The Cumberlege report: informed consent revisited

Last week saw the publication of “First Do No Harm”, a review led by former junior health Minister Baroness Julia Cumberlege, which explains the way our healthcare system responded to reports of harmful side effects from:

  • hormone pregnancy tests
  • the drug sodium valproate given during pregnancy and
  • pelvic mesh implants.

The review suggests a number of ways in which healthcare might be improved to strengthen patients’ voices by creating a system that “listens, hears and acts – with speed, compassion and proportionality”.

Hormone Pregnancy Tests were used from the 1950s. A large number of women given these tablets went on to suffer miscarriages and stillbirths or to deliver babies with very significant birth defects, both physical and intellectual. Although a direct causal link remains contentious, as one doctor put it as long ago as 1964:

“If there are grounds for suspecting that a drug may be teratogenic, its use in early pregnancy must be stopped. It would be morally indefensible to put the suspicion to the test”.

More so after alternative methods of pregnancy testing became widely available from 1967 onwards – yet it was not until 1978 that all hormone pregnancy tests were withdrawn from the market.

Sodium valproate is primarily used to treat epilepsy. Evidence has long been available that it can cause physical and neurodevelopmental problems in children born to mothers who take it during pregnancy. A higher incidence of spina bifida, cleft palate and limb defects has been demonstrated, as well as of intellectual and behavioural disability. Some women have had more than one child affected, and many people exposed to the drug in utero suffer from anxiety, depression and loneliness.

Pelvic mesh implants have been used to treat pelvic organ prolapse and stress urinary incontinence. Many women who have had mesh surgery now suffer from chronic pain and nerve damage, some so badly that they are wheelchair dependent. Others report worsened incontinence, or voiding difficulty, or have had their sex lives destroyed. The ongoing physical and psychological difficulties can be so serious that women describe being virtual prisoners in their own homes because these meshes were designed to be permanent, they are by their very nature difficult to remove – especially when years have passed since they were inserted. Many women were not warned of the possible complications or offered alternative, more conservative, treatments such as pelvic floor physiotherapy, or more traditional surgery without mesh being used. Nor were they subsequently warned of the risks of attempts at mesh removal.

What is evident in all three treatment groups is that many women have been deprived of the opportunity to make informed treatment choices by the failure of their doctors to give them sufficient information about complication rates and possible risks. Had they been properly advised, many say they would have made different choices, especially where the risks were to their unborn child. Sadly, many live with the guilt that they took a tablet during pregnancy that may have caused their baby avoidable harm.

Five years ago, the legal case of Montgomery v Lanarkshire Health Board clarified the law on consent to medical treatment. The Court has now explained that it is not (and never has been) sufficient for a doctor to tell a patient only what other reasonable doctors would tell her. Instead:

“The doctor is … 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 … 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.”

Baroness Cumberlege’s report also discusses the duty of candour – doctors telling patients when things have gone wrong – and the need to create a healthcare system in which professionals feel they can be open and honest, with the aim of preventing future harm. Many clinicians are of course already entirely open and honest, and skilled in providing patients with the information they need to give proper consent to treatment. However, we should be aiming at properly informed consent in all cases, and a culture in which patients are actively listened to. When things go wrong, they need an honest explanation and appropriate medical assistance.

For more information about a potential claim in any of these areas, get in touch with our clinical negligence solicitors.