Ethicon headquarters. Photo: Wikimedia Commons

Ethicon's decision to use a Pennsylvania-based company to manufacture its pelvic mesh products is the reason why nearly 100 lawsuits against the mesh-maker should remain in the Keystone State, according to a new ruling shedding light on how judges in Philadelphia may interpret the U.S. Supreme Court's high-profile pronouncement in Bristol-Myers Squibb v. Superior Court of California.

The opinion, which Philadelphia Court of Common Pleas Judge Arnold New issued May 18, comes out about six months after he denied the Johnson & Johnson subsidiary's bid to have a significant portion of the pelvic mesh litigation removed from the First Judicial District for lack of jurisdiction.

According to New, the issue came down to how much involvement the Bucks County, Pennsylvania-based Secant had in making the pelvic mesh, and how closely that company's role tied into the claims the plaintiffs are making.

Citing the testimony of a former Ethicon employee, New said the Pennsylvania company performed an “integral portion” of the manufacturing.

“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 said. “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.”

While the decision directly affects nearly 100 cases pending in Philadelphia's pelvic mesh litigation, it offers some insight into how one of the country's busiest mass tort dockets may exercise its jurisdiction over cases involving out-of-state plaintiffs.

The 13-page opinion is one of the first in Pennsylvania to delve into how trial courts should interpret Bristol-Myers Squibb, which made clear that out-of-state plaintiffs can't sue companies where the defendants aren't considered to be “at home,” or haven't conducted business directly linked to the claimed injury. Some defense attorneys have referred to it as a “game-changing” decision for state-court mass tort programs, but so far the decision has resulted in only four cases being tossed from Philadelphia, which has long been regarded as a hub for pharmaceutical litigation and has recently produced several multimillion-dollar verdicts for plaintiffs in consolidated litigations, including pelvic mesh.

The jurisdictional dispute in the mesh litigation focused on the relationship between Ethicon and Bucks County biomaterials supplier Secant, which manufactured the mesh used in all of Ethicon's products except for the Prolift +M. The type of mesh used in that product was manufactured by a non-Pennsylvania company.

Although Ethicon contended that Secant's role in the manufacturing process was not sufficiently linked to the plaintiffs' claims, New said that, since the plaintiffs raised manufacturing defect claims, the conduct was sufficiently related.

“Moving defendants argue the non-Pennsylvania plaintiffs' theories of liability focus on the design of the pelvic mesh medical devices, the manner in which the mesh is cut, and implementation techniques, none of which is controlled by Secant,” New said. “At this stage of the proceedings, the non-Pennsylvania plaintiffs have alleged manufacturing defect claims, and a portion of the manufacturing process occurred at Secant's Pennsylvania facility; accordingly, this court has specific personal jurisdiction.”

Kline & Specter attorney Shanin Specter, who is a lead attorney for the plaintiffs in the pelvic mesh litigation, said Ethicon's role in making the devices was “clear.”

“It's clear that J&J has significant affiliation with Pennsylvania in the vaginal mesh cases both because that's where the mesh was made and because other J&J activity in Pennsylvania was key to mesh development,” Specter said in a statement. “We are confident that Superior Court will agree that jurisdiction in Pennsylvania is proper.”

A spokeswoman for Ethicon declined to comment.