Risky business? The risks and benefits of umbilical cord blood collection

Medical Law Review

Volumn 18, Issue 3, 2010, Pages 330-362

  Devine, Karen ^a  

^a UNIVERSITY OF KENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BONE MARROW TRANSPLANTATION; CORD BLOOD STEM CELL TRANSPLANTATION; ETHICS; HUMAN; INFORMED CONSENT; LEGAL ASPECT; LEGAL LIABILITY; MEDICAL ETHICS; NATIONAL HEALTH SERVICE; RISK ASSESSMENT; UNITED KINGDOM;

BONE MARROW TRANSPLANTATION; CORD BLOOD STEM CELL TRANSPLANTATION; ETHICS, MEDICAL; GREAT BRITAIN; HUMANS; INFORMED CONSENT; LIABILITY, LEGAL; RISK ASSESSMENT; STATE MEDICINE;

EID: 77956293316     PISSN: 09670742     EISSN: 14643790     Source Type: Journal    
DOI: 10.1093/medlaw/fwq020     Document Type: Article

References (227)

1. CP McGuckin and others, 'Production of Stem Cells with Embryonic Characteristics from Human Umbilical Cord Blood' (2005) 38 Cell Proliferation 245.
2. Matthew, from North Carolina, USA, was only 5 years old when he became the first recipient of this innovative procedure, which was carried out on 25 February 1988 at a hospital in Paris. Matthew suffered from a rare but potentially fatal genetic disorder known as Fanconi's anaemia.
3. J Kurtzberg, A Drapkin Lyerly and J Sugarman, 'Untying the Gordian Knot: Policies, Practices and Ethical Issues Related to Banking of Umbilical Cord Blood' (2005) 115 Journal of Clinical Investigation 10, 2592.
4. D Nelkin, 'Banking on Blood: The Strange Made Familiar and the Familiar Made Strange' (1998) 5 Civilisation 3, 24.
5. KK Ballen, 'New Trends in Umbilical Cord Blood Transplantation' (2005) 105 Blood 10.
6. GR Burgio and F Locatelli, 'Transplant of Bone Marrow and Cord Blood Haematopoietic Stem Cells in Paediatric Practice, Revisited According to Fundamental Principles of Bioethics' (1997) 19 Bone Marrow Transplant, 12, 1163.
7. Lifeline Cord Blood Bank.
8. P Vanelli and others, 'Cardiac Precursors in Human Bone Marrow and Cord Blood: In-vitro Cell Cardiogenesis' (2004) 5 Italian Heart Journal 5, 384.
9. MD Newman and others, 'Transplantation of Human Umbilical Cord Blood Cells in the Repair of CNS Diseases' (2004) 4 Expert Opinion on Biological Therapy 2, 121.
10. A Taguchi and others, 'Administration of CD34 Cells after Stroke Enhances Neurogenesis via Angiogenesis in a Mouse Model' (2004) 114 Journal of Clinical Investigation 3, 330.
11. A Jensen, H M Vaihinger and C Meier, 'Perinatal Brain Damage - from Neuro-protection to Neuro-regeneration Using Cord Blood Stem Cells' (2003) 98 Medizinische Klinik (Munich) at 22 (In German).
12. Newman (n 9).
13. J Kurtzberg and others, 'Placental Blood as a Source of Haematopoietic Stem Cells for Transplantation into Unrelated Recipients' (1996) 335 New England Journal of Medicine 3, 157.
14. 'Cord blood stem cells cure paralysis', ABC Online (28 November 2004) accessed 10 July 2010.
15. The Royal College of Obstetricians and Gynaecologists (RCOG), the Royal College of Midwives (RCM), the American College of Obstetricians and Gynaecologists (ACOG), the European Commission's Group on Ethics in Science and New Technologies (EGE), and the American Academy of Pediatrics (AAP) do not support the routine collection of UCB.
16. RCOG Scientific Advisory Opinion Paper No 2 (June 2006) 'Umbilical Cord Blood Banking' accessed 10 July 2010.
17. GR Burgio, E Gluckman and F Locatelli, 'Ethical Reappraisal of 15 Years of Cord Blood Transplantation' (2003) 361 Lancet 9353, 250.
18. RCOG (n 16) 2.
19. Owing to the confines of this paper, only the risks involved in the UCB collection process are examined and discussed.
