We have long subscribed to the notion that many of the cases we defend end up looking very like a trashy romance novel: you lied to me, you damaged me, and you abandoned me. We half expect Fabio to be called to the witness stand. It's the lie that sets the drama in motion. Even when a product liability case includes claims of design defect and negligence, the real action resides in the claim of failure to warn. Understanding science can be hard. But everybody understands (or thinks they understand) a lie. What if there's no lie? A lie aligns with a legal theory of misrepresentation. Without a lie, no cause of action lies and there certainly isn't much of a heavy-breathing romance story, right? Well, we'd like to think so. But some plaintiffs have alleged that, even if there isn't a flat-out lie, the company made products too attractive to resist. Lip-stick was applied to a pig. And, somehow, the plaintiff was divorced from all rational faculties. The story changes only a little: you seduced me, you damaged me, and you abandoned me.
We can talk about what a lie is, and we can agree that lies are bad. What's a seduction? And what makes a seduction bad? Last week we were listening to an interview with Mike Nichols, the director of some great movies (Who's Afraid of Virginia Woolf? The Graduate), and currently directing Philip Seymour Hoffman in Death of a Salesman on Broadway. Nichols attended (here comes the weekly shameless plug) the University of Chicago and, along with Elaine May, raised comic improvisation to high-ish art. No Nichols-May, and maybe no Second City. And no Saturday Night Live. And no Bill Murray. And no Adam Sandler. (Say, wait a minute ….) Nichols talked about the intricacies of improvisation. Improvisation, by the way, is something that most litigators should study more. More "Yes-and"-ing and less "No, you're wrong"-ing, and we'd be more successful and less miserable. Nichols realized that all scenes can be broken down into three categories: seductions, fights, and negotiations. For us, that was what NPR calls a "driveway moment." We had arrived home, but we stayed in the car to hear the end of the interview. This idea of things breaking down into seductions, fights, and negotiations seemed like a key that could unlock a very big door. Most of what we do as lawyers falls into those three categories. (At least for litigators. We're not sure how much seduction is going on over at the Tax Group.) Seduction can be effective. Seduction can be fun. But can seduction be a cause of action, or save an otherwise defective cause of action?
We do not think so. Few plaintiff theories are as overused, overblown, and, ahem, overpromoted as overpromotion. Whenever we see a case that gives any credence to an overpromotion theory, we have mixed emotions the same way most tv critics have mixed emotions about the new HBO show Newsroom: we cannot decide if it is horrible or merely stupid. Plaintiffs claim that a drug or device manufacturer overpromoted a product when the plaintiffs do not have anything real to address. There is no data to support a finding of seduction. There might be 50 Shades of Gray, but there's no epidemiology supporting any of them. Jurors are finders of fact. An overpromotion theory essentially says that facts do not matter. How can a jury find that overpromotion -- whether the "over" pertains to quantity or quality of the promotion -- overwhelmed someone's ability to make a rational choice? Isn't that assessment especially hard when, because of the learned intermediary rule, the jury is being asked to discern whether overpromotion made a doctor stop thinking like a doctor?
Earlier this week, a federal judge granted the defendant summary judgment in a Seroquel case, and held that the plaintiffs' overpromotion theory could not save the case. Patteson v. AstraZeneca, L.P., Civ. No. 10-1760-JEB (D.D.C. July 9, 2012). [Disclosure alert: While at a former firm, the author of this post worked for AstraZeneca on Seroquel litigation. But (1) that is history; (2) he had nothing to do with the Patteson case, and (3) you do not really expect an unbiased review, do you?] The facts in Patteson are straightforward. In May 2006, the doctor began prescribing Seroquel to the plaintiff to treat her insomnia. That was an off label use. The plaintiff's condition improved while she was on the drug. Nevertheless, within a year she began experiencing trouble walking and muscle spasms. It was not until January of 2008 that she was ultimately found to have tardive dyskinesia, a movement disorder linked to her Seroquel use. The plaintiffs (the patient and her husband) filed a complaint asserting nine claims against AstraZeneca and her doctor, all based on their alleged failure to warn her of the risks associated with Seroquel.
The central problem for the plaintiffs' lawsuit was that the doctor was aware of the possibility that Seroquel carried a risk of tardive dyskinesia at the time he prescribed the drug to the plaintiff. He did so after considering multiple factors. This scenario is, of course, a classic example of a learned intermediary exercising professional judgment. The learned intermediary doctrine "excuses a manufacturer from warning each patient who receives the drug where it has properly warned the prescribing physician of the dangerous propensities of its product." Slip op. at 7. The plaintiff did not dispute the existence of this doctrine here, but contended that it was called off both because the doctor did not know of the risks and because AstraZeneca's warnings were rendered ineffective by the "overpromotion" of Seroquel. Id.
