Abstract
Suppose that a doctor carrying out a treatment or advising on a treatment or acting as an expert in litigation or writing or lecturing about a treatment is in a minority so far as contemporary medical opinion is concerned. It may be a matter of choice for the doctor between treatment A (the majority practice) or treatment B (the minority practice), and the minority treatment may be of an innovative character. Unfortunately, things went badly wrong, the patient suffered harm and the doctor finds him/herself a defendant in a case for clinical negligence. What is the legal duty of the doctor? Is it sufficient that he/she acted in good faith? Or that he/she was a competent doctor? Or that he/she was a doctor following the practice of a substantial number of doctors, albeit a minority? Or that he/she was in effect acting ‘on his/her own’? The legal test is: Was the doctor following the practice of a responsible body of medical clinical opinion, albeit a minority opinion? Medicine has made huge advances over the years – one of the great achievements. But many advances have come about because of the initiative of one individual or a small group of individuals, often in the face of strong disbelief or opposition. The medical profession is a conservative profession, understandably so in view of the obvious inherent risks. Original ideas may not be well received. Therefore, the minority innovative doctor must proceed carefully because he/she runs the risk of a medical mishap, criticism and litigation.
The doctor in a minority
Suppose that a doctor carrying out a treatment or advising on a treatment or acting as an expert in litigation or writing or lecturing about a treatment is in a minority so far as contemporary medical opinion is concerned. It may be a matter of choice for the doctor between treatment A (the majority practice) or treatment B (the minority practice), and the minority treatment may be of an innovative character. Unfortunately, things went badly wrong, the patient suffered harm and the doctor finds him/herself a defendant in a case for clinical negligence.
What is the legal duty of the doctor? Is it sufficient that he/she acted in good faith? Or that he/she was a competent doctor? Or that he/she was a doctor following the practice of a substantial number of doctors, albeit a minority? Or that he/she was in effect acting ‘on his/her own’? The legal test is: Was the doctor following the practice of a responsible body of medical clinical opinion, albeit a minority opinion? The assessment of medical risks and benefits genuinely held by a competent doctor or distinguished expert, which is reasonable and responsible and sustains logical analysis, will be accepted by a judge, albeit a minority opinion.1–3,
a
Naturally enough, the judge will want to be satisfied about ‘the responsible body of medical opinion’. Relevant factors are likely to include:
The personal qualifications, experience, status, seniority and reputation of the doctor. The length of time the treatment in question has been used in the profession. The research and literature available and consulted. The degree of consultation with appropriate colleagues. The evidence of clinical trials. The patient suffered from incurable Creutzfeldt-Jakob disease. Early experiments on mice indicated a possible treatment, favoured by responsible medical opinion, believed to be harmless, and this treatment was judicially approved, albeit a marginal or even perhaps surprising decision.
4
The recommendations, if any, of the National Institute for Health and Care Excellence (NICE) and any other relevant bodies of standing, such as the Royal Colleges and the General Medical Council (GMC). The novel or innovatory nature of the treatment. The instructions and advice of the manufacturers and suppliers of the equipment used and the drugs. The fluctuations, if any, in recent times in the practice of the treatment. The outcomes of the treatment over the period of use in medicine. The quality of the evidence and the credibility of the doctor as a witness.
The role of the judge
The judge is not a medical expert. He/she is faced with the evidence of the treating doctor and two conflicting experts. His/her judicial duty is to scrutinise and to test the logic of the evidence, which may be assumed to be expert, honest, consistent, reasonable and logical unless and until exposed not to be. It is for the judge to accept expert evidence on clinical judgment that measures up to the scrutiny. As Lord Scarman said: It is not enough to show that there is a body of competent professional opinion which considers that there was a wrong decision, if there also exists a body of professional opinion equally competent, which supports the decision as reasonable in the circumstances. It is not enough to show that subsequent events show that the operation need never have been performed, if at the time the decision to operate it was reasonable in the sense that a responsible body of medical opinion would have accepted it as proper … In the realm of diagnosis and treatment there is ample scope for genuine difference of opinion and one man clearly is not negligent merely because his opinion differs from that of other professional men … The true test for establishing negligence in diagnosis or treatment on the part of a doctor is whether he has been proved to be guilty of such failure as no doctor of ordinary skill would be guilty of if acting with ordinary care.
1
,5–7
A mother died, and her baby was born severely disabled. The case turned on the administration of a second dose of prostin by the midwife. The judge found that this practice conformed to the relevant guidance and was reasonable, logical, consistent and, accordingly, acceptable. 8
At the end of the day, for good legal reason, the judge may draw an adverse inference from the medical evidence 9 , 10 or reject the medical evidence. The evidence may be unclear, unauthenticated, conflicting or unconvincing.
