Friend-of-the-Court Brief on the Issue of Scientific Evidence: Filed with the U.S. Supreme Court in Daubert V. Merrell Dow Pharmaceuticals

All parties have consented to the submission of this brief.

Statements of interest of each amicus appears in an Appendix to the brief [but are not presented in New Solutions' version].

Frye v. United States, 293 F. 1013 (D.C. Cir. 1923).

Fed. R. Evid. 702.

Davis , “The ‘Shotgun Wedding’ of Science and Law: Risk Assessment and Judicial Review,” 10 Colum. J. Envtl. L. 67 (1985); Bonine J. and McGarrity T. , The Law of Environmental Protection, pp. 797–815, 861–866 (2d ed. 1991), and see, for example, Natural Resources Defense Council v. Texaco Refining & Marketing, 800 F. Supp. 1, 7, n.2 (D. Del. 1992).

There is a debate in the case law, which we do not address, concerning whether or not Rule 703 applies the “reasonably relied upon by experts in the particular field” standard only to the raw data relied upon, or also to the interpretation of that data. See, for example, Christopherson v. Allied-Signal Corp., 939 F. 2d 1106, 1114, 1118–20 (5th Cir. 1991); ( Clark J. , concurring in the result), cert, denied, —U.S. —., 112 S. Ct 1280 (1992). For present purposes, it suffices to note that there is some objective, non-contextual review appropriate under Rule 703, at least insofar as expert testimony relies on hearsay.

Compare Lynch v. Merrell-National Laboratories, 830 F.2d 1190 (1st Gr. 1987); Richardson v. Richardson-Merrell Inc., 857 F.2d 823 (D.C. Cir. 1988), cert, denied, 493 U.S. 882 (1989) with Brock v. Merrell Dow Pharmaceuticals, 874 F.2d 307, modified, 884 F.2d 166 (5th Cir. 1989), cert, denied, 494 U.S. 1046 (1990).

DeLuca v. Merrell Dow Pharmaceuticals, 911 F.2d 941, 958–59 (3rd Cir. 1990).

We note mat, as the DeLuca court stated, sufficiency of the evidence would, in a toxic tort case such as this one, necessarily be tested against the burden-of-proof standard under applicable state law. 911 F.2d at 958–59.

For example, the expert evidence might show that it is 10 percent more likely that a person exposed to a particular substance will get cancer than one who is not so exposed, while indicating at the same time that 90 percent of the people who get the same form of cancer have no such exposure, and must have gotten the cancer from some other, unknown source. Under those circumstances, it is arguable whether summary judgment might be appropriate in a toxic tort context because there is no evidence indicating that it is more probable that the particular case of cancer in question was caused by the putative exposure than by one of the unknown causes.

We note that the very same expert evidence would, however, almost surely support a regulatory or judicial finding that the substance in question presents an unreasonable risk to human health and should be prospectively excluded from the market under a statute providing for exclusion on that standard. See also Part II, infra. The reason for the different results is that the substantive inquiries are fundamentally different where the question is causation of an individual injury, as opposed to assessment of the risk posed to the population as a whole. Any per se evidentiary approach, in contrast, would treat the two situations as equivalent, and exclude the expert evidence entirely in a court case in both circumstances.

Final Guidelines for Developmental Toxicity Risk Assessment, 56 Fed. Reg. 63798 (1991).

Id. at 63799 (emphasis added).

Id at 63801.

Environmental Protection Agency, Guidelines for Mutagenicity Risk Assessment, 51 Fed. Reg. 34006, 34008 (1986).

See also Environmental Protection Agency, Proposed Guidelines for Assessing Female Reproductive Risk, 53 Fed. Reg. 24834, 24836 (1988) (reiterating the need for reliance on “evaluation of toxicological data from humans and experimental animals …” in making reproductive and developmental risk assessments) (emphasis added); Occupational Safety and Health Administration, Final Standard for Occupational Exposure to Ethylene Oxide, 49 Fed. Reg. 25734, 25743–4 (1984) (describing the agency's “comprehensive review of the scientific evidence … from many investigations in several species of experimental animals … as well as positive results from several human studies,” and noting that a rat study “provided the strongest evidence” of the carcinogenic properties of EtO).

See, for example, Gill T.J. , “The Rat As An Experimental Animal,” 245 Science 269 (1989).

