Introduction
Medical confidentiality in the context of genetics raises interesting tensions because the information in question is not only relevant to an individual patient, but also to family members. The information is more relevant to relatives closer in degree, and the chance of it being relevant reduces the further away in the family tree the relative is from the original patient. It is possible that the interests of the patient and the family member may conflict – such as where a patient does not wish to share genetic information with a family member – but where that information might allow that family member to obtain a diagnosis and take action to avoid a negative outcome. Such a situation raises important and interesting legal questions, which have been reinvigorated by recent case law.Footnote 1
In ABC v St George's,Footnote 2 the claimant argued that a healthcare practitioner (HCP) who had failed to disclose genetic information to a family member was liable to that family member in negligence. The Court of Appeal allowed an appeal from the High Court, which had struck out the claim as having no reasonable cause of action at a preliminary hearing before trial.Footnote 3 The claim may now be tried, and it will be for the lower court to determine if an HCP has a legal duty to disclose genetic information to any family member of their patient. It is our contention that a blunt exclusion of any duty in all circumstances pushes the balance of rights too far in the direction of the maintenance of confidentiality. As a result of this approach, an HCP would be well advised to maintain confidentiality in all circumstances, notwithstanding ethical arguments in favour of disclosure, as they will never be liable for failure to disclose to a third party, but could be liable for breach of confidence. This, in our view, is problematic.
In this paper we focus on the conflicts between the rights of individuals and the rights of third parties.Footnote 4 We first examine the nature of the duty of confidence as it applies in these circumstances, and the extent to which it can appropriately accommodate the familial nature of genetic information. We then consider the situations in which an HCP might owe a third party family member a tortious duty of care. We conclude that in most cases, there will be no duty owed to third parties, but that in certain limited circumstances, a duty of care should arise. We argue that controls on liability can better be imposed by consideration of breach, rather than by imposing a blanket exclusion of all duties of care.
This is a paper focused primarily on the law of confidence and duty of care to third parties in genetics, more than ethical and professional obligations. Although the bioethics literature informs the law in important respects, and is relevant to our analysis, our discussions are mainly focused on the legal position, rather than the moral or ethical argumentation. Moreover, we integrate an exploration of the duty of confidence and the law of tort as it applies in this field, in the light of recent scientific and case law developments.
I. Genetic information and the family
As has been extensively rehearsed elsewhere,Footnote 5 unlike many other types of information, genetic information is not only relevant to the individual patient, but also to family members. There are many diseases which have some genetic component. Heart disease and cancer ‘run in families’, and can arise from different genetic and environmental causes.Footnote 6 However, the types of diseases with which this paper is concerned have a much stronger and more clearly defined genetic basis.
Single gene disorders involve mutations in a single gene that lead to a disease state, for example Huntington's disease or cystic fibrosis.Footnote 7 Most single gene disorders are rare.Footnote 8 An autosomal dominant disorder is a genetic disease which will manifest itself if an individual possesses at least one affected copy of the relevant gene, with a 50% risk that offspring will inherit the mutation from the affected parent. Many autosomal dominant disorders either have a delayed age of onset or exhibit reduced penetrance, that is, there is not a 100% chance that the person will exhibit symptoms of the disease in question.Footnote 9 An autosomal recessive disorder is a disorder which requires two affected copies of the gene to manifest clinically. When an individual concerned possesses only one of two affected copies of the gene, they are a carrier, and they do not manifest the disease, or will have very mild symptoms in comparison with the disease state.Footnote 10 An X-linked disorder is one which is inherited via the X chromosome, and may be either dominant or recessive. An X-linked dominant disorder manifests very severely in males, and often leads to spontaneous loss of an affected pregnancy or neonatal death; females have less severe features than males. An X-linked recessive disorder is encoded on the X chromosome such that a female who possesses one normal copy and one affected copy of the gene will not manifest the disease (although may have some minor features of the condition), but a male,Footnote 11 if he inherits the affected copy of the gene, will manifest the disease.Footnote 12
This classification of diseases is something of an oversimplification. Not all disease genes are fully penetrant, and there may be variable severity in how a disease manifests in different individuals who all carry the same mutation, even within families. Moreover, later onset diseases may have an earlier or later age of onset, and there are myriad genetic and environmental factors which influence disease course. Genetic inheritance is complex, and research continues in an attempt to further elucidate disease inheritance mechanisms.Footnote 13
As may be evident from this short recital of genetic disease mechanisms, while the genetic information of an individual diagnosed with a genetic disease (the proband) may also be relevant to members of his or her family, the extent to which that information is relevant will vary depending on factors such as the closeness of the relationship (eg first degree relatives versus more distant relationships) as well as the nature of the disease (dominant versus recessive, penetrance, likelihood of spontaneous mutation causing the disease). It is therefore an oversimplification to contend that all genetic information is equally relevant to all the family of the proband – there is a degree of nuance. However, what is clear is that where a proband has been diagnosed with a genetic disease, then members of his or her family may have an increased risk of themselves having that genetic mutation and therefore the disease. HCPs working in the field of clinical genetics are therefore very concerned to disseminate the information through the family.
In many cases, where family relationships are reasonably cordial, there is no conflict between any duty to warn third parties and the duty of confidentiality, where the patient is prepared to disclose information, or gives permission for an HCP to disclose information to family members.Footnote 14 Where, however, a patient refuses permission to disclose, as in the case of ABC,Footnote 15 then a conflict between the duty of confidentiality, and any potential duty to third parties may arise. Although such cases may be relatively rare in practice, perhaps partly due to the care with which genetics professionals manage family communications,Footnote 16 they nonetheless present an interesting legal question which demonstrates the need for the law to develop in a flexible and appropriate manner to accommodate emerging medical technologies. Moreover, as genomic medicine becomes integrated into mainstream clinical practice, it seems likely that the number of these cases will increase.
II. Recent case law
Two recent cases have provided the first English cases which are relevant to the question of confidentiality and the duty to warn in the context of genetic testing. In both, the claim was brought by a relative of the proband who had suffered damage as a result of the failure of the treating HCP to inform of the possibility of inheritance of a specific genetic condition.
