Law and ethics of deep brain stimulation

International Journal of Law and Psychiatry

Volumn 35, Issue 2, 2012, Pages 130-136

  Schmitz Luhn, Björn ^a   Katzenmeier, Christian ^a   Woopen, Christiane ^a  

^a UNIVERSITY OF COLOGNE   (Germany)

Author keywords

Deep brain stimulation; Germany; Law and ethics of new treatment methods; Medical ethics; Medical law

Indexed keywords

ARTICLE; BRAIN DEPTH STIMULATION; CLINICAL PRACTICE; CLINICAL RESEARCH; COUNSELING; HUMAN; INFORMED CONSENT; LAW; LEGAL ASPECT; MEDICAL ETHICS; MEDICAL RESEARCH; POLICY; RISK ASSESSMENT;

BIOMEDICAL ENHANCEMENT; DEEP BRAIN STIMULATION; GERMANY; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL DISORDERS;

EID: 84857109039     PISSN: 01602527     EISSN: 18736386     Source Type: Journal    
DOI: 10.1016/j.ijlp.2011.12.007     Document Type: Article

References (106)

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3. TadeM. Spranger and Henrik Walter eds., 2009)
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7. For information in general and concerning different forms of side effects, inter alia, id. at "Medikamentöse Behandlung" and "Operative Behandlungsverfahren"/"Indikationen"; C.D. Marsden, Problems with Long-Term Levodopa Therapy for Parkinson's Disease, 2 Clin Neuropharmacol Suppl 32-44 (1994)
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12. A first study assessed the improvement of the quality of life in long-termPD patients, indicating that DBS often leads to far better results than medication
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15. Scellig S.D. Stone et al., Stimulation of Entorhinal Cortex Promotes Adult Neurogenesis and Facilitates Spatial Memory, 13 (38) The Journal of Neuroscience 13469-13484 (2011).
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18. Christiane Woopen, Personale Identität und Neuromodulation. Zu möglichen Auswirkungen Tiefer Hirnstimulation auf Personalität und Persönlichkeit [Personal Identity and Neuro-Modulation. On Possible Effects of Deep Brain Stimulation on Personhood and Personality], in MENSCHENWÜRDE IN DER MEDIZIN: QUO VADIS? [HUMAN DIGNITY IN MEDICINE: QUO VADIS?] (Jan C. Joerden, Eric Hilgendorf and Felix Thiele eds., forthcoming 2011) (F.R.G.).
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21. Cf., e.g., Bundesgerichtshof [BGH] [Federal Court of Justice] Nov. 18, 2008, 62 Neue Juristische Wochenschrift [NJW] 1210 (2009)
22. BGH May 11, 1982, 35 NJW 2121 (1982)
23. BGH Mar. 14, 2006, 166 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 336, 339 (all F.R.G.).
24. E.g. in cases of dystonia, see LEITLINIEN NEUROLOGIE, supra note 4, no. 030-039.
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26. Ezekiel Emanuel, David Wendler and Christine C. Grady, An Ethical Framework for Biomedical Research, in THE OXFORD TEXTBOOK OF CLINICAL RESEARCH ETHICS 123-135 (Ezekiel Emanuel et al. eds., 2008).
27. all Berufsordnungen der Landesärztekammern [Codes of Professional Conduct of the German States' Chambers of Physicians], § 2 (F.R.G.).
28. Volker Lipp, Heilversuch und medizinische Forschung [Treatment Attempt and Clinical Trial], in ARZTRECHT [MEDICAL LAW] ch. XIII para. 42 (Adolf Laufs, Christian Katzenmeier and Volker Lipp eds., 6th ed. 2009)
29. Erwin Deutsch, Das Vertragsrecht des Probanden [The Proband's Contract Law], 56 Versicherungsrecht [VersR] 1609 (2005) (all F.R.G.).
30. DECLARATION OF HELSINKI: ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS B 18 and B 21 (World Medical Association ed., as amended 2008) [hereinafter DECLARATION OF HELSINKI].
31. In specific, DECLARATION OF HELSINKI, supra note 20, at A 6, B 11, 16, 20 and 23.
