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This post is about product liability but not particularly about prescription medical products. But since this subject is something Bexis has labored over for so long, we’re invoking the McFadden exception to deviate from drugs and devices for the moment.
But if you’ve got a product liability case of any sort in Pennsylvania or involving Pennsylvania law, we think you’ll be glad we did.
Pennsylvania product liability law has, generally, been rather notorious for its really strict version of strict liability, which precludes any reverence to “foreseeability” or “reasonableness.” E.g., Lewis v. Coffing Hoist Division, Duff-Norton Co., 528 A.2d 590, 591 (Pa. 1987); Azzarello v. Black Brothers Co., 391 A.2d 1020, 1031 (Pa. 1978). Things were so bad that, rather than have his pharmaceutical clients tough it out, Bexis argued (successfully) for “across the board” application of Restatement (Second) §402A, comment k so that strict liability simply doesn’t apply in prescription medical product cases. See Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996).
Due to the “ne’er the twain shall meet” attitude of Pennsylvania law towards negligence on the one hand and strict liability on the other, “strict liability” became the source of a variety of doctrinal or evidentiary propositions that adversely impacted defendants. Such as:

  • The jury is instructed that a product is “defective” merely if it had, or lacked, “any element” necessary to make it safe/made it unsafe. Azzarello, 391 A.2d at 1027-28.
  • Balancing of risks and utility of alternative designs is not something that juries do (since that would involve “reasonableness”), with the plaintiff bearing the burden of proof. Instead defendants have to bring pre-trial motions, on which they bear the burden of proof, asking that their products be found “not unreasonably dangerous” as a matter of law. Moyer v. United Dominion Industries, Inc., 473 F.3d 532, 538 (3d Cir. 2007).
  • There’s no comparative fault in strict liability that would reduce a verdict where the plaintiff did something stupid. Kimco Development Corp. v. Michael D’s Carpet Outlets, 637 A.2d 603, 606 (Pa. 1993).
  • Heck, you can’t even introduce evidence of a plaintiff’s dumb actions unless you can argue that the plaintiff’s screw-up is the “sole cause” of his/her injuries. Charlton v. Toyota Industrial Equipment, 714 A.2d 1043, 1047-48 (Pa. Super. 1998).
  • Evidence of industry standards is inadmissible in strict liability – it goes to a defendant’s “reasonable care.” Lewis, 528 A.2d at 594.
  • Several decisions hold that a product’s compliance with mandatory government regulations – which means you get fined or go to jail for violations – isn’t admissible in strict liability. E.g., Sheehan v. Cincinnati Shaper Co., 555 A.2d 1352, 1355 (1989).
  • Double heck – even evidence that the design alternative or risk was scientifically unknowable at the time of the accident has been excluded. Carrecter v. Colson Equipment Co., 499 A.2d 326, 330-31 (1985).

Thus, in Pennsylvania it’s commonplace for plaintiffs to dismiss their negligence counts shortly before going to trial – to ensure that defendants are disadvantaged by Pennsylvania’s peculiar rules that have grown up in the shadow of the proposition that “negligence principles” have “no place” in strict liability.
For the last decade, Bexis has been hard at work trying to tear down the wall between negligence and strict liability, and thus eliminate these pro-plaintiff rules. In one of his earlier cases, he helped resuscitate, to some extent, the proposition that evidence can be relevant to both strict liability and negligence. Spino v. John S. Tilley Ladder Co., 696 A.2d 1169, 1172 (Pa. 1997) (evidence of lack of similar accidents admissible). Another of his cases saw the Supreme Court narrow the divide between negligence and strict liability. Duchess v. Langston Corp., 769 A.2d 1131, 1144 (2001) (subsequent remedial measures inadmissible in both negligence and strict liability; alternative feasible design an “essential element” in strict liability).
After Duchess, Bexis started filing briefs explicitly advocating that Azzarello strict liability be overturned and replaced by the negligence-based standard for design and warning defects as provided in the Restatement (Third) of Torts. Three justices (you need four for an outright majority) agreed in a concurring opinion in Phillips v. Cricket Lighters, 841 A.2d 1000, 1013 (2003) (Saylor, J. writing). He’s kept it up ever since. The court dodged the issue in Harsh v. Petroll, 887 A.2d 209, 216 n.16 (2005), conceded that strict liability needed “overhaul” in Pennsylvania Dept. of General Services v. U.S. Mineral Products Co., 587 Pa. 236, 253-54, 898 A.2d 590, 601 (2006) (“DGS”), and finally expressly took up the issue in Bugosh v. I.U. North America, Inc., 942 A.2d 897 (2008) (per curium).
But in the meantime, the Third Restatement issue came up in another context before the Third Circuit. This time, it was the plaintiff’s ox being gored. That’s because restrictions on use of “foreseeability” or “reasonableness” don’t always benefit plaintiffs – just most of the time. The flip side is that merely being a “foreseeable plaintiff” or being injured by “foreseeable misuse” aren’t enough under Pennsylvania law. In Berrier v. Simplicity Corp., 413 F. Supp.2d 431, 442 (E.D. Pa. 2005), the court held that, because non-user bystanders were only “foreseeable” plaintiffs, there was no strict liability where the plaintiff was not a user of the product. Because the court also threw out negligence, there was an appealable order. Berrier involved Grampa running over his five-year old grand daughter’s foot in a power mower (yes, this was warned against, but it happened anyway).
Well, a five-year-old can’t be a “user” of a riding lawnmower – so the plaintiff, not the defendant, had to sneak “foreseeability” into strict liability to have a claim. Bexis, in his brief in Berrier, was able to demonstrate quite convincingly that every bystander liability case in the history of mankind employed a “foreseeable plaintiff” rationale. In the meantime, the Pennsylvania Supreme Court pitched in with its holding in DGS that – under traditional Pennsylvania product liability law – “a manufacturer can be deemed liable only for harm that occurs in connection with a product’s intended use by an intended user; the general rule is that there is no strict liability in Pennsylvania relative to non-intended uses even where foreseeable.” 898 A.2d at 600.
Bexis, wanted (as usual) the Third Restatement, although he believed the Pennsylvania Supreme Court was the more appropriate court to make the decision, and said so. Bexis also wanted (as always) the defendant to win. Alternative design is an essential element of liability for design defect under the Third Restatement (yet another reason to like it). The District Court had also ruled that the plaintiff had insufficient evidence of an alternative feasible design. 413 F. Supp.2d at 448. So Bexis could argue that, no matter what standard the court used, the defendant should win. That is, unless the appellate court disturbed the district court’s case-specific finding in this regard – something that Bexis (who as amicus only argued legal propositions, not case-specific facts) didn’t have to defend.
At first, the Third Circuit took the logical way out in Berrier. It certified the Third Restatement question to the Pennsylvania Supreme Court. Berrier v. Simplicity Manufacturing, Inc., 2008 WL 538912 (3d Cir. Jan. 17, 2008). The Pennsylvania Supreme Court, however, having just agreed to hear the same question in Bugosh, declined to accept the certified question. Berrier v. Simplicity Manufacturing, Inc., 959 A.2d 900 (Pa. 2008).
So the question of whether Pennsylvania law should be changed, or alternatively the five-year-old with the mangled foot was out of court, was squarely back in the Third Circuit’s lap. Having tried, but failed, to get the Commonwealth’s highest court to make the decision, the Third Circuit then sat on things for a further six months, presumably expecting the Supreme Court to rule. That didn’t happen either.
It’s entirely possible (we don’t know) that Berrier had become the oldest case on the Third Circuit’s docket while all this was going on.
So the other day, with the same issue still pending in the Pennsylvania Supreme Court, the Third Circuit predicted that the Pennsylvania Supreme Court would overturn the 1977 Azzarello case and instead adopt the negligence-based standard of the Third Restatement of Torts:

