The science veil over tort law policy: How should scientific evidence be utilized in toxic tort law?

Law and Philosophy

Volumn 24, Issue 2, 2005, Pages 139-210

  Cranor, Carl F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

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[No Author keywords available]

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EID: 77949685044     PISSN: 01675249     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF02743251     Document Type: Article

References (304)

1. Larry Wright, Critical Thinking (New York: Oxford University Press, 2001), p. 233.
2. U.S. Congress, Office of Technology Assessment, Identifying and Regulating Carcinogens (Washington, D.C.: U.S. Government Printing Office, 1987), pp. 199-220 [herinafter referred to as OTA, Identifying].
3. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).
4. L. Dixon and B. Gill, 'Changes in the Standards for Admitting Expert Evidence in Federal Civil Cases Since the Daubert Decision' (Santa Monica, CA: RAND Institute for Civil Justice, 2002).
5. Carol L. Krafka, Meghan A. Dunn, Molly Treadway Johnson, Joe S. Cecil, and Dean Miletich, 'A Survey of Judges' and Attorneys' Experiences, Practices, and Concerns Regarding Expert Testimony In Federal Civil Trials', Federal Judicial Center, Washington, D.C. (forthcoming).
6. Michael A. Green, Bendectin and Birth Defects: The Challenges of Mass Toxic Tort Substances Litigation (Philadelphia: University of Pennsylvania Press, 1995), 368 pp. [herinafter referred to as Green, Bendectin].
7. and Paul Thagard, How Scientists Explain Disease (Princeton: Princeton University Press, 1999), 263 pp. [hereinafter referred to as Thagard].
8. Clayton P. Gillette and James E. Krier, 'Risk, Courts and Agencies', University of Pennsylvania Law Review 38 (1999): 1077-1109.
9. C. Cranor, 'Risking Justice and Truth: The Judicial Admissibility of Science Subsequent to Daubert v. Merrell-Dow Pharmaceutical', presentation to The International Public Interest Law Conference, University of Oregon Law School, March 2002 and at 'Good Science or Junk Science: Should Courts Decide?' Wayne State University Law School and Philosophy Department, September, 10-11, 2002.
10. Michael Gottesman, Georgetown Law Center, presentation at 'Science the Courts, and Protective Justice', February 27, 2003, sponsored by the Science and Environmental Health Network and Georgetown Environmental Law and Policy Institute.
11. Barefoot v. Estelle, 463 U.S. 880 at 900, 103 S.Ct. 3383 at 3398 (1983).
12. There may or may not be a hearing on the issue, although often there is; a judge may merely review expert reports and depositions and make a decision.
13. Fleming James, Jr. and Geoffrey C. Hazard, Jr., Civil Procedure, 2d Ed. (Boston: Little, Brown and Company, 1977), p. 149. (Defendant is entitled to judgment as a matter of law, since there is no genuine issue as to the facts between the litigants.)
14. Ibid., pp. 527-599.
15. Carl E Cranor, Regulating Toxic Substances (New York: Oxford University Press, 1993), pp. 3-5 [herinafter referred to as Cranor, Regulating].
16. Ibid., pp. 12-48.
17. Green, Bendectin, p. 16.
18. Carl E Cranor and David A. Eastmond, 'Scientific Ignorance and Reliable Patterns of Evidence in Toxic Tort Causation: Is There a Need for Liability Reform?' Law and Contemporary Problems 64 (2001): 6, 12-13 [herinafter referred to as Cranor and Eastmond, Scientific Ignorance].
19. James Huff and David Hoel, 'Perspective and Overview of the Concepts and Value of Hazard Identification as the Initial Phase of Risk Assessment for Cancer and Human Health', Scandinavian Journal of Work Environment and Health 18 (1992): 83-89.
20. National Research Council, Toxicity Testing: Strategies to Determine Needs and Priorities (Washington, D.C.: U.S. Government Printing Office, 1984), p. 84.
21. John C. Bailor, University of Chicago, and Eula Bingham, University of Cincinnati, members of'the 1984 NRC Committee, personal communications at Collegium Ramazzini, Bologna Italy, 2002.
22. EPA, EDF, CMA Agree on Testing Program Targeting 2,800 Chemicals', Environmental Health Newsletter (Business Publishers, Inc., Silver Spring, MD). 37 (Oct. 1998): 193.
23. Elain M. Faustman and Gilbert S. Omenn, 'Risk Assessment', in Casarett and Doull's Toxicology (Curtis D. Klassen ed., 6th ed. 2001), pp. 85-86.
24. U.S. Congress, Office of Technology Assessment, Screening and Testing Chemicals in Commerce (Washington, D.C., U.S. Government Printing Office, 1995), p. 3.
25. OTA, Identifying, pp. 126-127.
26. Gerald Markowitz and David Rosner, Deceit and Deception: The Deadly Politics of Industrial Pollution (Berkeley: University of California Press, 2002) (a detailed study of lead and vinly chloride).
27. Margaret A. Berger, 'Eliminating General Causation: Notes Towards a New Theory of Justice and Toxic Torts', Colum. L. Rev. 97 (1997): 2135 [hereinafter referred to as Berger, 'Eliminating General Causation'] (citing studies of Agent Orange, asbestos, Bendectin, silicone breast implants, the Dalkon Shield, thalidomide, tobacco, MER/29, alachlor, atrazine, formaldehyde, and perchloroethylene).
28. For other references, see Cranor and Eastmond, 'Scientific Ignorance', p. 14.
29. See Ricardo Alonso-Zaldivar and Davan Mahara, 'Tests Show Firestone Had to Know, Probers Say; Safety: Congress Cites New Evidence Against Tire Maker as Sentiment Swings in Favor of Criminal Penalties in Such Cases', Los Angeles Times, Sept. 21, 2000, at CI.