20. For an example, see A v National Blood Authority [2001] 3 All ER 289.
21. For example, the Sale of Goods Act 1979 (with regard to the collection kit) and the Supply of Goods and Services Act 1982 (in the context of service provision).
22. C Witte, 'Cord Blood Storage, Property and Liability Issues' (2005) 26 J Legal Med 275.
23. S Munzer, 'The Special Case of Property Rights in Umbilical Cord Blood for Transplantation' (1999) 51 Rutgers LR 3, 493.
24. RCOG (n 16) 5.1.
25. The HTA is the competent authority under the EU Tissue and Cells Directive 2004/23/EC for regulating human application establishments.
26. HTA, 'New Rules for Cord Blood Collection' (30 April 3008) accessed 10 July 2010.
27. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on Setting standards of quality for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells.
28. Licences are obtained from the HTA after completion and evaluation of a 'Compliance Report Licence Form'. The process can take up to 3 months.
29. RCOG (n 16) 5.
30. Bleeding within the brain, which places pressure on the nerve cells and can cause damage to the brain.
31. N Ende, 'Cord Blood Collection: Effects of Newborns (Medical-Legal)' (1995) 86 Blood 12.
32. F Bertolini, 'Response of Bertolini to Ende - Cord Blood Collection: Effects on Newborns (Medical-Legal)' (1995) 86 Blood 12.
33. Ende (n 31).
34. The health professional's duty extends not only to treatment, diagnosis and advice, but also to the provision of information. See Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871; Pearce v United Bristol Hospitals Healthcare NHS Trust [1999] PIQR 53 and Chester v Afshar [2004] UKHL 21.
35. CryoCell International, accessed 10 July 2010.
36. 'Controls wanted on sale of human tissue', BBC News Online (19 June 1998) accessed 10 July 2010.
37. Chester v Ashfar (n 34).
38. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per Lord Woolf MR.
39. Chester v Ashfar (n 34) at [55] per Lord Hope.
40. Pearce v United Bristol Healthcare NHS Trust (n 34).
41. As seen in the earlier risk disclosure cases of Sidaway v Bethlem Royal Hospital Governors [1985] 1. All E.R 643; Gold v Haringey Health Authority [1988] QB 481 and Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151.
42. As evidenced in Smith v Tunbridge Wells Health Authority [1994] 5 Med LR 334; Wyatt v Curtis [2003] EWCA Civ 1779; Chester v Afshar [2004] UKHL 21 and Birch v UCL Hospital NHS Foundation Trust [2008] EWHC 2237 (QB).
43. Sidaway v Bethlem Royal Hospital Governors (n 41) at [900] per Lord Bridge. Lord Bridge provided the example of a 10% risk of a stroke from an operation to demonstrate what he considered a serious harm that required disclosure. In contrast, a 0.1-0.2% risk of stillbirth was not considered to be significant enough to warrant disclosure in Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per Lord Woolf MR.
44. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per Lord Woolf MR, followed in Chester v Afshar (n 34) at [86] per Lord Hope.
45. Department of Health (DH) Expert Maternity Group, Changing Childbirth (HMSO, London 1993).
46. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per Lord Woolf MR.
47. GR Burgio and F Locatelli, 'Transplant of Bone Marrow and Cord Blood Haematopoietic Stem Cells in Paediatric Practice, Revisited According to the Fundamental Principles of Bioethics' (1997) 19 Bone Marrow Transplantation 12, 1163.
48. EA Meyer, K Hanna and K Gebbie (eds), The National Institute of Medicine of The National Academies, Board of Health Sciences Policy, Cord Blood - Establishing a National Hematopoietic Stem Cell Bank Program (National Academies Press, Washington DC, 2005) 47.
49. HLA, or Histocompatibility Antigens as they are also known, are proteins found on the surface of almost every cell in the body.
50. C Thomas Scott, Stem Cell Now - from the Experiment that Shook the World to the New Politics of Life (Pearson Education Incorporated, PI Press, New York, 2006) 218.
51. B Hering, The Charity Guide, 'The Challenge' accessed 10 July 2010.
52. National Blood Transfusion Service, 'Survival Shouldn't Be about Luck' (Spring 2004) The Donor 16. http://blood.co.uk/pdf/publications/donor_Spr2004.pdf accessed 10 July 2010.
53. AM Regan, S Bewley and R Warwick, 'Banking Obstetric-related Tissues and Cells: What Every Maternity Unit Must Know' (2008) 18 Obstetrics, Gynaecology and Reproductive Medicine 3.
