What is the use of a consent form?

What is the point of a consent form?  Surely if a patient signs up to a risk, or signs up to the statement that there is no guarantee that a particular person will perform the planned procedure, the patient’s signature will protect the health care provider from being sued if the risk arises or if there is a change of personnel.   No!  In the former case, just because a patient ‘signs up to’ a risk, they do not sign up to a risk (even if listed) if resulting from negligence.  In the latter case, the real issue is what was the patient told, and not what the form says, about who would perform the procedure.

A useful reminder of just what protection a consent form provides is given by the case of Jones v Royal Devon and Exeter NHS Foundation Trust (a County Court case heard by Recorder David Blunt QC).   In this case, there was a change of personnel performing a procedure between consenting and the actual procedure, and the health care provider sought in its defence to rely on the consent form which stated that ‘no guarantee is given that a particular person will perform the procedure’ when a claim was made for an adverse (but – as the judge found – non-negligent) result.

In Jones v Royal Devon and Exeter NHS Foundation Trust the judge concluded that the evidence indicated on the balance of probabilities that the patient had been given to understand by the trust’s personnel that her operation was to be performed by C. It was more probable than not that the patient had sought her GP’s advice as to whether she should wait until C was available and that the GP had stated that it would be preferable to wait for him. It was also likely that when S had seen the patient a week before the operation, he had not told her that he would be carrying it out. Nor had he told her on the morning of the operation. The patient had only learned that C would not be performing the operation when she was about to go into theatre.

Accordingly, the judge held that the trust had breached its duty of care to her. That was too late a stage to provide her with that information. A decision taken so late was unlikely to be taken freely: the patient would be aware that if she declined the operation, she would lose her place in the queue for the operation, a number of people would be inconvenienced, the slot for the operation would be unlikely to be filled and NHS time would be wasted.

“Mrs Jones’s evidence, which I accept, is that she only learned that Mr Chan would not be performing her operation when, effectively, she was about to go into theatre. Realistically, in the light of the guidance referred to above, Mr Myhill [counsel for the Trust] did not challenge the proposition that if Mrs Jones’s evidence in relation to this were accepted, then the Defendant was in breach of its duty of care to her. That it was too late a stage at which to provide her with this information was accepted by both the medical experts who gave evidence before me: a decision taken ” so far down the line” is unlikely to be taken freely: apart from anything else, the patient would be aware that if he or she declined, at that stage, to undergo the operation, he or she would lose his or her place in “the queue”, a number of people would necessarily be inconvenienced by it, the “slot” for the operation would be unlikely to be filled by anyone else, and time which would be precious, not only to the NHS and its personnel but also to other patients waiting for operations, would be wasted.”  (para 37)

 “Although in the present case there was no breach of the duty to warn Mrs Jones of the risks of the operation it was an infringement of her right “to make an informed choice as  to whether, and  if so when, and  by  whom she would be operated on”.” (para 70)

This is reflected in the DoH Guidance (“Reference guide to consent for examination or treatment”):

“The validity of consent does not depend on the form in which it is given. Written consent merely serves as evidence of consent: if the elements of voluntariness,  appropriate  information  and   capacity   have   not   been satisfied, a signature  on a form  will not make the consent  valid.”

The points to take away from the case are: 

  1. Written consent, and a ‘consent form’, can do no more than serve as evidence of what was discussed, and if it wrongly represents what was discussed (and that is proved on the balance of probabilities) then the consent form cannot assist the health care provider.
  2. Including in the consent form a statement that there is ‘no guarantee that a particular person will perform the procedure’ is on the face of it evidence that the patient, in giving informed consent, was informed that there was no guarantee that a particular person would perform the procedure.
  3. If the evidence accepted by the court (on the balance of probabilities) is that that was not the information given to the patient, but that the patient was led to believe that the procedure would be carried out by a particular individual, then the case will be assessed on the basis that the patient was so informed.
  4. If damage is proved to have occurred at the procedure, although non-negligently, then subject to causation the patient can recover damages (Chester v Afshar).
  5. To establish causation the patient needs to prove (on the balance of probabilities) that but for that assurance the patient would not have agreed to undergo the procedure at all, or not at that time.
  6. The more significant or potentially risky the procedure, and the more significant the difference in experience or expertise is between the practitioner for whom the patient was consented and the practitioner in fact carrying out the procedure, the more likely the patient is to establish causation.

Often there is no discussion as to who will carry out the procedure but of course the patient may assume that the person consenting them will do so.  If that is not the case then that needs to be spelt out, and even if the consent form reflects that, there is much to be said to tick, or initial, it as having been discussed.

The moral is to be straightforward with the patient (who is going to operate?  Do you know?) and to document what is discussed, and not simply rely on a standard form as to what should have been discussed.  Alternatively if there is, unexpectedly, a change of personnel from that notified to the patient, then the patient should be notified at the earliest opportunity, the implications should be discussed with the patient, and the opportunity to postpone the operation should be given.

[Who or what is medico-legal minder?  Terms and conditions apply]

The medical expert, area of expertise and seat belts

Medico-Legal Minder has previously commented on the dangers inherent in the requirement in Form RTA3 under the RTA Protocol (in relation to low value soft tissue injury claims) that the expert express an opinion in relation to the effect of not wearing a seat belt on the claimant.[1]  Not only does this require an understanding as to the law in relation to the reduction in damages for failing to wear a seat belt[2] but it needs a very clear approach to the expert’s expertise in providing such opinion to ensure that any opinion given is within the expert’s area of expertise.

This issue was considered in the recent case of Wilson v Gerami.[3] In a pre-trial hearing in a claim outside the RTA Protocol in which the claimant sought to have redacted parts of the defendant’s medical expert’s report addressing this issue, the judge adjourned the issue to the trial judge to give the defendant an opportunity to obtain justification from the expert for his provision of this opinion.  The expert’s medical expertise and CV, however impressive, is unlikely to provide evidence of the expert’s expertise in expressing an opinion as to the difference in injuries had a seat belt been worn in the particular circumstances of the accident, and if an opinion was to be expressed on this issue, the expertise justifying expressing such an opinion has to be provided.  An expert must never stray outside her area of expertise.[4]  As the Practice Direction to Part 35 of the Civil Procedure Rules states (para 2.2)

‘Experts should assist the court by providing objective, unbiased opinions on matters within their expertise …’

The judge also conceded that the boundary between the areas of expertise of a medical expert and an accident reconstruction expert might not easily be drawn.  In this case the parties had permission to obtain expert evidence from both fields but the defendant had chosen to obtain it only from the medical expert.

[Who or what is medico-legal minder?  Terms and conditions apply]

[1] See Section 7.6 Writing Medico Legal Reports in Civil Claims – an essential guide (Eyre & Lynden)

[2] Froom v Butcher [1976] QB 286

[3] Lawtel AC9101525 (3/5/17)

[4] See Section 4.2.2  Writing Medico Legal Reports in Civil Claims – an essential guide (Eyre & Lynden)