United States: New Jersey – At The Intersection Of The Scientific Method And The Rule Of Law

Last Updated: September 14 2016
Article by Michelle Yeary

The decision in Carl v. Johnson & Johnson, 2016 WL 4580145 (N.J. Super. Law, Sep. 2, 2016) is masterful. It is a well-researched, well-vetted, and well-written decimation of plaintiffs' expert case. It is the type of Daubert opinion that defendants long for. It is lengthy and there is so much in it that is good, to cover it all we'd simply have to re-print the decision here. Which we won't do. However, we strongly encourage you to read this decision. If you aren't embroiled in an expert battle right now, bookmark this case and come back to it. The thoroughness and attention to detail by the court in the face of an obvious lack of those things by plaintiffs and their experts makes this a real page-turner.

The decision actually was entered in two cases, both brought by women who were diagnosed with ovarian cancer who in these lawsuits allege their cancer was caused by their use of powder containing talc. Defendants filed motions challenging all five of plaintiffs' experts and moved for summary judgment on the grounds that absent expert testimony, plaintiffs could not meet their burden of proof. Id. at *2. The court held a Daubert (in NJ Kemp) hearing and heard testimony from both plaintiffs' and defense experts. In addition, the court requested that the parties provide the court with copies of "all reports, abstracts, epidemiology studies, and peer-reviewed articles" relied on by any of the experts in formulating their opinions.   Id. (emphasis added). That resulted in the court receiving approximately 100 pieces of scientific literature – which the court apparently read and used in analyzing the expert evidence presented. Id. A serious undertaking. One which clearly inured to the benefit of the defense in this case, and frankly a deep dive on the science most often favors the defense. We welcome an informed and educated court. As this court stated at the outset: "Courts are experts in the law, not science." Id. And juries are experts in neither. Which is why we greatly appreciate a court that takes seriously its role as the crossing guard at the intersection of science and law in the courtroom.

The first several pages of substantive discussion in the opinion are a close examination of the evolution of New Jersey law on the admissibility of expert evidence. Perhaps of slightly more interest to those of us sitting/practicing in New Jersey, we'll try to sum it up concisely. As the law started to develop, for an expert's opinion to be admissible it had to be based on a valid methodology – the opinion "must be supported by 'prolonged, controlled, consistent, and validated experience." Id. at *5 (citation omitted). Then specifically in regard to reliance on epidemiology as evidence of causation, courts began to address not just methodology but also the expert's reasoning in applying or relying on that methodology to reach his/her conclusions. "The appropriate inquiry is not whether the court thinks that the expert's reliance on the underlying data was reasonable, but rather whether comparable experts in the field would actually rely on that information." Id. What would other experts rely on?   Non-litigation based or driven research and peer-reviewed literature. Id. at *6.

Where neither exists, an expert witness is obligated to explain to the court how she/he proceeded in arriving at his/her conclusions by referencing some objective source(s), e.g., a peer-reviewed article in a reputable medical/science journal, the public pronouncements of an agency with respected authority on the issue, or a learned treatise on the issue, in order to demonstrate that she/he has followed the scientific method at the standard maintained by some recognized minority of scientists in his/her area of science.

Id. So, in New Jersey an expert has to be able to "explain pertinent scientific principles and to apply those principles to the formulation of his or her opinion." Id. Hence, admissibility turns on both reasoning and methodology.

Following this legal analysis, the court next examined the "building blocks" of the scientific method. Id. at *8. The court starts with what has become "the primary generally accepted methodology for demonstrating a causal relationship" – epidemiological studies. The decision describes the types of epidemiological studies and key terms like statistical significance, relative risk, bias, and confounding factors. Id. at *8-9. It is a nice, lay description of these concepts that can be used in explaining them in other cases and courtrooms. Most importantly, the court is clear that while epidemiology can be used to identify an association between an agent (product) and an event (injury), "an association is not equivalent to causation." Id. at *9. "Assessing whether an association is causal requires an understanding of the strengths and weaknesses of the study's design and implementation, as well as a judgment about how the study findings fit with other scientific knowledge." Id. So, you can't just look at a study's conclusions, you have to look at how it was conducted and you have to put the results in context. If it's the only study to find an association, you've got to treat it like the outlier that it is.

The court then lists all of the other "building blocks" of the scientific method as they pertain to the particular issue of an association between talc and ovarian cancer – laboratory studies, cancer biology and research, animal studies, and agencies which study cancer. Id. at *10-11. In other words, the totality of the scientific evidence must be evaluated, not just select epidemiological studies. And finally, the court sets forth the Bradford Hill criteria which it considers the "mortar" for the scientific method – it's what holds all the building blocks together. Id. at *11. These are a set of factors adopted by the scientific community as a guide to whether an "observed association" may be causal. While not intended to be applied rigidly, they include things like "strength of association" (statistical significance); temporality (time relationship between cause and effect); and plausibility ("whether there exists a biologically plausible mechanism by which the agent could cause the disease"). Id.

