The first mass tort trial over a Johnson & Johnson unit’s pelvic mesh product ended in a $3.35 million verdict for the plaintiff, and the jury is weighing punitive damages.
After eight weeks, the jury on Monday found Ethicon, the manufacturer, liable for injuries from the Gynecare Prolift surgical mesh implant.
The case, In Re Pelvic Mesh/Gynecare Litigation, No. 291, consolidates 2,182 suits in Atlantic County Superior Court.
The litigants are women who claim they experienced complications as a result of implantation of one of several pelvic mesh products to treat organ prolapse — where organs slip or sink out of place — or urinary incontinence.
Linda Gross of Watertown, S.D., filed her complaint in November 2008, claiming she underwent 18 surgeries to correct injuries caused by a Gynecare Prolift mesh implant.
Witnesses included plaintiff expert Anne Weber, a urogynecologist who spent three days on the witness stand, as well as Gross’ treating physicians and a family doctor.
Gross’ attorneys also called, as adverse witnesses, Scott Ciarocca, who oversaw research and development of Gynecare Prolift, and Piet Hinol, an Ethicon staff urogynecologist.
After five days of deliberation, the jury found in 7-2 votes that Ethicon failed to warn Gross’ doctor about possible side effects and made fraudulent misrepresentations to Gross.
The jury found no cause of action on Gross’ defective-design claim (9-0) and a fraudulent misrepresentation claim as to Gross’ doctor (7-2).
The jury’s compensatory damages award is made up of $1.1 million for pain and suffering, $1 million for future medical expenses, $500,000 for future lost wages, $385,000 for past medical expenses, $180,000 for past lost wages, and $185,000 for Gross’ husband’s per quod claim.
Superior Court Judge Carol Higbee ruled early on that the jury should be allowed to consider punitive damages in a separate trial, which began Tuesday with economic expert testimony, arguments, the jury charge and about 30 minutes of deliberation.
The jury was scheduled to continue deliberations Wednesday morning.
Gynecare Prolift, marketed and sold by Somerville-based Ethicon beginning in 2002, was designed for minimally invasive implantation through the vagina, and J&J has maintained that the products are safe.
But the plaintiffs say they have a high failure rate, cause serious complications and necessitate corrective surgeries, despite their billing as safer than other surgical methods.
The products allegedly erode into organs and vaginal walls, causing chronic pain, pain during sexual intercourse, scar tissue and other injuries.
Filings began in 2008, shortly before the federal Food and Drug Administration first announced that complications were being reported, and the Supreme Court centralized the suits before Higbee in September 2010.
A previous trial date was pushed back when J&J appealed Higbee’s May 2011 decision barring its use of expert physicians who had previously treated the plaintiffs. The ruling effectively disqualified 1,000 doctors, whose ranks grew as more complaints were filed, the defendants argued.
The Appellate Division reversed Higbee’s ruling based in part on the relatively small number of doctors who have experience with pelvic mesh.
Last June, J&J announced it would begin removing some mesh products from the market, citing "their commercial viability in light of changing market dynamics" and denying the move was motivated by safety issues.
Plaintiff counsel Adam Slater, of Mazie Slater Katz & Freeman in Roseland, who tried the case with David Mazie of the same firm, says the verdict shows that J&J and Ethicon “didn’t care about anything as much as they cared about sales and marketing.”
Mazie says it’s “a big deal to actually have fraud determined in a product liability case.”
The other plaintiff counsel in the case were Benjamin Anderson of the Anderson Law Offices in Cleveland and Jeffrey Grand of Bernstein Liebhard in New York.
Says Christopher Placitella of Cohen Placitella Roth in Red Bank, who represents other pelvic mesh plaintiffs: ”The hope is it won’t take too many more trials before the parties can sit down and have a serious discussion.” He adds, “Obviously, the jury was concerned with the defendants’ conduct, and I think it bodes well for the future.”
Kelly Crawford of Riker Danzig Scherer Hyland & Perretti in Morristown, Ethicon’s lead defense counsel, deferred comment to Ethicon.
Spokeswoman Sheri Woodruff, in a statement, pointed out that it was a mixed verdict and said: "While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications."
In addition to the 2,182 suits against Ethicon, Higbee also is managing 391 suits against Murray Hill-based C.R. Bard over a similar pelvic mesh product.
As of Jan. 14, there also were 9,207 pelvic mesh suits pending in multidistrict litigation before U.S. Chief Judge Joseph Goodwin of the Southern District of West Virginia. In addition to 2,985 suits against Ethicon and 1,660 against C.R. Bard, there are suits connected to similar products made by American Medical Systems Inc. (2,807), Boston Scientific Corp. (1,647) and Coloplast Corp. (99).
The first known trial over allegedly injurious pelvic mesh of any sort was heard last year in Kern County Superior Court in Bakersfield, Calif. In a July 2012 verdict, the jury found C.R. Bard 60 percent liable for the plaintiff’s injuries and awarded $5.5 million.
"It’s too early for a trend, but the signs are good," Placitella says.