The trial lasted nine days and jurors took one day to deliberate.
Tina Burris had a Gynecare Prolift Anterior Pelvic Repair System (Prolift), and a Gynecare TVT-Secur (TVT-S), implanted on August 5, 2008, by Dr. Desrene Brown at Bluffton Hospital in Bluffton, Ohio.
Ethicon's Gynecare is a subsidiary of Johnson & Johnson (JNJ), maker of transvaginal and hernia mesh repair systems.
The TVT-S was used to treat stress urinary incontinence (SUI), while pelvic organ prolapse (POP) was intended to be treated by the Prolift. Dr. Brown had learned how to implant the device after being referred to a cadaver clinic arranged by a sales rep.
According to her complaint, Burris experienced pudendal neuralgia and muscle damage causing chronic pelvic and leg and vaginal pain, as well as dyspareunia and painful bladder filling syndrome.
She has difficulty standing, sitting, or walking for lengthy periods of time.
Burris V. Ethicon, Case No 3:20-cv-01450-JRK was filed in the U.S. District Court for the Northern District of Ohio on July 1, 2020, after being transferred from multidistrict litigation in West Virginia.
Presiding Judge James R. Knepp II was assigned the case.
The only issue before the 12 jurors was the company’s failure to warn the doctor about the device risks. It is the doctor's responsibility to then inform the patient of all of the known risks of a device so they have true informed consent.
But the failure to warn count was answered by Ethicon’s evidence. Jurors decided that Dr. Brown had received adequate warnings about the risk of erosion and dyspareunia or pain with sex. For her part, Dr. Brown said she eventually stopped implanting Prolift because of her concerns about its safety.
Prolift was marketed by Ethicon Women’s Health & Urology in March 2005, which failed to notify the US Food and Drug Administration (FDA) before it sold the device.
In the 2013 Linda Gross trial, the company admitted it bypassed FDA notice because the Gynemesh material was similar to suture. Ethicon didn’t feel it needed a new clearance. See Linda Gross v Ethicon (here)
However, Prolift was a unique product - a larger amount of mesh, pre-cut and packaged with trocars made it a novel product. It wasn't until Prolift M+ was marketed several years later that the FDA realized Prolift was already on the market.
Transvaginal mesh trials face another stumbling block. Some states require the plaintiff name a safer alternative design, made from the same material, that the doctor could have used instead.
This creates a dilemma when the material in question, in this case polypropylene, is suspected to be the problem.
In the Burris case, her expert, Dr. Niall Galloway, M.D. (Emory) believes there is no safe mesh. His expert report does not suggest that a POP mesh without arms might represent a safer alternative that would do less damage.
Even Ethicon removed Prolift from the market by the company in 2012, allegedly for economic reasons, after multiple injury complaint reports were received by the U.S. Food and Drug Administration (FDA).
With no safer alternative, the defective design count was out. A failure to warn was all that remained.
The judge threw out punitive damages.
Ms. Burris was represented by Ben Martin, Laura Baughman of Dallas, and Greg Vigna Law, in their first of many pudendal neuralgia cases.
As for future cases Dr. Vigna, M.D., JD tells Mesh News Desk,
“As far as safer alternative design for POP devices and slings we are good with the path we are on. We believe that it is time to sue doctors on every sling implanted that results in neurological injury, along with the manufacturers."
The next trial for Martin Baughman will be in Houston later this year concerning the Ethicon TVT-O. The Jen Snowden case naming Ethicon’s Abbrevo transvaginal mesh will be tried in Dallas in November.