The 1996 consensus statement on thyroid disease by the Royal College of Physicians of London and Society of Endocrinology ¹⁴ stated: ‘each District General Hospital should have access to an experienced thyroid surgeon’. Although surgery of the endocrine glands is currently the scene of dispute between general surgeons (endocrine/upper gastrointestinal/hepatobiliary), head and neck, oromaxillofacial, ENT surgeons and urologists, no individual group has an unassailable right to care for and treat the patients. The needs of the patient must come first. The introduction to the British Association of Endocrine and Thyroid Surgeons (BAETS) guidelines¹⁵ states:

“[the guidelines do] not define an endocrine surgeon or specify who should practice endocrine surgery … Elective endocrine surgery will not be in the portfolio of every District General Hospital, but where it is, based on experience and caseload, it should be in the hands of a nominated surgeon with an endocrine interest. Those patients requiring more complex investigation and care as detailed in the guidelines should be referred to an appropriate centre. These rare and complex diseases will only be managed effectively by multidisciplinary teams in Units familiar with these disorders … this category includes patients with endocrine pancreatic tumours, adrenal tumours, thyroid malignancy especially medullary thyroid carcinoma, familial syndromes and those requiring reoperative thyroid and parathyroid surgery.”

The advantages of subspecialisation

It is all too easy to lose sight of the important issues:

1. The surgeon should have been appropriately trained.

In the UK, the higher surgical trainee who declares an interest in endocrine surgery should spend at least 1 year in an approved unit, which should consist of:

• one or more surgeons with a declared interest in endocrine surgery;

• an annual operative workload in excess of 50 cases (verified by BAETS audit);

• on-site cytology and histopathology services;

• at least one consultant endocrinologist on site, holding one or more dedicated endocrinology clinics per week, with joint clinics or formal meetings held not less than once per month;

• a Department of Nuclear Medicine on site;

• on-site magnetic resonance imaging (MRI) and computed tomography (CT) scanning.

In practical terms flexible rotations between regions may be required for more specialised areas of endocrine practice, such as adrenal surgery.

The current syllabus (www.iscp.ac.uk/documents/syllabus_GS_2010.pdf) and subspecialist curriculum (www.baes.info/Pages/BAETS%20Guidelines.pdf) for endocrine surgical training in the UK are well defined. Examples of how endocrine surgical operative experience and competence for an individual trainee can be identified and rated (www.nthst.org.uk/Assets/Files/RITA_forms/NTHST_OpComp_Endocrine_v_1.doc) are available, and in future will help define what constitutes ‘appropriately trained’.

2. The surgeon must be part of an experienced multidisciplinary team.

Complication rates following thyroid, parathyroid and adrenal procedures are higher in patients treated by non-specialists, and lower when ‘high-volume’ surgeons operate or patients are treated in high-volume centres.16–20 This is also true for paediatric endocrine surgery.^21,²² Supervised trainees and newly established endocrine surgeons can perform thyroid surgery safely.^23–25

The care of patients with thyroid cancer should be the responsibility of a specialist multidisciplinary team (MDT) that comprises surgeon(s), endocrinologist and oncologist (or nuclear medicine physician) with support from pathologist, medical physicist, biochemist, radiologist and clinical nurse specialist. All should have expertise and interest in the management of thyroid cancers and show commitment to continuing education in the field.

There is evidence from the UK and the USA to support a continued need for subspecialisation in endocrine surgery and adherence to good practice, e.g. total thyroidectomy and lymph node dissection is the standard of care in patients with medullary thyroid cancer (MTC) yet 10–15% of patients with MTC undergo less than total thyroidectomy and 30–40% of patients have no cervical node dissection.26–29 MTC is rare; all patients should be referred for surgical treatment to a cancer centre.

3. As the quality of the care received by the patient is paramount it should be subject to assessment by audit and benchmarking against agreed standards.

In 1998, a retrospective study from a single district hospital identified that only 42% of patients with thyroid cancer presenting with a thyroid nodule had preoperative fine-needle aspiration cytology (FNAC).³⁰ In contrast, BAETS audit data from 2009 reported that 82% of treated patients, confirmed at histology to have a neoplastic lesion, underwent fine-needle aspiration (FNA) prior to the operation.²⁹ The collection of such prospective information on endocrine surgical activity in the UK is crucial, not only for issues of surgical subspecialisation but for education and training. For UK surgeons, continuing full membership of the BAETS is conditional upon the submission of their clinical activity to the audit. It is likely in the future that General Medical Council (GMC) revalidation will require confirmation that surgeons take part in comparative national audit. The following standards and outcome measures are suggested as being applicable to current endocrine surgical practice.

