Thursday, October 21, 2010

Federal Court finds South Dakota would adopt learned intermediary doctrine because another federal court had found North Dakota would

The Federal District Court for the district of South Dakota has issued an interesting opinion in which it dismisses a claim against a prescription drug manufacturer by applying the learned intermediary doctrine even though the state courts in South Dakota have not yet decided whether to adopt that doctrine. The case is called Schilf v. Eli Lilly & Co., and it is available here. In this case, the plaintiffs’ 16-year-old son committed suicide while on Cymbalta, an Eli Lilly antidepressant. The parents sued, claiming that the drug's warnings were inadequate because they did not warn about an increased risk of suicidal thoughts and behaviors in children and adolescents on antidepressants. After discovery, Eli Lilly moved for summary judgment based on the learned intermediary doctrine (which allows a manufacturer to avoid liability as long as it adequately warns the physician who then has to duty to warn the patient). One interesting thing about the case is that the courts in South Dakota had not decided whether to adopt the learned intermediary doctrine, so the federal court had to predict whether it was likely that the South Dakota Supreme Court would adopt the learned intermediary doctrine. In deciding that it would be likely, the court cited Ehlis v. Shire Richwood, Inc., 367 F.3d 1013 (8th Cir. 2004), in which the Eighth Circuit predicted that the Supreme Court of North Dakota would adopt the doctrine. I have not idea whether this will be well received in South Dakota. Does South Dakota always follow what North Dakota does? Do South Dakotans resent being compared to North Dakotans? I just don't know. Why what North Dakota does in terms of tort would be relevant to what South Dakota would be likely to do is a mystery, but there you have it. I think the court could have reached the same result (and avoided this potentially politically incorrect approach) by simply basing its decision on an analysis of South Dakota law and tort policy. The fact of the matter is that the learned intermediary doctrine is still applied in most jurisdictions and that there are policy reasons to support it in most cases. (I say "most cases" because I think the argument is weaker in cases that involve direct to consumer advertising, but that does not seem to have been an issue in this case.) Adopting the learned intermediary doctrine does not, by itself, absolve the manufacturer of liability, though. The court still has to determine that the manufacturer provided warnings to the doctor and that the warnings were adequate. Having done that, then the court addressed cause in fact: would the doctor have prescribed the drug anyway? In a comment about the case, the folks from the Drug and Device Law Blog describe this part of the case this way: The prescriber also was asked whether he still believed that the decision to prescribe Cymbalta was correct. That question is often a key moment in a prescriber’s deposition. The deposition room goes quiet; many people subconsciously hold their breath, as they know that the entire case could hinge on this one answer. Experienced defense counsel will act nonchalant, trying to communicate nonverbally to the prescriber that the answer is a given rather than communicating that the answer is a really big deal. Then the prescriber answers, and everyone exhales. Here, the prescriber said yes. Based on that testimony, the court held there was not sufficient evidence of causation to allow the question to be submitted to the jury.

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