United States: Pennsylvania Federal Court Uses Tincher To Find Claim For Strict Liability Manufacturing Defect In Medical Device Case

Last Updated: December 8 2016
Article by Michelle Yeary

It's been two years since we applauded the downfall of Azzarello in Pennsylvania. Two years since the Pennsylvania Supreme Court ruling in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Two years since we opined that we didn't think Tincher changed Pennsylvania law applicable to prescription medical products much at all. After all, Hahn v. Richter, 673 A.2d 888 excluded prescription medical products entirely from Azzarello strict liability twenty years ago, so Tincher's reworking of strict liability shouldn't be of much consequence. And, our prediction has largely held true. We really haven't mentioned Tincher much since here on the DDL blog, other than to point out the serious flaws in plaintiffs' attempts to argue that Tincher somehow altered Pennsylvania's negligence-only standard for prescription medical product litigation and that plaintiffs' theory had been rejected by the first courts to consider it.

Now, two years later, we have to report that a Pennsylvania federal court used Tincher to allow a strict liability manufacturing defect claim to proceed in a medical device case – in what we view as a misconstruction of both Tincher specifically and Pennsylvania products liability law (especially post-Lance) generally.

The case is Wagner v. Kimberly-Clark Corp., slip op., No. 16-4209 (E.D. Pa. Dec. 1, 2016). During the installation of a feeding tube, a piece of the tube came off in plaintiff's stomach and she had to undergo several procedures to have to have it removed. Wagner, slip op. at 2-3. Plaintiff's complaint brings claims for negligence, strict liability, and breach of warranty. Defendant moved to dismiss the latter two claims. Id. at 1. Plaintiff did not oppose dismissal of the breach of warranty claim. Id. at 13. As for strict liability, the court dismissed strict liability design defect and failure to warn on the ground that neither is allowed under Pennsylvania law for prescription medical products. Id. at 6 n.3. But the court was unwilling to find the same was true as to plaintiff's strict liability manufacturing defect claim.

We thought the issue of strict liability manufacturing defect had been put to rest, or at least into a very deep slumber, after Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). It was our tiny sliver of a silver lining to Lance, that the Pennsylvania Supreme Court reaffirmed prior law precluding all strict liability in prescription medical product cases:

Plaintiff contends that Hahn does not prevent strict liability claims based on manufacturing defects. This Court does not agree. Although federal courts are currently split on this issue of whether 402A applies to medical devices, and some allow strict liability claims to proceed when a manufacturing defect is alleged, the decisions of these courts pre-date Lance. There, the Pennsylvania Supreme Court reiterated the principle that a strict liability claim based on a defective prescription drug is barred. In explaining this principle, the Court did not exempt from this bar a claim based on a manufacturing defect. Based on the above, this Court predicts that the Supreme Court of Pennsylvania would come to the same conclusion with respect to defective medical devices.

Terrell v. Davol, Inc., 2014 WL 3746532, at *5 (E.D. Pa. July 30, 2014). But unlike Terrell, Wagner relies exclusively on pre-Lance cases that allow strict liability manufacturing defect claims. Wagner, slip op. at 8. In response to defendant's argument that the court should be looking at more recent precedent, the court stated that regardless of date, there remains a split of authority. Id. at 12 n.9. But date is very important if all the cases that allow the claim pre-date a Pennsylvania Supreme Court decision disallowing it.

It is with this outdated frame of reference that the Wagner court then applies the Tincher ruling that "[n]o product is expressly exempt [from strict liability] and, as a result, the presumption is that strict liability may be available with respect to any product, provided that the evidence is sufficient to prove a defect." Id. at 9. But Tincher explicitly recognized that prescription medical products are the exception to the "any product" rule. The Tincher Court did that by citing to Hahn. See Tincher, 104 A.3d at 382 ("but see Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (Pa. 1996) (manufacturer immune from strict liability defective design claim premised upon sale of prescription drugs without adequate warning") (emphasis added). Wagner reads this as adopting an exception for prescription drugs but not for prescription medical devices. Id. at 11 n.8. In other words, Wagner reads into Tincher that it purposely drew a distinction between prescription drugs (which were not before it) and prescription medical devices (which were also not before it). But that requires the court to completely ignore the overwhelming precedent, in Pennsylvania and nationally, equating prescription drugs and prescription medical devices for comment k purposes. Doing just that, Wagner concludes that the surgically installed feeding tube is more like the bricks at issue in Tincher than the prescription drug at issue in Hahn. Id. at 9.

So, Wagner looks to old cases that allow strict liability manufacturing claims against both prescription drugs and medical devices and interprets the non-prescription medical product case of Tincher to exempt from strict liability only prescription drugs and arrives at the conclusion that Pennsylvania would recognize strict liability manufacturing defect claims for medical devices. To borrow from our prior post in which we disdainfully responded to this type of use of Tincher, "[i]t makes no sense that Tincher, which was primarily devoted to moving strict liability design defect cases closer to negligence, would somehow expand strict liability sub silentio (that's legal Latin for "without explicitly saying so") in the prescription medical product area, while simultaneously reining it in everywhere else." We think the same of the decision in Wagner. It makes no sense. It is an unsupported expansion of Pennsylvania prescription medical products law. Tincher is a great decision. It completely revamped strict liability in Pennsylvania. But strict liability does not apply to prescription medical products in Pennsylvania and never has – in any form. Tincher doesn't change that.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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