If all Vermont had given us was fantastic cheese and Ben & Jerry’s ice cream, that would have been plenty. But the 14th state has also given us some interesting politicians (Calvin Coolidge, Howard Dean, Bernie Sanders), some riveting fictional characters (Simon LeGree, Pollyanna, Hawkeye Pierce), the setting for the sitcom that stuck the landing better than any other, Newhart, and, of course, perfect Autumn foliage. Vermont has been called home by one of our greatest playwrights, David Mamet, and one of our finest character actors, Luis Guzman (Out of Sight, Carlito’s Way, etc.). We hear that Guzman does ads for Cabot Creamery. We’d love to see those ads. Wait a minute – maybe through this internet thing we can do just that. Hold on a second. Okay, here you go. While we’re at it, here’s a scene from Out of Sight with Guzman, Catherine Keener, and Jennifer Lopez. Please please please, do yourself a favor and see Out of Sight if you haven’t already. It might be Soderbergh’s and Clooney’s best movie. It is certainly J Lo’s best. It has a wonderful array of character actors: Ving Rhames, Steve Zahn, Dennis Farina, Don Cheadle, Albert Brooks, and the aforementioned Mr. Guzman. The romance scene between Clooney and J Lo is perfect, melding expectation and experience into a sensory now-now-now. See it! Now back to the law biz. By the way, the lawyer we most admire graduated from U. Vermont’s law school.
For the moment, let's put aside the fact that Vermont gave us Wyeth v. Levine. (Sigh.)
The opinion we are cheddaring about today, Drake v. Allegan, Inc., 2014 U.S. Dist. LEXIS 151830 (D. Vermont October 23, 2014), comes from Vermont and it isn’t half bad. But it might be close to that. The plaintiff sued the defendant, alleging that its Botox product injured him. Both parties filed Daubert motions to exclude the other side’s experts. The court ended up entirely denying the plaintiff’s motion to exclude the defendant’s medical causation expert and partly granting the defendant’s motions to exclude the plaintiff’s regulatory and medical experts. If we were defense counsel in the Drake case, we’d call that a good day and reward ourselves with a dish of Vermont’s state pie (apple) drizzled with maple syrup, with a side of Vermont’s state beverage (milk, of course). And there would be fromage.
The plaintiff in Drake sought to preclude the defendant’s medical expert, but did so by mischaracterizing the scope of the defense expert’s opinions. The court correctly examined the defense expert’s opinion regarding the relationship between Botox and seizures as being authored “in the context of criticizing Dr. Hristova’s causation opinions rather than as a standalone opinion.” Drake, 2014 U.S. Dist. LEXIS 151830 at *8. The defense expert was playing defense, and that necessarily involves a more relaxed standard: “It is difficult to prove a negative, which in this case would be a lack of evidence supporting a causal connection between Botox injection and seizures.” Id. The defense expert did not opine with certainty that the plaintiff did not experience seizures. Rather, that expert opined that it could not be concluded with a reasonable degree of medical certainty that the plaintiff had experienced seizures or had epilepsy. There are certain advantages to being the defendant, after all. One of those is not having the burden of proof. We have written before about how defense experts can be held to a lower standard.
The plaintiff argued that the defense expert had completely disregarded EEG results. Not true; he “simply did not consider it diagnostic by itself.” Id. at *10-11. The defense expert had properly relied on the plaintiff’s medical records and his own medical training to interpret the symptoms. That his “conclusion is different from the other doctors’ conclusions is not a sufficient reason to exclude his testimony because in its role as gatekeeper a court is not concerned with experts’ conclusions but rather their methods.” Id. at *11. The plaintiff also challenged the defense expert’s qualifications, because he was not an allergy specialist. But the court concluded that the defense expert was “not required to specialize in allergic reactions in order to opine that [the plaintiff] may have experienced one since he bases his opinion on his own medical training and clinical experience.” Id. That is a good result for the defense here. And yet we can imagine cases where that outcome would sound less delightful to our ears. Admittedly, we practice what our high school religion teacher contemptuously called situational ethics.