54. BH Lubin and others, 'Cord Blood Banking for Potential Future Transplantation' (2007) 119 Pediatrics 1.
55. The term 'in-utero' means 'within the uterus'.
56. 'Stem Cells: Therapies for the future?' European Commission Research DG/Life Sciences Directorates Projects Catalogue (18-19 December 2001) accessed 10 July 2010.
57. NJ Chao, SG Emerson, and KI Weinberg, 'Stem Cell Transplants (Cord Blood Transplantation)' (2004) 1 Hematology 354.
58. Otherwise known for transplantation purposes as 'a perfect match' or an 'A-grade match'.
59. V Rocha and others, 'Graft-Versus-Host Disease in Children Who Have Received a Cord Blood or Bone Marrow Transplant from a HLA-identical Sibling' (2000) 342 N Eng J Med 25.
60. J Wagner and others, 'Successful Transplantation of HLA-matched and HLA-mismatched Umbilical Cord Blood from Unrelated Donors: Analysis of Engraftment and Acute Graft-Versus-Host Disease' (1996) 88 Blood 3, 795.
61. SJ Proctor and others, 'Umbilical Cord Blood Banks in the UK Have Proved Their Worth and now Deserve a Firmer Foundation' (2001) 323 BMJ 60.
62. 'The 2 minute treatment that could save my baby's life (20 years from now!)' The Daily Mail (25 May 2004).
63. SK Middleton, 'Parents freeze umbilical cord cells for future spare part surgery' Times Online (14 May 2006) accessed 10 July 2010.
64. H Wagner, 'UmbilicalCord Blood Banking' USA Today (March 2000) accessed 10 July 2010.
65. D Nelkin, 'Banking on Blood' (1998) 5 Civilisation 3, 24.
66. These are: Biovault Human Tissue Bank Ltd, Cells 4 Life, Cells Limited, CryoGenesis International Limited, Future Health Technologies, Smartcells International, The UK Cord Blood Bank and The Virgin Health Bank.
67. RCOG (n 16) at recommendation 7(5).
68. American College of Obstetricians and Gynaecologists (ACOG), 'Routine storage of umbilical cord blood for potential future transplantation' ACOG Committee Opinion No.183 (Washington DC, 1997).
69. See also J DeFao, 'Is it worth banking your baby's cord blood? Doctors say hard sell of hope is deceptive', San Francisco Chronicle (20 June 2005) accessed 10 July 2010.
70. AAP Working Group on Cord Blood Banking, 'Cord Blood Banking for Potential Future Transplantations: Subject Review' (1999) 104 Pediatrics 1, 116.
71. NM Fisk and others, 'Can Commercial Cord Blood Banking Be Scientifically and Ethically Justified?' (2005) 2 PLOS Med 2.
72. Opinion of the European Group on Ethics in Science and New Technologies (EGE) to the European Commission. Opinion No. 19 (March 2004) 'Ethical Aspects of Umbilical Cord Blood Banking' at 2.1.
73. NM Fisk and R Atun, 'Public-Private Partnership in Cord Blood Banking' (2008) 336 BMJ 642.
74. Smart Cells International, accessed 10 July 2010.
75. For the purpose of this paper, a 'UCB unit' is the total amount of UCB collected and stored from a singular incident of UCB collection.
76. Alberta Heritage Foundation for Medical Research (AHFMR), 'Cord Blood Transplantation', Technical Note TN3, 6 (University of York, Canada, 1996).
77. UCB transplants using a single UCB unit can only benefit paediatric patients or small adults weighing approximately 40-45 kg.
78. E Gluckman and others, 'Outcome of Cord Blood Transplantation from Related and Unrelated Donor: Eurocord Transplant Group and The European Blood and Marrow Transplantation Group' (1997) 337 N Eng J Med 373.
79. JE Wagner and others, 'Transplantation of Unrelated Donor Umbilical Cord Blood in 102 Patients with Malignant and Non-malignant Diseases: Influence of CD34 Cell Dose and HLA Disparity on Treatment-related Mortality and Survival' (2002) 100 Blood 1611.
80. P Rubinstein and others, 'Outcomes among 562 Recipients of Placental-Blood Transplants from Unrelated Donors' (1998) 339 N Eng J Med 22 1565.
