Duty of care in genomic medicine: who is liable?

3 September 2017 by

Clinical Genetics is a field of medicine concerned with the probability of an indvidual’s condition having an hereditary basis.  The journal Medical Law International has just published an article  about the scope of potential duties of care owed by  specialists in this field to people with heritable diseases.  The authors draw out the features of genomic medicine that open the door to new liabilities; a potential duty owed by clinicians to third party family members, and another legal relationship that may be drawn between researchers and patients.

Background

There is no legislation on the duties involved in genome sequencing in the United Kingdom, and, in the absence of this, any new legal duties on the part of professionals in clinical genomics need to be established within the common law of negligence. Civil lawyers are familiar with the standard framework for establishing whether a duty of care is owed, based on these three consecutive questions:

  1. Was the damage was reasonably foreseeable
  2. Was there was sufficient “proximity” between the claimant and the defendant and
  3. Would it be fair, just and reasonable to impose a duty: see Lord Bridge of Harwich in Caparo Industries plc v Dickman [1990] 2 AC 605, 617-618

These principles are neat enough as they are laid out but only take us as far as the facts of any particular case, particularly the Caparo test outlined in para (3).

This relatively new field of medical endeavour is unusual in that it is concerned with the management of a family rather than one individual. More generally, in the field of genomic medicine, there is a “close interaction between care and research”, resulting in “the real possibility” that genomics researchers will be found to owe a legal duty to disclose findings to participants.

So we have two new possible avenues of liability here; that of clinicians to third parties, and that of researchers to patients.

Duty of care to third parties: family members in genetics cases

A genetic diagnosis reaches beyond the individual, into the past and future of the family. The case of ABC v. St George’s Healthcare NHS Trust & Ors lays out the scenario. Father is found to be suffering from Huntington’s disease, a mutation which has a fifty percent chance of appearing in the next generation. Genetic clinicians are obliged to take and store a detailed multi-generation family history. Communication of risk to relatives is “integral” to this practice, unless, of course, it is expressly forbidden, as it was by the father in the ABC case. Initially the duty of confidentiality prevailed; the High Court struck out the claim brought by the daughter as she was not party to the doctor–patient relationship and therefore was owed no duty of care. But the proceedings were restored on appeal,  with Irwin LJ noting that the clinical geneticist is in quite a different position to the conventional clinician.

He or she often comes to know of a health problem already present, or potentially present, in the third party, and which means the third party requires advice and, in conditions other than Huntington’s Disease, may require treatment, potentially life saving in its effect.

In such circumstances, said Irwin LJ, the third party is not a patient, but “should become a patient.”  Nevertheless he was prepared to acknowledge that so far we have insufficient floodgates against potential claims

It may be that the distinction I have tentatively suggested as applying to genetic cases might on close consideration be thought insufficiently robust to sequestrate genetic cases from a broad range of other situations.

The question of clinicians’ duty to family members has been tested in the US. As early as 1996, a New Jersey court outlined “the duty to warn of avertable risk from genetic causes”. This, said the judge, was by definition a matter of familial concern, and the floodgates fear could be met by the argument that this was ‘sufficiently narrow’ to serve the interests of justice. The state legislature reacted by ruling out this duty to warn, but the judge’s words resounded across the Atlantic. As Irwin LJ said,

The ambit and content of the duty of care in such cases has long been a matter of common law, developed by judicial decision. If that were to cease to be so, the law would ossify in this area.

There is as yet no established legal duty to look for or return secondary findings in the United Kingdom, so a claim relating to such findings would need to satisfy the court that it would be ‘fair, just and reasonable’ under Caparo impose a duty. But the authors of  the article  under consideration argue that as practice develops, particularly in the investigation and analysis of wider findings from genomics, the potential existence and scope of such duties cannot be discounted.

Genetic research teams: duty of care to patients

If there is a known mutation linked to a disease, health care professionals will report these genetic variants, as they turn up in their patients, to an accredited laboratory. The problem is that the interpretation of this data is still in its infancy, and  different laboratories may well reach different conclusions. One laboratory might say that a given shuffle in the gene sequence is an indicator of disease, another will clear it. There will always be variation in developing practice, particularly in medicine. But this is not a reason to evade the question of how to determine the standard of care, in genomic medicine, that could be considered reasonable, step (3) above, or even proximate, step (2).

