Hynes, Paul F --- "Doctors, Devices and Defects: Product Liability for Defective Medical Expert Systems in Australia" [2004] JlLawInfoSci 2; (2004) 15 Journal of Law, Information and Science 7
* Paul Hynes is Special Counsel with national law firm Hunt & Hunt, and is Adjunct Professor of e-Commerce Law, Commercial Law and e-Government Law at the University of Canberra.
[1] Commonwealth of Australia, National Electronic Decision Support Taskforce, ‘Electronic Decision Support for Australia’s Health Sector’, Nov 2002 (‘The Taskforce Report’).
[2] Taskforce Report, above n.1, at p 16.
[3] Taskforce Report, above n.1, at p 10.
[4] Taskforce Report, above n.1, at p.1.
[5] Nicolas P Terry, ‘An eHealth Diptych: The Impact of Privacy Regulation on Medical Error on Malpractice Litigation’, 27 Am J L. and Med 361, at pp.374 – 377.
[6] Arnold J Rosoff, ‘Symposium: On being a physician in the electronic age: peering into the mists at point-&-click medicine’, (2002) 46 St Louis L.J. 111.
[7] Megan L Scheetz, ‘Note: Toward Controlled Clinical Practice Guidelines: the Legal Liability for Developers and Issuers of Clinical Pathways’, (1997) 63 Brooklyn L. Rev 1341; Arnold Rosoff, ‘The role of clinical practice guidelines in health care reform’, (1995) 5 Health Matrix 369, at pp.374 -377.
[8] Taskforce Report, n.1 supra, at p 61, referring to a paper prepared for the Department of Health and Aged Care by B Milstein, ‘Legal Issues in General Practice and Computerisation’.
[9] The technologies are described in greater detail in the text accompanying notes 23ff infra. This paper will be focussing on systems which assist in the diagnosis of medical conditions. Such systems are commonly referred to as Medical Expert Systems (MES) or Clinical Diagnosis Support Systems (CDSS). In this paper reference will be made generally to MES.
[10] See generally Nicolas P Terry, ‘When the “Machine That Goes “Ping” Causes Harm: Default Torts Rules and Technologically–Mediated Health Care Injuries’, 46 St Louis U.L.J. 27 (2002).
[11] Jonathan K Gable, ‘An Overview of the Legal Liabilities Facing Manufacturers of Medical Information Systems’, 2001, 5 Quinnipiac Health L.J. 127, at pp.148 -149; Brian H Lamkin, ‘Comments: Medical Expert Systems and Publisher Liability: a Cross Contextual Analysis’, (1994) 43 Emory L. J. 731, at pp754 – 756.
[12] Lamkin, above n.11 at pp.736 – 740; Gable, above n.11, at p 140; Frank D Nguyen, ‘Regulation of Medical Expert Systems: A Necessary Evil?’, (1994) 34 Santa Clara L. Rev. 1187, at p.1195.
[13] Lamkin, above n.11 at p.740; Gable, above n.11, at pp.145 – 146; Nguyen, n.12 supra at p.1198.
[14] See generally: Nathan D Leadstrom, ‘Internet Web Sites As Products Under Strict Liability: A Call for An Expanded Definition of Product’, (2001) 40 Washburn L. J. 532, Daniel McNeel Lane Jr, ‘Publisher Liability for Material that Invites Reliance’, (1988) 66 Tex L. Rev. 1155, Jonathan Mintz, ‘Strict Liability for Commercial Intellect”, (1992) 41 Cath.U.L.Rev. 617, Lars Noah, ‘Authors, Publishers, and Product Liability: Remedies for Defective Information in Books’, (1998) 77 Of. L. Rev. 1195, Roy W Arnold, ‘Note: The persistence of caveat emptor: Publisher immunity from liability for inaccurate factual information’, (1992) 53 U Pitt. L. Rev. 777.
[15] Winter v GP Putnam’s Sons, 938F.2d 1033 (9th Cir.1991).
