TVT and TVT-O, surology.com

Mesh Medical Device News Desk, September 24, 2018- After four days of deliberation, jurors in the trasnsvaginal mesh case of Susan McFarland v. healthcare giant Johnson & Johnson (Ethicon) ended in a deadlocked jury.

Judge Michael Erdos had no option but to call for a mistrial.

McFarland v Ethicon [1307-01577] opened August 27 in the Philadelphia Court of Common Pleas.

Jurors had before them an option to declare that Ethicon negligently designed the TVT-O (tension free vaginal mesh-obturator- see graphic) polypropylene transvaginal mesh. They were also given the option to award punitive damages.

TVT-O is part of the Ethicon family of meshes and designed to support the urethra and treat incontinence. It is also the most controversial mesh still on the market, according to doctors who used to use it.

*NEW ADD* JURY MAKEUP

Philadelphia Court of Common Pleas

The jury make up in McFarland v. Ethicon was 3 men and 9 women.

Of the men- one was younger and two older.  Of the women- three were younger and six were middle age or older.
A verdict required 10 of the 12 jurors to agree.  They agreed on the first two questions which were statute of limitations and negligent design. There were two holdouts on whether the mesh was the cause of her injury and two others changed to join the two holdouts on causation.

The primary defense was that Ms. McFarland’s injuries were caused by age and menopause-related vaginal atrophy. That really came down to a battle of the experts and the plaintiff’s testimony.

*New Add Plaintiffs’ attorney Tracie Palmer tells MND:

Traci Palmer, Kline Specter

“Johnson & Johnson and Ethicon relied heavily on the fact that the TVT-O, as well as its predecessor, the TVT, are still on the market to bolster their claim that the TVT-O is safe for women. Nonetheless, the jury saw through their defense and found that Ethicon failed to use due care and that the TVT-O was negligently designed.”

“We look forward to trying the case again in Philadelphia and proving that the negligently designed TVT-O caused Mrs. McFarland’s injuries. “

Defense attorney Melissa A. Merk of Drinker Biddle & Reath LLP asked the court to grant a mistrial in a September 24 letter to Judge Michael Erdos.

Melissa Merk, Drinker Biddle & Reath

“A jury’s failure to agree deprives any of the interim steps of finality,” as there is no splitting of claims, she writes.

On September 18, defense had asked for a directed verdict on the negligent design-defect claim on the basis that the plaintiff had exceeded a two-year statute of limitations; that the design defect claims are preempted by federal law; and that the plaintiff cannot show the product was unsafe for every woman for every purpose.

This was the seventh transvaginal mesh trial in the Philadelphia Court of Common Pleas.  All but one have awarded plaintiffs compensation for their injuries as well as punitive damages totaling more than $105 million.

 

Interestingly, Johnson & Johnson also had a mistrial declared in a Pasadena, California courtroom on the same day over its baby powder the plaintiff alleged was laced with asbestos causing her mesothelioma.  The last similar case in a St. Louis courtroom awarded $4.69 billion in July to 22 women who b lame the talcum powder for their cancers.

 

BACKGROUND ON TVT-O

This is the first transvaginal mesh case in this jurisdiction concerning the TVT-O polypropylene mesh. TVT-O is run through the obturator space (see the graphic at head of this story for a full explanation).

In September 2017, Palmer along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon over another mesh in the TVT family (TVT-Secur).

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.

 

MCFARLAND BACKGROUND

Dr. Liang Bartkowiak MD

Susan McFarland, 67,  underwent the implantation of a Tension Free Vaginal Tape-Obturator system (TVT-O) by Liang R. Bartkowiak, M.D. on April 3, 2008.

Since then she has experienced vaginal pain, urinary tract infections which are frequent, dyspareunia, recurrent SUI, new onset urge incontinence and urinary frequency.  Within the year she complained to Dr. Bartkowiak she could “feel something in her vagina” and she had vaginal bleeding and dyspareunia.   She was identified with a “right periurethral TVT erosion through the vaginal vault.”

On September 29, 2009, Dr. Bartkowiak performed a revision surgery on Ms. McFarland. She removed “very tight adhesions of the tension-free vaginal tape on the right periurethral area” and “trimmed” the TVT-O.

Ms. McFarland continued to experience vaginal bleeding, dyspareunia, frequent urination and leakage as well as frequent and severe urinary tract infections.  An appointment with another doctor, urologist, Henry C. Wong, M.D. and he performed a cystoscopy on Ms. McFarland and noted incomplete emptying with a recent increase in urinary tract infections and dyspareunia since implantation of the TVT-O device.

In August 2013, she was diagnosed with vaginal atrophy and dyspareunia and received a Premarin prescription.

A third doctor, urologist Stephen Yanoshak, D.O diagnosed her with “urinary frequency, nocturia, incomplete emptying of bladder, recurrent urinary tract infections and both SUI and urge incontinence.”

She continues to suffer from SUI and urge incontinence, urinary tract infections that are frequent and severe, dyspareunia so painful she rarely engages in intercourse and emotional and psychological injuries.

 

RUSHED TO MARKET 

The plaintiffs claim TVT-O was rushed to market in 2001 without properly evaluating its safety or efficacy, and that it is defective in its design and unsafe for use in women, and that Ethicon continues to market and Sell the TVT-O without proper warnings, despite its knowledge of the defects.  From Motion in Limine (here).

Both the TVT and TVT-O were cleared to market through the FDA’s 510(k) process which requires only to name a predicate device. In this case it was the ProteGen made by Boston Scientific. ProteGen was voluntarily recalled from the market because it did not perform as intended.  The TVT-O was intended to be an improvement on the TVT and sales profits were estimated to exceed $34 million by 2010.

Feeling the pressure from competitors, Project Mulberry’s goal was to bring the TVT-O to market. Ethicon’s product development plan called for 24 months of review, which was shortened to eighteen month, then 12 months.  Finally, considering the eroding TVT business, a revised timetable of just 9 months was settled upon.

“Project Mulberry is critical to GYNECARE’s success in the incontinence marketplace,”   and “We MUST make this project happen in a short period of time,” said an email from Ronnie Toddywala to multiple recipients on June 24, 2003.~ Toddywala, Ethicon VP of Research & Development.

To meet the company goals of nine month before launch, defendants decided to forgo any clinical studies of the TVT-O, even though Dan Smith had suggested six months of clinical testing.

 

DEFECTIVE MESH/ v  Negligent Design?

Plaintiffs in previous cases have determined the TVT-O is defective because

*Polypropylene is unsuitable for use in a woman’s vagina

*The transobturator insertion technique carries the risk of additional complications including injury to obturator nerve

*the mesh is machine cut making it excessively rigid, frays, degrades, rope and lose particles (laser cut mesh became available in the 4Q of 2006 for TVT products)

*the mesh degrades

*the mesh causes chronic foreign body reaction

*the mesh causes infections and the formation of bio-film

*the mesh incites fibrotic bridging leading to scar plate formation and mesh encapsulation

*the mesh shrinks and contracts

*toxicity testing reveals it is cytotoxic, meaning toxic to the body’s cells causing cell death or injury

Ethicon never studies what effect there might be on patients implanted with machine cut mesh, while Ethicon continued to market and sell TVT products with machine cut mesh, including the TVT-O.

 

SIX PRIOR CASES

Of the six cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case.

Others include:

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.