In a recent decision, New Jersey Appellate Court applied the expert admissibility standard from the New Jersey Supreme Court’s landmark decision In re Accutane Litig., 234 N.J. 340 (2018) as a basis for reinstating two multi-county litigation cases alleging ovarian cancer from Johnson & Johnson’s talc-based baby powder. Carl v Johnson & Johnson, A-0387-16T1, Balderama v Johnson & Johnson, A-097816T1, 2020 WL 4497263, at *1 [NJ Super Ct App Div Aug. 5, 2020]; (collectively “Carl”).

In Accutane, the New Jersey Supreme Court permitted the consideration of the Daubert factors as part of the court’s gatekeeping function in expert admissibility, and applied the framework of the Federal Judicial Center’s Reference Manual on Scientific Evidence (the “Manual”). In re Accutane Litig., 234 N.J. at 352-53. According to the Manual, the assessment of an epidemiologic study’s methodology presents three questions: (1) Whether the study supports an association between an agent and a disease; (2) Limitations of the study (bias, confounding, sampling error); and (3) Whether the evidence supports a causal connection. Id. at 354.

The epidemiologic approach follows several steps to determine whether an association between an agent and a specific disease exists. After establishing an epidemiologic association between exposure to a particular agent and the development of a specific disease, researchers must then consider whether that association “reflects a true cause effect relationship.” Id.

The New Jersey Appellate Court, following Accutane, discussed the seminal factors proffered by Sir Austin Bradford Hill[1] (the “Hill” factors) to determine whether an observed epidemiologic association may support a “true cause-effect relationship.” Carl, at *2. The nine Hill factors used to evaluate general causation are: (1) strength of association; (2) consistency of results; (3) specificity; (4) temporal relationship of exposure to the agent preceding the disease; (5) biological gradient; (6) biological plausibility; (7) coherence; (8) beneficial effect from taking preventative action against the agent in question; and (9) analogy to the known causal relationship between another agent and disease.

Epidemiologic studies examine the question of “general causation,” that is whether the agent is “capable of causing disease.” In contrast, the question of “specific causation” is whether an agent caused disease in a particular individual. See Accutane, at 352. Although the Hill factors may not serve as the primary evidence for specific causation, epidemiological studies that support general causation may support specific causation when certain criteria are met, such as the degree of plaintiff’s similarity to the study populations in exposure, disease and other relevant factors. Id. at *7.

In Carl, Plaintiffs’ obstetrics/gynecology epidemiologist provided general and specific opinions for both plaintiffs. Plaintiffs’ chronic disease epidemiologist only opined on general causation. In applying the Accutane framework, the New Jersey Appellate Court in Carl found plaintiffs’ two principal causation experts’ reliance on epidemiological studies consistent with the Manual and the Hill factors. The New Jersey Appellate Court found that plaintiffs’ experts applied methodologies generally accepted by experts in the field, and reasonably relied on underling epidemiological data in formulating their opinions.

The New Jersey Appellate Court found that the trial court went beyond its gatekeeper role in favoring defendants’ scientific methodologies over plaintiffs’ by improperly undertaking the assessment of the credibility of their opinions. The New Jersey Appellate Court reversed the trial court’s exclusion of plaintiffs’ experts, and, in turn, reversed the summary judgment for the defendants. As a result, this ruling allows the New Jersey multicounty talc-based body powder products litigation to proceed to trial.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.

[1] Austin Bradford Hill, The Environment and Disease: Association or Causation? President’s Address, 58 Proceedings of the Royal Society of Medicine 295 (1965).