[Drug and Device Law] Pruning 'Expert' Opinions on Risk-Benefit and Corporate Knowledge
“Ignorance is like a delicate fruit; touch it and the bloom is gone.” - Oscar Wilde
March 25 is a significant day in legal history. On this date in 1911, the Triangle Shirtwaist factory in New York City caught onfire, killing 146 workers. (One of those lost souls was the great-grandmother of a member of the DDL blogging team.) The factory owners were charged with manslaughter on the theory that they had locked the fire exits to keep the workers from taking smoking breaks on the fire escapes. The formidable trial lawyer Max Steuer represented the owners and secured a defense verdict by showing that a key plaintiff witness had rehearsed her story a little too well. Two decades later, on March 25, 1931, the Scottsboro Boys were arrested for rapes they never committed. Witnesses made up inculpatory testimony. The trials were a sorry, sordid affair, resulting in death sentences, followed by multiple U.S. Supreme Court decisions on the issues of effective assistance of counsel and racial exclusion of jurors. To Kill a Mockingbird might have drawn on some aspects of the Scottsboro Boys case, but the real life matter was much more complicated and dramatic. One of the defendants escaped and was later (much later: 1976) pardoned by, of all people, Governor George Wallace.
Today’s case is not nearly so epic, but it is nevertheless notable for the trial court’s smart and stout decision to stop a plaintiff expert witness from testifying about things she had no business talking about. The case is Heineman v. American Home Products Corp., 2015 U.S. Dist. LEXIS 30445 (D. Col. March 11, 2015). We were far less happy about the Heineman case when we wrote about it here last Summer, when the court missed an opportunity to end the case on clean learned intermediary grounds because it overcomplicated the issue of identifying who was the prescriber. This time, the court was confronted with the plaintiffs’ proffer of opinions by an expert to the effect that (1) the risks of diet drugs outweighed their benefits, and (2) the defendant’s post-marketing surveillance stunk and it knew its labelling was inadequate. The expert was Dr. Cheryl Blume. She is a pharmacologist. We have blogged about several other cases involving Dr. Blume. Here, for example. And here. And here. There are others. You get the idea. Since, as Dr. Parisian told us at a deposition last year, she is retiring soon, we suppose that Dr. Blume will become the go-to expert for saying what needs to be said, at least as far as DDL plaintiff lawyers are concerned. We are reminded of something Bill Buckley once said about a former ambassador: “He knows a lot about the Soviet Union, all of it wrong.” Dr. Blume comes into every case knowing A Lot.
The Heineman judge conducted a Daubert hearing and took testimony from Dr. Blume. In its opinion, the court gives a nice blow-by-blow account of the hearing. First, we learn that “[a]fter several hours of general direct examination of Dr. Blume, the Court called counsel to the bench and observed that, thus far, the Plaintiffs’ questioning of Dr. Blume, though extensive, had not begun to approach the Defendant’s foundational challenges to the recited opinions. With the consent of counsel, the Court took over the examination of Dr. Blume.” Heineman, 2015 U.S. Dist. LEXIS 30445 at *13. Now that’s an involved judge. Most of the time, from our defense hack perspective, an involved judge is a very, very good thing at a Daubert hearing. That proved to be the case here. The judge issued an oral opinion excluding the two opinions at issue, though other of Dr. Blume’s opinions might have been admissible. If a trial happened, a big part of the defense job would be making sure that plaintiffs’ lawyers and expert would not smuggle the excluded opinions back into the case.
Not surprisingly, the plaintiffs were unhappy with the exclusion of the risk-benefit and company conduct opinions. They moved for reconsideration. The court took a second-look at the record, then seized the opportunity “to clarify and amplify that ruling.” Id. at *24. It made things, if anything, a bit worse for the plaintiffs. (This reminds us of a high school teacher who, when challenged on the grade for a particular answer on a test, would insist on regrading the entire test. Invariably, the supplicant would end up with an overall worse grade. We did not know it at the time, but this teacher had a very judicial approach to motions for reconsideration.)
Not surprisingly, the plaintiffs were unhappy with the exclusion of the risk-benefit and company conduct opinions. They moved for reconsideration. The court took a second-look at the record, then seized the opportunity “to clarify and amplify that ruling.” Id. at *24. It made things, if anything, a bit worse for the plaintiffs. (This reminds us of a high school teacher who, when challenged on the grade for a particular answer on a test, would insist on regrading the entire test. Invariably, the supplicant would end up with an overall worse grade. We did not know it at the time, but this teacher had a very judicial approach to motions for reconsideration.)
