MEDICOLEGAL   ASPECTS OF   ANAESTHESIA   PRACTICE
Panel Discussion: Dr. S Kumbhar, Dr. Sunila Sharma, Dr. Swati Gadgil, Judge, Police
Moderator: Dr. Pratibha Kane

Anaesthetists work in a challenging environment, many times compared to the cockpit, a nuclear reactor or an oil rig.There are ‘hours of boredom and moments of terror’ needing continuous vigilance and a sharp mental  status to react  instantly to any adverse situation. The stakes are high as consequences of a misjudgment or mistake are grave. Every anaesthetic intervention is associated with rare but serious complications, in spite of taking adequate care and caution. This fact is not usually disclosed to the patients who have unrealistic expectations of a perfect outcome. Thus every accident, error of judgement or complication is perceived to be negligence. Litigation against anaesthetists is on the rise and a routine procedure has the potential of becoming an anaesthetist’s nightmare- jeopardizing his career.Special precautions must be taken to protect our reputation, practice, our assets , our health and life from medico legal risk.
This panel discussion is aimed at understanding relevant legal principles, recommendations to prevent litigation and how to respond with a credible defense ( Documentation).
Every adverse event is an opportunity for learning, development and preventing future risk. Insights from incident reporting, patient feedback, complaints, closed claims analysis and litigation can be integrated in our practice for continuous improvement.
IMPORTANT   LEGAL PRINCIPLES RELATED TO ANAESTHESIA
Illegal Act
Violation of any Statutory Acts like The Pre-Conception & Prenatal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994, Medical Termination of Pregnancy Act 1971 is a crime. It is held that the anaesthesiologist will not escape responsibility by claiming ignorance of the illegal acts of the surgeons. He may be held as party to the crime or co- conspirator.
Law of Medical Negligence
Negligence is the opposite of diligence.
Negligence is the omission to do something which a reasonable man, guided by those considerations which ordinarily regulate the conduct of human affairs, would do or doing something which a prudent and reasonable man would not do.


Any negligence by an act or omission of a medical practitioner in performing his/her duty is known as medical negligence.

The Winfield's triad has to be established:

• That the anaesthetist had a legal duty to take care and caution,
• There was a breach of that duty, and
• Injury or damage was directly caused by that breach

