Legal and regulatory responses to innovative treatment

Medical Law Review

Volumn 21, Issue 1, 2013, Pages 65-86

  Chan, Tracey Evans ^a  

^a NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

Author keywords

Innovative treatment; Medical negligence; Research regulation

Indexed keywords

ARTICLE; ETHICS; EXPERIMENTAL THERAPY; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; MALPRACTICE; MEDICAL RESEARCH; OFF LABEL DRUG USE; PATIENT SAFETY;

BIOMEDICAL RESEARCH; HUMAN EXPERIMENTATION; HUMANS; MALPRACTICE; OFF-LABEL USE; PATIENT SAFETY; THERAPIES, INVESTIGATIONAL;

EID: 84883153620     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fws025     Document Type: Article

References (82)

1. See A Mastroianni, 'Liability Regulation and Policy in Surgical Innovation: the Cutting Edge of Research and Therapy' (2006) 16 Health Matrix 351, 370-1
2. See, generally, R Levine, Ethics and Regulation of Clinical Research (2nd edn, Urban & Schwarzenberg, Baltimore 1986) 3-6
3. S Verdun-Jones and D Weisstub, 'Drawing the Distinction Between Therapeutic Research and Non-Therapeutic Experimentation: Clearing a Way Through the Definitional Thicket' in D Weisstub (ed), Research on Human Subjects: Ethics Law and Social Policy (Pergamon, Oxford 1998) 95
4. DH Cowan, 'Innovative Therapy versus Experimentation' (1985) 169 Torts Ins L J 619, 623
5. SMC v Martin Huang, Singapore Medical Council (SMC), Kathmandu (2009) 26-8; SMC v Erwin Kay and SMC vWong Yoke Meng, SMC, Annual Report (2010) 24-6;,http://www.healthprofessionals.gov.sg/content/hprof/smc/en/topnav/publication.html..
6. Repetitive transcranial magnetic stimulation is a form of brain stimulation that uses a magnet instead of an electrical current to activate the brain. Unlike electroconvulsive therapy, in which electrical stimulation is more generalised, rTMS can be targeted to a specific site in the brain: US National Institutes of Mental Health, Brain Stimulation Therapies,,http://nimh.nih.gov/health/topics/brain-stimulation-therapies/brain-stimulation-therapies. shtml..
7. 2001,,http://www.healthprofessionals.gov.sg/content/hprof/smc/en/topnav/guidelines.html. [emphasis added].
8. B Freedman and others, 'Demarcating Research and Treatment: a Systematic Approach for the Analysis of the Ethics of Clinical Research' (1992) 40 Clin Res 653-60 at 654
9. See D Cowan, 'Innovative Therapy: the Responsibility of Hospitals' (1984) 5 J Leg Med 219
10. See T Lewens, 'Distinguishing Treatment from Research: a Functional Approach' (2006) 32 J Med Ethics 424, at 426
11. [1997(] [emphasis added], http://www.moh.gov.sg/content/moh_web/home/Publications/guidelines/national_medical_ethics_committee_guidelines/1997.html..
12. See n 28 [emphasis added]
13. See, for example, I Goldiamond, 'On the Usefulness of Intent for Distinguishing Between Research and Practice, and Its Replacement by Social Contingency: Implications for Standard and Innovative Procedures, Coercion and Informed Consent, and Fiduciary and Contractual Relations' in The Belmont Report, see n 1, Appendix A at 14-4
14. See N King, 'Experimental Treatment: Oxymoron or Aspiration?' (1995) 25 Hastings Cent Rep 6 at 11
15. J McKinlay, 'From Promising "Report" to "Standard Procedure": Seven Stages in the Career of a Medical Innovation' (1981) 59 Millbank Mem Fund Q/Health Soc 374 at 392-3
16. See L Noah, 'Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy', Am J Law Med (2002) 361 at 400-1
17. N King and G Henderson, 'Treatments of Last Resort: Informed Consent and the Diffusion of New Technology' (1991) 42 Mercer Law Rev 1007 at 1023-4
18. J Lantos and J Frader, 'Extracorporeal Membrane Oxygenation and the Ethics of Clinical Research in Pediatrics' (1990) 323 N Engl J Med at 412
19. F Miller, 'Ethical Issues in Surgical Research' (2005) 15 Thorac Surg Clin 543, 545
20. M Eaton and D Kennedy, 'Innovation in Medical Technology: Ethical Issues and Challenges' (Johns Hopkins University Press, Baltimore 2007) 31
21. See N Frost and R Levine, 'The Dysregulation of Human Subjects Research' (2007) 298 JAMA 2196
22. S McKinlay, 'Experimentation in Human Populations' (1981) 59 Milbank Mem Fund Q Health Soc 308 at 320
23. See National Bioethics Advisory Commission, 'Ethical and Policy Issues in Research Involving Human Participants' (NBAC, Bethesda 2001) 35
24. S Strasberg and P Ludbrook, 'Who Oversees Innovative Practice? Is There a Structure that Meets the Monitoring Needs of New Techniques?' (2003) 196 J Am Coll Surg 938, 942. There is some support for this approach in Ancheffv Hartford Hospital 799 A.2d 1067 at 1071-2 (Conn. 2002), but it was framed as a factual question to be answered with the assistance of expert evidence.
25. See S Hellman and D Hellman, 'Of Mice but Not Men: Problems of the Randomized Clinical Trial' (1991) 324 N Engl J Med, 1585
