A complication by itself does not constitute negligence and Doctors cannot be held liable merely a patient dies due to complication - Adv. ROHiT ERANDE.©

Important Case indeed for Medicos. Thanks to Hon. Kerala High Court. 

A Case where, Surgeons, Anaesthetists and nurses were framed under the charges of murder of a patient, dismissed. 

A complication by itself does not constitute negligence and Doctors cannot be held liable merely a patient dies due to complication”

 Not only Qualified Anaesthetists, but Trained Anaesthetists are also allowed to administer Anaesthesia for electro laparoscopic sterilization”

 “The Court rejected the finding of Forensic Medicine Expert who held that deceased was administered with spinal anaesthesia and not the general anaesthesia, on the sole basis that injection mark reaching the spinal canal was found in Autopsy !.

 “Spinal or general Anesthesia, it is the choice of the Anesthetist”

 Adv. ROHiT ERANDE.©

Case details :

IN THE HIGH COURT OF KERALA AT ERNAKULAM   PRESENT

Coram : THE HONOURABLE DR. JUSTICE KAUSER EDAPPAGATH

Delivered on : THURSDAY, THE 2ND DAY OF FEBRUARY 2023 / 13TH MAGHA, 1944

Case no. CRL.A NO. 22 OF 2014 AGAINST CP 97/2008 OF JUDICIAL MAGISTRATE OF FIRST CLASS

DR. BALACHANDRAN V/s. State   of Kerala      

Judgment Link :

https://hckinfo.kerala.gov.in/digicourt/Casedetailssearch/fileview?token=MjAzMzAwMDAwMjIyMDE0XzEucGRm&lookups=b3JkZXJzLzIwMTQ=

 

The Judgment starts with the relieving words for Doctors :

1.  The judgment starts with the wordings that while dealing with criminal prosecution for medical negligence, the trial courts often ignore the following principles :

Though doctors’ aura of Godliness and holiness is a myth, they are volunteers who take the risk of dealing with the most intricate, delicate, and complex machine on earth - the human body. Any surgical procedure or medical intervention  on  this highly compound machine carries some inherent risk. There is always the chance that the treatment does not go as planned. When things go wrong, it is not always the fault of the doctor. A complication by itself does not constitute negligence. There is a big difference between an adverse or untoward event and negligence. However, there is a growing tendency to accuse the doctor of an adverse or untoward event. Nothing can be more professionally damaging and emotionally draining than being arrayed as an accused in any such action. A surgeon, under fear of facing criminal prosecution in the event of failure for whatever reason – whether due to his fault or not- cannot perform at his best. The Judicial Forums, in the process of fixing parameters of liability in the cases of medical negligence, must aim at striking a careful balance between the autonomy of a doctor to make judgments and the rights of a patient to be dealt with fairly, recognizing the complexity of the human body, inexactness of medical science, the inherent subjectivity of the process, and genuine scope for error of judgment...”

Facts in short :

2.                 One Smt.Mini Philip, a young lady aged 37  years, walked to the operation theatre at Deen Hospital, Punalur, on 25/9/2006 at 3.30 p.m. to undergo sterilization by laparoscopy, a procedure that provides permanent birth control, with the hope that she could safely return home after  few hours. But  destiny had something else in store for her and after the surgery, she developed respiratory complications and was put under oxygen support.

3.                 Though she was shifted to Poyanil Hospital, Punalur, at 9.00 p.m. and then to  Ananthapuri  Hospital, Thiruvananthapuram, at 11.30 p.m. for expert management, her life could not be saved. She breathed her last on the next day at 5.30 p.m. at Ananthapuri Hospital.

