Informed Consent – were you informed?
Prior to undergoing any treatment, as a patient, you must agree to what is proposed based on a full understanding of what is to happen. This is known as giving consent and it is needed regardless of the procedure.
For your consent to be valid, it must be voluntary and informed, and you must have the capacity to understand in order to make the decision.
The Montgomery v Lanarkshire case of March 2015 drew fresh attention to informed consent and redefined the standard for informed consent and disclosure of risks.
Montgomery vs Lanarkshire Health Board
For many years, judges dealt with the issue of consent in the same way as other medical negligence claims. The standard test for medical negligence is known as the “Bolam” test, after the legal case in which it was first set out clearly. In brief summary, a doctor’s duty to warn patients about risks was based on whether they had acted in line with a responsible body of medical opinion. If a doctor could prove that they had dealt with consent in the same way as some other doctors usually dealt with it, it would not be negligent.
However, in March 2015 the UK Supreme Court said that this was no longer the correct way to deal with questions of consent for medical treatment, and the Bolam test was replaced. The case of Montgomery v Lanarkshire Health Board has resulted in an important development in relation to the court’s consideration of arguments surrounding consent to medical treatment.The Montgomery test means doctors have to take much greater care when providing you with information.
In brief, Nadine Montgomery, a pregnant woman with diabetes and of small stature, had raised concerns that her baby might be too big to be delivered vaginally. She had not, though, asked about the ‘exact risks’. Expert evidence presented a 9-10% risk of shoulder dystocia where a diabetic woman gives birth via vaginal delivery, but Mrs Montgomery was not warned of the risk of shoulder dystocia, or offered a caesarean section as an alternative.
Shoulder dystocia happens when the baby’s shoulders get stuck during delivery and is a rare, but serious complication. In the court case, it was accepted that shoulder dystocia can cause serious complications for mother and baby, but also accepted that the risk of cerebral palsy was low- at around 0.1%.The obstetrician looking after Mrs Montgomery felt that if she was told of the increased risk, she would have opted for a caesarean, but he did not believe this was in her best interest. He therefore took the decision not to disclose the risks of shoulder dystocia to Mrs Montgomery. Unfortunately, shoulder dystocia did happen. Mrs Montgomery’s son was born with fetal hypoxic injury, resulting in cerebral palsy due to complications after his shoulders got stuck during the birth. Mrs Montgomery claimed for Medical Negligence, arguing she should have been told of all the risks. Over £5 million was awarded in damages, after an appeal went to the Supreme Court.
The Supreme Court said that times had changed. Patients should no longer be seen as merely people who receive treatment. They ruled that people have the right to appropriate information and choices in order to then make an informed decision about their treatment.
Doctors must now ask themselves three questions:
- Does the patient know about the material risks of the treatment proposed?
- Does the patient know about reasonable alternatives to this treatment?
- Has reasonable care been taken to ensure the patient understands this?
Failure to adequately make you aware of the material risks involved in a suggested treatment, or of any reasonable alternatives (including the option of doing nothing), means you are not giving informed consent to the procedure or treatment. If you would have made a different decision, and you subsequently suffer harm as a result of those risks, there is a strong case for Clinical Negligence against the surgeon and/or hospital NHS Trust responsible
The Montgomery judgement details what a patient would consider to be material risk:
‘The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
‘The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.’
If you did not give informed consent or have suffered as a result of Medical Negligence which has resulted in an injury, contact Osborne Morris & Morgan’s specialist Medical Negligence team today on 01525 378177 or online.