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Disclosure of Adverse Events in

Fertility Practice

Associate Professor Tina Cockburn QUT Faculty of Law

Disclosure of adverse events in

fertility practice

• The nature and extent of adverse events in fertility practice

• Why disclose adverse events?

• Implementing open disclosure

• Consequences of failure to disclose adverse events

THE NATURE AND EXTENT OF ADVERSE

EVENTS IN FERTILITY PRACTICE

Adverse events in fertility practice

• Clinical

• Laboratory-based

• Administrative errors

Loss of sperm, eggs or embryos

– Errors that lead to gametes or embryos being lost or degraded which may result in diminished reproductive opportunity

IVF patients lose embryos in

South Australia storms

IVF mix-ups

• Gametes or embryos employed in fertility care are not those originally intended for use in the patient undergoing treatment, potentially leading to the birth of a child with an unplanned genetic parentage.

Backwell v AAA (1996) Aust Torts Rep

81-387• D inseminated P with incompatible donor sperm.

• D discovered error > told P not to worry & return next week for pregnancy test.

• Test revealed P pregnant

– D advised termination – risk of stillbirth

– D threatened P that if baby stillborn, her identity might be revealed & publicity might cause closure of clinic.

– D told P that if she did not terminate, further IVF might be difficult to receive

• P terminated pregnancy

• P suffered depressive disorder

• Held: compensatory damages and $60,000 exemplary damages

Administrative Errors:

Record keeping failures Re Human Fertilisation & Embryology Act 2008 [2015] EWHC 2602 (Fam)

• “This judgment relates to a number of cases where much joy but also, sadly, much misery has been caused by the medical brilliance, unhappily allied with the administrative incompetence, of various fertility clinics. The cases I have before me are, there is every reason to fear, only the small tip of a much larger problem.

• …

• The question of who, in law, is or are the parent(s) of a child born as a result of treatment carried out under this legislation … is, as a moment's reflection will make obvious, a question of the most fundamental gravity and importance. What, after all, to any child, to any parent, never mind to future generations and indeed to society at large, can be more important, emotionally, psychologically, socially and legally, than the answer to the question: Who is my parent? Is this my child?”

HFEA (UK), Adverse incidents in fertility clinics

2014: lessons to learn (17 September 2015)

2014: 465 Incidents – 60,000 cycles (~1%)

A grade incidents: 2

B grade incidents: 166

C grade incidents: 232

Near miss/not incident: 65

HFEA (UK), Adverse incidents in fertility clinics

2014: lessons to learn (17 September 2015)

Classifying 465 incidents

Clinical: 212

Laboratory: 114

Administration: 102

Other: 37

WHY DISCLOSE ADVERSE EVENTS IN

FERTILITY PRACTICE?

Why disclose adverse events?

– Patient expectations

– Duty of candour

– Good clinical practice

– Health systems and individual service provision quality improvement

– Organisational and individual risk management benefits

“Open disclosure is a patient right, is anchored in professional ethics, considered good clinical practice, and is part of the care continuum.” (p11 OD Framework)

“Principles of open and honest communication with patients have special significance in reproductive medicine. Fertility treatments are often stressful, and patients may be particularly sensitive to the statements of their doctors. In addition, errors in reproductive medicine may affect the couple’s ability to have a child. In errors that are particularly serious—where embryos are mistakenly transferred to the wrong couple—the error may lead to the birth of a different child than was intended. Such births can lead to significant emotional turmoil and the burdens of custody lawsuits, which can adversely affect all involved parties, including the children.” ASRM 2016

Australian Medical Council Good Medical

Practice: A Code of Conduct for Doctors in

Australia

3.10 Adverse Events When adverse events occur, you have a

responsibility to be open and honest in your communication with

your patient, to review what has occurred and to report

appropriately. When something goes wrong, good medical practice

involves:

3.10.1 Recognising what has happened

3.10.2 Acting immediately to rectify the problem, if possible including

seeking any necessary help and advice

3.10.3 Explaining to the patient as promptly and fully as

possible what has happened and the anticipated short and long

term consequences

3.10.4 Acknowledging any patient distress and providing appropriate

support

Code of Practice for Assisted Reproductive

Technology Units

• Part 1: Clinical Criteria 4. Adverse Events

The Organisation must acknowledge and investigate adverse events.