 

4.                 On 26/9/2006, the Vanchiyoor Police registered a crime under section 174 of Cr.PC based on Ext.P1 FI statement given by the uncle of the deceased (PW 1) alleging medical negligence on the part of the doctors who conducted surgery and administered anesthesia as well as the nurses who  assisted  them.  Later Punalur Police reregistered the case as Crime No.590/2006 and conducted the investigation. PW17, the investigating officer, in accordance with the direction of the Apex Court  in  Jacob Mathew v. State of Punjab and Another (AIR 2005 SC 3180), requested the District Medical officer, Thiruvananthapuram, to constitute an Expert Panel and to give their views on  the allegation of medical negligence. Accordingly, a five-member Expert Panel was constituted, and the committee  forwarded Ext.P4 report on 16/6/2007. The matter was again referred to the Apex Body, and two reports of the Apex Body marked as Ext.P15 dated 3/8/2010 and Ext.D9 dated 20/4/2009  were  obtained. Based on the reports, PW17 incorporated the offences under sections 304 and 201 r/w 34 of IPC. After investigation, final report was filed at the Judicial First-Class Magistrate Court III,

Punalur, against the accused, six in number, who are the doctors and nurses at Deen Hospital. The learned Magistrate, after complying with the statutory formalities, committed the case to the Additional Sessions Court V, Kollam (for short ‘the court below’) for trial and disposal.

5.                 All the accused appeared at the court below and they faced trial for the offences punishable  under sections  304  and 201 r/w 34 of IPC. After full-fledged trial, the court below found that the offence under section 304 of IPC was not attracted. However, it found that there is evidence to show that the accused have committed the offences  punishable  under  sections  304A and 201 r/w 34 of IPC, and they were convicted for the said offences. All of them were sentenced to undergo simple imprisonment for one year for the offence under section 304A r/w

34 of IPC and simple imprisonment for three months for the offence under section 201 r/w 34 of IPC.  The Trial Court held that :

(i)           The accused No.1 was not a qualified anesthesiologist and thus incompetent to administer anesthesia to the deceased.

(ii)         The accused No.1 gave spinal anesthesia instead  of general anesthesia, and the defective anesthesia administration ultimately resulted in the death of the patient.

(iii)       There  were   lapses  in  the   pre-operative  and  post-


 

operative management of the patient.

 

(iv)        The doctors involved in the procedure were not trained in laparoscopy, and the hospital had no accreditation to conduct laparoscopic surgery.

(v)          The surgery and nurses’ notes were not kept properly.

 

Challenging  the conviction and sentence, the Doctors approached the high Court.

I have heard Sri.S.Sreekumar, the learned Senior Counsel appearing for the accused No. 1, Sri. Jayanth Muthuraj, the learned Senior Counsel appearing for the accused No.2, Sri. P. Vijayabhanu, the learned Senior Counsel appearing for  the accused No.3, Sri. S. Ananthakrishnan, the learned Counsel appearing for the accused Nos. 4 to 6, the learned Amicus Curiae Sri. V. Vinay and Smt.T.V.Neema, the learned Senior Public Prosecutor.

6.                 The learned counsel for the accused impeached the findings of the court below on appreciation of evidence and the resultant finding as to the guilt. They submitted that in the absence of any evidence on record to prove culpable negligence against the accused, the court below grossly erred in convicting them. The learned Senior Public Prosecutor Smt.T.V.Neema, on the other hand, supported the findings and verdict handed down by the court below and argued that necessary ingredients ofsections 304A and 201 r/w 34 of IPC had been established.

Held :

7.                 This is an unfortunate case where  a  37-year-old healthy lady lost her life following a simple procedure for laparoscopic sterilization. The records show that the complication developed immediately after the surgery, and despite earnest efforts, her life could not be saved. The prosecution attributed negligence to the doctors who were part of the surgical team as well as the nurses who assisted them. The accused No.3 is the doctor who did the procedure, and the accused No.1 is the doctor who administered anesthesia. The accused Nos.4 to 6 are the nurses who assisted accused Nos.1 and 3. Even as per the prosecution version, accused No.2, the gynaecologist, was in no way involved in the surgical procedure. The role attributed to her is that the deceased consulted her a week ago, and she admitted the deceased to the hospital for laparoscopic sterilization. As against accused No.3, there is no specific  allegation  of negligence. The accused No.4 is a qualified nurse,  and  the accused Nos. 5 and 6 are nursing assistants who only assisted the  accused Nos.1 and 3.

It has been observed that “The prosecution has no case that they did something or failed to do something which ought to have caused the death of the deceased”. The main allegation is against accused No.1. It is alleged that accused No.1 is not a qualified anesthesiologist, and he administered spinal anesthesia instead of general anesthesia.  

