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The Biomedical Researcher and Subpoenas: Judicial Protection of Confidential Medical Data

Published online by Cambridge University Press:  24 February 2021

Angela R. Holder
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Abstract

An increasing number of medical researchers are being subpoenaed to testify or to supply records in cases in which they have not agreed to become involved as expert witnesses. The researchers’ published works are alleged to have formed the basis of the opinions of physicians testifying as expert witnesses in these cases. Although the courts usually protect confidential medical data, the considerable burden of quashing these subpoenas is still imposed upon researchers and their universities. This Article argues that courts should protect these research records from subpoenas.

Type
Articles
Information
American Journal of Law & Medicine , Volume 12 , Issue 3-4: Public Health & The Law , 1986 , pp. 405 - 421
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1986

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References

1 See, e.g., Note, The Public Scholar and the First Amendment: A Compelling Need for Compelling Testimony?, 40 GEO. WASH. L. REV. 995 (1972)Google Scholar; Nejelski, & Lerman, , A Researcher-Subject Testimonial Privilege: What to Do Before the Subpoena Arrives, 1971 Wis. L. REV. 1085Google Scholar; O'Neil, , Scientific Research and the First Amendment: An Academic Privilege, 16 U.C. DAVIS L. REV. 837 (1983)Google Scholar.

2 United States v. John Doe, 460 F.2d 328, 332 (1st Cir. 1972), cert. denied, 411 U.S. 909 (1973); United States v. John Doe, 332 F. Supp. 938, 941-42 (D. Mass. 1971).

3 John Doe, 460 F.2d at 333-34.

4 583 F. Supp. 991 (E.D.N.Y. 1984), rev'd, 750 F.2d 223 (2d Cir. 1984).

5 Id. at 993.

6 In re Grand Jury Subpoena Dated Jan. 4, 1984, 750 F.2d 223 (2d Cir. 1984).

7 Id. at 225.

8 United States v. IBM, 83 F.R.D. 92 (S.D.N.Y. 1979).

9 Id. at 95.

10 Kaufman v. Edelstein, 539 F.2d 811 (2d Cir. 1976).

11 Id. at 821.

12 494 F. Supp. 107 (E.D. Wis. 1980), aff’d sub nom. Dow Chem. Co. v. Allen, 672 F.2d 1262 (7th Cir. 1982).

13 Allen, 494 F. Supp. at 113.

14 Buchanan v. American Motors Corp., 697 F.2d 151 (6th Cir. 1983); Wright v. Jeep Corp., 547 F. Supp. 871 (E.D. Mich. 1982).

15 547 F. Supp. 871 (E.D. Mich. 1982).

16 Id. at 874.

17 Id. at 875.

18 697 F.2d 151 (6th Cir. 1983).

19 Id. at 152.

20 Richards of Rockford, Inc. v. Pacific Gas & Elec. Co., 71 F.R.D. 388 (N.D. Cal. 1976).

21 Id. at 390.

22 99 Misc. 2d 235, 415 N.Y.S.2d 780 (N.Y. Sup. Ct. 1979).

23 Id. at 236-37, 415 N.Y.S.2d at 781-82.

24 Annot, ., Physician-Patient Privilege as Extending to Patient's Medical or Hospital Records, 10 A.L.R.4th 552 (1981)Google Scholar. An excellent discussion of privileged communications may be found in Developments in the Law—Privileged Communications, 98 HARV. L. REV. 1450 (1985).CrossRefGoogle Scholar

25 E.g., N.Y. Civ. PRAC. LAW § 4504 (Consol. Supp. 1987); CAL. EVID. CODE § 994 (West 1980). See W. WADLINGTON, J. WALTZ & R. DWORKIN, CASES AND MATERIALS ON LAW AND MEDICINE 170-202 (1980); Orr v. Sievert, 162 Ga. App. 677, 678-79; 292 S.E.2d 548, 549 (1982); Williams v. Sistrunk, 417 So. 2d 14, 15 (La. Ct. App. 1982).

26 See FED. R. EVID. 501.

27 E.g., Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556, 566 (7th Cir. 1984).

28 E.g., Caesar v. Mountanos, 542 F.2d 1064, 1065 (9th Cir. 1976), cert. denied, 430 U.S. 954 (1977); Williams v. Thomas Jefferson Univ., 54 F.R.D. 615, 616 (E.D. Pa. 1972); Conyers v. Massa, 512 P.2d 283, 284 (Colo. App. 1973); Anderson v. Florence, 288 Minn. 351, 358, 181 N.W.2d 873, 877 (1970).

29 E.g., Johns-Mansville Prods. Corp. v. Cather, 208 Miss. 268, 281, 44 So. 2d 405, 408 (1950); see Commonwealth ex rel. Romanowicz v. Romanowicz, 213 Pa. Super. 382, 385-86, 248 A.2d 238, 240 (1968); Holder, , The Physician's Duty to Testify, 219 J.A.M.A. 1541 (1972)CrossRefGoogle Scholar.

