Free Case Evaluation
Connect
With Us

Day Three: Huskey v. Ethicon Searching for Pain Solutions

courthouse twoThis 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.

##

As typically happens, many pelvic mesh patients undergo a round robin of treatments in a desperate search for some relief following complications that can occur after a transvaginal mesh placement.

Jo Huskey, 54, went on that search after she received a TVT-O pelvic mesh implant to treat her incontinence in February of 2011. In this third day of her product liability case against Johnson & Johnson, Huskey’s medical condition was revealed to the nine jurors.

Dr. Gretchen Byrkit, ob/gyn

Dr. Gretchen Byrkit, ob/gyn

Huskey returned to the implanting physician, Dr. Gretchen Byrkit of Decatur, Illinois who did a partial removal after Jo Huskey complained of pain.  When that didn’t work, she was referred to a specialist, a urogynecologist from Southern Illinois University, Dr. Sohail Siddique.  He too did a partial removal of polypropylene mesh that had eroded through her pelvic organs, but he only removed a portion of the plastic strip that sat under her urethra where it was placed for support.  That too failed to resolve her pain.

Gretchen Dean, physical therapist

Gretchen Dean, physical therapist

Gretchen Dean was the next referral. The physical therapist had been focusing on resolving pelvic pain in patients for 15 years.   She described Jo as a “spunky” and “joyful” personality  who enjoyed sports activities. Even though she had had back surgery in 1996 that didn’t stop her from kayaking and biking, said Mrs. Dean.

But a series of treatments including electrical stimulation and diaphragmatic breathing had only lowered her pain to a “3” out of ten. The most improvement came from a prescription to the antidepressant/painkiller Cymbalta.

She was no longer that joyful personality. Dean described her as on edge and aggressive in her pursuit of a solution to her never ending pain.

TOT sling, Scottish Pelvic Floor Network

TOT sling, Scottish Pelvic Floor Network

Mrs. Dean said Huskey had a lot of trigger points in her pelvic floor the “obturator was the most painful” and that pain did not subside. Dean asked her to stop exercising and cut back on work. Eventually Mrs. Huskey was unable to work, injections from Dr. Siddique offered moderate relief and pain would flair again after the injections. The best relief she ever got was a 2 out of 10 pain level, said Dean.

The diagnosis – sacroiliac  joint dysfunction, which was causing Huskey’s pelvic pain. Did the pain come from pelvic mesh or were Huskey’s exercise habits, her previous back and shoulder surgery and hysterectomy contributing to her pain?

That question will eventually have to be answered by the jurors when this federal case goes to the jury next week to determine damages in this product liability case.

Surgery and trauma can affect muscles, said the therapist. “The pelvic pain was certainly adding to the SI dysfunction, whether it was the cause we don’t know but the pelvic pain was annoying her SI joint,” said Dean leaving open the direct conclusion.

 

###

David Robinson, former Medical Dir. Ethicon

David Robinson, former Medical Dir. Ethicon

Dr. David Robinson has reportedly been designated as the J&J go-to guy to deal with litigation against the company over its pelvic mesh products. That’s why he has been seen in videotaped depositions answering questions for J&J in two previous trials – Linda Gross in New Jersey, ($11.1 million) and the Carolyn Lewis case (directed verdict for J&J last February).

Robinson again appeared via videotape as the plaintiff’s wrap up their case in Huskey v. Ethicon (J&J).

Dr. Robinson was a Topeka, Kansas-based paid consultant for Ethicon and the ob-gyn was early on approached about using the new tape. At first he wasn’t interested but then saw how a colleague was benefiting from the association and how his practice exploded with the new transvaginal mesh slings. Eventually Dr. Robinson began implanting about 100 slings and year and soon became the Medical Director Worldwide for Ethicon Women’s Health and Urology, which was known then as Gynecare, from November 2005 through December 2010.

He was essentially asked today – What did the company know and when did it know its transvaginal tape products had problems?

Laser Cut Mesh v Mechanical Cut Mesh

Prolene mesh

Prolene mesh

Mrs. Huskey was implanted with a polypropylene that was cut by laser and not machine, the last innovation in the TVT line of products including the TVT, TVT-O and TVT-Secur, all pelvic mesh products to treat incontinence.

Dr. Robinson appeared on videotape and was questioned why the company made the TVT-O with a laser cut when Dr. Carl Nilsson, one of the inventors of the TVT for Ethicon, would not use laser cut mesh. He felt it was not elastic enough.

Documents showed that inside the company, executive Allison London Brown asked for a study comparing laser cut to mechanical cut mesh to make sure they were acting the same in a clinical setting. Ethicon chose not to do that study. Why not? “The data showed they were equivalent” said Robinson.

Meanwhile the company’s brochures extolled the virtues of the Gynecare TVT Retropubic System. “Over a decade of clinical data” it said pointing to studies by Dr. Nilsson. Robinson agreed. But the plaintiffs’ attorney on tape asked Robinson wasn’t that data and those promises based on mechanically cut mesh? Yes, said Robinson.

Robinson’s job was quality control of the products and that meant keeping an eye on adverse events. Robinson said the company relied on data to see unusual spikes in reporting of complications. Not just the number of complications but the severity of those complications were supposed to be important.

