Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we landed at Dulles for our connecting flight home, the queue at
A federal court recently placed Colorado amongst the states that apply Restatement (Third) of Torts §6(c) in design defect cases. That’s a good place to be when you’re defending a medical device company. Section 6(c) creates a tougher burden for design defect plaintiffs than does Restatement (Second) of Torts. Showing a safer alternative design isn’t enough. And that’s important, because there are often alternative designs for medical devices. Section §6(c) instead focuses on prescribing doctors and their risk-benefit analysis:
A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
Restatement (Third) of Torts § 6(c). In short, if a reasonable doctor would choose to use the device for any class of patients, knowing the risks, it is not defectively designed – regardless of whether there might be an alternative design.
The facts of the Colorado case, Haffner v. Stryker Corp., No 2014 U.S. Dist. LEXIS 137214 (D. Col. Sep. 29, 2014), show how this can work. The plaintiff had knee replacement surgery, but later needed revision surgery. He was allergic to the cobalt and nickel contained in the knee replacement system. So he sued, claiming, amongst other things, that the system was defectively designed. Id. at *1, 2, 7.
Potentially the most important Pennsylvania product liability case in a generation was argued before the Pennsylvania Supreme Court on October 15, 2013. That’s Tincher v. Omegaflex, No. 17 MAP 2013. As we mentioned before, the Pennsylvania high court took Tincher expressly to decide whether current Pennsylvania product liability law, based on Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), and that court’s extremely strict form of strict liability under Restatement (Second) of Torts §402A (1965), should be maintained, or, alternatively, be replaced by the Third Restatement of Torts. As we’ve also discussed, the Third Restatement’s largely (except manufacturing) negligence basis for product liability would eliminate a number of plaintiff-friendly evidentiary exclusions that have arisen under Azzarello’s progeny. Tincher is a big deal – even by the standards of Biden-speak.
Bexis filed an amicus brief in Tincher for PLAC, but since the argument was in Pittsburgh, he didn’t attend the oral argument. The argument, however, was eventually televised, and he has been able to obtain a CD of the proceedings. We’d post it, but the CD came with a warning from the Pennsylvania Supreme Court that it was not for public use, so we’re not about to get crosswise with the justices. You’ll just have to settle for our summary. We’re not starting at the beginning. Rather, we’ll begin at 40:51 on the argument videotape, where counsel argued:
I would not be adverse to Azzarello being overruled; that I do believe that it’s caused headaches. [comment from Justice Saylor omitted]
It’s caused headaches for the Court. It’s caused headaches for trial courts and I think the time has come for a modification or overruling of Azzarello and moving the courts of our state back to strict liability as it’s followed by other jurisdictions, without these kinds of problems; these kinds of headaches.
In honor of the Pennsylvania Supreme Court’s recent grant of an appeal on the Restatement (Second)/Restatement (Third) in Tincher v. Omega-Flex, we are republishing as a guest post a very good article (pre-Tincher, of course) that we recently read on this topic written by Dan Cummins of Foley Comerford & Cummins, who…
This just in: Finally, the Pennsylvania Supreme Court has taken the Restatement Second/Restatement Third issue for products liability. Here’s the order. Here is the relevant language:
AND NOW, this 26th day of March 2013, the Petition for Allowance of Appeal is GRANTED, LIMITED TO the issue set forth below. . . .
whenever we watch a drug or device trial (easier and easier to do now with
various internet services) we walk away thinking that the two key prongs to any
defense are context and the doctor’s choice of treatment. Plaintiff lawyers are skilled at
We posted before about a case, Sikkelee v. Precision Airmotive, Corp., ___ F. Supp.2d ___, 2012 WL 2552243 (M.D. Pa. July 3, 2012), in which the court persisted in applying the Restatement Second §402A rather than Restatement (Third) of Torts, Products Liability §2 (1998), despite not one, but two, published Third Circuit opinions predicting…
We’re Pennsylvania lawyers (at least we started that way) so we figure we can be excused for following Pennsylvania law more closely than other states. One of the key topics our Pennsylvania law posts have covered is the continuing saga of the Third Restatement of Torts − particularly in the federal courts.
