Federal Courts Predict the Pennsylvania Supreme Court Will Except Medical Devices from Strict Liability under § 402A

The federal courts in Pennsylvania continue to rage against the machine, seeking to expand or at least protect the foothold established for defendants in product liability cases – even in the wake of Tincher v. Omega Flex. In Cogswell v. Wright Medical Technology, Inc., Judge Bissoon of the Western District of Pennsylvania held that, under Pennsylvania law, there is no strict liability cause of action for manufacturing defects found in medical devices. (A copy of this opinion is attached here for your convenience.)

Although the Pennsylvania Supreme Court has yet to squarely address the issue, Judge Bissoon had no hesitation in finding that Comment k to § 402(A) of the Restatement (Second) of Torts applies to product liability cases. Comment k, titled “Unavoidably unsafe products,” states:

[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs…. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The seller of such products…is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Restatement (Second) of Torts § 402A cmt. K (1965) (emphasis in original). The basic reasoning behind this exception to strict liability is apparent: the overall social good that products such as prescription drugs provide militates against the application of strict liability because – by their very nature – there is no way to ensure their safety in application. Further, should strict liability be applied to manufacturers and/or purveyors of products, like prescription drugs, this creates a potentially disastrous disincentive for drug manufacturers to continue such manufacture or to continue developing new drugs. Put simply: the social utility of the product outweighs the social utility of applying strict liability to protect a consumer.

The Pennsylvania Supreme Court has indeed adopted Comment k with regard to prescription drugs. See Lance v. Wyeth, 85 A.3d 434, 438 (Pa. 2014). As Judge Bissoon approvingly states, “[t]o hold manufacturers of prescription drugs liable for ‘unforeseeable reactions to their products…would stifle the incentive to produce new products.’” Cogswell at 3, citing Hahn v. Richter, 628 A.2d 860, 871 (Pa. Super. 1993) aff’d, 673 A.2d 888 (Pa. 1996).

At issue in Cogswell is the question of whether the Pennsylvania Supreme Court would extend the exception to strict liability articulated in Comment k from prescription drugs to medical devices. In Cogswell, the plaintiff underwent two hip replacement surgeries. Cogswell at 1-2. Since these surgeries, Mr. Cogswell has experienced tremendous pain in his right hip and has undergone several further surgeries in an attempt to alleviate this pain and rectify the complications with his replacement hip. Id. at 2. In addition to raising claims sounding in negligence, Mr. Cogswell also raised causes of action in strict liability for manufacturing defect, failure to warn, and design defect. Defendant moved to dismiss each of the strict liability counts, arguing that Comment k ought to preclude them as a matter of law when applying Pennsylvania product liability law.

Plaintiff raised arguments against Defendant’s motion on several levels. First, Plaintiff argued that Comment k should have no application to medical devices at all, as the replacement hip “is distinguishable from prescription drugs, which are unavoidably safe, because the risks alleged in this case could have been avoided.” Id. at 3-4. This is an interesting argument: in effect, Plaintiff argues that because this type of medical device can be designed and manufactured in such a way that does not render it unavoidably dangerous, Comment k cannot apply.

Judge Bissoon roundly rejects this argument as “unpersuasive, as the law in Pennsylvania requires the Court to determine the application of Comment k categorically, not to conduct a case-by-case analysis of each particular product.” Id. at 4. In other words, Comment k applies to all medical devices or to none. Citing a Pennsylvania Superior Court case that there is no reason why Comment k should not apply to medical devices, Judge Bissoon (in something of a fiat moment) held that Comment k applies to medical devices as a category. Id.

Each of Plaintiff’s remaining arguments were found wanting in the wake of the extension of Comment k to include medical devices. Only one of Plaintiff’s remaining arguments required more than a cursory rejection from the Court. Here, Plaintiff posited that, even if Comment k applies to medical devices, Comment k does not bar strict liability for Plaintiff’s manufacturing defect claim. Plaintiff relies on an unreported case from the Eastern District of Pennsylvania, “which states that Comment k does not intend to shield a seller from liability for products which have been ‘manufactures.’” Id. The reasoning is straight forward: even in cases where a product is unavoidably dangerous, a manufacturer should not be shielded from liability caused by failing to manufacture the product as intended.

Although Judge Bissoon acknowledges a split in authority on this question within the federal courts applying Pennsylvania law, she relies upon Lance to hold that Pennsylvania recognizes no strict liability manufacturing defect cause of action. “[T]he Pennsylvania Supreme Court in Lance declined to hold prescription drug manufacturers strictly liable and did not include an exception for manufacturing defects. Lance, 85 A.3d at 438. Had the Pennsylvania Supreme Court intended an exception to the strict liability rule, it presumably would have articulated one.” Cogswell at 6. While one might wonder why the Pennsylvania Supreme Court would have created an exception for a category of products it had not yet recognized as falling under Comment k, the logic and result of Cogswell are sound.

It will be interesting to see if this begins another back-and-forth between the federal bench and the Pennsylvania bench regarding the law of product liability in Pennsylvania.

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