81. Collated data suggest that a minimumnucleated cell dose should be 1.5 × 10/7 nucleated cells/kg.
82. Engraftment occurs when donated cells start to grow, a major sign of which is the neutrophil recovery-the presence of more than 500 neutrophils, a type of white blood cell, for more than 3 days in a row. Until this occurs, the patient remains open to viruses and disease.
83. RC Wardlow and DL Porter, 'Umbilical Cord Blood Transplantation: Where Do We Stand?' (2002) 8 Biol Blood Marrow Transplant 12, 637.
84. S Takahashi and others, 'Comparative Single-institute Analysis of Cord Blood Transplantation from Unrelated Donors with Bone Marrow or Peripheral Blood Stem-cell Transplants from Related Donors in Adult Patients with Hematologic Malignancies after Myeloablative Conditioning Regimen' (2007) 109 Blood 3, 1322.
85. P Solves and others, 'Comparison Between Two Cord Blood Collection Strategies' (2003) 82 Acta Obstet Gynecol Scand 5, 439.
86. L Lasky and others, 'In-utero or Ex-utero Cord Blood Collection: Which Is Better?' (2002) 42 Transfusion 10, 1261.
87. RL Sparrow and others, 'Influence of Mode of Birth and Collection on WBC Yields of Umbilical Cord Blood Units' (2002) 42 Transfusion 2, 210.
88. P Solves and others, 'In-utero or Ex-utero Cord Blood Collection: an Unresolved Question' (2003) 43 Transfusion 8, 1174.
89. These factors include first-born infants, prolonged labour, increase in gestational age and increased birth weight, which appear to contribute to high cell dose.
90. See C Donaldson and others, 'Impact of Obstetric Factors on Cord Blood Donation for Transplantation' (1999) 106 Br J Haematol 1, 128.
91. See also CP McGuckin and others, 'Cord Blood Revelations - The Importance of Being a First Born Girl, Big, on Time and to a Young Mother!' (2007) 83 Early Hum Dev 733.
92. DV Surbek and others, 'Optimising Cord Blood Mononuclear Cell Yield: a Randomized Comparison of Collection before vs after Placenta Delivery' (1998) 22 Bone Marrow Transplant 3, 311.
93. A Wong and others, 'Cord Blood Collection before and after Placental Delivery, Levels of Nucleated Cells, Haematopoietic Progenitor Cells, Leukocyte Sub-populations and Macroscopic Clots' (2001) 27 Bone Marrow Transplant 2, 133.
94. JN Barker and others, 'Transplantation of 2 Partially HLA-matched Umbilical Cord Blood Units to Enhance Engraftment in Adults with Hematologic Malignancy' (2005) 105 Blood 3, 1343.
95. W Wiktor-Jedrzejczak and others, 'Simultaneous transplantation of three cord blood units in adults with high risk acute leukaemia' (2005) 106 Blood American Society of Hematology Annual Meeting, Abstract 5457.
96. Cell expansion is the term given to a technique where the total nucleated cell dose in a given unit can be increased.
97. E Sphall and others, 'Transplantation of Ex-vivo Expanded Cord Blood' (2002) 8 Biol Blood Marrow Tranplant 7, 368.
98. In 2003, a new cell expansion device called the Aastrom Replicell System was successfully used to treat twenty-seven patients with malignant and non-malignant disorders, see J Jaroscak and others, 'Augmentation of Umbilical Cord Blood (UCB) Transplantation with Ex-vivo Expanded UCB Cells: Results of a Phase 1 Trial Using the Aastrom Replicell System' (2003) 101 Blood 5061.
99. More recently, Israel-based Gamida Cell, in a joint venture with Teva Pharmaceutical Industries Ltd, announced that the first patient in its multi-national, multi-centre trial had received a UCB transplant using its cell expansion device, the StemExw. Its market launch took place in March 2009.
100. S Robinson and others, 'Ex-vivo Expansion of Umbilical Cord Blood' (2005) 7 Cytotherapy 3, 243.
101. M Baker, 'Banking on the Future of Stem Cells' (2008) 452 Nature 263.
102. Alberta Heritage Foundation for Medical Research (AHFMR), Cord Blood Transplantation (University of York, Canada, 1996) Technical Note TN3, 6.
103. RCOG (n 16) 5(1).
104. A review of the literature in 2004 concluded that what is defined as early and delayed clamping has varied widely over the years, see AGS Phillip and S Saigal, 'When Should We Clamp the Umbilical Cord?' (2004) 5 NeoReviews 4.
