CM v The Executor of the Estate of EJ & Ors

On 30 May 2013, I determined an urgent application brought by way of Originating Summons under the inherent jurisdiction. The application was made without formal notice having been given to the First and Second Respondents although, as will be apparent from the judgment below, the Second Respondent had informal notice of the application. At that hearing, I made Declarations sought by the Applicant, CM. The application had been supported by a statement from CM, and from her solicitor Mr Stewart Duffy; I also had available medical expert reports from Dr. S (Consultant Clinical Virologist) and Dr. K (Consultant Histopathologist). I heard submissions from Mr James Berry, on behalf of CM.

Given the unusual nature of the application, and the relief granted, I indicated that I would give my reasons at a later date. My reasons are set out in the judgment which follows.

In the early evening of 25 May 2013, CM, a medical doctor, a consultant and professor at one of London’s principal teaching hospitals, was driving home, off duty, in South East London, when she saw a body lying motionless on the pavement. Passers-by had stopped by the body. CM parked her car, and attended the scene. The body was of a woman (now known to be “EJ”); she had, it appears, fallen from a building nearby to where she lay. It was obvious that EJ was seriously injured, and she had bled profusely. CM performed emergency first aid on EJ, seeking to facilitate the possibility of her breathing by stabilising and clearing the neck and airways. Paramedics were called. Despite the efforts of CM and the paramedics, EJ died at the scene. In the course of the resuscitative efforts, CM’s hands became covered with EJ’s blood.

When home, about an hour after first attending to the body, CM washed EJ’s blood from her hands; she then noticed that she had a number of abrasions on her hands (probably caused by the alcohol hand wash which she uses in her work). Understandably anxious about the risk of being infected with a blood-borne disease from the deceased, CM sought, obtained, and commenced a course of prophylactic antiretroviral medication. These drugs have significant and unpleasant short-term side-effects which, I am told, have left CM feeling extremely unwell (including myalgia, nausea, diarrhoea, and fever); these powerful drugs have the potential to cause long-term harm (including renal, liver and pancreatic dysfunction).

CM plainly wishes to establish whether there is any risk that she has been contaminated by any serious blood-borne illness such as the HIV antibody/antigen, the hepatitis B virus (HBsAg), hepatitis C, and/or HTLV1 and 2 antibodies. This can be done by testing EJ’s blood or human tissue in an Enzyme Immuno Assay machine. Were CM to contract any one of the named diseases it would inevitably have devastating implications for her life, quite apart from the impact on her eminent career in the medical profession.

The Coroner for South East London (the Second Respondent to this application), into whose custody EJ’s body had been placed, was contacted and asked for his co-operation in obtaining samples of EJ’s blood or tissue. The Coroner, who has no free-standing power to permit the sampling or testing of EJ’s blood/tissue for this purpose, responded to the request in these terms (29 May 2013):

“The Coroner, Dr. Palmer, has no objections to the blood sample being taken and tested by an appropriate medical professional who you instruct, as long as you are satisfied that you have appropriate authorisation to do so.”

The police investigating the circumstances of EJ’s death established that she was a foreign national, and some four days after EJ’s death managed to trace a family member, EJ’s mother’s cousin, (“OP”). OP was advised of CM’s interest in obtaining a sample of blood or human tissue for the purposes of testing as outlined above; in an e-mail to the Coroner of 29 May, OP said this:

“It took a while for me to learn about the passing away of [EJ]. Her parents live [abroad] and they don’t know about the situation yet. I will be contacting them to let them know. Although I am not the legal next of kin, I will be the go between as I am the closest relative she has got here. Her mother is my first cousin and on her parents’ behalf I am willing to give my permission for the doctor who helped [EJ] at the scene to be provided with her blood sample. I would also like to take this opportunity to thank the said doctor for her efforts in trying to help [EJ].”

CM seeks the Declarations in the High Court, as she is concerned that the legal basis for taking samples in these circumstances is not entirely clear; she regards it desirable that the Coroner, and the doctors who have agreed to test the samples, have the necessary re-assurance that they are not acting unlawfully.

CM made the application, and I determined it as indicated above, as a matter of urgency on 30 May 2013; the post-mortem examination had taken place earlier that morning. Samples of blood and tissue had been taken by the pathologist instructed by the Coroner (awaiting my decision); the longer the delay in testing the relevant material, the greater the risk of blood haemolysis and deterioration of the samples, with consequent impact on the reliability of the results.

Collection, removal, storage and use of human tissue (defined as material that has come from a human body and consists of, or includes, human cells) in these circumstances is governed by the provisions of the Human Tissue Act 2004; the 2004 Act creates a range of offences for removing, storing or using human tissue for purposes without appropriate consent. Under the 2004 Act the Human Tissue Authority (“HTA”) was established to regulate activities concerning the removal, storage, use and disposal of human tissue; the HTA has in turn published helpful Codes of Good Practice to which I have had regard when considering this application.

‘Consent’ is the fundamental principle of the 2004 Act, and the associated HTA Codes; consent underpins the lawful removal, storage and use of body parts, organs and tissue.

