Tuesday, 9 July 2013
Medical Innovation and the Law of Negligence
Lord Saatchi has been promoting the Medical Innovation Bill in the media. He has a deep personal commitment to the Bill but some of the reasoning he has given for the need for the legislation seems to me to be fundamentally flawed He believes that clinical negligence law stands in the way of clinical innovation and in the Daily Telegraph he seems to make the striking claim that clinical negligence law is the reason why there is no cure for cancer. He writes:
"Any deviation by a doctor is likely to result in a verdict of guilt for medical negligence. The law defines medical negligence as deviation from that standard procedure. But as innovation is deviation, non-deviation is non-innovation. This is why there is no cure for cancer."
I am not sure that there will be one reputable clinical practitioner or clinical negligence lawyer who would agree with him.
The law on medical negligence has been clear for over 50 years since Bolam-v-Friern Hospital Management Committee  1 WLR 582: a doctor is not negligent if he or she acts in accordance with a practice accepted as proper by a responsible body of medical men and women skilled in that art merely because there is a body of opinion that takes a contrary view. So, if 95% of doctors would not give a certain kind of cancer treatment but 5% would, and that 5% represents a reasonable body of opinion, then it is not negligent to give that treatment.
The law does not define medical negligence as deviation from standard procedure.
There is case law which demonstrates that medical negligence law does not hinder innovative treatment, even treatment previously untested on humans. In Simms-v-Simms  2WLR 1465 the court considered an application that two persons suffering from variant Creutzfeld Jakob disease should be given innovative treatment which was new and untested on humans. The court decided that the first question was whether the doctors would be acting in accordance with a responsible and competent body of relevant professional opinion as per Bolam, and the court held that there was a responsible body of professional opinion that supported the innovative treatment.
So the law of clinical negligence is not an obstacle to innovation. There are of course already guards against reckless experimentation given without patient consent. The General Medical Council for example issues numerous guidelines including those on obtaining patients' consent to treatment which is part of a research project. I did have one case where a cancer patient died of the toxic effects of High Dose Interferon. The drug was being used as part of a trial and the clinician did not abide by the protocol for the trial. He continued to prescribe the drug when the patient's liver function tests were very significantly abnormal. Do we really want legislation which would protect a practitioner from departing from carefully thought through trial protocols, or which would remove reasonable protections from patients?
I have recently written a series of blog posts on bringing claims for delay in diagnosing cancer. If nothing else they surely show how very difficult it is to bring a successful claim. The Bolam test provides a substantial shield for medical practitioners to defend allegations of negligence and claimants have the difficult task of proving causation when the allegedly negligent treatment has been given to a terminally ill patient.