Opinion ID: 76908
Heading Depth: 2
Heading Rank: 4

Heading: Reliance on FDA Reports and Recommendations

Text: 64 O'Donnell also placed great weight on a Food & Drug Administration (FDA) proposal to severely restrict the sale and distribution of herbal supplements containing ephedrine. But the FDA did not publish those rules because the General Accounting Office (GAO) reviewed the FDA data and found a need for further study. 65 The GAO determined that the FDA's methodology relied heavily on adverse incident reports without sufficient scientific controls. In other words, the FDA employed a flawed methodology to reach its proposal to restrict ephedrine in herbal supplements. In response to this criticism, the FDA withdrew the proposed rules. 66 But O'Donnell's use of FDA data and recommendations raises a more subtle methodological issue in a toxic tort case. The issue involves identifying and contrasting the type of risk assessment that a government agency follows for establishing public health guidelines versus an expert analysis of toxicity and causation in a toxic tort case. 67 The Reference Manual on Scientific Evidence explains that 68 [p]roof of risk and proof of causation entail somewhat different questions because risk assessment frequently calls for a cost-benefit analysis. The agency assessing risk may decide to bar a substance or product if the potential benefits are outweighed by the possibility of risks that are largely unquantifiable because of presently unknown contingencies. Consequently, risk assessors may pay heed to any evidence that points to a need for caution, rather than assess the likelihood that a causal relationship in a specific case is more likely than not. 69 Margaret A. Berger, The Supreme Court's Trilogy on the Admissibility of Expert Testimony, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE, 33 (Federal Judicial Center, 2d. ed.2000). Obviously, in a toxic tort case the court must focus on assessing causation, not on a cost-benefit analysis for restricting the sale and use of a drug. As Dr. Eaton explains: 70 [i]t is important to recognize that the procedures commonly used in risk assessment for the purpose of establishing public health guidelines that represent acceptable exposure levels for large populations are often, in this author's opinion, of marginal relevance to estimating causation in an individual — e.g., whether a particular chemical caused or contributed to a particular disease or illness in a given person. Although toxicological data — and the basic principles of toxicology outlined above — are useful for both (establishing guidelines for protection of public health and establishing causation), there are substantial differences in approach. 71 Eaton, supra, at 34. 72 He then gives a helpful explanation of this difference. Public health guidelines, however, should not be interpreted as predicting exact levels at which effects would occur in a given individual. Id. 73 Because a number of protective, often worst-case assumptions... are made in estimating allowable exposures for large populations, these criteria and the resulting regulatory levels ... generally overestimate potential toxicity levels for nearly all individuals. Furthermore, because these guidelines are intended to be protective of all individuals in a population, including the very young, the very old, and other potentially sensitive individuals, the theoretical risks from exposure at the guideline range level is likely to be substantially over-estimated for the large majority of individuals in the population. 74 Id. at 34-35. 75 Understanding how government agencies establish rules for public health is important in this case for two reasons. First, in trying to determine the reliability of an expert's opinions based on agency rules, it is important to know both what the agency intended by setting the guidelines and how the expert uses the guidelines to support his opinions. The court is not rejecting public health rules from consideration in a Daubert analysis. Rather, in ruling on methodology issues, the trial court should understand what the rule really means about causation for the specific plaintiff, not simply about protecting the public-at-large from risk of harm based on a risk-utility analysis of the drug. 76 As this court explained in Rider : [the] risk-utility analysis involves a much lower standard than that which is demanded by a court of law. A regulatory agency such as the FDA may choose to err on the side of caution. Courts, however, are required under the Daubert trilogy to engage in objective review of evidence to determine whether it has sufficient scientific basis to be considered reliable. 77 295 F.3d at 1201. 78 The Court of Appeals for the Eighth Circuit further explained the difference between a public agency approach and a courtroom causation approach in a case involving Parlodel. 79 The FDA's approach differs from ours in another critical aspect. The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability. The methodology employed by a government agency `results from the preventive perspective that the agencies adopt in order to reduce public exposure to harmful substances....' The FDA's 1994 decision that Parlodel can cause strokes is unreliable proof of medical causation in the present case because the FDA employs a reduced standard (vis-a-vis tort liability) for gauging causation when it decides to rescind drug approval. 80 Glastetter, 252 F.3d at 991 (internal cites omitted). 81 Consideration of the risk-utility or the cost-benefit approach versus the expert-causation approach is important in this case for a second reason. O'Donnell testified at the Daubert hearing in a way more adjusted to agency-risk analysis than courtroom-causation analysis. For example, he said: [s]o the issue of risk benefit is, what is the benefit? If there is no proven benefit, it's all risk. So the risk benefit analysis is lopsided on the risk side. Also, when asked about how much Metabolife is too much, he said: I don't have a number. I've said I think it's unreasonable to combine caffeine because it adds to the toxicity. I don't see a beneficial effect in using this in the population. This implies a risk-benefit analysis, which does not directly focus on the question of causation in these four Plaintiffs — the heart of this toxic tort case. 82