[16] Birmingham v Fodor’s Travel Publications, Inc, 833 P.2d. 70 (Hawaii 1992). The High Court's recent decision in Swain v Waverly Municipal Council [2005] HCA 4 (9 February 2005) stands in contrast to the decision in Birmingham. In Swain, a man was seriously injured when he dived into waves on part of a beach between flags used by the Council to indicate a safe swimming area. In effect, the decision of the High Court suggests that the fact that the information was intended to be relied on created a relationship between the injured party and the Council, sufficient to sustain liability.
[17] Jones v J B Lippincot Co, 694 F.Supp 1216 (D.Md. 1988).
[18] See note above n.14.
[19] Appleby v Miller, 554 NE 2d 773; 1990.
[20] Mintz above n.14 at pp620 to 621.Noah, above n.14 at p1208; Arnold, above n.14 at 799 to 802.
[21] See Nancy Plant, ‘The Learned Intermediary Doctrine: Some New Medicine for an Old Ailment’, (1996) 81 Iowa L. Rev. 1007, Timothy A Pratt and John F Kuckelman, ‘The Learned Intermediary Doctrine and Direct to Consumer Advertising of Prescription Drugs’:
http://www.thefederation.org/ public/Quarterly/Fall000/pratt.htm
[22] Brian Hurwitz, Clinical Guidelines and the Law – Negligence, Discretion and the Law, Radcliff Medical Press, 1998, at 67 – 68; Scheetz, above n.7, at p.1354.
[23] Taskforce Report above n.1 at p 1.
[24] Mark A Musen, Yuval Shahar, Edward H Shortliffe, Clinical Decision Support Systems, Chapter 16 . at www.ie.bgu.ac.il/mdss/ch16-finalpdf at p.602.
[25] Musen supra at n.24 at p.602; see also Jonathan K Gable, ‘An Overview of the Legal Liabilities Facing Manufacturers of Medical Information Systems’, (2001) 5 Quinnipiac Health L.J. 127, at p.135.
[26] Ibid.
[27] Musen supra at n.24 at p.602, Enrico Coiera, ‘Artificial Intelligence in Medicine’, taken from Chapter 19 of The Guide to Medical Informatics, the Internet and Telemedicine, 1997 , http://www.coiera.com/aimd.htm at p.3.
[28] Coiera above n.27 at p.4.
[29] Id.
[30] Musen above n.24, at 602; Coiera above n.27 at p3.
[31] Nguyen, above n.12.
[32] Lamkin, above n.11 p.733 - 734.
[33] Musen above n.24, at 602.
[34] DXplain is a clinical support system developed at Massachusetts General Hospital – it takes a set of clinical findings including signs, symptoms, laboratory data – and produces a ranked list of diagnoses, providing justification for each and suggests further investigations – see Coiera above n.27 at p.4.
[35] Lamkin above n.11 at p.734.
[36] See for example GTN Burger, AM Van Ginneken, H Hollema, ‘Computer based Diagnostic Support Systems in Histopathology: What Should They Do?’, 2001 , http://adams.mgh.harvard.edu/PDF_Repository/1005_ BURGER.PDF
[37] Lamkin above n.11 at p.735.
[38] Teng Liaw, “Decision support in clinical practice’, Ch. 14 Health Informatics, http://infocom.cqu.edu.au/HNI/BooksOnline/chapter_14.pdf
(2), Nguyen above n.12 at p.1191; Lamkin above n.11 at p.735.
[39] Teng Liaw, above n.38 at (2).
[40] Ibid.
[41] Ibid.
[42] Lamkin above n.11 at p.735.
[43] Rosoff, above n.5, at (3).
[44] Ibid.
[45] Teng Liaw, above n.38 at (3).
[46] Ibid.
[47] Ibid.
[48] Ibid.
[49] Teng Liaw above n.38 at (3).
[50] Id See also Musen, above n.24 at pp608–610.
[51] Rosoff, above n.6, at (3).
[52] Arnold Rosoff, ‘Article: The role of clinical practice guidelines in health care reform’, Summer 1995, 5 Health Matrix 369, at p.369.
[53] Scheetz, above n.7 at p.1348
[54] Rosoff, above n.6, at 4.
[55] Ibid.
[56] Scheetz, above n.7, at p.1350.