See 8 Encyclopedia Britannica 740–47 (1991).

Watson J.D. , Molecular Biology of the Gene (4th ed., 1987).

See also National Academy of Sciences, National Research Council, Biological Markers in Reproductive Toxicology (1989); National Academy of Sciences, Principles for Evaluating Chemicals in the Environment (1975).

A partial list of federal laws, regulations and standards in which animal studies are used to assess human health risks includes: The Federal Insecticide, Fungicide, and Rodenticide Act, 7. U.S.C., Secs. 136–137, and accompanying regulations, for example, 40 C.F.R. 154.7(a)(2)(i); Federal Food, Drug and Cosmetic Act, 11 U.S.C. Sec. 348(c)(3)(A)((“no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal”); the Consumer Product Safety Act, 15 U.S.C Sec. 2079(a) and the Federal Hazardous Substances Act Sec. 2(f)(1)(A), 15 U.S.C. Secs. 1261, 1262, and accompanying regulations, for example, 16 C.F.R. Sec. 1500.17(a)(10), and 43 Fed. Reg. 12308–12310 (animal studies are the basis for classification as banned hazardous substances of self-pressurized household substances containing vinyl chloride monomer). Safe Drinking Water Act, 42 U.S.C. Secs. 300(f), et. seq. and accompanying regulations, for example, 44 Fed. Reg. 68624, 27; Toxic Substances Control Act, 15 U.S.C Secs. 2601–2629 (1976), especially Sec. 2603(b)(2)(A) (providing for “standards for the development of test data,” including “epidemiological studies, serial or hierarchical test, in vitro tests, and whole animal tests,” emphasis supplied); Federal Water Pollution Control Act, Sec. 307(a), 33 U.S.C. Sec. 1317(a) (1976), and accompanying regulations, for example, 41 Fed. Reg. 30476–77 (1976) and 42 Fed. Reg. 6532 (1977) (proposed and final discharges standards for PCBs based on evidence of animal carcinogenicity); Federal Clean Air Act, 42 U.S.C. Sec 7412, and accompanying regulations, for example, National Emission Standards for Hazardous Air Pollutants: Proposed Standard for Vinyl Chloride, 40 Fed. Reg. 69532 (December 24, 1975) (rationale for the standard includes animal test data demonstrating carcinogenicity of vinyl chloride as well as epidemiological studies); Occupational Safety and Health Act, 29 U.S.C. Sec. 655, and standards issued thereunder, for example, OSHA Cancer Policy, 29 C.F.R. Sec. 1990.111(a), relying on positive results in high-dosage animal tests “to establish the qualitative inference of carcinogenic hazard to workers,” and 39 Fed. Reg. 35890, 35891 (1974), 38 Fed. Reg. 10929 (1973) (OSHA exposure standards for vinyl chloride and ethyleneimine, respectively, based on animal studies indicative of carcinogenicity); and the Resource Conservation and Recovery Act, 42 U.S.C. Sec. 6901 et. seq., especially 42 U.S.C. Sec. 6421 and implementing regulations at 40 C.F.R. Sec 261.11(a) (including as a hazardous waste substances that “have been shown in scientific studies to have toxic, carcinogenic, mutagenic or teratogenic effects on humans or other life forms.” (emphasis supplied)).

EPA Final Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 33992, 33995–96 (1986).

Office of Science and Technology Policy, Chemical Carcinogens: A Review of the Science and its Associated Principles, 50 Fed. Reg. 10372, 10378 (1985); see also EPA Final Guidelines for Carcinogen Risk Assessment, supra, 51 Fed. Reg. 33995 (human epidemiology “can rarely be used to make a causal inference”).

See Silbergeld E.K. , “The Role of Toxicology in Causation: A Scientific Perspective,” 1 Courts, Health Science & the Law 374, 381 (1991) (“[n]otions of cause in science involve knowledge of mechanism. They go beyond the accumulation of linked observations …”); see also Evans A.S. , “Causation & Disease,” 49 Yale J. Biol. & Med. 175 (1976).

Davis D.L. , “Changing Policy Rules of Environmental Epidemiology,” 3 Statistical Science 281 (1988).

Latin , “Good Science, Bad Regulation, and Toxic Risk Assessment,” 5 Yale J. Reg. 89, 103 (1988).

