Law firm partner Emma Galland explains the different types of claims that could arise post complication and advises on ways to deal with them.
It is an unfortunate fact that no matter how diligent and experienced a practitioner is, complications can occur with any procedure. This, combined with the so-called litigation-culture, and increasing patient expectations, means that most practitioners will find themselves dealing with a complication, complaint or claim at some point in their career.
It’s important that practitioners have a clear process in place to deal with complications if they do occur and, where early resolution is not possible, know how best to manage any consequential refunds/claims. This article explains some of the avenues of recourse a patient may have following a complication, and the key steps practitioners can take to deal effectively with the consequences.
Broadly speaking, and for the purposes of this article, a complication is any event that was not anticipated by the patient/practitioner resulting from a procedure, treatment or illness. In my opinion, to deal most effectively with a complication, practitioners should be aware of the subjective impact of it on the patient and be mindful of how that patient’s individual circumstances will affect their response to it. For example, a patient who lives alone in a remote area, is likely to find that a complication affecting mobility will have a greater impact than one who lives in a city with family close by. Dealing efficiently with complications as soon as they arise, may, ultimately, avoid matters from escalating into a serious complaint or claim, which could in turn damage your reputation and your business. While it is not possible to identify all possible courses of actions for patients following a complication, I find that the most frequent outcomes include:
The professional and statutory duty of candour1 will also be engaged following a complication and, for that reason, we deal with a practitioner’s obligation arising from that duty first, discussed below. Following a complication, it is also important to consider the duty to notify insurers and seek their approval to any steps proposed to deal with it.
The duty of candour applies to both individuals (the professional obligation) and organisations registered with the Care Quality Commission, referred to from now on as the CQC (the statutory obligation).2 It is worth noting here that due to differentiating laws in Scotland and Ireland, this would be different again. As I am qualified in England and Wales, I will be discussing these areas specifically. Practitioners who are not registered with the CQC may not be required to comply with the statutory obligation. Regardless, however, those practitioners who are registered with a professional body should still comply with their professional obligation.
Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 20142 requires providers to be open and transparent in the event of a complication. Specifically, in the event of a notifiable safety incident (NSI), explained below, the registered person/provider must, as soon as is reasonably practicable, notify the patient, offer an apology and investigate the NSI.3 It is a statutory requirement to provide an apology. This is not the same as an admission of liability – which should not be given without the specific agreement of the insurers. The apology should be an acknowledgement that something unexpected occurred which has impacted upon the patient. The notification should be made orally initially, where possible, and followed up in writing (see below).
A NSI is an event with unintended/unexpected consequences which may, in the opinion of the registered provider or registered person, have caused death, severe harm, moderate harm or prolonged psychological harm of at least 28 days.3
Moderate harm is defined as harm that requires a moderate increase in treatment, and significant, but not permanent harm. A moderate increase in treatment is defined as ‘an unplanned return to surgery, an unplanned re-admission, a prolonged episode of care, extra time in hospital or as an outpatient, cancelling of treatment, or transfer to another treatment area (such as intensive care)’.2 This may include additional follow-up treatment such as injecting hyaluronidase following a lip filler complication where nodules are present from the initial treatment. It is important to remember that an incident may be a NSI even if it is unclear what, if any, harm has been caused. The threshold for meeting this requirement is law – if there is any suspicion that the requisite harm ‘may’ have been caused by an unexpected/unintended incident, the practitioner should consider notifying the patient in this way. This situation may arise where, for example, a complication occurs.
The provider must follow up the NSI notification in writing, including details of the investigation that will take place, and the likely timescales. At its conclusion, the patient must be advised either orally (with a clear record of any conversations) or in writing, of the outcome of the investigation.
If the registered person/registered provider breaches the statutory duty of candour (or is unable to demonstrate that the statutory duty has been complied with – for those practitioners who are registered with the CQC), the CQC can impose a fine of up to level four of the standard scale (currently £2,500) per offence.4 If the registered person/registered provider can demonstrate that all reasonable steps were taken to comply with the duty of candour, this may prevent any sanctions.
It is therefore important that registered providers/registered persons keep careful documentation of any notifications both orally and in writing.
An ex gratia payment is a payment made ‘out of goodwill’, as per its Latin translation. By this I mean, when there is no obligation on the practitioner to pay it. As such, it is up to the practitioner to decide if they would like to make an ex gratia payment as a result of a complication. This kind of payment is often made, for example, to recompense the patient for the costs of the treatment, particularly if the complication has meant that the treatment was unsuccessful.
