Research

MJA 195 (6) · 19 September 2011340

vast body of literature in eth-

ics, law and medicine

addresses informed consent

— the process by which patients

make decisions about participation in

medical treatment and research

through learning the benefits, risks

and options.

Most of this scholarship

is normative.

Although empirical

research on the topic has grown in the

last 20 years,

3,4

there remains remark-

ably little empirical information on

how the consent process actually

functions (and malfunctions) in clini-

cal practice.

3,5

Medicolegal data can provide a valu-

able window on this crucial aspect of

care. We identified informed consent

disputes in a large sample of medical

negligence claims and health care

complaints resolved over a 7-year

period. Our aim was to describe the

frequency, characteristics, clinical cir-

cumstances and outcomes of these

cases to inform efforts to prevent them.

Methods

Avant Mutual Group Limited (Avant)

and the Office of the Health Services

Commissioner of Victoria (HSC) pro-

vided data for the study. Avant,

through its wholly owned subsidiary

Avant Insurance Limited, provides

coverage to about 55% of registered

medical practitioners in Australia. The

HSC has statutory responsibility for

receiving, investigating and resolving

written complaints about providers

made by the users of health care ser-

vices in Victoria.

The human research ethics com-

mittee at the University of Melbourne

approved the study.

Case identification

We established definitions for claims,

complaints and cases (Box 1). Our

study definition of what constituted a

dispute over informed consent (a

“case”) was patient centred.

We did

not seek to evaluate the reasonable-

ness or legitimacy of patients’ allega-

tions, with one exception: if a patient

alleged a failure to warn of the risks of

an outcome that occurred, and there

was strong clinical evidence in the

case file that the outcome had not in

fact occurred, we excluded the case.

Our sample frame consisted of all

medical negligence claims brought

against Avant-insured doctors in New

South Wales, Victoria and Queens-

land between 1 January 2002 and 31

December 2008, and complaints

lodged with the HSC during the same

period.

From 7846 claims, we identified 397

candidate cases through searching for

keywords (eg, informed, consent,

warn, risks, explain, disclose) in free-

text précis of the allegations (two to

five sentences written by claim man-

agers). We then examined the full

When informed consent goes poorly:

a descriptive study of medical negligence

claims and patient complaints

Research

Objective: To describe the frequency, characteristics, and outcomes of

medicolegal disputes over informed consent.

Design and setting: Retrospective review and analysis of negligence claims

against doctors insured by Avant Mutual Group Limited and complaints lodged

with the Office of the Health Services Commissioner of Victoria that alleged

failures in the informed consent process and were adjudicated between

1 January 2002 and 31 December 2008.

Main outcome measures: Case frequency (by medical specialty), type of

allegation, type of treatment.

Results: A total of 481 cases alleged deficiencies in the informed consent

process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence

claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons

experienced dispute rates that were more than twice those of any other

specialty or subspecialty group. 92% of cases (442/481) involved surgical

procedures and 16% (77/481) involved cosmetic procedures. The primary

allegation in 71% of cases was that the clinician failed to mention or properly

explain risks of complications. Five treatment types — procedures on

reproductive organs (12% of cases), procedures on facial features excluding

eyes (12%), prescription medications (8%), eye surgery (7%) and breast

surgery (7%) — accounted for 46% of all cases.

Conclusions: The typical dispute over informed consent involves an operation,

often cosmetic, and allegations that a particular complication was not properly

disclosed. With Australian courts now looking to patient preferences in setting

legal standards of care for risk disclosure, medicolegal disputes provide valuable

insights for targeting both quality improvement efforts and risk management

activities.

Abstract

Andrew J Gogos

MB BS, Neurosurgical

Registrar

Richard B Clark

DHSc, Epidemiologist

Marie M Bismark

MBChB, LLB, Senior

Research Fellow

Russell L Gruen

MB BS, PhD, Professor

David M Studdert

LLB, ScD, MPH, ARC

Federation Fellow and

Professor

3,5

1 Royal North Shore

Hospital, Sydney, NSW.

2 Avant Mutual Group

Limited, Melbourne, VIC.

3 Melbourne School of

Population Health,

University of Melbourne,

Melbourne, VIC.

4 Department of Surgery,

The Alfred Hospital,

Monash University,

Melbourne, VIC.

5 Melbourne Law School,

University of Melbourne,

Melbourne, VIC.

d.studdert@

unimelb.edu.au

MJA 2011; 195: 340–344

doi: 10.5694/mja11.10379

1 Definitions

Claim: a written demand for

compensation.

