We’ve ranted recently about plaintiff expert witnesses who believe they are the world’s foremost authority on everything. We’re on that subject again today because we just love it when those windbags get deflated. And because these folks like to pontificate – they have been anointed as experts, after all – their own words often can be used not only to dig their graves but to build the coffin and hammer in the nails. The plaintiffs’ expert at issue in In re Trasylol Products Liability Litigation, No. 08-MD-01928 (S.D. Fla. Feb. 24, 2010), Mark Eisenberg, M.D., was that kind of guy.

The opinion concerns Bayer’s motion to exclude five elements of Dr. Eisenberg’s testimony. He is a clinical epidemiologist and cardiologist. We’ll get the bad news out of the way first: the court said that Dr. Eisenberg could offer his opinions that lysine analogues were preferable to Trasylol in CABG (coronary artery bypass graft) surgery and that Trasylol is associated with an increased risk of myocardial infarction and graft occlusion. Id. at 8-15. We don’t even know what lysine analogues are, so we have a hard time second-guessing the court’s rulings, which turned on a lot of arcane scientific evidence. From the court’s description, Dr. Eisenberg’s opinions rested on fairly shaky grounds, but at least these subjects were within his area of expertise.

We did get a kick out of one part of the discussion of this issue: Dr. Eisenberg did not know that the FDA had not approved lysine analogues for CABG surgery – in other words, that the use he was advocating as the preferred alternative to Trasylol was an off-label use. We’ll look for the opportunity to use this decision when plaintiffs’ lawyers argue that off-label uses are inherently unsafe, wrong, etc. because they have not been approved by the FDA.

The good news in this decision is that the court smacked the good doctor down when he tried to move from the narrow areas on which he had some expertise to those broader areas – i.e., everything else – on which he had an opinion. First, the doctor tried to bolster his opinion that lysine analogues are better than Trasylol by saying that they are more cost effective, but the court said that cost-effectiveness was not relevant. Id. at 10. Second, the court stopped the doctor from testifying that marketing was the reason Trasylol was widely used, as the court found that the doctor was not an expert in marketing or its effects. Id. at 22-23. Third, the court barred the doctor from testifying about Trasylol’s mechanism of action, based on his admissions that he is not an expert in that area and on the court’s conclusion that insufficient scientific evidence to support that opinion. Id. at 24-25. Plaintiffs’ counsel tried to salvage this opinion by characterizing it as “non-substantive testimony,” but the court rejected that nonsense, finding that the requirements of Daubert apply to all proffered expert testimony. Id. at 24-25 & n.40.

Our own view is that if the expert’s testimony is “non-substantive,” then his testimony is necessarily “not helpful” to the jury, a waste of time, and therefore independently excludable.
The real fun came when the court considered his opinions that Bayer breached ethical standards by allegedly failing to respond to “safety signals.” Id. at 15-16. Bayer objected for many reasons, including that this testimony was irrelevant and outside his area of expertise. The court found “instructive” the opinion in In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531 (S.D.N.Y. 2004), in which the court had rejected doctors’ opinions about the ethical obligations of pharmaceutical companies. Slip op. at 19.

Plaintiffs’ counsel tried to dance around this point by saying that Dr. Eisenberg didn’t really use the words “ethical” or “unethical” in his testimony. News flash to the other side: when you are quibbling about synonyms, you are losing. The court looked at the substance and found that he was offering an opinion about what Bayer should have done to comply with drug safety principles. Id. at 19. He denied being an expert in corporate ethics but testified that “the average lay person could have some opinions about corporate ethics.” Id. at 20. The court then included a quotation of his testimony that goes on for a single-spaced half a page, which shows that the guy was blowing hot air. In the course of his soliloquy, the doctor acknowledged that his opinions were not based on FDA regulations or guidelines or, frankly, anything:

Just because I can’t name these guidelines doesn’t mean they don’t exist. I think that they probably do exist, but whether they exist or not, any reasonable person who saw a safety signal with a drug would want to pursue that to ensure the patient’s safety is ensured. It’s, you know, common sense. If you ask a man on the street about this they would say: Yes, I want to know whether this drug is harmful to me. And it’s the responsibility of the drug company to do that.

Id. at 21 (emphasis added). This doesn’t sound like expert testimony at all.

And that is precisely the point: the doctor’s ethics opinions were no different from the opinions of the “man on the street.” If the doctor’s boundless expertise had included the law, he would have understood that the law allows experts to testify only in areas where they have greater expertise than “the average lay person.” The court found the expert’s opinions on corporate ethics inadmissible because they were based only on the doctor’s subjective beliefs rather than expert knowledge. Id. The court also found that the opinions were irrelevant and rested on speculation about Bayer’s motivations, which is not a proper subject of expert testimony. Id.

The lesson for experts with boundless opinions is that they are entitled to their opinions – they can talk about them to the man on the street, write about them, heck, they can even blog about them. They just can’t testify about them in a court of law.