105. In modern day healthcare, however, early (or immediate) cord clamping is regarded as being performed within 15 s and delayed as 45-60 s after delivery of the baby, see AGS Philip, 'Delayed Cord Clamping in Preterm Infants' (2006) 117 Pediatrics 4.
106. PF Van Rheenan and BJ Brabin, 'A Practical Approach to Timing Cord Clamping in Resource Poor Settings' (2006) 333 BMJ 954.
107. Placental Blood Collection: Effects on Newborns
108. Ende (n 31).
109. Ende (n 31).
110. JE Wagner and others, 'Transplantation of Umbilical Cord Blood in 50 Patients: Analysis of the Registry Data' (1994) 84 Blood (Suppl.1) 395a.
111. S Saigal and others, 'Placental Transfusion and Hyperbilirubianeamia in the Premature' (1972) 49 Pediatrics 3, 406.
112. JS Mercer, 'Current Best Evidence: a Review of the Literature on Umbilical Cord Clamping' (2001) 46 J Midwifery Womens Health 6, 402.
113. Hypothermia is a dangerously low body temperature of below 95°F (35°C).
114. Polycythaemia is caused by an overload of red blood cells, which thickens the blood and makes it harder to circulate through the body. This in turn can cause the baby to experience breathing difficulties.
115. Medical University of South Carolina. Health Information Centre. 'Polycythaemia' accessed 10 July 2010.
116. Mercer (n.103).
117. SJ McDonald and P Middleton, 'Effects of Timing of Umbilical Cord Clamping of Term Infants on Maternal and Neonatal Outcomes (Protocol)' (2003) Cochrane Database Syst Rev 1 Art No: CD0040747.
118. Mercer (n.103).
119. M Rajnik and others, 'Early Cytokine Expression Induced by Hemorrhagic Shock in a Non-resuscitated RatModel' (2001) 49 Pediatric Res 4S and 44A.
120. Mercer (n.103).
121. KB Nelson and others, 'Neonatal Cytokines and Coagulation Factors in Children with Cerebral Palsy' (1998) 44 Ann Neurol 4, 665.
122. Bleeding within the brain, which places pressure on the nerve cells and can cause brain damage.
123. GJ Hofmeyr and others, 'Periventricular/Intraventricular Haemorrhage and Umbilical Cord Clamping. Findings and Hypothesis' (1988) 73 South Afr Med J 2, 104.
124. GJ Hofmeyer and others, 'Hasty Clamping of the Umbilical Cord May Initiate Neonatal Intraventricular Hemorrhage' 29 (1989) Med Hypotheses 1, 5.
125. First, it has been suggested that as the results were based on a sample size and was conducted in the poor resource setting of Africa, its results cannot be comparatively reliable for industrialised countries. Secondly, since the study was carried out over 22 years ago, advancements in medical technology have since been introduced in modern day healthcare practices. Necessary equipment such as ventilation support units, which would not have been available to the newborns who took part in the trial, may today be available and the risks that were once present might now be addressed by the use of twenty-first century medical technologies. See Bertolini (n.32).
126. Ende (n.31).
127. Bertolini (n.32).
128. JS Mercer and others, 'Delayed Cord Clamping in Very Preterm Infants Reduces the Incidence if Intraventricular Haemorrhage and Late-onset Sepsis: A Randomised, Controlled Trial' (2006) 117 Pediatrics 4, 1235.
129. H Rabe, G Reynolds and J Diaz-Rosello, 'Early versus Delayed Umbilical Cord Clamping in Preterm Infants' (2004) Cochrane Database Syst Rev 4 Art No: CD0040747.
130. 'Delay cord cutting aids babies', BBC News (17 October 2004) accessed 10 July 2010.
131. T Levy and I Blickstein, 'Timing of Cord Clamping Revisited' (2006) 34 J Perinat Med 4.
132. Rajnik (n.111).
133. DJR Hutcheon, 'Commercial Cord Blood Banking - Immediate Cord Clamping Is not Safe' (2006) 333 BMJ (Letter) 919.
134. Typically, in-utero collection involves the cord being clamped after delivery of the child and a needle (with attached syringe) being inserted into the umbilical vein, which can be done more than once to ensure optimum retrieval of cells. The needle is connected to a closed collection bag containing an anticoagulant-a substance that inhibits blood clotting-into which the blood is drained.
135. With the ex-utero method, the clamped cord and placenta are delivered intact and transferred to a collection tray to allow gravity to drain the UCB from the cord into the collection bag, or onto sterilised absorbent sheets where the needle is then inserted as per the in-utero method.
