[Drug and Device Law] More Drake Dreck - Vermont Federal Court Refuses to Overturn Botched Botox Verdict
“We’ve seen this movie before.” That is something people say when they encounter something that seems simultaneously dreadful and predictable. That is how we felt upon reading the latest dismal opinion out of the Drake Botox litigation in Vermont federal court. We’ve blogged about this case several times before, bemoaning the blundering approach taken towards the learned intermediary, heeding presumption, and Daubert doctrines. The result was that the jury heard all the wrong stuff in this case. An avalanche of improper evidence swept over the jury box, and the plaintiff walked off with $2.7 million in compensatory damages and $4 million in punitives. The defendant filed post-trial motions for judgment as a matter of law and, in the alternative, for a new trial. The result was nothing if not consistent: a reiteration of earlier, rotten rulings and denial of the defendant’s post-trial motions. You can read the bad news here: Drake v. Allergan, Inc., 2015 U.S. Dist. LEXIS 66932 (D. Vt. May 22, 2015).
In our earlier posts we tried to say something nice about Vermont. For instance, in 1777 it independently declared its independence from Britain and remained a separate "Vermont Republic" for 14 years before joining the union. These days, it has a socialist senator with ambitions to be president. But mostly, we stuck to the theme of cheese. Sometimes we mentioned other fine dairy products from Vermont. That reminds us of a recent discussion we heard about what the world would be like if every man had to be named John. You might think such a discussion is frivolous, but you’d be wrong. It makes at least as much sense as the opinion we’ll be perusing today. Be that as it may, perhaps the most profound consequence of the John-only rule would be that Ben & Jerry’s ice cream would be called John & John’s. How’s that for counterfactual scenarios that make you reconsider your worldview?
Today, we decided to go a different route. We looked for movies that were set in Vermont, or at least had some connection to the Green Mountain State. An odd pattern emerged. For example, consider Mr. Deeds Goes to Town. That Capra classic is about a rich yokel who visits New York City, handles the boozing and partying badly, tries to give away his money, and ultimately faces a commitment hearing. Two spinsters from his Vermont hometown testify against him. They say Mr. Deeds is “pixillated.” On cross-examination, it turns out that these biddies believe that everyone is pixillated, including the judge. Somewhat less classic and not nearly as good as Mr. Deeds Goes to Town was Funny Farm, a ‘comedy’ about a couple whose misadventures on a Vermont farm turn out to be everything but funny. Chevy Chase had already entered his pointless mugging phase, and the movie is a perfectly miserable way to waste 101 minutes of your life. But at least no one tells you that Funny Farm is any good. By contrast, lots of people praise Dead Poets Society, even though it is purely pretentious twaddle. Robin Williams plays a new poetry teacher (his name is Keating for crying out loud) at a Vermont prep school that is curiously full of future film and tv stars (Ethan Hawke, Robert Sean Leonard, Josh Charles, etc.) There is a nice clue to the movie’s stupidity in the fact that the rallying cry is “O Captain, My Captain,” surely the worst poem Whitman wrote. Teenage narcissism is never pretty, and Dead Poets Society wallows in it. We end our tour of cinematic Vermont with a couple of Hitchcock’s lesser known efforts. Spellbound was largely set in a Vermont insane asylum. It is most famous for a dream sequence assembled by Salvador Dali. Hitchcock’s personal favorite among all his movies was The Trouble With Harry. Harry causes trouble by turning up dead in the Vermont countryside. Nutty locals play a weird game of moving the body for no good reason. The rubes exhibit a disquieting disinterest about disinterment.
A commitment hearing, a funny farm, neurotic adolescents, an insane asylum, and bucolic eccentrics. Bernie Sanders. Wyeth v. Levine. On this evidence, we think that the two senior citizen witnesses in Mr. Deeds Goes to Town might be on to something: everybody in Vermont really is crazy. The Drake case is merely cumulative evidence on this point.