The burden of proof is on the plaintiff to prove that there was negligence.
The plaintiff must prove that the doctor did not possess  the necessary skills or qualification or his conduct fell way below the standard of any doctor of that specialty in that location at that time. This is in accordance to the Bolam Principle(1)
Justice McNair in 1957 held that “a medical practitioner is not negligent if he has exercised reasonable skills and ordinary care. He need not possess the highest skill or give greatest care”. Every error of judgement, accident or mistake is not negligence. In 1957 Lord Denning in Woolley and Roe v Minister of Health in 1954 held that “Assigning blame of all complications on doctors would be great injustice and disastrous to society”.(2)
There are two kinds of medical negligence: Criminal negligence and Civil negligence.
Criminal negligence is alleged in the event of an unexpected death. Sec 304 A of the Indian Penal Code 1860(IPC): causing death by negligence without the intention to cause death. This is a bailable offence with the punishment of up to 2 years of imprisonment and fine. (Sec 304 IPC is a non bailable offence).
For conviction of a doctor in a criminal case, the recklessness and rashness should be of such a high degree which can be described gross negligence. Before 2004, there were no guidelines for differentiating between criminal and civil negligence and many doctors were arrested for deaths of patients during treatment. The issue of criminal negligence and arrest of doctors was decided in the Supreme Court in the judgements important cases. (3,4)    In Martin F. D’Souza v. Mohd. Ishfaq, Civil Petition No.3541 of 2002, decided on February 17, 2009, the Supreme Court has ruled that a private case of criminal negligence against a doctor or hospital should not be entertained unless a competent doctor states that there is prima facie evidence of gross negligence.(5) Usually the commissioner sets up a credible expert panel from a government collage and only after the panel reports that there is a prima facie case of medical negligence, a notice is issued to the concerned anaesthesiologist or hospital. This is necessary to avoid harassment to doctors who may not be ultimately found to be negligent.
Civil negligence: Civil litigation under tort is an expensive process with stamp duty, so most lawyers file civil suits under Consumer Protection Act 1986 for deficiency of service or negligence.
Consumer Protection Act 1986 (CPA)
Litigation under this act does not require a stamp fee. It is an inexpensive, simple procedure and there is speedy disposal of the cases in these courts.
The Supreme Court decision of IMA vs V.P Shantha and Others   in 1995 has brought the services of the doctors decisively and conclusively under the ambit of CPA.(7)  The status of the doctor has drastically changed from the respected and revered position to a mere service provider. Our patients have changed from obedient blind followers to educated customers, demanding accountability and sometimes unrealistic perfect outcomes.
The Legal Liability Of An Anaesthetist : The concept of the anaesthesiologist as an independent speciality is new in law and precedents are evolving. In the earliest judgements, the principle was that the surgeon was the captain of the ship and the anaesthetist worked under his direction, so the liability was only of the surgeons. Later the anaesthetist was thought to be a servant of the hospital or surgeon as the patient did not directly hire our services, so not made liable under CPA for deficiency of service.All these contentions are laid to rest by the decision of Dr. Rashmi  Fadnavis case. (8) A landmark decision was given by National Commission in 1998, where the learned judge has specifically mentioned that the anaesthetist is a qualified professional who uses his own skill and judgment and is not under the direct orders of the hospital or surgeon. (No master servant relationship).  Even if the patient does not hire our services directly and there is no previty of contract with the patient, he pays for our services  and is our customer .We owe him a duty to take care and caution and he can move against us  for deficiency of service or negligence under the CPA 1860 sec 2(1) (g).
The expert witness: Both parties have the right to produce an expert witness from the specialty in question to support their claim. Standard of care is decided by the testimony of the expert witness in accordance with the Bolam test. The expert’s stature and credibility is judged on his education, training, nature and scope of practice, memberships and affiliations, and publications. Courts have dismissed the complaints when complainant has not produced expert witness to substantiate his claim.(9,10)
Res Ipsa Loquitor: The Latin phrase ‘res ipsa loquitor’ means the ‘thing speaks for itself’. In cases of medical negligence it means that the results of the medical act point out to the negligence. Contrary to the ordinary rules of proving a case, the court presumes negligence in these cases.
Contributory Negligence is a valuable Legal Defence.  A pregnant patient with co-morbidities like diabetes, hypertension, and obesity are more likely to suffer complications. If it can be shown that the patient did not take adequate care and caution, did not follow our orders leading to injury, it either defeats the claim or the damages are diminished. (11)  For example a patient instructed to stay nil by mouth (NBM), has eaten before the procedure leading to a Mendleson’s syndrome, contributory negligence can be put forth as a defence.
Vexatious Litigation: Sec 26 of the CPA has a provision for Dismissal of frivolous or vexatious complaints by the District, State or National Commission and an order can be passed to pay the opposite party the cost of 10,000 rupees.(12)

Law Related To Consent
The most important Legal foundation of consent stems from Article 21 in the Constitution of India 1949: Protection of Life and Personal Liberty. Every human being who is an adult (18 yrs) and of sound mind, has the fundamental right to determine what should happen to his or her body, the right of Self-determination.
Sec 92 Indian Penal Code (IPC) 1860: When operating in good faith to save life and limb, consent is not required. Human life is more important than legal formalities.(9)
The ethical basis of consent states that the patient has a right to information and understanding of risk of any procedure she is advised to undertake. 
Dilemma of Disclosure: There is always the dilemma of how much to tell the patient. Remote risks are usually not required to be discussed.( 10)Need for disclosure of material risk and informed consent was established after a spate of cases in the US and UK where the plaintiffs alleged that had they known all the material risk, they may not have undergone the procedure.  In Chester v Afshar (2002)(11) the judges held that in modern law, medical paternalism (doctor knows best) no longer rules and a patient has a prima facie right to be informed of a small, but well established risk of serious injury as a result of any intervention. This judgment has set a new precedent for disclosure of all material risk. Taking an informed consent is particularly difficult in obstetrics. Education, information and addressing doubts and fears ideally must be must be done early in the antenatal period. Informed consent is time consuming, expensive and can sometimes cause undue anxiety and the patient may refuse a much-needed treatment.
Vicarious Liability
Every person is responsible for his own acts or omissions but a master has to accept liability of acts committed by his servants/ agents. This is vicarious liability. It is not applicable to criminal liability. Hospitals are made vicariously liable for acts done by their staff, obstetricians and anaesthetists. The principle holds that the hospital is responsible for the actions of their employed staff and visiting consultants.                       We can be made liable for any injury caused by our residents and junior doctors who are directly under our orders.
Law Related To Documentation:
The law related to documentation can be summed up in one sentence ‘what is not written is not done.’ Anaesthesia records are legal documents. The preoperative notes must mention co- morbidities, ASA grading and specialist referencing. All important instructions should be given to the patient in written form for clarity and recall. Essence of discussions of high risk or uncertainty needs to be documented. Anaesthesia record is an evidence of vigilance or the lack of it.  A detailed 5 min record of vital signs, time and dose of medications, critical anaesthesia events and surgical events are recommended by the Indian Society of Anaesthesiologists (ISA). Blank spaces in printed forms may be interpreted as substandard care. Electronic records are thought to be more truthful but artefacts must be initialled and explained before submission. A record must not be changed especially in the event of complications but notes may be added later. Signature and date on the record makes the anaesthesiologist responsible for what has been written. Documents are the property of the hospital and a copy of it can be given to the patient for a fee.
.Essential Perioperative Documentation

