Photo of Bexis

No, we didn’t attend the Bartlett oral argument, but the Supreme Court has become wonderfully efficient at providing argument transcripts.  So we’ve read through the argument.  Our strongest impression is, boy, is Bartlett a change from the “traditional” tort claims that the Supreme Court has previously considered in connection with FDCA preemption.  See Wyeth v. Levine, 555 U.S. 555, 565 (2009) (considering only the “narrower question” of “an adequate warning” claim; avoiding preemption of a “duty to contraindicate”); PLIVA v. Mensing, 131 S. Ct. 2567, 2573 (2011) (addressing “tort law requir[ing] a drug manufacturer that is or should be aware of its product’s danger to label that product in a way that renders it reasonably safe”); Medtronic, Inc. v. Lohr, 518 U.S. 470, 491 (1996) (discussing “pre-emption of traditional common-law remedies” in the context of parallel claims); Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (referencing “traditional state tort law” in context of parallel claims); cf. Riegel v. Medtronic, Inc., 552 U.S. 312, 337 n.7 (2008) (dissent; also referencing “traditional common-law remedies”).

Not so in Bartlett.  At oral argument, the Court was required to contemplate “absolute liability scheme[s]” providing that “whether it’s unreasonably dangerous or not it causes an injury, you pay, to spread the costs.”  Transcript at 11.  As Chief Justice Roberts understood the plaintiff’s argument:

It’s just a question under strict liability that if you follow the same Federal standard and market this in our State, you’re going to pay the compensation for the reason of, you know, spreading the costs.  We don’t want you to do something different.  We just want to say that you want to do the same thing as the Federal government, and then you’re going to have to pay.

Id. at 20.  And as plaintiff’s counsel later put it himself:

What the State law is seeking to do here . . . is to impose liability where there is proof of an unreasonably dangerous product.  That unreasonable danger entails evidence of a risk/benefit analysis that looks at the overall risks to the population against the overall benefits that are provided for the drug.

Id. at 26-27.

The same Court that barely approved the constitutionality of legislatively adopted national health insurance last Term now gets to grapple with tort claims that aim to accomplish pretty much the same thing – but without any legislative imprimatur and with contingent fee-level transaction costs right off the top (before even considering our side’s fees).

The Court also heard about “pure” design defect – without alternative design, and without regard to warnings, where the manufacturer of a drug that “benefits, you know, 99.9 percent of the people” is still “going to have to compensate” that other “0.1 percent.”   Transcript at 29 (Roberts, CJ).  The Court was presented with argument that where “the risks outweigh the benefits . . . you should not market this [drug] at all.”  Id.  Justice Sotomayor brought up Restatement (Third) of Torts, Products Liability §6(c), asserting absolute liability on a theory that “no reasonable practitioner, knowing all the benefits and risks, would ever prescribe this drug.”  Id. at 8.  As the DoJ warned, that theory posits that a drug “should not be marketed because it should never be prescribed.”  Id. at 25.  By the way, in 15 years no state has adopted §6(c) in any prescription drug product liability case.  See Bexis’ book  §3.03 (compiling every case that has so much as mentioned §6(c)).  This type of liability is about as far from traditional tort law as you can get.

And don’t forget − all of these hypothetical state-law claims are being advanced against the maker of a prescription drug that is, and remains, approved for marketing by the FDA.  Transcript at 45 (admission of plaintiff’s counsel).

After shaking our heads, we just have to say, paraphrasing an old Olds ad, “that’s not your father’s product liability.”  This isn’t close to the kind of well-accepted tort theories that the Supreme Court has considered in its previous FDCA preemption cases.  We could be wrong, but we doubt that any of these theories were taught in any law school tort class attended by any of the justices.  Nor are these theories the recognized law of many – if any – of the states.  The Third Restatement requires (that is, the parts that courts have actually adoptedsee GA, IL, IA, KY, MA, NE, NM, NY, SC, TX, and WI (by statute)) alternative design for design defect and rejects liability theories that products are “defective” simply because their overall risks outweigh their benefits.  See Third Restatement §2.  The Second Restatement recognized concepts of “inherent risk” (which could only be warned about) and “unavoidably unsafe” products. See Second Restatement §402A, comments i, k.  When courts crossed these lines (as happened in New Jersey and Louisiana), state legislatures quickly acted to restore state law to well-accepted principles.

