[Drug and Device Law] SDNY Dismisses Manufacturing and Fraud Claims in Fertility Drug Case, But Conflates and Confuses the Rest
By all rights, it should be Sullivan writing about the Sullivan case. But John is taking a well-deserved vacation. We do not know if Sullivan’s travels more closely approximate a Bexis expedition, which involves long hikes where one must dodge rattlesnakes and gila monsters, or if Sullivan is more like today’s correspondent, who is content to plop down in a BeNeLuxian cafe and down a couple of Chimays before staggering past museum walls adorned with Brueghel and van Ruisdael masterpieces.
Sullivan v. Aventis, Inc., 2015 WL 4879112 (S.D.N.Y. Aug. 13, 2015), is no masterpiece. It offers a crabbed reading of Bartlett to support its stubborn refusal to expand that case’s generic preemption to brandeds, it conflates design defect and warning theories, and its reasoning often seems incomplete or incoherent. We’re not saying that the Sullivan case is a complete train-wreck, but it is not exactly pleasant beach reading either.
The Sullivan case was brought by a woman who claimed that she suffered birth defects because her mother had taken an allegedly defective fertility drug. She alleged that the drug’s half-life was too long and that the manufacturer had failed to supply the requisite warnings. The legal claims included design defect, manufacturing defect, failure to warn, misrepresentation, breach of express and implied warranties, and unjust enrichment. New York law controlled.
Before we get to the standard product liability issues, we must first dawdle over an interesting argument raised by the defendant: that the Sullivan case was an impermissible claim of “wrongful life.” Our law school moot court topic was on wrongful life, and the philosophical perplexities of that issue do not seem to have been resolved over the intervening decades. New York law does not smile upon claims that boil down to an assertion that had things not gone wrong, a baby would not have been born, because the pregnancy would never have happened or because the parents would have terminated the pregnancy if they learned of the birth defects. Any “injury” suffered by the children “would require resolving the philosophical or theological ‘mystery’ of whether ’nonexistence’ is preferable to existence.” Sullivan, 2015 WL 4879112 at *2. This line of reasoning is called the “nonexistence problem.” Id. The Sullivan court ultimately held that this case was a prenatal tort, rather than a wrongful life case, because the plaintiff’s design defect theory was that the drug could have been designed in a way that would have permitted the plaintiff to be born without the birth defects. The problem with the court’s reasoning is that there really was no reason to know whether such a drug could have been designed and approved. There is still a “nonexistence problem” - the nonexistence of a safer alternative. In any event, it really is hard to see how the plaintiff’s failure to warn claim survives the ban on wrongful life claims. The failure to warn claim must be premised on the position that the plaintiff’s mother would not have taken the drug if she or her doctor had been warned. But then the plaintiff would not exist, right? Not so, says the court. The plaintiff might have been born anyway. Really? This same plaintiff? Who is engaging in theology now?
Let’s retreat from the spiritual issues and head back to hum-drum tort law. Not to put too fine a point on it, the Sullivan court’s discussion of preemption and design defect leaves us praying for clarity. The defendant correctly argued that the logic of the SCOTUS opinion in Bartlett means that design defect claims against even branded drugs must fail, because any alternative design could not be implemented absent action by the FDA. That is the impossibility theory logic behind the Bartlett decision. The Sullivan court escapes this logic the same way a squid escapes danger: by emitting a lot of confusing ink. The Sullivan court discussed New York’s risk-utility test for design defect, and then pointed out that manufacturers can avoid liability by strengthening the product’s warning label. Okay, so now we have bounced from design defect to failure to warn. Does the court understand that those are separate issues? We would say we are baffled and disappointed by the court’s conflation of the issues, but if it means that there really is no true design defect claim in the case, then we suppose that would not be so bad. Unfortunately, we are not sure we understand what the court thinks it understands.
Moreover, according to the Sullivan court, the defendant could have submitted a design for a safer product before obtaining FDA approval. The plaintiff was essentially suggesting that the defendant should not have submitted the drug design that the FDA approved as safe and effective. How is that not different from the stop-selling theory that the SCOTUS rejected in Bartlett? We cannot know that any such redesign is possible. Talk about a nonexistence problem! And then, to get around that little problem, the court says that even if a redesign was not possible, nothing stopped the company from submitting a stronger warning. Thus, again, the court conflates design and warning theories. The Sullivan court wishes away Bartlett and applies Levine without any sense of its nuances (would a Changes Being Effected have been permissible?).
