11th Greek Australian Legal and Medical Conference
Crete, Greece 2007

HIV Transmission from Doctor to Patient: A Legal and Ethical Conundrum

William J Keough BA LLB Dip Crim

Prelude

On 22 January 2004, officials of the CHU mère-enfant Sainte-Justine (hereinafter the Ste Justine Hospital) in Montréal, Canada, announced it was recommending that 2,614 patients be tested for HIV infection. The patients involved in the trace-back were mostly children who had undergone surgical procedures at Ste Justine by Paediatric General Surgeon, Dr Maria Di Lorenzo, who contracted HIV in 1990 following a needle stick injury whilst treating an HIV infected newborn.

Dr Di Lorenzo performed the operations over a 13 year period between 1990 and 2003 – on average 200 operations per year. In 1991 Dr Di Lorenzo advised the Director of Professional Services at Ste Justine of her condition. A group of Dr Di Lorenzo’s colleagues at Ste Justine set up a special Committee to discuss Dr Di Lorenzo’s condition and to determine what kind of medical work Dr Di Lorenzo could perform.

Dr Di Lorenzo was permitted to return to her surgical privileges as long as her patients were exposed to no risk. Dr Di Lorenzo was not required to inform the parents or guardians of her patients of her serological status as part of the informed consent interchange. Dr Di Lorenzo ceased working in June 2003 and died in August 2003.

Ste Justine Hospital administration was not made aware of Dr Di Lorenzo’s serological status until early January 2004, despite a number of her colleagues being privy to such information.

Introduction

The object of this paper is to examine the issue: whether, and to what extent, HIV-infected health care workers may be obligated to inform patients of their serological status prior to providing medical care and treatment as part of the informed consent interchange.

As a backdrop to this discussion, it is important to note that much academic ink has been spilt regarding whether, and to what extent, HIV-infected health care workers should be restricted in their practice. This is also true of the subject of whether, and to what extent, patients have a right to know the serological status of their health care providers.1

These questions have been debated against a background of a considerable body of epidemiological evidence establishing that the possibility of transmission of HIV from an infected health care worker to a patient is, in the words of one commentator, “vanishingly small”.2

How Can HIV Be Transmitted In The Clinical Health-Care Setting?

The risk of HIV transmission in the health-care setting arises from the performance of invasive medical, surgical and dental procedures, the definitions of which tend to vary from one country to country.

The definition favoured by the Australian Medical Association is: “. . . any procedure that pierces the skin or mucous membrane or enters a body cavity or organ. This includes surgical entry into tissues, cavities or organs or repair of traumatic injuries. Exposure prone procedures are a subset of invasive procedures and is a term characterized by the potential for direct contact between the skin (usually finger or thumb) of the health care worker and sharp surgical instruments, needles or sharp tissues (spicules of bone or teeth) in body cavities . . .”. 1

Whilst invasive procedures can provide an avenue for the transmission of HIV, it is not invasive procedures, per se, which create the risk, but accidents during such procedures which can result in exposure.

For the transmission of HIV from health care worker to patient to occur, the infected health care worker would have to sustain an injury during an invasive procedure, bleed into the wound and/or have the sharp object causing the injury re-contact the patient’s open wound thereby resulting in the patient’s exposure to the health care worker’s blood.

Estimates of Risk

Whilst patients can be infected by health care workers in the same manner in which health care workers can be infected by patients (ie: through percutaneous exposure), the risks are not symmetrical.

A patient virtually stands no chance of being splashed by large amounts of the health care worker’s blood. A health care worker who is cut will spill far less blood than a patient undergoing invasive surgery, and a health care worker who feels a cut may step away from a patient before any blood is spilt. Indeed, universal infection control procedures in the perioperative setting dictate that there is never an occasion to use a needle on a patient after it has been pricked by a health care worker. Accordingly, the risk of transmission from a health care worker to a patient is thought to be significantly lower than the risk a patient poses to a provider.

Due to the limited number of reported cases of HIV transmission from health care worker to patient, it is difficult to quantify such transmission; however, available published material tends to quantify the risk at a very low level. Indeed the Center for Disease Control in the United States estimates the risk of HIV transmission to a patient from an invasive procedure to be in the range of 1:40,000-to-1:400,000 from HIV positive surgeons, and 1:200,000-to-1:2,000,000 from HIV infected dentists.2 Similarly, another study3 estimates the risk of acquiring HIV infection after a single at-risk exposure averaged 0.5% with the frequency of percutaneous exposure ranging from 1 to 15 per 100 operations, with cardiothoracic surgery reporting the highest rates of exposure - mucocutaneous contamination by blood splash occurring in 50% of cardiothoracic procedures.

Accordingly, the risk of HIV transmission from health care worker to patient is both epidemiologically and, in practical terms, much lower than the risk of transmission from infected patients to doctors.