Medicolegal aspects of endocrine surgery

Even if Trusts, teams and individual clinicians adhere conscientiously to all the requirements of good clinical governance, errors may still occur or will be thought by the patient to have occurred. In this section we cover the specific steps needed to avoid complaint and litigation in endocrine surgery, and suggest some responses should it occur, with an outline of the processes involved. In legal actions the jurisdiction that applies is that of the country in which injury occurred.

Consent

A formal process of consent in surgery is essential as it is that consent that renders surgical intervention legal. Consent requires that the patient has the capacity to understand the process,³¹ has the information about the nature and the purpose of the surgery to allow informed consent, and provides consent voluntarily. Failure to respect these principles means that there was effectively no consent, and the doctor is therefore open to charges of battery or to a claim of negligence. Negligence is the failure to take reasonable care.

In the hallmark UK case of Sidaway, Lord Justice Dunn said that ‘the concept of informed consent forms no part of English law’.³² There is no explicit legal meaning to the term ‘informed consent’ used by doctors. The case of Sidaway involved a patient who experienced spinal cord complications after an operation on a cervical vertebra as treatment for nerve root pain. She had not been informed about this particular rare complication when she gave her consent, and she claimed that she would not have had the operation if more information had been available. In this case, the patient was not warned because the neurosurgeon judged the risk to be remote, i.e. less than 1%. The problem highlights the potential gap between the ‘patient standard’, which is what the patient might wish to know, and the ‘professional standard’, which is what the doctor thinks the patient ought to or needs to know. Patients who experience a complication from an operation will, with the wisdom of hindsight, wish they had been told about a rare but damaging complication, whereas surgeons might reasonably not tell patients of all potential risks that could occur.

In the matter of consent (as in most other medico-legal issues), case law in England and Scotland tends to reflect the application of the ‘Bolam test’ (see below), namely that the information that the surgeon needs to give is the information that a reasonable and responsible member of the medical profession would think it proper to give in the circumstances. The amount of information that is given to validate ‘informed’ consent is not defined in law. The rule of thumb is that it should be any risk that is likely to occur in more than 1–2% of cases, but it is important to remember that the quality of information given for consent in medical care is an ethical not a legal requirement of a doctor and is to do with the respect for the autonomy of the patient.³³ Sidaway puts the onus on doctors to decide what information to give; the ethical requirement is merely to give what the doctors’ best judgment of each patient defines as the patient’s need, and to give it in terms appropriate to the patient’s understanding and their education. This trend is also likely to be encouraged by the Council of Europe’s Convention on Human Rights: Biomedicine, 1997, which explicitly notes the ‘need to restrain the paternalist approaches which might ignore the wishes of the patient’.³⁴ It is better to look at the process of ‘informed’ consent as part of a shared decision- making process, founded in adult debate with patients about the management of their disease. The risks and consequences of various treatment options should be discussed in sufficient detail to be understood so that patients can make informed decisions. In practical terms the surgeon, or somebody who is familiar with the disease and its treatment, must sign the consent form together with the patient. We recommend the use of patients’ information sheets (as illustrated in the BAETS Guidelines), but remember that their use does not obviate the need for detailed personal discussions between patients and surgeons (Box 7.1). Key issues to consider in risk management with regard to matters of consent include keeping contemporaneous notes of conversations held with patients about consent and knowledge that a signed consent form is not in itself enough to demonstrate that a patient gave valid/informed consent.

Box 7.1 Key issues in risk reduction on matters of consent

• Obtain consent well before the operation

• Do not obtain consent after sedation has been given

• The doctor obtaining consent should be knowledgeable about the procedure and its potential complications

• Explain ‘material risks’

• Answer questions in an open and honest manner

• Do not alter the consent form after the patient has signed it

• Do not exceed the authority given by the consent form

When things do not go smoothly

Only a tiny percentage of problems and errors mature into a complaint. Errors can occur without associated complications and we should be aware that complications may arise without errors as well as a result of errors. It is clear that if complaints are handled effectively and promptly, and if there is good and honest communication of facts, the number of complaints that mature into litigations are few. One of the virtues of proper handling of complaints is that they often show that although things did not turn out for the best, the problems that occurred were within the boundaries of those experienced in medical care and were not a sign of negligence. It is much more common for complaints to reflect a sequence of unsatisfactory events in the patient’s care and in 72% of instances a perception of staff insensitivity or a communication breakdown is the element that precipitates the complaint.³⁵ Other factors that may precipitate a complaint include failure to investigate or treat (25%) and a claim of lack of clinical competence (20%).

