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Legal Consequences of Disposable Dialyzer Reuse

Published online by Cambridge University Press:  24 February 2021

Scott G. Hallquist
Scott G. Hallquist*
Affiliation:
University of North Carolina
*
United States Court of Claims.
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Abstract

This Article discusses potential legal liability for adverse effects resulting from reuse of disposable hemodialysis equipment. After explaining the dialysis process and the health risks involved with the reuse of dialyzers, the Article outlines possible theories of recovery for injured dialysis patients. The Article describes the possibility of recovery under a negligence theory against either the treating physician or the institutional provider, and includes a discussion of applicable statutory law. The remainder of the Article discusses possible recovery under the theory of strict liability.

Type
Articles
Information
American Journal of Law & Medicine , Volume 8 , Issue 1 , Spring 1982 , pp. 1 - 25
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2020

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References

1 Rettig, End-Stage Renal Disease and the “Coii” of Medical Technology, in Department of Health, Education and Welfare, Medical Technology: The CuLntrr Remind Health Care Costs? 88 (S. Altman & R. Blend on 1979).

2 Id.

3 G. Wiluncmyre, Reuse of Sinclf.-Use Hemodialyzers 4-11 (1979).

4 Id.

5 Id. at 3.

6 For a discussion of one cost-cutting alternative by the primary reimbursement source, the Health Care Financing Administration (HCFA) of the Department of Health and Human Services, see Schorr, federal Plan to Encourage Home Dialysis, Cutting Medical Costs, Stirs Patient Fears, Wall St. J” Apr. I, 1982, at 29, col. 4. Under the authority of the 1978 Social Security Amendments, 42 U.S.C. § 426-1 (Supp. 1979), victims of end stage renal disease arc eligible for federal reimbursement of dialysis costs.

7 G. Willingmyrk, supra note 3.

8 Deane, Blagg, Bower, DcPalma, Gulch, Ranter, Ogden, Sadler, Diemscn, Teehan & Sosin, A Survey of Dialyzer Reuse Practice in the United States, 7 Dialysis and Transplantation 1128 (1978) [hereinafter cited as Deane).

9 See, e.g., Bilinsky, & Morris, , Hemodialysis Coil Reuse: A Safe and Economical New Method, 218 J. A.M.A. 1806 (1971)CrossRefGoogle ScholarPubMed.

10 See, e.g., infra notes 26-30 and sources cited therein.

11 G. Wim.incmyri, supra note 3, at 30.

12 Id. at 14-18. These conditions would include assurance of quality control inspection, maintenance of adequate reprocessing and storage environments, verifiable records of use of each dialyzer and detailed reports of sterilization procedures. Id. ai 30.

13 National Association of Patifnts on Hemodialysis and ‘Fra nsi*la station, Dialyzer Reuse—NAPHT’s Statlmi nt ok Position (1979).

14 G. Willingmyre, supra note 3, at 19.

15 Interview with Margaret Diener, NAPHT Executive Director (October, 1981).

16 First, the kidney excretes toxins and metabolic by products whose concentrations in the body must be minimized. Second, the kidney regulates the balance between water and electrolytes (salts) in the body fluids, purging excess water and salts. Third, the kidney plays a major role in regulating the body's acid/base balance, through the excretion of monobasic acid phosphate and organic acids. See generally C. Best & X. Taylor, Physiological Basis of Medical Practice (16th ed. 1979); C. Gutch & M. Stoner, Review of Hemodialysis for Nurses and Dialysis Personnel (3d etl. 1979); Henderson, Hemodialysis in 1 G. Strauss & J. Welt, Diseases of the Kidney -121 (L. Early & C. Gottschalk, 3d cd. 1979).

17 Among these conditions are polycystic nephritis, hypertensive renal disease, com-plications of diabetes mcllitus and systemic lupus crythematosis, cancer, and infections of the urinary tract. See generally supra note 16 and sources cited therein.

18 These include acute urcmic toxemia; the accumulation of urea and other metabolic by-products to toxic levels; h)pcrtcnsion or very high blood pressure; ischcmia, an imbalance in the body's electrolyte levels; and hyperacidosis, id.

19 G. Willingmyre,, su/>ra note 3, at 4.

20 Id. at 8.

21 See Rilinsky fc Morris, supra note 9, and infra notes 26.30.

22 By October I. 1982. the United States will have spent $1.8 billion in ESRD program expenditures to keep 700,000 patients alive on dialysis. SchoiT, supra note 6.

