October 10, 2017, PLLR E-Newsletter

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Jury finds for another patient injured by Ethicon pelvic mesh

Surgical knife and tension-free vaginal tape for TVT operation

The plaintiff—who suffered injuries resulting in severe and permanent incontinence—alleged that the mesh devices were defectively designed in that the polypropylene material was too stiff and dense and had holes that were too small to properly integrate into the vaginal tissue. The jury awarded $57.1 million, including $50 million in punitive damages. Ebaugh v. Ethicon Inc.
 

When Ella Ebaugh complained of stress urinary incontinence, her doctor recommended she undergo surgery to receive a pelvic mesh device. In May 2007 at age 41, Ebaugh was implanted with the Gynecare TVT-Secur System. The device consists of polypropylene mesh tape that is implanted through an incision in the vagina and placed below the mid portion of the urethra to form a sling. The sling is designed to keep the urethra in place when the patient coughs, laughs, or strains in other ways that exert pressure on the pelvic muscles controlling the urethra.

Ebaugh's incontinence persisted after the surgery, and she underwent a second surgery several weeks later to have a second device—the TVT Retropubic system—implanted. The second device was implanted on top of the first one.

In 2011, Ebaugh visited her doctor with complaints of severe pelvic pain and sudden urges to urinate. Cystoscopy confirmed that the mesh had eroded into her urethra. She underwent cystoscopic removal of the mesh in 2011, which seemingly cured her problems. In 2012, however, her symptoms returned, and doctors discovered that she had another mesh erosion, this time in her urethra and in her bladder.

Ebaugh underwent vaginal surgery to remove mesh from inside and around the urethra, as well as open abdominal surgery to try to locate the bladder erosion. In 2015, she experienced a third urethral erosion of mesh, and had yet another vaginal surgery to remove it. Doctors were unable to remove all of the mesh, however. She now suffers from chronic pain, dyspareunia, and intrinsic sphincter deficiency, marked by severe and permanent incontinence.

Ebaugh sued Ethicon, Inc., which designed and manufactured the TVT devices, and Ethicon’s parent company, Johnson & Johnson. The plaintiff alleged that the devices were defectively designed in that the polypropylene mesh material was too stiff and dense and had holes that were too small to properly integrate into the vaginal tissue.

In addition to asserting design defect claims, the plaintiff alleged that the defendants negligently designed the devices. The plaintiff introduced internal J&J emails showing that the company was aware of problems with the devices and attempted to manipulate the medical literature to cover up the problems.

The jury awarded $57.1 million, including $50 million in punitive damages and $7.1 million in compensatory damages. The defendants have filed a motion for post-trial relief, focusing on the statute of limitations.

Citation: Ebaugh v. Ethicon Inc., No. 130700866 (Pa. Ct. Com. Pl. Phila. Cnty. Sept. 7, 2017).

Plaintiff counsel: AAJ members Kila B. Baldwin, Tracie L. Palmer and Elia Robertson, all of Philadelphia.

Plaintiff experts: Bruce Rosenzweig, gynecology, Chicago; and Tom Margolis, urogynecology, San Francisco.

Defense experts: Jamie Sepulvada, urogynecology, Miami; and Janet Tomezsko, urogynecology, Skokie, Ill.

Comment: This case is the fourth verdict against Ethicon in Philadelphia’s pelvic mesh mass tort program. In late 2015, a jury awarded $12.5 million to a woman who suffered permanent injuries after receiving Ethicon’s Gynecare Prolift device. Last year, a jury awarded $13.5 million to another woman who was permanently injured after the Ethicon TVT mid-urethral sling doctors implanted eroded, resulting in multiple complications. This April, a jury awarded $20 million—including $17.5 million in punitive damages—to Margaret Engleman, who experienced a host of similar problems after receiving the TVT-Secur. A month later, another jury awarded $2.16 million to Sharon Beltz, who suffers from chronic, severe pain after complications from Ethicon’s Total Prolift, another polypropylene mesh device.

More state cases are pending against Ethicon in the Philadelphia mass tort pelvic mesh litigation as well as in other states. Federal cases have been consolidated in the U.S. District Court for the Southern District of West Virginia.