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.

An unexpected bit of good news as we go into November. Bexis will be presenting at the Reed Smith annual client CLE program on big-deal pending cases.  In preparation, he took a look at the SCOTUSBlog page for Merck Sharp & Dohme Corp. v. Albrecht, No 17-290 (that’s the Supreme Court name for In re Fosamax in the Third Circuit).  There’s a new entry from last Friday: “Justice Alito is no longer recused in this case.”  See also, from the Supreme Court’s official docket:

Oct 26 2018 Justice Alito is no longer recused in this case.

That’s good news for our side, because as we mentioned at the time certiorari was accepted:

We do note one unfortunate aspect of the order granting review: “Justice Alito took no part in the consideration or decision of this petition.” Since Justice Alito has historically supported preemption – he wrote the dissent in Wyeth v. Levine, 555 U.S. 555 (2009) – that means we’re short a vote.

Not any more. Our understanding, based on something we heard several years ago, is that Justice Alito at one time held stock in Merck. Evidently not any longer. While we’re not counting our chickens in Albrecht before they’ve hatched, we’re not playing a man short any longer, either. So we like our side’s chances in Albrecht even better now.

For more of our Albrecht/Fosamax coverage see here, here, here, and here.

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016).  With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date.  The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.

Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury.  Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury).  The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue.  Id. at 699.

[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.

Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).

Continue Reading Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

Zika virus, Olympic unpreparedness, economic collapse, presidential impeachment − a lot of things have gone wrong in Brazil lately. But we’re not here to talk about any of that. Here’s something that went right: Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016). Brazil is the second major branded (innovator) drug preemption win in an Invokana case in little over a month.

Yes, we brought you the first one, too, right here (discussing Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299 (W.D. Tenn. May 6, 2016)).

In Brazil the plaintiff brought the usual defect claims (manufacturing, design, warning) under Georgia law. The defendants moved to dismiss.

In the most significant part of the Brazil opinion, the defendants successfully asserted preemption. First and foremost, we direct our readers’ attention to the last holding in Brazil, because it has potentially the widest impact. The court held that, under the preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), no warning claims could be asserted against anybody other than the then-current holder of a drug’s New Drug Application (“NDA”). Why? Because nobody else had the ability to change that drug’s warnings.

Defendants argue that Plaintiff’s claims against Janssen Ortho, which are premised on a failure to warn, are preempted because Janssen Ortho is not the NDA applicant and thus cannot seek to change [the drug’s] label. [A different entity] holds the NDA for [the drug]. The Court agrees. When a company does not have the NDA, it has no more power to change the label of a drug than a generic manufacturer. A distributor, even of a brand name drug, has no power to change labeling. That power lies with the applicant who filed the [NDA]. Because Janssen Ortho could not independently do under federal law what state law requires of it,’ the state law claims brought against it are preempted.”

Brazil, 2016 WL 3180299, at *11 (citation and quotation marks omitted) (emphasis added).

Continue Reading Something Went Right In Brazil