The Response of Ethics

American courts in the early 1990’s developed a body of jurisprudence that provided that, regardless of the remote possibility of transmission of AIDS from an HIV infected health care worker, the serological status of the health care worker is the type of information that a reasonable patient may deem important before deciding to either undergo or forego medical or surgical treatment.

The courts have long recognized that a patient’s informed consent to a medical procedure is an essential prerequisite to the performance of any procedure. The doctrine of informed consent is rooted in both moral theory as well as legal theory. Faden and Beauchamp argue that respect for autonomy is the most frequently mentioned moral principle in the literature on informed consent, where it is conceived as a principle rooted in the liberal western tradition of the importance of individual freedom and choice.4 They go on to argue that whilst nearly all contemporary analyses focused on the autonomous person, the central focus in relation to an appreciation of the doctrine of informed consent is an autonomous choice – or, more specifically, autonomous action.5

A distinction is drawn by Faden and Beauchamp between a person who has the capacity to be independent and in control, and the actions of that person that reflect the exercise of such capacities.6

In the medical arena, many issues about consent concern failures to respect autonomy, ranging from non/under-disclosure of material information about a medical procedure to the non-recognition of a refusal of medical interventions.

In the legal context, informed consent is not strictly about how best to respect a patient’s autonomy or to enable autonomous decision-making per se. Indeed, Faden and Beauchamp argue that in case law the justification for informed consent is couched in rights language – the patient’s right to self-determination – and the primary concern of the law is to prescribe duties that devolve upon physicians in order that this right is protected.7

The Response of the Law

So what are the duties incumbent upon physicians to ensure that a patient’s exercise of his/her right to self-determination is an informed one? In the United States and Canada, the Courts have held that the relationship between a health care worker and a patient is a fiduciary one based on trust and confidence.8 It has been held that this relationship imposes upon a physician a duty of utmost good faith and dealing which, in turn, finds expression in revealing to a patient that information which in the patient’s best interests, the patient should know.

Just what information a health care worker must disclose in order to fulfill such obligation is the subject of much debate - and a particularly complicated issue when dealing with HIV infected health care workers.

The law in Australia in relation to the nature and amount of information that health care workers are required to provide to patients is settled. In Rogers v Whittaker9, whilst rejecting the notion that the doctor-patient relationship is wholly fiduciary in nature, the High Court held that a patient should be warned of a ‘material risk’ and that, “ a risk is material if, in the circumstances of a particular case, a reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to it, or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. The duty is subject to the therapeutic privilege”.10

In Rogers, the appellant argued that the issue of whether the failure to warn of the risks associated with ophthalmic surgery constituted a breach of the appellant’s duty of care should be resolved by an application of the Bolam Principle, a principle derived from a direction to a jury in the English case of Bolam v Friern Hospital Management Committee11, to the effect that that a health care worker is not negligent if he acts in accordance with a practice accepted at the time as proper by a responsible body of medical opinion even though other health care workers adopt a different practice. In rejecting Bolam, the High Court said that it is for the Courts to adjudicate on what is the appropriate standard of care after giving weight to the paramount consideration that a person is entitled to make his/her own decisions about his/her life.

In summary, except in those cases involving the notion of therapeutic privilege, evidence of medical practice will not be decisive in determining the level of information to be given to a patient.

Whilst the application of the test in Rogers in the context of an HIV infected health care worker is untested in Australia, it is argued that, although a patient may be likely to prove that the risk of HIV transmission is material and would result in the patient foregoing a procedure, proving causation is often insurmountable in a strict informed consent case seeking recovery of damages, unless the patient actually contracts the disease from an HIV infected health care worker.

Prelude Revisited

Given that none of Dr Di Lorenzo’s patients tested positive for HIV, it is argued that any action against Ste Justine Hospital for failing to warn the parents/guardians of Dr Di Lorenzo’s patients as to her serological status would fail on a strict informed consent basis.

The Response of the Medical Profession

Whilst the law grapples with HIV in the health environment, the responses of the medical profession was to codify the professional standards into guidelines with the stated objective of safeguarding the interests of both the health care worker and the patient.

The Center for Disease Control recommended the following measures:

In response to the Ste Justine Hospital case, the Québec College of Physicians published Guidelines providing inter-alia as follows:

In contrast, the Australian Medical Association considers there is an obligation on infected doctors to ensure that they only perform invasive procedures where:

Discussion

A prominent theme emerging from the professional guidelines is that health care workers who perform exposure-prone procedures, and who learn that they are infected with a blood-borne pathogen, are ethically required to report the fact to their profession’s regulatory body. Such obligations also extend to health care workers being – and remaining – aware of their serological status.

The general tenor of the various guidelines is steeped in self-regulation. Infected health care workers are ethically required to review their practice of medicine, health risks and health status. They have an ethical duty to seek appropriate evaluation and advice from a specialist and comply with all directions in relation to the management of their condition.

