Tuesday, December 04, 2012
The Learned Intermediary Doctrine – a Plaintiff with No Evidence Loses
We talk a lot about the learned intermediary doctrine. It’s rooted in the reality of the physician-patient relationship. Patients gain access to prescription drugs only through doctors who have the expertise to understand and weigh the risks and benefits of the drugs. The learned intermediary doctrine, accordingly, says that pharmaceutical companies’ duty is to warn doctors, not patients, about the risks of prescription drugs. The plaintiff still bears the burden to prove proximate causation. But in these cases it is with regard to the prescriber, so the plaintiff must prove that the doctor would have made a different prescribing decision if she had the information that plaintiff claims she should have had.
Although this seems like a simple proposition, from time to time (maybe more often than that), courts mistreat the learned intermediary doctrine. We told you about one court, for instance, mangling it so much that the doctrine became an affirmative defense with the burden on the defendant not the plaintiff. The court allowed the case to survive summary judgment, reasoning that a jury could simply choose to disbelieve the prescriber’s testimony that, knowing what the plaintiff said he should have known, he still would have prescribed. So much for plaintiff’s burden.
This is not to say that all courts get it wrong. Many get it right. The Court of Common Pleas in Philadelphia did here, granting judgment to the defendant because the prescriber had passed away, leaving the plaintiff with no way to prove that the prescriber would have acted differently with the allegedly proper warning. This leaves you with the morbid impression that you’re better off with a prescriber who is dead rather than alive and well and saying the right things. See what bad law can do. A Texas court in the Zyprexa litigation also got it right (for the most part) here, granting judgment to a defendant because, among other things, the prescriber knew the alleged risk so a different warning couldn’t have mattered. The Fifth Circuit affirmed, explaining that the plaintiff has the burden to prove that the learned intermediary would have acted differently with a different warning.
Now comes another circuit court, the second circuit in McClamrock v. Eli Lilly & Co., 2012 U.S. App. Lexis 24539 (2d Cir. Nov. 29, 2012), issuing a good learned intermediary decision (applying North Carolina law) from the Zyprexa litigation. It’s a short opinion. But it’s from a circuit court, so that’s good. And it has one sentence that’s very good. It explains in no uncertain terms which side has the burden to prove proximate causation – that is, to satisfy the learned intermediary doctrine – and what happens when that side does nothing about it:
Because [the plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [his prescriber] was unaware that diabetes was a risk associated with Zyprexa when he prescribed it warranted granting summary judgment in favor of Eli Lilly.
Id. at *2-3. In other words, when there’s no evidence at all that a different warning would have changed things, like with the deceased prescriber in the Court of Common Pleas opinion, plaintiffs lose. The defense doesn’t have to prove a thing.
That’s how the learned intermediary doctrine works.Now, the Second Circuit’s opinion in McClamrock is unpublished, which can limit its value. But then again Lexis published it. And now so have we (sort of). And it has the added benefit of being right. So that’s something, and maybe you can make something of it.