30 E.g., Battista v. Bellino, 113 N.J. Super. 545, 574, 274 A.2d 595, 596 (App. Div. 1971).

31 E.g., Jordan v. Kelly, 728 F.2d 1 (1st Cir. 1984); Glenn v. Kerlin, 248 So. 2d 834, 836 (La. Ct. App. 1971); Alexander v. Knight, 197 Pa. Super. 79, 177 A.2d 142 (1962).

32 E.g., Unitk v. Kessler Memorial Hosp., 107 N.J. Super. 121, 125-26, 257 A.2d 134, 136 (Law Div. 1969); Tucson Medical Center v. Rowles, 21 Ariz. App. 424, 520 P.2d 518, 523 (1974).

33 See Marchand v. Henry Ford Hosp., 398 Mich. 163, 168-69, 247 N.W.2d 280, 282-83 (1976).

34 E.g., Apicella v. McNeil Laboratories, Inc., 66 F.R.D. 78 (E.D.N.Y. 1975).

35 Holder, When Researchers are Served Subpoenas, 7 IRB: A REVIEW OF HUMAN SUBJECTS RESEARCH, July-Aug. 1985, at 5. See also Grinnell Corp. v. Hackett, 70 F.R.D. 326 (D.R.I. 1976).

36 See FED. R. EVID. 611, 705.

37 See FED. R. EVID. 401, 705.

38 Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556, at 565.

39 FED. R. CIV. P. 26(c), cited in Lampshire v. Procter & Gamble Co., 94 F.R.D. 58, 60 (N.D. Ga. 1982), vacated, 708 F.2d 732 (11th Cir. 1983); see also Maurer, , Compelling the Expert Witness: Fairness and Utility under the Federal Rules of Civil Procedure, 19 GA. L. REV. 71 (1984)Google Scholar.

40 5 U.S.C. § 552 (1976).

41 E.g., Sterling Drug Inc. v. Harris, 488 F. Supp. 1019, 1028 (S.D.N.Y. 1980); Webb v. Department of Health & Human Servs., 696 F.2d 101, 108 (D.C. Cir. 1982).

42 445 U.S. 169 (1980).

43 Id. at 171.

44 Id. at 172.

45 Id. at 182.

46 Id. at 174-75, 186.

47 Id. at 186.

48 704 F.2d 1280 (9th Cir. 1983).

49 Id. at 1290.

50 Id. at 1291.

51 Holder, supra note 35; Parker v. Richardson-Merrell, No. CV-80-00077107-5 (Conn. Super. Ct., Stamford Dist. Dec. 19, 1984)(order quashing subpoena).

52 In re Application of R. J. Reynolds Tobacco Co., in Page v. Lincoln Electric Co., 136 Misc. 2d 282, 285-86, 518 N.Y.S.2d 729, 733.

53 Id. at 284-85, 518 N.Y.S.2d at 732.

54 Id. at 284-85, 518 N.Y.S.2d at 733.

55 See, e.g., Murray, & Pagon, , Informed Consent for Research Publication of Patient Data, 32 CLINICAL RESEARCH 404 (1984)Google Scholar; Appelbaum, , Roth, & Detre, , Researchers’ Access to Patient Records: An Analysis of the Ethical Problems, 32 CLINICAL RESEARCH 399 (1984).Google Scholar

56 Holder, Do Researchers and Subjects Have a Fiduciary Relationship?, IRB: A REVIEW OF HUMAN SUBJECTS RESEARCH, Jan. 1982, at 6.

57 Lampshire v. Procter & Gamble Co., 94 F.R.D. 58, 60 (N.D. Ga. 1982), vacated, 708 F.2d 752 (11th Cir. 1983).

58 Id.

59 See infra notes 61-64 and accompanying text.

60 Herbst, , Ulfelder, & Poskanzer, , Adenocarcinoma of the Vagina—Association of Maternal Stilbestrol Therapy with Tumor Appearance in Young Women, 284 NEW. ENG. J. MED. 871 (1971).CrossRefGoogle Scholar

61 Andrews v. Eli Lilly & Co., 97 F.R.D. 494, 499 (D. 111. 1983).

62 Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556, 558 (7th Cir. 1984).

63 Id. at 560.

64 101 F.R.D. 355 (N.D. Ga. 1984), aff'd, 758 F.2d 1545 (11th Cir. 1985); see also Curran, , Protecting Confidentiality in Epidemiological Investigations by the Centers for Disease Control, 314 NEW ENG. J. MED. 1027 (1986)CrossRefGoogle Scholar.

65 Farnsworth, 101 F.R.D. at 357.

66 See, e.g., 45 C.F.R. § 46.107 (mandating that at least one member of an IRB be “knowledgeable” in the law). See generally R. LEVINE, ETHICS AND REGULATION OF CLINICAL RESEARCH (2d ed. 1986).

67 See, e.g., Holder, supra note 35.

68 E.g., Deitchman, 740 F.2d at 563.

69 In re Application of R. J . Reynolds, 136 Misc. 2d at 286, 518 N.Y.S.2d at 733.

70 See Buchanan v. American Motors Corp., 697 F.2d 151, 152 (6th Cir. 1983).

71 FED. R. CIV. P. 26(c).

72 42 C.F.R. Part 2a.

73 21 C.F.R. § 1316.21; 28 C.F.R. § 22.28.