ABC v St George's
ABC v St George's Healthcare NHS Trust,Footnote 17 involved unusual facts: in 2007, the claimant's father killed the claimant's mother. He was convicted of manslaughter on the grounds of diminished responsibility and detained under the Mental Health Act 1983.Footnote 18 In 2009, he was diagnosed with Huntington's disease. At the time, the claimant, who was pregnant, was attending family therapy sessions, with her father and therapists from the first defendant, St George's Healthcare NHS Trust. Sessions took place both before and after the father's diagnosis was confirmed.
The father did not want his daughters to be informed of his diagnosis: he was concerned that they ‘might get upset, kill themselves or have an abortion’.Footnote 19 Following discussion, the medical staff decided to respect his confidentiality: the claimant was not informed and her pregnancy continued. In 2013, the claimant tested positive for the Huntington's Disease gene.Footnote 20
A claim was brought in negligence: it was argued that the defendants owed a duty to warn the claimant and that, by failing to disclose her father's diagnosis, the defendant had been in breach of that duty. The breach had caused damage, in that the claimant was denied the opportunity to terminate the pregnancy.Footnote 21 The defendants applied to have the claim struck out, as having no reasonable cause of action. In the High Court, Nicol J found that it would not be ‘fair, just and reasonable’ to find that the defendants owed the claimant a duty of care;Footnote 22 and that the duty claimed would involve a ‘giant step’,Footnote 23 contrary to the incremental approachFootnote 24 emphasised in Michael v Chief Constable of South Wales Police.Footnote 25 Accordingly, the application succeeded.
The Court of Appeal allowed an appeal:Footnote 26 Irwin LJ, giving the only judgment, applied the Caparo Footnote 27 test of proximity, foreseeability and whether it would be ‘fair, just and reasonable’ to impose a duty of care. Assuming, for the purposes of the application, that the elements of proximity and foreseeability had been made out, he considered the nine reasons that the defendant had set out that it would not be ‘fair, just and reasonable’ to impose a duty to disclose confidential genetic information.
The reasons included that the interest of the third party in receiving the information was a private interest that could not prevail over the public interest in maintaining confidentiality; that it would encourage HCPs to disclose when not justified; that the HCP would be subject to conflicting duties of confidentiality to the patient and disclosure to the third party; that it would undermine trust in HCPs and discourage patients from disclosing information; that it would cause HCPs to put undue pressure on patients to consent to disclosure; that it might be damaging to the third party's mental health to receive the information; and that it would place an additional burden on HCPs which would distract them from their role in treating patients.
The court noted that an HCP in possession of genetic information which affected a third party would, in some circumstances, be under an existing professional, as opposed to legal, obligation to disclose. The conflict between the duty of confidence to the patient and a professional obligation to prevent harm to others already existed and it was not established that to make the professional obligation legally binding would cause the problems claimed. Accordingly, none of the policy considerations was sufficiently powerful to justify allowing the claim to be struck out before trial.Footnote 28 Furthermore, the Supreme Court had held, in Montgomery v Lanarkshire Health Authority,Footnote 29 that, in the case of informed consent, it was necessary to impose legal obligations to reinforce professional obligations, in order that HCPs would meet those obligations.
The Court of Appeal also considered the American cases of Tarasoff Footnote 30 and Safer v Pack,Footnote 31 although it did not expressly endorse the cases.Footnote 32 In both of these cases, it had been held that an HCP was, in some circumstances, under a duty to disclose confidential information to a third party. Of particular relevance was Safer: in this case, the plaintiff was the daughter of one of the defendant's patients, who had died of colo-rectal cancer in the 1950s. The plaintiff later suffered from the same condition, and claimed against the doctor for failing to warn her of her own risk of developing the disease. The Superior Court of New Jersey held that they saw ‘no impediment, legal or otherwise, to recognising a physician's duty to warn those known to be at risk of avoidable harm from a genetically transmissible condition’.Footnote 33
Smith v University of Leicester NHS Trust
Following the successful strike out application in the High Court of ABC, a further claim in respect of a genetic disorder was brought in Smith v University of Leicester NHS Trust.Footnote 34 In this case, there was a failure to diagnose adrenomyeloneuropathy, a genetic disorder: the HCP ordered diagnostic tests but they were not carried out. As a result, the patient was not diagnosed until one of the claimants (his second cousin) was himself diagnosed with the childhood variant of the condition, adrenoleukodystrophy. The claim was against the HCP who failed to diagnose the condition at the earliest opportunity: had the earlier diagnosis been made, the claimants could have been tested at an earlier stage and taken steps to ameliorate their condition. As in ABC, the strike out application was granted: the court held that it would not be ‘fair, just and reasonable’ to impose a duty on an HCP in relation to a third party who was not a patient.
In this case, the reason that the relative was not informed was that the HCP had failed to diagnose the patient, rather than that the HCP was respecting the patient's refusal to consent to disclosure of his genetic information.
III. Competing duties?
The nature of the English adversarial system is that cases tend to focus on either the question of the duty of confidence or the duty to warn. However, in the case of disclosure of genetic information to relatives against the wishes of the proband, the two duties are directly competing. We therefore examine the law relating to the duty of confidence, before considering the potential scope of the tortious duty to warn.