But Robinson said he had no absolute number for the severity of complications with pelvic mesh? “I had no absolute number in mind, not that I recall,” he said other than the ease of use and a shortened time of recovery.

The attorney asked, “It’s true no one knows what the 20 year exposure rate for mesh is, right?” Right, said Robinson.

Christy Jones, Dave Thomas, Ethicon

Christy Jones, Dave Thomas, Ethicon

This is the just the second of four intended bellwether cases to be heard before Judge Goodwin in this Charleston, WV federal courtroom. The Huskey case should conclude Friday with the possibility that the plaintiff, Mrs. Huskey will take the stand. The defense could wrap up its case by the middle of next week.

This court has 22,000 similar cases pending against J&J and 66,000 against seven manufacturers of pelvic mesh.

J&J has had no favorable jury verdicts so far though no jury has awarded anything close to the $11.1 million to Linda Gross in February 2013. Linda Batiste was awarded $1.1 by a Dallas jury in April and the company quietly settled with three plaintiffs in Joplin, Missouri this year. The Lewis case ended in Charleston after J&J asked for and was granted a directed verdict in its favor by Judge Goodwin last February. ##

6 Comments

  1. Kitty says:

    Thank you so much Jane for this report.

  2. All Meshed Up says:

    As always, Thank you Jane.

    In the interview with Dr Robinson, does anyone else start feeling queasy with his answers? Slick, dismissive and obviously well versed in obfuscation. When did Dr’s start becoming politicians? Just saying.

    How can J&J say that their PP TVT Mesh( or any PP mesh for that matter!) is safe when there is NOT any 20 year study of the effect of PP in the body? How can J&J say with any great confidence that a machine cut is any better than a laser cut? Especially when no study has been done and there is evidence that machine cut edges can be sharp, frayed and cause their own problems regardless of being made of PP?

    I think it is also telling with Dr Robinson’s history after discovering the financial benefits of associating himself with Ethicon and their vaginal mesh products. When it comes down to financial gain or actually paying attention to patient complaints, financial gain wins out every time.

    When will the FDA actually do something about all of the thousands of mesh complaints that have been submitted? Instead we are ignored, belittled and treated as any other lab rat would be. Because according to what Dr Robinson says there are no long term studies being done. No! Hold it. The long term studies are being done! ON US………..

    • Kitty says:

      all meshed up——you are so right What eve4r happened to the the women (i’m sorry I don’t mean to exclude your piolypropylene) When I was in Home care a number of years ago I ran into many women that most likely are dead now—bower movement coming out of the vagina—inability to urinate without a catheter. No studies or complaints were ever done im sure-=–because that was 2002—or if they were done the shredder got them,.

    • Jane says:

      These are my very symptoms. Leg pain, back and groin pain. My TVT broke twice

      during surgery. I’ve been going to PT for a few months and doing the breathing also. Diagnosed with

      myofascial pain and have been working on the trigger points. But that has not

      helped the stabbing leg pain I get every night.

      I don’t relate well to meds and have been prescribed Cymbalta, Lycria, Savella, Tramadol, Meloxicam & Gabapentine.

      I have had hallucinations or very scary dreams that someone is killing me or felt groggy and lifeless. Now trying Nortriptyline.

      Lucky to get 4 hours a sleep a night.

      • Kitty says:

        so so sad

      • All Meshed Up says:

        Hello Jane, I too have been put through many of the nerve pain drugs out there with the same effects you describe. I am now trying another round of Lyrica. I was doing Gabapentin but had nightmares. For someone that has PTSD from the service, inducing nightmares was not good. For years I have been using a low dose Vicadin (5mg) with a 200mg Acetaminophen and 600mg of Ibuprofen. That usually will quell my pain and at give me some modicum of relief. The Lyrica, which I started yesterday, makes me feel tired and even more stupid than I am normally. I will try it for another few days if I can stand it but as I have said, I have tried most of those nerve pain drugs with little or no success. I do use a topical anesthetic ointment that does help with the skin sensitivity that I experience.

        Getting the nerve cut that was causing me pain was done but what happened is now my right leg ALWAYS feels hot and sweaty, even when it is not. Having the nerve cut to supposedly “stop” the nerve pain does not work in many instances. Bruce Rosenberg can testify to that. I get the shooting pains but what what I experience, as I believe most mesh victims with PP do, is the dull, throbbing sometimes intense pain around my surgical site and where my little Kugel monster is.

        I am being told, and I prefer to believe the Dr.’s at this point, is that I am suffering from nerve regeneration pain and “false” nerve pain where even though the nerve is dead the body still thinks it is there. The body just thinks the nerve is sending pain responses all the time so that is what you “feel”. Nothing stops that that I can find.

        And this comes to the point of my ramble here. When you have had mesh and then had it removed or modified, every time you cut into the body you are just doing more nerve damage and scarring. Much less having a foreign object in you that is adhering to tissue or cutting into tissue as it migrates. Having the Mesh is only part of our problem. The surgeries that follow only exacerbates what was already damaged.

        Thank you Jane for your tireless reporting of this issue that affects so many men and women. God Bless you and all the extended Mesh Family. Best Wishes……..

Post a Comment

Your email is never published nor shared. Required fields are marked *

*
*

© 2016 - 2017 Mesh Newsdesk. All rights reserved.
This news website is designed by NextClient.com.