Did you ever wish there was a way to get a definitive answer to those age-old issues that have been plaguing humans since the beginning of time? Like — is it worse to fail at something or never attempt it in the first place? Or — does nature shape our personalities more than nurture? What
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…
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.
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.
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.
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.
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…
We’ve been pondering what to do with the latest 70+ page whopper from the Philadelphia Court of Common Pleas for a couple of weeks. All the while Maya v. Benefit Risk Management, 2012 Phila. Ct. Com. Pl. Lexis 449 (Pa. C.P. Philadelphia Co. Dec. 31, 2012) (also at 2013 WL 663158 – but essentially useless due to lack of internal pagination), has been sitting around, begging for us to take it on.
What would it take to make Maya better?
Well, just about everything would have to be substituted. If that happened the $10 million plaintiff’s verdict in Maya would be toast…. Which reminds of the classic substitution scene from the movie Five Easy Pieces (hence the title of the post). That was pretty brutal, but so is the opinion in Maya. We’ll try to be less brutal in our analysis than Jack Nicholson was before he became a Lakers fan. But without any substitutions – well, ATRA might want to think again before letting the Philadelphia court system off the hook.
A lot of things could be said about the Maya decision – since it touches on so many issues. But we’ll limit ourselves to five – the five theses in Maya that are just plain wrong.
Waiver for Preserving Too Many Issues
Maya was another high-stakes SJS/TENS case. This medical condition is terrible, but it is an example of what used to be called an “idiosyncratic reaction.” Most doctors – at least those not serving as plaintiffs’ experts – admit that they don’t know what triggers the disease. It’s been blamed on just about every drug (prescription or non-prescription) imaginable, but it could just as well be a reaction to something else in the environment, something that’s ordinarily non-bioreactive, such as plastic. But plastic manufacturers don’t have to keep records of adverse reactions. Drug companies do, and those reactions duly get listed on product labeling – whether there’s causation or not.
The other day we posted about Von Downum v. Synthes, 2012 WL 5463900 (N.D. Okla. Nov. 8, 2012), primarily concerning its fraudulent joinder holding – in accord with the “overwhelming weight of authority” in other states – that a hospital cannot be strictly liable for claimed defects in drugs and medical devices that are used in medical procedures within its walls. Id. at *5. (Note: the defense still lost, but on other grounds).
“Overwhelming” authority, at least when it’s in favor of a pro-defense proposition, is something that we like addressing, so as we hinted in our previous post, we’re looking more deeply into the issue of hospital strict liability. While we almost always represent manufacturers, not hospitals, the notion that they could be strictly liable as “distributors” or “intermediate sellers” of our clients’ products is not a theory that we ever want to see the light of day. The answer’s simple – such liability would inevitably result in hospitals turning around and pointing the finger at our clients. We don’t like seeing defendants pointing fingers at each other. Almost always, the only beneficiary from that is the plaintiff. Not surprisingly, that’s often the precise reason why smart plaintiffs’ lawyers (don’t kid yourself, most of them are) press such theories.
The first thing we normally do in such situations is take a look at the Restatement (Third) of Torts, Products Liability. We find the Restatement’s position in §20 (“Definition of ‘One Who Sells or Otherwise Distributes’”):
[I]n a strong majority of jurisdictions, hospitals are held not to be sellers of products they supply in conjunction with the provision of medical care, regardless of the circumstances.
Restatement (Third) of Torts, Products Liability § 20, comment d (1998). That’s because, in most instances courts have decided that hospitals predominantly provide services, and thus do not qualify as “sellers” subject to strict product liability.
That brings us to the heart of the matter – what are that “strong majority of jurisdictions”?
So we go to the cases.