Fidelma Fitzpatrick.
Fidelma Fitzpatrick. (Photo: Peter Goldberg)

The first federal bellwether trial began on Monday against Johnson & Johnson in a case alleging one of its transvaginal mesh devices is defective.

Johnson & Johnson’s Ethicon Inc. unit faces 33,000 lawsuits worldwide claiming its pelvic mesh devices, which are used to treat urinary incontinence and pelvic organ prolapse, have caused women pain and forced them to undergo subsequent surgeries to remove them.

Monday’s trial, which is taking place in Charleston, W.Va., is the first before U.S. District Judge Joseph Goodwin to tell jurors about Ethicon’s TVT-O pelvic mesh sling. On Feb. 19, Goodwin threw out the first pelvic mesh trial in federal court against Ethicon involving another device, the TVT.

“This trial is critically important to women and their families from across the U.S. who have needlessly suffered from injuries related to pelvic mesh implants,” said Jane Akre, news editor of Mesh News Desk, in a prepared statement on Monday. Akre is monitoring the trial on behalf of a consumer group called the We Are Mesh Survivors Coalition, which plans to ask Congress this week to consider investigating the devices. “We will be closely monitoring this case and will document testimony provided by the plaintiffs, J&J and any medical experts with involvement.”

Jo Huskey and her husband, Allen Huskey, sued Ethicon in 2012 after a TVT-O pelvic mesh eroded in her body.

“She developed an erosion—an infection—and had to have two removal surgeries, one of which was pretty invasive,” said Fidelma Fitzpatrick, a member in the Providence office of Motley Rice, one of the attorneys on the plaintiffs trial team. “Because of the mesh and scar tissue and damage done, like excising the mesh, she has very significant pain caused by damaged muscles on her pelvic floor.”

On April 30, Motley Rice negotiated an $830 million settlement with another pelvic mesh device manufacturer, Endo International PLC, to resolve claims against subsidiary American Medical Systems Inc. in Minneapolis.

The Huskey trial is expected to last eight days.

Edward Wallace, partner at Chicago’s Wexler Wallace, lead trial counsel, did not respond to a request for comment. Ethicon is represented at trial by Christy Jones of Butler Snow in Ridgeland, Miss., and David Thomas, founding member of Thomas Combs & Spann in Charleston.

Johnson & Johnson spokesman Matthew Johnson issued a statement via email: “We empathize with Mrs. Huskey’s medical situation, and we are always concerned when a patient experiences adverse medical conditions. However, we believe that the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of our TVT-O midurethral sling for the treatment of stress urinary incontinence. We have always made patient safety a top priority and will continue to do so.”

Last year, Johnson & Johnson lost an $11 million verdict in New Jersey state court in a trial involving a South Dakota woman who underwent 18 operations in six years after being implanted with a different Ethicon device.

On April 3, a jury in Dallas, hearing a case in Texas state court, awarded $1.2 million in the first trial in the nation over the TVT-O sling, which they found was defectively designed. Huskey, who lives in Illinois, has sued under Illinois law.

“Texas has different law than Illinois, so we’re applying a different set of laws and different things we have to prove,” Fitzpatrick said. “But it is the same device, and we’ll be hopeful the jury in West Virginia does what the jury in Texas did.”

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