We will not be the first to comment on the Eighth Circuit’s affirmance earlier this week of summary judgment in Boehm v. Eli Lilly & Co., 2014 WL 904202 (8th Cir. March 10, 2014), nor will we be the last. The case is that good and that important. (And, unlike some of the recent cases we’ve dithered over, it is published! It is precedential! We are excited!) The court combined a nice learned intermediary analysis with an even nicer Daubert analysis. The virtues of the Eighth Circuit’s decision are obvious enough, but there are a couple of wrinkles in it that caught our eye.
The first wrinkle is a reminder of how creative plaintiff lawyers can be and how they will do just about anything to try to evade the learned intermediary doctrine. (Arkansas law supplied the learned intermediary rule in this case.) In Boehm, the plaintiff alleged that he suffered from a movement disorder called tardive dyskinesia (TD) as a result of taking Zyprexa for his bipolar disorder. His legal claim was for failure to warn. But this claim suffered from many problems. Let’s count them: First, the Zyprexa label expressly warned about TD as a possible side effect. Second, the treating/prescribing doctors were aware that atypical antipsychotics such as Zyprexa could cause TD. Third, those doctors still prescribe Zyprexa. Fourth, the doctors testified that an alternative warning about the risk of movement disorders would not have changed their decisions to prescribe Zyprexa to treat Boehm’s bipolar disorder.
Faced with that sort of overwhelming record, what’s a clever plaintiff lawyer to do? No matter how clear and comprehensive the warning, a plaintiff lawyer will extract some detail that is absent from the label, and then try to inflate that into some potentially changed behavior on the part of the doctor. What if that detail is hokum? Keep reading.
The Boehm court helpfully reproduced the pertinent part of the doctor depositions. Here is the deposition of one of the treaters:
[Boehm’s counsel]: I’m going to ask you about something that – a figure that I have seen here, that 15 percent – and I will ask you if you are aware of this. But 15 percent of those who have taken neuroleptics, such as Zyprexa, for three years, develop tardive dyskinesia?
[Dr. Kaczenski]: Yes, that’s a number I have known for a long time.
Plaintiff’s counsel then exploited that answer during the deposition of another treater:
[Boehm’s Counsel]: Did you receive any information that once a patient is prescribed Zyprexa for three years, one in six patients will develop tardive dyskinesia? Were you told that?
[Dr. Miller]: No.
Q. All right. If you had known that, and that is an established fact in this case pursuant to Doctor Kaczenski’s deposition testimony *** — that the inciden[ce] of tardive dyskinesia increases to one in six patients after three years of use, would you still have prescribed that to Tim Boehm?
A. Not for that long.
Voilà! Or, maybe, abra cadabra! Has the plaintiff successfully made the learned intermediary doctrine disappear? Not quite. At least, not for a court that is really paying attention. The district court was aware that “Dr. Kaczenski did not offer the 15% risk figure on his own; the percentage was part of a leading question.” Boehm, 2014 WL 904202 at *3. It was hardly, as the question suggested, “an established fact in this case.” (But you’ve got to admire the chutzpah.) Accordingly, the court requested briefing on whether the alleged 15% risk was supported by scientific evidence that would be admissible under Daubert.
Naturally, the plaintiff obliged by proffering the opinion of one of his paid experts, a psychiatrist who opined that “Zyprexa is capable of a high rate of incident tardive dyskinesia/dystonia after three years of use, affecting between 15-20% of those prescribed the drug.” Id. That is a classic ipse dixit. (That is, it’s just a guy with credentials saying ‘I’m smart and I say so.’) When the defendant challenged that opinion as lacking scientific support, the expert submitted two supplements to his report. It reminds us of those late night commercials that keep saying, “Wait, there’s more.” First, there was an article on the National Empowerment Center website stating that “Different studies quote different rates of tardive dyskinesia ranging from 15%-20% for people using [antipsychotics] for more than three years.” It also stated that Zyprexa “has been found to cause TD,” but it listed no sources for its information. Second, an expert witness hawked his plaintiff-TD-testifying wares on a webpage and bloviated, without citing a source, that the cumulative rates of TD are in the range “of at least 15%-20% for the first three years.” Id. Not very impressive stuff, as far as scientific evidence is concerned, is it?
But wait, there’s more.
The plaintiff expert again supplemented his report with a 2010 peer-reviewed study comparing TD incidence rates for users of first-generation and second-generation antipsychotic drugs. The study did not appear to substantiate the 15% assertion, and, in fact, showed that bipolar patients taking Zyprexa can expect better results than other patients.
None of this impressed the court very much, and it had little difficulty concluding that the plaintiff and its expert and the 15% allegation flunked Daubert. Indeed, some of the materials relied upon by the plaintiff’s expert undermined the 15% figure. And now we come to the second wrinkle in the case. The district court concluded that the materials in the expert’s first supplement – “a blog post and website advertising” – were a “deficient foundation” to support the 15% risk figure. Id. at *4.
(Awkward pause.) Well. Harrrrumph.
While we have no doubt that the blog post relied upon by the plaintiff expert was insufficiently reliable, we do think it is possible that some blog posts can be utterly reliable — authoritative, even. Maybe you’re reading one right now. At least we occasionally cite things.
Anyway, the Eighth Circuit ends up rejecting the plaintiff’s imaginative and energetic sidestep of the learned intermediary doctrine: “On appeal, Boehm places great emphasis on the testimony in which Dr. Miller agreed that prescribing Zyprexa for three years was ‘too long’ given the 15% risk of developing TD. But that testimony was based on Boehm’s counsel instructing Dr. Miller that a 15% risk factor for Zyprexa users has been established by Dr. Kaczenski’s testimony, which was untrue.” Id. at *5. Just so.
The Eighth Circuit also wasted little time in disposing of the plaintiff’s overpromotion theory. It was by no means clear that Arkansas law would countenance such a theory, but even if it did, the case was bereft of the requisite “individualized proof” that a drug manufacturer’s excessive promotion of its product caused the plaintiff’s physician to initiate or maintain the prescription at issue. The court allowed that there was evidence in the record of aggressive marketing that stressed the medicine’s “safety”, “efficacy,” and “ease of use” for treating bipolar patients, but there was no evidence that any company representative made statements to the treating doctors “that negated the package insert warning, and there is no evidence their prescribing decisions were affected.” Id. at *6.
We are impressed by the Eight Circuit’s reasoning … even if that court is less than impressed by the force of blog posts.