Following spinal surgery, within six hours, a doctor administered an anti-thrombotic chemo-prophylaxis which led to paraplegia. The judge rejected the evidence of the medical expert for the doctor that such a practice was administered by other surgeons because the point was not raised until cross-examination at the trial. The postsurgical treatment by the doctor did not reflect an acceptable practice in the view of a reasonable body of surgeons, and no risk and benefit assessment had been carried out. 11 , b
Informed consent
We have moved from medical paternalism to patient autonomy. The patient must be in a position to give informed consent to any medical treatment. So, this imposes a duty upon the doctor to warn the patient of the risks – namely the risks that the patient would reasonably want to know about before deciding whether proceed with the treatment.12–15, c It is neither practical nor sensible to warn of every conceivable risk. There is no point in blinding the patient with science, or frightening them unnecessarily. So, in each speciality, a professional practice has developed to consider how best to inform the patient sufficiently whilst retaining his/her confidence. The minority doctor will need to explain that he/she is proposing a minority and innovative treatment and give reasons accordingly, explaining why he/she is not recommending the alternative majority treatment, explaining the material risks, covering all the matters to which the patient might be expected to attach significance, and giving the patient the opportunity to think again or seek another opinion or decline the treatment. The only exception – a therapeutic exception – appears to be where disclosure would be detrimental to the patient, for example if it would cause unnecessary psychiatric or psychological harm which could lead to an unwise decision by the patient.
A patient underwent a hysterectomy and suffered nerve damage and chronic postsurgical pain. She claimed that she had not been warned of the risk, and had been deprived of the opportunity of declining the operation. She failed because there was no evidence that any responsible body of surgeons, not even a minority, was aware of the risk and gave a warning, and anyway, even if warned, she would still have proceeded. 16
The interests of those suffering mental incapacity are protected by the Mental Capacity Act 2005, the involvement of the Official Solicitor and an independent mental capacity advocate. 17 , 18
The role and responsibility of the doctor
The role and responsibility of the minority doctor in any particular case will depend to some extent on whether he/she is the treatment doctor, in which case he/she bears full responsibility, or whether he/she is in a lesser role, for example an expert giving an opinion, in which case he/she will be subject to challenge by the other experts involved, the lawyers in the case and the judge, or a medical author, when the standing of his/her reputation and that of the journal will affect influence, or a lecturer, when the standing for his/her reputation and that of the institution will affect influence.
The minority doctor should always be professionally aware that he/she is in a minority, regularly consider and reconsider his/her position, disclose the fact that he/she is a minority doctor and be prepared to justify his/her opinion.
Dr Andrew Wakefield, a gastroenterologist and an anti-vaccine activist, was the principal doctor in a minority group involved in the MMR controversy. He was a treating doctor, a research doctor and a medical author in reputable journals. After a lengthy and exhaustive inquiry, the GMC found him guilty of serious professional misconduct and unfit to practise and erased him from the register on 24 May 2010 for dishonesty and failing to act in the best interests of vulnerable child patients. The findings were that he was irresponsible and acted with a callous disregard for the distress and pain caused to children by carrying out clinically unnecessary and invasive tests on children. He used unethical medical techniques, and his MMR vaccine research did not have ethical approval. He failed to disclose conflicts of interest, and he brought the medical profession into disrepute. 19 , 20
Conclusion
Medicine has made huge advances over the years – one of the great achievements. However, many advances have come about because of the initiative of one individual or a small group of individuals, often in the face of strong disbelief or opposition. The medical profession is a conservative profession, understandably so in view of the obvious inherent risks. Original ideas may not be well received. Therefore, the minority innovative doctor must proceed carefully because he/she runs the risk of a medical mishap, criticism and litigation.
Failure to provide statutory protection
In 2014, an attempt was made in the Medical Innovation Bill (see Appendix) to provide a degree of statutory protection for the innovative doctor because it was alleged that the protection afforded by common law was inadequate, unclear and unpredictable. The Bill failed to make progress in Parliament. The purpose of the Bill was to encourage responsible innovation. A responsible decision would be based on plausibility and effectiveness, consideration of the risks and likely success rate and the likely consequences, discussion with colleagues, explanation to the patient and consent.
Footnotes
Declaration of conflicting interests
The author declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
Funding
The author received no financial support for the research, authorship and/or publication of this article.