IV. Duty of confidence
That a duty of confidence exists in relation to medical information is axiomatic. The traditional formulation of an equitable duty of confidence, with its three elements is: the information is of a private, personal or intimate nature; it is imparted in circumstances imposing an obligation of confidence; and it has been disclosed without authorisation.Footnote 35
Case law since the introduction of the Human Rights Act 1998 has reformulated the cause of action in terms of private rather than confidential information,Footnote 36 and the question is whether there is a ‘reasonable expectation of privacy’.Footnote 37 It is doubtful whether the reformulation of the test in light of the Human Rights Act 1998 has made any material difference in relation to the law applicable to medical information. Genetic information (at least insofar as it has medical implications) is private,Footnote 38 and there is a reasonable expectation of privacy in relation to genetic information obtained or imparted in the medical context. The respect for the medical duty of confidentiality is well encapsulated by Lord Philips MR in Ashworth Security Hospital v MGN Ltd, who stated ‘It is well settled that there is an abiding obligation of confidentiality as between doctor and patient, and in my view when a patient enters a hospital for treatment, whether he be a model citizen or murderer, he is entitled to be confident that details about his condition and treatment remain between himself and those who treat him’.Footnote 39 The case law of the European Court of Human Rights has equally upheld the importance of confidentiality of medical information under Article 8 of the European Convention on Human Rights (ECHR). Respecting the confidentiality of health data is a vital principle in the legal systems of all the contracting parties to the ECHR.Footnote 40
Whilst the existence of the duty in a medical context is relatively uncontroversial, the flexibility of the test arises in relation to the question of breach. In such a case, a party needs to avail themselves of a legitimating reason for disclosure, typically either consent or the public interest.Footnote 41
In the context of disclosure of genetic information, consent is undoubtedly the most practical legitimation of disclosure and those working in clinical genetics work hard to gain consent to disclosure.Footnote 42 This may be facilitated through explanations and counselling prior to testing of the proband, and the use of follow-up counselling. Clinical genetics professionals may also attempt to circumvent strained family relationships through offers to convene meetings, provision of appropriate letters for the proband to distribute to family or offers to communicate with other HCPs (including GPs) where this might help facilitate disclosure.Footnote 43 Despite the complications in practice, as a matter of law the question of consent is largely uncontroversial – consent will either be present or absent, and will be a question of fact in a particular case.Footnote 44
In contrast, however, the question of disclosure in the public interest is more complex. The equitable duty of confidence is traditionally seen as a balancing of two competing public interests: the public interest in the maintenance of confidence on the one hand; and the public interest in disclosure on the other.Footnote 45 Similarly, an Article 8 analysis requires the balancing of competing interests to determine whether disclosure is in the public interest.Footnote 46 The cases on disclosure in the public interest in medical law can be characterised as falling into three broad categories: prevention of harm to others; prevention or detection of crime; and teaching, research or audit.Footnote 47 It is only the first of these categories which will be of relevance to an HCP wishing to disclose genetic information to a third party member of the family of the proband.
The paradigm English case about disclosure in the public interest is W v Egdell. Footnote 48 The plaintiff, who was suffering from paranoid schizophrenia, shot and killed five people and injured two others in 1974. His plea of guilty to a charge of manslaughter was accepted, and he was detained in a psychiatric hospital. In support of his application for a transfer to a regional secure unit some 12 years later, the plaintiff sought a report from the defendant as an independent consultant psychiatrist. The defendant's report did not support the plaintiff's application; it disclosed that the plaintiff had a long standing and continuing interest in homemade bombs, and did not accept the view that the plaintiff was no longer a danger to the public. The plaintiff withdrew his application to the tribunal and refused to consent to the defendant disclosing the report to the medical officer at the secure hospital. However, the defendant disclosed the report without consent to the medical officer of the psychiatric hospital. On discovering the disclosure, the plaintiff sued for breach of confidence. It was held that whilst a duty of confidence was owed, and that maintenance of the duty of confidence was a matter of public interest, the public interest in maintaining the confidence (so that patients can trust their HCPs) must be balanced against the public interest in favour of disclosure (to the protect the public). Disclosure was justified in this case. The court held that what was required to justify disclosure in the public interest was a real, and not merely theoretical, risk of imminent and serious harm.
Other cases on disclosure in the public interest are few. Virtually all other cases have been about the disclosure of private information in the press, and the focus has rather been on the balancing of the public interest in the maintenance of confidentiality or privacy against public interest in disclosure pursuant to the Article 10 right to freedom of expression.Footnote 49 In Stone,Footnote 50 the court considered the application of Article 8 to the question of whether it was in the public interest to disclose the private medical information about a convicted murderer in the context of a report into the failures of the system of psychiatric and social care. The court held that the balance was in favour of disclosure, and was particularly influenced by the fact that the publicity and need for the report arose out of the criminal acts of Mr Stone. This conclusion was reached solely in relation to Article 8, and was bolstered by reference to Article 10. Other cases which balance the Article 8 rights of individuals against the public interest draw more heavily on the public interest aspects of the Article 10 right to freedom of speech.Footnote 51 Such Article 10 rights are unlikely to be engaged in the question of disclosure of genetic information to family members of the proband, so the case law provides little assistance.
Balancing – relevant considerations
The application of the law in this field to the disclosure of genetic information is complex. Egdell was a case where the requirements were all clearly satisfied on their facts – there was a real risk of serious physical harm, with a clear degree of imminence. Difficulties arise in the way in which the test can be applied in the genetic context, however, in all three aspects of risk, imminence and seriousness. Each of these considerations will need to be viewed in a more nuanced manner than in the typical scenarios in cases such as Egdell, where there was an imminent risk of serious criminal harm from a psychiatric patient.
The courts have traditionally viewed the duty of confidence as important and have been slow to find a public interest in disclosure in the absence of serious physical harm, or an Article 10 interest. It therefore seems plausible that for a disease which has an adult onset, with variable penetrance (such as for example BRCA breast cancer) that the traditional requirements would not be satisfied. This may sit uneasily with many clinicians, and potentially with the General Medical Council guidance on the duty of confidence.Footnote 52
In light of Article 8 considerations, a more flexible view can and should be taken. In Stone, the court spoke of the need to examine the facts and circumstances of each case, and to adopt a ‘close and penetrating examination’.Footnote 53 Accordingly, a balance must be struck between the Article 8 rights of the proband, as against the Article 8 rights of the family members.
Risk
The court in Egdell spoke of a real, rather than merely theoretical, risk. In that case, the risk was seen to be real, although the person likely to manifest the risk was still in a secure unit, and unlikely to be released into the community for some time, and only after satisfying a number of other conditions set by various tribunals. The risk posed by genetic mutations should satisfy this criterion in many cases. There are two different ways that risk can be variable in genetics. First, as the familial closeness to the proband decreases, the risk decreases. For example, where a great-grandchild of a person with a neurodegenerative disease is concerned, there is a 12.5% risk of them carrying the mutation.Footnote 54 Secondly, for diseases with variable penetrance, the risk of developing the disease may be lower. For example, some diseases have a high correlation between carrying a mutation and experiencing the disease. In other cases, other factors may influence whether the disease manifests, or whether it is serious or more minor, or the age of onset. All these factors may be taken into account by a court when considering the risk to others.