136. Solves (n.83).
137. 'Needlestick Injury' is the term given to accidental injuries caused by the use of needles.
138. Solves (n.83).
139. RCOG (n.16) at 5(1).
140. D Dickenson and P Vineis, 'Evidence-based Medicine and Quality of Care' (2002) 10 Health Care Anal (2002) 10, 243.
141. Directive 2004/23/EC (n.27).
142. RCOG (n 16) 5(1).
143. Division of Reproductive Health, World Health Organisation (WHO), Geneva, Report of a Technical Working Group Safe Motherhood: Care in Normal Birth, A Practical Guide, Chapter 5 (7) 'Care of the mother immediately after delivery of the placenta' (1996) at 33.
144. The 'uterine fundal height' is the distance between the top of the pubic bone and the uterus, calculated in centimetres. This is measured during pregnancy to estimate the number of gestational weeks of the foetus. After birth, it can be used to monitor the contraction of the uterus. Observations with regard to fundal height and blood loss are particularly important to the well-being of the mother because if the uterus contracts insufficiently, blood may accumulate within the uterus.
145. Division of Reproductive Health, WHO (n.136).
146. Post-partum haemorrhage (PPH) is a potentially life threatening complication of vaginal and Caesarean section births resulting in blood loss in excess of 1,000 ml. Between 1 and 10% of all pregnancies experience complications associated with PPH and approximately 17% of maternal mortality are caused by PPH.
147. RCOG (n.16) at 5(1).
148. Severe pre-ecalmpsia is the most serious of common pregnancy-related conditions. It is caused by a defect in the placenta, which results in the mother experiencing symptoms such as high blood pressure, protein in the urine, and severe swelling in parts of the body. While the symptoms of preeclampsia can be managed during pregnancy, they are only alleviated by delivery. Effects to the baby typically present as poor foetal growth. Severe pre-eclampsia occurs in 1 in 50 pregnancies and is responsible for the deaths of 3-5 women and 500-600 babies per year.
149. Checking that the placenta has expelled completely is crucial because retained placental tissue can be associated with post-partum haemorrhage and infection.
150. For a detailed analysis of placental examination, see JF Yetter III, 'Examination of the Placenta' (1998) 57 Am Fam Physician 5.
151. Abnormalities detected in the placenta and umbilical cord may indicate abnormal foetal development and perinatal morbidity.
152. An employer is vicariously liable for torts that occur during the course of employment when the nature of the activity is closely connected to their role in that employment. See Lister v Helsey Hall [2001] UKHL 22.
153. Wilkinson & Clyde Coal Co v English [1938] AC 57 at [78] per Lord Wright.
154. The UCB collector is also at risk themselves from this type of injury and consequent infection from blood-borne diseases, see C Leliopoulou, H Waterman and S Chakrabaty, 'Nurses Failure to Appreciate the Risk of Infection from Needlestick Accidents - a Hospital based Survey' (1999) 42 J Hosp Infect 1, 53.
155. In 2002, it was revealed that mixed-race twins had been born to a white couple after sperm at an IVF clinic had been mislabelled. This led to the introduction of a 'bar-coding' system of labelling to prevent further mishaps. Despite the new system, the same mistake occurred in 2007 and again in May 2009 at the Guy's and St Thomas' Hospital, London.
156. See N Shaikh, 'Fertility Watchdog Investigates Serious IVF mix-ups at London Hospital' (Progress Educational Trust, 3 May 2009) Bionews 4320.
157. LC Edozien, 'NHS Maternity Units Should not Encourage Commercial Banking of Umbilical Cord Blood' (2006) 333 BMJ 801.
158. Directive 2004/23/EC (n 27) Art. 8.
159. There is a large body of academic literature pertaining to the social and ethical implications of recognising property in the body and whether the law should acknowledge such rights, for example, see R Hardcastle, Law and the Human Body - Property Rights, Ownership and Control (Hart, Oxford and Portland 2007) Ch 3.
