Observations Ethics Man

Defending the sophisticated consent attack

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g6432 (Published 28 October 2014) Cite this as: BMJ 2014;349:g6432
  1. Daniel K Sokol, barrister and medical ethicist, 12 King’s Bench Walk, London
  1. daniel.sokol{at}talk21.com

What can doctors do to protect themselves against allegations that they failed when obtaining consent to ensure that the patient understood information?

A few weeks ago I spoke on the subject of consent to solicitors who represent claimants in clinical negligence cases. I encouraged them to consider the possibility of invalid consent at the outset of a claim rather than as an afterthought. I told them that I had infiltrated enemy lines, into the trenches that are hospital wards and GP surgeries, and discovered that there is a gap between the lofty ideal of consent, as reflected in the guidance of the General Medical Council and the law, and the gritty reality on the front line.

The next week I gave a talk on consent to clinicians and, as an act of atonement, advised them on how to defend themselves against the very attacks I revealed to the lawyers. There is one sophisticated attack of which readers should be aware.

Not enough just to impart information

When seeking consent, it is not enough for doctors to warn a patient of a risk. They must do so in a manner that the patient will understand. What is said by the clinician is not necessarily what is understood. This sounds trite, but it has significant implications, as illustrated by two legal cases.

In the first case Mrs Al Hamwi sought damages for the birth of her severely disabled child and the costs of bringing him up.1 She alleged that the consultant obstetrician did not properly explain the risks of amniocentesis and that, as a result, she declined the test. The way the consultant presented the risk, which included a description of the needle piercing the baby’s skull, led her to believe that the risk of miscarriage from the test was in the region of 75%. In fact, the risk was about 1%. If the risks had been explained correctly, Mrs Al Hamwi claimed that she would have opted for amniocentesis and the child would not have been born.

The judge in that case stated that “a clinician must take reasonable care to give a warning which is adequate in scope, content and presentation, and to take steps to see that the warning is understood.” The judge found that the consultant did impart accurate and balanced information on the risks of amniocentesis. He stated, “Clinicians should take reasonable and appropriate steps to satisfy themselves that the patient has understood the information which has been provided; but the obligation does not extend to ensuring that the patient has understood.”

In the second case Mrs Lybert underwent a sterilisation after giving birth to her third child.2 Believing that she was sterile, she had unprotected sex and became pregnant 15 months after the sterilisation procedure. She sued the health authority for not telling her that the procedure might fail. The consultant gynaecologist claimed that he did inform Mrs Lybert of the risk of conception. His notes stated that the procedure was “not 100%.” The judge concluded that the consultant did give a warning but that it was “not of a nature in terms of force and emphasis as to impinge on the plaintiff’s thoughts . . . the warning was not sufficiently ‘clear and comprehensible.’” If a proper warning had been given, the judge found that the couple would have used contraception, and the pregnancy would probably not have occurred.

Consent may be invalid

Invoking these cases, I encouraged the audience of solicitors to ask their clients whether they had understood the risks of their ill fated procedure. If not, the consent may have been invalid, even if the doctors could show that they informed the patient of the risk.

By this stage readers may well exclaim that the law is an ass, but the General Medical Council, in its booklet on consent (section 34), also instructs doctors: “You should check that the patient understands the terms that you use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome.”3

So what can doctors do to protect themselves against the allegation that they failed to take “reasonable and appropriate steps” to satisfy themselves that the patient understood the information? They can invite patients to ask questions after the explanation. This is the “Q” in the “PARQ” acronym (procedure, alternatives, risks, questions). A leaflet, with encouragement to read it, is also helpful. Some clinicians tape or digitally record consultations and provide a copy to the patient. Perhaps consent forms should be altered to encourage clinicians to check the patient’s understanding.

The importance of a careful, legible note in the medical records cannot be overstated. Although tedious now, that note may save you later. Although merely a suggestion, a statement along these lines may do the trick in most cases: “Procedure, alternatives and risks explained in clear terms. Questions invited but none asked. Patient appears to understand. Leaflet provided. Patient advised to read.”

And remember that the manner and the content of the consent may vary with the characteristics of the patient.

The medical profession, clinical ethicists, and defendant lawyers should reflect on practical ways to counter this rather subtle consent attack.

Notes

Cite this as: BMJ 2014;349:g6432

Footnotes

  • Competing interests: None declared.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References

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