Consent, and ensuring that there is evidence of good consenting practice, is important to fulfil ethical obligations of autonomy as well as legal requirement. It can minimise the risk of a successful claim being brought forward, for failing to obtain informed consent from a patient.

This article considers developments in the law, the nuances of consent in plastic surgery and practical considerations to minimise the risk of litigation.

The Law Pre-Montgomery

For many years the legal test for consent was no different to the general test applied for treatment, this being the Bolam test; i.e a doctor had to discuss options/warn of risks in line with the practice of a responsible body of medical opinion in that same speciality. This was an objective clinician focussed view, rather than a subjective patient centred test, and did not necessarily take account of the specific needs of an individual patient. The case of Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] confirmed the applicability of the Bolam test in relation to consent.

Despite a number of small shifts in the law, through various cases, it was the decision in Montgomery in 2013 when change finally came.

Montgomery v Lanarkshire Health Board [2015]

Montgomery moved the focus of consent away from the professional Judgment of a clinician, into a more patient-centric approach. The case related to a child born with shoulder dystocia. There was failure from the obstetrician to warn about the increased risks of a vaginal delivery of a large child, particularly given the small stature and diabetes status of the mother, Nadine Montgomery, which increased the risk associated with a large baby and shoulder dystocia in particular. The obstetrician’s view was that the risk of shoulder dystocia did not require specific discussion with diabetic patients, as the risk was very small and this would be supported by a body of obstetricians. The Supreme Court considered that the appropriate approach was a subjective one and the obstetrician should have provided information about all material risks, disclosing any risk to which a reasonable person in the patient's position would attach significance, and reasonable alternative options: see Capsticks Insight: Montgomery – the law of informed consent.

Recent Decisions

A number of cases have clarified the position in certain scenarios following Montgomery.

• Duce v Worcestershire Acute Hospitals NHS Trust [2018]
  • In this case, where Capsticks represented the Defendant Trust, the Claimant underwent a hysterectomy and developed Chronic Post-Surgical Pain (CPSP). It was alleged that the Court needed to consider what risks were, or should have been, known to the medical professional in question; and were those risks material. The Court in finding for the Defendant held that CPSP was not widely known about at the time and therefore, whilst informed consent moved towards a more patient focussed practice, there are circumstances where Bolam still applies. Courts will not look to impart up to date knowledge retrospectively.
• Bilal and Malik v St Georges’ University Hospital NHS Trust [2023]
  • The Claimant alleged that the Defendant’s surgeon was negligent in not offering alternative treatment options for his severe spinal pain. He underwent emergency surgical intervention, following attendance at A&E, and suffered a spinal cord injury. The Claimant’s claim failed on the basis that a reasonable and responsible body of surgeons would have determined there to be no alternative treatment.
• McCulloch v Forth Valley Health Board [2023],
  • This was a Supreme Court case and is therefore binding. Mr McCulloch had been admitted with acute pericarditis and sadly passed away roughly two-weeks later of a cardiac arrest. The allegations related to the decision not to administer or offer non-steroidal anti-inflammatory drugs (NSAIDs) as a treatment. The Supreme Court found themselves in the Defendant’s favour on this issue, on the basis that the doctor did not consider the use of NSAIDs to be appropriate and that decision would be supported by a responsible body of cardiologists. The Court confirmed that, in respect of what options should be offered to a patient, it was appropriate to consider the professional practice test; i.e.
    • a doctor cannot only inform the patient about the treatment option(s) the doctor prefers; and
    • the doctor must explain all of the reasonable alternatives, including risks; but
    • the doctor is not obliged to inform a patient of treatments which the doctor does not themselves consider to be reasonable (even if an alternative body of opinion would consider the alternative treatment to be reasonable).

Therefore, whilst the patient may have the final say as to what treatment to choose, the decision as to the ‘menu’ of options given to the Claimant is a matter of professional Judgment for the clinician. This decision of the Supreme Court reaffirms the approach in Duce i.e. that to some extent professional opinion does still matter and Bolam continues to play a role in the consent process.