– Provide evidence of implementation and review of:

• policies/procedures to systematically collect, analyse causal factors, review and act on all adverse, unplanned and untoward events.

• Adverse events, including serious adverse events and serious notifiable adverse events…

• Serious Notifiable Adverse Events … must be reported to RTAC...

• Part 2: Good Practice Criteria 2. Patient Information

The Organisation must provide patients with information that is accurate, timely and in formats appropriate to the patient.

– Provide evidence of implementation and review of policies/procedures: to ensure patients receive written and verbal information covering diagnosis, investigation and fertility treatment options.

• Information must include but not be limited to:

– processes, costs, risks and outcomes… Fertility Society of Australia, Reproductive Technology Accreditation Committee (Revised August 2015)

IMPLEMENTING OPEN DISCLOSURE:

POLICY AND GUIDELINES

Open disclosure

• Open disclosure is the open discussion of

adverse events that result in harm to a patient

while receiving health care with the patient, their

family and carers.

– http://www.safetyandquality.gov.au/wp-content/uploads/2013/03/Australian-Open-Disclosure-

Framework-Feb-2014.pdf

Dr Lucian Leape on disclosure and apologies in health care

https://www.youtube.com/watch?v=bJLsh9VTLmI

Open Disclosure: Elements

• an apology or expression of regret, which should include

the words ‘I am sorry’ or ‘we are sorry’

• a factual explanation of what happened

• an opportunity for the patient, their family and carers to

relate their experience

• a discussion of the potential consequences of the

adverse event

• an explanation of the steps being taken to manage the

adverse event and prevent recurrence.

Medico Legal Risks: 45

Inadequate training &education: 43

Time Constraints: 18

Fear of scaring patients:18

Advice from insurers: 16

Cost: 6

Studdert, Piper and Iedema “ Legal Aspects of open

disclosure II: attitudes of health professionals: Findings

from a national study” MJA 2010

Barriers to open disclosure

Facilitating Open disclosure: Apology

protections

• Apology of sympathy

• “I am sorry that this happened to you”

• Apology of fault

– “I am sorry that I did this to you”

Dovuro Pty Ltd v Wilkins [2003] HCA 51

• D distributed canola seed contaminated with weed seed to growers

• Media release: – “we apologise to canola growers… This situation should not have occurred.”

• Letter to growers:

– (Referring to its) “failing in its duty of care to inform growers as to the presence of these weed seeds”

HELD:

• “statement …. cannot be an admission of law, and it is not useful as an admission of failure to comply with a legal standard of conduct. There is no evidence that the author of the statement knew the legal standard.”

– Gleeson CJ at [25]; see also Kirby J at [173]

Apology provisionsApology defn incl fault

Not admission of liability

Not relevant to fault

Not admissible evidence

ACT X X X X

NSW X X X X

Tas X X X

WA X X X

Qld X X X X

NT X

Vic X

SA X X X X

Based on Prue Vines “Apologising to Avoid Liability: Cynical Civility or Practical Morality” (2005) 27 Sydney Law Review

483 at 490 , as amended following subsequent legislative changes

CONSEQUENCES OF FAILURE TO

DISCLOSE ADVERSE EVENTS:

- DISCIPLINARY ACTION

- CIVIL CLAIMS

“Errors do not necessarily constitute

improper, negligent, or unethical

behaviour, but failure to disclose them

may.”

