Advertisement

A Legal Viewpoint on the Relevance of Phenotypic Variation to Risk Assessments

  • John G. HarkinsJr.
  • Ellen Kittredge Scott
  • William J. Walsh
Part of the Basic Life Sciences book series (BLSC, volume 43)

Abstract

Despite substantial efforts to regulate the discharge of hazardous and potentially hazardous substances into the general environment and into the workplace, there is a residual level of such substances that will remain there for some time. Moreover, much remains to be learned about materials which are still regularly discharged; and continuing discharges at some level are virtually inevitable even as to substances about which we know a great deal.

Keywords

Phenotypic Variation Supra Note Sickle Cell Trait Expert Testimony Handicapped Individual 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Comm. on Public Works, National Air Quality Act of 1970, S. Rep. No. 91–1196, 91st Cong., 2d Sess. 7, 10 (1970).Google Scholar
  2. Conference Report on SARA, H. R. Rep. No. 99–962, 99th Cong. 2d Sess. 294, reprinted in, 1986 U.S. Code Cong. & Ad. News 3276, 3387.Google Scholar
  3. EPA, Air Quality Criteria for Lead, 42 Fed. Reg. 63076 (December 14, 1977). See also Lead Industries Association v. EPA, 647 F.2d 1130, 1155–56 (D.C. Cir.), cert. denied, 449 U.S. 1042 (1980) (statute is preventative in nature and requires EPA personnel to use their judgment in face of uncertainty and to err on the side of protecting people’s health).Google Scholar
  4. EPA, Air Quality Criteria for Lead, 42 Fed. Reg. 63076 (December 4, 1977).Google Scholar
  5. See R. Kimbrough, et al., Health Implications of 2, 3, 7, 8-Tetrachlorodibenzo-p-Dioxin (TCDD): Contamination of Residential Soil, 14 J. Toxicol. Environ. Health 47 (1984) (describing the rationale for the one part per billion soil cleanup level for TCDD used by EPA at hazardous waste sites which assumes a child eats 10 grams of soil per day).Google Scholar
  6. EPA, Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 33,992 (Sept. 24, 1986).Google Scholar
  7. EPA, Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. at 33,998.Google Scholar
  8. EPA, Guidelines for Carcinogen Risk Assessment, 51 Fed. Reg. 33,992 (Sept. 24, 1986).Google Scholar
  9. 21.
    U.S.C. §348(c) (3) (A).Google Scholar
  10. H.R. Rep. No. 2284, 85th Cong. 2d Sess. 4–5 (1958), reprinted in, Legislative Record of 1958 Food Additives Amendment to Federal Food, Drug, and Cosmetics Act at 12–13, (C. Dunn ed. 1959) (“Legislative Record”); S. Rep. No. 2422, 85th Cong. 2d Sess. 2–3 (1985), reprinted in, Legislative Record, supra at 64 and n.106.Google Scholar
  11. FDA, Sulfiting Agents: Revocation of GRAS Status for Use on Fruits and Vegetables Intended to be Served or Sold Raw to Consumers, 51 Fed. Reg. 25,012 (July 9, 1986) (Final Rule).Google Scholar
  12. See also Sulfiting Agents; Proposal to Revoke GRAS Status for Use on Fruits and Vegetables Intended to be Served or Sold Raw to Consumers, 50 Fed. Reg. 32,830 (August 14, 1985) (Proposed Rule); Report of the Ad Hoc Review Panel on the Re-examination of the GRAS Status of Sulfiting Agents at 60 (January 31. 1985),Google Scholar
  13. 51.
    Fed. Reg. 43, 900 (December 5, 1986); 51 Fed. Reg. 25,021 (July 9, 1986).Google Scholar
  14. See E. Calabrese, Ecogenetics, Genetic Variation in Susceptibility to Environmental Agents at 331 (John Wiley & Sons, 1984).Google Scholar
  15. See United Steelworkers of America v. Marshall, 647 F.2d 1189, 1238 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981).Google Scholar
  16. Other potential sources of protection may be found in the United States Constitution and the Civil Rights Acts. For a variety of reasons, these avenues of relief are often less successful. See McGarity and Schroeder, Risk Oriented Employment Screening, 59 Tex. L. Rev. 999, 1022 n.104 (1981).Google Scholar
  17. Many states have fair employment practice laws which in some instances prohibit discrimination on the basis of factors not contained in federal law. For instance, New Jersey law protects against employment discrimination based on “atypical hereditary cellular blood traits,” N.J. Stat. An. §10:5–12a (West Supp. 1985), while Florida, North Carolina and Louisiana prohibit discrimination in employment based on sickle cell trait. For a discussion of these state law analogies, see [1986] 3 Empl. Prac. Guide (CCH) 20,000–29,335.Google Scholar
