Blackwell v. Wyeth

In Blackwell v. Wyeth, 408 Md. 575, 971 A.2d 235 (2009), the plaintiffs filed suit against the defendants, arguing that administered vaccinations, which were thimerosal-laden, caused autism and mental retardation. Id. at 578-79. One of the plaintiffs' experts, Dr. Geier, used a differential diagnosis to establish "a genetic susceptibility thesis . . . ." See id. at 614. In doing so, he "performed urinary porphyrin, mercury toxicity, testosterone and genetic polymorphism tests . . . ." Id. at 615. The circuit court concluded that none of these were "generally accepted by the medical community, including clinical geneticists and pediatricians, as appropriate tests for either the work-up of a patient with autism or to determine the underlying cause of autism." Id. The court then noted that Dr. Geier failed to consider unknown genetics -- the most important alleged cause of autism -- when conducting the differential diagnosis. Id. Based on that, the circuit court concluded that the "causation opinions on the etiology of autism cannot be based on a differential diagnosis that includes thimerosal as a potential cause of autism because the science does not support the plaintiffs' purported theory of a causal connection between thimerosal-containing vaccines and autism . . . ." Id. On appeal, the plaintiffs argued that the circuit court was incorrect in holding that Dr. Geier neglected to consider unknown genetics. Id. at 616. According to the plaintiffs, Dr. Geier considered genetics, and genetic interactions, but "unknown genetics accounted for less than 5% of autism cases, and he need not discount all possible causes." Id. Because there was significant authority suggesting that unknown genetics accounted for the majority of autism cases, the Court of Appeals held that the court did not err in concluding that unknown genetics was the most prevalent cause of autism. Id. at 617. Moreover, the Court articulated: We agree that Dr. Geier did not sufficiently consider genetics in his differential diagnosis equation. This conclusion is similar to that reached in Wilson, supra, 370 Md. at 191, in which we recognized that the State's expert, in applying the product rule, did not account for a genetic linkage between siblings, who may have died of SIDS, rather than been murdered by their father. Based on the circuit court's rejection of Dr. Geier's underlying hypothesis and methodology, i.e. the identification of specific genes and differential diagnosis, we hold that its ultimate determination -- that Dr. Geier's genetic susceptibility theory is no more than hypothesis and conjecture, devoid of a generally accepted methodology to support it -- should not be disturbed by us. (Id. at 617-18.) The Court applied Frye-Reed to a novel theory of causation. Drawing from the Supreme Court's decision in GE v. Joiner, 522 U.S. 136 (1997), the Blackwell Court held that where an expert derives an untested hypothesis from generally accepted theories and research methods, the trial court must weigh the "analytical gap" between the established theories and methods on one figurative side, and the expert's opinion on the other. 408 Md. at 605-08 ("Generally accepted methodology, therefore, must be coupled with generally accepted analysis in order to avoid the pitfalls of an 'analytical gap.'").