30. Richard A. Oppel, Jr., 'Environmental Tests Falsified, U.S. Says', New York Times, Sept. 22, 2000, at A14
31. Melody Petersen, 'Settlement Is Approved in Diet Drug Case', New York Times, Aug. 29, 2000, at C2.
32. David Willman, 'The Rise and Fall of the Killer Drug Rezulin. People Were Dying as Specialists Waged War Against Their FDA Superiors', Los Angeles Times, June 4, 2000, at AI
33. David Willman, 'Risk Was Known as FDA Ok'd Fatal Drug', Los Angeles Times, Mar. 11, 2001, at A1 and In Re: Phenylpropanolamine (PPA) Multi-District Products Liability Litigation (Western District of Washington).
34. Markowitz and Rosner, Deceit and Deception.
35. See, e.g., Gayle Greene, The Woman who Knew Too Much: Alice Stewart and the Secrets of Radiation (Ann Arbor: The University of Michigan Press, 1999) (describing governmental attempts in the United States and Great Britain to preclude researchers from data and vigorously to fight their findings concerning exposures to nuclear radiation)
36. Matthew L. Wald, 'U.S. Acknowledges Radiation Killed Weapons Workers', N.Y. Times, Jan. 29, 2000, at A1. The governmental requirements for rocket fuel have now resulted in substantial contamination of the nation's groundwater with perchlorate (a rocket fuel component) and other known toxicants that are only now coming to public attention (In Re: Redlands Tort Litigation (2001), referenced in Lockheed Martin Co. v. Superior Court, 109 Cal. App. 4th 24 (2003)).
37. Michael D. Green, 'Safety as an Element of Pharmaceutical Quality: The Respective Roles of Regulation and Tort law', St. Louis University Law Journal 42 (1998): 163-190.
38. Cranor and Eastmond, 'Scientific Ignorance', pp. 6, 12-13.
39. Cranor, Regulating, pp. 1248.
40. Cranor and Eastmond, 'Scientific Ignorance', pp. 20-24.
41. Richard Marcus, 'Reexamining the Bendecting Litigation Story', Iowa Law Review 83 (1997): 231.
42. James T. Richardson, 'Bendectin and Birth Defects: the Challenges of Mass Toxic Substances Litigation, by Michael Green and Science at the Bar: Law, Science, and Technology in America, by Sheila Jasanoff', Judicature 81 (1997): 86
43. Francis E. McGovern, 'Judicial Centralization and Devolution in Mass Torts: Bendectin and Birth Defects: the Challenges of Mass Toxic Substances Litigation, by Michael D. Green', Michigan Law Review 95 (1997): 2077
44. Betsy J. Grey, 'Book Review: Bendectin and Birth Defects: The Challenges of Mass Toxic Substances', Jurimetrics Journal 37 (1996): 83.
45. Green, Bendectin, p. 1.
46. Ibid., pp. 3, 144.
47. Ibid., pp. 121-158.
48. Ibid., pp. 157-158.
49. Philip J. Hilts, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (New York, Alferd K. Knopf, 2003), p. 151.
50. Green, Bendectin, p. 89.
51. Ibid., p. 88 (quoting the federal judge in Toole v. Richardson-Merrell, Inc.).
52. Ibid., p. 128.
53. Ibid., p. 129.
54. Blum v. Merrell Dow Pharmaceuticals, Inc. 33 Phila. Co. Rptr. 193 at 236 (Court of common pleas, Philadelphia County, 1996). (The judge additionally noted that the company picked and chose the scientific data to use about the safety of its products (at 218), that scientific researchers groveling[ly] sought research funds from the drug company to produce results that 'may save the company large sums of money... (which is rather what [one of the scientists] thought when [he] undertook this study)...' (219), that there was a sycophantic relationship between [one of the scientists that did research on Bendectin] and the attorneys representing Merrell Dow, a relationship which clearly affected the objectivity of his approach and the validity of his writing on the drug bendectin (225), that there was legitimate concern about a medical industrial complex (analogous to the military industrial complex against which President Eisenhower warned) (248), that scientific consensus opinion in the relevant 'scientific community' can be and has been manipulated when the financial stakes warrant the effort (249)).
55. Ibid., p. 258.
56. Green Bendectin, p. 15.
57. Ibid., p. 19.
58. Ibid., p. 20.
59. See Daubert, 509 U.S. 579, 582 (1993).
60. Ibid., p. 583.
61. Joseph Sanders, 'Scientific Validity, Admissibility and Mass Torts after Daubert', Minnesota Law Review 38 (1994): 1387.
62. See Daubert v. Merrell Dow Pharms., Inc., 727 E Supp. 570, 575 (S.D. Cal. 1989), aft'd, 951 E2d 1128 (9th Cir. 1991), vacated, 509 U.S. 579 (1993).
63. See Frye v. U.S., 293 E 1013 at 1014 (D.C. Cir. 1923) (emphasis added).
64. Green, Bendectin, at 309.
65. See Daubert v. Merrell Dow Pharms., Inc., 951 E2d 1128, 1131 (9th Cir. 1991), vacated, 509 U.S. 579 (1993).
66. Ibid., pp. 1129-1130.
67. The existence of a large amount of contrary evidence seems relevant to the issue of sufficiency of the evidence, not the issue of admissibility (See Sanders, 'Scientific Validity').
68. Daubert v. Merrell Dow Pharms., Inc., 951 E2d at 1131.
69. See Daubert, 509 U.S. at 597-598.
70. Daubert v. Merrell Dow Pharm., Inc., 43 E3d 1311 (1995). This controversial opinion endorsed a legal requirement for causation that a group exposed to a substance must have a relative risk of two compared with a control group that poses both scientific and legal issues. (Carl Cranor, John G. Fischer and David A. Eastmond, 'Judicial Boundary Drawing and the Need for Context-Sensitive Science in Toxic Torts after Daubert v. Merrell Dow Pharmaceuticals, Inc.', Virginia Environmental Law Journal 16 (1996): 1-77, pp. 37-40.)
71. Wright & Miller Treatise, 29 Fed. Prac. & Proc. Evide. w at Note 13.
72. See Daubert, pp. 588-589.
73. McCormick on Evidence, 3rd Ed., Edwin W. Cleary et al., ed. (St. Paul, MN: West Publishing Co., 1992), pp. 909-911 and Daubert v. Merrell-Dow Pharmaceutical, 509 U.S. at 592.