[57] Lowell Brown and Joan Procopio, ‘Sailing through uncharted waters: outcomes measurement, practice guidelines and the law’, (1995) 16 Whittier L. Rev. 1021, at p.1021; Scheetz, above n.7, at p.1350.
[58] Rosoff, above n.6, at 4.
[59] Ibid.
[60] See Arnold Rosoff, ‘Evidence Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines’, (2001) Journal of Health Politics, Policy and Law, April 2001, http://www.dukepress.edu/jhppl/
[61] Rosoff, above n.6 at text accompanying n.12.
[62] Rosoff above n.52 at p.392, Rosoff, above n.6 at text accompanying notes 3 to 7.
[63] Vincent M Brannigan and Ruth E Dayhoff, ‘Liability for Personal Injuries Caused by Defective Medical Computer Programs’, (1981) 7 Am. J. L. and Med. 123, at p.125.
[64] Rosoff, above n.6 at text accompanying notes 3 to 7.
[65] Scheetz, above n.7, at p.1361.
[66] Ibid.
[67] Ibid.
[68] Ibid.
[69] Rosoff, above n.6 at text accompanying n.10, ff.-Rosoff discusses this in relation to the perceptions of practitioners who may distrust the CPGs for this reason.
[70] See generally Rosoff, above n.7 The evidentiary value of CPGs or EBM also being affected by the use to which the evidence is put, whether in prosecuting claims where there has been a failure to use the CPGs, or used as a defence where the CPGs have been followed. See also Hurwitz, above n.22 at pp36 – 50.
[71] Ibid.
[72] Brannigan, above n.63 at p.125.
[73] Ibid.
[74] Ibid.
[75] Ibid at p.126.
[76] Ibid.
[77] Ibid; Lisa Dahm, ‘Article: Restatement (Second) of Torts section 324A: An innovative theory of recovery for patients injured through the use or misuse of health care information systems’, (1995) 14 J. Marshall J Computer & Info L 73, at p89.
[78] Brannigan, above n.63 at p.126.
[79] Nguyen, above n.12, at p.1192.
[80] Ibid.
[81] Ibid.
[82] Ibid.
[83] Ibid.
[84] Brannigan, above n.63 at p.131.
[85] Nguyen above n.12, at p.1192.
[86] See below text accompanying notes 189ff.
[87] Lamkin above n.11 at p.742.
[88] Ibid.
[89] Marnie Hammond, “The defect test in Part VA of the Trade Practices Act 1974(Cth) defectively designed?’, (1998) 16 TLJ 29.
[90] Lamkin above n.11 at p.742; Brannigan, above n.63 at p.135.
[91] Brannigan, above n.63 at p.135; Lamkin, above n.11 at 743.
[92] Hammond, above n.89, at p.31; Brannigan, above n.63 at p.135.
[93] Ibid.
[94] Brannigan, above n.63 at p.135 – example of defective aeroplane door latches; Hammond, above n.89 at p.31, gives the the example of toys made of plastic which shatters.
[95] As noted by Hammond, above n.89, at p.31, a design defect may be a misnomer, as the design choice may be judged not to be a defect, when assessed by a court.
[96] Hammond, above n.89, at p.31.
[97] Lamkin above n.32 at p.743; Brannigan, above n.63 at p.136.
[98] Lamkin above n.11 at p.743; Brannigan, above n.63 at p.136 - 137.
[99] Where the program would be referred to as ‘bespoke’.
[100] 1992
[101] A search on Lexis and on Austlii databases showed approximately12 cases at the High Court or State Supreme Court exercising federal jurisdiction. See also Jane Stapleton, ‘The conceptual imprecision of “strict” product liability’, at p.9 (n17) (1998) 6 TLJ 260.
[102] The influence of the First Amendment has already been referred to. See generally the references referred to in above n.14.
[103] Other defences include relating to mandatory compliance with standards and ‘finished goods’ are set out at s75AK(1) (b) and (d) TPA.
[104] Section 75AN, TPA.
[105] s4 TPA.
[106] No. N G485 of 1989 FED No. 20 Trade Practices.
[107] Re:ASX Operations Pty Limited and Australian Stock Exchange Limited And: Pont Data Australia Pty Limited No. G344 of 1990 FED No. 710 Trade Practices (1991) ATPR para 41-069; 97 ALR 513; 19 IPR 323; 27 FCR 460.