The overseas diaUsis community, which lias practiced more extensively than the domestic community, has produced the bulk of the literature reporting reuse methods and equipment. See, e.g., Ahmed, & Goldsmith, , Automated Dialyier Riming Machines, 4 Dialysis & Transplantation 75 (1975)Google Scholar; Bell & Figueroa, Hemodialysis Cost Reduction by Artificial Kidney Storage: A Simple, Effective Technique for the Reuse of Coil Kidneys, 1970 Rrit. Mr.D. J. 788; Miach, Evans, Wilcox & Dawborn, The Reuse of a Disposable Dialyier for Home Dialysis, 1976 Mid. J. Acstl. H6; Vandenbroucke, Stragier & van Ypcrscldc Sirihou, Efficiency of Automated Reuse of Disposable Diatyzers, Proc Euroitan Dialysis Proc. Transplantation Ass’n 591 (1977).

23 G. Wimjngmyrf, supra note 3, at 19.

24 Id.

25 Id. at 19-25.

26 Several writers have reported outbreaks of bactcrial infections resulting from the use of non-sterile reused dialyzers, leading to a discontinuance of the practicc by the aficctcd ccnters. Kurhnel k I.undh, Outbreak of Psuedomatias Cepacia Bacteremia Related to Contaminated Reused Coils, 5 Dialysis & Transpi-wtation *14 (1976); Neff & Malowany. Reuse of Dialysis Coils. 219 J. A.N1.A. 1765 (1972); Wagnild. McDonald, Craig. Johnson. Hanley. Uman, Ramgopal & Beirne. Pseudomonas Aeruginosa Bacteremia in a Dialysis Unit, Relationship to Reuse of Coils, 62 Am. J. Mi:d. 672 (1977). Although there is infection risk associated with conventional single-use dialysis, the repeated handling, non standardized sterilization procedures, and possibility of accidentally switching dialyzers among patients magnifies these baseline, or inherent, risks. One report noted several incidents in a survey in which patients were inadvertently dialyzcd with a dialyzer previously used by another patient. Deane, supra note 8. at 1130. The risk of contracting serum hepatitis, which is already elevated among dialysis patients and provider personnel, is also increased by the additional handling occasioned by reuse. Fatality rates for hepatitis infections observed among dialysis patients have been recorded at between five and ten percent, and for systemic blood infections at somewhat less than five percent. Stamm, Stamm Highlights Device-Related Infections. in Hospital Infiction Control 100 (June 1978).

27 pyrogenic, or fever-producing reactions which arise following dialysis are generally attributed to substances created by bacteria, known gencrically as endotoxins, which trigger a patient's immunological defenses. These substances can ctoss dialyzer membranes. Hindman, Favero, Carson, Petersen, Schonberger & Solano, Pyrogenic Reactions During Hemodialysis Caused by Extramural Endotoxin in 2 Lancet 732 (1975); Raij, Shapiro, and Michael, Endo-Toxemia in Febrile Reactions During Hemodialysis, in 4 Kidney Int’l 57 (1973). Reuse has been cited as a contributing factor to the incidence of pyrogenic reactions experienced by dialysis patients, with an occasional severe reaction resulting in hospitalization. Bell & Figueroa, supra note 22; Deane, supra note 8; Kuehnel & Lundh, supra note 26; Wing. Brunner. Brynger. Chantler, Donckerwolckc, Gurland. Jacobs & Selwood, Mortality and Morbidity of Reusing Dialyzers, 2 Brit. Med. J. 853 (1978).

28 Formaldehyde in aqueous solution, or formalin, is used as the sterilizing and storage solution in virtually all reuse procedures which have been reported. If this compound is not thoroughly rinsed from the dialyzer prior to use, a residue can trigger burning sensations, numbness of the lips and tongue, a rapid drop in blood pressure, and hemolysis (destruction of red blood cells). The consequences of a more massive iatrogenic infusion could be catastrophic.