If you require a reminder about what happened in the Drake case, here goes. The case was brought by parents on behalf of their son. The son had cerebral palsy. His doctor injected Botox into the boy’s calves to treat lower limb spasticity. The law suit claims that these injections caused the boy to develop a seizure disorder. After a thirteen-day trial, the jury found the defendant negligent and found that punitive damages were warranted. One of the key plaintiff witnesses in the case was Dr. Hristova, who testified about medical causation. One piece of evidence on which Dr. Hristova relied was a study that the defense lawyer thoroughly discredited during cross-examination. The trial judge concluded that even though the plaintiff expert’s main support had been undercut, a reasonable jury could conceivably have found that Botox caused the seizures because Dr. Hristova relied on the “totality of circumstances.” Those circumstances included seizure rates in clinical trials, a study, adverse event and anecdotal reports, biological plausibility, theoretical mechanisms of action, an FDA guidance, the Botox label, the temporal connection between Botox usage and the seizures, and the lack of an alternative explanation. The court acknowledged that no single piece of this evidence would necessarily may have been conclusive in isolation, but “together it paints a picture sufficient to support the jury’s finding on medical causation.” That's like saying that seven Vermont cowpies smell sweeter than one. If any picture is being painted, it is a picture of a court letting pretty much everything in that the plaintiffs wanted, and then letting the jury do anything it wanted.
The case was about a failure to warn. To borrow an overused phrase, the issue was what did the defendant know and when did it know it? And what, exactly, did it failure to tell the doctor? The evidence in the Drake case is astonishingly weak. There was “evidence suggesting that the overall rate of seizures in Allergan’s clinical trials was higher in Botox groups than in placebo groups and that Allergan may have selected favorable data to make this fact less obvious in its reports to the FDA.” That is not only speculative, but it seems to run afoul of Buckman preemption. As the court phrases it, it sounds as if the failure to disclose arose from the company’s communications with the FDA that, at least according to the plaintiffs, were less than candid. That is a claim of fraud (if you could even call it that) on the FDA. But such fraud would be for the FDA to pursue, not the Green Mountain Boys.
And, anyway, what does that purported hoodwinking of the FDA have to do with the doctor’s decision to use Botox? If you read our prior posts on the Drake case, you know that the treating doctor never-ever said that a different warning would have changed his risk-benefit calculation. The doctor also said that such calculation was based on his own training and experience, not on anything the manufacturer said or did not say. The judge did not care. Even if the jurors believed the doctor’s testimony that he relied on his training and experience, “they could have nevertheless relied on a variety of evidence to conclude that Allegan’s promotional efforts over the years also played a substantial part in Dr. Benjamin’s choice to treat J.D. with Botox and to select the dose he administered.” That is, the court speculated that the jury could have speculated about how promotional efforts could have somehow impacted the doctor’s decision, even if the doctor disclaimed such impact. To be fair, the court would probably reject our characterization of this ‘reasoning’ as mere speculation. After all, the plaintiffs had presented evidence that the defendant’s employees “had direct contact with Dr. Benjamin during two separate time periods.” Not just contact, but direct contact. Wow. But where is the evidence that the nature of such contact amounted to fraudulent understatement of risk? It gets worse. The court also speculates that the “jury also could have reasonably inferred that doctors may be influenced by drug promotion but may not be consciously aware of how the promotion has influenced their behavior.” Yikes. Now the court is piling speculation on top of speculation. We’re almost in the nutty world of subliminal advertising (which, by the way, has been as thoroughly discredited as Dr. Hristova’s basis for her medical causation opinion). Was there any support for the notion that company promotions can overcome a doctor’s will without that doctor knowing it? Of course there was, if you believe the testimony by plaintiff super-expert Dr. David Kessler, who “described a study by the World Health Organization and Health Action International finding promotion influences attitudes more than doctors realize.” Did Dr. Kessler tie that study to the treating doctor in this case? We do not know. And we bet that, as far as this court was concerned, it does not matter.
