After studying this chapter you should be able to:
Knowledge criteria
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Discuss the issues of confidentiality and consent in under 16-year-olds (Fraser competency) and vulnerable adults
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Outline the legal regulation of abortion, sexual offenders, assisted reproduction the relative legal status of the fetus and the mother
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Describe the principles of child protection
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Describe the principles and legal issues surrounding informed consent
Clinical competencies
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Obtain informed consent for the common procedures in obstetrics and gynaecology
Professional skills and attitudes
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Be aware of the legal rights of and provisions for pregnant women
Principles and legal issues around informed consent
When a woman agrees to a surgical procedure or a specific method of treatment, it is essential that the implications of benefits and risks are explained to her or informed consent to such treatment is not obtained. Indeed, it is a fundamental law of medical and legal practice that a doctor must obtain consent from the patient for any particular medical or surgical treatment and that without appropriate consent a procedure may constitute an act of assault or trespass against the person.
Secondly, the patient must receive sufficient knowledge of any proposed treatment to make a valid choice about whether or not to consent. The consent form provides evidence that consent has been given for a particular procedure, but it only has meaning if it is evident that the patient did actually understand the nature and implications of the procedure.
In explaining the nature of a procedure to any woman, it is important to explain the purpose of the operation and the potential complications. Given that there may be a range of complications for any operation, the question arises as to how far it is necessary to go in explaining all the potential complications, given that this may induce disproportionate anxiety about a series of very remote risks.
In general terms, a risk in excess of a 1 % chance should be explained to the patient, although this is a guideline rather than an absolute figure. Where the risk is well under 1 %, but is serious and would influence the quality of life subsequently if it occurred, this also needs to be explained in detail so that an informed decision can be made by the patient as to whether she wishes to proceed with that procedure. Where there are non-surgical methods of treatment that could be used instead of a surgical procedure, these also need to be explained to the patient.
A common example that addresses the issues of informed consent is the information given to patients before sterilization about potential failure rates. During the 1980s a substantial number of legal actions were based on alleged failure to inform patients that there was a significant risk of failure and that pregnancy could follow any of the commonly used sterilization procedures. The patient bringing a claim would generally allege that no advice was given about the risk of failure and subsequent pregnancy and that, had such advice been given, either the woman would not have had the operation or she would have continued to use contraception after the sterilization procedure. It is now standard practice to advise all patients, both female and male, that there is a risk of failure and to record a statement to the effect that such advice has been given. In regard to sterilization, the character of the menstrual cycle also needs to be borne in mind. Where the periods have been particularly heavy or irregular, and have been controlled during treatment with the oral contraceptive pill (OCP), when the OCP is ceased after the sterilization the abnormal periods will almost certainly return. If the patient is made aware of this likelihood, she may well decide to just continue the OCP rather than having the sterilization performed.
The failure of a sterilization procedure in either sex may result from a method failure or recanalization. In the female, a clip may be applied to the wrong structure, may transect the tube during application, or not remain closed. In each of these instances, pregnancy usually occurs within 6 months of the procedure. The second cause of failure is recanalization of the Fallopian tubes or, in men, the vas deferens. This may result in a pregnancy many years later and is an unavoidable risk of the procedure. Despite the signing of a consent form that records the risk of failure, errors of technique are generally indefensible.
A consent form does not protect either the patient or the surgeon if performance of the procedure is faulty.
It is important that consent is obtained by a member of staff who is medically qualified and who signs the consent form with the patient after explaining both the nature of the procedure and the potential complications. Ideally the procedure should be performed in the follicular phase of the cycle or alternative contraception given in that cycle.
Ideally, consent should be obtained by the surgeon who is performing the procedure. There are limitations as to what can be reasonably included in a consent form and it is common practice to include a general statement, either in the text of the consent form or in the patient’s records, that the risks and the intended purpose of the procedure have been explained to the patient. Such a general statement is often found to be inadequate when defending a medicolegal case, and it is much better if headings of the matters discussed are recorded on the consent form or within the medical record at the time the consent form is signed.