The Court asked Dr. Blume whether a retrospective risk-benefit review was something that she typically did. You know, as opposed to a litigation-driven, result-oriented piece of hocus-pocus. Dr. Blume is nothing if not savvy. She told the court that as part of her corporate practice, “she would occasionally conduct retrospective risk-benefit reviews for existing drugs, such as when her company purchased the rights to domestically distribute a drug that was already in use overseas. She explained that ‘we would be given opportunities to license products, the same drill that I gave you in such detail was also undertaken, and at the end of it, the pencil went down and we said ‘we can’t take the risk.’ The benefits sometimes were great, but for our size company and the goals of our company, we couldn’t take the risk of what we saw lurking in there.’” Id. at *16. That’s pretty clever. It can be tougher to test an opinion based on experience than one based on, say, peer-reviewed literature. But it was not clever enough.
The court saw that Dr. Blume’s “assessment as to risk-benefit is not tied to any objective standard. It is instead, a function of her experience and expertise.” Id. at *22-23. Of course, Rule 702 does permit an expert to rely upon experience and expertise in formulating an opinion. Still, when an expert is relying primarily on experience, the witness is required to explain how that experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts. The problem in this case is that the corporate risk-benefit analysis that Dr. Blume relied on – which had a heavy business component - was utterly different from the health and safety risk-benefit opinions being offered in this case. Basically, Dr. Blume said that the diet drugs could, at most, produce a loss of a couple pounds, which she characterized as a “de minimis” benefit. Dr. Blume did not identify any specific or generally accepted measure that experts in the field use to quantify the “benefit” associated with a drug, or how “benefits” and “risks” are compared. She did not compare the weight loss benefits among different drugs. She did not consult with the other experts about the medical benefits of the weight loss. In sum, in “determining the benefits of the drugs, it does not appear that Dr. Blume brought any more expertise to bear on the question than would any layperson (or, at least, any layperson advised of the weight loss data for the drugs.)” Id. at * 27-28. Moreover, Dr. Blume conceded that she could not make a risk-assessment for any particular patient.
So much for the risk-benefit opinion.
Now on to the sort of expert opinion that is not aimed to help the jury, but, rather, is aimed to supplant the jury. We hardly see a case where plaintiffs do not produce an expert armed with little more than literacy and indignation, who reads company documents with a certain point of view, and who pronounces the company to be a bad actor. In Heineman, Dr. Blume read company documents and did not like them even a little. (Or maybe she liked them a lot.) According to her, the corporate documents demonstrate that people in the company’s safety surveillance department did a poor job and also knew that the product labelling was inadequate. (At least, we think that is what the proffered opinion was. As the court remarked, this opinion varied and was hardly pellucid.) The court saw this opinion for what it was, and for what it was not: “the opinion really isn’t that [the Defendants] failed to conform with the standard of care: it is that corporate documents demonstrate that [the Defendants] failed to conform as to the standard of care….I find that Dr. Blume has no methodology that is reliable for determining that the documents demonstrate. Ultimately, the plaintiffs will be able to put on the documents at trial, and the jury will decide what the documents demonstrate.” Id. at *32. Dr. Blume offered no “specialized knowledge” that would “help the trier of fact to understand” the corporate documents themselves. Id. at *32-33. There was no evidence that the company documents “themselves are so opaque or incomprehensible that the trier of fact requires Dr. Blume’s assistance to parse them.” Id. at *33. The usual payoff point for the plaintiffs would have been for an expert to race through a carefully culled set of documents, assisted by PowerPoint slides with colorful call-puts, with the expert sorrowfully/angrily concluding that the company knew better, but decided to value dollars over lives. It is a closing argument masquerading as an expert opinion. At the heart of the opinion is a perusal of documents followed by a Vulcan mind-meld as to what people at the company truly knew and believed. The Heineman court joined “a number of the other courts in finding that Dr. Blume may not testify as to what [the Defendant] knew or didn’t know.” Id. at *41.
Dr. Blume’s opinions were offered to help the plaintiffs, not the jury. As a result, they were not able to do either.
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Posted By Steve McConnell to Drug and Device Law at 3/25/2015 07:30:00 AM --
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