Pennsylvania Court Says Johnson & Johnson Subsidiary Must Pay $12.8 Million Prolift Mesh Damages Award

The Pennsylvania Superior Court recently ruled that Johnson & Johnson and its subsidiary, Ethicon Inc., must pay $12.8 million in damages after an Indiana plaintiff won her case alleging that the companies’ medical mesh device contained a dangerous defect.

At Trial: Prolift, Arguments, and Results

Ethicon marketed a surgical mesh system known as the Prolift Kit. The Prolift mesh is implanted in the abdomen to provide additional support to prolapsed internal organs. The plaintiff in the case, an Indiana resident, claimed that the Prolift mesh she received in 2009 caused a number of ongoing medical problems, including chronic pain. After three additional surgeries to address the problems caused by the mesh, the plaintiff brought suit against Ethicon in a Pennsylvania court in 2013.

At trial, the plaintiff presented testimony from medical experts who discussed problems with the Prolift mesh design, including that the mesh was too heavy and that the plastic used as part of its manufacture could cause inflammatory reactions, creating or worsening medical problems. The plaintiff’s initial surgeon also testified that he would not have recommended Prolift to the plaintiff if Ethicon had provided adequate warnings about the risks associated with the device.

At the end of the trial, the jury awarded the plaintiff $12.8 million.

On Appeal: Arguments and Results

Johnson & Johnson and Ethicon filed an appeal in the Pennsylvania Superior Court. On appeal, the defendants asserted that their arguments at trial concerning jurisdiction should have prevailed, that the plaintiff had failed to meet the statute of limitations, that they should have received a new trial based on evidentiary and instructional errors by the trial court judge, and that the damages award itself should be reduced or vacated.

The company’s jurisdiction argument drew heavily from the 2017 U.S. Supreme Court case Bristol-Myers Squibb v. Superior Court of California. In that case, a class action was filed in the San Francisco Superior Court claiming that Bristol-Myers Squibb’s pharmaceutical Plavix contained dangerous defects. The class action included 86 California residents and 592 non-California residents. Bristol-Myers Squibb argued that neither the non-California plaintiffs, their injuries, nor Bristol-Myers Squibb had any connection to California, so California had no jurisdiction over the cases involving the non-Californians.

The U.S. Supreme Court held that the California courts could not exercise specific jurisdiction over Bristol-Myers Squibb, because the lawsuit itself did not “aris[e] out of or relat[e] to the defendant’s contacts with the forum.”

In other words, because the non-California residents could not show that their Plavix injuries had anything to do with California (e.g., they did not buy their Plavix pills in California, Bristol-Myers Squibb did not make Plavix in California, and so on), California could not claim jurisdiction over their cases. The plaintiffs would have to file suit in a place somehow connected with their claims, such as the states where they purchased their prescriptions or a state in which Bristol-Myers Squibb developed or manufactured Plavix.

In the Prolift case, Ethicon and J&J made a similar argument: that Pennsylvania did not have jurisdiction because Ethicon and J&J are not Pennsylvania companies and the plaintiff was not a Pennsylvania resident, but an Indiana one. However, the Pennsylvania Superior Court rejected this argument, noting that Ethicon had significantly more connections with Pennsylvania than Bristol-Myers Squibb had had with California.

Similarly, the appeals court rejected Ethicon and J&J’s other arguments, concluding that the company was responsible for the trial verdict and the damages awarded. The plaintiff also filed a cross-appeal, arguing that the trial court should have awarded additional “delay damages” on the entire damages verdict, not only on the compensatory damages portion. The appeals court rejected this argument as well, maintaining the damages amount at $12.8 million.

Experts and Jurisdiction: What Matters?

A key part of the appeals court’s analysis in determining that Pennsylvania had specific jurisdiction over Ethicon was “Ethicon relied heavily on an Allentown, Pennsylvania gynecologist…for the development, study, and marketing of Prolift.” The trial evidence included information about Ethicon’s retention of the Pennsylvania doctor for three clinical studies, and it mentioned a meeting between the Pennsylvania doctor and Ethicon staff in 2006 “for guidance concerning the marketing and development strategy for Prolift.”

While the doctor involved in the creation of Prolift does not appear to have been called as an expert witness in the case, his involvement in the product’s design, testing, and marketing discussions – and the reliance of the Pennsylvania appeals court on this fact – raises questions about the future of specific jurisdiction in product liability claims. If consulting researchers or other experts is enough to support jurisdiction, what other sorts of contacts might also allow a company to face litigation in a particular state, even when neither it nor the plaintiff is a resident of the state? Future cases will doubtless explore this new question in greater detail.