[108] No. N G627 of 1990 FED No. 580 Trade Practices.
[109] para. 123
[110] para. 123 -125
[111] para. 125
[112] ASX Operations n.107above.
[114] at p.54.
[115] Caslec above n.108, at para 34; Gail E Evans and Brian F Fitzgerald, ‘Information Transactions under UCC Article 2b: Ascendancy of Freedom of Contract in the Digital Millenium’, [1998] UNSWLJ 56, at http://www.austlii.edu.au/au/journals/UTSLR/1998/46.html>(n 30)
[116] Caslec above n.108, at para 35.
[117] [1997] Fleet Street Reports 351.
[118] Evans and Fitzgerald, above n.115, at (n 32).
[119] See for example Appleby v Miller above n.19, at p.776; Brannigan, above n.63 at p.130.
[120] Arnold, above n.14 at p.792; Noah, above n.14 at p.1218.
[121] See Mintz, above n.14.
[122] Some of which, at least in respect of contractual matters, may now have been overtaken by UCITA.
[123] David W Lannetti, ‘Toward a revised definition of “product” under the Restatement (Third) of Torts: Product Liability’, February 2000, 55 Bus Law 799, at (n 94).
[124] Lannetti, above n.123, at (n99).
[125] Ibid.
[126] Ibid.
[127] Mintz, above n.18, at p. 617.
[128] Ibid.
[129] Saloomey v Jeppeson & Co., [1983] USCA2 531; 707 F.2d 671, 1983US App. LEXIS 21800; Brocklesby v United States, [1985] USCA9 1290; 767 F.2d 1288 (9th Cir.1985); Fluor Corp. v Jeppeson & Co., 170 Cal. App. 3d 468.
[130] [1991] USCA9 605; 938 F2d 1033 (9th Cir 1991)
[131] at p.1035
[132] [1981] USCA9 479; 642 F2d 339 (9th Cir. 1981)
[133] Brannigan, above n.63 at p.132
[134] See above n.129.
[135] Fluor, above n.129.
[136] Fluor, above n.129 at p.476.
[137] Brannigan, above n.63 at p.131; Lannetti, above n.123, at (n.105).
[138] Brannigan, above n.63 at p.131.
[139] American Law Institute, ‘Restatement (Third) of Torts: Product Liability’, 1998, Comment §3.
[140] 188F Supp.2d 1264;2002 US Dist Lexis 3997 at 1279.
[141] The author could only find one Australian authority which resembled in any way the aeronautical charts cases. In ACCC v Hungry Jack’s Pty Ltd 1996 955 FCA 1, Hungry Jack’s was prosecuted successfully for failing to meet mandatory standards in relation to sunglasses which were being supplied as part of a promotion. The basis for the failure was that the glasses distorted the depth perception of the wearer. Had the cause of action been under Part VA, from an injury received in reliance on the information being passed through the glasses (rather than injury by the glasses), Australia might arguably have had its own precedent in this area.
[142] Brannigan, above n.63 at p.132.
[143] Ibid.
[144] Ibid.
[145] Brannigan, above n.63 at p.132.
[146] Ibid.
[147] Ibid.
[148] Robert Bradgate, ‘Beyond the Millennium - The Legal Issues: Sale of Goods Issues and the Millennium Bug’, 1999 (2) The Journal of Information, Law and Technology http://www.law.warwick.ac.uk/jilt/99-2/bradgate.html
[149] Bradgate, above n.148.
[150] s.75AD(2).
[151] s.75AC(1).
[152] Hammond, above n.89, at p.62; cf Stapleton, above n.101, at p.13.
[153] Hammond, above n.89, at p.62.
[154] Ibid.
[155] Hammond, above n.89, at p.62.
[156] Ibid.
[157] Ibid.
[158] Ibid.
[159] Stapleton, above n.101 at p.13.
[160] Ibid.
[161] European Directive 85/374/EEC.
[162] Stapleton, above n.101 at p.14.
[163] American Law Institute, Restatement of the Law, Second, Torts, 1965.