There was more – anti-preemption arguments by plaintiff as categorical as her liability theories.

One of plaintiff’s arguments would abolish impossibility preemption altogether, the Court was told, because “you can always escape liability if you simply stop selling.”   Transcript at 21 (DoJ argument).  “[I]f you could simply stop selling, that would be a way of — of cancelling impossibility preemption.”  Id. at 19.  As plaintiff’s counsel himself put it:

[T]he [state] duty here . . . can be complied with by not selling the drug.  There’s nothing in Federal law that requires or mandates the sale of these drugs.

Id. at 46.

“I don’t think anybody here can argue with a straight face that simply paying a judgment in strict liability is impossible.”  Id. at 43.

Well . . .  yes one can.  This go-out-of-business argument is an old canard that plaintiffs have tried and failed with before.  We remember seeing it decades ago in pre-Geier in airbag cases. E.g., Wood v. General Motors Corp., in which the court held:

[Plaintiff] argues that her suit will have no regulatory effect because [defendant] has the choice of paying the damages award without modifying the design of its vehicles. . . .  In these circumstances, [defendant’s] choice to avoid modification of its design seems akin to the free choice of coming up for air after being underwater.

865 F.2d 395, 410-11 (1st Cir. 1988).  As defense counsel put it at the oral argument, “this impossibility doctrine under preemption is premised on the fact that parties will engage in conduct.” Transcript at 55.

The biggest problem with the go-out-of-business argument, after Mensing anyway, is that it proves way too much.  As Justice Alito pointed out at the oral argument, a state could do practically anything and avoid “impossibility” preemption, because anyone can always opt not to do anything at all.  Transcript at 46-47 (discussing state adopting highway laws contrary to the rest of the country; “you could comply with the rules by not driving”).  That’s an important point, because in Mensing, the Court rejected the “take steps” argument against impossibility preemption, likewise because it proved too much – it “would render conflict pre-emption largely meaningless because it would make most conflicts between state and federal law illusory.”  131 S. Ct. at 2579.  Rather, “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”  Id.  As long as those conclusions hold, we should be OK in Bartlett.

And we think that they will, because the end result of any of the very non-traditional tort theories being bandied about in Bartlett, is the same − if a company doesn’t stop selling, there’s no other way out – it has to pay.

That’s not what’s going on in a strict liability regime. They’re saying, we’re not saying you should have a different structure, we’re not saying anything about warning; we’re saying if you do this, [sell the product] you’re going to have to pay for the damage.  It’s not − it’s not a different duty.  And I think that’s what’s underlying the argument that, well, you can just stop selling, because you don’t have to adjust how you’re going to make the drug.  You understand that it’s going to be the same as the Federal drug, but our system is, you pay for the damage.

Transcript at 18-19 (DoJ argument).  If there’s a “deeper view of what State law requires,” from the plaintiff’s perspective, we think that’s it.  Id. at 49 (plaintiff’s argument).

When reading the exposition in the Bartlett transcript of all these wild tort theories that:  (1) elevate compensation over anything and everything else, and (2) leave going out of business as the only way to avoid product liability, our thoughts were inescapably drawn to the old (and we’d say thoroughly discredited) slogan coined by Karl Marx, “from each according to his ability, to each according to his need.”  That’s exactly what these types of strict/absolute liability claims are all about:  compensation (as Marx might say in his native German) uber alles.  If you’re a big drug company, you pay (unless you go out of business like Oldsmobile did). If you’re an injured plaintiff, you recover, even if the drug helps the vast majority of users.  Hence our term “tort Marxism.”