Imminence
In Egdell, the court attached some significance to the imminence of the harm in question – the potential release from a secure hospital, and ultimately into the community. Genetic diseases are rarely imminent, in the sense that harm will arise within hours or days. Many genetic diseases may be late onset, and the harm may arise many years into the future. However, medical interventions or screening may be possible at an early stage, and lifestyle changes can begin very early. In this sense, whilst the ultimate serious harm may not be immediate, some efforts to avert that harm may imminently be possible.
Serious harm
The question of whether harm is serious in the genetic context is also complex. Some cases may be clear, for example where the consequences of the disease are serious and there is an intervention possible. An instructive example is the case of a sudden cardiac death mutation where a defibrillator may be implanted, and/or medication may prevent sudden death, or the option exists to have increased screening or monitoring for early symptoms of the conditions (eg in Lynch syndrome which predisposes to various cancers). However, other genetic diseases, such as Huntington's disease are serious but have no (yet) known interventions. However, genetic medicine advances rapidly, and new treatments arise. To avoid disclosure now on the basis that there is no currently known treatment makes a decision frozen in time. Unless there is a means to regularly revisit decisions made on this basis, then there is a chance that someone is deprived of a chance to obtain treatment in the future, on the basis that their risk of inheriting the condition is not made known to them.
Even where there is no means to prevent a serious outcome such as death, there may be other steps which an individual might wish to take if they know about their risk. The opportunity to make reproductive choices is an obvious matter – including undertaking invasive testing of a pregnancy or seeking preimplantation genetic diagnosis to avoid passing on a familial condition. Other options include changing life choices, such as avoiding particular careers or doing things at a younger age to avoid missing out on opportunities if predisposed to a late onset condition.
In addition, harm could be constituted by the failure to know about carrier status, and thus passing on a genetic condition to a child. Would the balance be in favour of disclosure to relatives who could only be carriers, rather than having the condition themselves? Those individuals will not have serious health consequences themselves, but they would be able to use the information to make informed reproductive choices.
Arguably, the flexibilities inherent in the human rights (or indeed equitable) approach enable the court to take a more expansive view of harm. Accordingly, these types of harm which might be more problematic for a tort claim could be sufficient to justify disclosure in the public interest.
Balancing of competing rights
The balance in the case of disclosure to family members, in contrast to most of the cases in this field, is not between competing Article 8 and Article 10 rights, but rather competing Article 8 rights. The right in question is of one individual keeping medical information confidential, as against the right of another person to have access to information which is important for their private and family life. The courts will balance these rights taking into account all the circumstances, and cannot prioritise one person's convention right over another. Such balancing will necessarily be highly dependent on the facts of the case, and courts are ideally placed to weigh the relevant and competing factors, in conducting an ‘ultimate’ balancing exercise applying the proportionality test to the rights of each party.Footnote 55
Ethical duty vs legal duty?
Whether HCPs have an ethical duty to disclose information to family members is the subject of extensive commentary and discussion in the bioethics literature. The dominant model is known as the joint account model, and was proposed by Parker and Lucassen in a paper in the British Medical Journal in 2004.Footnote 56 In that paper, Parker and Lucassen argue that as genetic information is shared by more than one individual (like information about a joint bank account), the ethical problem faced by a clinician is not whether to respect confidentiality, but instead, ‘what, if anything, would justify excluding others from the joint account’. They suggest that, on the joint account model, it is assumed that information should be made available to all account holders unless there are good reasons to do otherwise.
Since publication, the joint account model has been widely cited, and has been broadly adopted in bioethics literature.Footnote 57 It has informed the guidelines from the Joint Committee on Medical Genetics about consent and confidentiality to the extent that the guidelines recommend a record of discussion form for genetic testing which includes a statement that ‘I acknowledge that my results will sometimes be used to inform the appropriate healthcare of family members’ rather than asking for agreement to sharing.Footnote 58
The joint account model draws on a model of autonomy that is relational in nature. In contrast to more traditional conceptions of autonomy which underpin the focus on the individual in biomedical ethics, relational autonomy is increasingly being adopted as the basis of bioethical approaches, particularly with respect to the ethical, legal and social implications of genetics and genomics. A relational approach enables a more nuanced approach to ethical questions, with a focus on the development of individual autonomy through social embeddedness and relationships with others.Footnote 59 Such an approach seems intuitively more attractive for questions about genetics, where relatedness, and relationships, are at the very core of the subject matter that gives rise to the ethical questions.
The extent to which the law of confidence can accommodate a strongly relational autonomy approach is unclear. As Foster and colleagues acknowledge, courts are unlikely to ‘take on a completely relational approach to the law’.Footnote 60 It seems that the most appropriate means to do so is to incorporate considerations as to relatedness into questions of disclosure in the public interest. A wider conception of the public interest, which takes account of the relational nature of the information in question, seems possible and appropriate. Indeed, when balancing the public interest in press publication privacy cases, questions of the rights of children and other family members are balanced by the courts in weighing the public interest in maintence of confidentiality versus freedom of expression.Footnote 61 An approach to autonomy which considers the individual as embeded within their social context and family relationships can be accommodated in this way.
What seems less workable is a broad adoption of the ethical joint account model as a legal model which sees the information in question as ‘belonging’ to all family members jointly. First, it is not clear who the information would be ‘owned’ by. As noted above, information has diminishing relevance to family members the further away from the proband they are in relatedness. However, there is still a chance that the information is relevant. As Liao notes, different types of genetic information will have stronger reasons to be shared with family members than others, due to the nature of disease inheritance.Footnote 62 It seems unlikely that a broad conception of joint ‘ownership’ of genetic information would be in accordance with Article 8 obligations. Finally, treating genetic information in this exceptional manner seems unwarranted, as other health information (such as cholesterol levels) is private to the individual, whilst nonetheless having some relevance for family members.Footnote 63
Interestingly, in research carried out into patient views on the sharing of genetic information with family members without consent, the patient views arguably aligned more with the law of confidence than the joint account model.Footnote 64 Dheensa and colleagues found that the patients they studied found it generally acceptable that an HCP share information with family members without consent and that while they considered that this would indeed be a breach of confidence, that the ‘harm was trivial compared with the benefit of knowing about the risk’. In our view, this approach broadly accords with the authorisation of disclosure of confidential information in the public interest, with the justification framed in terms of preventing illness that could lead to avoidable harm.Footnote 65
The joint account model serves a useful purpose to facilitate discussion as to the nature of genetic information and the way in which it is practically treated in the clinical genetics context. To the extent that the joint account model reflects the true practice of clinical genetics (the ‘law in practice’) then it is essential that regard is paid to the congruence between it and the law. The joint account model usefully highlights the potential difficulties that can arise where there is familial conflict, and proposes an ethical approach to confidentiality and genetic information. It is not, however, a true reflection of the legal approach to genetic information and confidentiality, and to apply the joint account model as a justification for disclosure without regard to the legal duty of confidence would be potentially problematic and could lead to liability for breach of confidence.
