Disclosure of adverse events in fertility practice

Associate Professor

Tina CockburnQueensland University of

Technology

Faculty of Law

t.cockburn@qut.edu.au

Disclosure of adverse events in fertility practice

The nature and extent of adverse events in fertility practice

Why disclose adverse events in fertility practice?

Implementing open disclosure: policy and guidelines

Consequences of failure to disclose adverse events: Disciplinary action

Civil liability

THE NATURE AND EXTENT OF ADVERSE EVENTS IN

FERTILITY PRACTICE

Adverse events in fertility practice

Loss of sperm, eggs or embryos

IVF mix-ups

Loss of sperm, eggs or embryos

Errors that lead to gametes being lost which may result in diminished reproductive opportunity

IVF mix-ups Gametes or embryos of one person or couple

mistakenly used with gametes or embryos of another person or are mistakenly transferred to another person or couple, potentially leading to the birth of a child with an unintended genetic parentage

Incidence of adverse events in fertility practice

Human Fertilisation and Embryology Authority (HFEA) UK:

April 2010 - March 2011: 564 errors, including losing embryos and sperm (50,000 IVF cycles)

Category A or B (IVF mixups) - 275 cases 2010/2011 cf 62 cases 2007/2008

Compare: April 2007 - March 2008: 182 incidents IVF errors have trebled in three years

HFEA spokesperson: ―The HFEA openly encourages the reporting of incidents and continues to work closely with centres to improve quality. As a result, centres are continuing to respond positively to the opportunity to share lessons learned from incidents which have been reviewed and vigorously investigated.‖

http://www.bionews.org.uk/page_104952.asp?dinfo=TxOkrAWWidfdjhQtYxoK6pUW

WHY DISCLOSE ADVERSE EVENTS IN FERTILITY

PRACTICE?

Why disclose adverse events?

Duty of candour Honest and open communication

Good clinical practice Respect for patients by treating them as autonomous

individuals Aspect of informed consent

Health systems and individual service provision quality improvement

Patient expectations Organisational and individual risk management

benefits

Why disclose adverse events in fertility practice?

―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.‖

Disclosure of medical errors involving gametes and embryos, http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf, 1313

Duty of candour

―Honest, effective and open communication is the foundation of the relationship between clinicians and patients. Telling the truth is always the right thing to do. Concealing the truth is wrong.‖

Barron and Kuczewski (2003)

Australian Medical Association Code of Ethics 2004 (rev 2006)

1.1a Consider first the well-being of your patient 1.1v When referring your patient to institutions or

services in which you have a direct financial interest, provide full disclosure of such interest.

1.1w If you work in a practice or institution, place your professional duties and responsibilities to your patients above the commercial interests of the owners or others who work within these practices.

2.1a Build a professional reputation based on integrity and ability.

2.1d Report suspected unethical or unprofessional conduct by a colleague to the appropriate peer review body

2.1gKeep yourself up to date on relevant medical knowledge, codes of practice and legal responsibilities.

Medical Professionalism 2010 (AMA)

2. The medical profession in society ―2.4 Society grants the medical profession a high level

of professional autonomy and clinical independence because it trusts doctors to put the individual patient’s interests first.‖

3. Medical professionalism ―3.2 Although individual doctors have their own

personal beliefs and values, the medical profession upholds a core set of values, including (but not limited to): respect; trust; compassion; altruism; integrity; justice; accountability; protection of confidentiality; leadership, and collegiality.‖

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

Ethics Committee of the American Society for Reproductive Medicine

(2011)1. Clinics have an ethical obligation to disclose errors out of respect for

patient autonomy and in fairness to patients.2. Errors that affect the number or quality of gametes or embryos

should be disclosed unless they clearly have a minimal effect on patient interests.

3. It is obligatory to disclose immediately errors in which the wrong sperm are used for insemination or gametes or embryos are mistakenly switched and the result is embryo transfer, conception, or the birth of a child with a different genetic parentage than intended.

