A Pennsylvania state court judge has refused to dismiss some 120 transvaginal mesh lawsuits from a mass tort proceeding currently underway in the Philadelphia Court of Common Pleas, rejecting Ethicon, Inc.’s assertion that the venue is inappropriate.
All of the lawsuits were filed on behalf of plaintiffs who reside outside of Pennsylvania. In seeking their dismissal from the venue, Ethicon had 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.
However, Judge Arnold New rejected those arguments in an order dated May 18th, noting that Bucks County, Pennsylvania-based Secant had manufactured an “integral portion” of Ethicon’s pelvic mesh devices.
“For each of these devices, Secant Medical Inc. knits Prolene filament into mesh according to specifications set forth by moving defendants at its Bucks County facility before returning the knitted mesh to moving defendants for further processing,” New wrote. “Since a portion of the manufacturing process of the Gynemesh/Gynemesh PS, Prolene, Prolift, Prosima, TVT, TVT-Exact, TVT-Obturator and TVT-Secur pelvic mesh medical devices occurs in Pennsylvania, this court’s exercise of specific personal jurisdiction comports with traditional notions of fair play and substantial justice.”
More than 100,000 plaintiffs have filed lawsuits in courts across the country over injuries and complications they allegedly sustained due to defective transvaginal mesh implants marketed by Ethicon and other medical device manufacturers.
Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding the serious complications that have been reported regarding these devices, including mesh perforation, mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. Three years later, the agency reversed its prior position that transvaginal mesh complications were a rare occurrence.
In 2016, the FDA reclassified transvaginal mesh indicated for pelvic organ prolapse surgery as high-risk medical devices. Among other things, the reclassification prevents such implants from obtaining regulatory clearance through the agency 510(k) program, which does not require a new medical product to undergo human clinical trials before coming to market if a manufacturer can show that it is “substantially equivalent” to a previously-approved device.
The Pennsylvania mass tort program has already tried a half dozen Ethicon transvaginal mesh lawsuits.
The most recent case concluded last fall, when a Philadelphia jury awarded $57 million in punitive and compensatory damages to a woman who said she had endured chronic pain since receiving Ethicon’s TVT-O mesh device in 2007.
Four other Pennsylvania cases have concluded in favor of plaintiffs, with damages ranging from $2.16 million to $20 million.