Where there is no refusal to communicate, then both the legal approach and the joint account model are consistent: whether there is consent to disclosure and therefore no breach in the traditional model, or the information is part of the joint account, HCP, proband and third party will be satisfied as to their legal rights and responsibilities. The difficulties (as in all areas of law) arise at the margins, where conflict arises. In the type of case which concerns us in this paper, where the proband refuses either to consent to disclosure or to pass on the relevant information to third parties, the law and the joint account model seem likely to result in different outcomes.
The duty to family members
The duty of confidentiality is a duty owed to the proband. Those family members who may share genes with the proband are third parties: external to the confidential relationship. It is, as considered above, permissible in some circumstances to disclose information to third parties. However, no duty to a third party can arise under a duty of confidentiality.
In the absence of a confidential or contractual relationship between the HCP and the third party, a legal duty to disclose can only arise in tort: specifically, in negligence. A claim in negligence requires that the HCP owes a duty of care to the third party: without such a duty, the negligence claim fails at the first hurdle. The third party must also show that the HCP breached that duty by acting unreasonably,Footnote 66 and that the breach caused the third party damage.Footnote 67 Although damage, in the context of negligence, is usually restricted to physical injury, psychiatric injury in the form of a recognised mental illness, property damage and economic loss, it has also been held to include interference with the claimant's right to reproductive autonomy.Footnote 68 Courts have also allowed negligence type claims to succeed on the basis of violation of the claimant's rights.Footnote 69
While the Court of Appeal's judgment in ABC opens the door to there being a duty imposed on HCPs to inform third parties of genetic information, there is as yet no authority that an HCP owes a general duty of care to any third party. However, as we argue below, third party duties have been imposed in a number of different areas, including psychiatric injury,Footnote 70 wrongful birth,Footnote 71 failure to protect from personal injuryFootnote 72 and causing economic loss.Footnote 73 Our analysis of these cases concludes that both precedent and legal principle both support the imposition of a limited duty of care on HCPs, where they are aware of information that would seriously affect a third party. The duty would be to take reasonable steps to ensure that third parties who bear sufficient proximity to the patient and who will foreseeably be seriously affected are aware of the information.
We also consider whether, in the context of healthcare, it is necessary to use duty of care as a ‘control mechanism’, to keep the tort of negligence within acceptable bounds. We conclude that such a control mechanism is not justified in this context.
V. The duty to warn
A duty to warn is a duty to inform a claimant of information, which the defendant knew or should have known, which would have allowed the claimant to avoid harm. As far as English courts are concerned, a failure to warn is a ‘pure omission’Footnote 74 and there is no general duty for pure omissions in English tort law: unless there is a pre-existing duty of care, a person is not liable in negligence for a failure to warn.Footnote 75 If applied to the clinical context, this would mean that an HCP is not liable for any failure to warn a non-patient, even if the omission causes easily preventable harm to that person. Prima facie, an HCP owes a duty of care to his patients, but not, under usual circumstances, to non-patients: until the HCP accepts a patient into his care, there is no duty of care.Footnote 76
Duties in tort to third parties
When the case ABC Footnote 77 comes to trial , the claimant, as a third party to the doctor-patient relationship, will have to establish that the defendants owed a duty of care to her in the form of a duty to warn, which was co-existent with the duty owed to the primary party, her father. Co-existing duties are not unprecedented: in fact, there is no reason, either in legal principle or binding precedent, that such duties should not exist.Footnote 78 The principle that a duty to one person – in contract or tort – excludes a duty to a third party, if it ever was part of English law,Footnote 79 was conclusively laid to rest by Donoghue v Stevenson.Footnote 80 In that case, the contractual duty owed as a manufacturer to the buyer of the ginger beer did not prevent a duty of care being owed to the consumer.
Duties to third parties collateral to duties to primary parties exist in many other areas of negligence: there is a general duty on all of us not only not to injure our ‘neighbours’Footnote 81 – those who are foreseeably affected by our acts – but also not to cause psychiatric harm to those bearing a close tie of love and affection to our neighbours.Footnote 82 This applies in all contexts where physical injury is caused by negligence, including the medical context.Footnote 83
Also in a medical context, it has been found that an HCP can owe a duty not to cause economic loss to a third party: in wrongful birth cases, damages have been awarded to both parents,Footnote 84 despite there being no doctor-patient relationship between the HCP and the father.
Third party duties have also been held to exist in cases of economic loss: where a person owes a duty to one party, there are circumstances in which there will also be a duty to a third party who foreseeably suffers loss as a result of a breach of the duty to the first party. Perhaps the clearest example of this is the case of White v Jones:Footnote 85 in this case, solicitors negligently delayed attendance upon a client who had instructed them to redraft his will. Before the client was able to execute the new will, he died, with the results that the intended beneficiaries under the new will received no legacies. In the claim against the solicitors, the House of Lords held, 3-2, that the solicitors did owe a duty of care to the intended beneficiaries. This was based on the assumption of responsibility doctrine established in Hedley Byrne v Heller.Footnote 86 Two other casesFootnote 87 also found that professionals owed a duty of care to third parties foreseeably affected by their negligence.
