Opinion ID: 76908
Heading Depth: 2
Heading Rank: 5

Heading: Reliance on Anecdotal Consumer Complaints

Text: 83 The FDA's adverse events reports (AERs) and other consumer complaints also provided another important source for O'Donnell's opinions. But these FDA reports reflect complaints called in by product consumers without any medical controls or scientific assessment. Under the adverse events reporting system, consumers call in to describe medical problems that they think they are experiencing from taking a product. These complaints provide the basis for the AERs. O'Donnell also considered the same type of complaints called into the Metabolife health-line. Yet, both O'Donnell and Hakim testified that such anecdotal reports do not prove causation. 84 Uncontrolled anecdotal information offers one of the least reliable sources to justify opinions about both general and individual causation. The GAO found that the FDA's heavy reliance on the AERs without sufficient scientific controls undermined the FDA's analysis, yet O'Donnell relies on them in a significant way. This again implies that O'Donnell follows more of a federal agency risk analysis approach, rather than a courtroom causation analysis. It also shows that he relied on data that lacks the indicia of scientific reliability. 85 F. O'Donnell's Methodology Ultimately Fails to Satisfy the Requirements of the Daubert Rubric or to Otherwise Comport with the Basic Methodology which should be Utilized by Experts in Toxic Tort Cases 86 While we have addressed certain types of unreliable evidence used by O'Donnell in reaching his opinions in this case, we find it necessary to also note that O'Donnell's methodology would have failed to survive the Daubert inquiry using those guidelines set forth in Daubert itself. The Supreme Court in Daubert identified four nonexclusive factors for trial courts to use in determining the reliability of scientific opinions; i.e.: (1) whether the theory can and has been tested; (2) whether it has been subjected to peer review; (3) the known or expected rate of error; and (4) whether the theory and methodology employed is generally accepted in the relevant scientific community. Daubert, 509 U.S. at 593-94, 113 S.Ct. 2786. 87 There is no doubt that O'Donnell's theory of the toxicity of the ephedrine/caffeine combination can be tested, as can most theories; but, he has offered no evidence of any testing of his theory, and therefore, he has shown no proof for support of his opinions by the scientific community. General acceptance of his theory would offer important support for the reliability of his opinion. As the United States Supreme Court has explained: 88 Finally, general acceptance can yet have a bearing on the inquiry. A reliability assessment does not require, although it does permit, explicit identification of a relevant scientific community and an express determination of a particular degree of acceptance within that community.... Widespread acceptance can be an important factor in ruling particular evidence admissible, and a known technique which has been able to attract only minimal support within the community ... may properly be viewed with skepticism. 89 Id. at 594, 113 S.Ct. 2786 (internal citations omitted). 90 O'Donnell has also failed to present evidence of any peer review of his opinions about the extreme toxicity of ephedrine and caffeine or that their use can cause strokes and heart attacks. He submitted no publication linking ephedrine and caffeine to strokes and heart attacks beyond the general incident rate or background risk for these two very common ailments. He likewise failed to offer any testimony about the known or expected rate of error of his theories, and although he has provided unsupported testimony about the general acceptance within the relevant scientific community of his broad principles of pharmacology, he has offered no testimony about the acceptance of his specific opinions. In fact, his own sources say that their studies cannot be used to show causation. 91 It is also important to consider what other evidence O'Donnell failed to present that might have supported the reliability of his opinions in this case. He offered no epidemiological data. He offered no clinical trials. He offered no animal studies to support his opinions. O'Donnell also offered no long-term studies about the toxicity of the ephedrine/caffeine combination on humans. As even O'Donnell explained: [l]ong term studies are used for chronic use to determine safety; still, he offered opinions about the safety of Metabolife in absence of such long-term studies. 92 Ultimately, O'Donnell failed to show the trial court either that his opinions were based upon reliable sources and data or that his methodology comported with that criteria listed in Daubert or with those standards otherwise utilized by experts in the field of toxicology. It was therefore error to admit his testimony to establish general causation at trial.