Products Liability Law Daily Strict liability ban for suits involving drugs not extended to medical devices
Wednesday, July 29, 2020

Strict liability ban for suits involving drugs not extended to medical devices

By Robert B. Barnett Jr. J.D.

The Pennsylvania Supreme Court would most likely rule that whether the ban was to be extended would be determined on a case-by-case basis, rather than create a categorical ban.

In a case alleging strict liability and negligence against the manufacturer of a mesh implant, a Pennsylvania federal district court predicted that the Commonwealth’s highest court would not extend to prescription medical devices the automatic bar on strict liability claims that Pennsylvania imposes in prescription drugs cases. Whether the strict liability ban should be extended beyond prescription drugs is to be determined on a case-by-case basis, which will be more fully developed during discovery. In addition, the court ruled that the suit for a 1999 hernia surgery was not time-barred by the two-year statute of limitations because the patient had no way of learning until 2019 that the mesh implant was still in his body. As a result, the patient’s claims for both strict liability and negligence were allowed to proceed (Patchcoski v. W.L. Gore & Associates, Inc., July 28, 2020, Mannion, M.).

Background. On July 23, 1999, a patient underwent hernia repair surgery, during which a GORE-TEX Soft Tissue Patch manufactured by W.L. Gore & Associates, Inc., was implanted. Two years later, he underwent additional surgery. One month after that, he had more surgery and subsequently was diagnosed with an abscess. Three months later, he was diagnosed with an infected Gore mesh. Two months later, he had more surgery, this time to remove the Gore mesh. His problems never really went away completely. In 2017, he was told that the mesh might have caused his medical problems. In the summer of 2019, he discovered that the infected Gore mesh had never been removed. He and his wife sued Gore in Pennsylvania state court for strict liability, negligence, and loss of consortium. Gore removed the case to federal court and filed a motion to dismiss.

Statute of limitations. Gore sought dismissal on statute of limitations grounds because the mesh had been implanted in 1999 and suit had not been filed until 2019—well beyond Pennsylvania’s two-year limitations period for products liability claims. The claim arose, however, not when the implantation occurred but when the patient discovered that the Gore mesh caused the injuries. On March 21, 2017, the patient was informed that the Gore mesh could have been the cause of his ongoing symptoms. At that point, however, he thought that the mesh had been removed in 2001. It was not until the 2019 that he learned that the mesh was still inside him. Although suit had been filed more than two years after he first learned that the mesh might be the cause, it was filed within two of the date he learned that it was still inside. As a result, the court refused to dismiss the suit on statute of limitations grounds, and it gave the parties the right to conduct discovery to further explore this issue.

Strict liability. The patient was asserting a strict liability claim that was based on both a design defect and a manufacturing defect. Examining the allegations, the court concluded that the patient "pled enough facts" to state a strict liability claim. He alleged that the mesh was defective, unreasonably safe, and not suitable for implantation. It had caused him harm, and he alleged that discovery would reveal that the mesh was the proximate cause of that harm. That was enough to survive the motion to dismiss, the court found.

Strict liability ban. The court next turned to the less clear question of whether Pennsylvania law prohibited the strict liability claim. Pennsylvania law bans strict liability claims for "unavoidably unsafe products" that are incapable of being made safe for their intended and ordinary use (Comment k to Section 402A of the Restatement of Torts). The Pennsylvania Supreme Court has ruled that the ban applies to prescription drugs, but it has not ruled specifically on whether the ban extends to strict liability claims for medical devices. Parsing the various lower level cases on the issue, the federal court concluded that the high court would most likely rule that whether the ban was to be extended would be determined on a case-by-case basis. It would be unlikely, the federal court surmised, to create a categorical ban. Other lower court decisions extending the ban to devices were limited to the facts of those cases. As a result, the court refused to dismiss the strict liability claim based on Comment k without a more fully developed factual record.

Negligence. The court also found that the negligence claim was adequately pleaded. The patient alleged that he was injured by the faulty mesh, that Gore breached its duty owed to the patient, and that his injuries were proximately cause by that breach. Those allegations were enough to survive the motion to dismiss.

Loss of consortium. Finally, because the loss of consortium claim depended on the strict liability and negligence claims, it survived because they survived. Accordingly, Gore’s motion to dismiss the claims was denied in its entirety.

The case is No. 3:19-1556.

Attorneys: James J. Conaboy (Abrahamsen Conaboy & Abrahamsen, PC) for Edward Patchcoski and Susan Patchcoski. Gregory T. Sturges (Greenberg Traurig, LLP) for W.L. Gore & Associates, Inc.

Companies: W.L. Gore & Associates, Inc.

MainStory: TopStory MedicalDevicesNews SofLReposeNews DesignManufacturingNews DefensesLiabilityNews GCNNews PennsylvaniaNews

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