  18. 42.
    U.S.C. §§2003 et seq (1964).Google Scholar
  19. See generally B. Schlei and P. Grossman, Employment Discrimination Law, Ch. 2 (2d ed. 1984).Google Scholar
  20. 42.
    U.S.C. §2000e-2(e).Google Scholar
  21. B. Schlei and P. Grossman, supra note 18 at 341.Google Scholar
  22. See, e.g., Dothard v. Rawlinson, 433 U.S. 321 (1977) (state correctional facility had valid defense against claim that policy of refusing to hire women in maximum security male prison due to the impact of womanhood on a woman’s relative ability to maintain control); Weeks v. Southern Bell Telephone and Telegraph Co., 408 F.2d 228, 235 (5th Cir. 1969) (BFOQ defense did not apply to justify refusal to hire females for jobs requiring lifting over 3 0 pounds). In Diaz v. Pan American World Airways, 442 F.2d 385, 388 (5th Cir.), cert. denied, 404 U.S. 950 (1971), the Court of Appeals for the Fifth Circuit also required a showing that the “essence of the business operation would be undermined by not hiring members of one sex exclusively.” See generally B. Schlei and P. Grossman, supra note 18 at 244, 327, 341–60. See also Rothstein, Employee Selection Based on Susceptibility to Occupational Illness, 81 Mich. L. Rev. 1379, 1459 (1983).Google Scholar
  23. Griggs v. Duke Power Co., 401 U.S. 424, 432 (1971) (“Congress directed the thrust of the Act to the consequences of employment practices, not simply the motivation”)Google Scholar
  24. Albemarle Paper Co. v. Moody, 422 U.S. 405, 425 (1975) (plaintiff’s prima facie case is made by showing that “the tests in question select applicants for hire or promotion in a racial pattern signficantly different from the pool of applicants.”)Google Scholar
  25. Generally, statistical data is used to establish plaintiff’s prima facie case, which data must be validated and relevant to the geographical area and the labor pool. To support a finding of sufficient statistical significance, courts have employed a rule of “greater than two to three standard deviations” from the expected rate, see Castineda v. Partida, 430 U.S. 482, 496 n.17 (1977), or 80% of the selection rate of the group with the highest selection rate. See Uniform Guidelines on Employee Selection Procedures, 29 CFR Pt. 1607 (1978). See generally B. Schlei and P. Grossman, supra note 18 at 98 and Supp. 1985 at 15.Google Scholar
  26. Griggs v. Duke Power Co., 401 U.S. 424, 431 (1971).Google Scholar
  27. See also B. Schlei and P. Grossman supra note 18 at 83.Google Scholar
  28. Griggs v. Duke Power Co., 401 U.S. 424at 92.Google Scholar
  29. See Wright v. Olin Corp, 697 F.2d 1172 (4th Cir. 1982). See also Hayes v. Shelby Memorial Hospital, 726 F.2d 1543 (11th Cir. 1984). In Hayes the court held that “when a policy designed to protect employee offspring from workplace hazards proves facially discriminatory there is, in effect, no defense, unless the employer shows a direct relationship between the policy and the actual ability of a pregnant fertile female to perform her job” and questioned whether the hospital’s desire to avoid litigation which might arise from an injury to the fetus could constitute a business necessity. Id. at 1549, 155–53 n.15. See generally Rothstein, supra note 21 at 1460–66; Williams, Firing the Woman to Protect the Fetus: The Reconciliation of Fetal Protection with Employment Opportunity Goals Under Title VII, 69 Geo. L. J. 641 (1981); Comment, Birth Defects Caused by Parental Exposure to Workplace Hazards: The Interface of Title VII with OSHA and Tort Law, 12 J. L. Ref. 237 (1979).Google Scholar
  30. See Matthewman, Title VII and Genetic Testing: Can Your Genes Screen You Out of a Job?, 27 How. L. J. 1185, 1206 (1984); Rothstein, supra note 21 at 1387; C. Holden, Air Force Challenged on Sickle Trait Policy, 211 Science 257 (January 16, 1981); D. Uddin, L. Dickson, C. Brodine, Screening of Military Recruits for Hemoglobin Variants, 227 JAMA 1405 (March 25, 1974).Google Scholar
  31. 29.