74. Daubert, p. 592. This suggests that experts' testimony must be as reliable as witnesses who have firsthand knowledge of events about which they testify. Whether firsthand knowledge is particularly reliable is another issue.
75. Ibid., at 590.
76. Ibid., at 588 (quoting The Federal Rules of Evidence, section 702).
77. Justice Stephen Breyer, 'Introduction', Federal Reference Manual on Scientific Evidence (Federal Judicial Ctr. ed., 2d ed. 2000), p. 4.
78. Daubert, 509 U.S. at 592-593.
79. Ibid., at 594-595 (emphasis added).
80. See ibid., at 598 (Rehnquist, C.J., dissenting).
81. These are, 1) The falsifiability, or testability, of the theory guiding the technique used to reach the offered conclusion, 2) publication and peer review of the theory, 3) any known or potential rate of error of the technique, and 4) general acceptance within the relevant scientific community. See ibid., at 593-594.
82. There are several references to the presumption toward admissibility and the permissive nature of an admissibility decision (ibid., at 588-589).
83. Daniel Capra, 'The Daubert Puzzle', Georgia Law Review 32 (1998): 702; Wright and Mill Treatise, w at Note 5.
84. Defendants/Respondents, Merrell-Dow, expressed concerns that abandonment of 'general acceptance' as the exclusive requirement for admission [would] result in a free-for-all in which befuddled juries are confounded by absurd and irrational pseudoscientific assertions. However, the court noted, ' Vigorous cross examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.... Additionally, in the event the trial court concludes that the scintilla of evidence presented supporting a position is insufficient to allow a reasonable juror to conclude that the position more likely than not is true, the court remains free to direct a judgment.... and likewise to grant summary judgment..... These conventional devices, rather than wholesale exclusion under an uncompromising general acceptance test, are the appropriate safeguards where the basis of scientific testimony meets the standards of Rule 702 [of the Federal Rules of Evidence]' (Daubert at 595-596 (emphasis added)).
85. Breyer, Introduction, p. 4.
86. See, for example Michael H. Graham, 'The Expert Witness Predicament: Determining Reliable under the Gatekeeping Test of Daubert, Kumho and Proposed Amended rule 702 of the Federal Rules of Evidence', Miami Law Review 54 (2000): 317 at 324.
87. as well as Capra, 'The Daubert Puzzle'.
88. Michael Green, presentation to the Society for Epidemiological Research, June 19, 2002.
89. Michael Gottesman of Georgetown Law Center, who argued both Daubert and Joiner for plaintiffs before the Supreme Court, notes that before the mid-1980s there were no civil appellate court cases in which exert witnesses had been excluded because of admissibility reviews (presentation to 'Science, Courts and Protective Justice', Georgetown University Law Center, February 27, 2003).
90. Wright and Mill Treatise, w Text and Notes at Notes 57-73.
91. Cranor et al., 'Judicial Boundary Drawing', pp. 9-14.
92. and Capra, 'The Daubert Puzzle', p. 754.
93. D. Michael Risinger, 'Navigating Expert Reliability: Are Criminal Standards of Certainty Being Left on the Dock?' Albany Law Review 64 (2000): 99-152. The criminal-tort asymmetric treatment of expert testimony is increasingly discussed at conferences as well.
94. Green, Bendectin, p. 335.
95. Ibid., p. 330
96. quoting Peter Huber's, Galileo's Revenge: Junk Science in the Courtroom (New York: Basic Books, 1991), pp. 111-129.
97. Ibid., p. 330 (quoting an Orrefice speech).
98. quoting Howard Denemark, 'Improving Litigation Against Drug Manufacturers for Failure to Warn Against possible Side Effects: Keeping Dubious Lawsuits from Driving Good Drugs Off the Market', Case Western Reserve Law Review 40 (1987): 427-438.
99. Ibid., p. 337.
100. Ibid., p. 19.
101. Ibid., p. 20.
102. Michael J. Saks, 'Do We Really Know Anything about the Behavior of the Tort Litigation System - and Why Not?' Pennsylvania Law Review 140 (1992): 1184-1185.
103. Filings that increased faster included federal government suits for recovery of overpayments to individuals or firms, social security cases and contract litigation, yet these areas were not in crisis (Saks, ibid., pp, 1200-1201).
104. Green, Bendectin, p. 336.
105. Ibid., p. 337 (quoting a standard textbook on the effects of drugs on the fetus).
106. Ibid., p. 330 (emphasis added).
107. Ibid. p. 339.
108. Ibid., p, 340.
109. Ibid., p. 341.
110. Berger, 'Eliminating General Causation', p. 2135.
111. Green, Bendectin, p. 341. What would constitute appropriate administrative costs is a much vexed question that would have to address a number of different institutions to put it in context.
112. General Elec. Co. v. Joiner, 522 U.S. 136 (1997).
113. Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).
114. Joiner v. General Electric Co., 864 E Supp. 1310 (N.D. Georgia, 1994).
115. Joiner v. General Electric Co., 78 F.3d 524 (11th Cir., 1996)
116. General Elec. Co. v. Joiner 522 U.S. 136.
117. quoting Spring Co. v. Edgar, 99 U.S. 645, 658, 25 L.Ed. 487 (1879).
118. Cooter & Gell v. Hartmarx Corp., 496 U.S. 384, at 400 (1989)
119. quoting Anderson v. Bessemer City, 470 U.S. 564, 573-574.
120. If we take the language seriously - where there are two permissible views of the evidence, the choice between them cannot be erroneous - this poses a difficult problem for a judge faced with testimony that is on the frontiers of scientific research, precisely where legitimate scientific disagreements are highly likely. The abuse of discretion standard suggests that judges' admissibility decisions would not be reviewed no matter which choice was made, even if they consistently decided one way only, e.g., always for plaintiffs or always for defendants.
121. Carmichael v. Samyang Tire, Inc., 131 F.3d 1433 (1997).
122. Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).
