United States: The Demise Of Drug Design Litigation: Death By Federal Preemption

Last Updated: December 6 2018
Article by James Beck

That is the intriguing title of the latest law review article written by the "Rabbi of Torts," Prof. Aaron Twerski (we're not making this up, Prof. Twerski's Wikipedia page is the fifth result when we just Googled that phrase). Prof. Twerski, one of the ALI's reporters for the Restatement (Third) of Torts: Products Liability, has probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one of the more opaque parts of the venerable §402A. Indeed, in a prior article, Prof. Twerski divined fully eight different interpretations of comment k, the Second Restatement's discussion of, among other things, design defect claims involving prescription medical products (mostly drugs and vaccines, as medical devices were much less common back in 1965). See James A. Henderson, Jr. & Aaron D. Twerski, "Drug Design Liability: Farewell to Comment K," 67 Baylor L. Rev. 521, 542-44 (2015).

Then there's the Third Restatement, which sought to replace comment k's approach to design defect claims involving "unavoidably unsafe" products with:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

* * * *

(c) 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, Products Liability §6(c) (1998).

As we've chronicled on the blog, most courts still continue to grapple with comment k. Conversely, §6(c) has received a mixed and tepid response from the courts. Now Prof. Twerski has essentially concluded that further explication of the courts' Talmudic approach to comment k and design defect claims in our sandbox is futile – such claims are all federally preempted. That, of course, is something we've been saying on the Blog since the moment Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), was decided five years ago. See, e.g., here, here, here, and here. But we're just bloggers; Prof. Twerski is an institution. We're flattered simply to be cited as authority on par with law reviews and other scholarly works. See footnotes 6 & 19.

Here's a link to Prof. Twerski's latest article on SSRN. Its formal citation is, 68(1) Am. Univ. L.R. 281-304 (2018). The first thing we note about the article is that the title is limited to "drugs," as opposed to medical devices. Nothing in the article, however, expressly distinguishes medical devices, and Prof. Twerski concludes that the limited cause of action permitted by Restatement (Third) §6(c) – which treats prescription drugs and medical devices identically – is, indeed, preempted:

The Restatement test ultimately allows a common law design defect claim to prevail over the FDA's approval of a drug. The only thing that a defendant can do to escape liability is to stop selling the drug − a position that is in direct contravention of Bartlett. Perhaps for a drug that is so egregiously dangerous, the Supreme Court might craft an exception to Bartlett. But, otherwise, the Bartlett dissent is quite correct in predicting that the majority has rendered drug design defect immune from common law actions.

"Demise of Drug Design Litigation," 68(1) Am. Univ. L.R. at 302 (footnotes omitted).

As we've pointed out on a number of occasions, most recently in our discussion of Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018), the Mensing/Bartlett basis for impossibility preemption – that the FDA must pre-approve "major changes" to product designs, and therefore regulated manufacturers cannot act immediately and unilaterally to change "defective" designs, as state tort law requires − applies equally to design changes for both drugs and medical devices.

Interestingly, we also note that Prof. Twerski speculated that the Gustavsen preemption decision – then in the district court (the First Circuit decision was too recent to be in his article) – might be within "a small subset of design claims [that] may not be preempted." 68(1) Am. Univ. L.R. at 303. Prof. Twerski's reasoning was "that the Supreme Court might take issue with the FDA characterization of a change in volume of the drops created by the bottle's stopper as a 'major change' requiring FDA approval." Id. Well, the First Circuit affirmed preemption of "major changes," and it doesn't seem like the plaintiffs in Gustavsen are as optimistic about their case as Prof. Twerski's supposed they might be. They did not bother appealing to the United States Supreme Court, and the deadline for doing so has expired.

Another interesting perspective offered by Prof. Twerski is that Bartlett was improperly decided – not on preemption, but as a matter of New Hampshire state law. 68(1) Am. Univ. L.R. at 284. The Court in Bartlett held, as to New Hampshire product liability law:

But respondent's argument conflates what we will call a "strict-liability" regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an "absolute-liability" regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk). New Hampshire has adopted the former, not the latter. Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a "duty to design his product reasonably safely for the uses which he can foresee."

570 U.S. at 481 (string citation of New Hampshire cases omitted). Prof. Twerski's analysis, turning on a case Bartlett did not cite, Vautour v. Body Master Sport Industries, Inc., 784 A.2d 1178 (N.H. 2001), posits, instead, that in Vautour New Hampshire product liability became "absolute liability" based on pure risk/utility balancing, without any need for the plaintiff to assert an alternative design.

