Opinion ID: 1890564
Heading Depth: 1
Heading Rank: 8

Heading: Extrapolation

Text: DuPont and Pine Island argue that the Castillos' experts improperly extrapolated the dosage level of 20 ppb, which the Castillos' experts say is the low effect level, or the level at which cells exposed to benomyl are damaged. They argue, citing Wade-Greaux v. Whitehall Laboratories, Inc., 874 F.Supp. 1441, 1484 (D.Vi.), aff'd, 46 F.3d 1120 (3d Cir.1994), that, in vitro animal test data are not relied upon by experts in the field of teratology for extrapolating the results found directly to the human experience. Id. They further argue that direct extrapolation of data from tissue soaked in benomyl in a petri dish to the human body makes no sense, and that scientists do not generally accept this extrapolation. The Castillos respond that the petri dish studies are common. It does not matter that the tissue samples are soaked for a 24-hour period of time because the cell only divides once. The study examines the dosage at which the cell's division is affected. The information provides indicia for the substance's potential for toxicity but still requires further testing to determine whether the metabolic processes of a living organism will increase, decrease, or have no effect on the toxicity of the substance. Because scientists cannot ethically administer benomyl to humans, they use animal testing, which is the reason for the rat gavage study. Dr. Howard used DuPont's own studies which indicate that benomyl has a half life of 45 minutes, and that it would make one full pass through the mother's circulatory system in approximately 60 to 90 seconds, with the full dose in the mother's system passing through the placenta and to the fetus. According to the Castillos' expert, the fetus cannot rid itself of the toxin, so it soaks in it until the next pass through the mother's circulatory system, when it is slightly diluted. DuPont's data also suggests that in a dermal exposure incident, approximately 15% of the chemical penetrates the skin. Dr. Howard considered what clothes Donna Castillo was wearing when she was exposed, and her height and weight to determine the amount of skin exposed, and used DuPont's data to calculate the amount of benomyl that would have been absorbed and passed though her system to the fetus. The Castillos also respond that extrapolation is common in the scientific community, and quote a passage from Bernard D. Goldstein & Mary Sue Henifin, Reference Guide on Toxicology, in Reference Manual On Scientific Evidence 401, 410 (2d ed.2000): Two types of extrapolation must be considered: from animal data to humans and from higher doses to lower doses. In qualitative extrapolation, one can usually rely on the fact that a compound causing an effect in one mammalian species will cause it in another species. This is a basic principle of toxicology and pharmacology. The issue is not whether the in-vitro tests or the DuPont tests or the fact that the Castillos' experts relied upon professional experience are scientifically accepted methodologies. The issue is whether the use or extrapolation of the data from all of these sources to reach a conclusion is in itself generally accepted. The underlying methodology is not so much the testing as it is the use of the test results from the methodology to bridge the gap from raw data to a conclusion. Two Illinois cases directly address this extrapolation method. In Duran v. Cullinan, 286 Ill.App.3d 1005, 222 Ill.Dec. 465, 677 N.E.2d 999 (1997), the plaintiffs alleged that a birth defect was caused by a birth control pill taken while the mother was pregnant. In discovery, the plaintiffs' experts submitted essays explaining the time frame of the mother's ingestion of the pill and the ordinary development of the nervous system during pregnancy, then stated that additional supporting data for the causal connection between oral contraceptives and this unfortunate child's birth defects are extrapolated from a wide variety of defects appearing in the literature. Id. at 1001. The plaintiffs submitted forty-three epidemiological studies involving various birth defects and extrapolated the data from those studies. The essays additionally noted that animal studies indicate that oral contraceptives have significant teratogenic potential. The trial court granted the defense's motion for summary judgment. The appellate court reversed, holding that the fact that plaintiffs' experts had to extrapolate from various studies in arriving at their opinion rather than rely on a specific epidemiological study affects the weight of the testimony and not its admissibility. Id. at 1013, 222 Ill.Dec. 465, 677 N.E.2d 999. The Illinois court determined that extrapolating data is acceptable even though the court recognized that this method in and of itself would not likely be subject to a study submitted for peer review. In Donaldson v. Central Illinois Public Service Co., 313 Ill.App.3d 1061, 246 Ill. Dec. 388, 730 N.E.2d 68 (2000), the court found that experts' opinions that coal tar could have caused neuroblastomas were admissible under Frye. The plaintiffs' experts argued that while they could not specifically link neuroblastoma to the carcinogens involved, they were able to point to numerous studies directly linking those same carcinogens to other forms of cancer. Extrapolating from these studies, the experts conclude that, logically, the carcinogens could have caused the neuroblastomas at issue in this case. Id. at 78. The court acknowledged that the extrapolation opinions were obviously not strong opinions, but the opinions went to weight, not admissibility. Neither party here cites any case for the proposition that the way the Castillos' experts extrapolated from the data to reach their conclusions is or is not generally accepted. Amici argue that one cannot extrapolate from in-vitro tests to establish human teratogenicity or teratogenic threshold, citing Wade-Greaux v. Whitehall Labs., Inc., 874 F.Supp. 1441 (D.Vi.1994). Wade-Greaux applied the Daubert [5] test, not Frye. The testing in Wade-Greaux was admittedly not publishable or able to be subjected to peer review and was used in relation to anecdotal testimony and not raw scientific data. In this case, the Castillos' experts asserted they were not only using in-vitro data, they were using that in addition to other data, including data generated directly by DuPont's own scientists. [6] The Castillos' experts relied upon commonly accepted scientific methodology and used the data generated from that methodology in a new or novel way. At least one other state, Illinois, has held that the method of extrapolation meets the Frye test. The trial court in this case was correct in admitting the experts' testimony for consideration of the jury. The court ... must assure itself that the opinions are based on relevant scientific methods, processes, and data, and not upon an expert's mere speculation.... [I]t is important to emphasize that the weight to be given to stated scientific theories, and the resolution of legitimate but competing scientific views, are matters appropriately entrusted to the trier of fact. Berry, 709 So.2d at 569 n. 14 (quoting McDaniel v. CSX Transp., Inc., 955 S.W.2d 257 (Tenn.1997)). The Castillos met their burden. The exceptions DuPont and Pine Island take with the Castillos' experts' conclusions go to the weight of that testimony, not the admissibility.