123. Ibid., at 153.
124. Ibid., at 152.
125. Susan Haack, 'An Epistemologist in the Bramble-Bush: At the Supreme Court with Mr. Joiner', Journal of Health Politics, Policy and Law 26 (1999): 231-232.
126. Ibid., p. 232.
127. Ibid., pp. 233, 235.
128. Breyer, 'Introduction', Federal Reference Manual on Scientific Evidence, p. 4.
129. However, even this characterization conflates the admissibility of one party's evidence with the legal insufficiency of that party's evidence vis-à-vis the other party. See Sanders, Scientific Validity, for discussion of this point.
130. Richard Lempert, University of Michigan Law School, presentation at Good Science or Junk Science: Should Courts Decide? Wayne State University Law School and Philosophy Department, September, 10-11, 2002. (The claim that plaintiffs' evidence in Joiner was not reliable may be in error; it is currently under investigation by the author and David A. Eastmond as part of research on NSF Grant #99-10952. In particular the neo-natal mice studies so quickly dismissed by the district court and by the Supreme Court appear to be much better forms of evidence than they suggested (Research underway at the University of California, Riverside).)
131. Carl E Cranor, 'Daubert and the Acceptability of Legal Decisions', forthcoming in the Law and Philosophy Newsletter (2004)
132. Journal of Philosophy, Law and Science (2004).
133. Daubert, 509 U.S. at 592-593 (emphasis added).
134. Reviewing the courts' performance to date is not an easy task. Much of the record is simply not available. If courts have admitted evidence without protest from litigants on the other side, there will be no written record of the decision. Even if there has been a motion to exclude evidence, but evidence was admitted, there is likely to be little record unless there was an appeal and an appellate ruling on the issues. The most likely written records exist for evidence that was excluded at trial court with an appellate review. Thus, the discussion that follows inevitably reflects this bias. Most appellate decisions concern excluded evidence and most of those tend to uphold exclusion.
135. Paul Thagard, p. xv.
136. Ibid. He also offers a critique of logical and postmodern explanations of new scientific knowledge, providing an alternative to both.
137. Ibid., pp. 4, 240-241, There is much here that might interest philosophers of science, but it is not pertinent to this discussion.
138. See, for example, Cranor and Eastmond, 'Scientific Ignorance', pp. 128-145, for the most recent work.
139. Thagard, pp. 101-147.
140. Gilbert Harman, 'The Inference to the Best Explanation', Philosophical Review 74 (1994): 89-90.
141. Larry Wright, Critical Thinking. Thagard adopts much of this view, indicating that scientists can infer that the factor causes the disease if this hypothesis is part of the best explanation of the full range of evidence... [and that the factor that is identified as causing] the disease must be a better explanation of the correlation between the factor and the disease than the assertion that some other cause is responsible for both the factor and the disease.
142. Thagard, p. 129.
143. Brian Skyrms, Choice and Chance: An Introduction to Inductive Logic (Belmont, CA: Dickenson Publishing Copany, Inc., 1966).
144. Thagard (at 103) has a particular view about these matters, but we need not adopt it to have a reasonable picture of the search for causal explanations. Moreover, as Wright notes, often the mere fact that there are correlations between two things often provides something to be explained.
145. Skyrms, Choice and Chance, p. 107.
146. Skyrms, Choice and Chance, p. 107. Skyrms' account ofconditioning properties may in fact be somewhat wider than possible explanations endorsed by other views, but this is not germane to our discussion (I owe this point to Larry Wright).
147. Brian Skyrms, Choice and Chance, pp. 81-87.
148. Thagard, 131.
149. See, for example, Thagard, p. 129.
150. Skyrms, Choice and Chance, p. 107.
151. Hutchison and Lane, p. 10, for writers from different methodological perspectives that agree on this point.
152. Tom A. Hutchinson and David A. Lane, 'Standardized Methods of Causality Assessment of Suspected Adverse Drug Reactions', Journal of Clinical Epidemiology 42 (1989), put this point especially strongly, A causality assessment method must respect Fisher's fundamental rule of uncertain inference - never throw information away. That is, any fact, theory or opinion that can affect an evaluator's belief that [a particular exposure] caused an adverse event E must be incorporable by the method into the 'state of information' on which the assessment is based (p. 10).
153. See for example, Larry Wright, Practical Reasoning (New York: Harcourt, Brace Jovanovitch, Inc., 1989), p. 104,
154. Larry Wright, Critical Thinking, pp. 206-217.
155. McCormick on Evidence, pp. 541-542.
156. The Federal Rules of Evidence, section 401 (evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.)
157. For example, the neo-natal mice studies in General Elec. Co. v. Joiner and the rat studies in the Allen v. Pennsylvania Engineering suggesting that ethylene oxide can cause cancer are two such examples.
158. Thagard, p. 102.
159. Austin Bradford Hill, 'The Environment and Disease: Association or Causation?' in Sander Greenland (ed.), Evolution of Epidemiologic Ideas (Chestnut Hill, Mass: Epidemiology Resources, Inc., 1987), pp. 15-24.
160. See also, Douglas Weed, 'Underdetermination and Incommensurability in Contemporary Epidemiology', Kennedy Institute of Ethics Journal 7 (1997): 107-114.
161. See, for example, Tom A. Hutchinson and David A. Lane, 'Standardized Methods of Causality Assessment of Suspected Adverse Drug Reactions', Journal of Clinical Epidemiology 42 (1989): 12.
162. Thagard, p. 104.
163. Other desiderata - not necessary conditions - for assessing epidemiological studies include whether the hypothesis is biologically plausible, whether a study is consistent with other studies, whether there is evidence of a dose response relationship, and whether the time sequence between exposure and disease are biologically plausible, as well as how strong the association is. (See Austin Bradford Hill, 'The Environment and Disease', for further discussion.)
164. Thagard, p. 107.
165. Ibid., p. 109 (emphasis added).
166. see also, pp. 112, 120, 124, 132.