6,7

Complaint: a written request to the Health

Services Commissioner of Victoria for

assistance in resolving a dispute with a

health care provider.

Case: a claim or complaint in which a

patient (or patient representative) alleged

that —

• the quality or quantity of information

provided about a treatment before the

patient’s decision about whether to

undertake it was deficient; or

• the process through which the patient

was asked to consider such information

and make a decision was deficient.

◆

Research

341MJA 195 (6) · 19 September 2011

claim file on each of these to determine

whether it met our case definition (Box

2). About 20% of complaints received

by the HSC cannot be resolved easily

by the parties involved and are referred

to a dispute resolution process. These

“conciliated” complaints were our

focus. After ruling out conciliated com-

plaints in several categories (access,

administration, cost) that were

extremely unlikely to have involved

consent issues, three physician

reviewers examined the hard-copy

files associated with the rest (1415) to

determine which met our case defini-

tion (Box 2).

Data, variables and study

instrument

The data for this study came primarily

from hard-copy files. The variables of

interest were determined through a

review of the informed consent litera-

ture and a pre-review of 20 claim files

and 20 complaint files. We collected

information on patient characteristics

(sex, age); doctor characteristics (sex,

age, trainee status, specialty); location

of the incident (type of facility, clinical

setting); the specific treatment

involved in the episode of care; the

patient’s allegations; and the case

outcome.

Patients’ allegations regarding how

the consent was deficient were coded

into eight predefined categories

derived from a review of the informed

consent literature and refined in our

pilot work. Reviewers were permitted

to code up to five allegation types, but

were directed to identify a primary

allegation, defined as the one about

which the patient was most concerned.

This information typically came from

the initial statement of claim or com-

plaint letter, or subsequent allegations

made by the patient during the litiga-

tion or conciliation process.

We developed an electronic data

collection instrument to facilitate col-

lection of these variables and con-

ducted a pilot test of the instrument

on 30 cases before the formal review

began, making minor modifications

as appropriate.

Case file review

Two medically qualified reviewers

conducted the reviews onsite at

Avant offices (Melbourne, Sydney

and Brisbane) and the HSC (Mel-

bourne) between March 2009 and

January 2010. The reviewers under-

went a day-long training session that

covered the structure and content of

claim and complaint files, use of the

data collection instrument, and con-

fidentiality.

To test the reliability

of the review, a

random subsample of cases consisting

of about 10% (27) of the claims and

10% (23) of the complaints was re-

reviewed by the second reviewer, who

was blinded to the first review. We

report

κ scores

for the primary allega-

tion type and all allegation types

because they are the only variables

that required implicit judgements by

the reviewers.

Statistical analysis

Our analyses are descriptive. Counts

and percentages for the variables of

interest generally did not differ

between claims and complaints. We

therefore reported results in aggre-

gated form, except for variables with

intrinsic differences in structure (eg,

case outcomes).

We calculated the frequency of

informed consent disputes by spe-

cialty using rates and rate ratios.

Complaint rates are the total

number of consent-related com-

plaints over the study period,

divided by the sum of annual counts

of registered doctors in Victoria over

the study period (“doctor-years”).

Complaint rate ratios were calcu-

lated by dividing the complaint rate

for each specialty by the complaint

rate for a reference group (general

practitioners). Differences between

rate ratios for specialties were calcu-

lated using

␹

tests.

2 Derivation of study sample

File

review

File

review

Administrative

screen

Administrative

screen

9115

patient

complaints

Excluded 7217

complaints not

referred to

conciliation

7846

malpractice

claims

Electronic

keyword

397

candidate

claims

Study sample: n

481

263 claims

218 complaints

1415

candidate

claims

Excluded

7449

claims

1898

complaints

referred to

conciliation

Excluded 483

complaints regarding

access, administration

or costs

Files not available:

28 claims, 13 complaints

Informed consent not at issue:

93 claims, 1167 complaints

Duplicates:

13 claims, 17 complaints

3 Characteristics of informed

consent cases (n =481)

No. (%)

Case type

Claims

263 (55%)

Complaints

218 (45%)

Patient

Female

334 (69%)

Age, median years (IQR)

45 (35–56)

Doctor

Female* 46 (10%)

Age,

†

median years (IQR)

50 (43–57)

Trainee

19 (4%)

Facility ownership

Private

368 (77%)

Public

113 (23%)

Clinical setting

Primary care clinic

47 (10%)

Consulting rooms

303 (63%)

Hospital

131 (27%)

IQR = interquartile range. *The sex of the

doctor was missing for 25 complaints. † Data

available for claims only, and missing for six

claims. ◆

Research

MJA 195 (6) · 19 September 2011342

We used the same method to calcu-

late rates and rate ratios for claims by

specialty. However, Avant’s member

numbers within each specialty are

commercially sensitive and could be

back-calculated from specialty-level

claim rates. Therefore we present only

rate ratios for claims.

