United States: Guest Post – Tee To Green: Abilify MDL Daubert Opinion Allows Plaintiffs' General Causation Evidence

Last Updated: June 27 2018
Article by Curtis R. Waldo

Even the casual golf fan is likely familiar with gaudy stories involving John Daly. On his way to winning the 1995 British Open at St. Andrews, John Daly wolfed down Otis Spunkmeyer chocolate chip muffins to offset sugar cravings induced by alcohol withdrawal. Upon finishing second place at the World Golf Championship, Daly lost $1.65 million in Vegas, mostly at slots. Suffering a collapsed lung in the middle of a tournament, Daly quipped, "I only smoke two packs of cigarettes a day, not three, so I'll be alright." Daly self-diagnosed: "Everyone has addictions and my problem is that I have 5,000 of them. If it's not drinking, it's gambling; if it's not gambling, it's eating anything from burgers, doughnuts to M&Ms. The only addiction I don't suffer from is chasing women."

To that, Tiger Woods might say, "Hold my beer and watch this." Two years after Daly's last major win at the 1995 British, young gun Tiger Woods burst on the scene and won the Master's by 12 strokes. In contrast to Daly, through his years atop the PGA Tour, Tiger projected nothing but the utmost discipline and confidence. Tiger was manic about his fitness, and you would certainly never see him smoking or drinking on a golf course. Of course, the façade came crumbling down, and Tiger was eventually exposed as a "sex addict," subject to the same demons that haunted Daly.

Enter the Abilify MDL, where plaintiffs argue Abilify causes patients to develop "impulsive and irrepressible urges to engage in certain harmful behaviors, including gambling, eating, shopping, and sex." Op. (infra) at *1. This author is not aware if John Daly or Tiger Woods ever took Abilify, but if so, based on a March 15, 2018 opinion out of the Northern District Florida, they could conceivably attempt to blame their respective struggles with impulse control on the drug.

To the court's opinion, In re Abilify (Aripiprazole) Products Liability Litigation, 2018 WL 1357914 (N.D. Fla. March 15, 2018). Before diving into the law, the opinion spends several paragraphs describing the brain as a "tremendously complex biochemical system." I d. at *3. The brain contains billions of neurons, sending and receiving information to other neurons. Id. Electrical impulses are constantly being sent from neuron to neuron across gaps called synapses. Id. The impulses are housed by molecules called neurotransmitters. Id. Dopamine is an "integral" neurotransmitter, constantly telling the brain what it likes and doesn't like and thus playing a critical role in "pleasure, reward processing and motivation." Id. This becomes important later when the decision addresses plaintiffs' biological plausibility expert's argument that Abilify prevents the activation of dopamine molecules, causing the brain to increase the number of dopamine receptors. Id. When dopamine activates these receptors, a "potentiated" physiological response is triggered, resulting in the complained of impulsive behavior. Id.

Back to the law. Most notable in the legal discussion, after discussing the types of general causation evidence the Eleventh Circuit normally requires (epidemiology, dose-response, accounting for background risk), the decision stated that "in practice" any expert must also consider the "weight of the evidence" in coming to his conclusion. Id. at *9. Of course, "in practice," this may lead to an expert throwing any number of theories against the wall, seeing what sticks, and saying that he is considering the "weight of the evidence." Where the science stops and the weighing begins is not entirely clear. But what is clear is Eleventh Circuit law. The sort of vague, seat of the pants expert opinions allowed in Abilify should not have been. See Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245, 1253-57 (11th Cir. 2010) (affirming exclusion of unreliable differential diagnosis); McClain v. Metabolife International, Inc., 401 F.3d 1233, 1239-51 (11th Cir. 2005) (excluding various expert machinations ultimately based on the "post hoc ergo prompter hoc fallacy"). This precedent strongly indicates that the Eleventh Circuit has not, and would not, embrace the "weight of the evidence" approach taken in Abilify. Notably, Abilify cited only district courts from within the Eleventh Circuit, as well as cases from other, less rigorous courts of appeals. 2018 WL 1357914, at *9.

Moving to plaintiffs' evidence, purportedly the most persuasive was the "Etminan Study," a so-called epidemiological study drawn from an insurance claims database of millions of patients. Id. at *11-12. It just so happened that the author of the study, Dr. Etminan (an opthamologist from Canada) reached out to plaintiffs' counsel before he developed the research protocol for his study. Id. at *19. How fortunate plaintiffs' counsel must have felt when after they brought their Abilify cases; a doctor called to say he was about to conduct a study going to the central issue in the case, and imagine further the smile on face of plaintiffs' counsel when the study turned out to say exactly what plaintiffs wanted it to say. Imagine the smile on Dr. Etminan's face when those expert fee checks started rolling in.