167. Ibid., p. 109.
168. Ibid., p. 120 (taking from about 1498 to the 20th century to understand the mechanism of scurvy).
169. Kenneth S. Santone and Garth Powis, 'Mechanism of and Tests for Injuries', in W.J. Hayes, Jr. and E.R. Laws, Jr. (eds.), Handbookof Pesticie Toxicology (1991) (scientists know the mechanisms of some beneficial and some harmful effects of aspirin but not others (p. 169)).
170. In addition, Larry Wright suggests that mechanistic understanding may be much more useful when we are not sure about the causal properties of a substance than when we are quite certain. For example, we are certain about the relationship between drinking alcohol and poor mental judgment by an agent, but likely not the mechanism by which this occurs (personal communication).
171. Thagard, pp. 118-134.
172. Cranor and Eastmond, 'Scientific Ignorance', pp. 28-45, for a summary of kinds of evidence that consensus scientific bodies frequently draw upon for making causal judgments.
173. For a general discussion of kinds of evidence see the International Agency for Research on Cancer, 'Preamble to the Monograph Series', at http://193.51.164.1l/monoeval/preamble.html.
174. Thagard, p. 198
175. For the importance of social processes in shaping causal knowledge in medicine, see generally Thagard, pp. 167-198.
176. Kenneth R. Foster and Peter W. Huber, Judging Science: Scientific Knowledge and the Federal Court (Cambridge, MA and London: The MIT Press, 1997), pp. 241-245.
177. Cranor and Eastmond, 'Scientific Ignorance', pp. 28-34.
178. Although the examples are taken from federal jurisdictions, Daubert has had influence beyond federal circuits, since at least one-third of the state courts are following Daubert or adopting more stringent standards of review. Many of the remainder are not following Daubert, some even explicitly and virulently rejecting it. State courts may see Frye as either a more stringent or less stringent standard for reviewing expert testimony.
179. See, for example, Donaldson v. Central Illinois Public Service Co., 199 Ill. 2d 63 (2002).
180. This point must be phrased carefully; it is not that the kinds of evidence on which courts have insisted are poor kinds of evidence. Indeed, often it is quite the contrary, they may mistakenly insist on ideal evidence. The problem is that in a number of rulings the evidence courts have required may be evidence that scientists would ideally prefer, but it not necessary for inferences about the toxicity of substances.
181. Cranor, and Eastmond, 'Scientific Ignorance', pp. 34-45
182. For example, in Casey v. Ohio Medical Products, Inc., 877 F. Supp. 1380 (N.D. Cal 1995), the district court judge did not permit plaintiff to rely upon case studies and this court's reasons have been perpetrated and perpetuated throughout the legal system (but not a matter of legal precedent), very likely resulting in mistakes.
183. Wade-Greaux v. Whitehall Lab., Inc., 874 F. Supp. 1441 at 1450 (D.V.I.), aft'd, 46 E3d 1120 (3d Cir. 1994).
184. Cranor, and Eastmond, 'Scientific Ignorance', pp. 34-39.
185. Cranor et al., 'Judicial Boundary Drawing', pp. 31-32 and 49-55.
186. See Chambers v. Exxon Corp., 81 E Supp. 2d 661 (M.D. La. 2000) (citing Brock v. Merrell Dow Pharms., Inc., 874 E2d 307, 311 (5th Cir. 1989)), modified by, 874 E2d 307, 311 (5th Cir. 1989)
187. Wade-Greaux v. Whitehall Labs., Inc., 874 E Supp. 1441 (D.V.I. 1994).
188. See generally Green, Bendectin at 311-317.
189. Cranor et al., 'Judicial Boundary Drawing,' at 31-32.
190. Lucinda M. Finley, 'Guarding the Gate to the Courthouse: How Trial Judges are Using their Evidentiary Screening Role to Remake Tort Causation Rules', 49 DePaul L. Rev. 335 (1999) at 352-356 (noting that courts have adopted epidemiological thresholds in silicone breast implant cases).
191. Cranor et al., 'Judicial Boundary Drawing', pp. 33-49.
192. Hill, 'The Environment and Disease', p. 19. One of Hill's consideration (a cause must temporally precede the effect) is a necessary condition.
193. Thagard, pp. 103-104.
194. Green, Bendectin, pp. 311-317 (arguing that Bendectin and Agent Orange cases should not be generalized to other toxic agents). In both the Bendectin and Agent Orange cases there was particularly good, one might even say decisive (at the time) human evidence, which trumped other kinds of evidence pointing in other directions.
195. See also, Michael D. Green, Legal Theory: Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation, Northwester University Law Review 86 (1992): 678-681 [hereinafter Green, Expert Witnesses].
196. Green, 'Expert Witnesses'.
197. Cranor et al., 'Judicial Boundary Drawing', pp. 31-32;
198. Lucinda Finley, 'Guarding the Gate to the Courthouse: How Trial Judges are Using their Evidentiary Screening Role to Remake Tort Causation Rules', DePaul Law Review 49 (1999): 352-356.
199. Cranor, and Eastmond 'Scientific Ignorance', pp. 30, 34-39 (citing studies from the International Agency for Research on Cancer, the U.S. National Toxicology Program, and the U.S. Environmental Protection Agency.
200. Green, Bendectin, p. 316
201. Cranor, and Eastmond 'Scientific Ignorance', p. 30.
202. Green, Bendectin, p. 316.
203. Thagard, p. 102.
204. Ibid., p. 102.
205. See, for example, James Huff, 'Chemicals and Cancer in Humans: First Evidence in Experimental Animals', Environmental Health Perspectives 100 (1993): 204 [hereinafter referred to as Huff, 'Chemicals and Cancer'].
206. IARC, Overall Evaluations of Carcinogenicity to Itumans: Probably Carcinogenic to Humans (last modified Aug. 9, 2000) .
