Bexis is pretty pleased this morning. Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino). Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips). Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille. In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become. End of self-congratulatory gloat.
We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership. At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014). Now we have. While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety. The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.
On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly. Yes, Azzarello was that bad. The Court, however, did not adopt the Third Restatement in Tincher. Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles. We’ll be discussing that in more detail.
It could have been better, at least for non-drug device defendants (see the dissenting part of the concurrence/dissent), but compared to Azzarello the result is excellent.
Tincher’s Impact on Drugs and Medical Devices
First, how does Tincher affect drugs and medical devices, the primary focus of this blog? For prescription products, the short answer is “not much.” One of the adverse consequences of Azzarello’s negligence/strict liability dichotomy was precedent that rejected state of the art as a “negligence principle.” Largely as a result of concerns over liability for scientifically undiscovered risks (something the Supreme Court never really had to address), in Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (another case Bexis briefed) the Court excluded prescription medical products entirely from Azzarello strict liability using Restatement §402A, comment k. See Tincher, slip op. at 59 n.13 (describing Hahn holding as “where adequacy of warnings associated with prescription drugs is at issue, strict liability is not recognized as basis for liability”). Thus Tincher’s reworking of strict liability doesn’t affect prescription medical products because that theory wasn’t applicable in the first place. Indeed, one of Bexis’ worries about the Third Restatement was that eventually it might call the Hahn strict liability exemption into question. Without the Third Restatement, that doesn’t happen.
However, Azzarello strict liability has been imposed on manufacturers of over-the-counter (“OTC”) drugs. Dunson v. McNeil-PPC, Inc., 2009 WL 1178651, at *4-5 (Pa. Super. April 24, 2009); Wolfe v. McNeil-PPC, Inc., 773 F. Supp. 2d 561, 568 (E.D. Pa. 2011). Thus, OTC manufacturers will be able to take advantage of the post-Azzarello landscape, even on current appeals, if they’ve properly preserved the issue.
Generic drug manufacturers, however, should note Tincher’s express rejection of absolute liability. Slip op. at 85. This closes one (nonexistent) loophole to preemption that the Superior Court had attempted to leave open in the Reglan Trilogy.
Tincher’s Historical Overview
So what do we have? Fortunately, most of the first half (56 pages) of the Court’s opinion is prefatory and don’t require much discussion. The Court engages in a long historical review of early Pennsylvania strict liability cases under §402A. The purpose of this is to underscore how the Court in those cases made a number of overly broad and less-than-thought-out statements in the course of adopting and applying §402A. E.g., Tincher, slip op. at 44 (Webb v. Zern “offered little explanation of its reasoning for formally adopting the Second Restatement”); 49 n.11 (other “interim” cases decided “without offering any insight into foundational matters of concern”); 50 (several decisions “lapsed, generally, into comparisons with the more familiar negligence and warranty causes of action”). In discussing the plurality decision in Berkebile v. Brantly Helicopter Corp., 337 A.2d 893 (Pa. 1975), the Tincher court observed that the infamous “every element necessary to make it safe” language arose in a discussion of warning defects. Slip op. at 55. Tincher summed up the early §402A cases thusly:
[I]t is now apparent that the first decade of applying the doctrine of strict liability in Pennsylvania offered a series of missed opportunities to develop a vibrant and coherent body of common law on the issue.
Slip op. at 56. The foundation that these cases laid for strict liability was “confus[ed] and “formulaic”:
To the extent that the Court spoke to broader considerations, several trends became evident: . . . rhetoric emerged not only to distinguish strict liability from its negligence roots, but also to excise negligence principles and terms (such as foreseeability) from strict liability theory; the reliance upon formulaic reiteration of consumer protection-related policies, offered as a bulwark against attempts to dilute the application of strict liability theory in individual cases; and then a focus in strict liability theory that ultimately turned upon a statutory construction-type of analysis of the Second Restatement. Experience suggests that these trends, and fits and starts, have proven antithetical to the orderly evolution of our decisional law, one that must be responsive to new problems, perspectives, and consequences.
Id. at 57 (emphasis added). Ouch. That’s what one calls repudiation.
Tincher discussed Azzarello. It pointed out that the “every element” language from Berkebile “was quoted subsequently out of context by the majority in Azzarello as the standard of proof in a strict liability action.” Slip op. at 56. It explained the removal of “unreasonably dangerous” from jury consideration and pointed out that court’s reliance on the Cronin case from California. Id. at 57-58. “According to the [Azzarello] Court, in cases of an alleged defective design, the dispositive question is whether the product is safe for its intended use.” Id. at 59. Azzarello required that the jury be instructed that the manufacturer was a “guarantor” of safety and “should not be instructed on the “unreasonably dangerous” standard.” Id.
In discussing post-Azzarello cases, Tincher analyzed in detail the majority, concurring and dissenting opinions in Lewis, the holding of which was to exclude evidence of industry standards in strict liability cases as “negligence” related. Slip op. at 60-62. It also addressed “doctrinal separation” and the Court having been “adaman[t] that negligence concepts have no place in a strict liability action” expressed in the Kimco case refusing to allow comparative negligence in strict liability cases. Id. at 62-63 & n.14.
Turning to more recent cases, Tincher focused primarily on their discussions of the Third Restatement of Torts – not surprising, given that this was a question that the Court expressly intended to decide in Tincher. In Phillips, only one justice was willing to decide the case based on the Azzarello negligence/strict liability dichotomy. That justice thought the Third Restatement question waived (which in fairness it probably was, as Bexis raised it in an amicus brief). Tincher, slip op. at 64. One justice in Phillips did not agree on the negligence analysis. Three concurring justices in Phillips (including (then) Justice Castille) “advocated taking the opportunity to address foundational matters, to reassess Pennsylvania’s Second Restatement approach, and to examine the range of readily accessible, corrective measures, including adoption of the Third Restatement.” Slip op. at 65.
In relevant part, the concurrence addressed three points: first, that strict liability doctrine is embedded with concepts central to negligence theory; second, that ambiguities and inconsistencies in prevailing strict liability jurisprudence affected the proper disposition of the appeal; and third, that the Third Restatement’s approach would provide the most viable route to clarification and remediation of strict liability jurisprudence in Pennsylvania.
Id. (describing Phillips concurrence). Tincher goes on to describe the Phillips concurrence at length, in part because of the Tincher defendant’s advocacy of the same rationale. Id. at 65-68.
Tincher also discussed various Third-Restatement-related statements in the decade...