Handling complaints

Informal complaints should be dealt with as promptly and as honestly as possible in the context of normal communication. It is important to remember that if there has been a degree of error then admit to it and apologise early. An apology does not represent an admission of liability. However, we believe that if the surgeon or the person to whom the complaint has been made makes an honest and insightful assessment of the problem and considers that there has not been an error, there is no requirement to apologise. A verbal complaint that is dealt with orally should be recorded as a written or typed note and placed in the clinical record.

Nothing should be sent out in writing without first checking the text with the Trust’s complaints officer and/or your defence organisation. This is invaluable if an informal complaint subsequently turns into a formal one.

However skilfully they are handled, complaints can still turn into litigation, although in fact this occurs relatively rarelyand very few cases go to trial.

Complaints that turn into litigation

In the UK, formal claims under the Clinical Negligence Scheme for Trusts increased by 31% in 2009/10. In 2010/11 the National Health Service Litigation Authority (NHSLA) paid out more than £863 000 000 in respect of clinical negligence claims. Between April 2001 and March 2011, 63 804 claims for medical negligence files were opened: 38% were abandoned by the claimant, 45% were settled out of court, in 3% damages were approved/set by the court and the remainder were yet to settle.³⁶

The recent proposals by the UK Justice Secretary include reform of conditional fee arrangements and will hopefully serve to reduce legal costs, shouldered at present by professional indemnity organisations and the UK taxpayer.

As far as endocrine surgeons are concerned, cases will be based on personal injury owing to an alleged breach of duty by them or their team. A complication of surgery or a delay in diagnosis will be the probable reason. There are no published figures to indicate how often endocrine surgery in the UK has led to litigation in the past and how successful that has been. The best data, although incomplete, come from the USA where Bureau of Justice statistics indicate that 90% of all medical malpractice lawsuits are brought by patients who have suffered permanent injury, or by those representing someone who has died as a result of malpractice.

In 1993, Kern identified for analysis 62 cases of malpractice related to the surgical treatment of endocrine disease from 21 North American states between 1985 and 1991. In 54% of instances the problem arose from a surgical complication, almost all during thyroid surgery; 35% arose from delayed diagnosis, equally of thyroid and adrenal disease; and 11% were from morbidity attributed to radioiodine or propylthiouracil.³⁷ A more recent review³⁸ of cases from the North American LexisNexis Academic Legal database identified court reports of 33 medical malpractice cases involving thyroid surgery between 1989 and 2009; 46% involved injury to the recurrent laryngeal nerve. Most of the cases filed involved the adequacy of the consent process; the maximum jury award to a plaintiff was $3.7 million. In most cases that favoured the patient, although a consent form was signed it was felt that insufficient discussion took place with regard to the potential risks of surgery. The number of cases settled out of court during the same time period is unknown.³⁸ The estimated incidence of malpractice claims in thyroid surgery in the USA is 5.9 cases per 10 000 operations.³⁹

A case may well involve a claim that the surgeon has been negligent. Although negligence has lay meanings, it has very specific legal meanings.

Medical negligence

Surgical cases come to court almost invariably as a result of patients suing in an action for negligence. This is a civil prosecution.

Negligence is an area considered under the civil law called tort, i.e. civil wrongs. Any formal legal action in this area only succeeds if a particular legal formula is fulfilled. The components of this formula are:

1. A relationship must exist between the parties (the surgeon and the patient), which gives rise to a duty of care.

2. The duty of care must have been breached in some way due to an unreasonable act or omission by one of the parties. This breach of the duty of care is the negligence.

3. In addition to the negligence the injured party must have experienced some damage, loss or injury of a type recognised by the law.

4. The damage must have been caused by the other party, in this case the surgeon.

5. The action must be brought within a specified time after the injury has occurred (this is known as the period of limitation; see above).

Duty of care: As the NHS surgical patient will already have come under the care of a hospital, either as an outpatient or inpatient, the plaintiff will have no difficulty in establishing that the hospital Trust has a duty of care. In private practice (and this includes patients admitted to NHS pay beds) the relationship is primarily directly with the surgeon and separately with the other providers, such as the hospital, anaesthetist, pathology laboratory, etc. The duty of care in this latter situation arises through the ‘contract’ that arises implicitly between the surgeon and patient.

Breach of duty of care: The legal definition of a standard of care might include ‘the watchfulness, attention, caution and prudence that a reasonable person in the circumstances would exercise’.

