Delhi Journal of Ophthalmology

Legal Liabilities and Duties of a Doctor: Part 1

1Kirti Singh, 1Bhumika Sharma, 2Arshi Singh, 3Anju Lal 
1Guru Nanak Eye Centre, Maulana Azad Medical Sciences, New Delhi, India
2LVPEI, Bhubaneshwar, 3Delhi High Court, New Delhi 

Corresponding Author:

Kirti Singh
Professor, 
Guru Nanak Eye Centre, 
Maulana Azad Medical Sciences, New Delhi 
Email id: mail4kirti@gmail.com

Published Online: 26-JUL-2017

DOI:http://dx.doi.org/10.7869/djo.293

Abstract
The current ethos of degenerating doctor patient relationship is a cause of concern for medical fraternity. Ever increasing rate of medical malpractice cases, doctor patient conflict is draining the doctor of financial resources and professional satisfaction respectively, not to mention loss of dignity and peace. A key weapon in our defense against charge of “professional misconduct” is appropriate knowledge of what all is entailed by conduct as per legal language. This article is part of two sections, the first one deals with medical negligence, dereliction of duty, consumer protection act in relation to physicians, informed consent and documentation of records.

Keywords :medical negligence, act of omission/commission, medical tort, patient consent, consumer protection act CPA, medical records and documentation

Introduction

Current climate in our country is witnessing a degradation of doctor patient relationship, erosion of mutual trust leading to recurring conflict situations. Media, administrative set ups and governmental agencies are increasingly targeting health care facilities for perceived wrongs committed by physicians. Although conflict is both understandable and inevitable in all human dealings, its dramatic increase in the past decade is a cause of concern and introspection for the medical fraternity. Conflict if allowed to escalate, becomes destructive with the dissatisfied or trouble seeking patient, resorting to legal action seeking monetary compensation for “alleged /perceived maltreatment practices.” Research into doctor patient “difficult encounters” have identified some contributory factors to be - unreasonable / unscrupulous patients, yellow journalism, un -professionalism in doctors, lack of rapport due to poor communication skills.1 A triumvirate of clinical competence, effective communication skills and requisite knowledge of legal liabilities / responsibilities, on the part of the treating physician, has been recognized as the key to deescalate conflict and thwart litigation.2-4 Medical curriculum of India emphasizes training in clinical competence but is largely silent and fragmentary in aspect of communication skills and legal liabilities. These lacunae have been realized and the “Vision 2015” document of MCI reaffirms need to include training in communication skills to the graduating doctors.5,6 The third aspect “ requisite legal knowledge”, is still being overlooked and ignorance regarding legal liabilities often lands the physician in an unenviable position of being charged as a defendant, subjected to ignominy of a trial in either a consumer or criminal court. A claim that “I did not know,” does not hold any water in a court of law and since a charge of professional negligence has economic, social and legal consequences it is imperative that doctors become familiar with legal language and duties, so that they are not caught napping. This article dealing with the legal aspects related to medical practice with emphasis on ophthalmic practice, seeks to be a wake-up call for our ophthalmic brethren to be vigilant of malpractice claims and adopt requisite preventive measures. 

How, does the law define medical negligence ? 
What does tort mean ? 

Lack of clinical competence can be construed as negligence and Indian courts judge cases of medical negligence on basis of Bolam Test (Bolam V. Friern Hospital Management Committee 1957, IWLR 582). This test defines negligence as failure to act in accordance with “standards of reasonably competent medical men of that time, which may not be the highest expert skill”.7,8 Medical negligence can be punished by compensation or imprisonment as it can be considered both a civil or criminal wrong, depending on its gravity.9 However for the latter a very high degree of gross negligence needs to be proved. A patient approaching a doctor / hospital expects medical treatment in accordance with requisite knowledge and skill. He also expects the doctor to keep his/ patient’s interest in mind during treatment. This relationship thus assumes the form of a contract retaining essential elements of a tort and failure to discharge this obligation on part of doctor or hospital, a tortious liability. Tort is name given to a civil wrong (right in rem) which has harmed a person and this breach could attract judicial intervention.10 The person who commits the tortious act, is called a tortfeasor and owes a legal liability towards the victim. The victim or plaintiff can sue for damages by a lawsuit, but must prove that the act / or lack of it caused the harm/injury. The onus to prove negligence thus lies with the patient. Error in diagnosis or failure to cure a patient does not necessarily imply negligence.10 