[164] American Law Institute, Restatement (Third) of Torts:Product Liability, 1998, Comment d to §1; Hammond, above n.89, at p.26; Stapleton, above n.101.
[165] Hammond, above n.89, at p.26.
[166] American Law Institute, Restatement (Third) of Torts:Product Liability, above n.164.
[167] Hammond, above n.89, at p.26; American Law Institute, Restatement (Third) of Torts:Product Liability, n.164 supra.
[168] American Law Institute, Restatement (Third) of Torts:Product Liability, above n.164, §1.
[169] American Law Institute, Restatement (Third) of Torts:Product Liability, above n.164, §2(b).
[170] TPA s75AK(1)(c).
[171] References to design are references to ‘in house’ design – a discussion of liability of upstream providers is beyond the scope of this paper.
[172] Stapleton, n.101 supra at p.20.
[173] Stapleton, n.101 supra at p.22 – ‘even in the context of…merchantability ...from which the special product rules evolved, the legal norm was not expectations…the norm was the objective minimum standard of what would sell in that particular market’.
[174] TPA s 75AC(1).
[175] Stapleton, above n.101 at pp 22-23.
[176] Stapleton, above n.101 at p23.
[177] See TPA s75AC(3) which stipulates that no inference of defect is to be made because after the time of supply, safer goods of the same kind were supplied.
[178] Stapleton, above n.101 at p25.
[179] Stapleton, above n.101 at p26.
[180] TPA s75AK(1)(c). The wording of the European Directive at Art 7(e) is in almost identical terms ‘that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered’.
[181] Stapleton, above n.101 at pp.30 – 32.
[182] Ibid.
[183] Case C-300/95 [1997] All ER (EC) 481.
[184] Stapleton, above n.101 at pp.30 – 38.
[185] [2000] FCA 1099 (9 August 2000) Accessed on Austlii at http://www.austlii.edu.au/au/cases/cth/federal_ct/2000/1099.html
[186] Ibid at para 549.
[187] Stapleton, above n.101 at p.38.
[188] Stapleton above n.101 at p.10.
[189] See text accompanying above notes 64ff.
[190] See text accompanying above n.97 and 98.
[191] See text accompanying above n.166 and168.
[192] American Law Institute, Restatement (Third) of Torts: Product Liability, above n.164 Reporters Notes to Comment d: IID (p.73).
[193] Ibid.
[194] Hammond, above n.89, at p 69, notes that the phrase ‘entitled to expect’ is ambiguous – it could mean that although persons generally actually know that a certain risk exists, they are entitled to expect that it should not.
[195] s75AC(4).
[196] 75AC(2)(a).
[197] See Pratt and Kuckelman above n21 at (1).
[198] See for example the facts of Demuth Development Corp v Merck & Co 432 F.Supp 990 (EDNY 1977) where injury resulted from the use of an encyclopaedia of chemicals which misstated their toxicity, which was subsequently used in the calibration of equipment.
[199] Hammond, above n.89, at p75.
[200] Hammond, above n.89, at p.75. Hammond argues that such responsibility may be contrary to both deterrence and proper pricing in circumstances where the person with the greatest capacity for minimising any misuse is the person misusing the product.(Id at 75) This does not address the situation likely in the context of medical expert systems where the injured party may not be aware of the system’s misuse – if indeed the disintermediated output is a ‘misuse’.
[201] s75AK(1)(a).
[202] See text accompanying note 180 ff.
[203] See text accompanying above n.184 and 185.
[204] Hammond, above n.89, at p.41 ff.
[205] Ibid, at p.59.
[206] Ibid, at p.60.
[207] Ibid, at p.60; Nguyen above n.12 at p.1212.
[208] Section 41MA TGA.
[209] Commonwealth of Australia, Australian Medical Device Guidelines: An Overview of the New Medical Devices Regulatory System: Guidance Document 1. 2002.
[210] Ibid.
[211] Ibid.
[212] Guidance Document, above n.09 at (9).
[213] Ibid.
[214] Essential Principle 1
[215] Essential principle 2
[216] Essential Principle 6
[217] The ‘benefits to be gained from the use of a medical device for the performance intended by the manufacturer must outweigh any undesirable side effects arising from its use’.
[218] TGA s.41BH(2)