We don’t see many cases involving human tissue, but medical products derived from human tissue are actually quite common. Skin replacement products, tissue-engineered cartilage, compounds for treating bone fractures and tumors. Those kinds of things. Just yesterday in our annual Ten Best/Ten Worst Cases webinar we discussed a case involving transplanted human eye tissue.
Like many of you, we spend a large portion of our professional life litigating cases consolidated in MDLs. MDLs serve a purpose in this “mass tort” world, but they also breed laziness and complacency among plaintiff lawyers who amass “inventories” of clients they’ve never met and about whose claims they know nothing in the hope…
Not so long ago in a Circuit not so far away, the issue of whether design defect claims against branded prescription drug manufacturers are preempted was joined. Much like the origins of the Jedi or the major end-of-year holidays as we know them, one would expect a clearer published record of how this came to be. There can be a tendency to read back from recent experience and imbue our past selves with more knowledge or foresight that we actually had. For preemption of design defect claims against branded prescription drug manufacturers, we know we have been arguing for it for years and we are not quite sure why it took so long for a Circuit Court to adopt it. As we noted a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did find preemption, and did it pretty definitively. So definitively that it took our spot as top decision of 2015. Along the way, the court declined to follow a prior decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), which itself reversed decisions of the trial court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting summary judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying motion to alter judgment), each of which included the holding that pre-approval design defect and negligence claims were preempted. It is with the Longs/Wimbush decisions where our story starts, subject to some back story and with a healthy dose of links to past posts.
We first note, however, that it has long been our view, expressed in many posts and elsewhere, that design defect does not make much sense as a theory of liability for a prescription drug. In most cases, what the plaintiff alleges made the drug excessively risky and thus defectively designed cannot possibly be changed without making it a different drug. One of the principles of pharmacology is that changes to the chemical compound will typically affect both the desired and undesired effects in the body–or as the Supreme Court observed in Bartlett, “because of [a drug’s] simple composition, [it] is chemically incapable of being redesigned.” 133 S. Ct. 2466, 2475. Rarely, a true change to the “design” of the active compound can be identified—maybe chop off this ethyl group or change it from a racemic mixture to a stereoisomer—that will plausibly reduce the pertinent risk, while maintaining benefits and avoiding new risks. Even where that kind of proposed design change exists, the change would make the drug a different product, not a better version of the same product, which is what design defect is supposed to be about. There may be some cases where a plaintiff claims that a different balance of a combined drug’s ingredients, or an
inactive ingredient, or the delivery system should be changed to reduce the risk without making it a different drug. Even those cases, though, seem better suited to warnings-based claims.Continue Reading The Saga of Preempting Prescription Drug Design Defect Claims
If you are a parent, you’ve probably thought (more than once) that you speak a language your children do not understand. After all, when you say “put your shoes away” or “stop hitting your sister” or the more recent addition of “no iPads at dinner” – you believe these to be simple, easily understood directions. But when you’ve said them 5 times in the span of one hour, you start to question your own command of the language. What is it that is not getting through? What don’t they understand? You look for acknowledgement from your significant other that he/she understands you. While you take comfort in knowing that other adults comprehend, they are on your team already. You don’t need to convince your own side. But how do you finally drive it home to them.
How about when them are the plaintiffs? How many different courts, over how many years, in how many different ways can say the same thing – Pennsylvania does not recognize strict liability for prescription medical products. We are quickly approaching 20 years since Hahn v. Richter, 673 A.2d 888 (PA 1996) banned strict liability for prescription drugs and the extension of that ban to medical devices has been on solid footing for at least the last 10 years as well. But because the Pennsylvania Supreme Court has yet to explicitly state that the reasoning and ruling of Hahn applies equally to medical devices, plaintiffs keep filing strict liability device claims in Pennsylvania courts. And, appropriately, the courts keep shredding them.
Last week saw two such decisions from the Eastern and Western Districts of Pennsylvania. One case involved a spinal implant – Wilson v. Synthes USA Prods., LLC, 2015 U.S. Dist. LEXIS 92347 (E.D. Pa. Jul. 15, 2015). The other involved a hip implant – Cogswell v. Wright Medical Tech., Inc., 2015 U.S. Dist. LEXIS 92461 (W.D. Pa. Jul. 16, 2015). In both, plaintiffs tried to argue that Pennsylvania’s ban on strict liability did not apply to medical devices. In Wilson, plaintiff focused on the idea that medical devices could be “altered” to be more safe. Wilson at *7. The court was unpersuaded, finding instead that both drugs and devices are “unreasonably dangerous, but should not be subjected to strict liability because they benefit certain members of society.” Id. Plaintiff in Cogswell tried a similar argument contending that medical devices are different because the risks could have been avoided. Cogswell at *5. Again, the court was unpersuaded.
The Cogswell plaintiff, however, took the argument further. First, he tried to argue that prescription products are only covered by comment k (the basis for the strict liability ban in Pennsylvania) if certain caveats are met. Those caveats were not recognized by the Pennsylvania Supreme Court and therefore, weren’t recognized by the district court either. Id. at *6. Next, he attempted to distinguish a strict liability manufacturing defect claim as permissible, arguing that Hahn only applied to failure to warn. Not a new argument, but also not one that the court was willing to entertain. “Had the Pennsylvania Supreme Court intended an exception to the strict liability rule, it presumably would have articulated one.” Id. at *8.Continue Reading NO PRESCRIPTION MEDICAL PRODUCT STRICT LIABILITY IN PENNSYLVANIA
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.Continue Reading Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?
This is as short as the Tincher majority opinion (137 pp.) is long. Azzarello is overruled. The preliminary judicial evaluation of “unreasonable danger” is abolished. The jury considers it under a dual standard. The negligence/strict liability dichotomy originating in Azzarello is gone. The Third Restatement is not adopted. Haven’t finished reading. There will be more…
We made no secret that we were appalled by the result in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), as soon as it came down. We’re still appalled. Lance remains our current front-runner for worst decision of the 2014. But a couple of recent cases have suggested that there may be a very thin silver lining to Lance.
That has come about because, whatever its other faults (and they are many), Lance reaffirmed “this Court’s refusal to extend strict liability to prescription drug manufacturers,” 85 A.3d at 438 (citing in Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996)). “[F]or policy reasons, this Court has declined to extend strict liability into the prescription drug arena.” 85 A.3d at 453. Thus, what the court had previously ruled in Hahn about Restatement §402A, comment k precluding strict liability across the board remains intact: “the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability.” 85 A.3d 434, 45 n.19 (quoting Hahn, 673 A.2d at 891)).
These statements have had the effect of stemming what had been an unfortunate trend – again among Pennsylvania federal courts applying diversity jurisdiction that should know better − of allowing certain non-warning or warranty-based strict liability claims to survive.Continue Reading A Silver Lining To Lance?
The geezers in our family have been busy recently ululating over the rule of three celebrity deaths. We are not sure we have ever before witnessed a trilogy quite like Roger Ebert, Margaret Thatcher, and Annette Funicello. An aunt insists that it is actually a trilogy of three celebrity women, with fashion designer Lily Pulitzer…