We believe that Justice Saylor’s concurring opinion in Phillips foreshadows the Pennsylvania Supreme Court’s adoption of §§1 and 2 of the Third Restatement’s definition of a cause of action for strict products liability.

Berrier v. Simplicity Manufacturing, Inc., ___ F.3d ___, 2009 WL 1054684, slip op. at 36 (3d Cir. April 21, 2009). The Third Circuit did so with full knowledge that it was adopting a negligence-based standard for “strict” liability:

Justice Saylor was correct in recognizing that “[c]entral conceptions borrowed from negligence theory are embedded in strict products liability doctrine in Pennsylvania”. . . . Justice Saylor pointed out: “most courts and commentators have come to realize that in design cases the character of the product and the conduct of the manufacturer are largely inseparable.”

Slip op. at 41-42 (citations to the concurring opinion in Phillips omitted); accord id. at 53 (“We therefore conclude . . . that the time has come for this Court to expressly recognize the essential role of risk-utility balancing, a concept derived from negligence doctrine, in design defect litigation”); 54 (“recogniz[ing]” that the Third Restatement is “generally a negligence standard”).
Thus, at the cost of recognizing bystander liability (which every other state in the country seems to have allowed), we’ve gotten the Third Circuit on record as holding that Pennsylvania will henceforth follow the Third Restatement rather than Azzarello really strict strict liability. We see that as a pretty good trade since: (1) there was already bystander liability in negligence, and (2) Third Restatement “strict liability” is essentially negligence anyway, except for manufacturing defects.
So we’re advising our Pennsylvania colleagues, and any defense lawyer with a case under Pennsylvania law, that everything’s now back on the table. First of all, Berrier suggests to us that the Pennsylvania Supreme Court will be more likely to decide the pending Bugosh case on the merits, since answering this sort of fundamental question of state law (as the Third Circuit realized when it tried certification) is properly within the job description of a state supreme court. There was some discussion at the Bugosh oral argument that the case might not be an appropriate vehicle – that will be less important now. We don’t think the Pennsylvania Supreme Court wants to leave things up in the air for any significant length of time – since the result will be fundamentally different product liability standards being applied in federal versus state courts. Talk about the forum shopping possibilities!
We also think that the Third Circuit’s opinion is well-reasoned, thus we believe that, on the merits, it increases the likelihood that the Pennsylvania Supreme Court will reach the “progressive” result in Bugosh. See Slip op. at 46 (referencing “the more progressive approach adopted by the Third Restatement”) (quoting DGS, 898 A.2d at 616 n.2 (Newman, J. concurring and dissenting)).
But Berrier also means that as long as the Third Restatement question is open – and particularly in the federal courts where it is now recognized as the law of Pennsylvania – we advise preserving every strict liability issue. We recommend, among other things: (1) objecting to the Azzarello “any element” jury charge; (2) instead proposing “reasonable manufacturer” risk utility balancing jury instructions, such as those that are standard in other Third Restatement states; (3) requesting jury charges and verdict forms that include comparative fault; (4) offering plaintiff’s contributory conduct into evidence; (5) offering industry standards into evidence; (7) offering compliance with government regulations into evidence; and (8) offering (where it’s an issue) technological feasibility evidence.
There’s a good likelihood of success. In Berrier, the court indicated that evidence is admissible to “place[] feasibility in issue,” “to show the ‘state of the art’ of safety design at the relevant time,” and that such evidence is “similarly relevant” to “strict liability” as well as negligence. Slip op. at 12-13 n.7.
Now we wait for Bugosh.