A week or so ago Grantland tv critic Andy Greenwald penned a “can we talk” letter to Sunday night, asking how it managed to fall so far from greatness. Just last Spring we could plop down on our couch at the end of the weekend to watch Game of Thrones, Mad Men, Veep, and Silicon Valley. Even if some time-shifting was required, it was worth it. Now with the departure of the criminally underrated Boardwalk Empire, Sunday evening has morphed into a drama wasteland. (Sunday Night Football certainly has not supplied any drama. Did you see the dumpster fire that calls itself the Chicago Bears?) The sheer craziness of Homeland has driven us away, with a lead character who calls in drone strikes as she boinks her way into fresh intel. And then we get the competing stories of The Affair, a show that hasn’t attained Rashomon heights of greatness (“Look, the guy from The Wire and the girl from Luther are remembering different wallpaper designs!” “Why is the cop telling them completely different stories about his home life?”).
Let’s pour out some hooch in honor of Boardwalk Empire and remember its well-drawn characters, some of them plucked from the pages of history, and their poetic recitations of despair. The show has one of those historical characters, the gambler/gangster Arnold Rothstein (some say he fixed the 1919 World Series), sharing this bit of wisdom: “All of man’s troubles come from his inability to sit in a quiet room by himself.” As we plunge toward dotage, that sentiment seems very true. Ex-federal agent Van Alden (played by the great Michael Shannon, the same actor who declaimed the insane sorority letter) realized, on the doorstep of his personal doom, that “[w]e haven’t thought this through.”
We are feeling a bit of despair this week after reading an opinion that we do not think was thought through. Last week we identified some things we liked and some things we did not like so much in the Daubert rulings in the Drake case pending in Vermont federal court, where the plaintiff claimed injuries from Botox injections. This week we will look at the summary judgment rulings in that same case. We harbor no mixed feelings at all about the opinion; it is a complete stinker. Drake v. Allergan, Inc., 2014 U.S. Dist. LEXIS 154979 (D. Vermont October 31, 2014). The opinion was appropriately issued on Halloween. It is scary bad. It mucks up the learned intermediary rule, whilst pretending to steer clear of saying anything about it.
In one courtroom scene in Boardwalk Empire, a judge says this to a prosecutor: “I sympathize with your desire to bring purpose to your life, however this courtroom is not the place to do it.” That is a hard-headed judge. We like that judge.
But now let’s go to Vermont. In Drake, the plaintiffs brought an action on behalf of their son, J.D., alleging that he was injured after receiving an “overdose” Botox injection for treatment of lower-limb spasticity. They brought claims of strict liability/failure to warn, negligence, and violations of the Vermont Consumer Fraud Act, all premised on an alleged failure to warn about proper dosages. Here is an additional wrinkle in this Botox case: because the FDA has not approved Botox as a treatment for pediatric spasticity, the administration at issue was off-label. Off label or not, the treating doctor testified that Botox has been one of the standards of care for treating pediatric spasticity for over 20 years.
Since this is fundamentally a failure to warn case, it is worth noting that the Botox label contained a “black box” warning about the “Distant Spread of Toxin Effect,” which is allegedly what happened here. The insert also warned that the safety and effectiveness of Botox have not been established for the treatment of upper limb spasticity in pediatric patients and for the treatment of lower limb spasticity in adult and pediatric patients. So what was missing? The defendant’s Core Data Sheet stated that the maximum cumulative dose for children “should generally not exceed 8.0 Units/kg body weight.” The plaintiffs argued that this dosage limit should have been shared with the medical community and the public. When the defendant reported adverse events to the FDA, it characterized any pediatric dose great than 8 u/kg as an “overdose”. All that being said, the evidence seemed to show, as it usually does, that the treating doctor based his dosage decision upon his own experience, and not upon the label.
Why isn’t this case a goner based on the learned intermediary rule?
The court played a mean game of dodgeball, reasoning as follows: “[T]he primary disputes are whether the warning to Dr. Benjamin was adequate, and if that warning had been communicated to the Drakes, whether J.D.’s treatment would have been different. Accordingly, the Court need not predict at this time whether the Vermont Supreme Court would adopt the learned intermediary doctrine.” Drake, 2014 U.S. Dist. LEXIS 154979 at *15-16. “Accordingly”? Huh? By our count there is at least one Vermont trial court that applied the learned intermediary defense. That case, unsurprisingly, is not cited in Drake.
By at least one calculation, Vermont is one of the five smartest states in the union. “Accordingly” (see what we just did there?), the smart prediction seems to be that Vermont would likely embrace the learned intermediary rule. Vermont does not move its lips when it reads. Vermont does not step on rakes. Vermont changes the channel when Naked and Afraid comes on. It keeps clicking until it finds Antiques Roadshow or a Canadian Parliamentary debate. But the Drake court says it will not make the bold prediction of learned intermediary adoption, though what it does instead is embrace a three-step plaintiff gambit that we have seen all too often.
Before we get to that gambit, let’s remember how the learned intermediary rule should work:
- The plaintiff should specify what needed to be in the warning. Amazingly, some courts permit plaintiffs to evade this rather basic requirement until closing argument, if even then.
- The plaintiff should be forced to prove that the specific additional warning was something the prescribing doctor did not already know.
- The plaintiff should be forced to prove that if the prescribing doctor had seen the specific plaintiff-proposed warning, the doctor would have changed the prescribing decision.