160. See R v Rothery [1976] RTR 550 (CA) and Roche v Douglas (2000) 22 WAR 331 (WA SC).
161. See generally Moore v Regents of the University of California 793 P 2d 479 (Cal 1990).
162. Witte (n 22) and Munzer (n 23).
163. However, it is worth noting here that in Yearworth and others v North Bristol NHS Trust [2009] EWCA Civ 37, the CA held that a negligently damaged sperm sample, stored by a hospital on behalf of a patient undergoing chemotherapy treatment, was the patient's legal property, and a claim in negligence could be made in respect of that damage. The court determined that a 'fundamental feature of ownership' (at [45] per Lord Judge) was that only the claimant could consent to the storage and destruction of the sperm, and that storage had been carried out for his benefit for future use in case his treatment made him infertile. I would argue that if a sperm sample is capable of being classed as property that can give rise to compensation, then so too could privately banked UCB because it is collected and stored for the donor's future use and it is the donor, or their legal representative, who retains control over the stored unit.
164. While there have been no reported cases of a claim for property damage or personal injury from the negligent procurement of UCB in the UK to date, a claim in China is currently awaiting resolution in a Shanghai court. This follows a legal action by over 100 parents against a biotech company in January 2008 for the alleged procurement and storage of tainted UCB. At the time of writing, the court has refused to set a timetable and has asked the parties to engage in arbitration, but if this case is indicative of inadequate handling of UCB, the risk of a future UCB-related claim in the UK is not beyond the realms of possibility.
165. For a detailed discussion of the tort of negligence, see S Deakin, A Johnston and B Markesinis, Markesinis and Deakin's Tort Law (6th edn OUP, Oxford 2007) Ch 2.
166. SD Pattinson, Medical Law and Ethics (2nd edn Sweet & Maxwell, London 2009) at 70.
167. Bolam v Friern Hospital Management Committee [1957] 2 All ER 118.
168. Nursing and Midwifery Council (NMC), 'Standards of proficiency for nurse and midwife prescribers' (April 2006). This replaces the United Kingdom Central Council for Nursing, Midwifery and Health Visitors (UKCC) 'Guidelines for professional practice' (1996).
169. While an independent nurse and phlebotomist are professionals within their own field of expertise, the term 'informal' is used in this context to denote a UCB collector who is not a midwife and one that would not have the skills associated with the birthing process.
170. Wells v Cooper [1958] 2 QB 265 at [271] per Jenkins LJ.
171. RCM, 'Commercial cord blood collection' (Position statementNo.1 July 2002) accessed 10 July 2010.
172. RCOG (n 16).
173. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 at [587] per McNair J.
174. Bolitho v City & Hackney Health Authority [1998] AC 232.
175. D Dickenson, Body Shopping - The Economy Fuelled by Flesh and Blood (Oneworld, Oxford 2008) 47.
176. J Montgomery, Health Care Law (2nd edn OUP, Oxford 2003) 346.
177. KJ Moise, 'Umbilical Cord Stem Cells' (2005) 106 Obstet Gynaecol 6.
178. MA Jones, ' Informed Consent and Other Fairy Stories' (1999) 7 MLR 103.
179. Pattinson (n.157) 112.
180. Sidaway Appellants v Board of Governors of the Bethlem Royal Hospital [1985] 1 All ER 643.
181. Lord Bridge provided the example of a 10% risk of a stroke from an operation to demonstrate what he considered a serious harm that required risk disclosure.
182. Rogers v Whitaker (1992) 175 CLR 470 at [16].
183. Sidaway (n 183) at [902] per Lord Templeman.
184. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per Lord Woolf.
185. N Fox, C Stevens and R Ciubotariu, 'Umbilical Cord Blood Collection: Do Patients Really Understand?' (2007) 4 J Perinat Med 35.
186. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per LordWoolf MR.
187. Chester v Afshar (n 34).
188. Pearce v United Bristol Healthcare NHS Trust (n 34) at [59] per LordWoolf MR.
189. While there is an entire debate to be had on the issue of the 'best interests of the child', it is worth noting here that in the event of a negligence action, particularly in circumstances where the parents are in dispute over whether or not the cells should have been procured, a court may be called upon to decide whether the UCB had been collected in the best interests of the baby. If collection had been performed in the absence of a history of family disease, it is questionable whether collection posed more risks than benefits and may consequently hinder a UCB collector's defence.
190. Birch v UCL Hospital NHS Foundation Trust (n 42).
191. Rogers v Whitaker [1992] HCA 58 (1992) 175 CLR 470.
192. Canterbury v Spence (1972) 464.
193. Rogers v Whitaker (n 198) at [16].
194. For a detailed account and discussion of this case, see D Chalmers and R Schwartz, 'Rogers v Whitaker and Informed Consent in Australia: A Fair Dinkum Duty of Disclosure' (1993) 1 Med L Rev 139.
