Tuesday, October 19, 2010

The learned intermediary doctrine comes to South Dakota

Lawyers and their clients can win cases in all kinds of ways, from the cheap victories won by default or gross mistakes by the other side to the total domination victories won on every single point. Some victories come after bad rulings that encourage future claims, causing the client to echo the lament of Pyrrhus: “One more such victory would utterly undo me.” And others make you smile years later.

As we observed yesterday, probably the most satisfying victory for a drug company is a ruling that its warnings were adequate. But it is also satisfying to win when the facts show that the defendant’s conduct did not cause the plaintiff any harm – in other words, that the plaintiff’s injuries are not the defendant’s fault. And lawyers obtain professional satisfaction in winning a ruling that establishes a principle of law. Both of these satisfactions occurred in Schilf v. Eli Lilly & Co., 2010 WL 4024922 (D.S.D. Oct. 13, 2010).

Schilf is one of the recent cases concerning the adequacy of warnings on antidepressant drugs. The facts that led to the suit, as usual, are tragic – the plaintiffs’ 16-year-old son committed suicide while on Cymbalta, an Eli Lilly antidepressant. The parents sued, claiming that Eli Lilly should have warned 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 and lack of causation.

The court first had to decide whether the South Dakota Supreme Court would adopt the learned intermediary doctrine. The court followed the reasoning of 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 learned intermediary doctrine for two reasons: first, it is sound policy (hear, hear!); second, the S.C. of N.D. had adopted section 402A of the Restatement (Second) of Torts, which Ehlis said is one of the sources of the learned intermediary doctrine. Schilf concluded that the same reasoning applied in South Dakota, which also had adopted section 402A. 2010 WL 4024922 at *2. The court therefore predicted that the South Dakota Supreme Court would adopt the learned intermediary doctrine. Id.

This ruling may lend support to those people who think that North Dakota and South Dakota should merge into one big Dakota.

The court then considered whether the warnings Plaintiffs allege should have been given would have made a difference. The prescribing doctor testified that he was aware of those warnings, which had been announced by the FDA shortly before the doctor prescribed Cymbalta to the patient. Id. at *3.

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. Id. at *4.

Plaintiffs tried to counter with evidence that a reasonable physician, adequately warned, would not have prescribed Cymbalta, but the court did not allow this evidence to rebut the actual treating physician’s testimony that he did prescribe Cymbalta with adequate warnings and still would. Id. at *4 n.3. The court’s ruling was in line with many others, which we discussed here.

Plaintiffs also argued that the South Dakota Supreme Court would adopt the rebuttable presumption that an adequately warned doctor would have heeded an adequate warning, a/k/a the heeding presumption. The court sidestepped deciding whether the South Dakota court would adopt this presumption because the prescriber’s unequivocal testimony rebutted the presumption. Id. at *5. The court granted summary judgment in favor of Eli Lilly on all claims. Id.

Schilf is a good win for our side, as it includes a ruling that benefits all defendants (the learned intermediary doctrine applies in South Dakota, at least according to this federal court) and a ruling that this particular defendant did not harm this particular plaintiff.

2 comments:

whitecarol60 said...

The side effects of medicine is very risky. We must maintain a good
health care.Law

Anonymous said...

Appeals will tell more TRUTH!