Strict Liability Claims for Prescription Medical Products

There 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.

Since Hahn, Pennsylvania trial and appellate courts consistently barred strict liability claims based upon prescription drug defects. The Pennsylvania Supreme Court revisited the issue in early 2014, and once again held that “for policy reasons, this Court has declined to extend strict liability into the prescription drug arena.” Lance v. Wyeth, 624 Pa. 231 (Pa. 2014).

Similarly, in the years since Hahn was decided, the Superior Court of Pennsylvania found “no reason why the same [rationale] applicable to prescription drugs may not be applied to medical devices.” Creazzo v. Medtronic Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (emphasis added). Numerous federal district courts concurred, although the rulings were not unanimous. Compare Horsmon v. Zimmer Holdings Inc., 2011 U.S. Dist. LEXIS 130415 (W.D. Pa. 2011) with Dougherty v. C.R. Bard Inc.,' 2012 U.S. Dist. LEXIS 100374 (E.D. Pa. 2012) (finding that strict liability claims involving a manufacturing defect in prescription drug and device cases are not clearly barred in Pennsylvania).

Update

In July of this year, decisions were filed in the Eastern and Western District Courts of Pennsylvania addressing claims that the reasoning in Hahn did not apply to medical device litigation. Wilson v. Synthes USA Products LLC involved a spinal implant, while hip implant technology was at issue in Cogswell v. Wright Medical Technology Inc. In Wilson, the plaintiffs argued that, because medical devices could be altered or manufactured in different ways to render them more fit for their intended purpose, they should be subjected to equal or greater liability than other products. Judge Schmehl of the Eastern District found this argument unpersuasive, observing that “both medical devices AND prescription drugs could be manufactured in different ways to make them more fit for their intended purpose,” and further commenting that both are unreasonably dangerous, but should not be subjected to strict liability, given their benefit to certain members of society.

In Cogswell, Judge Cathy Bissoon of Pennsylvania's Western District addressed similar arguments and followed the line of cases, such as Creazzo, which applied the Hahn decision in the context of medical device claims. In Cogswell, however, the plaintiff also contended that Comment k did not bar strict liability for manufacturing defect claims. Here, Judge Bissoon recognized that a split of authority existed among federal district courts applying Pennsylvania law to manufacturing defect claims. Some courts had limited Hahn to its factual setting ' namely failure-to-warn claims ' and permitted manufacturing defect claims to proceed.

Others dismissed all alleged strict liability claims, using the reasoning of Comment k, Hahn and other rulings. In Lance v. Wyeth, 624 Pa. 231 (Pa. 2014), the Supreme Court of Pennsylvania addressed the split of authority and reiterated its long-standing rule that all strict liability claims are barred in prescription drug cases. Another federal court, following Lance , predicted that the Pennsylvania Supreme Court would conclude that all strict liability claims are also barred in medical device litigation. Terrell v. Davol, 2014 U.S. Dist. LEXIS (E.D. Pa. 2014) (Slomsky, J.).

Conclusion

The majority of state and federal court decisions in Pennsylvania continue to follow the reasoning of Hahn to preclude strict liability claims in medical device litigation. Until such time as the Pennsylvania Supreme Court addresses the issue, however, it seems clear that new and creative arguments will continue to be made in an effort to circumvent this precedent.

Michael D. Brophy, a member of this newsletter's Board of Editors, is a partner with Goldberg Segalla LLP, practicing out of the firm's Philadelphia office.

On July 16 of this year, decisions by two federal judges once again spoke to the Pennsylvania Supreme Court's silence on a fundamental issue of tort law applicable to prescription medical product liability claims in the Commonwealth.

Section 402A of the Restatement (Second) of Torts governs strict product liability claims in Pennsylvania. Webb v. Zern , 422 Pa. 424 (Pa. 1966). Thirty years after Webb, the court held that strict liability claims involving prescription medications were barred pursuant to Comment k of Section 402A. Hahn v. Richter , 543 Pa. 558 (Pa. 1996).

