United States: Reclast Plaintiff Experts Hobbled By Daubert

Last Updated: February 16 2017
Article by Stephen J. McConnell

We have long suspected that the reason some judges are hostile to Daubert is because application of the doctrine involves so much work. Rather than merely count whether there are enough other experts out there who seem to be saying something similar to what the proffered expert would say, judges under Daubert must act as gatekeepers who scrutinize the reliability of the expert's methods. Such an effort burns up pages, time, and calories. Is it any wonder that judicial opinions that simply wave junk science along to the jury, with the usual suggestion that cross-examination and juror common sense will separate the wheat from the chaff, are pretty short, whereas those judicial opinions that really test experts under Daubert and find them wanting can be as long as a Victor Hugo novel?

Recently, Judge Hopkins of the Northern District of Alabama issued a 119-page opinion throwing out a lot of plaintiff expert opinions in Jones v. Novartis Pharmaceuticals Corp., 2017 WL 372246 (N.D. Ala. Jan. 26, 2017). We read all 119 pages, so you don't have to, though the opinion is clear and pleasant enough. It is definitely no Les Miserables. Indeed, any sense of misery vanished when we saw a heading early on in the opinion entitled "General Requirements – Judge as Gatekeeper."

The plaintiff in the Jones case alleged that she experienced an atypical femur fracture ("AFF") as a result of her treatment with a prescription osteoporosis medication, Reclast. The plaintiff proffered a variety of expert opinions. The ubiquitous Dr. Suzanne Parisian submitted the usual magnum opus about how the drug had a "causal association"with the AFFs, how the defendant was on notice of that fact, and how the defendant violated much of the Federal Register and slapped on an inadequate label, There were also two retained and two nonretained medical experts who would opine on medical causation.

The Jones court began by observing that, like Caesar's Gaul, a Daubert analysis is divided into three parts: (1) whether the expert is qualified, (2) whether the expert's methodology is reliable, and (3) whether the expert's opinion would help the jury in determining scientific or technical issues. The Jones court also emphasized that the proponent of the expert bears the burden of satisfying this test. The existence of that burden should, by itself, prevent courts from issuing perfunctory blessings of junk science. But, too often, it does not.

The court granted in part the defendant's motion to strike the testimony of plaintiff's regulatory expert, Dr. Parisian, finding both that Dr. Parisian was not qualified to offer a number of her opinions and that her methodology was unreliable. Sadly, the Jones court held that a jury might benefit from an expert explaining how FDA regulations work. Why can't the judge simply issue instructions on such strictly legal matters? Nevertheless, the Jones court did manage to prune away many of Dr. Parisian's ambitions to deliver the plaintiff's closing argument. Besides being unduly long, with paragraphs upon paragraphs simply excerpting from company documents, Dr. Parisian's expert reports are exercises in false modesty. She usually claims that she is not offering any opinion about specific causation. She also usually throws in a sentence that "There are no unsupported opinions intended to be offered regarding the 'state of mind' or 'intent' of" the defendant. That sentence is clearly a response to prior court rulings forbidding Dr. Parisian from engaging in a Vulcan mind-meld with a corporate defendant, pretending to disclose inner thoughts and beliefs and aims. But what do you suppose she means by "unsupported"? Despite the disavowal of any intention to play the Amazing Kreskin, Dr. Parisian invariably goes on to opine on exactly those things about which she coyly claims agnosticism. If she is permitted to take the witness stand, you can bet she will tell the jury about how she used to wear the quasi-military uniform of the Public Health Service, and then explain how the company had wretched quality controls, knew its product was horrible, and was responsible for the injuries alleged, biblical plagues, and all the plot-holes in Batman Begins, The Hangover, and almost any random page in the Harry Potter series.