Negligence is labelled as a tort, it can be collateral, comparative continued, criminal, hazardous, active or passive, wilful, reckless or “ negligence per se “ . Black’s Law Dictionary defines negligence per se as “conduct, of action or omission, which may be declared as negligence without any argument or proof as it violates dictates of common prudence”.8,10 The three cardinal elements in negligence are- duty of care, failure to exercise it (dereliction) and consequent damages:11,12 

a. Duty of care: A person who holds himself ready to offer medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. A doctor must be under duty of care to be charged for negligence by the patient. Example - a doctor treating an ocular trauma case in the emergency room is under “duty of care”, but if a doctor gives first aid to a similar case during a road side accident, duty of care would not exist. Duty of care also does not exist in medicolegal examination for issuing medical certificate for disability.10,11 

b. Failure to exercise duty of care (Dereliction): This is defined as failure of a doctor to honour his duty owed to a patient. Such breach of duty may be an act of commission or an act of omission, with the latter carrying more punitive action, however this is disputed by critics who say omission can also be as deliberate and as unethical.13

Acts of omission: As the name suggests, it occurs due to failure, oversight, lapse or forgetting to perform an action, eg failure to get blood pressure tested prior to cataract surgery, failure to get second opinion in writing prior to performing a destructive procedure like enucleation. This failure to perform an act, called Actus reus (Latin for guilty act) in legal parlance, results in harm. 

Acts of commission: This implies consciously performing an act which is wrong eg removing a lens which was not cataractous, giving anti VEGF injection in wrong eye.9 Such acts should not have been performed as per standard accepted protocols and would not be undertaken by a prudent doctor.13 

c. Causation of damage to the patient on account of dereliction: This occurs if it is proved that breach of duty was the real cause of damage. Example: an anti VEGF injection caused endophthalmitis in the normal eye. Defective treatment cannot be counted as negligence unless supportive positive evidence including expert opinion is brought on record.8 

A doctor cannot be held negligent because a complication eg vitreous loss occurred if she/ he has followed the standard operating protocol of managing such complications.9 
A case by Supreme Court of India, Kusum Sharma Vs. Batra Hospital & Medical Research Centre” reported as 2010 AIR (SC) 1050, laid down 11 principles for medical negligence , of which a few are detailed , to understand the courts’ mind set .

- Breach of duty exercised by omission to do something which a reasonable, prudent man, guided by considerations which ordinarily regulate the conduct of human affairs, would do. 
- Negligence must be culpable/gross and not merely based upon an error of judgment or diagnosis.
- In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is not negligent merely because his conclusion differs from that of other professional doctor. 
- Often the doctor adopts a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient. In such cases result may not amount to negligence.
- It is our bounden duty and obligation of civil society to ensure that doctors are not unnecessary harassed or humiliated so that they can perform their professional duties without fear and apprehension.
- Medical professionals are entitled to get protection so long as they perform their duties with reasonable skill and competence and in the interest of the patients. 
- Under normal circumstances, the onus or burden of proof lies heavily on the patient to prove negligence.

Consumer Protection Act (CPA)

This act considers a patient who has hired services against a consideration, to be a consumer. In 1995 a verdict by Supreme Court on Indian Medical Association vs. V.P. Shanta and Others, 1996 AIR (SC) 550, clearly stated that medical profession comes under the ambit of Consumer Protection Act of 1986. The exceptions are hospitals and doctors working there, where no fee is charged for medical services except a nominal registration fee eg government hospital, who do not come under CPA.8,9 A government servant receiving services under CGHS, railway hospitals and other schemes is also not labelled as a consumer.9 In case of charitable hospitals where some patients are charged, the non-paying patients are also considered as consumers and the hospital comes under CPA.10 [Case of Additional director CGHS Pune v Dr RL Bhutani, I (1996) CPJ 255 (National commission 1996(1) CPR 136 (National Commission)]. 

Consent - Definition and implications 

The definition of “Consent” as per Section 13 of Indian Contract Act, 1872 states - “two or more persons are said to consent when they agree up on the same thing in the same sense.” This consent has to be voluntary (without any coercion, undue influence, fraud, misrepresentation) agreement, compliance, or permission for specified act or purpose.9,11 Any treatment or operation done without consent is equivalent to assault for which patient can legally claim for damage. Consent can be obtained from conscious, mentally sound adults free from undue influence, coercion etc. A person is said to be in sound mind when he is in a position to understand the consequences of the act or incidents, which will follow his consent and which are in his interest. (Samira Kohil V. Prabha Manchanda AIR 2008 SC 1385) Thus, a person of unsound mind such as a lunatic or a person under the influence of liquor or drugs cannot give valid consent to his doctor in respect of proposed treatment or surgery. Consent in context of doctor-patient relationship means grant of permission by the patient for an act, diagnostic or therapeutic, to be carried out by the doctor.

