Southern California Record

Friday, February 21, 2020

Johnson & Johnson vows to appeal $344 million judgment in Ethicon vaginal mesh verdict

State Court

By John Sammon | Feb 3, 2020

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SAN DIEGO – A spokeswoman for Johnson & Johnson and its subsidiary Ethicon vowed to reverse on appeal the decision levying a $344 million civil penalty against the company for allegedly marketing and selling pelvic mesh devices company officials knew were dangerous.

“The Company will appeal the decision reached in the State of California’s transvaginal mesh case," Ethicon spokeswoman Mindy Tinsley told the Southern California Record. “Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients, and the decision disregards the company’s full compliance with U.S. Food and Drug Administration (FDA) laws on medical device communications and the appropriateness of its actions.”

Last Thursday, San Diego Superior Court Judge Eddie Sturgeon handed down the verdict after a bench trial ran for nine weeks from July to October of 2019. The California Attorney General’s Office accused the company of withholding information from patients and doctors about the risks, side effects and complications associated with the implants.

The alleged complications included acute pelvic pain, extrusion, erosion and painful intercourse called dyspareunia. Expert witnesses testifying for the state said removal of the devices from the vagina were often extremely difficult like removing rebar from a sidewalk.

The pelvic mesh devices called Prolift and TVT (tension-free vaginal tape) slings made by Ethicon, allegedly caused vaginal injuries in women. Prolift is a clear polypropylene mesh with eight thin connecting arms.

The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014. The mesh is designed to help a sagging bladder condition called pelvic organ prolapse, or POP.

This was the first trial launched by a state attorney general seeking damages alleging unfair competition and false advertising. Attorneys for the state had hoped for a $798 million penalty against the company.

The trial which began on July 15 pitted attorneys for the California AG’s office who alleged J&J deliberately withheld information on the dangers of the mesh devices to make them easier to sell, versus attorneys for Johnson & Johnson who contended the instructions accompanying the mesh kits were never intended as a complete list of every possible complication. They maintained doctors didn't use the instructions called "IFUs" anyway because they already knew the surgical procedures,

Tinsley said the state had failed to produce evidence that proved any California doctor or patient had been misled by Ethicon.

“The State failed to call a single California doctor who has used one of Ethicon’s prescription mesh devices, or a single California patient who ever saw an Ethicon communication to testify at trial,” she said.

Tinsley said the company had presented expert witness testimony during the trial that demonstrated the value of the products in treating female incontinence.

“Ethicon called numerous California doctors with experience using Ethicon’s pelvic mesh devices to successfully treat the often-debilitating symptoms of stress urinary incontinence and pelvic organ prolapse in their patients, and those doctors uniformly disputed the State’s allegations,” she said.

Tinsley said in addition, 82 California surgeons publicly disagreed with the state’s lawsuit in its entirety, indicating in a letter to the California AG that they were not misled.

“They (surgeons) relied on their medical education and clinical experience, among other sources, to counsel patients on the risks of surgical mesh, rather than information provided by the manufacturer,” she added.

Tinsley said she expects the appeals process to take one to three years.   

During the trial California was represented by in-house attorneys from the AG’s office.

Ethicon was represented by attorneys from Covington & Burling.

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