32. (Muster-) Berufsordnung für die deutschen Ärztinnen und Ärzte [MBO-Ä] [Federal Model Code of Conduct for the German Physicians] § 15 (1) (1), and according rules in the Codes of Professional Conduct of the German States' Chambers of Physicians (F.R.G.).
33. Medizinproduktegesetz [MPG] [Medical Devices Act], Aug. 7, 2002, BGBl. I at 3146, as last amended Nov. 8, 2011, BGBl. I at 2178, §§ 20 et seq. (F.R.G.).
34. Bundesgerichtshof [BGH] [Federal Court of Justice] Mar. 27, 2007, 172 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 1 ("Arzneimittelheilversuch"), reviewed by Dieter Hart, Arzthaftung wegen Behandlungs- und Aufklärungsfehlern im Zusammenhang mit einem Heilversuch mit einem neuen, erst im Laufe der Behandlung zugelassenen Arzneimittel [Liability Due to Malpractice and Lack of Information of the Patient in Connection with a Treatment Attempt Using a New Pharmaceutical that has only during Treatment Recieved Approval], 25 Medizinrecht [MedR] 631 (2007), and reviewed by Christian Katzenmeier, 62 Juristenzeitung [JZ] 1104 (2007) (all F.R.G.).
35. Bundesgerichtshof [BGH] [Federal Court of Justice], Jun. 13, 2006, 168 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 103 ("Robodoc"), reviewed by Christian Katzenmeier, Aufklärung über neue medizinische Behandlungsmethoden - "Robodoc" [Informing Patients about new Forms of Medical Treatment - "Robodoc"], 59 Neue Juristische Wochenschrift [NJW] 2738, 2739 (2006), and reviewed by Benedikt Buchner, Der Einsatz neuer medizinischer Behandlungsmethoden - ärztliche Aufklärung oder präventive Kontrolle? [Use of new medical methods of treatment - an Issue of Informing the Patient or of Preemptive Control?], 57 Versicherungsrecht (VersR) 1460 (2006) (all F.R.G.).
36. Nevertheless, the documentation of individual treatment attempts as well as the publication of their findings is called for by the DECLARATION OF HELSINKI, supra note 20, at C 35.
37. Daniel Huys et al., Die tiefe Hirnstimulation bei psychiatrischen Erkrankungen. Historische Grundlagen [Deep Brain Stimulation and Psychiatric Diseases. Historic Foundations.], 82 Der Nervenarzt 1-12 (2011) (F.R.G.).
38. Kuhn et al.
39. E.g., with further reference given, Susanne Beck, Enhancement - die fehlende rechtliche Debatte einer gesellschaftlichen Entwicklung [Enhancement - a Lacking Legal Debate on a Social Development], 24 Medizinrecht [MedR] 95 (2006)
40. Wolfgang Eberbach, Die Verbesserung des Menschen [The Improvement of Humans], 26 MedR 325 (2008)
41. Kathrin Nitschmann, Chirurgie für die Seele? Eine Fallstudie zu Gegenstand und Grenzen der Sittenwidrigkeitsklausel [Surgery for the Soul? A Case Study on the Subject and the Limits of the Rule on Unconscionability], 119 Zeitschrift für die gesamte Strafrechtswissenschaft [ZStW] 547 (2007)Christof Stock, DIE INDIKATION IN DER WUNSCHMEDIZIN (2009) (all F.R.G.).
42. latest, e.g., Bauteile für die Seele [Building Components for the Soul], Die Zeit (F.R.G.), Aug. 16, 2007, at 29
43. Die versteckte Krankheit [The Concealed Disease], id., Nov. 19, 2009.
44. Michael Fuchs, Enhancement, in LEXIKON DER BIOETHIK 604-605 (Wilhelm Korff, Lutwin Beck and Paul Mikat eds., 2000) (F.R.G.)
45. Lennart Nordenfelt, On the Goals of Medicine, Health Enhancement and Social Welfare, 9 Health Care Analysis 15-23 (2001); Eberbach, supra note 33.
46. Saskia K. Nagel and Achim Stephan: Was bedeutet Neuro-Enhancement? Potentiale, Konsequenzen, ethische Dimensionen [What does Neuro-Enhancement Mean? Potential, Consequences, Ethical Dimensions], in NEURO-ENHANCEMENT. ETHIK VOR NEUEN HERAUSFORDERUNGEN [NEURO-ENHANCEMENT. ETHICS FACING NEW CHALLENGES] 19-48 (Bettina Schöne-Seifert et al. eds., 2009)