Basically, in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003), three justices of the Pennsylvania Supreme Court (Saylor, Castile (CJ) and Eakin) joined a concurring opinion stating that Pennsylvania’s old “super-strict” liability regime in place since Azzarello v. Black Brothers Co., 391 A.2d 1020, 1022 (Pa. 1978), was antiquated, unworkable, and should be replaced by the negligence-based standard of Restatement (Third) of Torts, Products Liability §2 (1998). Only a couple of justices, no longer on the Court, disagreed. However, since the issue was not before the court directly in Phillips, the opinion was a concurrence only and several justices did not take any position. Bexis knows. He wrote the amicus brief for PLAC in Phillips that addressed the Restatement Third issue.
It looked like the Supreme Court was going to resolve the question when it took a case called Bugosh v. I.U. North America. However, Bugosh was an asbestos case and the only appellants were intermediate sellers − not product manufacturers with which §2 of the Third Restatement (not to mention the Phillips concurrence) is primarily concerned. After this became clear at oral argument, the Pennsylvania Supreme Court dismissed Bugosh as improvidently granted. See Bugosh v. I.U. North America, Inc., 942 A.2d 897 (Pa. 2008) (order dismissing appeal). Again, Bexis knows. He participated in Bugosh for PLAC, and tried to help defense counsel grapple (unavailingly) with the intermediate seller issue.
Meanwhile the Third Circuit, in Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38 (3d Cir. 2009), while Bugosh was pending, had the same issue in a case where the plaintiff (a bystander/unintended user) would benefit from the adoption of the Third Restatement. After first trying, and failing, to get the Pennsylvania Supreme Court to take a certified appeal, the Third Circuit predicted the adoption of the Third Restatement as Pennsylvania law. We described Berrier here. Again Bexis participated for PLAC, this time arguing that a federal court should not predict such a momentous change in Pennsylvania law, and that the defendant clearly won under existing law, but that if the court were to reach the issue the Third Restatement was preferable to Azzarello.
Shortly after the Berrier prediction, Bugosh was dismissed. The defendant unsuccessfully sought reconsideration (technically recall of the mandate, given the timing), but the Third Circuit refused, so its prediction stood, notwithstanding Bugosh. We described all this here.
We found the decision in Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), interesting for at least three reasons. First of all, it’s another TwIqbal dismissal, so it goes on our TwIqbal cheat sheet.
But what’s even more interesting is precisely what the plaintiff wasn’t able to plead. …
We’re talking about the Restatement (Third) of Torts, Products Liability §2, to be precise. Being in Pennsylvania, for quite some time we’ve had more than a passing interest in this section of the Third Restatement and its essentially negligence (“reasonableness”)-based theory of product liability. For decades, Pennsylvania followed a “ne’er the twain shall meet” rule that strictly separated strict liability from “negligence concepts.” That approach was exemplified by Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978). But in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003), three justices of the Pennsylvania Supreme Court opined that a quarter century had proven wanting the “strict liability” of the Azzarello sort, and that Pennsylvania law should move to the negligence-based standard of §2. 841 A.2d at 1015-16. Full disclosure – Bexis filed a brief for PLAC in Phillips on the Restatement Third issue.
While three justices aren’t a majority of Pennsylvania’s seven-member Supreme Court, in Phillips they outnumbered the court’s Azzarello supporters 3-2 (there was a vacancy and an obscure concurrence in the result). In almost seven intervening years, the court has failed to address the issue squarely, although not for want of trying. The court thought it was going to decide the issue in Straub v. Cherne Industries, 880 A.2d 561 (Pa. 2005), but instead found there had been a waiver. The court tried again in Bugosh v. I.U. North America, Inc., 971 A.2d 1228 (Pa. 2009), but dismissed the appeal as improvidently granted after it turned out that the defendant was an intermediate seller, not a true manufacturer (that makes a difference in the Third Restatement, but it’s not important here).
Finally, the Third Circuit got fed up with the issue remaining undecided, and after trying unsuccessfully to get the Pennsylvania Supreme Court to accept a certified question, took the metaphorical bull by the horns and predicted that the court would eventually adopt the Third Restatement in Berrier v. Simplicity Manufacturing, 563 F.3d 38, 57 (3d Cir. 2009). As we discussed in an earlier post, that’s led to still more squabbling among the federal district courts.
Full disclosure – Bexis filed amicus briefs for PLAC in all of those other cases on the Third Restatement issue.
So the Third Restatement question has vexed Pennsylvania product liability law for quite a few years. Well, not too long ago we (well, Bexis, obviously) was expressing his frustration with this indeterminate state of affairs with regular blog reader whom we ‘re not sure wants to be publicly identified, so we won’t, and said reader mentioned that his/her home state of Wisconsin was in somewhat of the same boat.