Implied consent: This can be oral or by conduct. A patient walking into the hospital for examination is assumed to have given implied consent.13 But for sensitive issues like examining a trauma case, it is preferable to ask for written express consent, in presence of a witness, one of which should be the patient’s relative/ attendant. 

Exceptions to taking consent: A consent can be waived off, prior to an intervention/ treatment, if the patient is in coma, needs emergency treatment or for a medico legal case referred by a court of law for examination. In such situations treatment and even surgery may be conducted without consent with the proviso that treatment is in the interest of patient. In such situations it is advisable that decision to operate is ratified by a panel of two or more doctors, who decide on optimal plan of action. It needs to be remembered that failure to perform an emergency operation for want of consent also amounts to negligence.9 

Consent does not provide immunity from being held negligent either by a court or by Consumers Forums established under Consumer Protection Act, 1986 (CPA). Principles relating to consent have been given by Supreme Court of India in Samira Kohil V. Prabha Manchanda AIR 2008 SC 1385: 

i) A doctor must seek and secure patient’s consent before commencing a ‘treatment / surgery”. The consent should be real and valid, which means that patient should have capacity and competence to consent; voluntary; and on basis of adequate information concerning nature of treatment/ procedure.
ii) Informed consent: Adequate information to be furnished by doctor/ team member to enable patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that doctor should disclose - nature and purpose of proposed treatment and its purpose, benefits and effect; alternatives if any available; an outline of the substantial risks; and adverse consequences of refusing treatment/ procedure.14 The same must be explained in patient’s own language. A study analyzing triggers in ophthalmic litigation found lack of an informed consent form (63% cases) to be a key culprit generating prosecution.15 It must be remembered that taking informed consent does not imply explaining all remote, theoretical risks which may frighten or confuse a patient and result in refusal of consent for the necessary treatment. Thus taking consent needs use of effective communication skills. 
iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Similarly consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure, despite that unauthorized additional surgery would benefit or save considerable time and expense to patient, or relieve patient from future pain / suffering. The exception to this rule is where an additional procedure though unauthorized, is necessary to save life or preserve health of patient with delay being unjustified. 
iv) To safeguard against such situations, a common consent for diagnostic and operative procedures and for a particular surgical procedure / or additional procedure which may become necessary during the course of surgery, can be taken eg retinal surgery during vitrectomy or evisceration in case of extensive ocular trauma. 
v) For children ( under the age of 18) consent/permission needs to be given by parents and in case the child is above 7 years then “child assent” is also mandatory.14 

Documentation and Record keeping 

Proper documentation and record keeping is the time proven talisman which helps doctor in proving his competency and disproving negligent behavior. This documentation should begin in outpatient department where an OPD card must have – a clearly written full name (preferably in capital letters and legible writing / computerized), age, gender, with father’s / husband’s name or mother’s name in case of neonates. The complete address with contact numbers should be mentioned in both hospital records and OPD slip. 

The documentation of complaints, history, examination (primarily all positive findings and important negative findings) should be written along with date of examination and follow ups. The prescription should mention generic name of medications with their dosage and frequency. If relevant, side effects of prescribed drugs which can hamper daily activities should be mentioned eg for Brimonidine drops one may mention that patient should not drive for few weeks because of sedation side effect. This would be extremely important if the patient is a commercial driver by occupation. It may not be practical or feasible in a busy practice to explain or write about side effects of every drug prescribed, therefore a typewritten / photocopy of generic precautions can be attached to the records, with relevant information being highlighted.8 Certain dangerous adverse effects must be clearly written eg steroid usage beyond prescribed time causing irreversible visual loss due to glaucoma. The prescription should be signed and stamped, the latter carrying name and registration number of treating doctor. Such stamps should be in the possession of the treating doctor and not left unattended, to prevent misuse/ abuse. 

Since surgical complications are the most common cause of malpractice claims, and one study puts this figure to be as high as 94%15, surgical records should be meticulously written, recording all details including complications with their management. This would help in safeguarding the doctor in case of litigation, as records testify that standard protocols were followed.9 The discharge summary should carry a brief of investigation reports and it must document any complications, measures taken to correct it and treatment advised eg post capsule rupture occurred, anterior vitrectomy done, IOL placed in sulcus. Wherever possible electronic back up should always be made. This assumes importance in view of the fact that cataract surgery complications, retinal detachment and endophthalmitis are the most common triggers for negligence claims.15 

Follow up visits need to be clearly explained and mentioned. The discharge slip should also mention warning signs warranting attention and possible treatment where the patient needs to report immediately eg sudden diminution of vision / pain and/ or red eye. In addition the paramedical staff need to be sensitized, beforehand, to triage such patients and bring them to a senior doctor on a priority basis. 

