floor and reconstruction. I did not see Gynocologist. (dealing with the health of a female’s reporductive organs–vagina, ovaries uterus, breasts)

        • Jane Akre says:

          She said at one point, correcting Fitzpatrick, that she was a urogynecologist. Huummmm.. I thought that was strange too

  4. All Meshed Up says:

    Ethicon has no problem paying out a couple hundred million to payoff the medical community but God forbid they have to pay a mesh victim $40,000 for a life time of pain. We mesh victims must be the laughing stock for the manufacturers and the Doctors that take their money, grants and perks. The Manufacturers have multimillion dollar slush funds to pay off these “Doctors”, the FDA and to lie to the public about the safety of their products through them.

    I hope that this “pony tailed, girly, girl” Dr. will find herself without patients after this testimony of her’s. She obviously is another one of the Doctors that is more enamored with manufacturers money and attention than realizing what is happening to women with mesh.

    Again, it is the money, not the patient, that this Doctor cares about. She was paid an enormous amount of money by Ethicon to be their stooge. She was paid more than what many of these women would get in a MDL settlement.

    My suggestion is that SHE get a TVT implant to show how safe they are! Then let us talk about mesh safety in about 4 months with her surgeon.

  5. msm says:

    “…said Dr. Pramudji. “If it’s not enough warning, as a medical community we will let them know you need to give us more warning. This is not adequate.”

    How do they determine warnings are inadequate? Through testing on uninformed patients. A patient lives with pain and dysfunction causing their quality of life to plummet. A portion of the “medical community” (the pro-mesh community), reports a new complication to be added to the IFU and are probably rewarded for it. Surely they know that the manufacturer is throwing the docs under the bus. The manufacturer just reduced their liability but if that complication should happen again because of that product, the surgeon could find him/herself in court for malpractice. They knew the risk and warning and used the product anyway. A defense of informed consent would be unlikely because many surgeons don’t want to discourage patients from receiving this wonderful treatment and doubt that patients are smart enough to make an informed decision.

    For example:

    While some manufacturers admit and warn that infection could require removal of the sling (not just partial), Ethicon has chosen not warn even though numerous studies confirm the risk and potential need for removal.

    The AUGS has failed also. Read the position statement and the FAQ’s from the AUGS whose board members “have been identified as deeply financially indebted to industry in the form of honorariums, consulting and teaching agreements”.

    AUGS Position Statement:

    http://www.augs.org/d/do/2535

    FAQ for Providers:

    http://www.augs.org/d/do/2718

    FAQ for Patients:

    http://www.augs.org/d/do/2717

    In fact, the AUGS “Position Statement on Mesh Midurethral Slings (MUS) for Stress Urinary Incontinence” and “FAQ for Providers” completely fail to include the term “risk” or “infection”. While “Complications” is omitted from the position statement, there is use of the phrase “difficulties and complications” in one sentence of the FAQ for Providers.

    From the AUGS Patient FAQ:

    “Are mid-urethral slings safe?

    As with any surgery, complications can occur but they are typically MINOR and can usually be REPAIRED.”

    Are there studies on the effectiveness of “repairs”? Surely there must be. Right? How many “repairs”? How long do these “repairs last? How often is the patient required to return for a “repair”? What is considered “minor”? How often is a patient told to live with a “minor” complication? I haven’t seen those studies or statistics.

    “The doctor said pelvic pain and dyspareunia (painful sex) is very common in post-menopausal women, even without a medical device implant.”

    The statement that it is common for post-menopausal women to have painful intercourse as if it is a woman’s lot in life and something that should be accepted it degrading, insulting, and medieval. There are many treatments for post-menopausal issues but they won’t help pain from mesh. Perhaps she will have personal experience in this when she is older and wiser.

  6. Disgusted says:

    I hope the jury can see through the smoke and mirrors. I hope they understand that the Dr. was “paid off” or maybe even “bribed”. The fact that she didn’t have pain until 5 months after the TVT-O implant does not mean that the TVT-O was not the cause. Where is the evidence that it can shrink? It was established that it can erode, that alone could cause the spasms. I know they are severely limited in time, but it seems to me that the whole truth is not being told. I guess we all agree on that. I still totally disagree that dysparenuia is common with pelvic surgeries. I had plenty before the sling. Never a spasm. The only time I ever had spasms was after the sling was touched and causing me problems. I wish I would have known then that the whole thing needed to come out, I would be in much better shape today. I pray the jury will see the truth.

  7. msm says:

    “…said Dr. Pramudji. “If it’s not enough warning, as a medical community we will let them know you need to give us more warning. This is not adequate.”

    How do they determine warnings are inadequate? Through testing on uninformed patients. A patient lives with pain and dysfunction causing their quality of life to plummet. A portion of the “medical community” (the pro-mesh community), reports a new complication to be added to the IFU and are probably rewarded for it. Surely they know that the manufacturer is throwing the docs under the bus. The manufacturer just reduced their liability but if that complication should happen again because of that product, the surgeon could find him/herself in court for malpractice. They knew the risk and warning and used the product anyway. A defense of informed consent would be unlikely because many surgeons don’t want to discourage patients from receiving this wonderful treatment and doubt that patients are smart enough to make an informed decision.

    For example:

    While some manufacturers admit and warn that infection could require removal of the sling (not just partial), Ethicon has chosen not warn even though numerous studies confirm the risk and potential need for removal.

  8. karen says:

    I remember the good old days , when u had someone to take care of problems . Now they work for Johnson and Johnson.

  9. Mo Kay says:

    Dr. Pramudji sounded so arrogant and fake.

    That what happens when you get 75K

    Ruthless, and inconsiderate Teacher.

    • msm says:

      What goes around comes around. Her day of judgment will come. In the meantime, I hope she doesn’t hurt anybody else. I don’t see how people like that can sleep at night.

  10. Rhonda says:

    I had a Johnson and Johnson sling put in July 2010. Six months later I started finding pieces of the sling and when that happened the pain started and continually got worse. Had it removed 3 weeks ago and this is the worst pain I have ever had. It took longer than it should have because the mesh was all twisted. My doctor who removed it was wonderful but he was not able to get it all. I pray the jury sees all they pain and mental suffering that this has brought to many women. As far as I can see, and yes I may be biased, but 40,000 dollars will not touch the pain let alone all the doctor bills I have. Lord help us all if they are able to get by with this.

    • Jane Akre says:

      Rhonda… unfortunately partial removals often can make things worse especially if the doctors hurts delicate tissues or perforates organs. I certainly hope you have competent medical and legal help.

    • D. Craig says:

      Can you tell me who your surgeon is? I need one I can trust, Pramudji did two surgeries on me. My name is Deborah Craig and my e- mail is dclijah1@gmail.com

  11. Kitty says:

    Rhonda what color was the mesh pieces?

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