To sum up the positions of the three arguments in Bartlett succinctly:

Defendant Mutual – Emphasizes warnings as part of liability.  Wants to tack as closely to Mensing as possible.  Cautious about anything having to do with branded drugs.  Tort Marxism proves too much, since anybody can go out of business.

Department of Justice – “Design” theories whereby juries rebalance risks and benefits already balanced by FDA are preempted against all drugs, generic or branded.  The pay or go out of business rationale of tort Marxism also conflicts, directly, with FDA’s drug approval authority.

Plaintiff – Has no choice but to rely upon tort Marxism to avoid running afoul of Mensing, because tort Marxism doesn’t give a damn about “sameness,” whether as to warnings or design.  When pushed, grudgingly concedes that warnings play some role in risk utility balancing.

Fortunately, we don’t think that the Supreme Court (most of it anyway) was ready to buy into tort Marxism as espoused by a few radical tort professors.  As commonly understood, it’s the job of the FDA to make the decision whether the overall benefits of a drug to the public as a whole outweigh its overall risks.  When the FDA makes that decision, assuming it’s favorable, it approves the drug and allows the manufacturer to market it.  When a state-law jury second-guesses the FDA’s risk/benefit calculation, and through its damages award tells the defendant (under one of these tort Marxist theories) that it should never have sold its FDA-approved product in the first place, that’s what most people would call a “conflict.”  “Most people” here includes the current Justice Department – ordinarily no friend of preemption in product liability cases (it opposed preemption in Mensing, for example).

And fortunately, “most people,” seems to include most of the Justices who offered comments during the Bartlett oral argument.  Not surprisingly, Justice Scalia was volubly skeptical that a jury could “decide for the whole state what the . . . cost/benefit is for a very novel drug that . . . also can save some lives.”  Transcript at 28.  So was Chief Justice Roberts.  “They [the jury] say the risks outweigh the benefits, period.  So you should not market this at all.  And it does seem inconsistent with the – Federal regime.”  Id. at 29.  Justice Alito also understood what the plaintiffs were really arguing. Id. at 37 (“doesn’t that mean that the drug should never have been approved?”).  Justice Kennedy seemed rather confused, and not at all impressed, by plaintiff’s flip-flopping on whether or not warnings (which plaintiff tried to run away from because of Mensing) were part of the risk/benefit analysis.  See Id. at 39-40.

But put all them aside.  Given the palpable conflict between plaintiff’s tort Marxism and the FDA’s role in the evaluation and approval of prescription drugs, the member of the Court whose reaction most interested us was Justice Breyer, who has a history (Geier, Lohr concurrence) of respect for administrative decisionmaking.  Here’s what he had to say:

JUSTICE BREYER: We’re talking about what juries could find and that’s what − and I don’t know about Parkinson’s − I don’t know what these drugs are.  That’s why I said let the FDA say it.

Transcript at 36-37.

JUSTICE BREYER: Well, but then if you apply this − what is deeply bothering me in all these cases, and it’s why I came up with and said, the FDA has to tell us, you know.  Because just what you said before; what you say applies to sulindac also applies to 12 people who will tell the Mary Hitchcock Hospital up in Dartmouth that they can’t use a certain kind of chemotherapy.

You see, you could in certain horrible cases find a very sympathetic plaintiff who really did suffer terribly. And − and − and you are getting 12 people rather than the FDA. So my solution to it, which you know, because you read Medtronics [Riegel?/Lohr?], may not work; but it’s the best I can think of.

Tr. at 42-43.

Justice Breyer dissented in Mensing, as he mentioned at the oral argument (“I dissented in the other case, but I lost, okay?  So I lost, I lost.”  Id. at 32). If Justice Breyer remains inclined, as he indicated at the oral argument, to let the FDA “say it/tell us,” then it’s difficult to see how the plaintiff in Bartlett can cobble together a majority to save tort Marxism from preemption.

That point, we think, is a dialectic around which the defense lawyers of the world (and their clients) can unite.