Now let’s get to the defense challenges mounted against the plaintiff’s two experts. The first expert is Dr. David Kessler. Heard of him before? Sure you have. He was Commissioner of the FDA in 1990-97, serving under both Presidents Bush and Clinton. He has legal and medicine training. He has been at Yale and Berkeley, two institutions not exactly known for their affinity for American corporations or, for that matter, reality. (We’re not worried about receiving complaint letters/emails. The Yalies are too busy making bad policy, and the Berkeley grads won’t tear themselves away from the drum circle.) Kessler is a formidable witness who is always a top-level threat to hijack a case. The defendant sought to stop Kessler from 1) instructing the jury on the law or offering legal conclusions, 2) from narrating the evidence or regurgitating facts, and 3) from drawing inferences about the knowledge, motives, or intent of individuals or organizations. The court mostly did the right thing, ruling that Kessler could not “usurp the role of the court and instruct the jury on state tort law, narrate or regurgitate facts in a way that crosses the line into closing argument territory or speculate about other individual’s or entity’s motives, knowledge, or intent.” Id. at *14-15. That’s a pretty good smack-down. But the court also ruled that Kessler could “testify about the FDA’s regulatory scheme in general, FDA practices and procedures, Allergan’s compliance with FDA regulations, the FDA’s relationship with pharmaceutical companies, and the standard of care for the pharmaceutical industry based on his training and experience…. Dr. Kessler may be permitted to testify about another party’s knowledge if a jury would not otherwise understand the importance of certain facts without the benefit of his expertise – for example what is or is not common knowledge in the pharmaceutical company community based on his experience at the FDA.” Id. at *15-16. Has the court created a Swiss cheese hole big enough for Dr. Kessler to drive his truckload of anti-Pharma opinions through, straight into the jury box? If there’s a trial, the defense lawyers will need to put on their objecting shoes.
The defendant also moved to exclude the plaintiff’s medical expert, Dr. Anna Hristova, from offering four opinions: 1) an opinion that Botox caused the plaintiff to experience seizures, 2) an opinion on the adequacy of the Botox label, 3) an opinion on the permissibility of communications with doctors about potential drug effects, and 4) an opinion on Allergan’s alleged influence on the scientific literature concerning Botox. Here, the court waved through the proffered opinions in the first category, reasoning that an “expert is not required to back her opinion with published studies that unequivocally support her conclusions” (id. at *19), “[a]dverse event reports are … relevant when combined with other evidence, particularly epidemiological evidence” (id. at *21), “animal studies are some of the ‘pieces of the scientific puzzle’ that contribute to the reliability of Dr. Hristova’s opinion,” (id. at *22), and “[t]here is at least some evidence that Dr. Hristova’s causation opinion is biologically plausible” (id.).
On the second category, regarding the adequacy of the label, the plaintiff’s expert admitted that “she is not an expert in pharmaceutical labeling and has no relevant experience.” Id. at *24. Even so, the court permitted Dr. Hristova to “testify about how she would have interpreted the Botox label and the effect the label would have had on her as a member of the medical community treating patients with Botox.” Id. at *24-25. Meanwhile, the plaintiff agreed that the expert would “not testify about whether the label complied with FDA regulations.” Id. at *25. How sporting. Or maybe the plaintiff lawyers figured that Dr. Kessler would cover that particular part of the prejudicial waterfront.
The defendant sought to exclude Dr. Hristova’s opinions regarding what information the FDA would allow the defendant to share with physicians concerning off-label uses of Botox. After all, Dr. Hristova was not an expert in FDA regulations. Again, that freight would likely be carried by Dr. Kessler. Thus, the court ruled that Dr. Hristova “may not testify about whether sharing particular information would or would not violate the FDA’s ban on off-label promotion.” Id. at *26. But the defense lawyers will need to put on their not-kicking-open-any-door shoes, because the expert “will be permitted some latitude to defend herself.” Id. Whatever that means.
Finally, the defendant sought to exclude Dr. Hristova’s opinions regarding the defendant’s “alleged influence on the scientific literature concerning Botox.” Id. at *26. The plaintiff argued that the defendant “influences the literature by attacking articles questioning the safety of Botox and by financing and influencing the majority of favorable literature. Dr. Hristova has allegedly experienced Allergan’s ‘all-encompassing influence’.” Id. Golly, we’d hate to think that the poor plaintiff expert was harassed by scientific inquiry and the first amendment. The court really did split the baby here – which is to say that it committed intellectual infanticide. It ruled that “[o]pinions about the motive and intent of other actors is not a proper subject of expert testimony where a jury is capable of drawing its own inferences from the evidence. However, she may testify about any personal or firsthand knowledge she has regarding Allegan’s influence or attempted influence on her or other authors. She may also testify as a member of the medical community about her perception or understanding of the pattern of conduct of pharmaceutical companies to attempt to influence acceptance of their products.” Id. at *27. Rule 403, anyone? Anyone?
Clearing away the de brie in the Drake opinion, most of theDaubert rulings make sense. But while it might seem cheesy for us to say so, some bits make us bleu. Some smell like Limberger.