A recent win for the defense in New Jersey highlights how challenging an expert’s use of unreliable data and methods can be an effective way to prevail. The carefully drafted February 20, 2015 opinion by Judge Nelson Johnson of the Superior Court of New Jersey was a major win for the pharmaceutical manufacturer of Accutane, an acne medication, which the plaintiffs’ said caused them to develop Crohn’s disease. The decision is available here through Law360.
Judge Johnson issued his decision after a hearing that took several weeks, in order for the court to determine if the plaintiffs’ expert witnesses met the requisite New Jersey standard set forth in Kemp v. State of New Jersey, 174 N.J. 412 (2002). Under that inquiry, an expert witness must “be able to identify the factual basis for his/her conclusion, explain his/her methodology, and demonstrate that both the factual basis and underlying methodology are scientifically reliable.”
The judge noted that the plaintiffs’ experts had chosen to rely upon two small-based studies, rather than the nine broad-based studies that had millions of subjects that were relied upon by the defense expert witnesses, and that the plaintiffs’ expert witnesses had failed to perform a meta-analysis. In the end, although he believed the experts to be “eminently qualified” he concluded that “the opinions expressed by Plaintiffs’ experts are motivated by preconceived conclusions, and that they have failed to demonstrate ‘that the data or information used were soundly and reliably generated and are of a type reasonably relied upon by comparable experts.’” (Rubanick v. Witco Chem. Corp., 125 M.J.421, 477 (1991)).
The judge went on to scold the experts and the plaintiffs’ counsel by noting that the reliance upon the two small studies was “fatal and reveals the lengths to which legal counsel and their experts are willing to contort the facts and torture the logic associated with Plaintiffs’ hypothesis.” He also noted that the attorneys’ arguments that they had lines of evidence supporting their theory was “a ruse” and the experts had been “cherry picking the evidence” to support their theories with evidence that fell “at the bottom of the medical evidence hierarchy.” This, he noted, was not enough to “bridge the analytical gaps inherent in Plaintiffs’ hypothesis” that Accutane caused Crohn’s disease.
This decision shows how essential expert witness testimony is to causation in pharmaceutical litigation. This case highlights two fundamental flaws that can be pursued when attacking plaintiffs’ experts: (1) the thing from which their opinions are derived is unreliable and (2) failure to consider and sufficiently refute contrary evidence. It can be imperative for the defense to vigorously pursue the underlying data, not only that the experts rely upon but also the “data within the data”. Scientific and medical articles summarizing studies do not always provide the complete picture and simply relying on them without investigating their methods, the input and output data, can lead to conclusions that are not themselves reliable. Furthermore, all experts must consider all of the evidence and make a determination as to whether it is sufficiently reliable that they will rely upon it in forming their opinions.
While Roche will likely cite this decision as further evidence that Accutane does not cause Crohn’s disease, the pharmaceutical industry will be watching this matter carefully since Plaintiffs will likely appeal.