Clinical Guidelines – An Objective Mitigator of Litigation

BACKGROUND:

Consider these case scenarios:

1. V. Krishnakumar vs State of Tamil Nadu & Ors., 20151 – was filed for the little girl, Saranya (aggrieved at birth by loss of her vision) was awarded compensation 19 years later, by which time, she and her parents lost precious time for shaping her education/life/career. The doctors were held guilty using guidelines from across the globe as evidence.
2. P. B. Desai Vs State of Maharashtra & Anr., 20132 – was filed against the doctor and he was finally absolved of all ‘frivolous’ charges by the Supreme Court, after being convicted in three lower courts based on subjective evidence! Thus, a Padma Bhushan awardee, Senior Oncology Surgeon, Dr. Desai, spent 26 years of stress of litigation during the prime of his medical practice.
3. Against the Order / Judgment OS 607/1995 Vs The K.P.S.C, 20153 – for the death of a patient with post-traumatic fat embolism syndrome, treating Doctors of Trivandrum Medical College were convicted after 29 years of deliberations, during which theoretical evidence, for urinary diagnosis of Fat embolism syndrome, from Forensic Medicine text was considered.
4. Christian Medical College vs State Rep., 20104 – for a patient who developed Ca Breast when on HRT and underwent mastectomy, Criminal case registered based on the “expert” opinion given by two doctors (from Dermatology and Paediatrics) and the consultant physicians of CMC, Vellore, were convicted by Judicial Magistrate. Fortunately for the accused, “expert” evidence by the Ethics Committee, MCI, favoured their acquittal.
5. All of the aforementioned scenarios indicate a virtual “Damocles’ Sword”, perpetually over the heads of medical fraternity irrespective of the experience / reputation.

The magnitude of the litigation is equally worrying – A rise in the medico-legal cases by almost 400% in the Supreme Court alone in the last decade has been reported, by a legal resource, Manupatra.

The fact remains that we, as a body, failed to effectively self-regulate which we were empowered to do by the Indian Medical Council Act, 1956.

Lack of uniformity and accountability in what we do or say as a fraternity is possibly the single most important reason for our vulnerability and ‘miseries’.

Due to a general complacency on the part of the medical fraternity, the medical profession has been ‘losing’ its domain to external agencies who take control and attempt to regulate the medical profession; for example:

• The businessmen who invest in the health ‘industry’, dictate what the doctors ‘should do’ to ‘justify’ their ‘recruitment’,

• Cost of medical treatment is gradually being dictated by the insurance companies

• The courts have been periodically forced to take cognizance of unethical conduct.The “turning point” case of Kunal Saha Vs AMRI, 2013, with compensation of Rs.11.41 Cr., evoked widespread debate among the general public, legal and medical fraternity. In a “head to head” debate titled, “Are large compensation payouts for negligence good for medicine in India?” reported in the BMJ6, Dr Devi Shetty (Renowned Cardiac Surgeon), says, “In 2030 BC, the code of Hammurabi, the king of Babylon, was to chop off a doctor’s hand for making a mistake. This approach may prevent future mistakes but after some time few doctors would be left with hands to operate.” India’s current legal position on medical negligence is not vastly different from Hammurabi’s code.
• Hence the need for National Clinical Guidelines.

FORMULATION OF NATIONAL CLINICAL GUIDELINES :

• WHAT IS IT: These are essentially, evidence-based unequivocal protocols for practice of medicine for each specialty across our country. Cost of medical treatment is gradually being dictated by the insurance companies

• HOW DO WE FORMULATE: The Professional Regulatory Body (PRB, which is the Medical Council of India-MCI-, at present) could assume the Statutory Responsibility of heading such a formulation. The Council could short-list proficient academic stalwarts from each specialty of reputed institutions, in each state and Ad hoc committees could be constituted, or, more simply, the already existing individual national associations of specialists, like API (Association of Physicians of India), ISA (Indian Society of Anaesthesiologists) could undertake to formulate the framework in their respective specialties, and then the MCI can integrate it into the National Clinical Guidelines, like how the NICE (National Institute for Clinical Excellence) has done for the NHS (National Health Services) of UK. How frequently we need to update, can also be specified.

