Must the surgeon take the pill? Negligence duty in the context of cognitive enhancement

Modern Law Review

Volumn 77, Issue 1, 2014, Pages 60-86

  Goold, Imogen ^a   Maslen, Hannah ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Cognitive enhancement; Medical; Modafinil; Negligence; Omissions; Surgeon

Indexed keywords

EID: 84891543849     PISSN: 00267961     EISSN: 14682230     Source Type: Journal    
DOI: 10.1111/1468-2230.12056     Document Type: Article

References (60)

1. See, eg, J. Savulescu, 'Justice, Fairness, and Enhancement' (2006) 1098 Annals of the New York Academy of Sciences 321.
2. I. Singh, 'Will the "Real Boy" Please Behave: Dosing Dilemmas for Parents of Boys with ADHD' (2005) 5 The American Journal of Bioethics 34.
3. The Academy of Medical Sciences and others, Human Enhancement and the Future of Work (Report from a Joint Workshop, November 2012) 38 at http://www.acmedsci.ac.uk/p47prid102.html#downloads (last visited 22 May 2013) (citation omitted).
4. S. H. Rose and T. B. Curry, 'Fatigue, Countermeasures, and Performance Enhancement in Resident Physicians' (2009) 84 Mayo Clinic Proceedings 955. There is increasing support for enhancement in other areas in the ethics literature. See, eg, J. Harris and A. Chatterjee, 'Is it Acceptable for People to Take Methylphenidate to Enhance Performance?' (2009) 338 British Medical Journal 1532, 1533, arguing that it is 'not rational to be against human enhancement'.
5. O. J. Warren, D. R. Leff, T. Athanasiou, C. Kennard and A. Darzi, 'The neurocognitive enhancement of surgeons: an ethical perspective' (2009) 152 Journal of Surgical Research 167, 168.
6. J. A. Chandler, 'Autonomy and the Unintended Legal Consequences of Emerging Neurotherapies' (2013) 6 Neuroethics 249.
7. Analogies can be drawn with cases of diabetics failing to medicate appropriately before driving.
8. We have chosen surgeons in part because they are a professional group more likely to possess knowledge of, and be able to gain access to, cognitive enhancing pharmaceuticals. They have also been the target of calls for a professional obligation to take enhancing drugs. However, much of our discussion will apply to other professions for whom cognitive enhancement might arguably be beneficial, such as pilots and the military.
9. We explore these concerns in a forthcoming paper: H. Maslen and I. Goold, 'Obliging Surgeons to Enhance: Negligence Liability for Uncorrected Fatigue and the Problem of Causation'.
10. St George's Healthcare NHS Trust v S [1998] 3 WLR 936.
11. N. Bostrom and A. Sandberg, 'Cognitive Enhancement: Methods, Ethics, Regulatory Challenges' (2009) 15 Science and Engineering Ethics 311.
12. By comparison, the common law has already determined how it will deal with instances of negligence resulting from lack of appropriate training or skills (which are obtained via other, arguably 'enhancing' means such as education). In general, where fulfilment of a duty requires a certain degree of skill, knowledge or experience, the defendant's lack of these will not be a defence. See, eg, Nettleship v Weston [1971] 2 QB 691 (CA) (learner drivers); Wilsher v Essex Area Health Authority [1987] 2 WLR 425 (CA) (inexperienced doctors).
13. We might imagine a pharmaceutical intervention that increases a person's capacities beyond their usual level. This might consist in enabling her to stay alert and focused for longer than she is usually able to, following a normal full night of sleep. Alternatively, the effect might be to make her more alert and focused but for the usual amount of time, under the same conditions. The third possibility is that she is made more alert and focused and for longer than she is usually able, under the same conditions. Alternatively, we might imagine that, under different conditions, this pharmaceutical might enhance - or restore - the person's diminished capacities, which have been reduced due to a non-medical factor.
