In July 2006, 41-year-old Linda Gross received the Gynecare Prolift—a transvaginal mesh device designed to treat pelvic organ prolapse (POP). Ethicon, Inc., a Johnson & Johnson subsidiary, manufactured and sold the Prolift as part of a “POP kit” that included surgical trocars for implanting the polypropylene mesh device. Gross’s surgeon implanted the mesh into Gross’s pelvic wall through incisions made in the vagina, using the kit’s trocars to tunnel the mesh through skin, nerves, and tissue.
After the mesh was implanted, Gross began suffering from severe pelvic pain and swelling. Doctors later discovered that the device had eroded into her vagina, causing inflammation, scarring, and neurological damage.
Gross underwent 18 surgeries—including multiple procedures to remove pieces of the mesh and repair damage. She now suffers from severe, unrelenting pain in her legs and pelvis that makes it difficult for her sit comfortably, be active for more than a few minutes at a time, or engage in sexual relations with her husband. The constant pain forced her to leave her job as a nurse, and she is permanently disabled.
Gross and her husband sued Ethicon, alleging that the company failed to adequately warn her surgeon about the device’s risks and made fraudulent misrepresentations to promote it. The plaintiffs presented evidence that Ethicon aggressively marketed the device and provided inadequate product warnings and literature suggesting that the device could be removed easily and posed few risks. The plaintiffs also sought punitive damages, asserting that Ethicon was aware of complications associated with the Prolift before selling it but placed it on the market anyway, despite the red flags, in order to meet the company’s planned March 2005 launch date.
Gross testified at trial that she takes more than 20 different medications for pain and pelvic problems and that the pain is so bad, she rarely leaves the house and is fearful of dying.
Ethicon denied that the device was defective and argued that it adequately warned physicians about the risks.
The jury found that Ethicon failed to adequately warn Gross’s physician about the Prolift’s risks and made fraudulent misrepresentations to Gross. The jury awarded about $3.35 million in compensatory damages. In a second phase, the jury awarded $7.76 million in punitive damages.
Citation: Gross v. Ethicon, Inc., No. Atla-L-6966-10 (N.J., Atlantic Co. Super. Feb. 25, 2013).
Plaintiff counsel: AAJ member Adam M. Slater, AAJ member David A. Mazie, Cheryll A. Calderon, and Karen G. Kelsen, all of Roseland, N.J.; AAJ member Benjamin Houston Anderson, Cleveland; and Jeffrey S. Grand, New York City.
Plaintiff experts: U. Klinge, biomaterials; Aachen, Germany; Peggy Pence, FDA regulations, Newbury Park, Calif.; Anne M. Weber, urogynecology, Pittsburgh; Edmond Provder, vocational rehabilitation, Hackensack, N.J.; and Ronni Seltzer, psychiatry, Englewood, N.J.
Comment: The case is the first to go to trial among more than 1,800 lawsuits by women alleged injury from the Gynecare Prolift. Numerous other cases alleging injuries from transvaginal mesh devices are pending against Johnson & Johnson and other manufacturers, including an MDL in federal court. Johnson & Johnson removed several transvaginal mesh products, including the Prolift, from the U.S. market after the FDA in 2011 ordered the company to perform postmarket studies showing the efficacy and safety of the devices.
Last July, a jury awarded damages to Christine Scott, who suffered permanent injuries after receiving the Avaulta Plus Biosynthetic Support System, a similar product manufactured by C.R. Bard, Inc. (Scott v. C.R. Bard, Inc., No. No. S-1500-CV-266034 (Cal., Kern Co. Super. July 24, 2012).) The plaintiffs in Scott were represented by Elaine Houghton and Eugene R. Lorenz, both of Bakersfield, Calif.