The nature and extent of adverse events in fertility practice

In the lead up to our inaugural Assisted Reproductive Technology Summit, we spoke with Tina Cockburn, Associate Professor in Law at the Queensland University of Technology, Brisbane, and a researcher within the Australian Centre for Health Law Research. Tina’s area of research focuses on patient safety law and medico-legal issues arising out of innovative medical treatment, adverse medical outcomes and the communication of information, including patient consent and post treatment open disclosure. Tina spoke with us about her work, and the issue of open disclosure of adverse events in fertility practice.

Can you tell me about your research?

I am an Associate Professor in Law at the Queensland University of Technology, Brisbane, and a researcher within the Australian Centre for Health Law Research. My health law research focuses on patient safety law and medico-legal issues arising out of innovative medical treatment, adverse medical outcomes and the communication of information, including patient consent and post treatment open disclosure.

I am a member of the Queensland Law Society Health and Disability Law Committee. I have been researching in the area of open disclosure of adverse events for many years, and wrote the first comprehensive analysis of legal, ethical and policy issues relating to open disclosure published in Australia, which included a comparative analysis with international jurisdictions including Canada, the U.S. and the U.K (Tina Cockburn and Bill Madden, ‘Bundaberg and beyond: Duty to disclose adverse events to patients’ (2007) 14 Journal of Law and Medicine 501). My research has been funded by the Economic and Social Research Council (UK).

Two of my current research projects include: an ESRC (UK) Seminar Series, Liability v Innovation: Unpacking Key Connections, which aims to explore the relationships between tort liability, disciplinary proceedings, defensive medicine and the effect on innovation, and a transdisciplinary project, Communicating information about mammographic density to Australian women: assessing ethics, law and policy.

You plan to discuss open disclosure of adverse events in fertility practice. Could you tell me about some of the adverse events that can occur?

Adverse events which occur in fertility practice can be classified as: clinical (such as hospital admissions due to ovarian hyperstimulation syndrome); laboratory-based (such as loss of sperm, eggs or embryos and IVF mixups); and administrative errors (such as breaches of confidentiality and record keeping errors).

In the UK, it is a statutory requirement to report adverse events in fertility clinics to the Human Fertilisation and Embryology Authority (HFEA). The HFEA guidance for clinics describes an incident as “any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, their embryos/sperm/eggs or to staff of a licensed centre.” The HFEA publishes annual reports on adverse incidents in fertility clinics. The most recent report, ‘Adverse incidents in fertility clinics 2014: lessons to learn’, published on 17 September 2015, shows there were 465 incidents in UK fertility clinics in 2014. This equates to less than one percent of the 60,000 cycles of treatment that take place annually in the UK. Of the 465 reported incidents, most incidents were categorised as clinical (212), errors in the laboratory (114) and administration errors (102).

Incidents are also classified in terms of severity, with A grade incidents being the most severe. Examples of A grade incidents include a patient being implanted with an embryo that is intended for someone else, the death of a patient, or an incident which affects a number of patients (for example when a storage unit malfunctions which may irretrievably damage the embryos, eggs or sperm of a number of patients).  In the 2014 report, two incidents were classified as A grade, while 165 were grade B, and 232 were grade C.

What options are available to individuals who have experienced an adverse event? 

Options for redress for individuals who experience an adverse event in fertility practice include making a complaint to regulators about the conduct of health care professionals, and also commencing proceedings for compensation, including medical negligence claims. In addition to claims for physical injury to women and unborn children, there is potential for claims to be brought for recognised psychiatric injury which has been caused during the assisted reproduction process.

Just this week the New South Wales Supreme Court published a decision, McManus v Murrumbidgee Local Area Health Network [2016] NSWSC 1347. In that case the claimant, a woman whose unborn child died soon after birth, in circumstances that could and should have been avoided by an earlier caesarean intervention, was awarded more than $1.7 million to compensate her for the nervous shock she sustained. Similar claims for debilitating psychiatric injury arising out of futile or ineffective fertility treatment may be on the horizon. I have noted with interest that Sarah Dennis will give a presentation at the forthcoming Assisted Reproductive Technology Summit, on the topic, ‘Futile and ineffective IVF treatment: the emerging potential for claims in medical negligence’, and am looking forward to hearing this presentation.

The fertility industry has been under scrutiny these past few months due to their perceived lack of transparency about their success rates. What are your thoughts on this?

Consumers should obviously be provided with full information about the risks and benefits, and accurate evidence about the likelihood of success of fertility treatments so that they are placed in a position to make informed decisions as to whether or not to proceed.  Particular issues have arisen due to the inconsistent communication of information about success rates. For example, some clinics report success rates in terms of pregnancy, while others report in terms of live birth rate per embryo transfer. This problem persists because there is still no nationally consistent standard for reporting success rates, despite a recommendation by the Independent Review of Assisted Reproductive Technologies Committee in 2006 that success rates should be standardised nationally, “with the primary outcome presented being the rate of live birth per-cycle started.”

Another emerging issue is the potential for conflicts of interest to arise, including through referrals to companies which advertise no win no fee services to lobby the Department of Human Services on behalf of clients for early access to their superannuation as a payment option.

Do you have any suggestions for reform to protect patients and promote patient’s safety?

There is no legal duty to decline to offer elective procedures which might be regarded as unnecessary or unwarranted, provided the patient has made an informed decision to proceed: Morocz v Marshman [2015] NSWSC 325. Therefore, the best way forward may be to regulate to improve the communication of information to women about the risks and benefits, and likelihood of success of fertility treatments to better enable full, free and informed decision making.

In May 2016 the Medical Board of Australia issued guidelines for medical practitioners who perform cosmetic medical and surgical procedures: Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures, which will take effect on 1 October 2016. These guidelines aim to improve patient safety and enable improved decision making without imposing an unreasonable regulatory burden on practitioners (Dr Joanna Flynn AM, Chair Medical Board of Australia, 9 May 2016).

The guidelines include provisions relating to: recognising potential conflicts of interest; patient assessment; consent; and advertising and marketing. For example, the guidelines state that “medical practitioners must recognise that conflicts of interest can arise when providing cosmetic medical and surgical procedures and must ensure that the care and wellbeing of their patient is their primary consideration” (1.1) and “a medical practitioner should decline to perform a cosmetic procedure if they believe that it is not in the best interests of the patient.” (2.7). These guidelines could be readily adapted to regulate the provision of information and services by providers of assisted reproductive fertility technology.

Associate Professor Tina Cockburn will be presenting on the topic of open disclosure of adverse events in fertility practice in greater detail at the Assisted Reproductive Technology Summit. For more information, including our current agenda, please head to our website.