14. S. Grady, D. Aeschbach, K. P. Wright Jnr and C. A. Czeisler, 'Effect of Modafinil on Impairments in Neurobehavioral Performance and Learning Associated with Extended Wakefulness and Circadian Misalignment' (2010) 35 Neuropsychopharmacology 1910; C. L. Hart, M. Haney, S. K. Vosburg, S. D. Comer, E. Gunderson and R. W. Foltin, 'Modafinil Attenuates Disruptions in Cognitive Performance During Simulated Night-Shift Work' (2006) 31 Neuropsychopharmacology 1526.
15. J. A. Caldwell, 'Dextroamphetamine and Modafinil are Effective Countermeasures for Fatigue in the Operational Environment' (2005) US Air Force Research Laboratory at http://ftp.rta.nato.int/Public/PubFullText/RTO/MP/RTO-MP-HFM-124/MP-HFM-124-31.pdf (last visted 22 May 2013); J. V. Baranski, V. Gill, T. M. McLellan, D. Moroz, A. Buguet and M. Radomski, 'Effects of Modafinil on Cognitive Performance During 40 Hr of Sleep Deprivation in a Warm Environment' (2002) 14 Military Psychology 23.
16. C. Sugden, C. R. Housden, R. Aggarwal and B. Sahakian, 'Effect of Pharmacological Enhancement on the Cognitive and Clinical Psychomotor Performance of Sleep-Deprived Doctors: A Randomized Controlled Trial' (2012) 255 Annals of Surgery 222.
17. See J. A. Caldwell and J. L. Caldwell, 'Fatigue in Military Aviation: An Overview of US Military-approved Pharmacological Countermeasures' (2005) 76 Aviation, Space, and Environmental Medicine C39.
18. For a discussion of off-label use of modafinil, see B. Vastag, 'Poised to Challenge Need for Sleep, "Wakefulness Enhancer" Rouses Concerns' (2004) 291 Journal of the American Medical Association 167. For the results of a survey exploring off-label use of both methylphenidate and modafinil see B. Maher, 'Poll Results: Look Who's Doping' (2008) 452 Nature 674.
19. See variously G. Lynch, L. C. Palmer and C. M. Gall, 'The Likelihood of Cognitive Enhancement' (2011) 99 Pharmacology Biochemistry and Behaviour 116; D. C. Turner, T. W. Robbins, L. Clark, A. R. Aron and J. Dowson, 'Cognitive Enhancing Effects of Modafinil in Healthy Volunteers' (2003) 165 Psychopharmacology 260; S. E. Winder-Rhodes, S. R. Chamberlain, M. I. Idris, T. W. Robbins, B. J. Sahakian and U. Müller, 'Effects of Modafinil and Prazosin on Cognitive and Physiological Functions in Healthy Volunteers' (2010) 24 Journal of Psychopharmacology 1649; D. C. Randall, N. L. Fleck, J. M. Shneerson and S. E. File, 'The Cognitive-Enhancing Properties of Modafinil are Limited in Non-Sleep-Deprived Middle-Aged Volunteers' (2004) 77 Pharmacology Biochemistry and Behaviour 547; U. Müller, J. B. Rowe, T. Rittman, C. Lewis, T. W. Robbins and B. J. Sahakian, 'Effects of Modafinil on Non-Verbal Cognition, Task Enjoyment and Creative Thinking in Healthy Volunteers' (2013) 64 Neuropharmacology 490.
20. See, eg, S. E. McCabe, C. J. Teter and C. J. Boyd, 'The Use, Misuse and Diversion of Prescription Stimulants Among Middle and High School Students' (2004) 39 Substance Use and Misuse 1095; S. E. McCabe, J. R. Knight, C. J. Teter and H. Wechsler, 'Non-Medical use of Prescription Stimulants Among US College Students: Prevalence and Correlates from a National Survey' (2005) 100 Addiction 96.
21. Smith v Littlewoods [1987] AC 241, 271 (HL). See also Stovin v Wise [1996] AC 923, 943-944 (HL), per Lord Hoffman.
22. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582, 121 (QB).