207. See also Cranor, and Eastmond, 'Scientific Ignorance', pp. 34-45 and notes therein, for further discussion of this point. For example, the International Agency for Research on Cancer addresses negative studies as follows: When several epidemiological studies show little or no indication of an association between an exposure and cancer, the judgement may be made that, in the aggregate, they show evidence of lack of carcinogenicity. Such a judgement requires... [that] the possibility that bias, confounding or misclassification of exposure or outcome could explain the observed results should be considered and excluded with reasonable certainty. In addition, all studies that are judged to be methodologically sound should be consistent with a relative risk of unity for any observed level of exposure and, when considered together, should provide a pooled estimate of relative risk, which is at or near unit)' and has a narrow confidence interval, due to sufficient population size. Moreover, no individual study nor the pooled results of all the studies should show any consistent tendency for relative risk of cancer to increase with increasing level of exposure. It is important to note that evidence of lack of carcinogenicity obtained in this way from several epidemiological studies can apply only to the type(s) of cancer studied and to dose levels and intervals between first exposure and observation of disease that are the same as or less than those observed in all the studies.... [L]atent periods substantially shorter than 30 years cannot provide evidence for lack of carcinogenicity (IARC Monograph Series, Preamble, located at http://193.51.164.11/monoeval/StudiesHumans.html (last updated 17 December 1998; visited 31412002) (emphasis added).
208. Black v. Food Lion, Inc., 171 E 3d 308, 314 (5th Cir. 1999). (The underlying predicates of any cause-and-effect medical testimony are that medical science understands the physiological process by which a particular disease or syndrome develops and knows what factors cause the process to occur. Based on such predicate knowledge, it may then be possible to fasten legal liability for a person's disease or injury.) In Schudel v. General Electric Co., 120 F.3d 991,997 (9th Cir.1997), the court suggested a similar reason for rejecting evidence, although it was not central to its rejection.
209. Thagard, pp. 109-112.
210. Cranor, and Eastmond, 'Scientific Ignorance', pp. 38-39.
211. Santone, & Powis, 'Mechanism of and Tests for Injuries', p. 169.
212. Thagard, pp. 109, 112.
213. In domains in which causal knowledge is rich, there is a kind of feedback loop in which more knowledge about causes leads to more knowledge about mechanisms, which leads to more knowledge about causes. But in less well-understood domains, correlations and the consideration of alternative causes can get causal knowledge started in the absence of much comprehension of mechanisms. (Ibid., p. 109.)
214. Santone, and Powis, 'Mechanism of and Tests for Injuries', p. 169.
215. Green, 'Expert Witnesses', pp. 679-681.
216. Cranor et al., 'Judicial Boundary Drawing', p. 54 note 245.
217. Thagard, p. 141.
218. Consensus scientific bodies such as the International Agency for Research on Cancer or the National Toxicology Program have representative views.
219. For example, see Huff, 'Chemicals and Cancer', pp. 201,204 (stating that the array and multiplicity of carcinogenic processes are virtually common among mammals, for instance between laboratory rodents and humans). He adds, the more we know about the similarities of structure and function of higher organisms at the molecular level, the more we are convinced that mechanisms of chemical toxicity are, to a large extent, identical in animals and man (Id.) The EPA and the Federal Judicial Center Manual on Scientific Evidence concur
220. See Environmental Protection Agency, Proposed Guidelines for Carcinogen Risk Assessment, 61 Federal Register, p. 17,977 (1996), (IT]here is evidence that growth control mechanisms at the level of the cell are homologous among mammals, but there is no evidence that these mechanisms are site concordant [i.e., must be in the same tissue in rodents and humans].
221. Bernard D. Goldstein and Mary Sue Henifin, 'Reference Guide on Toxicology', in Reference Manual on Scientific Evidence (Federal Judicial Ctr. ed., 2d ed. 2000), at 419.
222. See Blum v. Merrell Dow Pharmaceuticals for a court's discussion of this point.
223. Cranor, and Eastmond, 'Scientific Ignorance', pp. 35-39.
224. Ibid., pp. 41-45.
225. Cranor et al., 'Judicial Boundary Drawing', p. 55.
226. See also Blum v. Merrell Dow Pharmaceuticals, Inc. 33 Phila. Co. Rptr. 193, for a judicial discussion of how even pharmaceutical firms' use of controlled animal studies assist understanding and correcting the results of human studies.
227. OTA, Identifying, pp. 126-127.
228. Faustman and Omenn, 'Risk Assessment', in Casarett and Doull's Toxicology, p. 86 (An agent's structure, solubility, stability, pH sensitivity, electrophilicity, volatility, and chemical reactivity can be important information for hazard identification. Historically, certain key molecular structures have provided regulators with some of the most readily available information on the basis of which to assess hazard potential.
229. J. Ashby and R. W. Tennant, 'Chemical Structure, Salmonella Mutagenicity and Extent of Carcinogenicity as Indicators of Genotoxic Carcinogenesis among 222 Chemicals Tested in Rodents by the U.S. NCI/NTP', Mutation Research 204 (1988): 17-115.
230. David, A. Eastmond, Chair, Department of Environmental Toxicology, University of California, Riverside, personal communication.
231. The Fifth Circuit Court of Appeals has argued that not even lie detector tests are subject to per se exclusions (United States v. Posado, 57 E3d 428 (5th Cir. 1995).
232. Strom, Brian L. ed., Pharmacoepideimology, 3rd ed. (New York: John Wiley & Sons LTD, 2000), p. 77.
233. Carl E Cranor, 'Justice, Inference to the Best Explanation and the Judicial Evaluation of Scientific Evidence', forthcoming in Topics in Contemporary Philosophy: Vol. H: Law and Social Justice, ed. Joseph Keim Campbell, Michael O'Rourke, and David Shier (Cambridge, MA: MIT Press, 2004), for further discussion of these points [hereinafter referred to as Cranor, 'Justice'].
234. and Carl E Cranor and David Strauss, 'Case Studies in Law and Science' (forthcoming).
235. The National Vaccine Injury Compensation Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub.L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C.A. w167 et seq. These cases are not traditional torts, and utilize somewhat different rules for the admissibility of expert testimony, but often cite Daubert.
