Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result: that while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not.
Plain and simple, the preemption result in Bartlett makes no sense.
Today we take a closer look at the Bartlett opinion and the reasoning, if it can be called that, that brought the court to its highly questionable result.
Two fundamental facts underlie Bartlett: First, the plaintiff had (at least in theory) lost her warning-based claim for lack of causation – the prescribing physician did not read or otherwise rely on the allegedly inadequate warning, rendering the warning non-causal. Second, for whatever reason, the defendant at trial made the strategic decision (which with the benefit of 20-20 hindsight now seems disastrous) not to offer any affirmative defense at all.
The plaintiff’s lack of a warning claim itself had two effects. One, plaintiff was damn lucky, because warning claims against generic drugs were precisely what the Supreme Court held to be preempted in Mensing. A verdict in Bartlett based upon a warning claim – the most common theory – would undoubtedly have been overturned before the First Circuit ever saw the case. Two, since both Mensing and Wyeth v. Levine, 555 U.S. 555 (2009), involved warning claims (again, they’re the most common), neither case was 100% on point.
Bartlett initially demonstrates why “design defect” simply doesn’t fit prescription drugs (some medical devices are different). As the First Circuit mentioned, you can’t change the “design” of something that “is a one-molecule drug; and the variations in [it] as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.” 2012 WL 1522004, at *2. The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy.
“Design defect” in the absence of any available alternative design amounts to absolute liability. It’s not a tort, but rather a judicially-imposed no-premium insurance policy. For that reason, the Third Restatement and an increasing majority of states (Wisconsin and South Carolina, at least, have changed during the lifespan of this blog) require proof of an alternative design as an essential element of all design-based claims.
New Hampshire, however, isn’t one of those states. In Vautour v. Body Masters Sports Industries, Inc., 784 A.2d 1178, 1183 (N.H.2001), the New Hampshire Supreme Court rejected the Third Restatement because of the alternative design issue. See Bartlett, 2012 WL 1522004, at *3. Vautour, however, involved exercise equipment, and the plaintiff offered alternative design evidence (albeit rather weak). It was not a case where there was no alternative design possible, and thus an attempt to impose absolute liability. Nor did Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981) – where the First Circuit allowed a design defect claim involving a prescription drug despite no state-court authority (contrary to proper Erie principles) – involve absolute liability, since that drug had two active ingredients, and the plaintiff argued that a better design would have had less of one of them. Id. at 655.
The only New Hampshire precedent involving a design defect claim where no alternative design was possible is Buckingham v. R.J. Reynolds Tobacco Co., 713 A.2d 381 (N.H.1998), a tobacco case where the plaintiff sought to impose absolute liability. The court rejected product liability for the design characteristics of a design that could not be changed. “When the plaintiff cannot allege that something is ‘wrong’ with the product, strict liability should not be used as a tool of social engineering to mandate that manufacturers bear the entire risk and costs of injuries caused by their products.” Id. at 384.
Bartlett, however, purported to follow Vautour because it was more recent than Buckingham. 2012 WL 1522004, at *3 (Vautour “followed after Buckingham”). In reality, however, the court did something quite different. For the first time under New Hampshire law, Bartlett permitted absolute liability – “design defect” liability for a design that the court admitted could not be changed. Bartlett reached an unprecedented result by applying Vatour, which did not involve the impossibility of an alternative design, in an impossibility situation. It did so, we would argue, in direct contravention of the holding in Buckingham rejecting “social engineering” through product liability litigation.
There was one final bulwark against absolute liability in Bartlett – Restatement (Second) of Torts §402A, comment k (1965), the “unavoidably unsafe product” doctrine, recognized in Brochu. Comment k precludes liability for the “unavoidably unsafe” attributes of a product as long as it bears adequate warnings and isn’t contaminated in some way. Here, however, the court ruled that the defendant slit its own throat by not putting on any defense. Comment k is an affirmative defense in New Hampshire, so by not presenting a defense, waived it. 2012 WL 1522004, at *3 (defendant “could still have avoided liability by proving [the comment k defense, but] abandoned that defense on the eve of trial”). To that extent, we can’t blame the court.