 

8.              Negligence, simply put, is a breach of duty of care resulting in injury or damage. Per se, carelessness is not culpable or a ground of legal liability, except in those cases where the law has imposed a duty of carefulness. The duty of care implies the responsibilities of individuals towards others within society. The duty of care may be understood as a legal obligation imposed on an individual requiring adherence to a standard  of  reasonable care while doing any act, particularly when lack of care could cause harm to someone else. When there is a legal duty not to do a thing on purpose, there is commonly a legal duty to take care not to do it accidentally.

Difference between Civil and Criminal negligence :

9.              In civil law, a duty of care is a legal obligation imposed on an individual requiring that he/she exercises a reasonable standard of care while performing any act that could foreseeably harm others. In medical practice, the law has imposed a duty of care on the doctors for treating patients. The duties that a doctor owes to his patient are clear. They include a duty of care in deciding whether to undertake the case, a duty of  care  in deciding what treatment to give, and a duty of care in the administration of that treatment. A breach of any of these duties gives the patient a right of action for negligence.

10.             The jurisprudential concept of negligence differs  in civil law and criminal law. Ordinary negligence is such failure to use care as would render a person civilly but not criminally liable. Criminal negligence is a greater failure and a  greater  falling below the standard of care and renders a man guilty criminally. The degree of negligence should be much higher for an act to amount to criminal negligence. Negligence not of such a high degree may provide a ground for action in civil law but cannot form the basis of criminal prosecution. The factor of grossness or degree does assume significance while drawing a distinction between negligence actionable in tort and negligence punishable as a crime.

 

11.        The medical negligence jurisprudence in India is characterised by a reliance on the  “Bolam  test”.  Bolam  v. Friern Hospital Management  Committee  {[1957]  1  W.L.R. 582}, a landmark English case on medical negligence, laid down the principle that “A Doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art...”. This principle has been widely accepted as decisive of  the standard of care expected from medical practitioners. The courts in India, including the Apex Court, invariably applied Bolam Rule as a touchstone to test the pleas of medical negligence. In Jacob Mathew (supra), a three-judge Bench of the Apex Court upheld the standard of the ordinary competent medical practitioner exercising an ordinary degree of professional skill, as enunciated in Bolam (supra). It was held that the standard of care must be in accordance with ‘general and approved practice’. The Apex Court affirmed the judgment in  Jacob  Mathew  (supra) in State of Punjab v. Shiv Ram and Others [(2005) 7 SCC 1], Nizam's Institute of Medical Sciences v. Prasanth S. Dhananka [(2009) 6 SCC 1] and Kusum Sharma and Others v. Batra Hospital and Medical Research Centre and Others (AIR 2010 SC 1050).

12.             The question of degree has always been considered relevant to fasten criminal liability on medical negligence. The Privy Council in John Oni Akerele v. The  King (AIR 1943 PC 72) put the standard for fastening criminal liability on a high pedestal and required the medical negligence to be “gross”.  It was held that a doctor is not criminally responsible for a patient's death unless his negligence or incompetence went beyond  a  mere matter of compensation between subjects and showed such disregard for the life and safety of others as to amount to a crime against the State. The Apex Court in Syad Akbar v. State of Karnataka (1980 KHC 527) opined that where negligence is an essential ingredient of the offence, the negligence to be established by the prosecution must be culpable or gross and not the negligence merely based upon an error of judgment. In Bhalchandra Waman Pathe  v.  State  of  Maharashtra  (1968 Mh. LJ 423), it was held that while negligence is an omission to do something which a reasonable man, guided upon those considerations which ordinarily regulate the conduct of human affairs, would do, or doing something which a prudent and reasonable man would not do; criminal negligence is the gross and culpable neglect or failure to exercise that reasonable and proper care and precaution to guard against injury either to the public generally or to an individual in particular, which having regard to all the circumstances out of which the  charge  has arisen, it was the imperative duty of the accused person to have adopted. In Dr. Suresh  Gupta  v.  Govt.  of  NCT  of  Delhi [(2004) 6 SCC 422], the Apex Court held that the degree of negligence required should be gross or reckless. A mere lack of necessary care, attention, or skill was considered insufficient to hold one criminally liable for negligence. It was observed that mere inadvertence or want of a certain degree of care might create civil liability but will not be sufficient to attract criminal liability. The soundness of this view of the Apex Court was subsequently doubted, considering that word “gross” is absent in section 304A IPC and that different standards cannot be applied to actions of the negligence of doctors and others. Consequently, the matter was placed for reconsideration before a Bench of higher strength. Three-judge Bench (Bench strength in Dr. Suresh Gupta was two) in Jacob Mathew (supra) on a reconsideration endorsed  the approach of  the high degree of negligence  being the prerequisite for fastening criminal liability as adopted in Dr. Suresh Gupta (supra). It was held that “In order to hold the existence of criminal rashness or criminal  negligence,  it  shall have to be found out that the rashness was of such a degree as to amount to taking a hazard knowing that  the hazard  was  of such a degree that injury was most likely imminent.” It was observed that the subject of negligence in the context of the medical profession necessarily calls for a treatment with a difference.