This is not the forum to rehash our strong objection to [absolute liability]. The point is that New Hampshire has embraced it. Thus, liability was not regulatory in the sense that Justice Alito set forth in Bartlett. New Hampshire did not impose a duty on [defendant] to develop a better warning nor did it require [defendant] to redesign [the drug]. It simply allowed a jury to find that the [drug], as designed with the warnings as given, was unreasonably dangerous.

68(1) Am. Univ. L.R. at 292-93 (footnotes omitted).

Pointing to the footnote in Bartlett (570 U.S. at 482 n.1) "sav[ing] for another day" the issue "whether a true absolute-liability state-law system could give rise to impossibility pre-emption," Prof. Twerski suggests that Bartlett should have come to grips with the application of impossibility preemption to an absolute liability system of product liability. 68(1) Am. Univ. L.R. at 293-94. We think that Bartlett actually did address absolute liability, perhaps back-handedly, in its discussion of the plaintiff's claim that the defendant should never have sold its FDA-approved product. What is that theory, if not absolute liability? Liability, under a stop-selling theory seems pretty "absolute" to us, since the only way to avoid liability would be not to sell the product at all. Bartlett had no trouble holding that theory preempted:

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases. In every instance in which the Court has found impossibility pre-emption, the "direct conflict" between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting. . . . Adopting the First Circuit's stop-selling rationale would mean that not only [Mensing], but also the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided. Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

570 U.S. at 488-90 (detailed description of particular cases omitted).

So, did Bartlett mess up New Hampshire law? Prof. Twerski makes a pretty convincing case as to what New Hampshire law actually is, but ultimately we don't think it makes much difference. First, we think that the majority in Bartlett was not interested in deciding the case based on New Hampshire having some sort of bats**t crazy tort regime, but rather wanted to emphasize preemption of more mainstream forms of product liability. Second, nothing in Bartlett, and in particular in its affirmance of "stop-selling" preemption, indicates that absolute liability would escape the fate of other, more widely accepted, design defect liability theories.

Ultimately, Prof. Twerski concurs in that assessment. Pure risk/utility balancing amounts to a definitively preempted stop-selling claim:

Can the state allow a common law remedy based on a finding of unreasonable danger, thus negating the FDA's determination that the drug is reasonably safe so that it is approved for marketing? . . . After running out of state common law duties to make the drug safer, the defendant was left with the sole option of not marketing a FDA approved drug to avoid tort liability. This remaining option, however, is an option that Bartlett teaches flies in the teeth of preemption jurisprudence.

68(1) Am. Univ. L.R. at 300-01 (footnotes omitted).

Second, the most widely followed design defect rationale – risk/utility balancing of reasonable alternative designs ("RAD") is precisely what Bartlett preempted:

[P]ost-Bartlett, it would seem quite clear that, for a drug that has received FDA approval, any argument that it can be modified by a RAD is federally preempted. Justice Alito's reasoning leaves little doubt when he said that "once a drug − whether generic or brand name- − is approved, the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug."' If a court were to find a post-FDA approval drug to be a RAD, it would almost certainly be struck down on the same impossibility grounds set forth in Bartlett.

Id. at 295 (footnotes omitted).

Third, Prof. Twerski ( like us) has only scorn for the "pre-approval design defect" theory that plaintiffs have turned to as an argument to avoid preemption.

How a court could censure a manufacturer for not developing a different drug without any assurance of its safety by the FDA is beyond comprehension. As to preemption, the court in [Mensing] made short order of the argument that a plaintiff could challenge an FDA approved drug based on the supposition of what the FDA might do if asked to respond to a change. . . . None of the cases opting for the "pre-approval theory" have adequately responded to either the common law or preemption arguments that negate this novel theory.

Id. at 296-97 (footnotes omitted).

Finally, as already discussed, the design defect theory enshrined in Restatement (Third) §6(c) also runs afoul of preemption. Id. at 302 (footnote omitted).

Thus, Prof. Twerski concludes that design defect claims involving prescription drugs are preempted no matter how the plaintiffs package them. In the end, however, Prof. Twerski sheds no tears over the demise of design defect litigation against FDA-approved drugs. Design-based theories have never really amounted to very much:

The overwhelming majority of cases against pharmaceuticals have always been based on failure to warn. . . . Drug design, despite the fascination of scholars with this issue, has played only a minor role in drug litigation. The pillars of the republic will not fall if this questionable theory is laid to rest.

Id. at 304. That's a sentiment with which we whole-heartedly agree. We are always interested in reading more of Prof. Twerski's views on design defect preemption – particularly with respect to prescription medical devices.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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