It is also important to ensure that the details concerning the patient’s name and the description of the procedure to be performed are correct. For example, it is not sufficient to write ‘sterilization’ to describe the operation when the procedure may be tubal cautery, clip sterilization or tubal ligation. The actual procedure to be performed must be written on the consent form.
The consent from must always be available and must be checked at the time of admission to hospital and in theatre before any operation is commenced. The condition of the patient at that time, including the date and normality of the last menstrual period should also be checked, where the procedure is being done more than 4 weeks after the previous review. The patient may have conceived in the interim and wish a change in the treatment previously proposed.
Litigation in obstetrics and gynaecology
Litigation in obstetrics and gynaecology has had a profound effect on the provision of maternity services. In the UK and Australia, the problem has been masked to some extent by Crown indemnity and its equivalent in Australia. The government provides insurance cover for all doctors and midwives practising within the public health services. However, in countries such as the US closure of maternity units and the reduction of maternity services are common events because of the risk of litigation and the size of the costs to defend a case or settle the damages awarded. The costs of insurance have to be passed on to the mothers or the services cannot survive. The reality of the situation is that, regardless of the issues of fault, unless damages are capped, maternity services are often commercially uninsurable. Indeed, in many parts of the US, obstetricians cannot actually purchase insurance cover as their specialty is considered to be too high risk.
When a patient decides to make a claim against her doctor, she will approach her solicitor. If the solicitor considers there is justification, s/he will advance the action by issuing a summons, seek access to the relevant case note records and then lodge an application for a hearing. If the case is to proceed, in England and Wales it will be heard in the High Court by Masters of the Queen’s Bench Division. Cases may also be heard in the County Court if the costs are below a certain figure. In the UK, cases are heard before a judge and not a jury. In Australia, cases are usually heard before a judge and jury. The case usually commences with the Barrister for the plaintiff outlining their perceived problem and the care given. This is generally reported widely in the daily press, often in large type on the first or second pages of the paper, and often resulting in severe adverse publicity for the doctor or hospital concerned. If it is ultimately proven that the doctor or hospital was not at fault, it is rare for the press to detail these findings as widely and the comments tend to be almost hidden in small type deep in the publication.
Medical litigation may occur soon after a problem has been perceived to have occurred by a patient, but may be delayed for some years. Where the problem does not involve a child, the litigation process must generally be submitted to the Court involved within 7 years of the ‘adverse’ event occurring. Where the condition of the child is the reason for the litigation, the case should reach the Court within 7 years of that child reaching ‘maturity’ – in other words the case can reach the Court any time in the 25 years after the ‘adverse’ event occurred. Because no-one can remember exactly what happened 12 months ago, let alone 25 years ago, the documentation about any adverse event must be extensive and detailed. There also tends to be a long time interval between the issuing of a summons and its hearing and between setting down a case for trial and the actual date of the trial.
Medical litigation is expensive and it is not therefore surprising that most plaintiffs in the UK are supported by Legal Aid. In Australia this is often not the case unless a large payout is expected. The Statement of Claim outlines the nature of the claim and it is up to the defendant to respond and either acknowledge or refute the allegations. The legally aided litigant has considerable advantages, as the Legal Aid fund meets all costs and there is usually no penalty for failure of a claim.
In an attempt to speed up the resolution of disputes in the UK and in Australia, new regulations have been introduced through the Civil Procedures Rules and were implemented as guidance to expert witnesses as recently as April 2002.
The rules specify that the primary responsibility of an expert is to the Court and that this responsibility overrides any obligation to any other person from whom the expert has received instructions or payment.
After providing a report, the format of which has now been standardized, the reports of the plaintiff’s and defendant’s experts are exchanged and some Courts advise the various parties to put one list of written questions to the experts. These questions must be put within 28 days of service of the report and the questions must be answered within a further 28 days.
It is now common practice for the Court to order that the experts should also meet to discuss a common agenda submitted by the solicitors of both parties and to prepare a joint report outlining the extent of agreement and disagreement. The joint report should outline the reasons for any disagreements and should enable many cases to be resolved out of court, resulting in a substantial reduction in the legal costs involved.
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