Mesh Medical Device News Desk, September 10, 2018 ~ The McFarland pelvic mesh trial is the seventh product liability case brought against Johnson & Johnson (Ethicon) in the Philadelphia Court of Common Pleas, over its allegedly defective pelvic meshes.
It should wrap up next week.
Lawyers for McFarland plan to rest their case today, with the defective design product liability case turning over to the defense version of the facts.
It has been busy two weeks for the plaintiff. Tracie Palmer of the Philadelphia law firm of Kline Specter is the lead counsel. Ms. McFarland’s trial began August 27th and is being heard in the Philadelphia Court of Common Pleas before Judge Arnold L. New [1307-01577].
The court is a favorable venue for the vast majority of pelvic mesh cases heard there so far.
On or about April 3, 2008 Ms. McFarland, 67, was implanted with Gynecare TVT-O by Dr. Liang R. Bartkowiak, MD at Altoona Hospital Campus – Main in Altoona, Pennsylvania.
Ms. McFarland has undergone one revision surgery.
As a result of the surgeries she, “has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including but not limited to, obligations for medical services and expenses.”
The case revolves around design defect, strict liability and negligence.
The action names Ethicon, Inc. Ethicon Women’s Health and Urology of Ethicon, Inc. and Secant Medical, a corporation located in Perkasie, PA in business jointly with Defendant Prodesco, Inc. the venue is correct in that plaintiff and defendants live and/or have business in the state of Pennsylvania.
Susan and Patrick McFarland are from Altoona, Pennsylvania.
The videotaped depositions of Dr. Charles Nager and Dr. Eric Rovner were played for the jury by McFarland’s attorneys.
There are two doctors representing AUGS (American Urogynecologic Society) and SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction) who wrote the medical society Position Statements on the mid-urethral sling (MUS) calling it the “Gold Standard.”
Charles Nager, M.D. is urogynecologist at UC San Diego in the AUGS, and past president of AUGS 2013-2014
See Frequently asked questions statement from Nager here.
The Position Statement on MUS AUGS/ SUFU (here) January 3, 2014, and was crafted to be used in mesh lawsuits.
Here is the Feb. 2018 version again repeating the gold standard assurances that polypropylene mesh mid-urethral slings are the standard of care and are safe and effective treatment for SUI.
The AUGS PFD (Pelvic Floors Disorders) Research Foundation 2017 Annual Report shows support of 44% from corporate partners, the makers of the polyproyolene pelvic mesh.
Dr. M. Tom Margolis was in the courtroom as a medical expert for the plaintiff.
Dr. Margolis has been one of the top critics of synthetic transvaginal mesh. The San Francisco Bay area urogynecologist believes it should be pulled off the market largely because transvaginal surgery is contaminated by passage through the vagina, a clean-contaminated field, which begins the cascading effects of infection.
Dr. Margolis is known for appearing as an expert witness on behalf of plaintiffs on at least a dozen trials. His expression, “the more mesh, the more mess,” is often repeated by the injured community and even in trial.
He has called polypropylene mesh the biggest crime against women in history and “evidence-based genital mutilation.”
At his clinic in the Bay Area of San Francisco, Bay Area Pelvic Surgery, in Burlingame, California, he performs an average of 10 major surgical procedures a week. Much of his practice at involves removing synthetic mesh from patients who have suffered numerous complications.
He adds that in the last 15 years the increasing number of baby boomers, availability of cheap polypropylene (synthetic) materials, a push by insurance companies for outpatient procedures and the added profit paid to physicians, has made synthetic sling procedures very popular.
Also involved was the videotaped testimony of Dr. Bruce Rosenzweig, a medical expert from Rush University in Chicago, who removes problematic mesh and who has testified at many trials. In the Huskey v. Ethicon trial in Charleston, WV, he told jurors the placement of the TVT-O in the adductor muscles can irritate the obturator nerve resulting in pain. He also said that the heavyweight, laser-cut mesh in the TVT-O led to mesh shrinkage and contraction and foreign body response near muscles and nerves – all contributing to pain.
Jurors listened to a videotape of Dr. Piet Hinoul, VP of Medical Affairs, Ethicon. He has been the designated corporate representative in all of the trials so far against the healthcare giant. It was his job to contact key opinion leaders and have them test and promote meshes as they were launched.
Dr. Meng Chen, of Ethicon was in charge of customer complaints, and listened to the adverse event reports coming into the company. She had made executives aware of the complaints and complications saying in a deposition used in the Huskey trial”These complications are not transitory,” yet the company did not make changes to the IFU (Instructions for Use).
Dr. Jorge Holste, a scientist with Ethicon has testified in previous trials that heavyweight meshes increase complications and Ethicon’s Prolene polypropylene mesh is considered a heavyweight, dense mesh.
Laura Angelini, was a VP of Marketing for Ethicon who helped bring Prolift onto the market.
DEFECTS WITH TVT-O
The Jo Huskey trial in Charleston, WV alleged there were six defects with the TVT-O. They include:
* It’s made with Prolene mesh
* Prolene mesh undergoes oxidative degradation
* Prolene mesh shrinks
* Prolene mesh deforms
* Prolene mesh is too heavy and causes chronic foreign body reaction
* Prolene mesh is placed in the obturator space
* Prolene mesh was laser cut
The defense is calling Dr. Robert Rogers, Dr. Liz Mueller, a urogynecologist from Illinois, and Ethicon engineer Katrin Elbert. In 2004, Ethicon did internal testing of the laser cut mesh and stretched it 20 percent and found it was three times stiffer than the mechanically cut mesh, she had testified in the Perry trial.
There was no discussion of the U.S. Food and Drug Administration’s clearance of mesh onto the market. The 510(k) is a fast-track system that requires little of manufacturers other than to name a predicate that is substantially similar to their device.
The case should wrap up by the middle of next week.
THE PHILADELPHIA COURT OF COMMON PLEAS
In September 2017, lead counsel Tracie Palmer, along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon.
Of the six cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case.
Hammons $12.5 million (Prolift), Dec. 2015
Carlino $13.5 million; (TVT), Feb 2016
Engleman $20 million, (TVT-S), April 2017
Beltz $2.16 million (Prolift), May 2017
Ebaugh $57 million (TVT and TVT-S), September 2017
The only favorable verdict for Ethicon was the Atkins case in June of 2017 (TVT-Secur). A new trial has been ordered in that case.