Products Liability Law Daily Does Pennsylvania recognize strict liability claims for manufacturing defects of prescription medical devices?
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Wednesday, June 26, 2019

Does Pennsylvania recognize strict liability claims for manufacturing defects of prescription medical devices?

By David Yucht, J.D.

A patient who experienced problems after having been implanted with pelvic mesh attempted to assert a manufacturing defect claim against the mesh maker despite an absence of precedent from the commonwealth’s highest court regarding whether the claim is viable.

Basing its decision on its belief that Pennsylvania law does not recognize strict liability as a cause of action for suing manufacturers of prescription medical devices, a federal district court in Pennsylvania dismissed with prejudice strict liability claims filed by a patient who had been implanted with a synthetic pelvic mesh for stress urinary incontinence. The federal court certified to the U.S. Court of Appeals for the Third Circuit the issue of whether a strict liability/manufacturing defect claim was viable because the Pennsylvania Supreme Court has never ruled on the issue (Rosenberg v. C.R. Bard, Inc., June 25, 2019, Robreno, E.).

A patient suffered from stress urinary incontinence that required surgical intervention. Her doctors implanted her with a C.R. Bard, Inc. Align® synthetic mesh system. She began experiencing complications such as severe lower quadrant pain, dyspareunia, and mesh erosion. According to the patient, the device’s manufacturer knew that its pelvic mesh system was defective and that there could be life-changing and irreversible complications from pelvic mesh removal. She asserted that the manufacturer had failed to provide proper warnings of the risks of pelvic mesh implantation and had concealed known risks. The patient sued the manufacturer based on various causes of action, including strict liability for design and manufacturing defects, strict liability for failure to warn, and negligence. The manufacturer filed a motion to dismiss all claims.

Strict liability. The court dismissed the patient’s strict liability claims with prejudice but certified the question of whether Pennsylvania recognizes a strict liability claim for a manufacturing defect of a prescription medical device for interlocutory appeal to the Third Circuit. The court based its decision on its belief that Pennsylvania law does not recognize strict liability as a cause of action for suing manufacturers of prescription medical devices.

In 2014, the Pennsylvania Supreme Court declined to extend strict liability into "the prescription drug arena." The federal court noted that since then, every federal district court to confront the issue has predicted that the Pennsylvania Supreme Court would extend the reach of that case precedent to prevent strict liability from becoming a cause of action for those injured by prescription medical devices. The federal court also noted that a Pennsylvania state trial judge had held that the strict liability claim could not be pursued against the manufacturer of an implantable medical device.

Negligence. The court also dismissed the patient’s negligence claim without she failed to state a plausible claim of negligence. There were only four paragraphs set forth in her negligence count, one of which merely incorporated by reference the strict liability allegations of the complaint and the remainder of which contained largely conclusory statements regarding duty, breach, and causation, the court remarked, finding that the patient failed to plead "a short and plain statement" of the claim showing that she was entitled to relief and failed to connect the facts she alleged with the specific negligence she asserted.

The case is No. 2:18-cv-04767-ER.

Attorneys: Lee B. Balefsky (Kline & Specter, PC) for Sarah Rosenberg. Gregory T. Sturges (Greenberg Traurig LLP) for C.R. Bard, Inc.

Companies: C.R. Bard, Inc

MainStory: TopStory DesignManufacturingNews MedicalDevicesNews PennsylvaniaNews

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