Consent in Plastic Surgery

Patients undergoing plastic surgery may, in some circumstances, be vulnerable or have both an unrealistic view of their current situation and expectations as to outcomes. Furthermore, these are often purely elective treatments where there is absolutely no medical need but at the same time, significant and invasive surgical procedures with all the inherent risks attached. Appropriate consent is therefore vital as the following examples show:

• Patient A v Surgeon B
  • In this Capsticks case, Patient A attended Surgeon B following childbirth and weight variation, unhappy with the appearance of her breasts. She underwent a breast augmentation and mastopexy but remained unhappy with the results It was alleged that there had been a failure to advise of all the relevant risks, or alternative options such as mastopexy alone, or different implant types and therefore the Claimant had not provided informed consent. There was a factual dispute as to whether such discussions took place, however, the evidence of these discussions was lacking. Without contemporaneous evidence, a Court would therefore have to determine whether it preferred the evidence of the Claimant or the Defendant. Given these risks, the claim required early resolution, costing the insurers of the surgeon over £95,000 in total when accounting for damages, claimant costs and defence costs.
• Casey Castello v Stefan Gonschior [2021].
  • This case related to allegations that the Defendant had caused a further deviation to the Claimant’s septum during a rhinoplasty procedure. The issue in the case was surgical technique, rather than consent, however the Judge spoke in some detail in the Judgment about the Defendant’s consent process. They noted the level of discussions held, a nine-page booklet having been given to the Claimant and his expectation management, stating that “the most striking impression I formed of the defendant was his wish to manage the expectations of his patients”. The Judge concluded that “I find it inconceivable that the Defendant would have recorded all of these caveats and risks in his notes and yet not delivered the same message clearly and on multiple occasions in his discussions with the claimant. It was in his interests to convey the message…”. This is an example of good consenting practice that allowed the Court to find that the surgeon had not caused the further septal deviation and so Judgment was in the surgeon’s favour.

Practical tips on good consenting

Those undertaking cosmetic work should be familiar with the Royal College of Surgeons’ Professional Standards in Cosmetic Surgery Guidelines. These refer to the GMC’s own guidance and adds a specialist element for cosmetic work. There are a number of pages dedicated to the “Partnership with Patients”. This covers what needs to be discussed, but also issues such as the reflection time to give to patients.

Surgeons should:

• ensure that they consider the specific patient and their concerns and ensure that they have discussed the relevant risks of any procedure being offered.
• Offer all alternatives that they consider to be reasonable, including the options in relation to not having the treatment in question.
• Evidence discussions so that the detail of consent is documented, including answers to any questions raised by the patient and confirm any literature that has been provided;
• Forward to the patient a detailed letter with what was discussed and send this to their GP if the patient is happy with that.
• Ensure consent discussions are undertaken well in advance of the surgery itself and that there is a suitable cooling off period;
• Ensure that the person undertaking the surgery is the person taking consent.

Litigation based around allegations of consent is still all too common. Good consenting, with clear evidence of this, not only ensures that ethical and legal obligations are discharged but also that the risk of litigation is minimised.

Incision Indemnity work with Capsticks, to advise health professionals and institutions on all aspects of medical malpractice claims, including consent. Alongside this, Incision member’s have access to a 24/7, in-house Medico-Legal team, free of charge. The team are on hand to assist with any queries or advice needed to prevent or manage a claim being made, with real life experience.

For further information please get in touch with a member of our team.

Capsticks:

Majid Hassan

Ed Mellor

Sarah Bryant

The EU General Data Protection Regulation (“GDPR”) was incorporated into UK law by the Data Protection Act 2018 (“DPA 2018”). It remains part of UK law even after Brexit.

One GDPR protection is the Article 17 right for individuals to have their personal data erased, also known as the ‘right to be forgotten’. It is exercised regularly, and the Information Commissioner’s Office has some general guidance on how to respond to data erasure requests. However, it is not an unrestricted right, and there are limits on what data an individual can get erased.

