Monday, August 02, 2010

Wrong on Learned Intermediary

A new book, Being Wrong, tries to describe the process of how people get things wrong, how it feels, and what it means. Wrongness can include all sorts of errors, including optical illusions, memory failures, neurological deficits, flights of imagination, or irrational beliefs. A worthy addition to this catalogue of wrongology can be found in a recent learned intermediary case, In re Levaquin Prods. Liab. Litig., 2010 U.S. Dist. LEXIS 75054 (D. Minn. July 26, 2010).


We just returned from a deposition of a prescriber, so this issue is near and dear to our hearts right now. Let's put aside the issue of whether the plaintiff ever specifies what the warning should have been. (Usually they don't. It descends into a game of whack-a-mole.) In most pharmaceutical failure-to-warn cases, it turns out that even if the requisite warning had been supplied to the prescriber -- indeed, if it had been writ large in neon and hung a few inches from the doctor's nose -- it wouldn't have made any difference; the same medicine would have been prescribed in the same way at the same time in the same dose. Because it's called the learned intermediary defense, some might rashly conclude that the burden of proof would be on the defendant to prove that the warning would have made no difference. But what the learned intermediary defense means is that the issue is whether the learned intermediary - usually the doctor -- was warned, not the ultimate consumer. And then it becomes an issue of causation: did the lack of a warning make any difference? That burden, friends, is on the plaintiff. (That's our position, anyway. We're not saying all jurisdictions agree; only the smart ones.)


The Levaquin opinion seems perfectly muddle-headed as to burden of proof. At one point it says, "If a defendant properly establishes the facts necessary to support the learned intermediary defense, a patient will be unable to show that the defendant's failure to warn the prescribing physician is a proximate cause of the patient's injury." Levaquin, 2010 U.S. Dist LEXIS 75054, *5. That is not clear and definitely not helpful. Later, the court discusses an earlier case that held that "a plaintiff must identify some omitted information that would have convinced the prescribing physician to alter the recommended course of treatment in order to establish causation for failure to warn under Minnesota's learned intermediary doctrine." Id. at * 23 (citing Bruzer v. Danek Medical, Inc., 1999 U.S. Dist. LEXIS 4483 (D. Minn. 1999)). That sounds more like putting the burden of proof on the plaintiff, where it should be. But when we look at how the Levaquin court treated the facts in the case, it's hard to believe that it didn't get burden of proof wrong, as well as just about everything else.


Before making the sad march through Levaquin, let's dart back to reality for a moment. Here's how a prescriber deposition typically goes: the defense asks questions about the plaintiff's medical records, the doctor lays out what went into the prescription decision (the PDR, literature, and experience count a lot; by contrast, whatever sales reps say counts almost not at all), and the doctor usually says that the prescription decision was a good one, even in light of whatever information subsequently came to light. Next, the plaintiff lawyer trots out internal company documents and keeps asking the doctor, "wouldn't you have liked to have known this? Isn't this interesting?" etc. Most doctors, being intellectually curious, open-minded types, generally say that, sure, they'd always be interested in learning new things. But, importantly, it is a rare thing for the plaintiff lawyer successfully to cajole the doctor into saying that the allegedly new "information" would have altered the prescription decision in any material way. On that record, plaintiffs flunk causation and the learned intermediary defense should send the case into the dustbin of history.


And then there's Levaquin. Plaintiff claimed that the defendant didn't adequately disclose that its drug posed a higher risk of tendon ruptures than other drugs in the same class. At his deposition, the doctor said that if there was information showing the drug "was having huge issues, I would consider it." Id. at *10 (emphasis in original). Under any sane, even-handed application of the learned intermediary doctrine, there's no way that such testimony should be sufficient for plaintiff to establish any sort of causation. But wait, there's more. Later in his deposition, the doctor testified that he was aware of information that the reporting rate for tendon disorders with the drug was higher than for other drugs. So the doctor already knew. Case closed, right? Not according to the court, because on a summary judgement motion the court must view the testimony most favorably to the plaintiff, and will therefore "disregard[] this later testimony indicating that Dr. Butner was aware of the tendonopathy distinctions among the fluoroquinolones." Id. at *11. We actually had to read that twice. That's error. We're not sure if it's an optical illusion, neurological deficit, or irrational belief (we suspect it's an irrational bias against summary judgment), but it's error. Reading the evidence favorably to the plaintiff cannot mean ignoring evidence going against the plaintiff. How would summary judgment ever be possible?