The White case significantly extended the reach of the assumption of responsibility approach to economic loss established in Hedley Byrne. Unlike Hedley Byrne and other cases in which a duty to a third party was found on the basis of assumption of responsibility, the claimants did not know that the defendants had been instructed, and therefore could not be relying on them to carry out their duty to the primary party: ‘[w]hat is important is not that A knows that B is consciously relying on A, but A knows that B's economic wellbeing is dependent upon A's careful conduct of B's affairs’.Footnote 88
The principle in White has been described by WittingFootnote 89 as the ‘extended Hedley Byrne’ principle.Footnote 90 The relevant elements of this principle have been set out as:
‒ comparative skill or expertise;
‒ actual knowledge;
‒ conscious decision to accept responsibility for primary Footnote 91 party;
‒ tight causal connection.Footnote 92
Applying these principles, a duty of care to a third party will arise: where a professional undertakes a duty to a primary party; that the defendant knows that breach will cause damage to a third party of the same type as the defendant is under a duty to prevent to the primary party; and there is no conflict between the interests of the primary and third parties.Footnote 93 This, coupled with causal proximity, creates a duty of care.
The relationship in White, between a professional and the third parties who are both proximate to his client and liable to suffer damage through the professional's acts or omissions, applies directly to the relationship between the healthcare professional and those who are proximate to the patient.
A similar principle was stated by the Court of Appeal in Watson v British Boxing Board of Control.Footnote 94 Having found, on the basis of assumption of responsibility, that the governing body of boxing owed duty of care to boxers, they went on to state a wider principle:
These casesFootnote 95 establish that, where A advises B as to action to be taken which will directly and foreseeably affect the safety or well-being of C, a situation of sufficient proximity exists to found a duty of care on the part of A towards C.Footnote 96
With this exception, the extended Hedley Byrne principle has been mainly applied to situations involving economic loss. However, that is a consequence of the principle being applied in circumstances where the duty to the primary party is to avoid economic loss, rather than physical injury. There is no reason that a duty for an HCP not to cause injury, by failing to warn, should not be founded on the same principle. Indeed, as a general principle, courts should be more ready to find a duty of care where the damage caused is physical rather than economic.
The contrasting approaches taken by the House of Lords in Marc Rich v Bishop Rock Marine Footnote 97 and the Court of Appeal in Perrett v Collins Footnote 98 illustrate this principle: in both cases damage was caused to a third party by negligent inspection of the means of transport in question. However, when it was argued that the Court of Appeal should apply the same approach to physical injury as to economic loss, Hobhouse LJ held:
What the Second and Third Defendants seek to achieve in this case is to extend decisions upon ‘economic’ loss to cases of personal injuries. It represents a fundamental attack upon the principle of tortious liability for negligent conduct which had caused foreseeable personal injury to others. That such a point should be considered to be even arguable shows how far some of the fundamental principles of the law of negligence have come to be eroded.Footnote 99
A similar approach was endorsed by Lord Hoffmann in Customs and Excise Commissioners v Barclays Bank plc,Footnote 100 in which he held that:
In the case of personal or physical injury, reasonable foreseeability of harm is usually enough, in accordance with the principle in Donoghue v Stevenson,Footnote 101 to generate a duty of care. In the case of economic loss, something more is needed.Footnote 102
Applying these principles to the doctor-patient relationship, it is clear that, in some circumstances, an HCP should owe a duty of care to third parties. As an example, consider the case of a paediatrician who negligently fails to diagnose a child with a contagious disease, such as meningitis, and allows her to return home.Footnote 103 The ill child then infects a sibling before dying of the condition. The sibling suffers permanent brain damage. In these circumstances, there is no doubt that the paediatrician does owe a duty of care to the child's mother and father.Footnote 104 If the shock of seeing her child die causes the mother to suffer a psychiatric illness, the paediatrician would be liable in negligence. It would clearly be ‘fair, just and reasonable’ for the paediatrician also to be liable to the sibling who contracted the disease and suffered personal injury.
Third party claims against HCPs are rare. In the case of West Bromwich Albion FC v El-Safty,Footnote 105 an orthopaedic surgeon had advised reconstructive surgery on a player's knee. The surgery was unsuccessful and the player was not able to play football: as a result, the football club lost his services while remaining liable for his wages. A claim by the footballer in negligence succeeded, with the surgeon admitting negligence.Footnote 106 However, the claim by the football club failed: the Court of Appeal held that the surgeon did not owe a duty not to cause financial loss to the footballer's employers. As Rix LJ pointed out, unlike Gorham, there was no ‘fundamental community’ between the patient's interests and his employer's interests: the employee's interest was financial, while the patient's interest was medical. The ‘fundamental community’ requirement seems to be that the damage to the third party is either the same or of the same type as the defendant was under a duty not to cause to the primary party. In successful third party claims,Footnote 107 the third party's interests coincided with the primary party's.
In general, third parties cannot recover for economic loss caused by physical injury caused to the primary party:Footnote 108 however, if there is a duty not to cause physical injury, as exists in the doctor-patient relationship, the fundamental community requirement will be met and the third party should be able to recover for physical injury.
Duty as a control mechanism
Duty of care is the preferred ‘control mechanism’ in negligence: by restricting the expansion of new duties of care, the courts have sought to control the proliferation of claimsFootnote 109 and to relieve defendants from indeterminate liability. As noted by Lord Nicholls in D v East Berkshire Community Health NHS Trust:Footnote 110
Abandonment of the concept of a duty of care in English law, unless replaced by a control mechanism which recognises this limitation, is unlikely to clarify the law. That control mechanism has yet to be identified.Footnote 111
One of the principal areas in which duty of care has been used as a control mechanism has been when determining the liability of public authorities for ‘pure omissions’, such as failure to prevent physical injury caused by a third party or external causes. The courts have consistently held that there is no duty of care in those circumstances. Decided cases have included a failure of the police to arrest a serial murdererFootnote 112 or persons who had threatened the claimant,Footnote 113 failure of a local authority to warn a resident that his neighbour was likely to cause him harm,Footnote 114 failure of a health authority to recognise that a patient under the care of a mental health team posed a danger to the public,Footnote 115 and failure of the police to respond to a 999 call.Footnote 116
This restrictive approach is largely based on public policy arguments.Footnote 117 In addition, where the claimant is a member of the general public, there will be no proximity between defendant and claimant: in the leading House of Lords case of Hill v Chief Constable of West Yorkshire Police,Footnote 118 the principal reason given by Lord KeithFootnote 119 for not finding the police liable for injury caused by their failure to arrest a serial murderer was the lack of proximity between the police force and a member of the general public. There was nothing to distinguish Jaqueline Hill from any other young woman who might become the murderer's next victim.Footnote 120 Similarly, in Palmer v Tees Health Authority,Footnote 121 there was insufficient proximity between the claimant, as a member of the general public with a young daughter, and the health authority that had failed to prevent her daughter's abduction and murder by treating or detaining the murderer.