All analyses were conducted using

Stata SE, version 10.0 (Stata Corp,

College Station, Tex, USA).

Results

A total of 3.4% (263/7846) of medical

negligence claims and 11.5% (218/

1898) of conciliated complaints

involved allegations of deficiencies in

the consent process. This corre-

sponds to rates of 1.3 claims per 1000

Avant member-years (95% CI, 1.2–

1.5) and 1.9 complaints per 1000 reg-

istered Victorian doctor-years (95%

CI, 1.7–2.2). In 65% of claims (95%

CI, 59%–71%) and 54% of com-

plaints (95% CI, 47%–61%), the con-

sent allegation stood alongside other

allegations about the quality of care

rendered.

Sixty-nine per cent of cases

involved female patients (Box 3).

Three-quarters of the incidents that

prompted cases occurred in privately

owned health care facilities and nearly

two-thirds occurred in consulting

rooms.

Cases by medical specialty

More than half (57%) of the cases

were against surgeons (Box 4). Four

surgical subspecialties — plastic, gen-

eral, orthopaedic and ophthalmic sur-

gery — accounted for 81% of all cases

against surgeons. Obstetrics–gynae-

cology (14%) and general practice

(11%) were the other prevalent spe-

cialties. Collectively, surgeons, obste-

trician-gynaecologists and GPs were

involved in 82% of cases.

The rate of complaints against plas-

tic surgeons was significantly higher

than that against any other type of

specialist. Rate ratios indicated that

this was true for claims as well.

A comparison of rate ratios

between claims and complaints

exposed some noteworthy differ-

ences. Plastic surgery, neurosurgery,

orthopaedics and vascular surgery

had the highest rate ratios for claims.

By contrast, there were no informed

consent complaints against neuro-

surgeons; and dermatology ranked

second highest for complaints, com-

pared with its ranking of ninth for

claims.

Type of allegation

In 71% of cases, the primary allega-

tion concerned a complication of

treatment that had not been men-

tioned or fully understood, and then

materialised (Box 5). The next most

common types of primary allegations

were that the scope of the consent

had been exceeded (10% of cases), the

risk that the procedure would confer

no benefit (as opposed to harm) had

not been mentioned (6%), and the

process by which consent was

obtained was unsatisfactory (6%).

Process allegations involved situa-

tions in which patients felt rushed,

pressured to proceed, or regarded the

language used as incomprehensible.

No case had as its primary allegation

that there were problems with con-

sent to experimental treatments or

research protocols.

Our instrument allowed the coding

of secondary allegations, of which

there were 205 (43% of cases; mean,

1.6 per case). Widening the analysis

in this way showed increased domi-

nance of undisclosed complications

(78% of cases) as an allegation; it also

increased the proportions of cases in

which patients were dissatisfied with

5 Allegations made in informed consent cases

* Sum to > 481 due to cases with multiple allegations. ◆

Complication not mentioned

Scope of consent exceeded

Lack of beneﬁt not mentioned

Process of obtaining consent was poor

No consent obtained

Alternative treatment not described

Identity of treating doctor not disclosed

Experimental nature

Primary allegation

Any allegation*

0 100 200 300 400

Number of cases

4 Frequency of informed consent cases, by medical specialty

Frequency (no. [%]) Rate* Rate ratio (RR)

†

Specialty All cases Claims Complaints Complaints Claims Complaints

n =481 n =263 n =218

Surgery

276 (57%) 144 (55%) 134 (61%) 18 22 69

General

65 (14%) 33 (13%) 32 (15%) 15 16 59

Plastic

63 (13%) 34 (13%) 29 (13%) 45 63 173

Orthopaedic

57 (12%) 31 (12%) 26 (12%) 16 26 61

Ophthalmologic

38 (8%) 16 (6%) 22 (10%) 15 18 56

Vascular

11 (2%) 5 (2%) 6 (3%) 18 24 70

Neurosurgery

8 (2%) 8 (3%) 0 (0) 0 32 —

Obstetrics–

gynaecology

66 (14%) 42 (16%) 24 (11%) 10 18 38

General practice

54 (11%) 43 (16%) 11 (5%) 0.3 1 1

Physician

23 (5%) 12 (5%) 9 (4%) 0.9 1 3

Dermatology

18 (4%) 3 (1%) 15 (7%) 21 4 81

Anaesthesia

18 (4%) 12 (5%) 6 (3%) 1 2 4

Other

26 (5%) 7 (3%) 19 (9%) — — —

* Per 1000 doctor-years. Rates not given for claims, owing to commercial sensitivity of insurance company raw data. † RRs are

the rate for each specialty divided by the rate for general practice. All RRs are significantly different from the general practice rate