Fortunately, there is a distinctive, sharp odor characteristic of formaldehyde, and the test procedures used to detect residues are reliable, tending to minimize the risks of an accidental infusion among conscientious service providers. Nevertheless, the latent immunologic changes which have been linked to formaldehyde-residual blood interactions in the dialyzer during storage and sterilization are more insidious. Ogden, Myers. Eskelson & Ziegler, Iatrogenic Administration of Formaldehyde to Hemodialysis Patients, T ransactions Dialysis & Transplantation F. Ml (1973); Orringer k Mat tern, Formaldehyde-Induced Hemolysis During Chronic Hemodialysis, 291 New Enc. J. Mfd. 141G (1976); Reveillaud, Dcschamps & Aubert, Risks of IV Administration of Formaldehyde to Hemodialyzed Patients, 11 Kidney Int'l 292 (1977).

29 After each dialysis session, a non trivial residue of blood and blood components remains in the dialyzer. Most of this material can be flushed from the device, but a significant fraction remains bound tightly to dialyzer surfaces or trapped in inaccessible areas of the device. During the formaldehyde-mediated sterilization, and storage process, chemical reactions between these residues and formaldehyde produce a new group of altered substances which can be introduced to the patient’s bloodstream during a subsequent dialysis session. Bird & Wingham, AntiS Antibodies in Renal Dialysis Patients, 1977 I.anclt 1218; Crosson, Moulds, Comty & Polcsky, A Clinical Study of Anti-,V (DP) in the Sera of Patients in a Large Repetitive Hemodialysis Program. 10 Kidney Int'l 463 (1976); Harrison, Jansson, Kronenberg, Mahoney &: Tiller, Cold Agglutinin Formation in Patients Undergoing Hemodialysis: A Possible Relationship to Dialyzer Reuse, 5 Austl. New Zealand J. Med. 1% (1975); Kaehny, Miller & White, Relationship He tween Dialyzer Reuse and the Presence of Anti-X-Like Antibodies in Chronic Hemodialysis Patients, 12 Kidney Int’l 59 (1977) [hereinafter cited as Kaehny].

30 Although studies have appeared with purported results to the contrary, the consensus among most clinicians is that the performance of a dialyzer after even a single reuse is considerably less efficient than that of a fresh unit. More leaks are recorded upon reuse, and the presence of clogged or otherwise occluded fibers rcduccs effective volume, and hence surface area, of the common hollow-fiber dialyzer types. Farrell, Eschbach, Vizzo & Babb, Hertwdialyzer Reuse: Estimation of Area I^oss from Clearance Data, 5 Kidney Int’l 446 (1974). In addition, the membrane itself has been demonstrated to lose permeability, particularly to middle and higher molccular weight molecules, after a single use. Raja, Kollmann, Kramer & Rosenbaum, Solute Transport in Reused Hollow Fiber Artificial Kidney, 13 Nfphron 325 (1974). These compromises in performance become progressively more severe as the unit is used in additional dialyses. Scanning electron microscopy clearly reveals great globs of debris and cellular material adhering to dialyzer surfaces even after a thorough flushing and sterilization cycle. Gunnarsson, Asaba, Kiibus, Soderborg, Wilkund &Bergtidn, Fibrin Deposition in Disposable Dialyzers Before and After Re use, 12 CLINICAL Nephrolocy 117 (1979). This decrease in dialyzer efficiency implies that a patient on a reuse program is not dialyzcd completely, particularly with respect to the higher end of the dialyzable molecular weight spectrum, during runs undertaken with reused units. Dialysis times are typically extended during runs with used units, and patients frequently report an overall less optimal sense of well-being following such a session. Interview* with Margaret Dicncr, NAPHT Executive Director (October, 1981).

31 42 C.F.R. §§ 405.1011, .2100 .2171 (1980).

32 5” infra note 110 and accompanying text.

33 42 VS.C. §§ 401-432 (1979).

34 Pub. L. No. 95*292, § 1881(f)(7), 92 Stat. 314 (1978).

35 N. Deane & J. Demis, Multiple Use of Hcmodialyzers, Final Report to the National Institute of Arthritis. Diabetes, and Digestive and Kidney Diseases (1981) (Contract No. N01-AM-9-2214).

36 Id. at 8.

37 See W. Prosser, Handbook of the Law of Torts § 55 (4ih cd. 1971); Restatement (Second) ok Torts § 281 (1965).

38 See supra notes 31-36 and infra notes 100*114 and accompanying text.

39 See H. Prosser, supra note 37, at § 30.

40 See id. § 36.

41 See generally id. §§ 41-45.

42 See C. Cutch & M. Stoner, supra note 16.

43 id.