Then the court moved on to application of the legal and scientific principles to the facts and evidence in the case. And it started with expressing disappointment with plaintiffs' expert presentation. The court felt as if plaintiffs' counsel wanted it "to wear blinders":

[Plaintiffs' experts] were generally dismissive of anything but epidemiological studies, and within that discipline of scientific investigation they confined their analyses to evidence derived only from small retrospective case-control studies. Both witnesses looked askance upon the three large cohort studies presented by Defendants. As confirmed by studies listed at Appendices A and B, the participants in the three large cohort studies totaled 191,090 while those case-control studies advanced by Plaintiffs' witnesses, . . . total 18,384 participants. As these proceedings drew to a close, two words reverberated in the court's thinking: "narrow and shallow." It was almost as if counsel and the expert witnesses were saying, Look at this, and forget everything else science has to teach us.

Id. at *12. Had the court done that, it would not have been respecting the scientific process. Id. at *8.

Pretty much from this point on in the opinion, we could quote almost every line as demonstrating just how poor a job plaintiffs' experts did and just how thorough a job the court did in seeing right through their "narrow and shallow" analysis. So, please be aware that we are just picking a few of our favorites. Such as the fact that plaintiffs' experts, in the absence of genuine explanation as to how talc-based powder causes ovarian cancer, based their conclusion on talc causing inflammation which in turn causes cancer. Seemingly lost on plaintiffs and their experts, but not on the court, was that the evidence in both cases was that neither plaintiff had any inflammatory tissue. Id. at *13.

Or, for example, plaintiffs' expert who testified as to "biologic plausibility", Dr. Graham Colditz, cited 4 articles on which he relied to reach his conclusion – that talc can travel to the ovary, it causes inflammation, which in turn causes cancer. But, as the court had read all of the studies, it was aware that while they addressed the impact of inflammation on ovarian cancer, none addressed the means by which talc travels to the ovaries or the means by which talc causes an inflammatory process:

Even the most generous reading of these four cited articles reveals that none of them proffers an articulation of a hypothesis – nor a means by which to test the same – setting forth a biologic mechanism by which talc-based powder may/can/possibly does cause ovarian cancer, Dr. Colditz's reliance upon these four treatises supports a finding by this court that he has failed to make a systematic review of the scientific literature and has ignored the rudiments of the scientific method in arriving at his conclusion that, "[t]hus it is established that talc can travel to the ovary, it causes an inflammatory response, and this mechanism is consistent with the increase of ovarian cancer that is observed."

Id. at *16. In the end, when asked about biologic plausibility by the court, Dr. Colditz's only response was "This is why there's got to be continuing studies to understand the whole process better." Id. at *17. In other words – "I don't know."

Moving on to plaintiffs' case-specific causation expert, Dr. Daniel Cramer, who not only also did a "narrow and shallow" examination of the epidemiology, but also attempted to use epidemiology to prove specific causation:

[E]pidemiology is concerned with the incidence of disease in populations, and epidemiologic studies do not address the question of the cause of an individual's disease. This question, often referred to as specific causation, is beyond the domain of the science of epidemiology. In short, Dr. Cramer's methodology appears to be litigation driven rather than objectively and scientifically grounded.

Id. (citations and quotation marks omitted). Moreover, Dr. Cramer cherry-picked the studies he relied on. When asked if he had performed a meta-analysis of the three more recent, significantly larger cohort studies, Dr. Cramer "tartly" responded: "I have not done that. The defense is very capable of doing that themselves." Id. You never want the court to describe your expert as "tart."

Finally, among the multitude of things that Dr. Cramer apparently didn't consider in reaching his conclusions, were plaintiffs' other risk factors for ovarian cancer. Both plaintiffs had a substantial list of possible alternative causes, to which Dr. Cramer showed a "stark disinterest." Id. at *20. The court's conclusion on Dr. Cramer's opinion is worth quoting:

Despite his failure to eliminate – or make an objective accounting of- those multiple risks, Dr. Cramer leaps to specific causation by the numbers. He is not concerned that he hasn't even attempted to postulate a plausible biological hypothesis for how talc causes ovarian cancer . . . . His opinions rely upon an incomplete/irregular methodology unlike anything upon which his peers would rely, and appear to be grounded only in his instincts and personal predilections.


We know we've become quote heavy in this piece, but the ultimate conclusion by the court on the interplay between general and specific causation and plaintiffs' burden is just too good to let pass by. So, we'll leave you with this:

As is true of most adversarial proceedings, the written reports and testimony of Plaintiffs' experts are much like a patch-work quilt; individual pieces that when sewn together create a single blanket. If well sewn, the blanket covers the issues required to meet Plaintiffs' burden of proof. Positing, for the sake of discussion, that each piece of cloth is sound, the fragments cannot become a quilt without thread. Without a clearly stated, demonstrable hypothesis of specific causation, grounded in a reliable methodology, there is no thread and the pieces of cloth remain disparate.

Accepting, for the sake of discussion, that the case-control studies relied upon by Dr. Cramer — to the exclusion of cohort studies, laboratory studies, cancer biology and the pronouncements of those agencies that study cancer – convey an inference that there is some type of causal association between talc and ovarian cancer, it means nothing without a hypothesis of specific causation. No witness for Plaintiffs ventured to articulate just how it is that talc in the ovaries, or, what it is about talc in the ovaries, that sets off a chain of events which purportedly causes ovarian cancer. Uttering the term inflammation does not explain the etiology of ovarian cancer, nor can the manipulation of numbers serve as a hypothesis for specific causation. Absent the thread, there is no quilt.

Id. at *21.

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

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