In Hahn , the Supreme Court of Pennsylvania considered whether a prescription medication used to treat back pain was defective because the manufacturer failed to provide sufficient warnings regarding intrathecal use of the drug. The ruling in Hahn turned upon application of Comment k of the Restatement (Second) of Torts, Section 402A, which provides:

There 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.

Since Hahn, Pennsylvania trial and appellate courts consistently barred strict liability claims based upon prescription drug defects. The Pennsylvania Supreme Court revisited the issue in early 2014, and once again held that “for policy reasons, this Court has declined to extend strict liability into the prescription drug arena.” Lance v. Wyeth , 624 Pa. 231 (Pa. 2014).

Similarly, in the years since Hahn was decided, the Superior Court of Pennsylvania found “no reason why the same [rationale] applicable to prescription drugs may not be applied to medical devices .” Creazzo v. Medtronic Inc. , 903 A.2d 24, 31 (Pa. Super. Ct. 2006) (emphasis added). Numerous federal district courts concurred, although the rulings were not unanimous. Compare Horsmon v. Zimmer Holdings Inc., 2011 U.S. Dist. LEXIS 130415 (W.D. Pa. 2011) with Dougherty v. C.R. Bard Inc.,' 2012 U.S. Dist. LEXIS 100374 (E.D. Pa. 2012) (finding that strict liability claims involving a manufacturing defect in prescription drug and device cases are not clearly barred in Pennsylvania).

Update

In July of this year, decisions were filed in the Eastern and Western District Courts of Pennsylvania addressing claims that the reasoning in Hahn did not apply to medical device litigation. Wilson v. Synthes USA Products LLC involved a spinal implant, while hip implant technology was at issue in Cogswell v. Wright Medical Technology Inc. In Wilson, the plaintiffs argued that, because medical devices could be altered or manufactured in different ways to render them more fit for their intended purpose, they should be subjected to equal or greater liability than other products. Judge Schmehl of the Eastern District found this argument unpersuasive, observing that “both medical devices AND prescription drugs could be manufactured in different ways to make them more fit for their intended purpose,” and further commenting that both are unreasonably dangerous, but should not be subjected to strict liability, given their benefit to certain members of society.

In Cogswell, Judge Cathy Bissoon of Pennsylvania's Western District addressed similar arguments and followed the line of cases, such as Creazzo, which applied the Hahn decision in the context of medical device claims. In Cogswell, however, the plaintiff also contended that Comment k did not bar strict liability for manufacturing defect claims. Here, Judge Bissoon recognized that a split of authority existed among federal district courts applying Pennsylvania law to manufacturing defect claims. Some courts had limited Hahn to its factual setting ' namely failure-to-warn claims ' and permitted manufacturing defect claims to proceed.

Others dismissed all alleged strict liability claims, using the reasoning of Comment k, Hahn and other rulings. In Lance v. Wyeth , 624 Pa. 231 (Pa. 2014), the Supreme Court of Pennsylvania addressed the split of authority and reiterated its long-standing rule that all strict liability claims are barred in prescription drug cases. Another federal court, following Lance , predicted that the Pennsylvania Supreme Court would conclude that all strict liability claims are also barred in medical device litigation. Terrell v. Davol, 2014 U.S. Dist. LEXIS (E.D. Pa. 2014) (Slomsky, J.).

Conclusion

The majority of state and federal court decisions in Pennsylvania continue to follow the reasoning of Hahn to preclude strict liability claims in medical device litigation. Until such time as the Pennsylvania Supreme Court addresses the issue, however, it seems clear that new and creative arguments will continue to be made in an effort to circumvent this precedent.

Michael D. Brophy, a member of this newsletter's Board of Editors, is a partner with Goldberg Segalla LLP, practicing out of the firm's Philadelphia office.