23. See further E. Jackson, Medical Law: Text, Cases and Materials (Oxford: OUP, 2nd ed, 2010) 103-104. It is worth noting that outside a usual medical context (such as the doctor responding to calls for assistance on an aeroplane), the doctor will probably be expected to meet the standard of care of a reasonable, competent doctor but there are statements obiter that she might be held only to the lower standard of not making things worse: see Capital & Counties plc v Hampshire County Council [1997] QB 1004, 1035, per Stuart Smith LJ.
24. East Suffolk Rivers Catchment Board v Kent [1941] AC 74 (HL).
25. The hospital's duty probably extends to providing properly skilled medical staff and an adequately equipped hospital. See Bull v Devon AHA [1993] 4 Med LR 117 (CA); Wilsher v Essex Area Health Authority n 14 above; Re R (a minor) (No 2) (1997) 33 BMLR 178 (CA).
26. See A (A Child) v Ministry of Defence [2004] 3 WLR 469 (CA).
27. The vicarious liability of hospitals for the surgeons they employ is well-established and broad in scope: Godden v Kent and Medway Strategic Health Authority [2004] EWHC 1629; Lloyd's Rep Med 521 (QB).
28. Those organisations holding themselves out as offering emergency services are expected respond to calls for assistance or treatment: Kent v Griffiths (No 3) [2000] 2 WLR 1158 (CA), although note also in relation to what that duty might entail: Barnett v Chelsea and Kensington Hospital Management Committee [1968] 2 WLR 422 (QB) in which it was said that the duty officer in a casualty department is not always obliged to see people who present for treatment, but must have a good reason for not doing so and should at least assess them.
29. Hence hospitals often display notices that they do not accept accident and emergency patients.
30. Bolitho v City and Hackney Health Authority [1998] AC 232, 242 (HL), per Lord Browne-Wilkinson (emphasis added).
31. R. Mulheron, 'Trumping Bolam: A Critical Legal Analysis of Bolitho's "Gloss"' (2010) 69 Cambridge Law Journal 609, 620.
32. French v Thames Valley Strategic Health Authority [2005] EWHC 459 QB at [112].
33. The Royal College of Surgeons of England, Good Surgical Practice (Devon: Latimer Trend & Company, 2008, reviewed 2010) 39 (emphasis added).
34. Establishing a causal connection between the fatigue and the error in a particular case would raise its own attendant problems, however we do not explore these here for reasons of scope. We note that there are, however, data showing a general connection between practitioner fatigue and medical errors. See, eg, M. Kramer, 'Sleep Loss in Resident Physicians: The Cause of Medical Errors?' (2010) 1 Frontiers in Neurology 128; C. P. Landrigan, J. M. Rothschild, J. W. Cronin, R. Kaushal, E. Burdick, J. T. Katz, C. M. Lilly, P. H. Stone, S. W. Lockley, D. W. Bates and C. A. Czeisler, 'Effect of Reducing Interns' Work Hours on Serious Medical Errors in Intensive Care Units' (2004) 351 The New England Journal of Medicine 1838; D. M. Gaba and S. K. Howard, 'Fatigue Among Clinicians and the Safety of Patients' (2002) 347 New England Journal of Medicine 1249. See also Agency for Healthcare Research and Quality, 'Making Health Care Safer: A Critical Analysis of Patient Safety Practices' (AHRQ Publication 01-E058, 2001) ch 46: 'Fatigue, Sleepiness, and Medical Errors'.
35. Negligence here would arise only if she had accepted the patient and so assumed a duty of care.
36. Great Ormond Street Hospital, 'Clinical Guidelines: Hand Hygiene' at http://www.gosh.nhs.uk/health-professionals/clinical-guidelines/hand-hygiene/ (last visited 22 May 2013).