• WHAT DO WE ENVISAGE: Under the “National Clinical Guidelines” we need the “A / B / C / D / E” of healthcare

APPROVAL / CONSENT

Precise guidelines with Clarity (which is lacking today) on Consent, which is most fundamental prior to undertaking any procedure. Ambiguity of which attracts penalty for Battery/Assault, under Indian Penal Code Sec. 350/351. Legal academicians from law institute of National repute, like the NLSIU, Bengaluru have agreed to help if sought. One such article from the legal fraternity, dealing with ‘Consent and medical treatment’ is worth a read. BASIC PROTOCOLS – precise management protocols which cannot / should not be breached, unless, adequately justified individually/by second opinion. For example, the medical officer in the emergency department of a hospital should be qualified/trained/certified appropriately and should follow the basics of emergency care like, C/A/B of Basic Life Support. After following such principles of mandatory care, the subsequent definitive care could be customised depending on the given set-up, which takes us to the next facet.

CLINICAL PATHWAYS :

These are guidelines8: which embody protocols and also provide flexibility to the plan and method of diagnostic/therapeutic care depending on the given set-up, which could be anything from a basic primary health care centre to a sophisticated corporate hospital. Such pathways (updates included) could be outlined by the association concerned and approved by the Statutory Body.

The classic example where such a system worked was the famous Maine Medical Liability Demonstration Project, which ran for period of 8 years on a trial basis using the Code of Maine Rules / Guidelines / Protocols developed by Maine Licensing and Registration Boards with 4 other National Medical and Surgical Associations. For the given guidelines in the four identified fields of obstetrics / gynecology, emergency medicine, radiology and anesthesia, the statute permits physicians electing to participate in the demonstration to use these guidelines as an affirmative defense in medical malpractice proceedings. Under the affirmative defense provision, use of guidelines as evidence is no longer a matter of the judge’s discretion.

It is worth noting that there was not a single case of malpractice claim filed against a doctor on medical conditions covered by the guidelines. Apparently, the plaintiff attorneys are more reluctant to file a lawsuit if they do not expect to achieve any success.

DUTIES OF PATIENTS AND PHYSICIANS

Enlisting the duties of BOTH patients and doctors which aims at emphasising on the value of trust and the responsibility imposed by trust. Services to empower patients like the NPSA (National Patient Safety Agency) and PALS (Patient Advocacy & Liaison Services) as under NHS, UK; wherein patients are provided information about medical care, as applicable to our country and also the opportunity to provide feedback of adverse events which could channelize grievances with purposefulness of finding a remedy (in the short term) and by adding to literature/evidence, therefore restructure guidelines (in the long term).

There are also patients who try to take advantage of their “favoured litigant status” and “no fees payable” status in the Consumer Court, and file frivolous lawsuits by fabricating medical records and alleging “consent not given”, there by putting a huge strain on both the medical and legal fraternities, while the patient himself stands nothing to lose. NABH’s Guidelines on Patient’s Responsibilities could be integrated here to prevent such issues.

ETHICAL GUIDELINES

These are possibly THE most relevant in health care.As quoted by Rabindranath Tagore,“a mind all logic is like a knife all blade .It makes the hand bleed that uses it.” While ethics in Healthcare cannot be overemphasised, incorporating such guidelines in our country is more relevant considering the fact that we have a dubious distinction of challenging a law meant for our own safety, for example, the ‘helmet rule for the two-wheeler riders’ which was challenged in the Madras High Court, Chennai!!