44 id.

45 Kolata, SMC Thrives Selling Dialysis, 208 Science 379, 381 (1980).

46 See generally W. Prosser, stipra note 37, at § 32; see also Lejeune v. United States Casualty Co., 227 F. Supp. 191, 194 (W.D. La. 19G1).

47 W.Prosser, supra note 37, at § 32.

48 See generally Swartz, , Products Liability: Manufacturer's Liability for Defective or Negligently Designed Medical and Surgical Instruments, 18 Dr Paul L. Rev. 3-18 (1969)Google Scholar; Physician and Hospital Liability for Defective Products Used in the Treatment of Patients. 46 Ins. Counsel J. 566 (1979); Watrous, Liability for Medical Appliances in Malpractice Suits: The Fly in the Ointment, 10 Ti:x. Tech l” Rev. 403 (1979); see also I.eff. Medical Devices and Paramedical Personnel: A Preliminary Context /or Emerging problems, 1967 Wash. U.LQ. 332.

49 See Darling v. Charleston Community Mem. Hosp., 33 III. 2d 326. 211 N.E.2d 253, cert, denied, 383 U.S. 946 (1965).

50 See W. Prosser, supra note 37, at § 32.

51 Id.

52 Id.

53 See, e.g., O'Brien v. Stover. 443 F.2d 1013 (8th Cir. 1972); Carmichael v. Reitz. 17 Cal. App. 3d 958. 95 Cal. Rptr. 381 (1971); Morrison v. MacNamara. 407 A.2d 555 (D.C. 1979); Francisco v. Parchment Mai. Clinic. 407 Mich. 325 . 285 N.W.2d 39 (1979) (per curiam); Koury v. Folio, 272 N.C. 366. 158 S.E.2d 548 (1968). See generally W. Harney. Medical Maltractice 96 (1973); C. Doutiiwaite. Jury Instructions on Medical Issues 371 (2d ed. 1980).

54 Hendry v. United States. 418 F.2d 774. 784 (2d Cir. 1969); Brown v. United States, 293 F. Supp. 13. 16 (F..D. Mo.), aff’d, 419 F.2d 337 (8th Cir. 1968).

55 See W. Prosser, supra note 37. at § 32.

56 Chumbler v. McClure,, 505 F.2d 489. 492 (6th Cir. 1974) (interpreting Tennessee law).

57 See supra notes 11-14 and accompanying text.

58 Medical Dcvice Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified in scatter sections of 21 U.S.C.) (requiring, inter alia, certain performance standards, premarket approval, rccord keeping and good manufacturing practicc for mcdical devices).

59 21 C.F.R. § 820.3(f) (1981).

60 21 U.S.C. § 360(i) (1976).

61 G. Willingmyre,, supra note 3, at 10-11.

62 Id. at 10.

63 Id.

64 See Johnston v. Black Co., 33 Cal. App. 2tl 363. 91 P.2d 921 (1939); Cochran v. Harper, 115 Ga. App. 277, 154 S.E.2d 461 (1967); Nelson v. Swedish Hosp., 242 Minn. 551. 64 N.W 2d 38 (1954).

65 Nelson v. Swedish Hosp., 242 Minn. 551, 64 N.W.2d 38 (1954) (where physician and hospital found negligent for failure to inspect X-ray machine, held defects not hidden, as evidenced by uncomplicated 30-minute inspection which would have revealed defects).

66 See generally W. Prosser,, supra note 37. at § 56. fl7 id..

67 Id.

68 Id. § 70.

69 Levett v. Etkind, 158 Conn. 567, 265 A.2d 70 (1969); Su v. Perkins, 133 Ca. App. 474. 211 S.E-2d 421 (1974).

70 fBoyd v. Badenhausen, 556 S.W.2d 896 (Ky. 1977).

71 See supra not” 67-70 and accompanying text.

72 See generally Note, The Hospital and the Stafl Physician—.-In Expanding Duty of Care, 7 Cuncinos L. Rr.v. 249 (1974).

73 See Overstreet Doctor*! Hosp. M2 Oa App. 893. 237 S E .2d 213 (1977).

74 The salaried physician is clearly an employe of the hospital. Brown v. La Sodetc Francaisc du Bten Faiuncc Mutuelle, 138 Cal. 475, 71 P. 516 (1903); Lundberg v. Bay View Hosp. 175 Ohio St. 133. 191 N.E.2d 821 (1963). Even if the doctor bills the patient direct), he may still be considered an emplo>ce of the hospital. James v. Holder. 34 A.D.2d 632. 309 N.Y.S. 2d 385 (1970).