37. Stefanyshyn v Rubin (1996) 34 CCLR (2d) 88 (Manitoba CA).
38. We return to this point in the section on framing the wrong below at pp. 81-83.
39. The classic case on high cost precaution is Miller v Jackson [1977] 3 WLR 20 (CA), but the facts are far from analogous here. In that case, the claimants were unhappy that balls were sometimes hit into their garden from a nearby cricket ground. The cost to prevent this risk was considered too high as it entailed closing the cricket club, which would have been greatly damaging to the public interest. See also Bolton v Stone [1951] AC 850 (HL); Tomlinson v Congleton [2003] UKHL 47; [2003] 3 WLR 705 (no breach where the risk was low and the cost of the precaution high).
40. K. Finke, C.M. Dodds, P.Bublak, R. Regenthal, F. Baumann, T. Manly and U. Müller, 'Effects of Modafinil and Methylphenidate on Visual Attention Capacity: A TVA-Based Study' (2010) 210 Psychopharmacology 317.
41. R. J. Thomas and K. Kwong, 'Modafinil Activates Cortical and Subcortical Sites in the Sleep-Deprived State' (2006) 29 Sleep 1471.
42. Y. N. Wong, S. P. King, W. B. Laughton, G. C. McCormick, P. E. Grebow, 'Single-dose pharmacokinetics of modafinil and methylphenidate given alone or in combination in healthy male volunteers' (1998) 38 J Clin Pharmacol 276.
43. See, eg, R. Kumar, 'Approved and Investigational Uses of Modafinil: An Evidence-Based Review' (2008) 68 Drugs 1803; B. D. McBeth, R. M. McNamara, F. K. Ankel, E. J. Mason, L. J. Ling, T. J. Flottemesch and B. R. Asplin, 'Modafinil and Zolpidem Use by Emergency Medicine Residents' (2009) 16 Academic Emergency Medicine 1311. Compare studies suggesting modafinil is well-tolerated: T. Roth, J. R. L Schwartz, M. Hirshkowitz, M. K. Erman, J. M. Dayno and S. Arora, 'Evaluation of the Safety of Modafinil for Treatment of Excessive Sleepiness' (2007) 3 Journal of Clinical Sleep Medicine 595. It is clear that more research is needed over a longer period to establish safety: see, eg, M. R. Cooper, H. M. Bird and M. Steinberg, 'Efficacy and Safety of Modafinil in the Treatment of Cancer-Related Fatigue' (2009) 43 Annals of Pharmacotherapy 721.
44. See D. Repantis, P. Schlattmann, O Laisney and I. Heuser, 'Modafinil and Methylphenidate for Neuroenhancement in Healthy Individuals: A Systematic Review' (2010) 62 Pharmacological Research 187 at [5.3]; D. Kim, 'Practical Use and Risk of Modafinil, a Novel Waking Drug' (2012) 27 Environmental Health and Toxicology 1. Other studies did not detect any serious side effects: Randall and others, n 21 above; Sugden and others, n 18 above; Winder-Rhodes and others, n 21 above.
45. It would be interesting to see how the court would handle a claim that a surgeon had caused harm by failing to take a medication that has a much stronger safety-profile. It is at least conceivable that a surgeon who suffered from a bad headache might be sued by her injured patient who claims that she was negligent in not taking paracetamol. However, to consider such a possibility here would be just as speculative since, to our knowledge, there have been no such cases. Further, it is important to note that even a drug like paracetamol is not one hundred per cent safe for all individuals.
46. On the courts' experience with the fallout from asbestos, see Fairchild v Glenhaven Funeral Services [2002] UKHL 22; [2002] 3 WLR 89 (HL) and subsequent cases. On thalidomide as a cause of birth defects, see G. Dunea and J. M. Last, 'Thalidomide' in The Oxford Illustrated Companion to Medicine (Oxford: OUP, 3rd ed, 2001). On DES, see National Cancer Institute 'Diethylstilbestrol (DES) and Cancer' National Cancer Institute Factsheet, 2011 at www.cancer.gov/cancertopics/factsheet/Risk/DES (last visited 23 May 2013). We are grateful to Professor Jane Stapleton for this point.
