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Denis Stearns – Guest Blogger – The Dissenting Justices in Wyeth v. Levine on the FDA-Approval of Drugs: “Is it Safe?”

In reading Justice Alito’s dissent in Wyeth v. Levine, the recent Supreme Court opinion holding that FDA-approval does not provide a complete defense to state law failure-to-warn claim, I was reminded of the horrifying torture scene in the 1976 thriller, Marathon Man. In this scene, Laurence Olivier, playing a Nazi war criminal, who also happens to be a dentist, is intent on getting an answer to a seemingly simple question, and answer that Dustin Hoffman, playing Thomas “Babe” Levy, has trouble providing.

Szell: Is it safe?
Babe: You’re talking to me?
Szell: Is it safe?
Babe: Is what safe?
Szell: Is it safe?
Babe: I don’t know what you mean. I can’t tell you something’s safe or not, unless I know specifically what you’re talking about.
Szell: Is it safe?
Babe: Tell me what the "it" refers to.
Szell: Is it safe?
Babe: Yes, it’s safe, it’s very safe, it’s so safe you wouldn’t believe it.
Szell: Is it safe?
Babe: No. It’s not safe, it’s… very dangerous, be careful.

In his dissenting opinion, Justice Alito strongly criticizes the majority opinion for framing the question presented as whether a drug company, like Wyeth, has a duty to provide “an adequate warning” about the use of a particular drug, in this case Phenergan, a drug widely used in the treatment of nausea. According to Justice Alito (and his fellow dissenters Chief Justice Roberts and Justice Scalia):

the real issue is whether a state jury can countermand the FDA’s considered judgment that Phenergan’s FDA-mandate warning label renders its intravenous (IV) use “safe.”

Dissent, slip op. at 2. What is particularly telling here is the “quotation” marks around the word safe. Just as I have put quotation marks around my use of the word quotation to indicate that Justice Alito is not, in fact, quoting anything, Justice Alito is using the quotation marks around safe to indicate that he is not referring to actual safety—that is, safety as a matter of demonstrable or agreed-upon fact. No, Justice Alito is referring to the FDA’s “considered judgment” and how deference to that “judgment” should require that we, as a matter of law, accept that Phenergan is “safe”—even if, in fact, it is not. And especially if a jury has, after considering all of the facts, rules that it is not.

What Justice Alito attempts to do by wielding quotation marks is to fence off, figuratively and nearly-literally, the term “safe” from dispute. There is an irony to this, however, because this strictest of strict constructionist is using a strategy first employed by deconstructionist to put a term into radical and infinite play (or “play”). Take a look at this quotation from the (in)famous Jacques Derrida, wherein he explains:

Every sign, linguistic or nonlinguistic, spoken or written (in the usual sense of this opposition), as a small or large unity, can be cited, put between quotation marks; thereby it can break with every given context, and engender infinitely new contexts in an absolutely nonsaturable fashion. This does not suppose that the mark is valid outside its context, but on the contrary that there are only contexts without any center of absolute anchoring. This citationality, duplication, or duplicity, this iterability of the mark is not an accident or an anomaly, but is that (normal/ abnormal) without which a mark could no longer even have a so-called "normal" functioning. What would a mark be that one could not cite? And whose origin could not be lost on the way?

J. Derrida, Signature, Event, Context, from MARGINS OF PHILOSOPHY, 307-330 trans. Alan Bass (U. Chicago Press 1982).

So with all due apologies for the headache I may have caused by foisting a quote from Derrida at you, the point being made here is this: Alito is following merrily in the footsteps of Derrida in asking us to recognize that the quotation marks around the word “safe” are intended to alert us to the fact that it has been ripped from its factual context—indeed, ripped from any context except that assigned to it by the FDA and its power to define what “in fact” safe means. This no doubt is why Justice Alito commences his dissent with the bromide that “tragic facts make bad law,” when what he really means is that “facts make bad law.”

What the dissent really wishes to accomplish through the power-play of its word-play is to put the word “safe” beyond the bounds of factual dispute. It will not be for the jury to decide whether a drug is “safe” or not. Wby? Because, according to the dissent:

Whether wisely or not, the FDA has concluded—over the course of extensive, 54-year long regulatory proceedings—that the drug is “safe” and “effective” when used in accordance with its FDA-mandated labeling.

Dissent, slip op. at 3 (emphasis mine); see also, ibid (“Congress made its ‘purpose’ plain in authorizing the FDA—not state tort juries—to determine when and under what circumstances a drug is ‘safe.’”). Thus, unlike the strategy that informs deconstruction, Justice Alito employs quotation marks as a kind of fence, putting the term safe off-limits to anyone seeking to define safety within its factual context.

And so we must return to our question: Is it safe? Is it safe?

  • Thanks for the interesting post.
    I am a little disturbed that “conservative” justices are so quick to encourage federal agency aggregation of power and extend the scope of implied preemption of state rights,particularly where the words of the statute do not provide for preemption.
    Alito also seems to be relitigating the factual determination of the lower court. Ginsburg had some stinging remarks at oral arguments regarding Wyeth’s characterization of the facts.
    Thomas, on the other hand, is great for putting his distaste for implied preemption out there. I am a bigger fan of stare decisis than he is, but if he thinks a line of cases is wrong-headed, he says so.