Application of evidence-based medicine in negligence claims

 Medical negligence is established when a doctor had a duty of care to the patient, there was a breach in the duty of care and the patient suffered damage as a direct result of the breach in duty of care.

The Bolam test has been traditionally used to assess two main issues of medical negligence - the standard of care as required by the law and whether the doctor accused of medical negligence has complied with that standard of care. This is decided by the medical opinion of expert ‘experienced’ doctors.

The Bolam test is satisfied if it is the opinion of the experts that the medical practice followed by the doctor is proper, even in the event of a mishap. Then he/she is not guilty of medical negligence. “A doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art… a doctor is not negligent if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view.” (Bolam v Friern Hospital)

In 2015, the UK Supreme Court passed a judgement in the case of Montgomery v Lanarkshire Health Board as a result of which doctors in UK are now required to ensure that the patient is aware of all possible risks associated with a treatment, howsoever, rare. The Montgomery judgement, unlike the Bolam test, is based on evidence

The Montgomery judgement has now made the Bolam test redundant ‘as a test to assess standard of care’. It is the court now which will review the available evidence and reach its own conclusion whether the line of treatment adopted was the required standard of care or not.

In this age of information, the practice of medicine has become evidence-based. Even the Courts require evidence to defend/prove an allegation of professional negligence. Evidence-based medicine avoids professional bias and conflict, which is a risk in experience-based medicine as it is the expert testimony of individuals.

But, it is just not enough to present evidence in your defence. What is important is the level of evidence. The level of evidence that you present before the law strengthens or weakens your defence.

A hierarchy of seven levels of evidence have been defined in declining order of significance from Level I to Level VII.

Level I is evidence from a systematic review or meta-analysis of all relevant randomized-controlled trials or clinical practice guidelines that have been developed on the basis of evidence. It ranks highest and cannot be challenged by an expert. 

Opinions of experts or expert committee reports are ranked lowest at level VII.

With evidence-based medicine fast becoming the norm, this shift from the Bolam test holds relevance for all doctors.

Calling in a large number of experts to give their opinion on what is “accepted clinical practice” may no longer be a good defence when defending a complaint of medical negligence.

Dr KK Aggarwal

National President IMA & HCFI

Recipient of Padma Shri, Dr BC Roy National Award, Vishwa Hindi Samman, National Science Communication Award & FICCI Health Care Personality of the Year Award

Vice President Confederation of Medical Associations of Asia and Oceania (CMAAO)

Past Honorary Secretary General IMA

Past Senior National Vice President IMA  

President Heart Care Foundation of India

Gold Medalist Nagpur University

Limca Book of Record Holder in CPR 10

Honorary Professor of Bioethics SRM Medical College Hospital & Research Centre  
Sr. Consultant Medicine & Cardiology, Dean Board of Medical Education, Moolchand
Editor in Chief IJCP Group of Publications & eMedinewS

Member Ethics Committee Medical Council of India (2013-14)  

Chairman Ethics Committee Delhi Medical Council (2009-15)

Elected Member Delhi Medical Council (2004-2009)

Chairman IMSA Delhi Chapter (March 10- March 13)

Director IMA AKN Sinha Institute (08-09)
Finance Secretary IMA (07-08)
Chairman IMAAMS (06-07)
President Delhi Medical Association (05-06)