The main policy issues considered by the courts in the context of third party claims have been the proliferation of claimsFootnote 122 and indeterminate liabilityFootnote 123 considerations: these apply to claims against individuals, such as accountants,Footnote 124 as well as public authorities. In the specific cases of claims against public authorities, the court has also cited the undesirability of encouraging defensive practices by public authorities,Footnote 125 the undesirability of second-guessing non-justiciable decisions, such as those relating to the allocation of public resources,Footnote 126 and distracting public authorities from their primary duties.Footnote 127 In ABC, Nicol J made specific reference to policy arguments applicable to public authorities, including the defensive practice argument and to the potential conflict between the public interest and a duty of care owed to an individualFootnote 128 when considering whether an HCP could owe a duty of care to a third party.
In the healthcare context, however, public authorities may be liable for omissions. In Kent v Griffiths,Footnote 129 the London Ambulance Service was found liable for a failure to attend within the promised time. The Court of Appeal held that a duty of care arose when the call was taken, and the defendant was liable for the damage caused by the failure of the ambulance to attend within a reasonable time.
On very similar facts, however, the Supreme Court held in Michael Footnote 130 that no duty of care arose when the 999 call was made and accepted by the police. Kent was distinguished on the grounds that no promise to attend was made, so that there was no assumption of responsibility.Footnote 131 However, the duty of care in Kent was not based on the promise to attend. The duty of care arose from the ambulance's place within the NHS, which provided services to individuals rather than to the public as a whole:Footnote 132 as a result, the public policy argument against finding a duty of care was much weaker than when considering the police and fire services.Footnote 133 Once the ambulance service had accepted the call, the duty of care arose, irrespective of any promises to attend.Footnote 134 In Michael, had Kent been applied, the duty would have arisen when the call handler told the victim that the call would be passed onto the South Wales Police.Footnote 135
An alternative control mechanism: breach of duty
In the context of clinical negligence, courts have used the ‘Bolam test’Footnote 136 and the test set out in Montgomery v Lanarkshire Health Board Footnote 137 as control mechanisms which have kept litigation within proper bounds. While Bolam remains the appropriate test for clinical negligence claims involving diagnosis or treatment, in Montgomery, the Supreme Court held that it should only be applied where the decision in question required solely medical expertise.Footnote 138 In cases where the decision is non-medical, such as which of the risks inherent in a specific procedure should be disclosed, or whether genetic information should be disclosed, the Bolam test is displaced by a requirement that the doctor should take reasonable care, as determined by the court.Footnote 139 This would be the appropriate test to apply when determining whether an HCP was negligent in not disclosing information to a third party.
By placing the control mechanism at the breach, rather than at the duty stage, courts have been able to maintain a balance: protecting HCPs from indeterminate liability and not encouraging defensive medicine while at the same time recognising that ‘the rule of public policy which has first claim on the loyalty of the law’ is that wrongs should be remedied.Footnote 140
The duty of care in the medical context
In the medical context, the reasons to hold that there is no duty to a third party fall away: the public policy reasons do not apply with such force; and duty of care is not needed as a control mechanism. As a result, the arguments against finding that an HCP might owe a third party – such as a first order relative of the proband – a duty of care become correspondingly weaker.
In the case of psychiatric injury caused by witnessing a traumatic event, the courts have developed a set of criteria, based on proximity and foreseeability and whether it is fair, just and reasonable to impose a duty,Footnote 141 which limit the extent of the duty. Footnote 142 By analogy, the duty to disclose information could be similarly limited by the courts to, for example, first and second order relatives, or those living in the same household. As has been recognised by the courts, such limits may be arbitrary, but are necessary to limit the scope of the tort and to protect defendants from indeterminate liability.Footnote 143
In this context, proximity would depend upon the relationship – domestic or genetic – between the primary party and the third party. So an HCP might owe a duty to warn of an infectious disease to the persons living with the patient, as primary party, but not to visitors to the household or members of the general public. An HCP who negligently discharged a patient who was still infectious might owe a duty of care to that patient's immediate family, but would not be liable for a general outbreak of the disease. Applying the concept of proximity to the case of genetic conditions, the HCP might owe a duty to first and second order relatives, but not to more distant relations. This requirement would allay any fears of an HCP facing indeterminate liability as a result.
To succeed, the claimant would still have to show that the HCP did not act reasonably. The existence of a duty of care does not mean that the HCP is liable for any harm caused: he will only be liable to the extent that his failure to act reasonably caused the injury. So an HCP treating a genetic disorder would owe a duty to any relative with the necessary genetic proximity. But to hold the HCP liable for any harm suffered, the relative would also have to show that he acted unreasonably. As the Superior Court of New Jersey held in Safer v Pack, the duty is to ensure ‘that reasonable steps be taken to assure that the information reaches those likely to be affected or is made available for their benefit’.Footnote 144
Depending on the specific circumstances, an HCP might discharge his duty to any relative by appropriate advice to the patient: for example, advising the patient of the risk to relatives and referring him to genetic counselling. If the HCP was aware that the patient was unwilling to pass on the information, then they might be under a duty to pass on the information, with the consequential breach of the patient's confidentiality, to any third parties with sufficient proximity to give rise to a duty of care.
Imposing such duties would not, as was suggested by counsel for the defendant in ABC,Footnote 145 place HCPs in a difficult position, or at least no more than their existing professional obligations do.
VI Drawing together the duty of confidence and the duty to warn
These two duties are the corollary of each other; in practice, questions about whether to disclose information to family members of a proband raise the issue of both the duty of confidence, and duty of care to third parties. But although the facts will be the same, the legal tests are separated, and approached differently depending on whether they are analysed from the point of view of the proband (duty of confidence) or that of the family member (duty to warn). Thus, the HCP at the heart of the matter will be faced with two potentially conflicting duties. It would be problematic if the application of the two legal tests led to conflicting outcomes.