The warnings on the Seroquel label could not have been more clear and explicit. AstraZeneca informed the doctor "of the risks associated with Seroquel by providing him with an FDA-approved product label, which contained clear, unambiguous language about the drug and, specifically, the risk of tardive dyskinesia." Id. at 8-9. Oddly, the plaintiff insisted that her doctor did not believe that Seroquel could cause tardive dyskinesia, even though the doctor repeatedly testified that "the risk[,] though present[,] was really very low," and later, he again discusses the risk of neuromuscular problems, including tardive dyskinesia, with Seroquel as "[r]are or infrequent." Id. at 9. Maybe the doctor thought (correctly as it so happens) that the risk of tardive dyskinesia was low, but "he clearly understood that it nonetheless existed." Id. We would say that the plaintiffs overpromoted their doctor's ignorance of the risks.
Now let's get to the overpromotion point. The plaintiff argued that "AstraZeneca should not be permitted to invoke the learned-intermediary doctrine where the drug manufacturer has 'overpromoted" the drug and 'erode[d] the effectiveness of otherwise adequate warnings' through its 'aggressive marketing tactics.'" Id. The Patteson court acknowledges that the overpromotion theory had not been "analyzed by the Courts of this jurisdiction." Id. at 10. So it looks at what other courts have done. Sadly, some judges have not laughed the overpromotion theory out of court. But even those courts that have given the overpromotion theory undue respect seem to have grasped how potentially overbroad and dangerous it is. The Patteson court never explicitly says whether it would recognize an overpromotion exception to the learned intermediary doctrine. What Patteson does say is that even if there was such an exception, it would not apply here. That is because the Patteson court read the precedents to require a plaintiff arguing in favor of application of the overpromotion exception with respect to a prescription drug to "establish with individualized proof that such overpromotion caused the physician to initiate or maintain the prescription at issue. General claims of overpromotion are not sufficient." Id. at 10, quoting In re Zyprexa Prods. Liab. Litig., 649 F. Supp.2d 18, 33 (E.D.N.Y. 2009)
Such "individualized proof" of an effective seduction is almost never going to happen. It did not happen here. While the plaintiffs in Patteson generally claimed that AstraZeneca directed "aggressive marketing tactics" towards the treating doctor, they pointed to no direct evidence in the record to suggest that the doctor "was ever exposed to messages minimizing the risk of Seroquel or promoting its off-label use." Id. at 11. All that the plaintiffs could do was direct the court to 31 visits by sales representatives to the treating doctor. Apparently, the plaintiffs sought to imply that the treating doctor simply must have been exposed to certain messages during those visits. That "evidence" does not cut it: "Repeated visits by sales representatives to a physician regarding a pharmaceutical drug alone, however, do not constitute overpromotion - there must be a link between these visits and misinformation that would make the prior warnings ineffective." Id.
Even read against the cases that most fully embraced the overpromotion theory, the facts in Patteson came up short. There was no evidence suggesting that AstraZeneca's representatives "minimized the risk of tardive dyskinesia or encouraged off-label use of Seroquel to treat insomnia during any of their visits" with the treating doctor. Id. at 12. Like the author of a bad work of history pretending to know what was going through the mind of Napoleon or Torquemada, the plaintiffs offer sheer speculation. For example: "it is probable that the AstraZeneca sales representative included the message that Seroquel was an effective sleep aid, and that the true dangers of the drug were misstated," and the doctor "was likely led to conclude that Seroquel was an appropriate treatment for Mrs. Patteson's insomnia." Id. quoting plaintiffs' brief (emphasis by the court). In any event, the plaintiffs' speculation was contradicted by the doctor. He was not seduced. And he ought to know, right?
Not according to the plaintiffs. They brought in another doctor -- who had nothing to do with the treatment of the plaintiff in this case -- to say that "AstraZeneca did in fact promote for numerous off label uses, including as a sleep aid. I make this assertion based on direct promotion to me as well as direct promotion to numerous psychiatric and neurological physicians known to me." Id. at 13. That statement was not based on any personal knowledge regarding the visits of AstraZeneca sales representatives to the treating physician. "[I] nstead, he bases his assertion on inferences from his own experience and his review of the representative call notes. Id. This doctor was presumably a purported expert witness on the objective reasonableness of the treater's conduct. (Have we ever groused about that sort of nonsense before? Yes, we have.) It is as if this new expert doctor was saying that the treating doctor might not know he had been seduced, but this new doctor did, because he had been the target of another seduction. The plot thickens. In this bodice-ripping novel, the new doctor is smarter, more virtuous, and probably better-looking. It's quite a yarn. But it is not evidence that any alleged overpromotion had any effect whatsoever on the treating doctor's prescribing decision. With no real evidence regarding the doctor's "exposure to the alleged overpromotion of Seroquel and no evidence that such efforts influenced his treatment," the plaintiffs could not "avail themselves of the overpromotion exception-even if the exception were to be recognized in this jurisdiction." Id. at 14.
We won't lie. We found the Patteson case to be a joy to read -- a real page turner. The reasoning is seductive. Still, it was no tawdry flesharama. Rather, it was almost as happy and heartfelt as a Rom-Com by the much-missed Nora Ephron. And we loved the ending.
Congrats to Earl Austin and Aaron Davidson at Baker Botts.