47. Nordenfelt, supra note 35; Thorsten Galert et al., Europäische Akademie zur Erforschung von Folgen wissenschaftlich-technischer Entwicklungen Bad Neuenahr- Ahrweiler, Memorandum Neuroenhancement, 2009 (11) Gehirn and Geist 40-48
48. Eugen Kunz, Gehirndoping: Unheil oder Segen? [Doping of the Brain: Curse or Blessing?], 28 Medizinrecht [MedR] 471 (2010)
49. Gisela Klinkhammer, Neuroenhancement: Auf dem Weg zum optimierten Gehirn, 106 Dtsch Ärztebl A-2179 (2009)
50. concerning questions of German constitutional law Josef F. Lindner, "Neuro-Enhancement" als Grundrechtsproblem, 28 Medizinrecht [MedR] 463 (2010); concerning criminal law
51. Reinhard Merkel, Neuartige Eingriffe ins Gehirn - Verbesserung der mentalen condicio humana und strafrechtliche Grenzen, 121 Zeitschrift für die gesamte Strafrechtswissenschaft [ZStW] 919 (2009) (all F.R.G.).
52. Galert et al.
53. Concerning consent and autonomy from both a legal and ethical point of view
54. Bundesverfassungsgericht [BVerfG] [Federal Constitutional Court] Jul. 25, 1979, 52 Entscheidungen des Bundesverfassungsgerichts [BVerfGE] 131; Bundesgerichtshof [BGH] [Federal Court of Justice] Nov. 19, 1985, 39 Neue Juristische Wochenschrift [NJW] 780
55. Adolf Laufs and Bernd-Rüdiger Kern, HANDBUCH DES ARZTRECHTS [HANDBOOK OF MEDICAL LAW] §§ 57 et seq. (4th ed. 2002); Erwin Deutsch and Andreas Spickhoff, MEDIZINRECHT [MEDICAL LAW] paras. 243 and, more general, 250-259, 265-281 (6th ed. 2008)
56. Erwin Deutsch and Andreas Spickhoff, MEDIZINRECHT [MEDICAL LAW] paras. 243 and, more general, 250-259, 265-281 (6th ed. 2008)
57. Christian Katzenmeier, ARZTHAFTUNG [PHYSICIAN LIABILITY] 324-325 and, more general, 322-350 (2002)
58. Christian Katzenmeier, Aufklärungspflicht und Einwilligung [The Duty to Inform and Informed Consent], in ARZTRECHT [MEDICAL LAW] ch. V, paras. 6 et seq. (Adolf Laufs, Christian Katzenmeier and Volker Lipp eds., 6th ed. 2009) (all F.R.G.).
59. 168 BGHZ 103 ("Robodoc"), supra note 27, at 109; 172 BGHZ 1 ("Arzneimittelheilversuch")
60. Such as intracranial bleedings, implying the risk of irreversible neurological damage, or cerebral cramps and infections as well as alterations of the individual identity or personality of the patient: See, in general, Günther Deuschl et al., A Randomized Trial of Deep Brain Stimulation for Parkinson's Disease, 355 N. Engl. J. Med. 896 at 906 (2006)
61. See, in general, Günther Deuschl et al., A Randomized Trial of Deep Brain Stimulation for Parkinson's Disease, 355 N. Engl. J. Med. 896 at 906 (2006)
62. F. J. Seijo et al., Complications in Subthalamic Nucleus Stimulation Surgery for Treatment of Parkinson's Disease, 149 Acta Neurochir 867-876 (2007)
63. P. Blomstedt and M. I. Hariz, Hardware-Related Complications of Deep Brain Stimulation: A Ten Year Experience, 147 Acta Neurochir 1061 (2005)
64. Müller and Christen, supra note 9. 42 Bundesgerichtshof [BGH] [Federal Court of Justice] Feb. 2, 1984, 90 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 103
65. BGH Feb. 5, 2000, 144 BGHZ 1; BGH Mar. 14, 2006, 166 BGHZ 336, 339;
66. Christian Katzenmeier, ARZTHAFTUNG [PHYSICIAN LIABILITY] 329-331 (2002) (all F.R.G.).
67. Christian Katzenmeier, Aufklärungspflicht und Einwilligung [The Duty to Inform and Informed Consent], in ARZTRECHT [MEDICAL LAW] ch. V, paras. 22 et seq. (Adolf Laufs, Christian Katzenmeier and Volker Lipp eds., 6th ed. 2009) (F.R.G.).
68. 168 BGHZ 103 ("Robodoc"), supra note 27, at 109; 172 BGHZ 1 ("Arzneimittelheilversuch"), supra note 26, with specific explanation by Katzenmeier, supra note 26, at 1108.
