New Jersey Rules No Scientific Connection Between Talc and Ovarian Cancer

This year, an emerging legal and scientific battle is brewing across the country as to whether use of talc products by women in the perineal area can lead to ovarian cancer. While the FDA has stated there is no established casual connection and those products remain on the market, two St. Louis courts permitted plaintiffs’ experts to testify as to a causal connection, which resulted in juries awarded $72 million and $55 million against Johnson and Johnson. Those verdicts have led to a spike in attorney advertising and lawsuits filed, both in St. Louis and New Jersey (as well as a smattering of cases in other states and federal court). Well, New Jersey has now chimed in and emphatically ruled that there is no established causal connection to support such a claim.

On September 2, 2016, New Jersey’s Superior Court precluded plaintiff experts in two lawsuits involving claims against Johnson and Johnson where the plaintiffs alleged that talc allegedly caused ovarian cancer. Judge Nelson Johnson barred the testimony of plaintiffs’ two experts, Drs. Daniel Cramer and Graham Colditz, because their general causation opinions were not based in science. Judge Johnson referred to the proffered opinions as made-for-litigation, highly speculative, seriously deficient, “narrow and shallow,” and not in conformance with any methodology used in the scientific community.

In New Jersey, the standard by which a court is to assess the admissibility of scientific opinions is governed by a modification of the Frye standard, as decided by the New Jersey courts in Landrigan v. Celotex Corp., 127 N.J. 404 (1992) and Kemp v. State of New Jersey, 174 N.J. 412 (2002). Emphasizing the importance of the integrity of the scientific process, Judge Johnson commented on its purpose as follows: “A Kemp Hearing is the intersection of the scientific method and the rule of law. If our court system is to be respected by the scientific community, then we must respect the scientific process. Essentially, the scientific method is the systematic pursuit of knowledge. This pursuit consists of those principles and procedures involved in the recognition and formulation of a problem, the collection of data through observation and experimentation, and the articulation and testing of a hypothesis by which to resolve the problem, and hopefully gain new knowledge useful to society.” (Decision, p. 12).

Following the Kemp hearing, Judge Johnson broadly criticized the “narrow and shallow” approach of the plaintiffs’ experts: “Throughout these proceedings the court was disappointed in the scope of Plaintiffs’ presentation; it almost appeared as if counsel wished the court to wear blinders. Plaintiffs’ two principal witnesses on causation, Dr. Daniel Cramer and Dr. Graham Colditz, were generally dismissive of anything but epidemiological studies, and within that discipline of scientific investigation they confined their analysis to evidence derived only from small retrospective case-control studies. Both witnesses looked askance upon the three large cohort studies presented by Defendants.” (Decision, p. 18).

With respect to Dr. Colditz, a medical doctor and epidemiologist, the court found that there were serious deficiencies in his methodology, which included relying on literature that did not support his hypothesis: “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 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.’” (Decision, p. 25). After discussing additional deficiencies, the court concluded “that the significant deficiencies in Dr. Colditz’s methodology and analysis herein described, render his opinions inadmissible in these proceedings, and that the Defendants’ motion to bar the testimony of Dr. Colditz is hereby GRANTED.” (Decision, p. 28).

Similarly, with respect to Dr. Cramer, an obstetrician and epidemiologist, the court concluded that he ignored fundamental principles of the scientific method and applied a “made for litigation” methodology in order to reach his conclusions: “Dr. Cramer’s methodology appears to be litigation driven rather than objectively and scientifically grounded.” (Decision, p. 30). The court pointed out that in all his prior studies on talc and ovarian cancer, Dr. Cramer never once reached the conclusion there was any causal connection: “In all his prior peer-reviewed articles, Dr. Cramer never once stated that he believes talc causes ovarian cancer; not in his articles of 1982, 1999, 2000 (with Gertig) and 2007 does he make such an assertion. In fact, in his study of 2007, he concluded, ‘[w]e are not claiming that a causal relationship between ovarian cancer and talc is proven for this case or in general.’ Yet now, after having never made such a claim, he asserts here not only general causation, but specific causation as to both Plaintiffs, and purports to do so by re-analyzing old studies and mingling the various risk factors for each Plaintiff in order to prove ovarian cancer by the numbers. This ‘methodology’ is not one based upon ‘prolonged, controlled, consistent and validated experiences.’” (Decision. pp. 30-31). The court went on to conclude: “His opinions rely on an incomplete/irregular methodology unlike anything upon which his peers would rely, and appear to be grounded only in his instincts and personal predilections. In short, the mingling of various rick factors and the purported ‘synergy’ between talc and other health conditions is highly speculative and does not conform to any methodology utilized in the scientific community.” (Decision, pp. 31-32).

The Takeaways

The primary takeaway from this decision is how crucial it is to educate the court on how science works. Jumping into a critique of a plaintiff’s expert’s opinions without taking the time to establish the scientific lenses through which those opinions need to be viewed, is a fatal mistake. Here, Judge Johnson realized as a threshold matter that the scientific method is paramount and any expert opinion that deviates from that method is not based in science and merely created for litigation.

Another takeaway is the importance of an actual hearing where the court can hear and assess the experts. Without a hearing, court will sometimes not be so willing to explore the scientific issues in connection with a motion to exclude an expert made solely on affidavits. A full hearing will ensure you have the court’s full focus and attention to educate and persuade. Requesting a hearing is crucial.

The final takeaway is effective use of defense experts to educate the court. All too often, defendants move to preclude plaintiff experts based solely on attacking their testimony, methodology and findings without the use of any defense experts. Some believe that offering a defense expert in connection with a Daubert or Frye motion will create the impression that this is simply a battle of the experts. When it comes to a true analysis of the scientific literature, and especially when educating the courts on complicated scientific issues, defense experts are crucial. In fact, Judge Johnson stated that the defendants’ expert’s testimony from Dr. Chodosh’s “was akin [to] turning on the lights in a dark room.”

After a full and fair hearing, coupled with an effective strategic approach by the defense, it became clear that the scientific literature does not establish any scientific causal link between talc and ovarian cancer.

Read the full decision here.

Tags: , , , ,


Be the first to leave a reply!

Leave a Comment