We have posted several times in the last few years (like here, here, here, and here) about cases alleging birth defects from maternal SSRI use during pregnancy. Perhaps because of the inherent sympathy for the plaintiff (offspring), it seems that plaintiffs in birth defect cases get extra chances to prove that have enough science to support their claims. Science in this area is undoubtedly complicated. For one thing, while ontogeny does not always recapitulate phylogeny, fetal development of placental mammals (of which humans are a relatively recently evolved species) varies, so extrapolation from animal studies on teratogenic effects is even harder than with studies of direct effects on animals. For another, ethical considerations generally preclude prospective clinical trials designed to study teratogenic effects. FDA’s treatment of drug labeling on the risks of teratogenic effects has reflected some of this dynamic.
Litigations pursuing birth defect claims seem to follow their own dynamic. Despite the oft-cited caution from Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996), that “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it,” it often seems like cases are pursued before there is science to support them, particularly if specificity of drug, dosage, and injury is going to be required. This may be due to the impact of statutes of limitations. It may also be because some courts are lenient on admissibility of causation evidence and there can be years from filing a case a case until Daubert (or equivalent) motions are decided. Another dynamic seems to be that the only proof as to whether the plaintiff’s mother took the drug during the relevant time can be her word, unless the plaintiff’s expert can argue that the birth defect can itself count as proof of exposure. We also sometimes see that general causation can be a harder concept for courts to understand than it should be.
Looking through our particular lens, we see all of this in K.E. v. Glaxosmithkline LLC, No. 3:14-cv-1294(VAB), 2017 U.S. Dist. LEXIS 13705 (D. Conn. Feb. 1, 2017), a case that came to the correct result—causation opinions excluded—but took an overly charitable route in arriving there. The case alleged that maternal use of the defendant’s SSRI during the first trimester of her pregnancy with plaintiff in 2001 caused him to develop a bicuspid aortic valve and accompanying regurgitation. The plaintiff was diagnosed with a bicuspid aortic valve in September 2010 (after evaluation following his father’s diagnosis with his own heart condition), by which time the drug’s label had been revised to reflect the pregnancy category D—“adverse reaction data from investigational or marketing experience or studies [of the drug] in humans”—and the manufacturer had sent a dear healthcare provider letter describing the basis for the change. Id. at **16-18. The purported prescribing physician testified that he would not have prescribed the drug to a patient whom he suspected was pregnant or recommended it for a pregnant woman based on the label as it was in 2001. Id. at **16-17. We say “purported prescribing physician” because he denied prescribing the drug to plaintiff’s mother until after the plaintiff was born, which is what his records and pharmacy records—but not plaintiff’s mother’s testimony—showed. Id. at **9-12. More on that later. After the bicuspid valve diagnosis, plaintiff’s records suggested that his mother had used the drug during pregnancy and his mother—plaintiff was still a minor—thought that there was a relationship. This was reinforced by a lawyer advertisement on television trolling for plaintiffs and she contracted and signed up with a law firm to pursue a lawsuit over plaintiff’s bicuspid aortic valve by September 2011. Id. at **18-19. Even though the statute of limitations in Connecticut for claims like this was two years, plaintiff waited until late July 2014—close to four years after the diagnosis—to sue. Within a year—pretty fast for such cases—the manufacturer moved to exclude plaintiff’s sole causation expert and for summary judgment on statute of limitations, lack of causation, and other problems with plaintiff’s proof. The decision we are discussing followed more than eighteen months later.