4. Clinics should promote a culture of truth-telling and should establish written policies and procedures regarding disclosure of errors to patients.

5. Fertility programs should have in place rigorous procedures to prevent the loss of gametes and embryos and to ensure proper identification of all gametes, embryos, and patients.

http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf

PATIENT

EXPECTATIONS

Being open with patients when things go wrong is an important component in the quality of care people receive; it is what patients expect and is indicative of openness and learning in order to prevent further incidents.

Australian Charter of Health Care Rights

Communication

MY RIGHTS: I have a right to be informed about services,

treatment, options and costs in a clear and open way.

WHAT THIS MEANS: I receive open, timely and appropriate

communication about my health care in a way I can understand.

Percentage of high and very high rating for honesty and ethical

standards

Roy Morgan Image of Professional surveys of Ethics and Honesty 2012

IMPLEMENTING OPEN DISCLOSURE: POLICY AND

GUIDELINES

Open Disclosure Standard

National Open Disclosure Standard 2003 Open disclosure: open communication when things go

wrong in health care.

Elements: Expression of regret (cf. Apology)

Factual explanation of what happened

Explanation of potential consequences of incident

Explanation of steps being taken to manage the event and prevent its recurrence

NOTE: ACSQHC Review of the Open Disclosure Standard 2012

Implementing open disclosure is difficult

Legal barriers:

adequacy of legislative protection for apologies

Uncertainty about law and fear of increased litigation

Physician barriers:

guilt and embarrassment

fear of reaction from peers

fear of punitive sanctions

Uncertainty about policy and practical guidelines

communication difficulties

See Iedema et al ―The National Open Disclosure Pilot: Evaluation of a policy implementation initiative‖ MJA 2008

Barriers to error disclosure

Ghalandarpoorattar, Kaviani and Asghari ―Medical error disclosure: the gap between error and practice‖ Postgrad Med J 2012; 88: 130-122

The process of disclosing adverse events in fertility practice

―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.‖

Disclosure of medical errors involving gametes and embryos http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf, 1314

Facilitating Open disclosure: Apology protections

Definitions

Apology of sympathy

Apology of fault

Legal consequences of apologies

Common law: Dovuro Pty Ltd v Wilkins [2003] HCA 51

Legislation: Civil Liability Acts Watson v Meyer [2012] NSWDC 36

Apology provisions

Apology 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

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

Civil Liability Act (NSW) 2002

68 Definition In this Part:

"apology" means an expression of sympathy or regret, or of a general sense of benevolence or compassion, in connection with any matter whether or not the apology admits or implies an admission of fault in connection with the matter.

69 Effect of apology on liability (1) An apology made by or on behalf of a person in connection with any matter

alleged to have been caused by the person: (a) does not constitute an express or implied admission of fault or liability by the person in connection

with that matter, and

(b) is not relevant to the determination of fault or liability in connection with that matter.

(2) Evidence of an apology made by or on behalf of a person in connection with any matter alleged to have been caused by the person is not admissible in any civil proceedings as evidence of the fault or liability of the person in connection with that matter.

Watson v Meyer [2012] NSWDC 36

Personal injury claim arising out of P falling from D‘s horse

Evidence: I said, "Did she have a fall from her horse?" and he said, "No, it was my fault, my horse". Held: [244] ―All that the defendant was saying was that the plaintiff had not

fallen from her horse but had fallen because it was "my fault, my horse". That is not an admission about liability, but a description of the accident. Accordingly, the evidence does not amount to an admission.‖

CONSEQUENCES OF FAILURE TO DISCLOSE ADVERSE EVENTS:

DISCIPLINARY ACTIONCIVIL LIABILITY

―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 action

Failure to disclose, especially where patients are deliberately misled may be unprofessional

conduct: Skidmore v Dartford & Gravesham [2003] UKHL 27

Re Steven L Katz MD Medical Board of California 2005

Medical Board of Qld v Popov [2009] QHPT 11

Re Steven L Katz MDMedical Board of California

(2005) Dr K (IVF specialist) mistakenly transferred 3 embryos

intended for DB into SB

Dr K knew of mistake 10mins after procedure but failed to tell either patient and did not record in medical records

SB had son and DB had daughter

Alleged deception and cover up for 1 ½ years and attempt to terminate SB‘s pregnancy

HELD:

mistaken transfer not gross negligence

but failure to advise of error and get informed consent to continued care was – active concealment was gross negligence.