If those requirements were rigorously imposed, and if doctors testify the way they usually do, most failure to warn claims would go away. Sometimes there is a very big fly in the ointment in the form of the heeding presumption. By our lights, that heeding presumption should not alter requirements 1 and 2 above. The tricky part is 3. Is it now up to the defendant to prove that the proposed warning would not have changed the prescribing decision? What is the result if the doctor refuses to speculate? Don’t plaintiffs still bear the burden of proof on causation? It can be a tough spot for the defendant, and often what happens at the prescriber deposition is that neither side asks the clear what-if question of the prescriber, possibly because no lawyer wants to take the fall for losing the case.
In Drake, the court said that Vermont had adopted a heeding presumption (true enough, as we reported here quite recently), and that the prescribing doctor “did not testify whether, had he been given a specific dosage warning, he would have done anything different with respect to J.D.” Id. at *17. Indeed, as plaintiffs gleefully pointed out in their opposition to the summary judgment motion, “[n]either side asked Dr. Benjamin at his deposition whether he would have done anything differently had he received an adequate warning regarding the maximum safe dose.” Id.
In Boardwalk Empire, Dr. Narcisse (we are not sure what he was a doctor of; maybe bumping off inconvenient people?) says, “Nothing is wrong if you see nothing wrong in it.” That’s a pretty nihilistic statement, isn’t it?
Armed with such nihilism, we are ready to look at the plaintiff three step process for circumventing the learned intermediary rule. First, get the treater to say that certain information is interesting and that the doctor would have liked to have known it. Doctors are scientists. They are nerds. Anything scientific is interesting. Who wants to come off as complacent and close-minded? Next, get the doctor to say that he/she might have conveyed this additional information to the plaintiff. Again, you can understand why some doctors would at least like to think that they might have shared information with the patient. Those two bits of testimony from doctors are not inevitable, but with some creative questioning, and maybe some creative canoodling during ex parte meetings, they can be yanked out of the doctors and deposited into the opposition brief. And then the third part of the anti-Learned Intermediary tango is simplicity itself: the plaintiff tut-tuts how if the doctor had shared this new information, the prescription would never have been accepted.
Perhaps we sound too cynical. Would litigants actually shade the truth to win a case? As Masseria (another true-to-life character in Boardwalk Empire) said, “Everyone dies; not everyone keeps their promises.”
Here is how that three-step end-run played out in Drake. In his deposition, the doctor allowed how the information about anything north of 8 u/kg being considered an overdose would have been “interesting.” Id. at *8. Uh oh. At the same time, the doctor tried to supply useful context. He pointed out that he would have read any such information against his clinical experience: “So you can pick a small number of cases and show that it was all because it was over 8 units per kilogram, but then in the clinical world of doing this for 12 years, hundreds of patients, thousands of times, in that dosing schedule, that I have not seen this type of response to the medication at those doses.” Id. at *8-9.
But still. That “but still” is something you have no doubt heard many times from people whom you have thrashed in an argument, as they stubbornly keep oscillating their jaw. The doctor in Drake testified that “if he had been informed of a maximum safe dose, and planned to exceed that dose, he would have included that fact in the information provided to the parents prior to their consent.” Id. at *9. Is that the exact language that the plaintiffs argued should have gone into the label? Or do we have a mismatch? We have the same questions when we see the ineluctable testimony by one of the parents to the effect that if the doctor had informed them “that he was going to give our son an overdose of Botox … we would not have moved forward with that.” Id. at *10. Is that what the doctor would have actually said: ‘I am planning on giving your son an overdose’? Or do we have a mismatch?
The doctor went on to testify that had the parents declined the Botox treatment for their son, he “would have acceded to their wishes.” Id. at *10-11. What else could he say?
Mind you none of this matters if the label is adequate. Many of the plaintiff’s symptoms are in the product insert. The plaintiffs contended that the warning was inadequate given that “the maximum dose of 8 u/kg is a bright line boundary beyond which the risk and hazards of Botox are exponentially greater.” Id. at *19. The label warned that the new onset seizures have been reported, but that “[t]he exact relationship of these events to [Botox] has not been established.” Id. Is there anything false about that? If so, the opinion does not disclose it. Instead, the plaintiffs argued that the warning language “was not sufficiently highlighted.” Id. The court thought that assertion was enough to create an issue of fact. Really? Couldn’t a plaintiff always make that argument?
The plaintiffs also argued that the defendant “illegally promoted the off-label use of Botox to treat pediatric spasticity at unsafe doses.” Id. at *20. There was evidence in the record that the defendant marketed Botox to physicians in general, and there were call notes suggesting that “hi-dose BTX” was discussed with the treater. The court concluded that the treater was a “target” of the defendant’s marketing efforts. Id. at *22. That “target” word always sounds bad, even though every marketer of every product in America (and probably the world) uses it. But here’s the thing: the treating doctor did not recall that his prescribing practices were influenced by discussions with the defendant’s sales representatives. He conceded in his deposition that it was possible such discussions occurred and he simply did not recall them. Id. Standing atop this messy concatenation of facts and almost-facts, the court espied a genuine issue of material fact as to whether the doctor was influenced by the defendant’s marketing. Wow. How could any jury arrive at such a conclusion without speculating?
Boardwalk Empire is no more, but the Drake case continues. Life isn’t fair. Neither, sometimes, is law. Maybe it’s like the lead character, Nucky Thompson, said: “No one likes to lose, but we all need to learn how.”