13.             Every death of a patient cannot, on the face of it, be medical negligence. There must be sufficient evidence to prove that the death is due to the alleged medical negligence.  The death should be the direct or proximate result of the negligent act alleged. A medical professional cannot be held liable simply because things went wrong from mischance  or  misfortune.  A mere deviation from normal professional practice is  not necessarily negligence. Nor could mere accident or untoward incident be termed negligence, also an error of judgment is not negligence per se. To convict a medical professional for criminal negligence, the prosecution must prove culpable and gross negligence beyond a reasonable doubt. It must also be shown that the medical professional did or failed to do something which, in the given facts and circumstances of the case, no ordinary skilled medical professional would have done or failed to do.

14.        The Anesthetist was saved, read how…

 

a.  The court below heavily relying on the oral evidence of PW 9 and Exts. P4, P6 and P19 found that accused No.1 was not qualified or competent to give anesthesia, and he wrongly gave spinal anesthesia instead of general anesthesia, which led to complications and the death of the patient, which was opposed by the Ld. Counsel for the Petitioners.

b.   Per contra, the learned Senior Public Prosecutor Smt. T.V. Neema as well as the learned Amicus Curiae Sri. V.Vinay relying on the observations in Jacob Mathew (supra), vehemently argued that any task which is required to be performed with a special skill by a medical professional would generally be undertaken to be performed only if he/she possesses the requisite qualification and skill for performing that task and a medical professional can be held liable for criminal negligence if he/she was not possessed of the requisite skill which he/she professed to have possessed. According to them, an Anesthesiologist who has a post- graduation or Diploma in Anesthesiology alone is qualified to administer anesthesia and since accused No.1 did not possess either of these qualifications, he was incompetent to administer anesthesia to the deceased.

c.   It was submitted by the Prosecution that the evidence on record establishes that the wrong administration of anesthesia by an incompetent person resulted in the death of the patient.

d.  The Court further observed : Admittedly the accused No.1 is only having an MBBS degree. He does not have either a diploma or a post-graduation in anesthesia.   However, the documents on record would show that he had undergone sufficient training  in anesthesiology and had vast experience in administering anesthesia. Ext.D2, the proceedings of the Principal, Medical College, Trivandrum and Ext. D3, the certificate issued by the Principal, Medical College, Trivandrum, establish that he was selected in the branch of anesthesia for Senior House Surgency, and he underwent it successfully.

e.   The Court relied upon the certificate issued by the Professor of Anesthesia, Department of Anesthesia, Medical College, Trivandrum on 31/10/1980, stating that the accused No.1 had worked as a Senior House Surgeon from 31/10/1979 for a period of one year; he has proved himself  reliable  and  can  manage cases independently and confidently.

f.    The Court also relied upon another certificate dated 1/11/1980 issued by the Associate Professor, Department of Anesthesiology, Medical College, Trivandrum, certifying that accused No.1 had intensive training in all the routine and special techniques in anesthesiology. Ext.D7 certificate and Ext.D8 seriescase list would show that he had administered anesthesia to several patients.

