Toxic tort risk assessment

See a/so Delaney Clause Federal Insecticide, Fungicide, and Rodenticide Act, US Food and Drug Administration, US Food, Drug, and Cosmetic Act, US Pesticides Risk Assessment, Human Health Toxic Torts. 

Judicial decisions in nonregulatory contexts such as toxic tort and product liability suits are likewise inconsistent in their consideration of the linear, no threshold model. As in the regulatory context, most cases find no problem with an expert s reliance on a risk assessment using the linear model. In a handful of cases, however, the court rejects reliance on a linear dose-response assumption. Eor example, one court in addressing the cancer risks from a low concentration of benzene in Perrier held that there is no scientific evidence that the linear no-safe threshold analysis is an acceptable scientific technique used by experts in determining causation in an individual instance (Sutera 1997). Another court decision concluded that [t]he linear non-threshold model cannot be falsified, nor can it be validated. To the extent that it has been subjected to peer review and publication, it has been rejected by the overwhelming majority of the scientific community. It has no known or potential rate of error. It is merely an hypothesis (Whiting 1995). The inconsistency and unpredictability of judicial review of risk assessments adds an additional element of uncertainty into the risk assessment process. 

Cancer risk assessments are also sometimes used in toxic tort and product liability litigation. In this context, courts express a much stronger preference for risk assessments based on human data and are more skeptical of animal studies. For example, the U.S. Supreme Court rejected the reliance of plaintiffs experts on animal studies showing that polychlorinated biphenyls (PCBs) can cause cancer, holding that the studies were so dissimilar to the human exposure and toxicity at issue in that case as to be without any value (GE 1997). This difference in the evidentiary approach of courts and agencies flows from the different institutional objectives (Allen 1996) ... 

In toxic tort and product liability litigation, the admissibility of new risk assessment methods and data must be approved by the trial judge before being presented to the jury. The U.S. Supreme Court announced a new standard for the admission of scientific data in 1993 in its Daubert decision (Daubert 1993). Under this new standard, federal judges must serve as a gatekeeper to ensure that scientific evidence is reliable and relevant, which includes an assessment of whether the evidence (i) has been empirically tested, (ii) has a known rate of error, (iii) has been peer-reviewed and published, and (iv) is generally accepted within the relevant scientific field. Many state courts have adopted a similar standard, although some still apply the earlier standard on admissibility (Frye 1923), which is whether the evidence is... 

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See also in sourсe #XX -- [ ]

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