FRE 702 And The Expert Testimony That Cannot Be Tested Due To Medical Ethic Standards

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In products liability action, plaintiff's causation expert opinion testimony as to how the charged product caused plaintiffs' alleged nasal sensory losses was excluded when the plaintiff could not show this expert evidence was reliable under FRE 702, his testimony was based on an "unproven theory" which, despite plaintiff's contentions that the theory could not ethically be "scientifically tested," as a result had not been published, subjected to peer review, or to error rate calculation, and so lacked acceptance in the scientific community, in Polski v. Quigley Corp., 538 F.3d 836 (8th Cir. 2008) (No. 07-3350)

In deciding to admit expert opinion evidence under FRE 702, whether the expert's theory has been tested, particularly in the medical or biological field, is central to finding whether it is sufficient reliable. But what if an expert's theory cannot be ethically tested? Will this per se preclude admission under FRE 702? While not answering this precise question, the Eighth Circuit did examine a case in which a plaintiff's sole expert as to medical causation claimed that his theory could not be tested due to medical ethics. The case provides a foundation for thinking about some of the problems this type of problem engenders.

In the case, the plaintiffs Polski sued defendant nasal spray provider Quigley alleging they had been injured as a result of using a nasal spray (Cold-Eeze) made and distributed by the defendant for the relief of cold symptoms. In addition to easing their breathing, they claimed that the spray left them with a "severe and permanent impairment of their senses of taste and smell." They consulted an otolaryngologist, a doctor specializing in the diagnosis and treatment of disorders of the ear, nose, and throat. That physician "found no physical causes for their sensory loss." This formed the basis of the plaintiff's suit against the defendant, which under applicable law, they carried the burden of showing causation -- that the defendant's nasal spray caused the sensory loss they experienced. Polski v. Quigley Corp., 538 F.3d at 836.

In presenting their case, the plaintiffs submitted the expert testimony of an otolaryngologist, Dr. Jafek, whom the defendant conceded was "an expert of otolaryngology, the anatomy of the nose, and the senses of taste and smell." The expert witness concluded that the defendant's spray caused the plaintiff's loss of sensation. He presumed that:

Cold-Eeze delivers a straight line spray capable of traveling several feet ... [so] that the Polski's use of Cold-Eeze caused their sensory loss. Dr. Jafek opined that the spray emitted from the Cold-Eeze bottle traveled into the nasal cavity and through the straight passageway to the olfactory epithelium, resulting in the zinc ions in the spray coming into direct contact with the olfactory epithelium of the user.
Polski v. Quigley Corp., 538 F.3d at 836. The circuit noted that the bulk of the expert's testimony all depended on "on the validity of this premise." He claimed it was "[b]ased on his own knowledge and expertise, his research, the research of others, and his observation."

The trial judge excluded the plaintiff's expert testimony because it was untested. According to the circuit, neither the witness had "tested this theory-nor did anyone else." In fact, the plaintiffs readily admitted "that Dr. Jafek had not scientifically tested this theory." However, the plaintiff's contended that the reason for this was that the theory "could not [be] ethically [tested] ... on live humans because research has shown that zinc may cause loss of smell and taste if it comes into contact with the olfactory epithelium." The trial judge excluded the plaintiff's expert testimony because it was untested. The theory it was based on was “not sufficiently reliable" to be admitted under Rule 702. In doing so, the judge granted summary judgment to the defendant because the plaintiff, on motion for summary judgment, had no medical expert testimony as to causation. Polski v. Quigley Corp., 538 F.3d at 836.

The plaintiffs appealed, but the circuit affirmed the grant of summary judgment to the defendant. According to the circuit:

Dr. Jafek's theory could have easily and ethically been tested by placing a substance with similar dispersal qualities to Cold-Eeze but lacking zinc or any other potential toxin into a Cold-Eeze bottle and administering the substance to participants as directed by Cold-Eeze's instructions. Following such an experiment, participants could be examined to determine whether the administered substance actually came into contact with the olfactory epithelium.
Polski v. Quigley Corp., 538 F.3d at 836. In essence, while a direct experiment with the substances involved in the plaintiffs case might not be possible given prevailing medical research ethics, it was possible to test a proposition sufficiently similar to the one involved in the case. The circuit noted the use of just such a substitute in that the development of the finding that loss of smell "can result from zinc ions coming into direct contact with the olfactory epithelium, reached its conclusion after conducting an experiment in which a zinc-sulfate solution (not zinc-gluconate) was applied directly to the olfactory epithelium." (citing Max M. Peet, Dean H. Echols, Harry J. Richter, The Chemical Prophylaxis for Poliomyelitis: The Technic of Applying Zinc Sulfate Intranasally, 108 JAMA 2184, 2186 (1937) ("It is evident that to be effective the spray must be directly applied to the olfactory area. We wish to especially emphasize this point.")).

In rejecting the opinion testimony of the plaintiffs' expert, the circuit observed one consequence of not attempting to test the theory, however indirectly. Without scientific testing the witness's "causation theory relied on an unproven and indeed untested premise. The district court applied Rule 702 following Daubert's guidance." Without the testing the various considerations to be examined under FRE 702 and Daubert did not exist. The theory 'has never been subjected to peer review and publication, nor has it been generally accepted in the scientific community, nor does it have a known or potential rate of error' which should be considered under Daubert.

The circuit found no problem with the trial judge's conclusion that the plaintiff's expert testimony should be excluded. Its decision “does not mean that Dr. Jafek's theory is necessarily wrong; it simply means that the theory meets none of the indicia of reliability identified in Daubert and therefore must be excluded.” As a result, the trial court was faithful to Daubert in finding that the plaintiffs' causation evidence "was not sufficiently reliable and too speculative to be presented to the jury." It would not satisfy the FRE 702 requirement of helpfulness to the jury.


While the Eighth Circuit did not directly address the issue of ethics in scientific testing, its affirmation of the trial court in the case does show that it is possible to consider substitutes for a direct test -- substitutes that will not offend the standards of the medical profession. The case also shows that without testing in science-related cases, it is fairly difficult to have any of the other factors Daubert identifies as allowing a court to conclude by a preponderance of the evidence that the proffered expert evidence is reliable.


Federal Rules of Evidence