69. Bundesgerichtshof [BGH] [Federal Court of Justice] May 22, 2007, 172 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 254 ("Racz-Methode"), reviewed by Andreas Spickhoff, Erforderliche Sorgfalt und Umfang der Aufklärungspflicht bei Anwendung einer Außenseitermethode [Standard of Due Care and Scope of Information that Has to Be Delivered to the Patient when Using a Non-Standard Therapy] 26 Medizinrecht [MedR] 87 (2008)
70. Marcus Vogeler, Die Haftung des Arztes bei der Anwendung neuartiger und umstrittener Heilmethoden nach der neuen Rechtsprechung des BGH [Physicians' Liability in Cases of Using New and Disputed Methods of Treatment according to the New Line of Justice by the Bundesgerichtshof], 26 MedR 697 (2008) (all F.R.G.).
71. Thomas Fuchs, DAS GEHIRN - EIN BEZIEHUNGSORGAN. EINE PHÄNOMENOLOGISCH-ÖKOLOGISCHE KONZEPTION [THE BRAIN - A RELATIONAL ORGAN. A PHENOMENOLOGIC-ECOLOGICAL CONCEPT] (2009) (F.R.G.).
72. Regarding the philosophical and psychological concepts of individual identity and personality Karsten Witt, Jens Kuhn, Lars Timmermann, Mateusz Zurowski and Christiane Woopen, Deep Brain Stimulation and the Search for Identity, Neuroethics (Springer, 2011), DOI: 10.1007/s12152-011-9100-1.
73. Concerning cases in which the patient may become dangerous for third persons after surgery, it is disputed whether the physician may disclose this information without prior consent of the patient, see further: Oberlandesgericht Frankfurt am Main [OLG Frankfurt/M.] [Frankfurt Ct. App.] Oct 5, 1999, 18 Medizinrecht [MedR] 196 (2000)
74. Christian Katzenmeier, ARZTHAFTUNG [PHYSICIAN LIABILITY] 331-333 (2002)
75. Horst Herzog, Die rechtliche Problematik von AIDS in der Praxis des niedergelassenen Arztes, 6 MedR 289 (1988) (all F.R.G.).
76. Walter Glannon, Consent to deep brain stimulation for neurological and psychiatric disorders, 21 Journal of Clinical Ethics 104-111 (2010).
77. Bundesgerichtshof [BGH] [Federal Court of Justice] Sep. 22, 1987, 102 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 17, 22
78. BGH Dec. 6, 1988, 106 BGHZ 153, 157
79. BGH Jun. 13, 2006, 168 BGHZ 103, 107 Katzenmeier, supra note 43, at paras.
80. inter alia, Bundesgerichtshof [BGH] [Federal Court of Justice] Sep. 22, 1987, 102 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 17, 25 (F.R.G.).
81. There is one exception for special cases of obsessive compulsive disorder.
82. Concerning "shared decision making", see Winand Gellner and Michael Schmöller: NEUE PATIENTEN - NEUE ÄRZTE? [NEW PATIENTS - NEW DOCTORS?] (2008); Norbert Schmacke, Kommunikation in der Patientenversorgung [Communication in the Medical Care of Patients], 2009 (04) Die Ersatzkasse [ErsK] 124 (all F.R.G.).
83. Norbert Schmacke, Kommunikation in der Patientenversorgung [Communication in the Medical Care of Patients], 2009 (04) Die Ersatzkasse [ErsK] 124 (all F.R.G.).
84. Christiane Woopen and Anne Rummer, Beratung im Kontext von Pränataldiagnostik und Schwangerschaftsabbruch, 27 Medizinrecht [MedR] 130-138 (2009) (F.R.G.).
85. Schwangerschaftskonfliktgesetz [SchKG] [Act for the Avoidance and Accomplishment of Conflicts concerning Pregnancy], Feb. 27, 1992, BGBl. I at 1398, as amended Dec. 8, 2010, BGBl. I at 1864, § 2a; Gendiagnostikgesetz [GenDG] [Genetic Diagnostics Act], Jul. 31, 2009, BGBl. I at 2529, as amended Oct 19, 2009, BGBl. I at 1864, §§ 7 and 10; Embryonenschutzgesetz [ESchG] [Embryo Protection Act], Dec. 13, 1990, BGBl. I at 2764, to be amended by the Act on Pre-Implantation Genetic Diagnosis (to be signed into law, passed by the Bundestag on July 6, 2011 and approved by the Bundesrat on Sept. 23, 2011), § 3a (3) (all F.R.G.). The latter is also awaiting further implementation by Ordinance of the Federal Government.