As the adage goes, ‘there is no smoke without fire’, there is a steep and surreptitious rise in the ‘medical malpractice’ (violation of ethics) as a study reveals ‘Unethical’ targets in India’s private hospitals, due to ‘financial targets’ set by certain hospitals13, such unethical ‘commission- based’ practice which if persists, could attract a legislation,and would thereafter qualify as ‘medical negligence’ (violation of law). The “unarticulated premise” of physician’s time spent with the patient determines the standard of care in the patient’s mind and also in the adjudicator’s mind should the patient litigate. India could be the first country to add this humane dimension to clinical guidelines which could provide the safest ‘handle’ protecting the patient (during treatment) and the physician (during litigation) from the ‘blade of all logic’. On the same note, in cases of medical negligence, as a prelude to judicial / quasi-judicial proceedings, a “Patient Grievance Redressal Cell” could be constituted using the infrastructure provided by the IMA, overseen by the PRB, which allows the aggrieved patient to interact with the physician, wherein most disputes are concluded even before they take shape of a law-suit, as successfully tried over the last two years by a private firm, “M/s LegalExcel Healthcare, Solicitors and Advocates, Bengaluru”, anchored by Prof.(Dr.) Joga Rao, for a chain of hospitals. More legislations for grievances for doctors/patients result in more complexities of law and more is the trust-deficit and counter-productivity. Whereas, a move such as this, where the ‘core’ of goodness/humanity (present in every human, at variable sensitivity though) in a person is touched, by the principles of natural justice, the solution could be, more often than not, reached almost instantly; thereby saving time/energy/mental and financial stress and most importantly, help in preserving the patient-doctor trust. In this context, it would be appropriate to cite the example of a baby, with terminal illness, who succumbed following a medical error. At the redressal forum, the baby’s mother, appreciated the doctor’s honesty and diligence and sought to blame destiny rather than the doctor, thus concluding the issue on a note of goodwill in a few hours, in what would otherwise be a long drawn legal battle (personal communication with Prof.(Dr.) Joga Rao). On a positive note, the Indian Medical Council is already implementing the Professional Conduct, Etiquette and Ethics Regulation, 2002, and taking deterrent action against errant doctors14 15 16 which augurs well for the future of ethical medical practice in our country.

HOW DO WE IMPLEMENT:

At the levels of

• Undergraduation and Postgraduation training
• Official websites of the IMA and MCI
• All physicians/patients/others through “mobile apps” by which, such guidelines are readily accessible ‘offline’ and easily updateable when ‘online’. This idea is borrowed from the fact that the legal fraternity have one single ‘app’ called “Indian Bare Acts Pack”, which includes vast information/guidance on Indian Penal Code / Criminal Procedure Code / Indian Evidence Act / Civil Procedure Code / Service Tax Law
• The proposed National Exit Test (NEXT) exam for all MBBS graduates, which, rather than opposing, the National Clinical Guidelines for general practitioners could be suggested as the ‘syllabus’ for the exam, which would help:

1. passing the exam easily!
2. providing patient care and fight litigation(when faced) confidently
3. government in improving healthcare
4. medical fraternity gain credibility

HOW DOES IT HELP:

• Ensures the basic standard of care to the poor/illiterate citizen
• Eliminates fear of litigation in the mind of a physician and therefore, facilitates the optimum medical care
• Evades “internetosis” (misled internet surfing), therefore needless confusion/ frivolous litigation
• Expedites adjudication of medicolegal cases, therefore, hastening justice to the aggrieved, be it the patient/physician
• Exclude bias when addressing matters of ethical violation among physicians

GOAL:

Providing uniform health care / lending credibility to the medical and legal fraternities and thus, enhancing the credibility of governance setting off a cycle of goodwill.

AS A SEQUEL – MEDICAL TRIBUNAL:

As a further step forward, once Statutory National Clinical Guidelines are formulated, the Medical fraternity could demand for CONSTITUTION OF MEDICAL TRIBUNALS. MEDICAL TRIBUNAL is an urgent need, considering the high level of proficiency required in matters of medicolegal disputes. While the consumer court (a Tribunal) aims at expediting, proficiency is conspicuously lacking, resulting in a situation of “justice hurried is justice buried”, when attempting to avoid a situation of “justice delayed is justice denied”, in the Civil Court. Medical Tribunal could be the ideal solution to address both the issues of ‘delay’ and ‘hurry’, when such a tribunal is constituted by representatives from the judiciary, experts from the said speciality of medicine and law, the two parties to the dispute and the respective counsels.

At this time now, when

• the government is sensitized (the PSC report)17,
• the judiciary is sensitized (the constitution of Oversight Committee)18 ,
• the doctors are sensitized (by the raising medico-legal litigation and violence)
• the patients are sensitized (subject to unethical practices and trust-deficit), it is possibly high time every association draws guidelines in a way aforementioned, so as to gain acceptance countrywide, so that we have a “method in the madness”!!

“There is nothing more powerful than an idea whose time has come” – Victor Hugo.

Self-Regulate or allow State-Legislate – is possibly the only choice we need to quickly make!