A successful negligence claim requires that the claimant demonstrates that the defendant (Trust or surgeon) was in breach of its duty of care. In English law the breach or lack of it is determined by judging what an equivalent body of other doctors would have done in similar circumstances. This is known as the ‘Bolam test’.

Bolam is the legal case cited in England.⁴⁰ In Scotland it is Hunter v. Hanley.⁴¹ Essentially these cases have the same conclusion, which is generally favourable to the surgeon.

The case of Bolitho v. City and Hackney Health Authority slightly changed the principles behind the Bolam judgment.⁴² Medical evidence from eight experts was divided. The judge accepted that both bodies of evidence were respectable and concluded that he was in no position to ‘prefer’ one view. This was in line with Lord Scarman’s view in another case that: ‘a judge’s preference for one body of distinguished opinion over another, also professionally distinguished, is not sufficient to establish negligence in a practitioner’.⁴³

The case was appealed eventually to the House of Lords, who supported the trial judge’s conclusion but added an important rider to the ‘Bolam test’ in that it was no longer sufficient for experts to claim that something was acceptable practice but they needed to show that in ‘forming their view, they, the experts, have directed their minds to the question of comparative risks and benefits and have reached a defensible conclusion on the matter’. Courts in the Republic of Ireland have in general also accepted the Bolam test but have spelled out the same limitations, that the treatment supported must be logical. Experts supporting or rejecting a particular course of action must therefore ground their views in a defensible clinical assessment of the pros and cons of any particular course of action.

A recent twist to this has been the position of guidelines and protocols. Many surgeons are apprehensive that they may not, on the basis of their own experience and reading, agree with protocols that are promulgated either nationally or within their own organisation, and therefore they might feel particularly threatened if they departed from those guidelines. Guidelines and protocols hold no special status legally and they should merely be regarded as an extension of the Bolam principle, as defining the views of other reputable practitioners. A guideline should not be published unless the authors can justify their joint view with reference to normal good clinical practice and the literature. Similarly, surgeons who depart from guidelines must be able logically and clinically to defend their departure from those guidelines. It is the courts who retain the right to decide whether a particular clinical practice is acceptable or not. Expert evidence of professional habits will carry the day in most cases, but surgeons cannot rely on this with complete certainty. There seem to be only a tiny number of cases where the court has chosen not to accept the expert medical evidence.

It is hardly surprising that doctors have a duty to keep themselves informed of major developments such as might be encompassed by guidelines. That duty cannot extend to a requirement that they know everything there is to know. A widely promulgated guideline could, however, in Lord Denning’s terms fall into a recommendation ‘so well proved and so well known and so well accepted that it should be adopted’.

Damage

Damage cited by plaintiffs must have been caused directly by the defendants’ negligence, not, for example, simply by progression of underlying disease. Damages subsequently awarded in the UK simply aim to place defendants in the position they were in before the damage was sustained, plus an element for pain and suffering. The situation in the UK is totally different from that pertaining in the USA, where juries, not judges, decide damages and a strong punitive element is often included. As a result, malpractice awards in the USA routinely are frequently over a million dollars.

Causation: Letters from solicitors will often use the term ‘causation’, a term not immediately understood by doctors (Box 7.2). In the legal setting ‘causation’ is merely the establishment of a factual and legal link between the breach of duty and the damage caused. This is often difficult to prove. Normally the ‘but for’ test is used. For example, ‘but for the failure to take a fine-needle biopsy at the first outpatient visit the patient’s thyroid carcinoma would have been diagnosed 6 months earlier’. Note that in negligence cases guilt or innocence is decided on grounds of ‘balance of probability’ rather than ‘beyond reasonable doubt’, as applies in criminal cases.

Box 7.2 Examples illustrating the legal meaning of causation

Causation

A patient comes into hospital for thyroidectomy. The cords are checked preoperatively and both move. After the operation the patient is hoarse and laryngoscopy shows one cord is not moving.

The plaintiff’s barrister could readily show that there was a duty of care, that there was damage and could prove causation. But it would be hard to prove negligence. Laryngeal nerve palsy ipso facto is not evidence of negligence.

No causation

A patient comes to the outpatient department with a long-standing mass in the neck. The mass is fixed to the surrounding structures. The surgeon neither biopsies the mass nor operates. Two weeks later the patient dies and the post-mortem shows an anaplastic carcinoma obstructing the airway.

There was a duty of care but there was no causation in that on a balance of probability failure to biopsy the mass or arrange treatment did not alter the outcome.