This article is written by Dr. Lalit Kapoor.

Introduction

Never before in the history of the medical profession in this country have we witnessed the kind of hostility and aggression against doctors that is evident today. The public perception of doctors is at its lowest in terms of integrity. Ironically, despite the mind-boggling advances in medicine which are being successfully applied by Indian doctors (at a fraction of international costs) in treating patients, the doctors in our country are being portrayed as incompetent and sub-standard apart of course, from being dishonest.

The medical profession is under intense public scrutiny and there is a serious trust deficit between patients and doctors. There is a quantum leap in the number of doctors and hospitals being litigated against. Humungous compensation awards are being handed down at the drop of a hat. Apparently, as far as doctors are concerned, Society and State seem to be in an attack mode! 

It is hence, all the more incumbent upon us to proactively steer away from potential medico-legal problems so as to pre-empt litigation and its attendant sequelae.

In recent times, a rise in the incidence of malpractice litigation against critical care physicians is perceptible. Hence it is appropriate to identify the medico-legal challenges by practitioners of critical care Medicine along with preventive measures (if any!).

What is it that makes intensive care physicians somewhat more vulnerable to medico-legal problems?

Intensive care units treat seriously ill patients. In spite of ‘intensive’ care and best efforts of the team, morbidity and mortality rate is high compared to other units. Reportedly, the mortality rate is 30 % — considerably more than the average risk. American statistics reveal that 1 out of 5 Americans will die in an ICU. Figures for our country are not available. The urgency, complexity and invasive nature of intensive care increase the risk of legal exposure to its practitioners. Life and death situations are common in intensive care settings and ICU caregivers may find themselves playing God at times!

The old assumption that intensive care saves lives and any injury or mishap that occurs in the process is therefore unquestionably accepted by patients or relatives no longer holds good.

What is it then that we need to do? 

We need to:

• Practice rational, evidence-based medicine and to keep updated on current guidelines and protocols.
• Familiarize ourselves with current laws (or absence thereof!) relevant to medical practice.
• To realize the inevitability of practicing defensive Medicine
• To identify potential problem areas and learn how to deal with them.

Legal issues arise out of allegations of negligence or malpractice. The simplest definition of negligence is: 

Deviation from accepted medical standards of practice as a result of which harm results to the patient.

What are the common allegations made against critical care physicians?

• Missed/Delayed diagnosis;
• Negligence in medical management including complications of procedures;
• Failure/Delay in Referral;
• Medication Errors;
• Hospital-acquired infection;
• Lack of Informed Consent;
• Failure of Communication with the Patient/ Relatives or with fellow care providers;
• Premature shifting from ICCU;
• Pertaining to end-of-life issues.

What are the potential problem areas we need to be especially alert to?

Record keeping/documentation of patient care

Record-keeping is one of the most deficient areas of medical practice in our country. Good records are critical to the delivery of safe and competent medical care .They are also your best defence against allegations of negligence. 

Remember: Good records = Good defence. And as far as the Law is concerned, what is not documented, never happened!

What are the qualities of good records? 

As is well-known, good records ought to be correct, clear, comprehensive, chronological and contemporaneous. 

CAUTION: Incredibly, even today, a large number of physicians record only the date of examination and do not think it essential to record the time of examination. To have to stress the importance of writing the time of examination, especially in an ICU setting, would surely be a no-brainer. And yet, this lapse in record –keeping is not as uncommon as one may imagine. It may be worthwhile for you to conduct a quick random audit of your case papers to confirm this.

TIME must inevitably follow DATE, in your patient entries. It may appear trivial but it could be of crucial importance in many a case.

Informed consent 

Another area that is a potential minefield, as far as medico-legal liability is concerned, is patient consent for undertaking treatment.

By now, all of us are aware of the importance of taking consent. Administering treatment in the absence of consent can be construed as negligence per se and even worse , could attract the criminal charge of assault and battery.

Absence of consent can amount to an ethical, civil and criminal wrong. It is therefore important to ensure valid, informed consent before accepting the responsibility to treat a patient.

Lately, consumer courts have magnified the issue of informed consent and if there is no evidence of negligence otherwise, lack of informed consent is cited as the offence. Hence , the great importance of understanding the concept of legally valid consent.

A few quick points about informed consent:

• Ingredients of informed consent -Make sure the patient understands the nature of his condition, the alternate treatments or procedures, nature of proposed treatment, risks of proposed or alternate procedures and the chances of success or failure of the treatment.
• Mere signature on a pre-printed consent form is not adequate. It should be specifically recorded that a discussion took place and patient/relatives were explained the contents.
• Consent should be ‘procedure specific’. Blanket consents are faulted by courts.
• The written consent should preferably be in a language which the patient / relatives can understand.
• Refusal of consent or denied consent should be recorded, signed and witnessed.

