On July 15, 2015, a federal judge with the U.S. District Court for Eastern District of Pennsylvania held that the exclusion from strict liability for prescription drug claims should also apply to prescription medical device claims.
Despite the fact that the Pennsylvania Supreme Court has yet to address whether the exemption for unavoidably unsafe drug products should apply to prescription medical devices, the federal judge relied on a ruling by the Pennsylvania Superior Court that had ruled in 2013 that there was no reason why the rationale for exclusion from strict liability for prescription drugs should not also apply to prescription medical devices.
A July 2014 federal court ruling from the U.S. District Court for the Eastern District of Pennsylvania had suggested that the Pennsylvania Supreme Court would extend the exclusion of strict liability claims in prescription drug cases to prescription medical device claims when the issue is presented to it, although a 2013 decision from the U.S. District Court for the Western District of Pennsylvania had allowed a strict liability claim for manufacturing defect against a medical device manufacturer.
The federal judge did allow, however, the plaintiffs to proceed with their claims for manufacturing defect, negligent design, negligence per se, and failure to warn against the defendant spinal implant manufacturer.
The plaintiff had surgery during which two rods called N-Hance spinal fixation rods manufactured by the defendant medical device manufacturer were implanted to repair the plaintiff’s spine. The plaintiff discovered two years later that the rods had failed and that his spine had fractured.
The plaintiffs’ product liability lawsuit alleged that a properly designed and manufactured spinal implant should not bend, break, or fail unless the implant was defectively designed and/or the implant was negligently manufactured. The defendant implant manufacturer filed a motion to dismiss, arguing that a strict liability claim against it was impermissible.
The federal judge stated that the plaintiffs’ sole argument for allowing strict liability for defective manufacturing claims against medical device manufacturers is that medical devices can be altered or manufactured in different ways to render them more fit for their purposes and therefore should be subjected to equal or greater liability than most products. The federal judge rejected the plaintiffs’ argument, stating, “I find this attempt to distinguish medical devices from prescription drugs to be unpersuasive, as both medical devices and prescription drugs could be manufactured in different ways to make them more fit for the purpose. Like prescription drugs, medical devices are known to cause possible harm, but the risks are outweighed by the benefits they provide for patients who need them.”
Source Wilson v. Synthes USA Products, PICS No. 15-1122.
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