December 6, 2021

Volume XI, Number 340

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December 03, 2021

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Third Circuit Sends Questions Regarding Medical Device Liability to Pennsylvania Supreme Court for Review

In Ebert v. C.R. Bard, the United States Court of Appeals for the Third Circuit determined that Pennsylvania state law is unclear on two issues of medical device liability, and sent the issues to the Pennsylvania Supreme Court for review.

In Ebert, a G2 clot filter made by Bard was placed into the plaintiff’s inferior vena cava. Although the filter was set to be removed after three years, it could not be removed because one of its struts broke, grew into the vein wall and was caught in the plaintiff’s pulmonary artery. Thus, the plaintiff was forced to undergo a procedure to remove the filter. The plaintiff then brought suit, alleging negligent design and strict liability.

The Third Circuit determined that the standards for analyzing liability for a medical device manufacturer under Pennsylvania law were unclear. First, the Court stated that it was unclear what standard of care should be applied to an implantable medical device in a negligent design claim. The Court, analyzing previous Pennsylvania law on the subject, including Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), framed the question for review by the Pennsylvania Supreme Court as to whether a plaintiff may prevail in a negligent design claim only by showing that the device was “too harmful to be used by anyone” or whether the plaintiff can prevail on another theory (such as whether there was an alternative, feasible design available).

Second, the Third Circuit determined that there are countervailing interpretations for whether strict liability claims apply to prescriptive medical devices. The Third Circuit, analyzing previous cases, found that there are three separate avenues for analyzing strict liability in the medical device context, namely, whether implantable medical devices (1) could be categorically subject to strict liability, (2) could be immune from strict liability or (3) could be immune from strict liability under Comment k to §402A of the Restatement (Second) of Torts on a case-by-case basis.

The Third Circuit sent both questions to the Pennsylvania Supreme Court for review. What remains to be seen is if Pennsylvania will ultimately issue distinct rulings on whether negligent design claims or strict liability claims can apply to a prescriptive medical device. Until then, Pennsylvania will continue to have unanswered questions on whether prescriptive medical devices are subject to negligent design or strict liability claims.

© 2021 Wilson ElserNational Law Review, Volume XI, Number 201
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About this Author

Kathleen D. Wilkinson, Wilson Elser, Complex Products Liability Lawyer, Pharmaceutical Litigation Attorney
Partner

Well known throughout Pennsylvania’s legal community for her consummate legal skills and uncompromising dedication, it is fitting that Kathleen Wilkinson served as chancellor of the Philadelphia Bar Association in 2013. As only the sixth woman to lead this 13,000-member organization founded more than 200 years ago, Kathleen’s standing as a former chancellor represents a particularly remarkable milestone in a distinguished career.

Kathleen built her practice and earned her reputation defending complex cases involving products, construction,...

215.606.3905
Alex Hammershaimb Environmental Tort Attorney Wilson Elser Moskowitz Edelman & Dicker LLP
Associate

Alex Hammershaimb represents established businesses and individuals in all aspects of complex litigation, including toxic tort, asbestos, products, construction, premises, professional liability, employment and labor litigation, insurance coverage, and medical devices and pharmaceuticals. 

Prior to working at Wilson Elser, Alex assisted in handling cases involving insurance company insolvencies and general commercial litigation, and litigated cases involving insurance coverage, subrogation, and consumer protection, including usury. He also has experience in cyber work, such as...

215-606-3943
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