The court pointed out that the plaintiffs elicited testimony suggesting that the defendant affected medical literature in various ways, including the inevitable “ghost-writing.” It does not sound as if any of these allegedly tainted publications (by the way – were they shown to be actually wrong?) were connected to the treating doctor’s decision. The most that the plaintiffs’ lawyer could force the treater to say was that the defendant had “been a part of all the experiences, influence, and training he has had” (undoubtedly true – but you could say the same thing about medical school, the evening news, the epic pronouncements of Dr. Kessler, and plaintiff lawyer ads), and that all of that together “would have had some influence in general over the practice.” That isn’t causation, that is pantheism. It has all the coherence of a Phish jam. Nevertheless, the court tells us that the jury “could have inferred” that the defendant’s promotion activities influenced the doctor’s “dosing choices, whether consciously or unconsciously.“ Maybe the jury was influenced by the babblings in Dead Poets Society. We don’t know. We’re just guessing. If you read the Drake opinion half as closely as you would read a Whitman poem, you’ll notice that almost every paragraph is heavily dosed with the word “infer.” Substitute the word “speculate” for “infer” and you will have a much more accurate appreciation for what this decision hath wrought.
Such judicial tolerance for speculation supports both the compensatory and punitive awards. As an initial matter, the court acknowledges that the Vermont Supreme Court jurisprudence on punitive damages “has not been a model of clarity.” Luckily, this federal court will inject clarity and rigor into the topic, right? Wrong. The plaintiffs were required to prove that the defendant’s conduct was outrageously reprehensible. The court then alludes to the defendant’s 2010 guilty plea regarding off-label promotion. That seems like dirty pool, given how fragile those governmental prosecutions for off-label promotion were. To the extent they were premised on the False Claims Act, the causation theories had the consistency of maple syrup – a sticky mess. And to the extent that the first amendment still exists in this country for commercial speech, the prosecutions were probably unlawful. See United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). But nobody wants to play chicken with the DOJ, so it is better to pay up than risk debarment at most or agency hostility at best. In any event, connecting the conduct at issue in the guilty plea with the particulars of the Drake case is another exercise in sheer speculation. Almost to the point of monotony, the court tells us that the jury “could also have inferred Allergan’s promotional efforts reached Dr. Benjamin…. The jury also could have inferred Dr. Benjamin was influenced by [a website promotion] because he testified that he referred to their website in his practice and had seen the dosing schedule before.” That is a lot of speculating – err, inferring – to get one to not quite proving any point, much less a point that would support punitive damages. But the court concludes that a “reasonable jury could have felt morally outraged by a corporation’s desire to put its bottom line above children’s health, safety, and even lives.” That line would have fit snuggly into the plaintiff’s closing argument. Heck, we’ll infer that it’s in there.
John & John's -- oops - Ben & Jerry's offers a sundae called the Vermonster. It consists of 20 scoops of ice cream, four bananas, and layers of brownies and other sweets. Now replace those goodies with turnips, guano, and glass shards, and you'd have the sort of Vermonster that the federal court whipped up in the Drake case. But let's be realistic. After all sorts of wrong, wretched evidentiary decisions, after having sat through a 13 day trial, and after hearing a jury deliver a Vermont spanking to an out of state corporate defendant, what are the odds that the court would own up to mistakes and fix things? It sometimes happens, but it is darned rare. That’s why we have appellate courts -- such as the Second Circuit, which decided Caronia.
John & John's -- oops - Ben & Jerry's offers a sundae called the Vermonster. It consists of 20 scoops of ice cream, four bananas, and layers of brownies and other sweets. Now replace those goodies with turnips, guano, and glass shards, and you'd have the sort of Vermonster that the federal court whipped up in the Drake case. But let's be realistic. After all sorts of wrong, wretched evidentiary decisions, after having sat through a 13 day trial, and after hearing a jury deliver a Vermont spanking to an out of state corporate defendant, what are the odds that the court would own up to mistakes and fix things? It sometimes happens, but it is darned rare. That’s why we have appellate courts -- such as the Second Circuit, which decided Caronia.
--
Posted By Steve McConnell to Drug and Device Law at 6/03/2015 07:30:00 AM --
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
No comments:
Post a Comment