Ethicon Vaginal Mesh Trial – Case Dismissed for Lack of Evidence

Federal Judge Dismisses Ethicon Vaginal Mesh Lawsuit

Ava Lawson | February 26th, 2014

Ethicon Vaginal Mesh Trial – Case Dismissed for Lack of EvidenceAfter a week-long Ethicon vaginal mesh trial in West Virginia district court, Judge Joseph Goodwin dismissed the claim “as a matter of law.” It was the first in a series of bellwether cases in MDL No. 2327, in which Ethicon (a unit of Johnson &Johnson) is defending allegations of defective design, breach of warranties and failure to warn regarding its controversial pelvic mesh devices – the TVT Retropubic and Gynecare Prolift systems.

The lawsuit was brought by a Texas woman named Carolyn Lewis who was implanted with the Ethicon vaginal mesh in 2009. After the plaintiff’s attorneys finished presenting her case, legal counsel for Johnson & Johnson filed a summary judgment, contending that Lewis had yet to show proof of product defect or manufacturer negligence.

Ultimately, after a mere six days of trial, Judge Goodwin ruled that Lewis failed to provide enough evidence to support her allegations of TVT pelvic mesh injuries, or that the product suffered design defects.  Judge Goodwin had already dismissed Lewis’ claim of failure to warn.

Ethicon vaginal mesh trial ends in defense verdict

Lawyers for the Texas woman argued that their client wasn’t required to prove that design defects in the device caused her injuries. In response to J&J’s summary judgment, the claimant filed a brief in which her attorneys stated:

“ As described in [the] plaintiff’s initial brief in design defect issues, Ethicon’s TVT product was defective primarily because it is a heavyweight, small-pore mesh, and because it is a mechanically cut mesh. The heavyweight, small-pore nature of the mesh leads to foreign body response, scarring, fibrotic bridging, shrinkage and nerve entrapment, which causes pain for the patient. The mesh also degrades in the body, leading to chronic inflammation. The plaintiff has further alleged that the TVT product was unreasonably dangerous when implanted in Mrs. Lewis because it was mechanically cut, which leads to fraying, roping, curling, and particle loss.”

The brief further notes that Dr. Piet Hinoul, the worldwide medical director for Ethicon’s energy franchise, acknowledged that it was theoretically possible that women could suffer painful sex and nerve damage causing lasting pain, even at the time the TVT was launched. Despite these efforts, Judge Goodwin ruled in favor of the defendants, Johnson and Johnson and its subsidiary Ethicon, which are facing another 10,000 transvaginal mesh lawsuits regarding similar injuries and complications with their products.

Status of transvaginal mesh litigation

Judge Goodwin is currently presiding over more than 40,000 vaginal mesh cases in West Virginia federal court, filed against manufacturers such as Boston Scientific, C.R. Bard, American Medical Systems and Cotoplast. Six different multidistrict litigations were established to handle the magnitude of claims.

Lewis’ Ethicon mesh lawsuit was the first in a series of ten bellwether trials — test cases that will be heard over the coming months in the Charleston court. Past bellwether verdicts include a $2 million award for plaintiff Donna Cisson, who suffered severe complications from a pelvic mesh system produced by Bard. The second bellwether case against Bard settled for an undisclosed sum just before opening arguments were made.

Plaintiffs have obtained other favorable verdicts in state courts as well. Last year, a New Jersey Supreme Court ordered Ethicon to pay $11.1 million in damages to a South Dakota resident who sustained permanent injuries from the Gynecare Prolift system. And in 2012, a California woman and her spouse won $5.5 million from Bard.

Meanwhile, consolidated federal litigation moves forward with the next bellwether trial for an AMS pelvic mesh lawsuit scheduled in April 2014.


  1. WV Gazette, Federal judge dismisses latest mesh trial in Charleston, http://www.wvgazette.com/News/201402180078

  2. U.S. District Court, Southern District of West Virginia, Bellwether Trials for MDL No. 2327, http://www.wvsd.uscourts.gov/MDL/ethicon/Bellwether_Trials.html