• Patient declaration (patient’s own disclosure of his medical status, medication, habits)
• Preoperative Visit Record
• ASA grading
• Co morbidities
• Specialist reference
• Consent: Informed, Separate Anaesthesia Consent
• Intra-operative record / Electronic records
• Intra-operative events (anaesthesia and surgical)
• Deviation from recommended  practice with reasoning
• Formal handing over to ICU/ ward/ transfer to other hospitals
• Postoperative written instructions for NBM period, PAIN, PONV management
• Relatives informed of transfer of responsibility of care
• Document fulfilment of Discharge criteria

The Litigation Cascade: Events leading to litigation
Litigation for an anaesthesiologist is not only expensive but involves stress, shame, guilt, alienation, uncertainty and fear which have driven many anaesthesiologists to depression and suicide.
In India we are yet not totally exposed as roles and responsibilities of the anaesthetist are not clearly known. Patients are reluctant to sue, as it is expensive and judges are seen to be biased towards the doctors. There is difficulty in getting an expert witness to testify against their own specialty. Litigation takes many years to settle and compensations are meagre. Litigation is pursued not only to gain monetary compensation for loss and suffering, but also to teach doctors a lesson.
Complications leading to death, poor outcome or permanent damage, poor service, and increasing cost leads to anger, confrontation, complaints and the threat of litigation. These interactions if not handled carefully and in time, can drive frustrated patients and their relatives to seek quick retribution by resorting to violence, damage to consultant and hospital property, refusal to pay fees and even approach the media to damage reputation.  Since 2008, many states have enacted law to protect healthcare personnel.  Violence against doctors and healthcare staff is a non bailable criminal offence, with imprisonment of 3 years and fine. (20) Litigation is a true indicator of what a patient expects and what the judges endorse as acceptable or substandard practice. Litigation and fear of large compensations is a driver for the change in the way we practice. 
PRECAUTIONS AND RECOMMENDATIONS FOR AVOIDING MEDICO LEGAL RISK

• Improving patient safety by raising standard of care

 Update knowledge and skills:.  Adhering to regional guidelines is a good defence. Deviations from guidelines may be held as substandard care, unless reasons for doing so are recorded. Keeping up to date, learning new skills should be an ongoing process.  Fortunately critical situations are rare in day to day practice therefore simulation training can be used to gain confidence in handling life threatening situations like amniotic fluid embolism. Communication skills can be learnt through workshops, role play and group discussions.
Protocols: Use of checklists, mnemonics jogs memory, enhances safety and ensure better outcome for the patients. ACLS algorithm states the expected standard response to a cardiac arrest. Institutional protocol for mandatory use of pre labelled syringes for drawing drugs can decrease errors related to wrong drugs. Safe Surgery Saves Lives initiative of the WHO in 2009 recommends a preoperative checklist which can prevent errors like wrong patient, wrong side surgery.
Training and Accreditation: Ideally anaesthetists must be adequately trained under supervision. Lack of supervision was the single most commonly associated factor in anaesthetic mishaps (21) and inadequate supervision was a factor in 32% of anaesthetic deaths. (22)
Infrastructure and monitoring: The Labour suite should be located close to the operation theatres. It must be equipped for resuscitation including 20% intra lipid rescue packs to treat accidental intravascular injection of local anaesthetic and total spinal.) Indian Society of Anaesthesiologists have recommended basic monitoring  standards which include a defibrillator. Non-compliance with these basic standards may be held as negligence.
The Human Factor: Team work to prevent performance error. Anaesthetists are well trained, experienced and highly motivated professionals but they are human beings and they have physiological and psychological limitations. David M Gaba a psychologist and an anaesthetist as early as 1987, suggested that more mishaps are due to human error than equipment failure.(24) A chain of relatively harmless individual psychological factors like momentary distraction or inattention (slips) can interact with presence of environmental latent factors like untrained staff, faulty equipment to precipitate a critical event. The brain is overwhelmed by the need to take simultaneous decisions called cognitive overload. This leads to memory failure (lapses), misjudgement (mistakes), leading to errors and accidents. Limiting hours of our work, encouraging team building avoids fatigue, stress and improves performance.
Preoperative Anaesthesia Check-up (PAC)
This aspect of anaesthesia practice is receiving a lot of attention as an evidence of care in cases filed under the CPA.  Co-morbidities, referrals advised, need for further investigations   must be documented.  If a patient for routine surgery shows high blood pressure or signs of asthma on the day of operation the anaesthetist must take the prudent decision to postpone the surgery. Negligence is held if a patient is not optimised for routine surgery. (25)

• Consent: Shared Decision Making.

