McFarland v. Ethicon Makes TVT-O Design the Focus in Philadelphia Pelvic Mesh Case

Jane Akre
August 21, 2018

TVT-O from

Mesh Medical Device News Desk, August 21, 2018 ~ Four new pelvic mesh lawsuits will be heard in the coming months after a long lapse with no trial action. The Philadelphia Court of Common Pleas is the next venue.

Monday, August 27, is the opening day of a jury trial in the case of McFarland v Ethicon, [1307-01577 Mcfarland Etal v Ethicon Women’s Health and Urology],. Ethicon is the medical device division of Johnson & Johnson and maker of the TVT-O.

Jury selection was last week and McFarland will be the 8th case heard in the Philadelphia Court of Common Pleas. All but one has yielded multi-million dollar compensation verdicts in the plaintiffs' favor. Kline Specter of Philadelphia is representing Ms. McFarland.

Image: Tracie Palmer, attorney for Kline Specter

On or about April 3, 2008 Ms. McFarland was implanted with Gynecare TVT-O by Dr. Liang R. Bartkowiak, MD at Altoona Hospital Campus – Main in Altoona, Pennsylvania. TVT-O stands for tension-free vaginal tape-obturator, referring to the obturator space through which the polypropylene mesh is woven.

See Dr. Bartkowiak, on Dollars for Doctors, a ProPublic Project. See the Vitals Reviews here.

Dr. Liang Bartkowiak, MD

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 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.

Traci Palmer, Kline Specter

The Complaint says J&J knew that its disclosures to the FDA were and are not complete and are misleading and that their pelvic mesh products “were and are causing numerous patients severe injuries and complication like those suffered …” by the plaintiff.

J&J “suppressed this information, and failed to accurately and completely disseminate or share this and other critical information with the FDA, health care providers, or the patients. “

In January 2012, the FDA ordered the Defendants to conduct randomized, controlled clinical testing of the pelvic mesh products and by June 2012 many defendants announced they were withdrawing some and or all of the pelvic mesh products from the market and would not be conducting randomized, controlled clinical testing ordered by the FDA.

“As of the date of the filing of this Complaint, neither the J&J Defendants nor the Secant Defendants have ever begun or completed any of the randomized, controlled clinical testing ordered by the FDA.”

The Complaint lists - defective manufacture and design; failure to warn; negligence; common law fraud; negligent misrepresentation; negligent infliction of emotional distress; breach of express warranty; breach of implied warranty; violation of consumer protection law; gross negligence; loss of consortium; signed by Lee Balefsky, on July 10, 2013.

Tracie Palmer will be the lead counsel. In September 2017, she along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon. Of the seven cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case in pelvic mesh litigation in that venue.

Two other product liability trials involving Ethicon's TVT-O have concluded it was defectively designed. They include Jo Huskey v. Ethicon ($3.27 Million) in September 2014 (here), and Linda Batiste v. Ethicon, ($1.2 million) in a Dallas court in April 2014 (here).

In the Huskey trial, it was argued that the heavyweight laser-cut mesh led to mesh shrinkage and contraction and foreign body response near muscles and nerves, all contributing to pain.


Gynecare no longer exists. Gynecare, Inc. was merged out of existence and into Ethicon, Inc. on January 3, 2000. Ethicon supplies Secant with spools of PROLENE polypropylene filament which it knits to produce large rolls of mesh per specifications.

J&J's Prolene Mesh

According to filings in the McFarland docket, defendant, Ethicon, has been busy trying to eliminate experts on behalf of McFarland.

Among them is Dr. Bruce Rosenzweig, a urogynecologist from Chicago and expert witness for the plaintiff, as is regulatory expert, Peggy Pence, PhD. Dr. Uwe Klinge, an expert on mesh after its removed from the body, has appeared at other trials and submitted an expert report in McFarland as has Vladimir Iakovlev, MD, who heads a hernia explant lab in Toronto, and the Mayo Clinics' Dr. Daniel Elliott.

The motion to exclude Dr. Klinge was denied as was the defense motion to exclude Dr. Pence. The defense motion to exclude Dr. Iakovlev MD was denied as well.

Besides the Ella Ebaugh case, other cases heard in the Philadelphia court include the Atkins’ case on the TVT-Secur which yielded zero for Ms. Atkins; Ms. Beltz was awarded $2.16 million; Ms. Engleman was a $20 million verdict for the plaintiff; Ms. Carlino $13.5 million; and Ms. Hammons $12.5 million.


In November in the same court the case of Emmett v Ethicon will be heard. 1307-01495 Emmett Etal vs Ethicon Women’s Health and Urology, Trial date: November 19, 2018. See docket here.

In Bergen County, New Jersey, two trials will be heard in Superior Court there with attorney Adam Slater representing the plaintiffs.

Oct 1, Catherine Burns v. Ethicon - Prolift Anterior and TVT-O, 013723-14, filed 2/2/2010

Oct 22, Sandra and Ernest Rios v. Bard - Avaulta Solo Anterior, 018689-14, filed 5/5/2014.


Mesh Trials so far

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