Ethical Limitations of Human Testing | Wunsch Law Firm Chicago
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Daubert and the Ethical Limits of Human Testing

It’s well known that some areas of research cannot be tested in human double-blind studies due to ethical prohibitions. Researchers cannot knowingly inflict harm to one group. See, e.g., In re Zoloft (Sertraline Hydrocholoride) Products Liability Litigation, 26 F.Supp.3d 449, 453 (US Dist. Ct. E.D. Penn. 2014)(“Although the “gold standard” for epidemiological studies is the double-blind, randomized control trial, such studies may not ethically be conducted on pregnant women.”)

Daubert, however, requires a Court to determine “testability” of an expert’s opinion without first ascertaining whether such testing could ever ethically take place. See generally, Stoner vs. Chiquita A. Fye, M.D., No. 5:15-CV-102(CAR)(US Dist. Ct. Georgia 2017)(“Daubert offers four non-exclusive factors that courts may consider in evaluating the reliability of an expert’s testimony: (1) testability; (2) error rate; (3) peer review and publication; and (4) general acceptance.”) If such testing is ethically impermissible to carry out, the “testability” element of Daubert can never be met.

It seems clear that a Court should not dismiss a case for failing to satisfy the testing element of Daubert when ethical restrictions prevent such testing from ever taking place. A rule that has no means­­––under any circumstance––of ever being met is simply an inapplicable rule. Any justiciable legal rule governing admissibility of evidence is one that provides a standard against which evidence can be evaluated. If no such evidence is ever capable of being obtained due to ethical limits, its absence should not be deemed a “failure to comply” with the rule. The rule simply does not apply.

“Petitioners Jason Daubert and Eric Schuller are minor children born with serious birth defects. They and their parents sued respondent in California state court, alleging that the birth defects had been caused by the mothers’ ingestion of Bendectin, a prescription antinausea drug marketed by respondent.”––these are the early lines from the Daubert opinion. Daubert vs. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 582 (1993).

Recently, researchers at the University of Toronto, Rujun Zhang, Navindra Persaud, have unearthed thousands of pages of previously undisclosed information dating back to the 1970s––Daubert was decided June 28, 1993––regarding this drug:

“This previously unpublished 1970s trial of medications for NVP [nausea and vomiting during pregnancy] that has been cited as supporting the use of doxylamine-pyridoxine has several important limitations: the final results of the study are not available, data from more than 30% of recruited individuals were not analyzed although the follow up period was only one week, few details about outcome determination or statistical analyses were provided. The integrity of the data is questionable because data from at least one investigator were subsequently excluded for reasons including “data recording in absence of patient visits”. The data known to be of questionable integrity was a small fraction of the data included in the available interim analysis and we do not know if problems with the integrity of other data were identified, the reason the final results of the trial are not available or the reason these results were not published previously. The risk of bias was high in several domains. Also, limited baseline data is available, the number of tablets taken by each participant is not available and that number could have doubled based on as needed use, the method by which physicians scored symptoms was not clear, outcome data is unavailable for 37% of participants in the placebo arm that was used as the reference for comparisons, p-values were one-sided and not corrected for the multiple comparisons made, the approach to accounting for the effect of missing data is not described and some information about adverse events may be missing.”[1]

The authors concluded: “The information published here for the first time about this 1970s trial allow for an assessment of the evidence base supporting the use of commonly used agents for nausea and vomiting of pregnancy: doxylamine and pyridoxine. While the analyzed data indicate differences from placebo for several combinations, the questionable data integrity, high drop-out rate, and other methodological concerns mean that the prescribing of this medication should not be based on this trial. No firm conclusion about the efficacy or safety of doxylamine or pyridoxine can be drawn from the limited available information. The claims about the efficacy of doxylamine and pyridoxine and the clinical practice guidelines and regulatory decisions that are based on this trial should be revisited. All of the available information about clinical trials of treatments for nausea and vomiting during pregnancy should be made publicly available so that informed decisions can be made by regulators, researchers, clinicians and patients.”

Evidentiary laws hinge on evidence. If testing evidence can never be ethically secured, then laws crafted to evaluate such evidence should not be utilized. As well, there’s always the possibility that not all relevant information has been provided through traditional channels of discovery, or that, if provided, there can be instances when the “integrity of the data is questionable.” Perhaps the Daubert case itself would have been decided differently if thousands of pages of information had been timely made available to all parties. It’s probably true as well that the entire framework of Daubert may need to be re-conceptualized since the assumption it makes––that the only admissible category of scientific testimony is that which is “testable,” “peer-reviewed,” and “generally accepted”––is too narrow. The Higgs boson was first suspected to exist in 1964; it was not until July of 2012––some forty-eight (48) years later––that its presence was confirmed by CERN’s Large Hadron Collider.

[1] Rujun Zhang, Navindra Persaud, 8-Way Randomized Controlled Trial of Doxylamine, Pyridoxin and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information, (Published: January 4, 2017)

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