26. See n 40. Similarly, Lewens considers research to refer to activity designed to answer questions that the 'medical research community would generally regard as scientifically important': see n 26 at 426.
27. JK Mason and GT Laurie, Law and Medical Ethics (8th edn Oxford University Press, Oxford 2010) at 612, seem to prefer this definitional approach: 'Research implies a pre-determined protocol with a clearly defined end-point. Experimentation, by contrast, involves a more speculative, ad hoc, approach to an individual subject'.
28. C Margo, 'When Is Surgery Research? Towards an Operational Definition of Human Research' (2001) 27 J Med Ethics 40 [emphasis added]
29. M McKneally and A Daar, 'Introducing New Technologies: Protecting Subjects of Surgical Innovation and Research' (2003) 27 World J Surg 930, 931-2
30. In respect of stem cells, see R Cash and others, Casebook on Ethical Issues in International Health Research (WHO, Geneva, 2009) at 12 and 44; in respect of the off-label use of a monoclonal antibody, see n 150 and HP Tan and others, 'Living Donor Renal Transplantation Using Alemtuzumad Induction and Tacrolimus Monotherapy' (2006) 6 Am J Transplant 2409; in respect of medical devices, Devathasan v SMC, see n 7, is potentially an example of an informal study
31. E Gladstein, 'What Is Research?' (2001) 51 Int J Radiat Oncol Biol Phys 288
32. See n 56 at 42 [emphasis added]
33. See, for example, E Ahrens, The Crisis in Clinical Research (Oxford University Press, New York 1992) ch 3
34. See N Fost, 'Ethical Dilemmas in Medical Innovation and Research: Distinguishing Experimentation from Practice' (1998) 22 Semin Perinatol 223, 224-5
35. See n 45, ch 2, for a brief review of the modern history of human research ethics
36. J Katz, 'The Regulation of Human Research - Reflections and Proposals' (1973) 21 Clin Res 785, 787
37. Innovative treatment raises distinct ethical issues within the realm of medical practice that would arguably require a different form of regulatory oversight: see the discussion below under Part V.B.
38. This was first suggested in basic terms by B Dickens, 'What Is a Medical Experiment' (1975) 113 CMAJ 635, 637
39. The exception being prospective legal review by a court where innovative therapy is offered to a patient who lacks decision-making capacity and the court is asked to authorise it or confirm that the therapy is in the patient's best interests: see, for example, Simms v Simms [2003] Fam 83
40. Slater v Baker and Stapleton (1797) 95 ER 860
41. Fortner v Koch 261 N.W. 762 (1935) at 765 (S.C. Michigan) [emphasis added].
42. M Greenberg, 'Medical Malpractice and New Devices: Defining an Elusive Standard of Care' (2009) 19 Health Matrix 423 at 433
43. See S McLean, 'Regulating Research and Experimentation: a View from the UK' (2004) J L Med Ethics 604 at 605
44. J Robertson, 'Legal Implications of the Boundaries between Biomedical Research involving Human Subjects and the Accepted or Routine Practice of Medicine' (31 December 1975), in the Belmont Report, see n 1, Appendix B at 4-6, was of the view that the basis of tort liability for standard and innovative treatment is identical. Rather, the factual inquiry in each case differs.
45. See, for example, Hood v Philips 554 S.W. 2d. 160 at 165 (1977) (S.C. Texas); Mastroianni, see n 2 at 384. [6] Med LR 362.
46. Bolitho v City and Hackney Health Authority [1998] AC 232 at 242 (HL): 'In determining what represents a responsible body of medical opinion, the court is not bound to follow expert evidence led by the defendant physician. It must be satisfied that that respectable body of medical evidence has a "logical basis", which requires the court to ensure that the experts had "directed their minds to the question of comparative risks and benefits and reached a defensible conclusion on the matter'.
47. See Maynard v West Midlands Regional H.A. [1984] 1 WLR 364 at 368.
48. See, for example, Baldor v Rogers 81 So.2d 658 at 660 (SC Florida, 1954).
49. In addition to respect for patient autonomy: see G Annas, 'Cancer and the Constitution - Choice at Life's End' (2007) 357(4) N Engl J Med 408 at 413: 'The right to choose in medicine is a central right of patients, but the choices can and should be limited to reasonable medical alternatives, which themselves are based on evidence'; see MacNeil, n 134 at 480-1; cf Helsinki Declaration, n 25
50. For a discussion of the uncertainties relating to 'logical analysis', see H Teff, 'The Standard of Care in Medical Negligence - Moving on from Bolam?' (1998) 18 OJLS 473 at 480-1;
51. R Heywood, 'The Logic of Bolitho' (2006) 22 PN 225 at 227-8