236. Cranor and Strauss, 'Case Reports'.
237. Casey v. Ohio Medical Products, 877 E Supp 1380 at 1385.
238. Brumbaugh v. Sandoz Pharmaceuticals E Supp. 2d 1153, 1156 (D. Montana, 1999).
239. Haggerty v. Upjohn Co. 950 E Supp. 1160, 1165 (S.D. Florida, 1996).
240. Eathleen R. Stratton, Cynthia J. Howe, and Richard B. Johnston, ed., Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (Washington, D.C.: (National Institute of Medicine) National Academy Press, 1994), 23-24.
241. Hutchinson, Tom A. and David A. Lane, Assessing Methods for Causality Assessment of Suspected Adverse Drug Reaction, Journal of Clinical Epidemiology 42 (1989a): 10-11.
242. and a related quite thoughtful article by Michael S. Kramer and David a. Lane, Causal Propositions in Clinical Research and Practice, Journal of Clinical Epidemiology 45 (1992): 639-649.
243. Stratton, et al., Adverse Events, pp. 23-24.
244. Gerald Klatskin and Daniel V. Kimberg, Recurrent Hepatitis Attributable to Halothane Sensitization in an Anesthetist, The New England Journal of Medicine 280 (March 6, 1969): 515.
245. Stratton, et al., Adverse Events, p. 86.
246. See Renate D. Kimbrough, 'Pathological Changes in Human Beings Acutely Poisoned by Dimethylnitrosamine', Banbury Report No. 12.
247. Ronald C. Shank and Deborah C. Herron, Methylation of Human Liver DNA After Probable Dimethylnitrosamine Poisoning, Nitrosamines & Human Cancer, 153-159 (Peter N. Magee ed., 1982).
248. Berton Roueche, 'The Lemonade Mystery', Saturday Evening Post, May-June 1982, at 58.
249. Henry Falk, John L. Creech, Jr., Clark W. Heath, Jr., Maurice N. Johnson and Marcus M. Key, Hepatic Disease Among Workers at a Vinyl Chloride Polymerization Plant, JAMA 230 (Oct. 7, 1974): 59.
250. Clark W. Heath, Jr., Henry Falk and John L. Creech, Jr., Characteristics of Cases of Angiosarcoma of the Liver Among Vinyl Chloride Workers in the United States, Annals of the New York Academy of Sciences (1975): 231.
251. Allan H. Conney, Induction of Microsomal Enzymes by Foreign Chemicals and Carcinogenesis by Polycyclic Aromatic Hydrocarbons: G.H.A. Clowes Mermorial Lecture, Cancer Research 42 (1982): 4875-4917.
252. International Agency for Research on Cancer, 'Polychlorinated Biphenyls', Monograph Series, Supplement 7 (1987): 322.
253. R. Michael McClain et al., Neonatal Mouse Model: Review of Methods and Results, Toxicologic Pathology (Suppl.) 29 (2001): 128-137.
254. and Samuel M. Cohen, 'Alternative Models for Carcinogenicity Testing: Weight of Evidence Evaluations across Models', Toxicologic Pathology (Suppl.) 29 (2001): 183-190. The author and a toxicologist, David A. Eastmond, have a paper in progress on this issue.
255. General Elec. Co. v. Joiner, 522 U.S. at 146-147.
256. General Elec. Co. v. Joiner, 522 U.S. at 152-153.
257. Ibid., at 154.
258. Sometimes courts appear to believe that the assessment of the risks of contracting a disease is a different task from assessing the causes of disease, and, thus, claim that weight of the evidence methodology used for risk assessment should not be utilized to assess causation. (Allen v. Pennsylvania Engineering Corp., 102 E3d 194, 197 (5th Cir. 1996).) Scientists themselves reject such a distinction. (David A. Eastmond, Chair, Environmental Toxicology, University of California, Riverside, personal communication.).
259. General Electric v. Joiner, 522 U.S. at 151-155 (Stevens, dissenting opinion).
260. Scientists and physicians involved in assessing adverse events from immunization propose a method for assessing vaccine-caused adverse events that is based on the best available information, [such that] [m]aximum use is made of all available information and nothing is arbitrarily discarded. Gerald M. Fenichel, David A, Lane, John R. Livengood, Samuel J. Horwitz, John H. Menkes and James E Schwarrtz, 'Adverse Events following Immunication: Assessing Probability of Causation', Pediatric Neurology 5 (1989): 287-290, at 290.
261. Tom A. Hutchinson and David A. Lane, 'Standardized Methods of Causality Assessment of Suspected Adverse Drug Reactions', Journal of Clinical Epidemiology 42 (1989): 10 (emphasis added).
262. See, Haack, 'An Epistemologist in the Bramble Bush', for some discussion of the puzzle metaphor.
263. Dauber v. Merrell Dow Pharm., Inc., 509 U.S. at 594-595 (emphasis added).
264. General Elec. Co. v. Joiner, 522 U.S. at 145-146.
265. Ibid., at 146.
266. See, for example, Skyrrns, p. 10.
267. Wright, Critical Thinking, pp. 374-382.
268. Thagard, p. 113.
269. Cranor, 'Justice', for further discussion of these points.
270. General Elec. Co. v. Joiner, 522 U.S.p. 520 (Justice Breyer concurring opinion (emphasis added)).
271. Carl E Cranor, Daubert and the Acceptability of Legal Decisions.
272. See, for example, Michael D. Green, 'Expert Witnesses and Sufficiency of Evidence', 86 NW. U. L. Rev. 643, 697 (1992), at 687 (The tort law is indifferent as between a plaintiff's erroneous recovery [a legal false positive] and a defendant's erroeous non-liability [a legal false negative]. Santosky v. Kramer, 455 U.S. 745,755 (1982) (adopting the standard set forth in Addington that in any given proceeding, the... standard of proof.., reflects not only the weight of the private and the public interests affected, but also a societal judgment about how the risk of error should be distributed between the litigants).
273. Addington v. Texas, 441 U.S. 418, 423 (1979) (explaining that the preponderance of the evidence requires litigants to share the risk of error in roughly equal fashion).