75 See Newton County Hosp. v. Nkkolson. 132 Ca. App. 164. 207 S.E.2d 659 (1974).

76 Seneris v. Haas. 45 Cal. 2d 811, 291 P.2d 915 (1955): Carcia v. Tamo. 380 So. 2d 1068 (Fla. App. 1980).

77 Seneris v. Haas, 45 Cal. 2d 811, 291 PJ?d 915 (1955); see also Mehlman v. Powell. 281 Md. 269. 378 A.2d 1121 (1977); Ri statement (Sicoso) or Agencv § 267 (1965).

78 Seneris v. Haas. 45 Cal. 2d 811. 291 P.2d 915 (1955).

79 Hoover v. University of Chicago Hosp. 51 111. App. 3d 263. 366 N.E^d 925 (1977).

80 Id. at 267 . 366 N.E.2d at 929.

81 Darling v. Charleston Community Mem. Hosp,, 33 111. 2(1 326, 211 N.K.2d 233* cert, denied, 383 VS. 916 (1965).

82 See Hernandez v. Smith, 552 F.2d 142 (5th Cir. 1971); Weeks v. I,atter-Day Saints Hosp., -118 F.2d 1035 (10th Cir. 1969); Tucson Gen. Hosp. v. Russell. 7 Am. App. 193, 137 P.2d 677 (1968); Shepherd v. McGinnis, 257 Iowa 35, 131 N.W.2d -175 (1961); Suburban Hosp. Ass'n Inc. v. Hodary, 22 Md. App. 186, 322 A.2d 258 (197*1): Starnes v. CharlotteMecklenburg Hosp. Auch., 28 N.C. App. *118, 221 S.E.2d 733 (1976); Iloltforth v. Rochester Gen. Hosp., 301 N.Y. 27, 105 N.E.2d 610 (1952); Peck v. Charles B. Towns Hosp,, 275 A.D. 302, 89 N.Y~S.2d 190 (1919); Jeffcoat v Phillips, 531 S.W.2d 168 (Tex. Civ. App. 1976).

83 See Richard v. Southwest I.a. Hosp. Ass*n, 383 So. 2d 83 (La. App. 1980).

84 See Register v. Wilmington Med. Center, Inc.. 377 A*2d 8 (Del. 1977).

85 m See Crumley v. Memorial Hosp. Inc.. 509 F. Supp. 531 (E.D. Tcnn. 1978); Mitchell County Hosp. Auth. v. Joiner, 229 Ga. MO, 189 S.E.2d *112 (1972); Darling v. Charleston Community Mem. Hosp., 33 111. 2d 326, 211 N.F.*2d 253, cert, denied, 383 U.S. 916 (1965).

86 Keene v. Methodist Hosp., 324 F. Supp. 233 (VI). Ind. 1971); Bilonoha v. Zubritzky, 233 Pa. Super. 136. 336 A.2d 351 (1975); Tonsic v. Wagner. 220 Pa. Super. 468, 289 Aid 138 (1972).

87 Hicks v. United Slates, 357 F. Supp. 434 (D.C. 1973), aff'd. 511 F.2d 407 (D.C. Cir. 1975): Penn Tanker Co. v. United States. 310 F. Supp. 613 (S.I). Tex. 1970); Steeves v. United States, 294 F. Supp. 446 (D.S.C. 1968); Kapuschinsky v. United States, 248 F\ Supp. 732 (D.S.C. 196G); Pederson v. Dumouchel. 72 Wash. 2d 73. 431 P.2d 973 (1967).

88 See Corlrto v. Shore Mem. Hosp.. 138 N.J. Super. 302, 350 A.2d 534 (1975), citing Fiorentino v. Wenger, 19 N.Y.Sd 407, 227 N.E.2d 296, 280 N.Y.S.2d 373 (1967).