52. See for example, Marriott v West Midlands HA [1999] LLR Med 23 at 28: Mulheron, n 95 at fn 103, classifies this case as an instance of an expert opinion failing to consider the comparative risks and benefits. It is submitted that this is difficult to support on the express reasoning of the court.
53. See, for example, Zimmer v Ringrose (1981) 124 DLR (3d) 215; Estrada v Jacques 321 SE 2d 240 (1984) at 255 (CA, NC). [493] F.2d 408 (1974) at 419 (CA 5th Cir.).
54. Sidaway v Bethlem Royal Hospital Governors [1985] AC 871 (HL)
55. See, for example, Hales v Pittman 576 P.2d 493 at 500; see also P Healey and A Samantha, 'When Does the 'Learning Curve' of Innovative Interventions Become Questionable Practice?' (2008) 36 Eur J Vasc Endovasc Surg 253, 256.
56. See Giesen, n 80 at 35; AM Capron, 'Informed Consent in Catastrophic Disease Research and Treatment' (1974) 123 Univ Penn Law Rev 340, 368
57. Healey and Samantha, see n 115
58. Giesen, n 80 at 35; cf Noah, n 39 at 407-8
59. P Taylor, 'Overseeing Innovative Therapy without Mistaking It for Research: a Function-Based Model Based on Old Truths, New Capacities, and Lessons from Stem Cells' (2010) 38 J L Med Ethics 286, 291-2
60. See, for example, Moore v Regents of the University of California 793 P.2d
61. See, for example, Estrada v Jacques, n 108 at 254: '...With experimental procedures the "most frequent risks and hazards" will remain unknown until the procedure becomes established. If the health care provider has a duty to inform of known risks for established procedures, common sense and the purposes of the statute equally require that the health care provider inform the patient of any uncertainty regarding the risks associated with experimental procedures. This includes the experimental nature of the procedure and the known or projected most likely risks.' [emphasis in original].
62. See, for example, P Schuck, 'Rethinking Informed Consent' (1994) 103 Yale L J 899
63. See P Freund, 'Legal Frameworks for Human Experimentation' (1969) 98 Daedalus 314 at 323; Capron, n 119 at 371-3
64. The analysis here is based on a private law conception of the issue. For a human rights centred discussion on patient consent and experimental treatment, see A Plomer, The Law and Ethics of Medical Research: International Bioethics and Human Rights (Cavendish, London 2005) ch 3.
65. See, for example, W Dondrop and G de Wert, 'Innovative Reproductive Technologies: Risks and Responsibilities' (2011) 1 Hum Reprod 4
66. H Edgar, 'Regulating Psychosurgery: Issues of Public Policy and Law' in WGaylin and others (eds), Operating on the Mind: The Psychosurgery Conflict (1975) ch 5 at 128
67. This was a major concern of Levine in his report to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research; see n 33 at 37
68. M Dublinsky and JH Ferguson, 'Analysis of the National Institutes of Health Medicare Coverage Assessment' (1990) 6 Int J Tech Assess Health Care 480 at 487
69. See for example, Eaton and Kennedy, n 45 at 104, reporting the consensus at the Lasker Foundation Forum on Innovation in Medical Technology
70. Edgar, n 136 at 128 and 132; MacNeil, n 134 at 483
71. New Zealand Ministry of Health, Operational Standard for Ethics Committees: Updated Edition (Ministry of Health, Wellington 2006)
72. D Price, 'Remodelling the Regulation of Postmodern Innovation in Medicine' (2005) 1 Int J L Context 121, 135
73. UK Department of Health, Health Service Circular HSC 2003/11: The Interventional Procedures Programme (12 November 2003); online:,http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_4064922..
74. C Ryan and DP Swanson, 'Clinical Research, Innovative Practice and IRB Review' (2007) 7 Am J Trans 748-50
75. W Biffland others, 'Responsible Development and Application of Surgical Innovations: a Position Statement of the Society of University Surgeons' (2008) 206(6) J Am Coll Surg 1204 at 1207-8
76. ISSCR, Guidelines for the Clinical Translation of Stem Cells (ISSCR 2008) at 15-6; online:,http://www.isscr.org/GuidelinesforClinicalTranslation/2480. htm..
77. UK Central Office for Research Ethics Committees, Governance Arrangements for NHS Research Ethics Committees (Department of Health, London 2001); online:,http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727
78. See also S Holm and E Cave, 'New Governance Arrangements for Research Ethics Committees: Is Facilitating Research Achieved at the Cost of Participants' Interest' (2002) 28 J Med Ethics 318 at 320
79. G Agich, 'Ethics and Innovation in Medicine' (2001) 27 J Med Ethics 295
80. I Ayres and J Braithwaite, Responsive Regulation (Oxford University Press, New York 1992) ch 4, 102-6. See also Cowan, n 22 at 250.
81. For example, the registry established by the American College of Surgeons in respect of surgical innovations: Biffl, see n 154 at 1208
82. Eaton and Kennedy, n 45 at 103; AHRQ, http://www.ahrq.gov/about/profile.htm..