    U.S.C. §§701–796 (1982). Many states have adopted their own laws prohibiting discrimination against handicapped individuals which, in many instances, provide greater protection than the Rehabilitation Act by encompassing a greater number of employers and including a greater number of persons within the protected group of handicapped individuals. See McGarity and Schroeder, supra note 16 at 1054–56; Rothstein, supra note 21 at 1436–37 n.392; Hoffman, Employment Discrimination Based on Cancer History: The Need for Federal Legislation, 59 Temp. L. Q. 1, 14–21.Google Scholar
  32. U.S.C. §§701–796 (1982). Many states have adopted their own laws prohibiting discrimination against handicapped individuals which, in many instances, provide greater protection than the Rehabilitation Act by encompassing a greater number of employers and including a greater number of persons within the protected group of handicapped individuals. See McGarity and Schroeder, supra note 16 at 1054–56; Rothstein, supra note 21 at 1436–37 n.392; Hoffman, Employment Discrimination Based on Cancer History: The Need for Federal Legislation, 59 Temp. L. Q. 1, 14–21.at §706 (7) (B).Google Scholar
  33. School Board of Nassau County v. Arline, 107 S. Ct. 1123, 1129 (1987) (“By amending the definition of “handicapped individual” to include not only those who are actually physically impaired, but also those who are regarded as impaired… Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.”).Google Scholar
  34. Regulations promulgated by the Department of Health and Human Services define “major life activities” as: functions such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, and working.Google Scholar
  35. 45.
    C.F.R. §84.3 (j) (2) (ii) (1985). Whether an impairment of employment, for example, is “substantial” necessitates a case-by-case inquiry into the “number and type of jobs which the individual’s impairment affects, the geographical area and employment opportunities therein and the individual’s own expectations and desires.” E.E. Black, Ltd. v. Marshall, 497 F. Supp. 1088, 1100–1101 (D. Hawaii 1980). An “otherwise qualified” individual is one who is able to meet all of the employment requirements in spite of his or her handicap. School Board of Nassau County v. Arline, 107 S. Ct. 1123, 1131 n.17 (1987) (citing Southeastern Community College v. Davis, 442 U.S. 397, 406 (1979)). In Mantolete v. Bolger, 767 F.2d 1416 (9th Cir. 1985), the court held that in order to screen out a handicapped individual on the basis that he or she is not otherwise qualified due to possible future injury, there must be a showing of a “reasonable probability of substantial harm,” a mere ‘elevated risk’ standard would not be sufficient. Id. at 1422. When a handicapped individual is not otherwise qualified, the court must also consider whether any “reasonable accommodation by the employer would enable the individual to perform the essential functions of the job. Arline, supra at 1131 n.17 (citing 45 C.F.R. §84.3(k) (1985)). “Accommodation is not reasonable if it either imposes… ‘undue financial and administrative burdens upon an [employer]’… or ‘requires a fundamental alteration in the nature of the program.’“Id. (quoting Southeastern Community College v. Davis, 442 U.S. 397, 410 (1979)).Google Scholar
  36. See A. Larson, The Law of Workmen’s Compensation §§ 2.00, 6.60, 7.00, 41.90, 80.33.Google Scholar
  37. See, e.g., The Radiogenic Cancer Compensation Act. S. 921. 98th Cong., 1st Sess., 129 Cong. Rec. §3924 (March 24, 1983), which proposes that all radiation cancer victims who, by use of radioepidemiological tables developed pursuant to the Orphan Drug Act, 42 U.S.C. §241, can establish a probability of causation of 51% or more, may recover damages in full up to a ceiling amount, while those who show a 10% or less probability of causation would be denied compensation, with those between 10% and 51% recovering proportionally.Google Scholar
  38. Fed. R. Evid. 4 01.Google Scholar
  39. Fed. R. Evid. 702.Google Scholar
  40. See Abraham and Merrill, Scientific Uncertainty in the Courts, Issues in Science and Technology 93 (Winter 1986).Google Scholar
  41. Lagakos and Mosteller, Assigned Shares in Compensation for Radiation-Related Cancers, 6 Risk Analysis 345 (1986).Google Scholar