It gets worse. When the plaintiff lawyer unearthed a couple of things the doctor didn't already know, here's what the doctor said when asked whether the new facts would have made any difference: "I don't know. I would have to be back in that situation at that point." Id. at * 15. So far so bad, as far as plaintiff's case goes, right? Naturally, the plaintiff lawyer persisted, trying to get what he must have felt he needed. But when the doctor was finally asked the ultimate question as to whether such new information would have changed the prescription, the answer was a resounding "No." The doctor "testified that even if he had known that Levaquin was reported to be ten times as tendon toxic as non-Fluoroquinolones, such knowledge would not have changed what he prescribed." Id. at *16. To be fair, the doctor allowed that the new information might have prompted him to make additional inquiries about his patient's condition, but no connection was made between such inquiries and any ultimately different effect on the plaintiff. Id. at 17. The allegedly inadequate warning must make a difference that matters. There's no evidence of that here. Instead, the court seems to think that rampant speculation can fend off summary judgment: "Such inquiries may have resulted in a different course of treatment, or may have prompted [plaintiff] to raise the issue of his previous tendon pain with Dr. Butner." Id. at *29. May have? The court is piling speculation upon speculation. At this point, we're getting the idea that the court is determined to resist summary judgment.


That idea is confirmed when the court starts discussing credibility. There's no getting around the fact that the prescriber basically testified that his decision was correct and that any new information wouldn't have changed the prescription. As the doctor himself said, he was "sticking by [his] guns." Id. at *17. If you're the defense lawyer, it's got to be hard to restrain your glee when you hear the doctor testify as follows: "When asked whether additional information about Levaquin's tendon toxicity 'could … have changed [his] prescribing Levaquin to' [Plaintiff], [the doctor] replied, 'I still would have gone with my knowledge at that point. As best I can ethically and morally reconstruct the situation, I would have picked the same medicine." Id. at * 31 (emphasis in original). Such testimony is, to say the least, inconvenient for the plaintiff and, apparently, for the court. So the court rules that the doctor's testimony "presents an issue of credibility that is within the province of the trier of fact." Id.


That's breathtakingly wrong. The only evidence in the record that new information would have changed the prescription would be … well, there actually is none. The only evidence says that there would have been no change. But, according to the court, the jury is free to disbelieve that. Let's break that down for a moment. There are cases where plaintiffs do not depose the prescriber at all. The defendant then dutifully files a summary judgment motion, arguing lack of any evidence that the inadequate warning caused any harm. Almost invariably, the plaintiff lawyer will then ask for leave to depose the prescriber, even if it is well after the discovery cut-off. And, again almost invariably, the court will indulge the plaintiff lawyer, either out of a silly sense of charity, or by invoking the fiction that the deposition will be a "trial deposition." But the point is that if there is no testimony by the prescriber, then there is no evidence of causation and the court should grant summary judgement in favor of the defendant. In Levaquin, the record is worse for Plaintiff than if there had been no deposition -- the prescriber clearly stated that additional information would have made no difference to the prescription. And now the court says that possible disbelief in such testimony raises a genuine issue of fact.


Under that theory, one can never get summary judgment based on testimony, since it's all subject to disbelief. For that matter, can't jurors also disbelieve documents? In short, the Levaquin court has either erected an edifice of judicial nihilism that means summary judgment is universally foreclosed, or it has seriously misapprehended the meaning of the learned intermediary rule. In either event, the Levaquin decision is a big package of Wrong.

3 comments:

Anonymous said...

I'm probably overlooking something obvious here, but isn't the learned intermediary doctrine an affirmative defense? So the plaintiff shouldn't have to prove that a different warning would have affected the prescriber's decision; the defendant should have to prove it would not have. Right? This decision doesn't seem "breathtakingly" wrong; it just seems like the judge is very cognizant about invading the province of the jury. As far as disregarding the prescriber's later testimony that he was aware of certain risks, the implication seems to be that the judge interpreted it to conflict with the prescriber's former testimony that he would consider new information if it existed.

Steve McConnell said...

First, learned intermediary is not an affirmative defense. Here's what we said back in April 2008:

We've often explained that the "learned intermediary doctrine" is just that -- a doctrine, and not an affirmative defense. Plaintiffs bear the burden of proving causation as part of their case-in-chief. Plaintiffs must therefore prove that a different warning on a drug's package insert would have changed the physician's conduct and avoided an alleged injury. Because the learned intermediary doctrine is not an affirmative defense, defendants do not bear the burden of proof.

Second, there is no contradiction between a doctor saying he would have considered certain information, and then saying that such information would not have changed the prescription decision.
Viewed fairly, and in its entirety, the doctor's testimony in the case permitted no rational jury to find warning causation.

Anonymous said...

A product manufacturer typically must provide an adequate warning to the ultimate user of its product. The end user/plaintiff typically bears the burden of proof on the issue of whether the product manufacturer provided an adequate warning.

For sound public policy reasons, the LED relieves a drug manufacturer from the duty to warn the end user/plaintiff provided the drug manufacturer gives an adequate warning to the physician. Absent proof of adequate warning to the physician, the typical rule applies, that is, the end user/plaintiff must demonstrate that the drug manufacturer failed to provide an adequate warning to the end user/plaintiff.

Your take on the LED fails to recognize that the LED relieves the drug manufacturer of a duty it would otherwise have and for that reason the burden to prove applicability of the LED falls on the drug manufacturer.