Obtaining separate informed anaesthesia consent is a good legal defence, as the risk of anaesthesia is separate from the risk of surgery. The process of a valid consent should follow the chain of “capacity...information.. Explanation...understanding... no force or coercion...” Discussion on plan of anaesthesia, mentioning some common side effects or risk, addressing patient fears and preferences is necessary before taking consent. Need for converting to general anaesthesia if regional fails needs to be mentioned. Documentation of the discussion, especially refusals is very valuable in cases of poor outcome. Taking consent in a language not understood by the patient may be held as negligence. The degree of disclosure is to be decided by the patient who may express his wish to know all the complications and risk. The remote risk of death may need to be discussed without alarming the patient, using analogy of crossing a road. This process is also called Shared decision making (SDM).
No effort to save the patient should be delayed for the lack of consent. Wide discretionary powers are given to doctors in emergency situations, to act in the interest of the patient in good faith. An oral or implied consent is acceptable, so there is no need to wait for consent in obstetric emergencies. In fact we may be liable for negligence in case of harm due to the delay.

• Rapport with the surgeon

Understanding the surgeon’ needs, punctuality, prior discussions on response times and techniques especially for category 1 Caesarean section are necessary. (27) Loose talk and derogatory remarks by the surgeons when faced with complications, confuse the patients and increase the chances of litigation.

• Issues related to Regional anaesthesia.

 Regional anaesthesia has gained popularity for caesarean sections as it avoids difficult intubation and aspiration risk. Nerve injury is implicated in a large proportion of claims. Alcoholic chlorhexidine, an effective bactericidal cleansing agent, was ruled the cause of a severe case of adhesive arachnoiditis after a routine spinal anaesthesia for caesarean section in Sutcliffe vs Aintree Hospitals 2008.Meticulous asepsis is important to prevent meningitis - masks, gowns, gloves should be worn.
Inadequate regional anaesthesia leading to extreme pain during LSCS and reluctance of the anaesthetist to convert to GA, in spite of severe pain has led to litigation. High neuraxial block after spinal or epidural anaesthesia causing severe hypotension, maternal death and neonatal brain injury or death is held as substandard care. (29)

• Issues related to General anaesthesia

 General Anaesthesia has a greater risk with higher incidence of obesity, older age, diabetes and heart disease . Not being able to intubate is not negligence but not following difficult airway algorithm leading to hypoxia and brain damage will be held as negligence.
Awareness under general anaesthesia is an important medico legal risk in obstetrics. In Ackers V: Wigan Health Authority (1991 ), damages of £ 13775 were awarded for awareness and pain under GA for caesarean section, resulting in psychological derangement. Disclosure of the likelihood of inadequate anaesthesia in high risk obstetric cases, in view of safety is recommended. Early detection of awareness, acceptance and empathy, explanation, reasoning and counselling are necessary to prevent post-traumatic stress disorder (PTSD). BIS monitoring has gained importance to prevent awareness.

Issues related to Documentation
Poor documentation means poor defence.  Table 1   gives a list of essential perioperative documents.  Complaints in case of negligence can be filed in civil court up to 3 years from the date of incident and in consumer court up to 2 years. It is advisable to keep personal copies of case records of patients who have had unexpected poor outcome or death, which can be referred to in case of a legal notice. Many cases of anaesthesia litigation have been lost due to inadequate, incomplete or illegible records. A thirty minute gap in monitoring period has been the issue leading to payment of compensation by anaesthesiologist in spite of standard care.
Communication  and Patient Satisfaction
Communication and developing rapport with our patients  is truly challenging. Research has consistently shown that patients are dissatisfied with doctor’s attitudes and the way they communicate. We spend our lifetimes gaining pharmacological and technical perfection but do not develop our soft skills. We need to use communication skills to create trust and understanding in the brief encounters we have with obstetric patients. Using communication skills like listening, answering, explaining, empathising greatly improves patient satisfaction.
In the event of complications, communication is more critical. Unrealistic expectations when not fulfilled causes disappointment, anger, and frustration. Good doctor patient relationship and effective communication is the plus factor, which can diffuse patient’s resolve of pursuing litigation. Arrogance, ridicule, rude behaviour, are negative communication behaviours which are likely to aggravate conflict. Lack of explanation or a wall of silence after any patient harm is perceived as a cover up for negligence. There is a trend towards litigation for low severity injuries like head ache, back ache which shows dissatisfaction towards the quality of care rather than the injury.
Apology: Traditionally doctors do not apologize for an untoward outcome fearing that it will be interpreted as guilt. Medical defence organizations and indemnity insurance companies are now encouraging their members to apologize for errors. This is a distinct change from the ‘deny and defend’ policy to try to prove doctor’s innocence. The Leap Frog group which works towards safety and quality in healthcare recommends that if a ‘never event’( iatrogenic injury) occurs, the organizations should disclose the error, apologize to the patient, report the event, and waive all costs associated with the event to decrease the risk of litigation. The patients also understand that doctors are not gods. 
In the unfortunate event of unanticipated table death, we must inform the police and insist on a post-mortem examination. We are expected to find out the cause for unexpected death under anaesthesia. A post-mortem examination does not need consent from the relatives. A lawyer’s expertise is required to squash the criminal complaint and seek anticipatory bail to avoid arrest.