  42. At best, in such circumstances, an expert can only state a probability of causation, and the most important evidence of that probability is epidemiology. For a discussion of judicial treatment of epidemiological evidence, see, e.g., McElveen and Eddy, Cancer and Toxic Substances: The Problem of Causation and the Use of Epidemiology, 33 Cleveland St. L. Rev. 29 (1984); Black and Lillienfeld, Epidemiologic Proof in Toxic Tort Litigation, 52 Fordham L. Rev. 7 32 (1984); Comment, Epidemiologic Proof of Probability: Implementing the Proportional Recovery Approach in Toxic Exposure Torts, 89 Dick. L. Rev. 233 (1984); Hall and Silbcrgeld, Reappraising Epidemiology: A Response to Mr. Dore, 7 Harv. Env. L. Rev. 441 (1983); Dore, A Commentary on the Use of Epidemiological Evidence in Demonstrating Cause in Fact, 7 Harv. Env. L. Rev. 429 (1983). See also Kaye, The Limits of the Preponderance of the Evidence Standard: Justifiably Naked Statistical Evidence and Multiple Causation, A.B.A. Res. J. 487 (1982).Google Scholar
  43. Restatement (Second) of Torts §461 (1965) (“The negligent actor is subject to liability for harm to another although a physical condition of the other which is neither known nor should be known to the actor makes the injury greater than that which the actor as a reasonable man should have foreseen as a probable result of his conduct.”)Google Scholar
  44. See, e.g., Tiderman v. Fleetwood Homes of Washington, 102 Wash.2d 335, 684 P.2d 1302 (1984) (because formaldehyde used in construction of mobile home was “harmful to some extent to a reasonably foreseeable and appreciable percentage of users,” manufacturer had duty to make its product safe for the plaintiff who allegedly sustained a severe and permanent case of asthma from her exposure); Advance Chemical Co. v. Harter, 478 So.2d 444 (Fla. App. 1985), rev, denied, 488 So.2d 829 (Fla. 1986) (abnormally severe reaction to ammonia fumes compensable); Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984) (rare reaction to long-term exposure to paraquat compensable).Google Scholar
  45. See, e.g., Ferebee v. Chevron Chemical Co., supra note at 1535, in which the Court stated: a cause-effect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound, such as use of tissue samples, standard tests, and patient examination, products liability law does not preclude recovery until a “statistically significant” number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical. In a courtroom, the test for allowing a plaintiff to recover in a tort suit of this type is not scientific certainty but legal sufficiency; if reasonable jurors could conclude from the expert testimony that paraquat more likely than not caused Ferebee’s injury, the fact that another jury might reach the opposite conclusion or that science would require more evidence before conclusively considering the causation question resolved is irrelevant.Google Scholar
  46. See, e.g., Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir.), cert, denied, 107 S. Ct. 437 (1986); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096 (1974).Google Scholar
  47. The point is illustrated by an opinion written by a well respected federal jurist, Judge John Minor Wisdom. In Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.), cert. denied, 419 U.S. 1096 (1974), Sabin oral polio vaccine had been administered to a child who thereafter contracted polio. Virus recovered from the child was of a wild type, thereby tending to negate on scientific grounds a causative relationship between the vaccine and the subsequent illness. The court nevertheless affirmed a jury verdict for the plaintiff on the ground of a failure to warn of a very small risk that the vaccine could cause polio and on the additional ground that it is desirable to spread the risk of an untoward result as a cost of manufacturing a product. While this case has nothing to do with phenotypic variation, per se, it seems to ignore evidence a scientist would deem relevant (the identity of the virus) and to credit evidence a scientist would view with caution (the mere sequence of events involving administration of the vaccine followed by the onset of polio).Google Scholar

Copyright information

© Plenum Press, New York 1988

Authors and Affiliations

  • John G. HarkinsJr.
    • 1
  • Ellen Kittredge Scott
    • 1
  • William J. Walsh
    • 1
  1. 1.Pepper, Hamilton & ScheetzPhiladelphiaUSA

Personalised recommendations