Ethicon, Inc. is at odds with plaintiffs over the appropriate jurisdiction for 90 transvaginal mesh lawsuits, as the device maker seeks to have the claims removed from a mass tort program now underway in the Philadelphia Court of Common Pleas.
Ethicon, a subsidiary of Johnson & Johnson, is named a defendant in 120 pelvic mesh lawsuits that are currently pending in Philadelphia. According to The Legal Intelligencer, the 90 claims at issue were filed on behalf of non-Pennsylvania residents.
In seeking to have the transvaginal mesh lawsuits removed from Philadelphia, Ethicon cited the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb v. Superior Court of California, which limited plaintiffs to filing suit in jurisdictions where defendants are headquartered or where a plaintiffs’ injuries are alleged to have occurred.
While Ethicon is based out-of-state, the Prolene filaments used in its transvaginal mesh devices were manufactured and supplied by Secant, which is headquartered in Pennsylvania. However, in a brief filed with the court on August 21st, Ethicon maintained that it only had a limited contractual relationship with the company.
“Plaintiffs have not shown and cannot show Secant was anything other than an independent biomaterials supplier,” Ethicon said. “The record reflects only what any contracting party would seek and expect: the delivery of what it has agreed to pay for and the means to assure the other side’s compliance. Merely contracting to have mesh knitted from filament by an independent company does not confer jurisdiction.”
However, attorneys representing transvaginal mesh plaintiffs rejected Ethicon’s arguments, writing in their own brief that the trial court had already addressed the jurisdictional issues when the mass tort was established. They also contend that Ethicon had a close relationship with Secant, often meeting at the company’s Pennsylvania headquarters. Finally, the brief notes that Ethicon also worked closely with a Pennsylvania gynecologist to develop its pelvic mesh devices.
“Through those contracts, Ethicon chose Pennsylvania as the location where Ethicon directed the design, manufacturing, testing and overall production process for Prolift mesh,” the plaintiffs’ brief states. “Ethicon chose Pennsylvania as the place where it funded extensive clinical studies and paid for the services of a prominent Pennsylvania consultant.”
Transvaginal mesh devices are intended to treat women suffering from pelvic organ prolapse and stress urinary incontinence. Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding serious complications potentially associated with transvaginal mesh, including mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. The agency has also reclassified transvaginal mesh used for prolapse repair as a high-risk medical device, after reversing its stance that complications associated with its use are rare.
The Pennsylvania litigation has already concluded five trials involving Ethicon transvaginal mesh lawsuits. Four juries have favored plaintiffs, awarding them damages of $2.16 million, $12.5 million, $13.5 million and $20 million. While one jury did rule in favor of Ethicon, the judge overseeing the case recently granted the plaintiff a new damages hearing after finding that the verdict was inconsistent with the evidence.
More than 54,000 women are currently pursuing pelvic mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
In 2012, Ethicon announced that it would stop selling several transvaginal mesh implants due to slowing sales and other commercial concerns. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.