89 Informed consent is a relatively recent development in the law. The earliest cases treated an unauthorized operation as giving rise to a cause of action in battery. Mohr v. Williams, 95 Minn. 261, 104 N.W.2d 12 (1905). While at least one jurisdiction retains that view today, Trogun v. Fruchtman, 207 N.W.2d 297 (Wis. 1973), the prevailing view recognizes a cause of action in negligence when the secured consent is not informed. Natanson v. Kline, 186 Kan. 393, 350 P.2d 1093 (I960); Kaplan v. Haines, 96 N.J. Super. 242, 232 A.2d 840 (1967).

90 460 F. Supp. 713 (N.D. 111. 1978).

91 Id.

92 Id. See also Nishi v. Hartwell, 52 Hawaii 188, 473 P.2d 116 (1970).

93 See Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972); Niblack v. United States, 438 F. Supp. 383 (D. Colo. 1977).

94 Miller v. Van Newkirk, 628 P.2d 143 (Colo. App. 1980).

95 Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

96 Mink v. University of Chicago, 460 F. Supp. 713 (N.D. 111. 1978); see also Emmett v. Eastern Dispensary & Casualty Hosp., 396 F.2d 931 (D.C. Cir. 1967).

97 See supra note 65.

98 C.F.R. § 812.122 (1981).

99 21 C.F.R. §§ 50.20* 50.25 (1981). The provisions arc:

§ 50.25 Elements of informed consent.

  • (a) Basic elements of informed consent. In seeking informed consent, (he following information shall be provided to each subject:

  • (1) A statement that the study involves research, an explanation of the pur-poses of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which arc experimental.

  • (2) A description of any reasonably forseeable risks or discomforts to the subject.

  • (3) A description of any benefits to the subject or to others which may rea-sonably be expected from the research.

  • (4) A disclosure of appropriate alternative procedures or courses of treatment, if any. that might be advantageous to the subject.

  • (5) A statement describing the extent, if any. to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.

  • (6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments arc available if injury occurs and. if so, what they consist of. or where further information may be obtained.

  • (7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects rights, and whom to contact in the event of a rcscarch-rclatcd injury to the subject.

  • (8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subjcct may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.…

100 See generally W. Prosser, supra note 37, at § 36.

101 See. e.g., Concord Fla. Inc. v. Lcwin, 341 So. 2d 242 (Fla. App. 1976). A minority of jurisdictions ueat sudi violations as rebuttable presumptions, Alarid v. Vanier, 50 Cal. 2d 617. 327 P.2d 897 (1958), or simply evidence of negligcnce, Staines v, Jones, 500 F.2d 1233 (8th Cir. 1974) (applying Nebraska law).

102 See Restatement, (SrcosD) of Torts § 286 (1977):

§ 286: When Standard of Conduct Defined by Legislation or Regulation Will Be Adopted

The court may adopt as the standard of conduct of a reasonable man the requirements of a legislative enactment or an administrative regulation whose purpose is found to be exclusively or in part

  • (a) to protect a class of persons which includes the one whose interest is invaded, and

  • (b) to protect the particular interest which is invaded, and

  • (c) to protect that interest against the kind of harm which has resulted, and

  • (d) to protect that Interest against the particular hazard from which the harm results.

Note, however, that the injury suffered must still be proximately caused by the breach of the statutory duty. Lister v. Campbell, 371 So. 2d 133 (Fla. App. 1979).

103 Carter v. William Sommerville & Son, Inc., 581 S.W.2d 274 (Tex. 1979).

104 Id. See generally Note, Negligence per se as a Theory of Action in California Medical Malpractice Cases, 11 U.S.F.L. Rev. 517 (1977) [hereinafter cited as California Medical Malpractice].

105 See, eg., Cal. Evid. Code §§ 660, 669 (West 1966 & Supp, 1982); see also Horn v. Clark, 221 Cal. App. 2d 622, 35 Cai. Rptr. II (1963).

106 Pub. L. No. 91-295, 90 Stat. 539 (1976).

107 42 U.S.C. § 426*1 (Supp. 1979).

108 See supra notes 31-36 and accompanying text. The reuse issue was first considered by the Department of Health, Education and Welfare (HEW) (now DHHS) in the context of another class of medical devices, disposable cardiac catheter and guidewires. In November, 1974, the General Accounting Office (GAO) notified the Secretary of HEW that GAO had noted that certain Department of Defense and Veteran’s Administration hospitals were resterilizing and reusing these devices. GAO had reported this to the appropriate agencies, which had subsequently discontinued the practice. GAO recommended that HEW, in conjunction with the Joint Commission on Accréditation of Hospitals (JCAH), establish criteria for non-federal hospitals and enforcc compliance via the certification program for participation in Medicare. See G. Wuxincmyr£, supra note 3, at 14.