Moreover, according to the Sullivan court, the defendant could have submitted a design for a safer product before obtaining FDA approval. The plaintiff was essentially suggesting that the defendant should not have submitted the drug design that the FDA approved as safe and effective. How is that not different from the stop-selling theory that the SCOTUS rejected in Bartlett? We cannot know that any such redesign is possible. Talk about a nonexistence problem! And then, to get around that little problem, the court says that even if a redesign was not possible, nothing stopped the company from submitting a stronger warning. Thus, again, the court conflates design and warning theories. The Sullivan court wishes away Bartlett and applies Levine without any sense of its nuances (would a Changes Being Effected have been permissible?).
The court’s discussion of comment K is similarly garbled. The clear terms of comment K should preclude a design defect claim, but the Sullivan court says that the design defect claim can proceed because the plaintiff “had adequately pleaded a failure to warn claim.” Sullivan, 2015 WL 4879112 at *7. Aaargh. When we see the usual panoply of product liability claims, we like to knock out as many as possible because we worry that a jury might be confused by the multiplicity and variety of the claims. Frankly, we do not expect that it is the court that will be confused by such multiplicity and variety. And now there is the Sullivan decision to remind us that such confusion is not confined to the jury room.
The defendant took a shot at getting rid of the design defect claim on the ground that the complaint did not come close to stating how a safer design (presumably with a shorter half life) could be possible. Here is what the court said, in rejecting the defense argument: “Defendant argues that the Iqbal-Twombly standard demands more detail concerning how the design should have been altered and why it was feasible. Imposing such a standard would require the plaintiff to possess technical or scientific knowledge about the inner workings of the product, which would contravene the notice pleading requirement….” Id. at *7. Not true. Rather, such a standard would require a plaintiff actually to know some facts supporting the claims before filing them. Why not do a little of that “technical or scientific” work before filing a complaint?
The Sullivan court did dismiss the manufacturing defect claim, because the plaintiff had simply failed to allege facts supporting such a theory. But even here, the court’s reasoning was unnecessarily muddy. The court says that the plaintiff did not allege “that the dose(s) administered to Plaintiffs mother deviated from other doses in anyway.” Id. at *8. Whatever. Dose-schmose. The plaintiff simply did not allege that the product consumed had deviated from its specs in any way, and that is the end of any manufacturing claim.
The Sullivan court gave short shrift to the defendant’s challenge to the failure to warn claim. In fact, we’d say that the court’s discussion is so empty and conclusory as to flunk the Iqbal and Twombly tests. All we get is that the defendant failed to warn doctors of the “purported dangers,” and “proximate cause may be inferred from alleged circumstances.” Id. What circumstances? We can only guess.
The court declined to dismiss the breach of warranty claims. That is annoying in itself. But it is interesting how, in also refusing to dismiss the negligent misrepresentation claim, the court discussed the issue of privity. Normally we see some sort of privity discussion with respect to warranty claims, as well. Not here. Why? Dunno. Further, the court dismissed the unjust enrichment claim because it duplicative. That is nice. But isn’t it clear from the court’s own discussion that every single theory in this case is duplicative except the failure to warn claim?
Let’s end on a happy note. The court dismissed the fraud claim because it was not pleaded with particularity under Fed. R. Civ. P. 9(b). Yay. The complaint did not allege any particular statements, advertisements, or anything else that the plaintiffs' mother saw. Nor did the complaint allege that the mother relied on any such statements, even if they were specifically identified. And the court did not believe that it could “infer reliance in these circumstances.” Id. at *9. Once again, we do not know what these "circumstances” are, but we agree. We also think that "these circumstances” should not permit a court to infer proximate causation for the failure to warn claim, and since the court seems to treat all the claims as one vast mess of a tort, the different conclusions are a bit confusing. But that is characteristic of the Sullivan decision. Some bits are okay, some are quite bad, and all of it is confusing.
We’d rather stare at a Brueghel. There is usually a lot going on his paintings, and they can seem a little chaotic. But it turns out that there is an underlying unity and beauty. We will stare some more at the Sullivan decision, but so far any unity or beauty elude our poor powers of perception. Come to think of it, the Sullivan decision reminds us of another Northern European painter: Hieronymus Bosch.
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Posted By Steve McConnell to Drug and Device Law at 8/26/2015 07:30:00 AM --
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