Anyway, Dr. Etminan examined the claims database to identify patients with diagnostic codes for a gambling or impulse control disorder. Id. at *11-12. He identified a separate group of patients with neither diagnosis. Id. Dr. Etminan compared the two groups and found the former more likely to have been prescribed Abilify in the year prior to their gambling or impulse control diagnosis—so much more likely, according to plaintiffs' experts, that an inference of causation could be drawn. Id. This study, and plaintiffs' experts' statistical analysis of the study, was plaintiffs' primary evidence of general causation.

The court acknowledged several flaws in the study, including that Dr. Etminan never actually looked at any medical records for any of these people. Id. at *13. Dr. Etminan didn't know if any of the patients even ingested Abilify (as opposed to merely filling the prescription). Id. at *14. If they did ingest the drug, Dr. Etminan didn't know how much they took. Id. At least one of the Abilify-taking patients in the database reported a compulsive gambling disorder only after seeing a lawyer advertisement saying Abilify caused compulsive gambling, suggesting his "diagnosis" (and likely that of other patients in the database) was colored by reporting bias. Id. at *20.

The study also appears to treat a gambling diagnosis like a flu virus—something one contracts and is "diagnosed" with. A small problem—the DSM says a gambling disorder takes up to 12 months to develop into a disease. Id. at *15. And as many readers are likely aware from personal experience or the experience of loved ones, one does not buy a lotto ticket and then seek out treatment for a gambling disorder. A likelier course is to wallow undiagnosed in heady indulgences for years, perhaps at a casino, golf course, seedy bar, or in the case of shopping addiction, perhaps the mall, until one hits the proverbial rock bottom (such as Tiger Woods' infamous single-car accident), at which time it becomes apparent that a trip to the psychiatrist is in order. Once one is on the psychiatrist's couch, recounting tales that would make John Daly look like a model of discipline and rationality, then maybe also comes an Abilify prescription.

This gets to the most critical flaw of the Etminam study, which is that the very disorders that may lead to impulse control issues—depressive disorders, anxiety disorders, and personality disorders—are often the disorders that Abilify attempts to treat. Claiming the same disorder being treated as a "adverse effect" of the drug used in treatment is a common plaintiff ploy. See, e.g. Colacicco v. Apotex Inc., 521 F.3d 253, 256 (3d Cir. 2008) (observing that suicide was also "inherent in depression," the condition the drug at issue treated), vacated on other grounds, 556 U.S. 1101 (2009) (preemption).

The Abilify opinion conceded problem with causation, but found no actual evidence that anxiety and personality disorders were related to increased exposure to Abilify. 2018 WL 1357914, at *18. While this may be true, the logical implications that follow are, well, hard to follow. One could imagine that of all the humans in the world with anxiety and personality disorders, a very small percentage are taking Abilify. But one could also imagine that of all those who take Abilify, a high percentage have anxiety and personality disorders, and as such, may be more inclined to have impulse control issues. After all, that is one of the reasons the drug was likely prescribed in the first place. Ultimately, the opinion found the medical literature to be "inconclusive on the question of whether depressive, anxiety and personality disorders are causal risk factors for pathological gambling." Id. This lack of evidence of a causal relationship between these disorders and impulse control was decisive; not merely the fact that as the DSM notes, "individuals with gambling disorder have high rates of comorbidity with [depressive, anxiety and personality disorders]." Id. Plaintiffs received a mulligan. One wonders where the burden of proof on the party offering the expert opinion went.

Next up was, plaintiffs' non-epidemiological evidence of causation, including evidence of a dose-response relationship and of biological plausibility. The analysis of this evidence is best summarized as, "maybe." Maybe it's plausible; maybe there is a dose-response relationship; maybe the case studies and adverse event reports show causation. Because the epidemiological evidence is sufficient, this is all gravy for plaintiffs, and defendants' arguments don't carry much weight. None of these "bolstering" studies were sufficient proof of general causation under Daubert by themselves, but because the epidemiological evidence was sufficient to meet plaintiffs' burden, the "bolstering" studies could come in, too. Why rake the sand trap when you're already on the green? Of course, whether a future jury will draw this distinction is another matter. One could certainly imagine a jury finding a single case study more persuasive than an epidemiological study of 6 million insurance claims.

After describing the general causation evidence, the Abilify opinion proceeded one-by-one through plaintiffs' experts, finding faults with many, though ultimately allowing the key epidemiology testimony, based on the serendipitously timed Etminan study. Id. at *36, et seq. Defendants' experts largely passed through, too.

Past the gatekeeper, and on to the jury. Good luck to each side in the second round. As John Daly said, "The first tournament is not the hardest one to win. It's always the second one."

This article is presented for informational purposes only and is not intended to constitute legal advice.

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