Jury selection begin July 11th and the case, filed in U.S. District Court for the Northern District of Ohio, could take several weeks. (See Case: 3:20-cv-01450).
The product liability case was originally filed in the Southern District of West Virginia, August 1, 2014 but was moved to Ohio after the multidistrict litigation court was closed. The Burris case is before Presiding Judge James R. Knepp II.
Two Ethicon Transvaginal Meshes:
· TVT-Secur (TVT-S)
Burris, age 43, 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-Blanchard Valley Health System in Bluffton, Ohio. The TVT-S is intended to treat stress urinary incontinence (SUI). Dr. Brown had taken a course through Ethicon to learn how to perform the Prolift procedure, which is designed to treat pelvic organ prolapse (POP). She provided patients with the manufacturer's brochure.
The complaint says Ethicon did not adequately inform Dr. Brown of the risks of Prolift; therefore, she was not in a position to disclose those risks to Ms. Burris. Dr. Mark Walters of the Cleveland Clinic removed a portion of the Prolift mesh in November 2011.
Today Ms. Burris claims she suffers pelvic and buttock pain diagnosed as pudendal neuralgia. Ms. Burris suffers from chronic numbness in her legs and worsening urinary complaints. She has difficulty standing, sitting, or walking for lengthy periods of time.
The plaintiffs' expert witness, Dr. Niall Galloway, M.D., is an Associate Professor of Surgery (Urology, retired from Emory) who will testify at trial as an expert witness on Ethicon's failure to warn.
Dr. Galloway believes Burris suffers from "pudendal neuralgia and/or muscle damage causing groin, leg, and vaginal pain; chronic, long term and life altering pelvic pain; dyspareunia; and painful bladder filling syndrome."
Also on the expert witness list is:
Jimmy Mays, Ph.D. – A professor of biomedical engineering specializing in polymer materials. (read about Jimmy Mays here)
Dr. Jerry Blaivas, M.D. – A board-certified urologist specializing in treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP). In the Jo Huskey trial (here), he testified that active women should not be implanted with a TVT-O.
Robert Tremp, Jr. – A life care planner who will testify about the physical limitations suffered by Ms. Burris and the financial resources she may need in the future.
Dr. Desrene Brown, M.D. – A board-certified Ob-Gyn and surgeon who implanted the Prolift in Ms. Burris.
Dr. Mark Walters, M.D. – He performed mesh removal and repair surgery on Ms. Burris in 2011 and 2021. He is affiliated with the Cleveland Clinic.
Dr. Howard Goldman, M.D. – A urologist, Dr. Goldman is expected to testify about Ms. Burris/ medical symptoms, diagnosis, and treatment.
Dr. Maurice Chung, M.D. – Dr. Chung treated Ms. Burris for pelvic pain and other symptoms, including injections to treat pudendal neuralgia.
Dr. Mark Conway, M.D. – A board-certified Ob/Gyn who treated Ms. Burris for ongoing pelvic pain in 2020.
Under the Ohio Product Liability Act, jurors will decide if Ethicon (Johnson & Johnson) failed to warn her physician about the risks and dangers of the Ethicon meshes and whether they are defectively designed.
Failure to Warn Claim - In order to prevail, the plaintiff must prove that Ethicon had a duty to warn about foreseeable risks, then breached that duty which led to the injury. An expert must testify to establish that causation, especially if it is outside of common knowledge.
Dr. Galloway could not directly relate the injury was likely caused by the TVT-S; therefore, the Defendants' Motion for Summary Judgment on the plaintiff's failure to warn claim was granted.
Design Defect Claim – Ohio is one of the states where the plaintiff must show there was a safer "alternative design" that should have been used. Ohio law says the plaintiff must prove "a practical and technically feasible alternative design" to the product at issue was available.
In his report, Dr. Galloway says:
"To a reasonable degree of medical certainty, Ms. Burris' injuries would not have occurred with alternative surgical intervention such as the Burch procedure, native tissue repair, or colpopexy. In addition, there were biologic materials, including autologous grafts, allografts and xenografts that would have been safer alternatives and would have alleviated the complications suffered by Ms. Burris."
But Ethicon argues biologics such as autologous slings do not qualify as an alternative design to the polypropylene mesh TVT-S.
According to Dr. Galloway, introducing mesh products into the marketplace violated the medical principle of "Do No Harm" and caused a predictable "public health crisis". He believes mesh products are unreasonably dangerous because the risks outweigh the benefits and because Ethicon misrepresented the potential for complications.
The court agreed with Ethicon that Dr. Galloway's statements about violating a medical principle should be excluded "as not relevant or helpful to the jury." Also excluded is Dr. Galloway's statement that a product was "unreasonably dangerous."
Dr. Galloway may testify as to why he believes the plaintiff's injuries were foreseeable.
Dr. Galloway is also prevented from stating at trial that exposed mesh is colonized and infected with bacteria causing infections in the woman. Cited studies show synthetic mesh is 'resistant to antibiotics and host defenses" and that infection 'has been found in as few as 31% and as high as 96% of cases involving the vaginal implantation of polypropylene mesh." Dr. Galloway bases his opinion on his own clinical experience supported by these studies and relevant medical literature.
Tina Burris was treated for a vaginal infection on August 20, 2008, only two weeks after she was implanted. Dr. Galloway in his deposition said that Burris was given antibiotics pre-surgery, which could have wiped out good bacteria leading to an active vaginal infection. The doctor will not be permitted in court to say her mesh was necessarily infected because it was exposed in the vagina.
Interestingly, Dr. Brown suspended any further use of the Prolift device after placing a Prolift into Ms. Burris. She learned from talking with other doctors and the American College of Obstetrics and Gynecology (ACOG) about the frequency of complications and the difficulty of removing the mesh. Dr. Brown testified that she would want to know what the company knew about a risk and that she would not have recommended a product to her patient otherwise.
Burris seeks punitive damages under the New Jersey Punitive Damages Act.
Expert Witnesses for the Defense may look familiar to readers of Mesh News Desk.
They include Laura Angelini, former V.P., global strategic marketing for Ethicon; Dr. Axel Arnaud, part of the European scientific team that developed and marketed Prolift; Scott Ciarrocca former engineer of Gynecare and specifically for Prolift; James Hart, former V.P. of medical operations at Ethicon; Dr. Piet Hinoul, former worldwide medical director at Ethicon; Gene Kammerer, an engineering fellow at Ethicon; Sean O'Bryan, a former senior product manager in the regulatory affairs department of Ethicon; Dr. Charlotte Owens, former worldwide medical director at Gynecare; Paul Parisi, former director of professional education at Ethicon; Dr. David Robinson, former medical director worldwide of Ethicon Women's Health and Urology; Renee Selman, former worldwide president Ethicon Women's Health & Urology; Price St. Hilaire, a division sales manager and marketing director at Ethicon; Martin Weisberg, former medical director for Ethicon and involved in the development and marketing of Prolift and Secur devices.