Licence revoked and $91,000 fine

Re Steven L Katz MDMedical Board of California

2005―Medical mistakes happen and when they do the only course open to the physician is to advise the patient of the medical error. In this respect, the situation facing respondent was not complex at all. 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. The standard of practice requires physicians to promptly and fully disclose errors to their patients. 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. These are the long standing and commonly understood principles guiding every physician confronted with a medical error.‖ p13

Civil liability

Tort – Negligence:

• Aspect of duty to provide proper medical

treatment and advice: Breen v Williams (1994) per Bryson J

• Aspect of reasonable aftercare and duty to follow

up: Wighton v Arnot [2005] NSWSC 367

Duty to disclose in tort

―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.‖

Breen v Williams (1994) per Bryson J

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.

Dr Arnot may not have been held negligent if adverse event

had been disclosed as no allegation of negligence in conduct

of procedure

Therapeutic Privilege?

― 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 cases of fertility error?

―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 may involve continuing the pregnancy, making advance arrangements about parentage, and securing legal counsel to take whatever steps they can to try for a workable, albeit unfortunate, outcome. Alternatively, it could involve a decision to terminate the pregnancy.‖ Disclosure of medical errors involving gametes and embryos The Ethics

Committee of the American Society for Reproductive Medicine http://www.asrm.org/uploadedFiles/ASRM_Content/News_and_Publications/Ethics_Committee_Reports_and_Statements/disclose_errors.pdf

Re Steven L Katz MD

Therapeutic privilege:

Dr K argued that 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

Exemplary and aggravated damages

Exemplary (punitive) damages

to punish and deter where conduct ―high handed, insolent, vindictive or malicious‖ or ―contumelious disregard of plaintiff‘s rights‖

Policy: ―justifying the award of punitive damages is an ancillary function of tortious intention‖ (Cane)

Aggravated damages

compensatory in nature to reflect circumstances and manner of defendant‘s wrong

Backwell v AAA (1996) Aust

Torts Rep 81-387 P artificially inseminated by D - sperm from incompatible

donor. D discovered mistake, told P not to worry and advised

her to return in a week for pregnancy test. When P discovered that pregnant, D advised termination

because of associated complications (including possibility of a still birth). D also threatened P that if baby stillborn, her identity might be revealed and that publicity might lead to closure of D‘s clinic. D also told P that if she failed to terminate, it might be difficult for her to receive further IVF at D‘s clinic or elsewhere.

P referred back to her own gynaecologist who, at P‘s request, terminated pregnancy.

P subsequently suffered depressive disorder (due to Catholic values and guilt)

Held: compensatory damages and $125,000 exemplary damages.

Exemplary and aggravated damages

Post Ipp review of law of negligence: NSW: prohibition on exemplary and aggravated

damages limited to negligence actions: CLA (NSW) s21

Qld: exemplary and aggravated damages prohibited subject to exceptions including ―unlawful intentional act done with intention to cause personal injury‖: CLA (Qld) s52

NT: general prohibition on exemplary damages in personal injury claims no exceptions: PIA (NT) s19 Intentional Tort (trespass) or negligence? Rogers v

Whitaker (1992) 175 CLR 479 per Mason CJ, Brennan, Dawson, Toohey and McHugh JJ at 490

Conclusions Ethics, policy and guidelines support open disclosure of

adverse events

Patients expect open and honest communication following adverse events but this does not always happen

Failure to disclose adverse events may give rise to disciplinary and civil liability consequences

Proposals for law reform to ensure open disclosure include enacting a statutory duty to disclose

Policy makers and health care providers need to have realistic expectations about what disclosure laws can accomplish