86. Tom L. Beauchamp, Informed consent: Its history, meaning, and present challenges, 20 Cambridge Quarterly of Healthcare Ethics 515-523 at 518 (2011).
87. Tom L. Beauchamp and James F. Childress, PRINCIPLES OF BIOMEDICAL ETHICS (6th ed. 2009).
88. Tobias Skuban, Katja Hardenacke, Christiane Woopen and Jens Kuhn, Informed Consent in Deep Brain Stimulation - Ethical Considerations in a Stress Field of Pride and Prejudice. 5 Frontiers in Integrative Neuroscience 7 (2011), DOI:10.3389/fnint.2011.00007.
89. E.g. Bundesgerichtshof [BGH] [Federal Court of Justice] Dec. 5, 1958, 29 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 33
90. Deutsch and Spickhoff 685
91. Katzenmeier 41
92. Volker Lipp, FREIHEIT UND FÜRSORGE. DER MENSCH ALS RECHTSPERSON [LIBERTY AND WELFARE. THE HUMAN BEING AS A LEGAL PERSON] (2000)
93. Mathias Nebendahl, Selbstbestimmungsrecht und rechtfertigende Einwilligung des Minderjährigen bei medizinischen Eingriffen [Autonomy and Consent of Minors Concerning Medical Treatments] 27 Medizinrecht [MedR] 197 (2009) (all F.R.G.).
94. in detail, Jochen Taupitz, GUTACHTEN 63. DJT A 52 et seq. (2000)
95. Dieter Schwab, Stellvertretung bei der Einwilligung in die medizinische Behandlung [Consent to Medical Treatment by Agency], in FESTSCHRIFT FÜR DIETER HEINRICH 511 at 518 et seq. (Erik Jayme, Dieter Schwab and Peter Gottwald eds., 2000) (all F.R.G.).
96. Dieter Schwab, § 1904 BGB [German Civil Code], in MÜNCHENER KOMMENTAR ZUM BGB (Franz-Jürgen Säcker and Roland Rixecker eds., 5th ed. 2008); Werner Bienwald, § 1904 BGB, in J. VON STAUDINGER'S KOMMENTAR ZUM BGB, paras. 1 et seq. (13th ed. 2006) (all F.R.G.).
97. Werner Bienwald, § 1904 BGB, in J. VON STAUDINGER'S KOMMENTAR ZUM BGB, paras. 1 et seq. (13th ed. 2006) (all F.R.G.).
98. Generally on the treatment of these diseases Reinhard Merkel et al., INTERVENING IN THE BRAIN 161 et seq. (2007); Ron L. Alterman and Michele Tagliati, Deep Brain Stimulation for Torsion Dystonia in Children, 23 Childs Nerv Syst 1033 (2007).
99. Ron L. Alterman and Michele Tagliati, Deep Brain Stimulation for Torsion Dystonia in Children, 23 Childs Nerv Syst 1033 (2007).
100. Bundesgerichtshof [BGH] [Federal Court of Justice] Dec. 5, 1958, 29 Entscheidungen des Bundesgerichtshofes in Zivilsachen [BGHZ] 33 (F.R.G.); Katzenmeier, supra note 43, at para. 42.
101. Katzenmeier 42.
102. e.g., a summary by Sonja Rothärmel, EINWILLIGUNG, VETO, MITBESTIMMUNG [CONSENT, VETO, CO-DETERMINATION] 93-116 (2004) further Deutsch and Spickhoff, supra note 39, at para. 686
103. Nebendahl, supra note 60, at 198 et seq.
104. Bundesgerichtshof [BGH] [Federal Court of Justice] Oct 10, 2006, 60 Neue Juristische Wochenschrift [NJW] 217 (2007), reviewed by Volker Lipp, 26 Medizinrecht [MedR] 292 (2008), but see review by Bernd-Rüdiger Kern, 2007 Lindenmayer/Möhring [LMK] 217, 220
105. Knut Amelung, VETORECHTE BESCHRÄNKT EINWILLIGUNGSFÄHIGER IN GRENZBEREICHEN MEDIZINISCHER INTERVENTION [THE RIGHT TO VETO OF PERSONS WITH LIMITED CAPACITY TO CONSENT TO BORDERLINE MEDICAL INTERVENTIONS] (1995) (all F.R.G.); Nebendahl, supra note 60. 67 Glannon, supra note 49.
106. e.g. in the State of North Rhine Westfalia (this subject matter belongs to the affairs of the States rather than the Federal jurisdiction): Gesetz über Hilfen und Schutzmaßnahmen bei psychischen Krankheiten [PsychKG NRW] [Statute on Help and Protective Measures Concerning Psychical Diseases], Dec. 17, 1999, GVBl. 662, as amended Apr. 5, 2005, GVBl. 332, § 18 (4) (F.R.G.).