Quite recently in a Delhi hospital, the procedure of inserting a central venous line resulted in injury to the jugular vein following which patient was shifted to a higher centre for emergency treatment. A complaint before the National Consumer Forum ended up with compensation of Rs 7 lakhs being awarded to the patient .The court averred that a specific informed consent ought to have been taken for the procedure which was invasive in nature and had the potential of causing serious complications.

Hospital Acquired Infections (HAI)

Allegations pertaining to HAI are of special significance in ICU patients on account of a higher incidence. Obviously, preventing HAI would significantly lower risks of bad results and therefore complaints.

In the event of such allegations, the hospital would need to establish that Infection control measures were in place (e.g. hand washing protocol, infection control committee, etc.} and documentation of such control measures would have to be proved.

Communication deficit

ICU caregivers need an extra dose of communication skills in view of the dynamic changes in clinical status of patients. A good proportion of malpractice allegations especially in the ICU setting have their genesis in a failure of communication.

Importantly, when we speak of communication, it refers not only to communication between you and the patient or relatives but also inter-communication between the multitude of caregivers viz. fellow consultants, resident doctors, nurses, physiotherapists and so on.

It is vital that there are no discordant notes in the communication with the patient or relatives. Differing versions are hazardous and all caregivers should be on the same page. It is important that the patient and family do not pick up conflicting messages about the patient’s progress and expected outcome.

The importance of patient notes and documentation has already been mentioned. The importance gets further emphasized when we realize that good patient notes are indeed a very good vehicle of communication between the various caregivers attending to the patient. The value of this would be further enhanced if the notes were to not only record clinical findings and events but the reason why decisions were made.

Finally, establishing a good rapport with the family of the patient (who are indeed the patient’s surrogate decision-makers) by empathizing with them in an emotionally difficult time pays good dividends in terms of quelling any grievances which could escalate into full-blown medico-legal issues.

Medico-legal challenges arising out of end-of-life issues and withdrawal of life support (wols)

This is a major challenge. Due to constraints of space, it is not possible to elaborate on this at length, but nevertheless, here are a few salient points.

• End-of-life issues are potential landmines for intensive care physicians
• In our country, changes in law have not kept pace with advances in medicine. We do not have an unambiguous legal stand on end-of-life issues. Lack of clarity of laws causes much stress in ICU caregivers.
• Though it is now accepted that the right to life includes the right to die with dignity, there are no clear answers to the question “Is it ethical to limit life-prolonging interventions when poor status of a patient indicates these to be non-beneficial?”
• An informal survey which I carried out in the leading ICUs in Mumbai revealed that self-designed formats for “DNR” have been created on which signatures of relatives are being taken. These are all invalid “DNRs” which will not stand in any court should they come up for legal scrutiny. Procedure for Living wills/advance directives have now been laid down by SC judgments (see below) and strictly speaking only these would be considered valid.
• Following 2 landmark SC judgments have attempted to initiate resolution of these dilemmas. Every intensive care physician must read the following judgments. There is no rocket science involved her. They are in simple English and are in fact, interesting to read.

Aruna Ramchandra Shanbaugh Vs Union of India – Delivered on March 07, 2011 by Justice Markandey Katju and J. Gyan Sudha Misra.

Common Cause (A Regd Society) Vs Union of India – Delivered on March 09 , 1918 by CJI Dipak Misra and Justice Khanvilkar.

• Theoretically, Passive euthanasia and making a Living Will / Advanced Directive are now legal in India. But the procedure to implement them are tortuous enough to make them impractical. Efforts by many public-spirited doctors and members of civil society to make these implementable are on and may yield results in the future.
• I propose to amplify on this very important issue in the next edition of GRASP.

To summarise:

• Critical care is a highly complex area of Medicine
• It is advisable to proactively steer away from potential medico-legal problems so as to pre-empt litigation and its attendant sequelae.
• Diligent record-keeping, precautions on informed consent and acquiring effective communication skills are antidotes to potential medico-legal challenges
• We must familiarize ourselves with laws relevant to medical practice. 
• And of course, the best way to deal with medico-legal problems is to prevent them.

Students of Lawsikho courses regularly produce writing assignments and work on practical exercises as a part of their coursework and develop themselves in real-life practical skill.

LawSikho has created a telegram group for exchanging legal knowledge, referrals and various opportunities. You can click on this link and join: