Dr. Govindarajan MJ writes about the medico-legal aspects of radiology and the importance of informed patient consent specific to the field.

Though the radiologist is as liable to face medico-legal issues as is any other medical professional, this article attempts to enumerate specific issues related to the field of imaging. The medico-legal issues in radiology practice in India can be divided into medical malpractice issues and non-compliance of the statutory guidelines.

Medical malpractice issues

Defined as a substandard level of care discharged by the healthcare professional resulting in the patient suffering damages, the three essential components of medical malpractice lawsuits are breach of duty, causation, and resulting damage. The onus lies with the plaintiff to prove these three components in a lawsuit.

The malpractice lawsuits can be against errors in diagnosis, act of commission or omission during an interventional procedure, failing to inform the relevant critical finding to the treating physician and misappropriate use of modalities, in that order of frequency.

1. Errors in diagnosis: They are the most frequent causes of malpractice suits and can be of two types, cognitive and perceptual errors.
   1. Cognitive errors are those in which an abnormality is seen but its nature is misinterpreted.
   2. Perceptual errors or the radiologic 'miss' are the ones in which a radiologic abnormality is not perceived by the radiologist on initial interpretation. The perceptual errors account for close to 80% of the lawsuits, which predominantly include missing breast cancers on mammography, missing lung nodules on chest radiograph and missing fractures on skeletal radiographs.

2. Act of commission or omission during an interventional procedure: It is the most frequent cause of malpractice lawsuits in interventional radiology and includes vascular injury leading to bleeding/dissection etc. as the commonest form.
3. Failing to inform the relevant critical finding to the treating physician and appropriateness in the use of the modalities/advice on further evaluation modalities: These are the infrequent causes of malpractice lawsuits in India. Other issues with serious potential to have legal implications are the contrast reactions, extravasations etc., particularly if the place in which the procedure is performed does not have the facility to treat the reactions or if the patient is not informed about the nature of the procedure, possible adverse reactions to contrast media, the existence of alternative procedures, the extent of the risks related to their use and, finally, the risks of refusing the procedure.

Non-compliance to statutory requirements

It is one of the main concerns in India as the implementation of guidelines is not uniform across the country. It can be AERB for the radiological equipments or PC PNDT act for ultrasound scanners. However, in recent times, most emphasis is given to the implementation of PC PNDT act which is meant to reduce the incidence of female foeticide and improve the falling female to male ratio in the country.

The PNDT act was enacted in 1994 and came into existence in 1996; it was amended in 2003 and became PC PNDT act. It was amended again in 2012 to strengthen the provisions to prevent the prenatal sex selection. The penal clauses include imprisonment and fine. Most cases documented under this act pertains to non-registration of the ultrasound clinics. This was followed in order of frequency by non-maintenance of records, communication of sex and advertisement for sex selection.

The radiologist can be held responsible under the jurisdictions of consumer courts, medical council, criminal negligence and law of torts, like any other medical professional.

Prevention is better than cure! Best action against malpractice suits is to prevent them from happening. This requires a great deal of patience to take patients into confidence, patient counselling, updating one’s knowledge, foreseeing complications and threats and adhering to the guidelines.

Finally, one can only take adequate precaution and act with care and diligence. Maintaining a good relationship with a patient often works better than the best-informed consent! And no person can assure himself/herself of no legal action just because of the presence of informed consent, aptly stated by The California Supreme Court –

“One cannot know with certainty whether a consent is valid until a lawsuit has been filed and resolved.”

Hence it is important to have medical indemnity insurance for a sufficient amount of money to have protection. Most of the corporate hospitals have made this mandatory for the consultant doctors.

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.