47. P. Robertson Jnr and E. T. Hellriegel, 'Clinical Pharmacokinetic Profile of Modafinil' (2003) 42 Clinical Pharmacokinetics 123.
48. See further M. Gill, P. Haerich, K. Westcott, K. L. Godenick and J. A. Tucker, 'Cognitive performance following modafinil versus placebo in sleep-deprived emergency physicians: a double-blind randomized crossover study' (2006) 13 Academic Emergency Medicine 158.
49. For example, in Baker v TE Hopkins & Son Ltd [1959] 3 All ER 225, while one might argue that Dr Baker was under a moral duty to do what he could to aid the men down the well, he was not under any legal duty to assist them where he had undertaken no obligation towards them, and where he would have been putting himself at considerable personal risk in attempting to rescue them (as, in fact, he did in attempting, fatally, to aid them). We are grateful to one of the anonymous reviewers for drawing our attention to this case in support of our point.
50. See, eg, Harrison v British Railways Board [1981] 3 All ER 679 (QB) and Ogwo v Taylor [1987] 3 WLR 1145 (HL).
51. Airedale NHS Trust v Bland [1993] AC 789, 891, per Lord Mustill.
52. Health and Social Care Act 2008, s 45G. Vaccinations are required for entry into certain professions, such as the medical profession, but this does not amount to obliging people to vaccinate.
53. St George's Healthcare NHS Trust v S n 12 above, 957, per Judge LJ. We are indebted to Professor Jane Stapleton for reminding us of the relevance of this decision.
54. Carolyn Swift and anor v Fitchburg Mutual Insurance Company (1998) 45 Mass App. Ct. 617, 621.
55. For example, the UK has not followed the example of the United States in incarcerating women who abuse substances during pregnancy on the grounds that they recklessly endanger their foetus.
56. In the United States there is authority that the failure to medicate would be regarded as a negligent omission, and there are cases in which the failure to take anti-epilepsy medication was framed as a negligent omission: Knoxville Optical Supply, Inc v Thomas 1993 WL 574 (TennCtApp Jan 04, 1993).
57. Sufferers of Type 1 diabetes are at risk of such episodes, as they are required to monitor their blood sugar and adjust it through the injection of insulin. A hypoglycaemic episode occurs when the body's blood glucose level drops such that there is insufficient sugar to balance the levels of insulin in the body. Hence, if a diabetic injects too much insulin or fails to take enough sugar, she may become hypoglycaemic, which leads to impaired cognitive ability and in some cases partial or complete unawareness. Normally, a diabetic will begin to sweat at the onset of a hypoglycaemic episode. Sweating occurs as the liver secretes glycogen to temporarily compensate for the imbalance in sugar/insulin levels. This warning sign generally occurs before the loss of cognitive function, and so the diabetic will have the opportunity to correct the condition by taking glucose. Once glucose is taken in some form, the person rapidly returns to their normal cognitive state.
58. There are important distinctions between the criminal and civil decisions on the issue of voluntary control and automatism, and these are discussed at length in cases such as Mansfield v Weetabix Ltd [1998] 1 WLR 1263, but these do not concern us here.
59. On the facts, Tarleton was not aware he was having a hypoglycaemic episode and there was no reasonable basis on which to say he should have been aware: Mansfield v Weetabix Ltd n 74 above. A similar approach is taken in situations where people have suffered heart attacks, strokes and gastric attacks and then injured others while in an incapacitated state. In these cases, too, the issue is whether the defendant was or ought to have been aware that she was about to lose conscious control of herself and yet continued to drive regardless. See, eg, Waugh v James K Allan Ltd 1964 SC 102 (HL); C (A Child) v Burcombe [2003] CLY 3030; Roberts v Ramsbottom [1980] 1 WLR 823 (QB).
60. See, eg, R. Goodman, 'Cognitive Enhancement, Cheating, and Accomplishment' (2010) 20 Kennedy Institute of Ethics Journal 145.