• Ethics manual, fourth edition: disclosure. Ann Int Med 1998; 7: 576-

94

Disciplinary actionRe Steven L Katz MD Medical Board of California (2005)

• Dr K mistakenly transferred 3 embryos meant for DB into SB

• Dr K knew of mistake 10mins later - did not tell either patient

or note in medical records

• SB had son and DB had daughter

• Alleged deception and cover up for 1.5yrs and attempt to

terminate SB’s pregnancy

• HELD:

– Mistaken transfer not gross negligence

– BUT failure to disclose error & obtain informed consent to

continued care - active concealment > gross negligence

– Licence revoked $91,000 fine

Re Steven L Katz MD (2005)

“Medical mistakes happen and when they do the only course open to the physician is to advise the patient of the medical error. … The decision to tell the truth is foundational, as is the basic principle that the patient has the right to make complex choices and decisions relating to her medical planning and care. … Patients have a right to be fully informed of errors and to have their medical options fully disclosed and discussed. Physicians are to be honest in their interactions with their patients, and in particular, to respect the right of their patients to makes choices about their healthcare. Physicians are required to recognise potential and actual conflicts of interest, and to place their patients’ interest above their own….” p13

Civil Claims: Aspect of duty to provide

proper medical treatment and advice

Breen v Williams (1994)“Informing a patient of what treatment has been given and what has taken place while doing so, whether or not there has been a catastrophe, is integrally and necessarily part of giving medical treatment to a person. One cannot stick a needle into a person and walk away wordless, as one would with a horse.” per Bryson J

• Ongoing duty to disclose after cessation of treating relationship if subsequently becomes aware or ought to become aware of adverse event: Mink v University of Chicago (1978) 460 F Supp 713

Civil Claims: aspect of reasonable

aftercare and duty to follow up

• Wighton v Arnot [2005] NSWSC 367

• Dr Arnot severed Ms Wighton’s right spinal accessory nerve

during surgical procedure.

• Studdert J found negligent the failures to:

– inform patient of his suspicion that he had severed that nerve

• Disclosure to the patient’s general practitioner may have been sufficient

– by appropriate examination to confirm that he had severed the nerve

– Refer patient to an appropriate specialist for timely remedial surgery.

• May not have been held negligent if had disclosed adverse

event - no allegation of negligent conduct of procedure

“ Dr Arnot said that he did not tell the plaintiff …because

of her emotional state and because it was only a

possibility that he had severed this nerve, and that

possibility he considered to be ‘probably wrong’ because

of his examination following surgery. … I do not find the

defendant’s explanation for not telling the plaintiff about

the division of the nerve to be an acceptable explanation.”

Wighton v Arnot per Studdert J at [69]

Therapeutic Privilege in Fertility Cases

• “Some might argue that the ethical duty to minimize harm

justifies not telling the patients of the error because

disclosure may be harmful, such as leading to a pregnancy

termination or creating stress. We believe this view is

misguided. Disclosure of the error will enable the persons

most directly affected to decide on a course of action. If a

pregnancy has been established, this course of action may

involve continuing the pregnancy, making advance

arrangements about parentage, and securing legal counsel

to take steps to develop a workable solution for this

unforeseen outcome. An alternative course of action may be

a decision to terminate the pregnancy.” ASRM 2016

Therapeutic privilege

• Re Steven L Katz MD:

– Dr K: the complexity of the situation presented an

opportunity for a physician to not disclose if the

physician felt that disclosure would cause more harm

than good.

– Finding: “The rationale for withholding information

from a patient should be carefully documented and

exercise of the therapeutic privilege is almost never a

basis for permanently overriding the obligation of

informed consent. It is ordinarily viewed as a

temporary situation. There is no evidence in this case

that would place either patient within this exception.” • p 15-16

Conclusions

• Ethics, policy and guidelines support open

disclosure of adverse events

• Patients expect open and honest communication

following adverse events but this may not always

happen

• Clinics should promote a culture of truth telling

and should establish written policies and

procedures regarding disclosure of errors to

patients.

• Failure to disclose adverse events may give rise

to disciplinary and civil liability consequences

• “We conclude that the best ethical practice is for

programs to have in place rigorous procedures to

prevent errors. To prepare for the possibility that

errors may occur despite these procedures,

programs should foster an environment of truth

telling that will allow prompt identification and

disclosure of errors to patients. It is recommended

that clinics have written policies and procedures that

outline how to reduce and disclose medical errors.”• ASRM 2016