274. See section II.
275. Moreover, even if courts were initially conscientious, but inaccurate in their review of scientific evidence, such mistakes can be perpetrated and perpetuated through the legal system by means of precedent or just by following sister courts. And, once even unwitting errors have been made, they can invite deliberate legal strategies by defendants or other judges to exclude experts in later cases. In addition, if courts do not make scientifically accurate decisions, this tends to drive quite good and respectable scientists from participating the law, a task that is not particularly pleasant at its best. If a judge excludes an expert in one case, this legal fact can be utilized in future proceedings and it does not take many such events before the expert will not want to participate or he or she will have a mistakenly acquired reputation that may contribute to exclusion in other cases. (Considerable anecdotal evidence suggests some well-known and quite respectable scientists have been excluded in recent years.)
276. Cranor, Regulating, pp. 8, 49-82.
277. and Carl F. Cranor, 'Science and the Law in the U.S.: Some Philosophic Issues and Recent Legal Trends', Politeia: Rivista di Etica e Scelte Pubbliche, Anno XIX. N. 70 (October 2003).
278. W. Page Keeton, Dan B. Dobbs, Robert E. Keeton and David Owen, Prosser andKeeton on Torts, 5th ed. (St. Paul, MN: West Publishing Co., 1984), pp. 165-168.
279. Green, 'Expert Witnesses' and Cranor, Regulating, pp. 30-48 (sometimes this relationship is mathematical and sometimes more empirical).
280. Magistrini v. One Hour Martinizing, 180 F. Supp. 2d 584-613 (2002), and personal communication, Gerson Smoger, Smoger and Associates, Oakland, California, a plaintiffs' attorney.
281. Soldo v. Sandoz Pharmaceuticals Corporation, 2003 WL 355931 (W.D.Pa).
282. See also Sanders, Scientific Validity, for discussion of this point.
283. Joe Cecil, Director of Research, Federal Judicial Center, personal communication.
284. 35 E3d 717 (3d Cir. 1994), cert. denied, 513 U.S. 1110 (1995).
285. In re TMI Litigation, 193 E3d 613,664 (3d Cir., 1999).
286. quoting Heller v. Shaw Industries, Inc., 167 F.3d 146, 153 (3d Cir. 1999).
287. Ibid., at 666.
288. Ibid., at 665 (quoting In re Paoli Railroad Yard PCB Litigation, 35 F3d 717 at 744) (emphasis added).
289. And, It]he test of admissibility is not whether a particular opinion has the best foundation, or even whether the opinion is supported by the best methodology or unassailable research. Rather, the test is whether the 'particular opinion is based on valid reasoning and reliable methodology.'... The goal is reliability, not certainty. Once admissibility has been determined, then it is for the trier of fact to determine the credibility of the expert witness. (Ibid. (quoting Kannankeril v. Terminix International Inc., 128 F.3d 802 (3d Cir. 1997).)
290. In Paoli, the Third Circuit twice reviewed district court decisions on the exclusion of expert testimony and evidence, overturning it each time, forcing the trial court finally to have a jury trial on the factual issues in the case. In a bifurcated trial in which causation issues were separated from liability, the jury decided nearly all issues against plaintiffs. When the jury trial and verdict were appealed to the Third Circuit, it upheld admissibility and other judicial decisions leading up to the jury verdict. The result? The appellate court appeared to insist that expert testimony and scientific evidence not be excluded for spurious reasons even though in the end a jury did not find for plaintiffs. That exemplifies a proper distinction between admissibility and ultimate legal correctness, leaving proper roles for both the judge (preliminary screening of the evidence) and the jury (the ultimate weighing and assessing of the correctness of plaintiff's versus defendant's evidence).
291. See Haack, An Epistemologist in the Bramble-Bush, who presents a particularly interesting example from research science: Chargaff's discovery that there are approximate regularities in the relative proportions of adenine and thymine, guanine and cytosine in DNA is hardly, by itself, strong evidence that DNA is a double-helical, backbone-out macromolecule with like-with-unlike base pairs; Franklin's X-ray photographs of the B form of DNA are hardly, by themselves, strong evidence that DNA is a double-helical, backbone-out macro-molecule with like-with-unlike base pair. That the tetranucleotide hypothesis is false is hardly, by itself, strong evidence that DNA is a double-helical, backbone-out macromolecule with like-with-unlike base pairs, and so on. But put all these pieces of evidence together, and the doublehelical, backbone-out, like-with-unlike base pairs, structure of DNA is very well warranted (in fact, the only entry that fits).
292. Of course, judges should not insist on what they regard as correct or probably correct expert testimony. Such a screening principle would resemble the Wade-Greaux decision, would be much too demanding for torts, would erect new and vastly higher barriers for plaintiffs than at present, intrude on the jury's authority and violate the Constitution, inter alia.
293. Cranor, 'Daubert and the Acceptability of Legal Decisions'.
294. Kumho Tire v. Carmichael, 526 U.S. at 523.
295. Green, Bendectin, p. 317, suggests that a decision based on the preponderance of the available evidence, rather than imposing an evidentiary threshold, would be closest in keeping with the role of the civil justice system. Thus where mature epidemiological evidence does not exist analysis of the sufficiency of plaintiff's evidence... would begin by considering the universe of available evidence of toxicity.
296. (Ibid., 316) This proposal may discomfit some because plaintiffs with relatively thin and attenuated evidence could bring a case to trial, [b]ut the reality is that stronger and better evidence is unavailable (through no fault of anyone) and a decision based on the preponderance of the available evidence, rather than imposing an evidentiary threshold, would be closest in keeping with the role of the civil justice system. For other suggestions.
297. see, Cranor and Eastmond, 'Scientific Ignorance', p. 47.
298. Judges sometimes have sometimes utilized this form of argument by analogy when they followed other courts in mistakenly excluding evidence.
299. Cranor and Eastmond, 'Scientific Ignorance', pp. 34-45.
300. Daubert, pp. 595-596.
301. There will remain substantial upfront costs for plaintiffs in particular because they have the burden of proof and because of the judicial scrutiny of experts.
302. Cranor and Eastmond, 'Scientific Ignorance', pp. 45-47.
303. Berger, 'Eliminating General Causation', pp. 2140-2144.
304. Cranor and Eastmond, 'Scientific Ignorance', pp. 45-47.