51 Fed. Reg. 34008.

The limitations of epidemiology are apparent from the foregoing discussion. Indeed, if plaintiffs here had relied on epidemiological data, there is little doubt that the defendants would have challenged that data as insufficient methodologically. The history of regulatory proceedings assessing the risks of toxic exposures demonstrates that questions have been raised about the validity and pertinence of data of all sorts, including published, peer-reviewed, epidemiological data. See, for example, Attachments to the Preamble for the Final Standard for Occupational Exposure to Lead, 43 Fed. Reg. 54353–54509 (1978); Occupational Safety and Health Administration, Final Standard for Occupational Exposure to Ethylene Oxide, 49 Fed. Reg. 25734, 25739 (1984).

NTP employs an external scientific review process to insure the integrity of its research, but results are not published in a peer-reviewed journal and would not meet the per se standard adopted by the Ninth Circuit in this case.

FIFRA Sec. 3(a), 7 U.S.C. Sec. 136(a).

FIFRA Sec. 3(c)(50(D), 7 U.S.C., Sec 136a(c)(5)(D).

FIFRA Sec. 3(c)(2), 7 U.S.C. Sec. 136a(C)(2).

40 C.F.R. Sec 158.80 (1988).

Similarly, Section 6 of FIFRA authorizes the Administrator to cancel or suspend pesticide registration if the product does not comply with FIFRA or generally causes unreasonable adverse effects on the environment. FIFRA Sec. 6, 7 U.S.C. Sec 136d. The Administrator's cancellation or suspension decision is not limited to consideration of studies published in peer-reviewed journals. In fact, the statute requires pesticide registrants at any time to submit to EPA “additional factual information” regarding a pesticide's unreasonable adverse effects, a category clearly far broader than only information published in a peer-reviewed journal.

EPA routinely cancels or suspends pesticides on the basis of studies not published in peer-reviewed journals. For example, on October 7, 1986, EPA issued an emergency suspension of a widely used pesticide ingredient, dinoseb. The suspension order was based upon scientific data EPA summarized as demonstrating that “dinoseb is a developmental toxicant in laboratory animals.” 51 Fed. Reg. 36636 (October 14, 1986). These data were unpublished studies submitted to EPA by dinoseb's manufacturers but deemed by the Agency to be scientifically valid and sufficient indicators of cause for concern to warrant suspension of the pesticide. See Love v. Thomas, 858 F.2d 1347 (9th Cir. 1988), cert, denied, 490 U.S. 1035 (1989).

Section 8(e), Toxic Substances Control Act, 15 U.S.C Sec. 2607(e).

Administrative Procedure Act, 5 U.S.C Sec 556(d).

Opp Cotton Mills v. Administrator, 312 U.S. 126, 155 (1941).

Richardson v. Perales, 402 U.S. 389 (1971).

McCormick , Evidence, Sec. 351.

See, for example, 16 C.F.R. Sec. 3.43(b) (FTC); 43 C.F.R. Sec. 4.122 (Interior).

See 29 C.F.R. Sec. 2200.72 (OSHA).

McCormick , Evidence Sec. 351; citing “Pierce, Use of the Federal Rules of Evidence in Federal Agency Adjudications,” 39 Admin. L. Rev. 1, 6 (1987).

See 29 C.F.R. Sec. 2200.71.

Prior to implementing the present rule, OSHRC allowed use of the Federal Rules of Evidence “insofar as practicable.” In proposing the present rule, OSHRC stated that the “insofar as practicable” standard created “uncertainty” and that “it is difficult to imagine a situation in which it would not be ‘practicable’ to follow the Federal Rules of Evidence.” 51 Fed. Reg. 23190 (June 25, 1986). OSHRC stated that “(i)n practice, the Commission expects that the revision of its rule on the admissibility of evidence would have only a limited effect on Commission proceedings … Even as to hearsay, where the Federal Rules were previously not followed strictly, the change to a strict application on the hearsay rules probably will not result in a significantly different resolution of factual issues. Often, evidence admitted under the Commission's lenient policy towards hearsay also would have been admissible under the Federal Rules.”

Davis , Administrative law of the Eighties, 1989 Supplement to Administrative law Treatise 382.

See Ref. 5, supra.

See p. 4, supra.