15.        The Trial court below relied the information given by the Medical Council  of India under the RTI Act which only says that a graduate of MBBS is required to complete an MD degree in the specialty of anesthesia or  a Diploma in the specialty of anesthesia to be qualified as an anesthesiologist. There is no quarrel with the proposition that to be qualified as an anesthesiologist, an MBBS graduate  should either obtain an MD degree in anesthesia or a Diploma in anesthesia.

16.        The Court concluded that after scrutinising various rules and regulations relating to the prescribed qualification for an anesthetist, it was reported that a doctor who has passed  MBBS and has training in anesthesiology is qualified to give anesthesia to a patient. The Apex Body, on perusal of various records, concluded that the accused No.1, after his MBBS, had undergone one-year Senior House Surgency in anesthesia at Medical College, Thiruvananthapuram, and he had the requisite qualification for giving anesthesia to the patient.

17.          The High Court also observed that the ld. Trial Court ought to have considered the copy of the minutes of the meeting of the Council of Modern Medicine held on 22nd  November 2007. Considering the representation given by the Indian Medical Association wherein it was resolved that doctors with MBBS registration are qualified to give anesthesia, even though said Resolution was passed after the incident, as the representation moved by the Indian Medical Association was to define the practice of anesthesia. Accordingly, it was resolved that the doctors with MBBS registration are qualified to give anesthesia.

Not only Qualified Anesthetists, but Trained Anesthetists are also allowed to administer anesthesia for electro laparoscopic sterilization

The Court further observed that the Quality Assurance Manual   for Sterilization published by the Government of India in 2006 nowhere states that anesthesiologists alone are considered qualified to administer anesthesia for electro laparoscopic services. On the other hand, what is stated is that trained anesthetists are qualified to administer anesthesia for electro laparoscopic surgeries. It was observed that there is no dispute that the accused No.1 is a trained anesthetist and allowed to administer Anesthesia if we consider the testimony of PW6, the Kollam District Medical Officer and member of the Expert Panel, who has admitted that an MBBS graduate who has undergone four months of training in anesthesiology is competent to administer anesthesia and thus the finding of the court below that the accused No.1 was not qualified and competent to administer anesthesia cannot be sustained.

The Court rejected the finding of Forensic Medicine Expert who held that deceased was administered with spinal anesthesia and not the general anesthesia on the sole basis that injection mark reaching the spinal canal was found in autopsy !.

 

The Court held that it has come out in evidence that to ascertain whether spinal anesthesia was administered, the best and sure test is to collect and analyze Cerebro Spinal Fluid (CSF),m which was admittedly not done and thus it was held that without  adopting the sure test for spinal anesthesia, the mere injunction mark is insufficient to conclude that spinal anesthesia was administered.

It is the choice of the Anesthetist to decide whether to administer general anesthesia or spinal anesthesia for  Laparoscopic sterilization:

PW9 admitted that laparoscopic sterilization could be done either under spinal anesthesia or general anesthesia. In Ext.P16, it is stated that local anesthesia is the preferred choice for a tubectomy operation. Thus, laparoscopic sterilization can be done under general anesthesia or spinal anesthesia.   So long as it is found that the procedure/treatment adopted was accepted by medical science, the medical practitioner cannot be  held negligent merely because he chose to follow that treatment/procedure and the result was a failure. A medical practitioner cannot be held criminally liable  simply  because things went wrong through an error of judgment in choosing one reasonable course of procedure/treatment in preference of another. A medical practitioner can only be held liable for criminal negligence if he fails to adopt a usual and normal course of treatment and the course adopted by him is one no professional man of ordinary skill would have taken had he been acting with ordinary care Thus, accused No.1 cannot be found at fault in administering spinal anesthesia even if the prosecution’s  version  that  spinal anesthesia was administered is believed to be true.

When 304A of IPC can be attracted ?

18.             To impose criminal liability under section 304A of IPC, it is necessary that the death should have been the direct result of a rash or negligent act of the accused. That act must be the proximate and efficient cause without the intervention  of another's negligence. The liability under this section is created on the assumption of foreseeability of consequences  that  could result from a wrongful act. Thus, for fastening the liability of criminal negligence on the accused, the administration of anesthesia, be it general or spinal, must be the direct  or proximate cause of death.

