Eastern District Chips Away at 402(a) in Medical Device Cases

Recently, the United States District Court for the Eastern District of Pennsylvania continued the federal courts’ test of Section 402(a) of the Restatement (Second) of Torts by concluding that allegations of manufacturing defects in medical devices and products are barred under Pennsylvania law.

In the case of Terrell v. Davol, Inc.., the plaintiff brought suit against the manufacturers of a medical mesh designed to aid in the treatment of hernias when it was discovered that the device was the cause of a severe gastrointestinal disorder.  In her suit, the plaintiff specifically alleged that the manufacturers were, among other things, strictly liable for certain alleged manufacturing defects in the mesh.  However, relying on longstanding Pennsylvania precedent barring strict liability claims against prescription drug manufacturers, the defendants moved to dismiss the plaintiff’s Section 402(a) claims for strict liability arguing that she could only recover if the production of the mesh was actually negligent.

In ultimately siding with the defendants and granting the motion to dismiss, Judge Joel H. Slomsky found that while Pennsylvania’s traditional interpretation of Section 402(a) has all but solidified strict liability for product manufacturers, an exception has been carved out for the makers of medications and medical devices.  Specifically, Judge Slomsky explained that Pennsylvania has adopted the reasoning of Hahn v. Richter in the context of medical devices to bar strict liability claims because the punitive effect would undermine the public’s access to potentially life-saving products.  Yet, Judge Slomsky went beyond the traditional principles of Hahn to more precisely conclude that Pennsylvania law even bars strict liability claims regarding manufacturing errors in the product at issue.  Instead, Judge Slomsky reasoned that the principles in Hahn implicitly operate to require a showing of negligence in the design or manufacture of a medical product before the plaintiff can recover as a matter of law.

While a subtle counter to Pennsylvania’s extreme products liability regime, the Court’s decision in Terrell reaffirms the evolving notion that modern products cases incorporate ordinary negligence principles by implying that liability should correlate with social utility.  In so holding, Terrell places further pressure on the Pennsylvania Supreme Court to finally decide the direction of products liability in the Commonwealth vis-à-vis the Restatement (Second) of Torts.

Thanks to Adam Gomez for his contribution to this post.  For more information, please email Paul Clark at .