109 G. Willingmyre,, supra note 3, at 16. The applicable statute foTbids the introduction into interstate commerce of a device which is adulterated or mislabeled. 21 U.S.C. § 331(a) (1976). Enforcement provisions include injunction, criminal penalties, and seizure. 21 U-S.C. §§ 332-33*1 (1976). Moreover, a presumption of interstate commerce is provided in the specific case of medical devices. 21 U.S.C. § 379(a) (1976).

110 G. Willingmyre,, supra note 3, at 17.

111 Id. at 15.

112 Shilkret v. Annapolis Emergency Hosp. Ass*n, 276 Md. 187, 349 A.2d 245 (1975); Cornfeldt v. Tongen, 262 N.W.2d 681 (Minn. 1977); Foley v. Bishop Clarkson Mem. Hosp. 185 Neb. 89, 173 N\W\2d 881 (1970); Mikel v. Flatbush Gen. Hosp., 49 A.D£d 581. 370 N.Y-S.2d 162 (1975); Stone v. Proctor. 259 N\C. 633. 131 S.E.2d 297 (1963).

113 See Block v. Michael Reese Hosp.. 93 111. App. 3d 578, 417 N.E£d 724 (1981); Pederson v. Dumouchel, 72 Wash. 2d 73, 131 P.2d 973 (1967).

114 See generally California Medical Ma(practice, supra note 104.

115 See supra notes 23-30 and accompanying text.

116 See supra notes 28-29 and accompanying text.

117 See Kachuy, supra note 29.

118 See infra notes 126*27 and accompanying text.

119 Mullins v. Bexar County llosp. Dist., 535 S.W.2d 41 (Tex. Civ. App. 1976); Ilelman v. Sacred Heart Hosp., 62 Wash. 2d 136. 381 P.2d 605 (1963).

120 See Kapuschinsky v. United States, 218 F. Supp- 732 (D.S.C. 1966).

121 Id.

122 See Carr v. St. Paul Fire fc Marine Ins Co. 384 F. Supp. 821, 828 (D.C. Ark. 1971).

123 Burford v. Baker, 53 Cal. App. 2d 301. 306, 127 P.2ti 941. 913 (1912); Borowski v. Von Solbrig, 14 III. App. 3d 672, 680. 303 N.E.2d M6, 152 (1973).

124 See Daniels v. Hadley Mem. Hosp., 566 F.2d 749, 752 (D.C. Cir. 1977); Boroxvski, 14 III. App. 3d at 680, 303 N.E.2d at 152.

125 “Res ipsa loquitur” translates loosely as “the thing speaks for itself.’ Where it appears that the defendant had exclusive control of the vehicle of harm, and common experience indicates that the harm would not have happened absent the defendant’s failure to exercise due care, there is a rebuttable presumption of negligence. See generally Seifert v. I.os Angeles Transit Lines, 56 Cal. 2d 498, 364 P.2d 337, 15 Cal. Rptr. 161 (1961); Goodyear Tire & Rubber Co. v. Hughes Supply. Inc., 358 So. 2d 1339 (Fla. 1978); City of Louisville v. Humphrey, 461 S.W.2d 352 (Ky. App. 1970); Prosser, The Procedural Effect of Res Ipsa Loquitur, 20 Minn. L. Riv. 241 (1936).

126 40 Ohio App. 2d 77, 317 N.F..2d 922 (1973).

127 Id. See also Walker v. Rumer. 73 111. 2d 495, 381 N.F..2d 689 (1978).

128 Shields, 40 Ohio App. 2d at 78-79, 317 N.E.2d ai 924-25.

129 id. at 79, 317 N.E.2d at 925.

130 id.

131 See infra note 156.

132 Shields, 40 Ohio App. 2d at 81, 317 N.E.2d at 925.

133 id. at 80-81, 317 N.E.2d at 925.

134 Id. at 82-83, 317 N.E.2d at 926-27.

135 id. at 83, 317 N.E.2d at 927.