The First Circuit did something else unusual in Bartlett – applying a pure “consumer expectation” test to an alleged defect in a prescription medical product. 2012 WL 1522004, at *3 (“an ordinary consumer would hardly know without further warning that [the drug] or any other ordinary analgesic carries a risk of the kind of ill effects and suffering that [plaintiff] encountered”). But that’s just not the law in most places, and Bartlett doesn’t cite anything to suggest that New Hampshire would choose this tangent. Prescription only drugs simply aren’t available to “ordinary consumers.” They require a physician’s prescription. They’re the epitome of a “complex” product as to which an “ordinary consumer” would have no expectations. In practically every other jurisdiction either the physician is considered the “ordinary consumer” (since they control use of the product) or “ordinary consumers” have no expectations other than what is stated in the product’s labeling, in which case plaintiffs are limited to warning defect claims. As stated recently:
"The consumer expectations test considers the same factors at issue in a failure-to-warn claim, and so its application is barred by Mensing. An ordinary consumer forms her expectations regarding the safety of drugs from her doctor or from the drug’s label. Thus, if [the drug] is dangerous beyond the expectations of the ordinary consumer, that can only be a symptom of [defendant’s] failure to update its label or communicate effectively with doctors."
Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962, at *6 (D. Md. Dec. 30, 2011). Accord Carlin v. Superior Court, 920 P.2d 1347, 1355 (Cal. 1996); Craft v. Peebles, 893 P.2d 138,154-155 (Haw. 1995); Pittman v. Upjohn Co., 890 S.W.2d 425, 430 (Tenn. 1994); Shanks v. Upjohn Co., 835 P.2d 1189, 1195 (Alaska 1992); King v. Danek Medical, Inc., 37 S.W.3d 429, 445 (Tenn. App. 2000); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (Cal. App. 1999); Rosci v. Acromed Inc., 669 A.2d 959, 969 (Pa. Super. 1995); Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987); Peterson v. Parke Davis & Co., 705 P.2d 1001, 1003 (Colo. App. 1985); Stilwell v. Smith & Nephew, Inc., 482 F.3d 1187, 1194 (9th Cir. 2007); Phelps v. Sherwood Medical Industries, 836 F.2d 296, 302-303 (7th Cir. 1987); In re Zyprexa Products Liability Litigation v. Eli Lilly & Co., 489 F. Supp.2d 230, 267 (E.D.N.Y. 2007); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007); Chamian v. Sharplan Lasers, Inc., 2004 WL 2341569, at *6 n.6 (Mass. Super. Sept. 24, 2004). Bartlett did neither. Rather, the court reached the singular conclusion that “ordinary consumers” have expectations about prescription drugs (which require a prescription precisely because they have risks) beyond those stated in the labeling. That’s a unique and dangerous holding.
But none of the First Circuit’s mangling of New Hampshire law matters much any more – at least in Bartlett. Those are all state-law issues, and if the defendant decides to “take it up” to the Supreme Court (as our prior post urged), there must be a federal question.
That question is preemption.
The First Circuit’s treatment of the preemption question is, if anything, even more peculiar than its flights of fancy under the guise of New Hampshire law.
Essentially, the Bartlett court thumbed its collective noses at the Mensing decision. Instead the decision purports to follow Levine despite: (1) Levine having nothing to do with generic drugs and (2) Levine having even less to do with design defect claims. Indeed, in Levine the Supreme Court went through contortions specifically to avoid having to decide a “failure to contraindicate” claim:
"[Plaintiff] also offered evidence that the [FDA-approved use] should be contraindicated and that [the drug] should never be administered [that way]. Perhaps for this reason, the dissent incorrectly assumes that the state-law duty at issue is the duty to contraindicate. . . . But, as the Vermont Supreme Court explained, the jury verdict . . . did not mandate a particular...
