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Liability for Personal Injuries Caused by Defective Medical Computer Programs

Published online by Cambridge University Press:  24 February 2021

Vincent M. Brannigan  and
Ruth E. Dayhoff
Vincent M. Brannigan
Affiliation:
Department of Textiles and Consumer Economics, University of Maryland, College Park, Maryland.
Ruth E. Dayhoff
Affiliation:
Veterans Administration Medical Center, Washington, D.C.
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Abstract

During the past ten years, the use of computer programs in medicine has become increasingly prevalent. As these programs proliferate, however, their potential to injure patients also increases. Although the question of liability for personal injuries caused by defective medical computer programs has not been addressed by the courts, it is inevitable that this question will arise in a judicial forum.

In this Article, the authors examine the questions a court will face when addressing this novel cause of action. They attempt to resolve some of these questions by exploring the relevant characteristics of medical computer programs and examining their relationship to the tort law doctrines of negligence and strict products liability. The authors conclude that medical computer programs will be treated as products by the courts, subjecting their manufacturers to strict liability in tort for any defects in the program that cause injury. As a result, the authors contend, hospitals are likely to face a new source of liability for patient injuries if, under the particular circumstances, they are deemed to be the manufacturer or the distributor of a medical computer program that causes an injury.

Type
Articles
Information
American Journal of Law & Medicine , Volume 7 , Issue 2 , Summer 1981 , pp. 123 - 144
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1981

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References

1 Implied warranty liability and strict products liability in tort overlap, and many products liability cases have used the terms interchangeably. See 2 Frummer & Friedman, Products Liability § 16.01 [1] (1981). For example, where warranty coverage has been extended to include parties not in privity of contract, the legal rationale for imposing liability on the basis of an implied warranty is virtually indistinguishable from that used in imposing strict liability in tort. See, e.g., Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358, 161 A.2d 69 (1960). The trend in recent years toward more frequent application of strict liability principles has been, in part, a means for imposing liability that would have been barred in a warranty action by disclaimer and privity defenses. The classification of a medical computer program as either a service or a product is useful to both warranty and strict liability theories.

2 Professional negligence might occur at one of several stages in the development and use of a medical computer program. If a programmer were alleged to have negligently conceived or implemented a program, his or her conduct would be measured against that of others in the profession. Similarly, if a physician were alleged to have negligently relied on or interpreted a program, his or her conduct, or the standard of due care, would be evaluated by reference to other physicians under similar circumstances.

3 W. Prosser, Handbook of the Law of Torts 143 (4th ed. 1971).

4 Id. at 161.

5 See generally W. Prosser, supra note 3, at 211, for a discussion of the res ipsa loquitur doctrine.

6 A plaintiff who seeks to recover on a strict liability theory is not precluded from recovering on a negligence or warranty theory. The advantages to strict liability, from a plaintiff's perspective, are (1) that the plaintiff need not prove that the defendant failed to exercise due care, and (2) that the traditional negligence and warranty defenses are not available to the defendant.

1 Although strict liability standards are supposed to obviate any need to determine the reasonableness of a defendant's conduct, some courts and scholars have recognized that the Restatement definition allows a “negligence” component to enter the strict liability formula by requiring that the product be sold in a condition “unreasonably dangerous” to the user or consumer. See note 8 infra and accompanying text.

8 Restatement (Second) of Torts § 402 A, at 347-48 (1965) [hereinafter cited as Restatement].

9 642 F.2d 339 (9th Cir. 1981).

10 The Jeppeson court found that although the chart contained accurate information, it was unsafe for its intended use because its graphic presentation of the information was misleading. Id. at 341-43. The product defect was thus a design defect. See also notes 21-32 infra and accompanying text for a discussion of design defects in products liability cases.

11 Id. at 343.

12 See pages 125-26 supra.

13 73 C.J.S. Property § 1 (1951).

14 See Restatement, supra note 8, § 402 A(l)(b).

15 W. Prosser, supra note 3, at 161.

16 See generally LaRossa v. Scientific Design Co., 402 F.2d 937, 940-41 (3d Cir. 1968); Hoven v. Kelble, 79 Wis. 2d 444, 456-60, 256 N.W.2d 379, 385-87 (1977); Annot., 29 A.L.R.3d 1425 (1970).

17 See Restatement, supra note 8, § 402 A(l)(b).

18 Id. §402 A(l).

19 Id. § 402 A, Comment i.

20 See D. Noel & J. Phillips, Products Liability In A Nutshell (West 1977); Twerski, Weinstein, Donaher & Piehler, The Use and Abuse of Warnings in Products Liability— Design Defect Litigation Comes of Age, 61 Cornell L. Rev. 495 (1976).

