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.