While there may be not always be an obligation to do so, prior to offering this kind of payment, it is advisable to undertake a full investigation to ensure that the payment is justified. Likewise, while an ex gratia payment is usually paid by the practitioner/clinic, rather than through an insurance policy, it is still important to seek the insurer’s approval to making the payment before doing so. In my experience, this will ensure that any future claim is not prejudiced and/or that insurance cover is not invalidated.
An ex gratia payment should be made outside of any formal court proceedings and progressing in this way may be preferable to avoid unnecessary legal costs being incurred. That said, I believe that it is advisable to make the offer (in writing) of the ex gratia payment as full and final settlement to avoid any litigation proceedings in the future, and to ensure that this proviso (that the payment is made in full and final settlement) is clearly set out.
This approach can be successful where there is a clearly defined amount which the patient may be able to claim (for example a refund on the cost of treatment). If the claim is for an uncertain sum of money (e.g. for pain and suffering) and/or is for a substantial sum of money, offering an ex gratia payment may not be advised. Legal advice and/or approval from your insurers should be sought.
Broadly speaking, if a negligence claim is made, a clinic/practitioner’s insurers will be involved in managing the claim and may instruct solicitors to act for the clinic/practitioner. The explanation below is therefore included by way of background. If a negligence claim is made, there are a number of requirements that must be met for it to be successful.
Firstly, the person bringing the claim, the claimant, must show that the person/organisation against whom the claim is brought, the defendant, owed them a duty of care. In cases involving medical treatment, it is broadly accepted that a duty of care is owed to patients by the medical practitioner/organisation, and this duty of care has recently been extended such that it may, in some circumstances, also be owed by administrative members of staff (which may include, for example, the reception team) within the organisation.
Secondly, having confirmed that the duty of care is owed to a patient, that duty of care must have been breached. The breach may have occurred in a number of ways but, in general terms, the claimant must show that the practitioner’s actions were not those of an ‘ordinary and competent’ practitioner acting within the same speciality, in accordance with the Bolam test.5 This test was later refined in the Bolitho case,6 which states that the analysis of the ‘ordinary and competent’ practitioner should be able to withstand logical analysis. For example, simply having supporting evidence is not enough. The supporting evidence must be able to stand up to challenge.
It is often thought that the test for assessing a claim stops at this point: if breach of duty has been established, then surely the claimant is entitled to damages. However, there is a further element; the claimant must prove that the breach of duty has caused them harm. This harm must flow from the breach of duty and not be merely incidental to it, this is referred to as the ‘causation’ test.9 For example, if a complication arose during a procedure (such as unexpected bleeding), if there was no breach of duty causing that bleeding and/or any breach of duty did not cause the unexpected bleeding, a claim for negligence would fail.
If the above three elements are met, damages will be awarded. It is important to remember that in England and Wales, damages are limited to putting the claimant in the position they would have been in had the breach of duty/incident not occurred. As well as reimbursing the patient for the treatment paid for, this will also include damage for the harm incurred. If the patient suffered from facial scarring as a result of the negligence, for example, the patient may also be able to claim in the region of £7,270-£23,980 based upon the Judicial College guidelines.7
Finally, if the patient considers that they have a valid claim, and paid for their procedures using credit (such as a credit card), they may be entitled to bring a claim under section 75 of the Consumer Credit Act 1974.8
This gives the patient the option to bring a claim against the credit card company if the supplier, in these circumstances the practitioner/clinic, has breached the contract between itself and the consumer. For example, if the treatment was paid for by credit and if the outcome was not as agreed (e.g. if the procedure did not give the results anticipated), the patient may be able to claim against the credit company. If that claim is accepted, the credit company will then seek to pass the costs on to the supplier, so the practitioner/clinic. This claim would be to reimburse the patient for the money paid for the services. Although this is not hugely common, it does happen.
In the event that a complication arises, I would suggest that the following steps should be taken immediately to ensure an effective response:
It is important to understand the type of claim that may be made against you and your professional and statutory responsibilities. Unfortunately, despite all best efforts and intentions, complications do sometimes occur. It is important that practitioners have appropriate procedures in place to mitigate the risks of those complications occurring, to take action following complications, and to reduce any harm which the patient may have suffered.
Upgrade to become a Full Member to read all of this article.