The MDL court in the Human Tissue mass tort litigation has issued a noteworthy Daubert and summary judgment decision. In re Human Tissue Products Liability Litigation, MDL No. 1763, 2008 WL 4665765 (D.N.J. Oct. 22, 2008). This multidistrict litigation arises from an alleged criminal enterprise to harvest tissue from human corpses without obtaining proper consents and without following appropriate regulations. The plaintiffs in this litigation include the recipients of processed tissue who allegedly suffered harm from the processed tissue product, as well as relatives of the deceased donors.

Certain defendants moved for summary judgment on the issue of general causation of the relevant infectious diseases of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis, cancer, and prion disease. General causation, of course, refers to whether a substance is capable of causing a particular injury or condition in the general population. See Perry v. Novartis Pharms. Corp., 564 F.Supp.2d 452, 463 (E.D.Pa.2008); Reference Guide on Medical Testimony, in Reference Manual On Scientific Evidence 439, 444 (Fed. Jud. Ctr., 2d ed.2000).

Defendants argued generally that the tissue at issue was incapable of infecting recipients with certain diseases due to the methods employed by the processing companies to disinfect and sterilize the allografts. But the motion only attacked the potential for the transmission of diseases short of sterilization.

Defendants also moved to exclude the proposed testimonies of several of plaintiffs’ experts. The central conflict among the experts involved time, not capacity. There appeared to be no genuine conflict among the parties that unprocessed bone tissue stored at room temperature can transmit HIV, HBV, HCV, syphilis, and cancer. Rather, the real issue was for what period of time can such bone tissue transmit these diseases– is it a matter of hours, days, months, or years? Defendants contend that the transmission of disease cannot occur after thirty days, and plaintiffs have sought to extend the period of transmission beyond thirty days. After a comprehensive review of the scientific literature, including epidemiology, animal, and in vitro studies, the court struck plaintiffs’ proposed expert testimony where they sought to opine that: (1) unprocessed bone tissue kept at room temperature for thirty days or longer can transmit HIV, HBV, HCV, syphilis, or cancer; (2) unprocessed bone tissue is a transmitter of prion diseases; and (3) the incubation periods of hepatitis and HIV are longer than six months.

Plaintiffs’ expert opinions regarding unprocessed bone tissue stored at room temperature for thirty days or more did not appear to meet the second and third parts of the Daubert and Fed.R.Evid. 702 inquiry– reliability of methodology and “fit.” The court noted that the opinions were derived from a literature review. When proposed expert testimony is not based upon the expert’s own independent research, but instead on such a literature review, the party proffering such testimony must come forward with other objective, verifiable evidence that the testimony is based on scientifically valid principles. The court did not question the reliability of the underlying studies, but rather the plaintiffs’ extrapolations from those studies to the ultimate conclusion. The extrapolations from these studies were not tested, were not subject to peer review, and had no known rate of error. The theory that these studies suggest the existence of general causation as framed in this litigation has not been generally accepted. Without plaintiff’s expert evidence, there was no evidence supporting plaintiffs’ theories of causation.

In an observation of special interest to readers of MassTortDefense, the court addressed the claim that the science was still evolving and an MDL court should not truncate the mass litigation before it develops. Multidistrict litigation courts are often confronted with evaluating limited or evolving scientific and medical theories and evidence. The absence of definitive scientific or medical knowledge is, said the court, a reality in some cases. Nevertheless, district courts are charged with the role of gatekeeper and can only allow presently reliable evidence. As courts have recognized, the Rules of Evidence may, on occasion, prevent the jury from learning about promising or potential clinically relevant information. See In re Reuzulin Products Liability Litigation, 369 F.Supp.2d 398, 438 (S.D.N.Y.2005). The Rules of Evidence, however, cannot be disregarded even if at a future date, medical and scientific literature proves the contrary. As Judge Richard Posner put it, “the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”  Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir.1996).

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