The arrangements for removing, storing and using samples lawfully in these circumstances are to be found in Section 1, Section 3, Section 5, Section 53(1) and Schedule 1, Part 1(4) of the 2004 Act. It is not necessary for me to set out these statutory provisions in full in this judgment; put simply, when read together, these sections establish that consent is required for material (such as blood or human tissue) to be removed, stored or used for “obtaining scientific or medical information, which may be relevant to a person including a future person.”

In the absence of requisite consent, the removal, testing, or storing of human tissue would be a criminal offence (section 5). As the HTA Code of Practice [1] makes clear:

“If there is no-one available in a qualifying relationship to make a decision on consent (and consent had not been indicated by the deceased person or nominated representative), it is not lawful to proceed with removal, storage or use of the deceased person’s body or tissue for scheduled purposes”.

The sources of appropriate consent (in relation to the removal, storage or use of relevant human tissue of deceased adults) are set out in Section 3 of the 2004 Act. Where the person from whom the human tissue or blood is to be removed has died, ‘appropriate consent’ means:

In this case it is of course impossible to ascertain EJ’s wishes as to the removal, storage or use of her relevant human material, and there is no evidence that she had appointed another person as her ‘nominated representative’ in this regard. It is necessary therefore to consider those who fall within the relationship of ‘qualifying person’. These persons are listed in hierarchy with “spouse, civil partner or partner” uppermost in the list, through a range of family relationships (i.e. “parent or child, brother or sister … step-father or step-mother, half-brother or half-sister” etc) to “friend of long-standing” at the end of the list (section 27(4)(h)). The legislation provides that consent should be obtained from the person whose relationship to the person concerned is accorded the highest ranking (section 27(6)).

In applying these principles, the person’s relationship with the deceased shall be left out of account if “having regard to the activity in relation to which consent is sought, it is not reasonably practicable to communicate with him within the time available if consent in relation to the activity is to be acted on.” (section 27(8)).

As for the Coroner, he has power to remove, store, and use human tissue and blood, for any purpose associated with his functions as, or under the authority of, a Coroner (Section 11(1) of the 2004 Act). The HTA Code of Practice in this respect reveals:

“A PM examination and the removal and storage of relevant material to determine the cause of death do not require consent from the relatives if these activities have been authorised by the coroner. However, following the cessation of the coroner’s authority, it is unlawful to use the retained material for a scheduled purpose set out in the HT Act, or to continue to store it with the intention of issuing it for a scheduled purpose, without appropriate consent.”

The effect of Section 11 of the 2004 Act and the Code above is that:

Given its underpinning importance in the legislation, I turn first, and importantly, to the issue of consent. I am satisfied that it is “not reasonably practicable” to seek the consents of EJ’s parents for the removal or use of blood or tissue from EJ “within the time available” (section 27(8)). At present these relatives are (certainly at the time of the hearing on 30 May 2013, they were) unaware of EJ’s death, and for the reasons outlined in §9 above, time is of the essence. There is no indication on the papers before me that EJ has other relatives in the list of “qualifying” persons available from whom consent could be taken.

That said, I regard OP as a person in a “qualifying relationship” within the definition of Section 3(6)(c) and Section 27(4)(h)), for the purposes of giving consent to the removal, storage and use of samples of EJ’s blood or human tissue. As a reasonably close relative, he can, in my judgment, properly be regarded as falling within the definition of a “friend of longstanding”.

I am further satisfied that (with reference to his e-mail of 29 May 2013, which I have set out in full in §7 above) OP has given relevant consent for the purposes of the 2004 Act.

I further consider that (with reference to his e-mail of 29 May 2013: see §6 above) the Coroner has indicated his agreement to the removal and testing of the relevant material (subject to the consent obtained from the qualifying person).

This opens the gateway for the exercise of my discretion under the inherent jurisdiction to authorise the removal, storage and use of EJ’s human tissue samples as sought by CM.

I pay high regard to the importance of respecting the integrity of the deceased’s body prior to burial or cremation; I bear in mind in this regard however that the corpse was inevitably to be subject to thorough post-mortem examination, necessarily involving dissection and inspection of EJ’s body parts. I am conscious of the need to be vigilant to the ethical considerations relevant to permitting the removal of body tissue for the purposes of testing for disease, particularly on behalf (and for the benefit) of a third party who was not known to the deceased. I have borne firmly in mind the constrictions of the statutory regime and Code.

On the other hand, I also take into account that CM’s request only arises in this case because she undertook an act of great humanity in attempting to save EJ’s life. While conscious that EJ herself has not been able to express a view about the issue before me, I bear in mind OP’s obviously sincere appreciation of CM for taking steps to attempt to save the life of EJ, and his wholehearted consent to this course. I am conscious that if this testing were not to be undertaken, CM would live for the foreseeable future in a state of profoundly anxious uncertainty as whether she had contracted a serious, life-threatening illness. This would doubtless affect not only her personal well-being, but also her ability to treat other patients in the context of her highly skilled profession. I also bear in mind that CM herself is suffering the harmful side-effects of the antiretroviral medication.

In the circumstances, I had little hesitation in granting the relief sought by CM and made the following declarations, namely:

Pursuant to the Declarations made on 30 May 2013 (above), the samples of EJ’s blood and tissue obtained at post mortem examination were tested for blood-borne diseases. I was pleased to be informed, shortly before delivering this judgment, that the test results were negative. CM has thus been able to cease the antiretroviral treatment to which she had developed a rare but serious reaction.