21 See, e.g., Volkswagen, of America, Inc. v. Young, 272 Md. 201, 220, 321 A.2d 737, 747 (1974).

22 See Uniform Product Liability Act, 44 Fed. Reg. 62714, 62723 (Oct. 31, 1979).

23 The question of whether to apply negligence or strict liability standards to defective design claims is discussed extensively in Roach v. Kononen, 269 Or. 457, 525 P.2d 125 (1974).

24 See, e.g., Henderson, Judicial Review of Manufacturers’ Conscious Design Choices: The Limits of Adjudication, 73 Colum. L. Rev. 1531 (1973).

25 Id. at 1570.

26 489 F.2d 1066 (4th Cir. 1974).

27 Id. at 1071-76. But see Seattle-First Nat'l. Bank v. Volkswagen of America, Inc., 11 Wash. App. 800, 525 P.2d 286 (1974).

28 264 Or. 457, 525 P.2d 125 (1974).

29 Id. at 463, 525 P.2d at 129.

30 Winters v. Sears, Roebuck & Co., 554 S.W.2d 565 (Mo. App. 1977) (seller servicing of a product becomes an extension of the manufacturing process; upon completion of servicing, the effect is a redelivery of the product with same assurances as the original sale). But see Hoover v. Montgomery Ward & Co., 270 Or. 498, 528 P.2d 76 (1974) (negligent installation of a nondefective tire by seller does not amount to the sale of a dangerously defective product).

31 Putensen v. Clay Adams, Inc., 12 Cal. App. 3d 1062, 1073-75, 91 Cal. Rptr. 318, 325-26 (1970).

32 See note 9 supra and accompanying text.

33 See, e.g., Johnson v. Sears, Roebuck & Co., 355 F. Supp. 1065 (E.D. Wis. 1973), discussed in text accompanying notes 39-40 infra (mechanical and administrative services provided by hospital not exempt from strict liability).

34 Morris, Physician and Hospital Liability for Defective Products Used in the Treatment of Patients, 46 Ins. Counsel J. (1979).

35 Magrine v. Krasnica, 94 N.J. Super. 228, 227 A.2d 539 (Hudson County Ct. 1967), aff'd sub notn. Magrine v. Spector, 100 N.J. Super. 223, 241 A.2d 637 (Super. Ct. App. Div. 1968), aff'd, 53 N.J. 259, 250 A.2d 129 (1969) (per curiam) (dentist, as mere user of a defective hypodermic needle, held not strictly liable for the injury to plaintiff-patient while obtaining dentist's services). But see Anderson v. Somberg, 67 N.J. 291, 338 A.2d 1 (1975) (provider may bear burden of proving lack of negligence).

36 Samuels v. Health & Hosp. Corp. of New York, 432 F. Supp. 1283 (S.D.N.Y. 1977).

37 Moore v. Underwood Memorial Hosp., 147 N.J. Super. 252, 371 A.2d 105 (App. Div. 1977) (blood is an unavoidably unsafe product).

38 See Restatement, supra note 8, § 402 A, Comment k.

39 355 F. Supp. 1065 (E.D. Wis. 1973).

40 id. at 1067.

41 74 Ill. App. 3d 932, 393 N.E.2d 588 (1979), rev'd, 83 Ill. 2d 277, 415 N.E.2d 351 (1980). The lower court held that an X-ray was a product introduced into commerce and that the hospital could thus be held strictly liable. On appeal, the Illinois Appellate Court held that strict liability was inappropriate under the circumstances; since the plaintiff alleged that he was overexposed to X-rays, rather than that the X-ray itself was defective, professional negligence was the appropriate standard of liability.

42 255 Pa. Super. Ct. 381, 387 A.2d 480 (1980).

43 Of course, an ordinary negligence action would always lie against a hospital.

44 See Magrine v. Krasnica, 94 N.J. Super. 228, 227 A.2d 539 (Hudson County Ct. 1967), aff'd sub nom. Magrine v. Spector, 100 N.J. Super. 223, 241 A.2d 637 (Super. Ct. App. Div. 1968), aff'd, 53 N.J. 259, 250 A.2d 129 (1969).

45 Vergott v. Deseret Pharmaceutical Co., 463 F.2d 12 (5th Cir. 1972).

46 Dewberry v. LaFollette, 598 P.2d 241 (Okla. 1979).

47 This conclusion is based on a manufacturing analogy: the party that assembles the parts and then sells them is considered to be the product's manufacturer. Since the hospital, in this instance, originates the program, logically it must be considered its manufacturer.

48 67 N.J.291, 338 A.2d 1 (1975)

49 Id. at 298, 338 A.2d at 5.

50 But see Abood, Pharmacist Dispensing: Service or Sale?, 20 Amer. Pharmacy 25 (1980).