The law, however, tends to complicate the ethical calculus in this area by placing onerous obligations on physicians to disclose a broad range of information to patients about the nature and effect of the proposed treatment. However, the issue as to whether or not the health care worker’s HIV status is material to the patient’s decision-making is unusual because the risks are based on the health care worker’s own personal characteristics, an element hitherto unknown in the informed consent analysis.

As HIV is contagious, the risks associated with invasive procedures makes the condition a hybrid between physician-specific and procedure-specific-risks. If an infected health care worker performs a non-invasive procedure, his/her HIV status poses no material risk and should, therefore, remain a physician-specific risk. However, if the same physician performs an invasive procedure, his/her HIV status becomes a procedure-specific risk given that the invasive procedure would not be risky ‘but for’ the physician’s HIV status.

This begs these questions:

These are questions ultimately for an Appeal Court; however, it is my view that a possible way of resolving these issues would be to require disclosure of material or otherwise unusual or special risks that are referable to the actual treatment. Only if a physician’s personal factors actually intervene in the treatment and cause injury to the patient is an action of negligence the appropriate avenue for addressing liability.

Indeed, where a patient tests positive after an invasive procedure, the plaintiff carries the burden of proving that the procedure was the source of infection. Absent a positive test, the plaintiff will fail on causation notwithstanding the ‘materiality’ or ‘risk’ posed by the surgeon’s serological status.

Conclusion

Legally mandating disclosure is not the answer. The law needs to properly focus not on the health care worker’s HIV status but rather on his/her conduct in a clinical negligence setting. It is reported the Dr Di Lorenzo was “meticulous in surgery”17 yet the focus of attention had been on her HIV status. It is asserted that in matters of patient safety, the health care worker’s competency and professionalism are paramount – not his/her HIV status.

The reach of the law (as demonstrated by the difficulties associated with causation in the context of negligent non-disclosure) is limited. Therefore, it comes as somewhat of a medico-legal paradox that, in a jurisdiction that has renounced the Bolam Principle, a professional community standard approach (ie: through professional associations) is the most appropriate way of dealing with and regulating HIV in the health care setting. I favour the approach of the Center for Disease Control and the Québec College of Physicians in this regard, with its emphasis on self-regulation.

The courts need to ensure that an appropriate level of objectivity is maintained in their assessments of liability. Regard ought to be had of the very low statistical risk of infection.

The stage is set for a potential flurry of legal activity in this new paradigm in the law of tort. Perhaps the legacy of Dr Maria Di Lorenzo is yet to be determined.

Endnotes

1. For example, see M Johnston, “HIV Testing of Health Care Workers: Conflict Between the Common Law and the CDC” (1993) 42 American University Law Review 479, K Lieberman and A Derse, “HIV and Health Care Workers and the Obligation to Disclose: Do Patients Have a Right to Know?” (1992) 13 Journal of Legal Medicine 333, L Gostin, “The HIV-Infected Health Care Professional: Public Policy, Discrimination and Patient Safety” (1990) 18 Law, Medicine and Health Care 303 and G Annas, “Legal Risks and Responsibilities in the AIDS Epidemic”, 18 Hastings Center Report 26 (Supp April-May 1988).

2. R Bayer, “Discrimination, Informed Consent, and the HIV Infected Clinician” 91997) 314 British Medical Jounal915 @ p.915.

3. AMA Position Paper on Blood-Borne Viral Infections, 1995, Revised 2004.

4. See for example, Bayer, opcit @ p.915, M Hagen et al, “Routine Pre-Operative Screening for HIV: Dies the Risk to the Surgeon Outweigh the Risk to the Patient?” (1998) 259 Journal of the American Medical Association 1357. See also L Robert et al, “Investigations of Patients of Health Care Workers Infected with HIV: The Center for Disease Control and Prevention Database” (1995) Vol 122, No 9, Annals of Internal Medicine 653.

5. V Puro et al, “Risk of HIV and Other Blood-Borne Infections in the Cardiac Setting” (2001) 946 Annals of the New York Academy of Sciences 291.

6. R Faden and T Beauchamp, A History and Theory of Informed Consent, Oxford University Press, 1986 @ p.7

7. Ibid @ p.8

8. Ibid

9. Ibid @ p.25

10. See for example, State ex rel McLeod v Seier SW 2d127, Norberg v Wynrib [1992] 92 DLR (4th) 449

11. [1992] 175 CLR 479

12. [1992] 109 ALR @ p.634

13. [1957] 1 WLR 582

14. CDC Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures, 40 Morbidity and Mortality Weekly Report 1 (Supp No RR 8 July 1991)

15. Collège des medicins du Québec, Position Paper, The Physician and Blood-Borne Pathogens, Guidelines for Physicians, 2004, @ p. 6.

16. AMA Position Paper, op cit, @ Recommendation 6.10.

17. A Picard, “AIDS-Surgeon Case to be Probed”, Globe and Mail, 24 January 2004.