195. Chester v Afshar (n 34).
196. Chester v Afshar [2000] WL 33201379 at [57] per Taylor J. Also, see evidence by neurosurgeon expert witnesses, Mr Findlay at [58] and Mr Frith at [59].
197. J Miola, Medical Ethics and Medical Law - a Symbiotic Relationship (Hart Publishing, Oxford and Portland, Oregon, 2007) 77.
198. B Dimond, Legal Aspects of Midwifery (2nd edn Elsevier Science Ltd, Book for Midwives Press, Cheshire, England, 2002) 188.
199. Chester v Afshar (n 34) at [26] per Lord Steyn.
200. The Royal College of Surgeons, Good Surgical Practice Guidelines (2002) to which Lord Steyn refers has now been replaced by the Good Surgical Practice Guidelines (2008) accessed 10 July 2010.
201. General Medical Council (GMC) Guidance, 'Confidentiality: Protection and Provision of Information' (April 2004) at para 7 accessed 10 July 2010.
202. GMC Guidance, 'Consent: Patients and Doctors Making Decisions Together' (June 2008) at para 5(b) accessed 10 July 2010. This replaces the previous guidance 'Seeking patient's consent: The ethical considerations' (2007).
203. B Hurwitz 'How Does Evidence-based Guidance Influence Determinations of Medical Negligence?' (2004) 329 BMJ 1024.
204. A Samanta and others, 'The Role of Clinical Guidelines in Medical Negligence Litigation: a Shift from the Bolam Standard?' (2006) 14 Med L Rev 3, 321.
205. The authors propose a 'half-way house' between the 'Bolam Test' and one in which guidelines rigidly define the standard of care. This, they suggest, would allow 'evidence-based science into judicial decision-making whilst at the same time permitting expert testimony to assess the exercise of clinical judgment'.
206. GMC 2008 (n.202) at para 32.
207. For some examples, see The GMC, Good Medical Practice (March 2009) Consent: para 36 accessed 10 July 2010.
208. See also Department of Health (DH), Reference guide to consent for experiment or treatment (March 2003) accessed 10 July 2010.
209. GMC 2008 (n 207) at para 32.
210. The principle in Smith v Tunbridge Wells Health Authority [1994] 5 Med L Rev 334 is that a doctor's duty is to take reasonable steps to ensure that the patient understands what (s)he is consenting to. However, it was held in Al Hamwi v Johnson and Another [2005] EWHC 206 that it may be too onerous a test for a doctor to ensure that the patient has understood the information they have been given. In this case, the provision of an information leaflet and use of a 'checklist' were deemed appropriate ways of conveying information, but as Miola points out, 'the impression given is that what is important is the imparting of the information and that it's effective communication - actual understanding on the part of the patient - is less critical'.
211. See: J Miola, 'Autonomy Rued Ok? (2006) 14 Med L Rev 108.
212. Clearly, the communication of issues involved in UCB collection comes into question here.
213. Chatterson v Gerson [1981] QB 432 at [443] per Bristow J.
214. Human Tissue Authority (HTA), 'Directions given under the Human Tissue Act 2004 implementing the Human Tissue Quality and Safety for Human Application) Regulations 2007' 002/2007.
215. Human Tissue (Quality and Safety for Human Application) Regulations 2007 r 6.
216. K Devine, 'Tying the Cord Around the Midwife's Neck: The Problem with Umbilical Cord Blood Collection' (2010) 26 Prof Neg 2, 83.
217. Statement by Sarah Nicholson, Risk Manager, National Health Service Litigation Authority (NHSLA) (Personal email correspondence on 26 January 2009).
218. Lister v Helsey Hall Ltd [2001] UKHL 22 at [70] per Lord Millett.
219. For example, see Wilsher v Area Essex Health Authority [1988] AC 1074.
220. Bertonlini (n 32).
221. GM Morley, 'How the cord clamp injures your baby's brain' (Unpublished paper) accessed 10 July 2010.
222. See also GM Morley, 'Can Hasty Clamping Injure the Newborn?' (1998) 7 Obstet Gynaecol Manag 29.
223. Smart Cells International, accessed 10 July 2010.
224. Notwithstanding collection on behalf of families with a history of disease.
225. Virgin Health Bank's 'Save Our Cells' campaign slogan during their launch in February 2007.
226. Ende (n 31).
227. RCOG (n 16) at recommendation 7(6).