(P < 0.05) except the RR for physicians. ◆

Research

343MJA 195 (6) · 19 September 2011

the consent process (to 17%) and

were unaware of alternative treatment

options (to 14%).

Reliability testing, based on 50 pairs

of reviews, showed excellent agree-

ment between reviewers. They agreed

on the primary allegation type in 92%

of the double reviews and overlapped

on the allegations identified in 99% of

cases. The

κ scores were 0.81 (95% CI,

0.58–0.95) and 0.98 (95% CI, 0.92–

1.00), respectively.

Type of treatment

The disputes arose in relation to a wide

array of treatments; however, cluster-

ing was evident. Thirty specific treat-

ments accounted for 71% of cases (Box

6). There was a heavy orientation

toward operations: 92% (442/481) of

cases involved surgical procedures and

16% (77/481) involved cosmetic proce-

dures. Five types of treatments — pro-

cedures involving reproductive organs

(57/481; 12% of cases), procedures

involving facial features excluding eyes

(57/481; 12%), prescription medica-

tions (40/481; 8%), eye surgery (36/

481; 7%) and breast surgery (32/481;

7%) — accounted for 46% of all cases.

Case outcomes

The cases took an average of 1.8 years

(interquartile range [IQR], 0.5–3.6

years) from filing to closure, with com-

plaints (median, 1.0 years; IQR, 0.6–1.6

years) resolved more quickly than

claims (median, 2.3 years; IQR, 1.3–3.5

years). Plaintiffs received payments in

51% (135/263) of claims. Eleven claims

proceeded to court verdict, and plain-

tiffs won damages in three. Monetary

restoration was paid to complainants

in 27% (59/218) of complaints but,

consistent with the functions of the

HSC, a much wider range of remedies

was sought and obtained in these and

other complaints.

Discussion

Of nearly 10000 Australian medico-

legal cases resolved in the 7 years

2002–2008, around one in 30 medical

negligence claims and one in nine con-

ciliated complaints included allega-

tions of problems with informed

consent. Five treatment types

accounted for nearly half of all cases:

reproductive, facial, medication, eye

and breast. Ninety-two percent of

cases involved surgical procedures and

16% involved cosmetic procedures.

The heavy concentration of informed

consent disputes around surgical pro-

cedures was also evident in other

aspects of our findings. Plastic sur-

geons, orthopaedic surgeons, vascular

surgeons, and dermatologists experi-

enced disproportionately high rates of

consent disputes. Moreover, about

three-quarters of the cases centred on

the allegation that certain complica-

tions, which ultimately affected the

patient, were not mentioned or prop-

erly explained before the treatment.

Thus, the concept of a “typical”

informed consent dispute has real cur-

rency: it is an operation, often under-

taken for cosmetic purposes, in which

the patient alleges that a complication

was not properly disclosed.

To the best of our knowledge, this is

the first study to investigate in a real-

world setting what happens when

informed consent goes poorly from

the patient’s perspective — poorly

enough to prompt complaints or liti-

gation. Unlike studies that have

probed patients’ views on what they

want or hope to be told before treat-

ment,

11,12

we profiled situations in

which patients “voted with their feet”

in proclaiming unmet expectations.

Improved understanding of these sit-

uations helps to spotlight facets of

care in which there is a gap between

what doctors do and what patients

want; it may also be instructive for

clinicians who are eager to avoid the

vicissitudes of medicolegal processes.

In our sample, the predominance of

cases alleging undisclosed risks related to

surgery is striking. High-profile court

battles over informed consent in the

United States,

Australia,

Malaysia,

New Zealand,

Ireland,

and Canada

have centred on precisely this scenario.