Typed records are preferred as illegible handwriting can have deciphering issues in case of legal claims or peer review. 

Storage of records 

Medical Council of India (MCI) requires records to be preserved for a period of three years for operative cases and 2 years for OPD records in case of adults and for 21 years in case of children. (Section 24 A CP Act 1986) Maharashtra Govt. has issued a GR No. JJH-29-66/49733, which states that OPD papers should be kept for 3 years, inpatient for 5 years and in cases of legal complications for 30 years.8,9 

What all records need to be kept? 

Informed consent or refusal of treatment/ investigation
Investigations (pathological, radiological, referrals/ opinion of other specialties)
Operative: Details of type of surgery, date, operating surgeon, anesthetist, concise preoperative and postoperative notes with description of condition on discharge. 
Discharge card - clearly mentioning follow up visit and emergency signs requiring patient to report immediately. Again a generic paper listing these can be attached or typed with requisite boxes being ticked. 
Referral: Date, nature of referral, probable diagnosis and condition at time of referral, reason for referral with expected course of action and prognosis should be mentioned. It is wise to get the copy signed by the patient, if future problems are anticipated. Medicolegal records, death register (manual and electronic) need to kept in safe custody.

Conclusion 

The one talisman which will help guard against spurious and malafide complaints is meticulous record keeping. Recorded facts speak in a court of law and best witness in case of clinical negligence claims. The value of establishing patient rapport using effective communication skills in immense. Proper patient counselling, giving realistic expectations, professionalism with ethics, ensuring open honest communication channel in case of mishap, daily documentation during follow up in case of a complication, record keeping for future reference, early recognition along with adoption of remedial strategies for an unhappy patient are some practices which an ophthalmologist should adopt to prevent being subject to malpractice case.

References
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  2. Ann PG, Rabatin JS, Manwell LB, Linzer M, Brown RL, Schwartz MD; MEMO Investigators. Burden of difficult encounters in primary care: data from the minimizing error, maximizing outcomes study. Arch Intern Med 2009; 169:410-4.
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  7. Jones JW. Law & ethics: The healthcare professional and the Bolam test. British Dental Journal 2000; 188:237-40.
  8. Kaushal AK. Medical negligence and liabilities of a doctor. In Medical negligence & Legal remedies. 3rd edition. Eds Arora M . N. Delhi Universal Law Publishing Co, 2004 pg8-63. 
  9. Deshpande AA. Legal aspects in ophthalmology. AIOS CME Series 27, N Delhi, All India Ophthalmic Sciences 2013 
  10. Pandit MS and Pandit S. Medical negligence: Coverage of the profession, duties, ethics, case law, and enlightened defense. A legal perspective. Indian J Urol 2009; 25:372–8.
  11. KV Raju. Medico Legal Aspects of Ocular Trauma. Kerala Journal of Ophthalmology 2010, Vol. XXII,(3):277-278.
  12. Rangnath M, Venkatachallaiah MN. Supreme court of India. AS Mittal & Others versus state of Uttar Pradesh and others on 12 May, 1989 Equivalent citations: 1989 AIR 1570, 1989 SCR (3) 241.
  13. Chaudhari Z and Kulkarni A N. Ethical and medicolegal aspects in ophthalmology. In Postgraduate ophthalmology Eds Chaudhari Z , Vanathi M Jaypee brothers medical publishers New Delhi, 2012 pg 2249 - 2265.
  14. Nijhawan LP, Janodia MD Muddukrishna BS , Bhat KM, K. L. Bairy KL Udupa N and Musmade PB. Informed consent: Issues and challenges. J Adv Pharm Technol Res 2013; 4:134–40.
  15. Santos W, Solari HP, Ventura MP. Litigation in ophthalmology: analysis of possible triggers. Arq Bras Oftalmol 2010; 73:501-4.

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Kirti Singh, Bhumika Sharma, Arshi Singh, Anju LalLegal Liabilities and Duties of a Doctor: Part 1.DJO 2017;28:47-50

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Kirti Singh, Bhumika Sharma, Arshi Singh, Anju LalLegal Liabilities and Duties of a Doctor: Part 1.DJO [serial online] 2017[cited 2020 Jan 20];28:47-50. Available from: http://www.djo.org.in/articles/28/1/legal-liabilities.html