Luckily, the Jones court was not taken in, not even a little. While in both her report and deposition Dr. Parisian disclaimed any opinion about medical causation, she wanted to testify about the "causal association" between Reclast and AFFs. The court held that she could not do so: "Despite her assertions to the contrary, Dr. Parisian has implicitly provided her own causation opinion in both her report and her deposition." But Dr. Parisian lacked both the qualifications and data to support such causation opinion. (Earlier this year, Bexis penned a post on Dr. Parisian's efforts to cobble together a "regulatory causation" line of attack against defendants.)  Further, despite the disclaimer about company knowledge and intent, it was clear from other opinions that Dr. Parisian was determined to talk about such knowledge and intent, including whether certain information put the company on notice of certain risks. The court held that she could not do so. Finally, while Dr. Parisian could opine that the label was inadequate (big surprise: we think that subject is beyond what she should be allowed to bloviate about), she could not hold forth as to whether and how a different warning might have impacted the prescribing decision of plaintiff's doctors. All in all, while we've seen decisions that clamped down even more on Dr. Parisian, Jones isn't too bad.

Now on to the causation experts. Here, the defendant did even better, as the Jones court excluded all the proffered opinions.

As is routine in the medical causation context, the Jones court separately discussed general causation (whether the drug can cause an injury) and specific causation (whether the drug caused the injury for this particular patient/plaintiff). In excluding the general causation opinion of the plaintiff's bone expert, the district court found that the Bradford Hill methodology for establishing medical causation (if you are reading this, odds are good you already have some familiarity with the Bradford Hill nine-part analysis; if you don't know them, Wikipedia will help – though, mind you, as we said in a recent post, we are hardly endorsing the use of Wikipedia in any court filing), on which the expert relied, requires as a first step the existence of an established association between a substance and a disease. Unfortunately for the plaintiff, her bone expert admitted that he could not point to a study in the peer-reviewed literature finding a statistically significant association between Reclast and AFFs. Oops. The plaintiff expert claimed to arrive at a causal association (presumably the same one that Dr. Parisian fervently wished to describe) by extrapolating from an alleged class-wide association between bisphosphonates ("BPs") and AFFs. The court rejected the attempted end-run because the expert himself was forced to admit that there are significant differences, including regarding the impact on material properties of bone, between the other class BPs, which are administered orally on a weekly or monthly basis, and Reclast, which is a once-a-year I.V. infusion. The Jones court next excluded the bone expert's specific causation opinion, (i) as unreliable in the absence of an admissible general causation opinion, and (ii) because, the court found, he inappropriately relied on Bradford Hill for specific causation when that methodology is directed to assessing general causation. The Jones court further held that to the extent the bone expert claimed to have conducted a differential diagnosis, it was admittedly only "limited," and in any case, he had failed to disclose any differential diagnosis in his expert report in violation of Federal Rule of Civil Procedure 26. (The Jones court acknowledged that what was afoot was really a differential etiology, not a differential diagnosis, but then proceeded as if it made no difference. But it does make a difference. Doctors perform differential diagnoses every day in their practice, while differential etiologies are almost always creatures of litigation.)

Plaintiff's expert statistician opined that Reclast clinical trial data provides "evidence of causality" based on a reanalysis of such data that he conducted. The Jones court found that the statistician was not qualified to perform his reanalysis because he lacked a medical degree and expertise on BPs or AFFs. The court also rejected the reliability of the expert's methodology in a number of respects, including (i) his selection of a supposed background rate for AFFs, (ii) his attempt, without the necessary qualifications, to reclassify events reported in a study as AFFs, (iii) his inclusion of an event that plainly failed to meet the AFF definition, (iv) his comparison of a point estimate to a lower bound confidence interval, and (v) his use of a one-tailed test rather than a two-tailed test to calculate a confidence interval. This part of the Daubert analysis involved some heavy-lifting, and the Jones court's reasoning is muscular.

Finally, the Jones court completely excluded the proffered opinions of two nonretained experts, doctors who had treated the plaintiff's fracture. The court held that the two doctors were unqualified to opine on causation and, in any event, they had failed to rule out alternative causes of the AFF. Interestingly, the Jones court also held that, absent a general causation opinion, a so-called differential diagnosis is inherently unreliable.

So after 119 pages of judicial reasoning, we end up with a healthily scaled-back Dr. Parisian and a quartet of medical experts excluded entirely. It was worth the read.

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

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