Defense attorneys fight against a powerful and widespread belief that mere exposure to a chemical or product that is suspected of causing harm (at any dose) is adequate proof of harm. And worse yet, that the burden to demonstrate that the chemical or product is not harmful falls on the product manufacturer, distributor, supplier, and/or regulators.
Defense attorneys fight against a powerful and widespread belief that mere exposure to a chemical or product that is suspected of causing harm (at any dose) is adequate proof of harm. And worse yet, that the burden to demonstrate that the chemical or product is not harmful falls on the product manufacturer, distributor, supplier, and/or regulators. This belief is made all the more acute when there is clear evidence of exposure (e.g, the substance can be readily detected in blood or urine samples).
Nowhere is this concept better developed than in the so-called “Precautionary Principle,” which is a guiding principle for regulatory activity in the European Union.
The EEA 2013 Report
A recent report by the European Environmental Agency (EEA) (Late lessons from early warnings: science, precaution, innovation) clearly articulates the philosophy that underlies the Precautionary Principle and provides a number of case studies that should be of interest to toxic tort attorneys that litigate cases involving complex scientific principles. The report highlights the pervasive view whereby the mere speculation that a substance may be harmful is synonymous with the view that the substance is harmful at any dose. This outlook underscores the need for litigators to educate the judge and jury as to the well-accepted scientific standard required to establish causation. This view is further compounded when the plaintiff can call on numerous studies that can, at best, be categorized as hypothesis-generating.
For example, the report highlights a number of exposures for which there is solid and emerging science questioning any legitimate adverse health concern, including the following examples: BPA and endocrine disruption, neo-nicotinoids toxicity to bee populations, mobile phones and brain cancer, and toxic concerns from nanotechnology. Of course, the authors of the report would argue that precaution trumps actual scientific evidence. But without a rigorous and agreed upon methodology to link an exposure to an adverse human health effect, it is impossible to determine whether or not that concern is valid. This is highlighted in the section of the report in which the authors attempt to evaluate the legitimacy of a number of false positive case studies (see below).
An Analysis of False Positives
When a substance is proposed to have an adverse health effect, that proposition could be correct or it could be incorrect. When the proposition (i.e., a health effect is proposed to be caused by an exposure) has been demonstrated to be incorrect (i.e. the health effect is demonstrated not to be caused by the exposure), that is considered a “false positive.”
The EEA report discusses the concept of “false positives” using 88 case studies where government regulation was undertaken based on uninformed/invalid abundance of precaution, but that were later deemed by some to be unnecessary. The authors of the report reviewed these cases and made a determination as to whether the example was a true “false positive” (i.e., presumed true when in fact it was false) or whether it was a mistaken “false positive.” Not surprisingly, the authorship of the report deemed the vast majority of cases were mistaken false positives for various reasons.
According to the report: “…the analysis shows that fear of false positives is misplaced and should not be a rationale for avoiding precautionary actions where warranted. False positives are few and far between as compared to false negatives and carefully designed precautionary actions can stimulate innovation, even if the risk turns out not to be real or as serious as initially feared.”
However, the analysis used by EEA to validate these false positives is severely flawed and does not stand up to scrutiny. Most of the cases were deemed mistaken false positives because “the jury is still out” on the risk. But this doesn’t mean that the example was a mistaken false positive. Indeed, the fact that the jury is still out on the risk of nearly 35 examples supports the view that these were indeed false positives based on the available scientific evidence (i.e., there is insufficient scientific evidence to support a causal inference for the proposed hazard). We would argue, therefore, that the vast majority of the false positives highlighted in the report are, indeed, legitimate false positives.
Precaution in the Regulatory Arena vs. Rulings in the Courtroom
The EEA Report emphasizes the role of precaution in the regulatory arena and one can wonder what the relevance of this is to the courtroom. Clearly, there is a very important difference in the level of evidence required to support a prescribed regulatory action and the level of evidence required to support legal action. Nathan Schachtman recently quoted Judge Jack Weinstein making this point quite nicely in the Agent Orange litigation:
“[a] government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship. A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him.”
The increased scientific rigor for admissibility required in the courtroom (over and above the rigor that should be required by regulatory agencies) makes it all the more important to educate judges and jurors as to the level of evidence required to support a true causal inference between an exposure and the injury alleged.
The EEA Report does make mention of these two different standards. For example the report highlights the difference between “early warning signals” and evidence used to support “scientific causality.” The report also makes the important distinction between “no evidence of harm” and “evidence of no harm,” although we would argue that the authors use these concepts to argue for a far too precautionary approach. Finally, it should be noted that the EEA Report makes explicit mention of civil compensation, tacitly linking the regulatory approaches espoused in their report to compensation in the courtroom.
We have discussed the appropriate methods that should be used to establish a causal inference in previous posts (see here, here, and here). When litigating cases involving alleged toxic exposures, it is critical to clearly address the appropriate methodology to establish causal inferences and the reliance on the appropriate level of evidence. The EEA report serves to highlight a powerful, inherent bias that litigators can expect to face from most jurors – i.e., that precaution equals causation. In order to offset this bias, the appropriate methods to establish causation must be clearly and effectively presented as part of the defense case.
The authors of the EEA Report are certainly not using these methods.
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