136 Section 402(A) of the Restatement (Second) of Torts (1977) states in part:

§ 102(A): Special Liability of Seller of Product for Physical Harm to User or Consumer

  • (1) One who sells any product in a defective condition unrcavinahly dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

    • (a) the seller is engaged in the business of selling such a product, and

    • (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

  • (2) The rule stated in subsection (I) applies though

    • (a) the seller has exercised all possible care in the preparation and sale of his product, and

    • (b) the user and consumer has not bought the product from or entered into any contractual relation with the seller.

Furthermore, comment f to § -102(A) indicates that liability is not limited to manufacturers of new products, but is applied to the seller of “any product/* including nonmanufacturing dealers in used products. Moreover, it has been held that one significantly modifying a used protluct prior to sale assumes the same status as a manufacturer of a new product. Green v. City of Los Angeles, 10 Oal. A pp. 3d 819, 838, 115 Cal. Rptr, 685, 697 (1971).

137 “Where the seller at the time of contracting has reason to know any particular purpose for which the goods are requited and that the buyer Is relying on the seller's skill and judgment … there is unless excluded or modified …, an implied warranty that the goods shall be fit for such purpose. U.C.C. § 2-315 (1978). “A ’sale’ consists in the passing of title from the .viler to the buser for a price.“ U.C.C. § 2-106 (1978).

138 “[U]nless excluded or modified, … a warranty that the goods shall be merchantable is implied in the contract for their sale… U.C.C. § 2.314 (1978).

139 See. e.g.. Silverhart v. Mt. Zion Hosp., 20 Cal. App. 3d 1022, 98 Cai. Rptr. 187 (1971); Magrine v. Krasnica, 91 N.J. Super. 228, 227 A .2d 539 (1967); Perlmutter v. Ileth David Hosp., 308 N.Y. 100, 123 N.E.2d 792 (1934); see generally Note, Products and the Professional: Strict Liability in the Sale-Service Hybrid Transaction, 21 Hastings L.J. 111 (1972).

140 Friend v. Child's Dining fiali Co., 231 Mass. 65, 120 N,E. 407 (1918); Newmark v. Gimbcrs, Inc.. 54 N.J. 585, 258 A2d 697 (1969).

141 See supra note 140.

142 Note, supra note 139 at 111-112.

143 54 N.J. 585, 258 A.2d 697 (1969).

144 Id. at 596-97. 258 A.2d at 702.

145 See e.g. Whitehurst v. American Nati Reti Crow, I Ariz. App. 326, 402 P.2d 584 (1965); Fisher v. Wilmington Gen. Hosp.. 51 Del. 554, 149 A.2d 249 (1959).

146 Restatement (Second) of Torts § 402(A) comment k (1977).

147 See Moore v. Underwood Mem. Hosp.. 147 N.J. Super. 252. 371 A.2d 105 (App. I)iv. 1977).

148 355 F. Supp. 1065 (D.C. Wis. 1973).

149 Id. at 1067.

150 id.

151 255 Pa. Super. 381, 387 A.2d 480 (1978).

152 id. at 382, 387 A.2d at 484. Another products liability action filed against a provider who supplied a defective orthopedic pin withstood a motion to dismiss in Cheshire v. Southhampton Hosp. Ass’n, 53 Misc. 2d 355, 278 N.Y.S.2d 531 (1967).

153 94 N.J. Super. 228, 227 A.2d 539 (1967), aff’d sub nom. Magrine v. Spector, 100 N.J. Super. 223, 241 A.2d 637 (App. Div. 1968), aff'd, 53 N.J. 259*, 250 A.2d 129 (1969).

154 20 Cal. App. 3d 1022, 98 Cal. Rptr. 187 (1971).

155 Magrine, 94 N.J. Super, at 234, 227 A.2d at 543.

156 Silverhart, 20 Cal. App. 3d at 1027 n.4, 98 Cai. Rptr. at 191 n.4.

157 Carmichacl v. Reitz, 17 Cal. App. 3d 958, 95 Cal. Rptr. 381 (1971); Lynk v. St. Joseph's Hosp., 87 Wis. 2d 914, 2 Prod. Limi. Rep. (CCH) f 8357 (1978); Gardner v. McDonald, 2 Prod. Liab, Rep. (CCH) f 8053 (1977).

158 Shivers v. Good Shepherd Hosp., Inc., 427 S.Wüd 104, 106 (Tex. Civ. App. 1968).

159 See Note, Strict Liability—The Medical Malpractice Citadel Still Stands, 11 Creighton L. Rr.v. 1357 (1978).