At present, an analysis of the duty of confidence may result in a conclusion that disclosure to third parties is in the public interest. Unless there is at least a limited duty to warn in certain circumstances, as outlined above, a risk averse HCP would be well advised to maintain confidentiality, as there will be no party with standing to sue for breach of duty to warn, but there will be a party with a potential cause of action for breach of confidence. Such a position will, it is submitted, skew practice too far in favour of confidentiality.
If the balance of the law is as argued above, then the outcomes of the application of the tests of duty of confidence and the duty of care will be consistent, as well as congruent with ethical obligations. In determining whether disclosure is either authorised (duty of confidence) or required (duty of care) we suggest that ultimately, the HCP (or court) will be required to balance the competing rights of the parties, and that the central question that will be key in these cases is that of the harm that will result to the third party concerned.
Although there are conceptual differences between these tests, the relevant factors which will feed into the analysis are likely to be the seriousness of the genetic condition in question, its treatability and the chance that the relative in question might inherit the condition. An HCP will need to consider each factual situation on its merits. The question of the threshold of seriousness and treatability is the subject of significant debate in the genetics community,Footnote 146 and HCPs will be able to draw on a body of professional opinion,Footnote 147 which will no doubt also serve to inform a court.
Serious, treatable conditions will have greater impetus for disclosure than less serious, or untreatable conditions. For example, a case of sudden cardiac death, with a clear genetic contribution, serious outcome and treatment in the form of medication or implantable defibrillator which allows the harm to be averted provides a good example where the balance is likely to be struck in favour of sharing.Footnote 148 Conversely, a condition with unclear genetic inheritance or low penetrance, with variable severity and late onset is likely to be one where the balance is struck in favour of maintaining confidence.
There will, however, be situations where the balancing exercise is more complex. We suggest that the cases most likely to be difficult to resolve will revolve around questions of whether there is legally actionable harm. An example is where there is a serious condition, but where at present there is no known treatment to modify disease course. Whether the law will recognise the personal utility that a party may attach to the mere possession of information, in the absence of any ‘use’ in the medical sense, is questionable. It must also be balanced against the harm that could result from forcing information on a person against their wish to know – a violation of the ethical principle of the ‘right not to know’.Footnote 149
Additionally, it is unclear whether the law would recognise harm in the loss of chance relating to reproductive autonomy. Prenatal testing, preimplantation genetic diagnosis or prenatal testing are all available to those who are aware they are carrying genetic mutations. However, whether the law would recognise a loss of chance in relation to these opportunities seems doubtful.
Arguments in favour of a more expansive view of harm seem more likely to be successful in the context of the duty of confidence, particularly by reference to a human rights analysis. Therefore, an HCP who chooses to disclose to a third party to avert harm of this nature may avoid liability. However, a third party who wishes to claim against an HCP for breach of a duty of care for failure to disclose will be unlikely to succeed due to the law of negligence's more restricted view of harm. It is our contention that this distinction in recovery reflects an appropriate balance – it provides freedom to an HCP who feels an ethical obligation to disclose, but does not impose liability for failure to disclose.
Applying the test outlined above in the cases of ABC v St George's and Smith v Leicester is instructive. We suggest that in neither case would the duty of care we propose be found to be breached. In ABC, had the HCPs wished to breach their duty of confidence, they could have argued that disclosure was in the public interest, although the fact that there is no known treatment for Huntington's disease, and that it is known that relatively few people undertake predictive genetic testing would have made that argument finely balanced. However, in the case of the duty of care, it is submitted that, whilst a duty should be owed, that in this case there would be no breach of the standard of care by maintenance of confidence. This is due primarily to the fact that there is no available treatment for this adult onset condition.
It seems likely that the outcome of Smith would also be unchanged. While it would be for the court to determine whether there was sufficient proximity, in the form of the genetic relationship between the patient and the third party, for there to be a duty, the claimant was the second cousin of the patient in question. This is a 5th order genetic relationship, with only 3% of genetic material shared between the parties. It is likely that the court would find insufficient proximity between the parties for there to be a duty of care.
Conclusion
The ultimate analysis in genetic information sharing cases will in essence relate to the nature of the harm which arises due to the failure to disclose. The concept of harm is likely to be problematic in many cases, as the type of harm arising may not be recognised in law. However, this failure of the law to recognise some types of harm arising in genetic information sharing is appropriate. The ethical judgements in these cases are not clear cut, and reasonable HCPs, and lawyers, may disagree as to the appropriate outcome. In the absence of clear ethical consensus, it seems appropriate that the law should not mandate disclosure. The appropriate outcome is that only in fairly rare cases should there be a duty to disclose, and in a slightly wider series of cases will disclosure be authorised.
As was noted in Montgomery, ‘[u]nder the stimulus of the Human Rights Act 1998, the courts have become increasingly conscious of the extent to which the common law reflects fundamental values’.Footnote 150 These fundamental values underpin the medical profession's ethical principles and it is desirable that legal obligations reinforce, rather than conflict with, professional obligations.Footnote 151 Most HCPs working in clinical genetics regard informing those who might be directly affected by their patients’ genetic information as something that a reasonable HCP should do, and there is a significant body of medical literature examining the circumstances in which disclosure is ethically desirable.Footnote 152 In some circumstances, where disclosing the genetic information would allow the relative to receive earlier treatment, they might regard that as outweighing their duty of confidentiality to their patient. An HCP who does disclose information to a family member in the face of opposition from their patient runs the risk of being liable for breach of confidence. To counterbalance this risk, it is our contention that, in limited circumstances, a duty of care should arise. This would make the law congruent with the GMC Guidance on Confidentiality in relation to disclosure of genetic information to family members, as well as the reported experience of many HCPs working in clinical genetics. It is our contention that this is an additional factor in favour of the rebalancing of the law we propose.
The familial nature of genetic information strains the individualistic approach of the law in relation to confidentiality and tort. However, the law is sufficiently flexible to accommodate scientific and medical realities. The law of confidence permits the disclosure of information in the public interest, and the flexibilities of the way in which public interest is interpreted permit disclosure in limited and appropriate circumstances. More controversially, we argue that, in certain limited circumstances, a duty of care should be owed by an HCP to third party family members. We contend that it is more suitable in this case for the limits on liability to arise at the stage of breach, rather than the duty of care imposition.
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