Doctors, surgeons and clinics in private practice often receive requests from patients to erase their data. If the patient is only asking to be removed from a marketing database, this is unproblematic. But difficulties arise where the data forms part of the patient’s medical records. Several Incision members have received such requests, with some patients actually citing GDPR. Patients have expressly asked doctors, surgeons and clinics to permanently destroy medical records, including (in some cases specifically) clinical photographs. The patient’s reasons are not always clear. Sometimes they genuinely feel vulnerable because their highly personal clinical photos are held for long periods, even though the doctor, surgeon or clinic is highly regulated and will keep the images safe. In other instances, it seemed that the patient was making a cynical attempt to get rid of evidence in preparation to make a complaint or claim.

So are doctors, surgeons and clinics obliged to destroy medical records in response to a GDPR ‘right to be forgotten’ request? Fortunately they are not, so records needed to defend a potential claim should be preserved. The right does not apply where the data is being held to comply with a legal obligation, and there are also exceptions where the data (in this case medical records) is being held under a duty of patient confidentiality for medical diagnosis or for the provision of healthcare. Therefore even where the course of treatment has completely finished, medical records including correspondence and clinical photos must not be destroyed. In private practice, doctors, surgeons and clinics must keep the patient records and clinical photographs complete, safe and secure for the periods required by The Private and Voluntary Health Care (England) Regulations 2001 (Schedule 3), which is usually eight years but can be longer for some classes of patient. Incision insureds have access to a detailed guidance note on records retention periods.

So as a doctor, surgeon or clinic manager in private practice, what should you do if a patient asks for their data or any part of their medical records and clinical photos to be erased? Incision insureds have access to excellent medico-legal guidance from dual-qualified doctors and lawyers. You should seek medico-legal guidance right away whenever you receive a ‘right to be forgotten’ request. The medico-legal team can help you assess whether there is any data that can and should be erased in response to the request, but also accurately identify any data which is actually part of the medical records and cannot be destroyed. The medico-legal team can also help assess the likely reasons behind the request. They can help create a reassuring and sensitive response where it seems that the patient is making the request out of a sense of vulnerability, to help preserve the relationship with the patient and prevent unnecessary complaints. But they can also help identify situations where the data erasure request indicates that the patient intends to make a complaint or claim. They can make sure that notification to insurers and other steps are taken to protect the position of the doctor, surgeon or clinic. Just as importantly, the medico-legal team can help you look at any permissions you might previously have received to use the medical records for other purposes such as training or even marketing, and assess whether the patient has now withdrawn those permissions so you should stop using the records for those other purposes.

But what about situations where you (or an employee or medical secretary on your behalf) has already erased patient records in response to a ‘right to be forgotten’ request, without realising that the right does not apply to medical records? In these situations you need to contact the Incision medico-legal team urgently. There can be regulatory implications for destroying medical records that should have been retained, even where this was done under a genuine misunderstanding of the law. Therefore the medico-legal team needs to get involved right away to help you manage and mitigate the situation. Incision insureds have cover for lost and destroyed records, so depending on the exact circumstances there could be insurance funding to help restore any records that can still be retrieved. The medico-legal team can also make notifications to protect your position in case the incident leads to an investigation from the regulator and you need insurance funding for your defence. The medico-legal team can also get you early advice from specialist healthcare regulatory lawyers where necessary, to make sure that any remediation work you need to do to protect you from regulatory sanctions is done promptly.

While patients might perceive the GDPR ‘right to be forgotten’ as very simple, in fact this is a complex area of law and regulation, with potentially serious implications for you if you take the wrong steps in response to an erasure request. If you are a doctor, surgeon or clinic in private practice and a patient asks you to erase the data you hold on them, or if you or an employee has inadvertently erased medical records that should have been retained, get proper medico-legal guidance immediately. Incision insureds have cover for lost or destroyed records, and cover for defence in regulatory investigations and claims, together with an outstanding medico-legal team who will help you manage and mitigate these difficult situations, to get the best available outcomes in these often difficult situations.

Incision July 2023