Subscribe-to-CVN-Blog-Graphic-small.png

Bellwether Ethicon Pelvic Mesh Trial Begins In California

Posted by David Siegel on Jan 26, 2015 3:53:00 PM

Bakersfield - Opening statements in a bellwether product liability suit alleging Johnson & Johnson's Ethicon unit designed a defective pelvic mesh product and withheld knowledge of the mesh's health risks began Monday in California state court.

Plaintiff Coleen Perry’s suit is the first case involving Ethicon’s “TVT-Abbrevo” sling system to be decided by a jury out of tens of thousands of pelvic mesh suits filed in state and federal court across the country. Perry had the device implanted in 2011 to treat a bladder problem called stress urinary incontinence, according to her complaint. Perry’s suit claims she later suffered painful side effects after her immune system reacted to the device’s propylene mesh and it eroded through her vaginal tissue.

During opening statements, Perry’s attorney Thomas Cartmell of Wagstaff & Cartmell LLP told jurors that Ethicon knew about the potential for propylene mesh to prompt an immune system response but failed to appropriately warn patients and physicians. Cartmell told jurors that if Perry and her doctor knew the TVT-Abbrevo couldn’t be easily removed and would remain in Perry’s body despite additional surgery, it never would have been used.

Cartmell told jurors that evidence would show Ethicon used a laser-cut mesh in the TVT-Abbrevo, which remains on the market, instead of mechanically-cut mesh to save money, despite knowing the laser-cut mesh was too heavy and stiff for implantation in vaginal tissue and having already developed safer, lighter weight alternatives to propylene mesh.

“The reason for this product was because they needed to protect their money,” Cartmell said, according to a Courtroom View Network webcast of the proceedings. “They should have used one of their lighter-weight meshes they had already developed and was in their arsenal.”

Cartmell said Ethicon falsely represented that the TVT-Abbrevo had been approved by the U.S. Food and Drug Administration. Instead the FDA had given a clearance to the device based on evidence submitted by Ethicon, Cartmell argued. He claimed that Ethicon didn’t provide the agency adequate information to make the clearance determination, because the studies used to support its application were based on other mesh devices.

While he didn’t ask for a specific amount of damages during his opening, Cartmell told jurors that the mesh would likely remain inside Perry’s body forever, and that she would probably never be able to engage in sexual intercourse with her husband again despite only being 50.

Representing Ethicon, Kim Schmid of Bowman and Brooke LLP told jurors the TVT-Abbrevo was the “gold standard” in pelvic mesh products, and that Perry only considered suing Ethicon after seeing a plaintiff attorney’s advertisement.

Schmid argued that Perry had numerous medical procedures in a nine-month span to treat organ prolapse, and that there was no way to definitively link the TVT-Abbrevo implantation to Perry’s current condition.

“The other surgeries involved the same risks and possible side effects as the TVT-Abbrevo,” Schmid said.

Ethicon has not fared well to date in state court trials over its pelvic mesh products. In 2013 a New Jersey jury socked the company with an $11.1 verdict - which is still being appealed -  over the Prolift system. That trial was also recorded by CVN. In April 2014 a Dallas jury slammed Ethicon with a $1.2 million verdict over its TVT-O product. Another trial over the Prolift, which was the first wrongful death claim against Ethicon to go before a jury, reportedly settled on Jan. 21 in Missouri state court.

The company has seen slightly better results in federal court, where the majority of pelvic mesh cases in the country are centralized in a sprawling multi-district litigation before U.S. District Judge Joseph R. Goodwin in West Virginia. Ethicon obtained a directed verdict in its favor at the first federal trial over its products in February 2014, but later suffered a $3.27 loss in a trial over the TVT-O sling the following September.

A third federal bellwether trial involving Ethicon is scheduled for March, according to court dockets.

The only pelvic mesh manufacturer to obtain defense verdicts in state court is Boston Scientific Corp., which prevailed in two cases in Massachusetts in 2014 but was later hit with an $18.5 million verdict by a federal jury. 

The current state court trial before Judge Lorna Brumfield is expected to last up to three weeks.

Attorneys for Perry and a representative for Ethicon did not respond to requests for comment from CVN.

The plaintiffs are represented by Wagstaff & Cartmell LLP, Richard A. Freese of Freese & Goss, Stewart Albertson of Albertson & Davidson LLP and by Peter De La Cerda of Edwards & De La Cerda PLLC.

Ethicon is represented by Bowman and Brooke LLP, William Gage and Burt Snell of Butler Snow LLP and by Soo Lin and Joshua Wes of Tucker Ellis LLP.

The case is Coleen Perry v. Ethicon Inc., et al., case number S-1500-CV-279123, in the Superior Court of California for Kern County.

 

Topics: Products Liability