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.

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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.

 

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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. ##