Ethicon Victor in Snowden v Ethicon Transvaginal Mesh Trial

Jane Akre
|
December 22, 2022

She’s among the youngest women to face off with Johnson & Johnson in court over their family of transvaginal meshes. (See Case number CC-19-05461-D County Court Law No. 4, Dallas County).

After a three-week trial before Judge Paula Rosales, the case went to the six-member jury on Thursday, December 22. Within a couple of hours they were back.

On Thursday, the jury returned with a verdict in favor of Ethicon (Johnson & Johnson).

This case is just the latest in a series of wins for J&J in the ongoing transvaginal mesh litigation since the trials resumed post-covid.

Snowden is shocked and disgusted with the verdict, but she is not planning on going away.

“I’m going to continue to fight. I have plans to petition the FDA and will keep fighting on every level I can. My urologist says he won’t use the transobturator mesh now because too many women are complaining of leg pain. I can’t sit back and let them do this to other women. My goal is to get the transobturator mesh off the market so it can’t hurt other women like me. There are safer alternatives.”  

The Case

Jen Snowden, now 38, received an Abbrevo pelvic mesh in March 2019 to treat stress urinary incontinence (SUI). It was an add-on surgery to a hysterectomy. Once active hiking, camping, and traveling, Snowden woke up from surgery screaming and did so for five days. Doctors relied on steroids and nerve blockers, but she soon traveled to St. Louis to have the embedded arms of the Abbrevo removed by Dr. Dionysios Veronikis. Snowden still suffers from chronic pain and nerve injury.

After at least three trial delays, the Snowden v Ethicon trial began in a Dallas County courtroom on November 30.

Dr. Oladell

The case is unique because Snowden sued Ethicon and her implanting doctor, Dr. Charmaine Oladell, M.D.

Pretrial Ethicon (Johnson & Johnson) argued with Dr. Oladell’s expert report, authored by Dr. Michael England, a Fort Worth, Texas physician, board certified in Female Pelvic Medicine and Reconstructive Surgery.

Dr. England was once a cheerleader for the company, known as a “preceptor” in the field, training other doctors on their use. But last March, he realized Ethicon was planning on throwing Dr. Oladell under the bus and blamed her for Snowden’s injuries. Dr. England has made a turnabout on the company line and now believes doctors should be told that at least 20 to 30 percent of pelvic meshes are removed due to complications.

Snowden was represented by Ben Martin and Laura Baughman of Martin Baughman, Dallas, and Charla Aldous of Aldous Walker LLP, Dallas. Butler Snow continues to represent Ethicon.

Abbrevo Still on the Market

Abbrevo is still on the market, and one in a family of J&J transvaginal meshes. Prolapse mesh to treat prolapse was taken off the market in 2019, but “slings,” such as Abbrevo, are still used today.

Abbrevo is a heavy-weight, small pore mesh made of Ethicon’s proprietary plastic polypropylene, Prolene.

The trial revealed that in 2003, TVT-O, the original obturator mesh, was the focus of Project Mulberry. The Gynecare division of J&J experienced a 15% decline in revenue in Europe and the U.S. since nine competitors had entered the market.

Years later, Belgian inventor, Dr. Jean de Leval, created the Abbrevo mesh device by retrofitting a TVT, cutting it down to a shortened size, re-sterilizing it, and using metal needles to implant it through the obturator muscles in 100 women. They were not told they were the subject of medical research.

As with other mesh developers, Dr. de Leval stood to be handsomely rewarded if his invention made it to market.

Abbrevo entered the market through the Food and Drug Administration’s 510(k) clearance in 2010, even though other doctors and consultants warned the heavy-weight mesh causes intense inflammation, shrinkage, and chronic foreign body reaction.

The Instructions for Use (IFU) that accompanies a medical device have been updated to strengthen the warnings about complications which include acute and chronic inflammation, acute and chronic foreign body response in all patients, the result of which is unpredictable, excessive scarring or tissue contraction, urinary retention independent of positioning or tension at implantation.  

Before covid, Ethicon suffered a series of courtroom defeats, with plaintiffs winning more than a dozen cases and being awarded anywhere from $1.1 million to $120 million.

The only other Abbrevo case that went to trial was Coleen Perry, tried in Bakersfield, California, in 2015. The jury awarded her $5.7 million.   

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