• Threat of litigation: Legal notice

 A legal notice may be the warning of   intention to litigate or to extract money. A well drafted reply within 30 days will serve as the basis of a Written Statement to be filed in case a Consumer Complaint is instituted against the doctor and/or hospital. Quite often a well prepared notice reply drives home the fact that the hospital and doctor will not succumb to pressure. This is the time to collect all documents and medical literature relevant to the case.

• Professional  indemnity policy : Ensure Adequate indemnity limit

 It is an insurance policy meant for doctors to cover liability falling on them as a result of errors and omissions committed by them whilst rendering professional service. The policy covers all sums which the insured professional becomes legally liable to pay as damages to third party in respect of any error and/or omission on his/her part committed whilst rendering professional service. Legal cost and expenses incurred in defence of the case, with the prior consent of the insurance company, are also payable, subject to the overall limit of indemnity selected.
Only civil liability claims are covered. Any liability arising out of any criminal act or act committed in violation of any law or ordinance is not covered. In case of any event likely to give rise to a liability claim as described above, insurance company should be informed immediately. In case any legal notice or summons is received, it should be sent to the insurance company. The company has the option of arranging the defence of the case.
Conclusion:
Patients harmed by serious anaesthetic mishaps suffer physically and psychologically. Senior consultants, top hospital authorities, commercial insurers and medical defence organizations must work together to seek early resolution of any conflict and settle early in the patient’s interest.
Even in the best resourced hospitals, accidents continue to happen. Emotional and financial burden for a serious anaesthetic mishap in obstetrics is immense for both parties. To manage litigation risk in obstetric anaesthesia, along with improving technology, due attention needs to be paid to the way we communicate with our patients. Empathy, transparency and sincerity are valued in most situations of conflict. Disclosure of material risks and shared decision making is the future. Reflection, introspection and efforts to raise the bar of standard of care to that in the locality, then to national levels and finally to global best practices should be a continuous objective for all anaesthesiologists.

References:
1.Bolam vs. Friern Hospital Management Committee (1957) 1 WLR 582

2.Roe v Minister of Health [1954] 2 All ER 131
3.Dr. Suresh Gupta vs Govt. Of N.C.T. Of Delhi & Anr (2004) Appeal (crl.) 778 of 2004
4.Jacob Mathew vs State Of Punjab & Anr  (2005) Appeal (crl.) 144-145 of 2004

5.Mohd. Ishfaq v. Dr. Martin D.’Souza, 2003 (1) CPJ 116 (NCDRC)

6. Penal Code, 1860, section 304-A and Code of Criminal Procedure, 1973, section 482. Dr. Krishna Prasad vs. State of Karnataka, 1989 ACJ 393 (Karn.-HC).

7..Indian Medical Association vs V.P. Shantha & Ors 1996 AIR 550, 1995 SCC (6) 651

8.Mumbai Grahak Panchayat vs. Dr. (Mrs.) Rashmi B. Fadnavsis & Anr.  1996 (1) CPR 137; 1998 (1) CPJ 49 (NCDRC)

9.Pt. Parmanand Katara v. UOI (1989) 3 SCR 997.
Urgency of caesarean section: a new classification. Lucas DN, Yentis SM, Kinsella SM, et al.  Journal of the Royal Society of Medicine 2000; 93: 346–50.

10.Sidaway  vs  Bethlam Royal Hospital (1985) 1 AIIER 64

11.Chester v Afshar [2002] EWCA Civ 724; [2003] QB 356.