Obviously research and clinical care traditionally have different goals. The goal of clinical care is to provide a benefit to the patient, whereas research is designed to produce generalisable knowledge to benefit society, and participants do not necessarily receive results from research. In the non-medical but analogous case of Sutradhar v Natural Environmental Research Council [2006] the House of Lords ruled that the British Geological Survey (researchers) could not owe a duty to the local population residents of the study area in Bangladesh when they were made ill by arsenic in the waters which the BGS had been commissioned to analyse for other purposes. As Lord Hoffmann said,

The BGS had no control whatever, whether in law or in practice, over the supply of drinking water in Bangladesh, nor was there any statute, contract or other arrangement which imposed upon it responsibility for ensuring that it was safe to drink. …. The duty of care depends upon a proximate relationship with the source of danger, namely the supply of drinking water in Bangladesh. [para 38]

But is the area of genomics research different in kind from the situation in Sutradhar? The authors of this paper warn that research and care can become blurred in this field, for example, when patients with undiagnosed conditions turn to exome or genome sequening for answers. Where does clinical care end, and research begin?  It may be justifiably assumed that the researcher is acting exclusively in the best interest of the individual patient. This so called “therapeutic misconception” by the patient in question may eventually be ruled out on Caparo grounds, but it would not be prevented in limine under the rule in Sutradhar. This is particularly the case where certain categories of results are part of the standard of care, such as where the outcome concerns the onset of a known disease in the patient or the patient’s potential offspring.

The boundary between clinical care and research, they say, “is not well defined for genomics”, and the test will always be subjective.

When the person undertaking the activity has two purposes or when different people participating in the same series of activities have different purposes, it may be very difficult to say into which category the activities fall. This difficulty is particularly likely to arise in activities undertaken by an academic clinician and/or in a teaching hospital with a research department

The article suggests a particular route for duty of care might well be expanded so as to include researchers. The duty of care for example may lie towards the clinical care team for the accuracy and competence of the work of the researchers. This duty of care may be one step removed from the patient, but it would still render the researchers liable to patients in a way analogous to surveyors or expert third parties, such as testing laboratories. The advice is provided to the clinic, but

the patient is reliant on appropriate information being passed to their clinical care team. In these circumstances, the patient could be argued as reasonably within the contemplation of the researcher, suggesting that a duty could be fair, just and reasonable. As practice develops, particularly in the investigation and analysis of wider findings from genomics, the potential existence and scope of such duties would benefit from further analysis.

A second potential source of liability for these wider professionals is a duty of care towards the clinical care team for the reasonableness, accuracy and competence of their work. In a sense, this could be seen as analogous with the duty of care of professional advisors towards other professionals – a duty of care one step removed from the patient. Researchers could be liable to patients in a way analogous to surveyors (Smith v. Eric S Bush (A Firm) [1990] UKHL 1),  or expert third parties, such as testing laboratories (Farraj & Anor v. King’s Healthcare NHS Trust (KCH) & Ors [2009] EWCA Civ 1203). It may be that the advice/service is provided to the clinic, not the patient, but

 the patient is reliant on appropriate information being passed to their clinical care team. In these circumstances, the patient could be argued as reasonably within the contemplation of the researcher, suggesting that a duty could be fair, just and reasonable.

Perhaps the most recent powerful authority against a duty to third parties is the House of Lords decision in Mitchell & Anor v. Glasgow City Council [2009] UKHL 11. This case concerned an allegation that a local authority owed a duty of care to someone who was injured by the criminal act of another council tenant. The House of Lords affirmed, that, under Caparo,

 a duty to warn another person that he was at risk of loss, injury or damage as the result of the criminal act of a third party would arise only where the person who was said to be under that duty had by his words or conduct assumed responsibility for the safety of the person who was at risk.

But in the field of genomic medicine, it is argued,  there are a host of different factors in play that might give rise to a duty to warn, even under Caparo. A different standard might apply given the emphasis put on patient autonomy in Montgomery v. Lanarkshire Health Board [2015] UKSC 11):

it is clear that all the ‘material risks’ that a reasonable patient (or a particular patient) would attach significance to should be disclosed as part of the consent process. This might extend to disclosure when discussing a general course of action, such as continuing with a pregnancy.

This was very much echoed by the Court of Appeal in ABC.   Irwin LJ noted that there had been a “strong trend” in recent authority in the field of clinical negligence, to emphasise the autonomy of the patient; the progress of the common law from Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] AC 871 to Montgomery v Lanarkshire Health Board [2015] AC 1430 demonstrated that trend.

After discussing the Court of Appeal ruling in the ABC case, the authors of the Medical Law International article observe that

this is a new area of legal challenge and there are reasons to believe that some claims by genetic relatives may succeed. This issue arises in all forms of genetic testing, but genomic technologies potentially increase the amount of information that may be valuable to a relative.

Here is the link to the full article: Exploring the potential duty of care in clinical genomics under UK law

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