Concerns about surgical risks not prop-

erly explained appear to be the heartland

of contemporary disputes between

patients and doctors over consent, at

least in Australia. By contrast, other types

of breakdowns in the consent process

that have attracted intense scholarly

attention and debate (eg, failure to can-

vass alternative treatments, patient com-

petence) appear to be infrequent triggers

of formal disputes, and still others (eg,

consent to services rendered as part of

research), however interesting from an

ethical perspective, are exotic in medico-

legal fora.

We found that one in six disputes

stemmed from cosmetic procedures.

The frequency of such cases is high,

but plausible. As the ultimate form of

elective treatment, patients’ tolerance

for risk in cosmetic procedures is

likely to be low, complications are

often visible, and the need to meet

the full cost of care through out-of-

pocket payments probably heightens

expectations.

Additionally, our results show that

disputes over informed consent are

usually associated with concerns that

the episode of care was substandard

in other ways. Different types of con-

cerns may interact. Dissatisfaction

with other aspects of care, such as its

6 Treatments associated with

informed consent cases (n =481)

Treatment No. (%)

Medication

40 (8%)

Skin or superficial lesion

excision

23 (5%)

Facial cosmetic

21 (4%)

Hysterectomy

20 (4%)

Breast enlargement or

reconstruction

17 (4%)

Liposuction or lipectomy

15 (3%)

Nasal surgery

14 (3%)

Breast reduction 13 (3%)

Arthroscopy 12 (2%)

Cataract

12 (2%)

Refractive surgery

12 (2%)

Spinal surgery

12 (2%)

Hernia surgery

11 (2%)

Endoscopy

10 (2%)

Epidural or spinal

anaesthesia

9 (2%)

Joint replacement

9 (2%)

Vaginal delivery

9 (2%)

Oophorectomy

9 (2%)

Laparoscopic

cholecystectomy

8 (2%)

General anaesthesia

7 (1%)

Treatment of varicose veins

7 (1%)

Bowel resection

6 (1%)

Dilatation and curettage

6 (1%)

Fracture repair

6 (1%)

Sterilisation — laparoscopic

clip

6 (1%)

Sterilisation — vasectomy

6 (1%)

Termination of pregnancy

6 (1%)

Delivery — lower uterine

segment caesarean section

5 (1%)

Laparoscopic gastric banding

5 (1%)

Regional anaesthesia

5 (1%)

Other

140 (29%)

Research

MJA 195 (6) · 19 September 2011344

technical quality, may prompt patients

to reflect unhappily on the consent

process; misunderstandings emanat-

ing from the consent process may lead

patients to second-guess the quality

of the care that followed; it may also

be true that clinicians who have prob-

lems with the consent processs also

experience problems delivering other

aspects of care. The most likely sce-

nario is that a mix of concerns operate

synergistically, producing a suffi-

ciently negative perception of the

overall care experience to move

patients to complain or litigate.

Our study has several limitations.

First, we describe perceived problems

with the consent process that spark

claims and complaints against doctors

and health care institutions, but our

sample may be unrepresentative of

broader quality problems in this area

because they are refracted through the

lens of patients’ claiming behaviour.

6,20

Second, we were constrained by the

information set available in claim and

complaint files. Finally, we took cases

at face value and did not seek to make

objective determinations about their

legitimacy, although whether this is a

true limitation is questionable in light

of the study objectives.

In setting legal standards for

informed consent, courts in many

countries

14-18

have moved towards

paying deference to what reasonable

patients would want to know before

choosing a treatment course. Our

study sheds light on patient prefer-

ences in a legal context. Consistent

with the quality improvement mantra

that “every defect is a treasure,”

fur-

ther research into disputes over

informed consent and other prevent-

able breakdowns in care is warranted.

It has dual potential to inform risk

management strategies and to guide

efforts to improve the way clinicians

and patients communicate about treat-

ment choices.

Acknowledgements: This study was supported by a

Linkage Grant from the Australian Research Council

(LP0989178), with partner contributions from the

Office of the Health Services Commissioner of Victo-

ria, the Victorian Department of Health, and Avant

Mutual Group Limited. David Studdert was supported

by a Federation Fellowship from the Australian

Research Council. Russell Gruen was supported by a

Career Development Award from the National Health

and Medical Research Council.

We thank the leadership group and staff at Avant and

the Health Services Commissioner of Victoria, whose

generous assistance made this study possible — in

particular, Beth Wilson and her staff, especially Lynn

Griffin. Dr Paul Nisselle helped conceive and launch

the project and Dr Atul Gawande provided helpful

comments on an earlier draft of the manuscript.

Competing interests: No relevant disclosures.

Received 30 Mar 2011, accepted 29 Jun 2011.

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