The Court ruled out the cause of death as wrong anesthesia !

19.             The cause of death stated is the combined effect of Brain Hypoxia and Adult Respiratory Distress Syndrome (ARDS) and the Prosecution witness  answered that spinal anesthesia could not cause ARDS.. In Ext. D10 report/Medical Audit Performa prepared by DW2 under the instruction from the DMO, the cause of death was shown as pulmonary oedema. It was found in the said report that after extubation, the patient developed pulmonary oedema. All these circumstances completely rule out the theory projected by the prosecution that the administration of spinal anesthesia caused ARDS/Hypoxia, which in turn resulted in the death of the patient.

Fallacy of Expert Reports :

20.             None of the Expert Panel Reports specifically attributes negligence to the surgeon, anesthetist or nurses who were part of the surgical team. It is only stated that the pre-operative workup, including pre-anesthesia workup, was not done properly at the Deen Hospital. In Ext.D9, the conclusion was that there were some lapses in the pre- operative and post-operative management. Even though the Expert Panel found that there was no pre- operative evaluation, there is absolutely no evidence on record, or even the prosecution does not have a case that it was on account of the said lack of proper pre-operative evaluation that the complication developed to the patient and the death has occurred. Admittedly, the Deen Hospital did not have a ventilator facility. The patient was shifted to Poyanil Hospital only after 3½ hours. The prosecution alleged that this was a crucial time and the patient could have been referred to a higher centre having better facilities much before. But, the evidence on record would show that immediately after the complication developed, the doctors at Deen Hospital did their best to save the patient. It has come out in evidence that two  anesthetists and  a cardiologist from other hospitals came to Deen Hospital and examined the patient. PW14 deposed that when he visited Deen Hospital at 6.30 p.m., he found that shifting the patient to a higher centre was dangerous. In the absence  of any material on record to suggest that the alleged lapses in the pre-operative or post- operative management of the patient at the Deen Hospital were the direct or proximate cause of death,  findings assume no significance.

21.             No doubt, this is an unfortunate case. But simply because a patient has not favourably responded to a treatment or a surgery has failed, the doctor cannot be held negligent per se for the offence under section 304A of IPC unless  the prosecution establishes beyond reasonable  doubt  the  culpable and gross negligent act on his part. That act must be  the proximate or direct cause of death of the patient. Such a shred of evidence is lacking in this case. None of the witnesses and documents discussed in the above paragraphs points the gross or culpable negligence on the part of any of the accused.

Allegations of evidence  disappearance also rejected :

22.             Section 201 IPC deals with causing the disappearance of evidence of an offence or giving false information to screen the offender. It was held that mere failure to maintain surgery notes, nurses’ notes or case sheets properly cannot be construed as intentional, causing the disappearance of evidence. Thus, the materials on record are insufficient to prove the allegation of the offence under section 201 of IPC.

Conclusion :

His Lordship was pleased to conclude   that  the prosecution has failed to prove the offences alleged against the accused beyond a reasonable doubt. There is no convincing evidence to connect  the accused with the  alleged incident.  At any rate, the accused are entitled to get the benefit of doubt. Hence, the conviction and sentence under sections 304A and 201 r/w section 34 of IPC cannot be sustained.

 

Why Sec.304 of IPC not attracted :

a.  Section 304 of IPC has two parts. Both parts deal with culpable homicide, not amounting to murder. The first part of section 304 of IPC deals with culpable homicide not amounting to murder when the act is done with the intention to cause death or bodily injury as is likely to cause death.

b.  The second part deals with culpable homicide not amounting to murder when the act is done without any intention to cause death or bodily injury as is likely to cause death but with the knowledge that his act is likely to cause death. A person responsible for a reckless or rash negligent act that causes death which he had knowledge as a reasonable man that such act was dangerous enough to lead to some untoward thing and the death was likely to be caused, may be attributed with the knowledge of the consequence and may be fastened with the culpability of homicide not  amounting  to murder punishable under section 304 Part II of IPC.

c.  It is settled that the knowledge contemplated under sections 299 and 304 of IPC is of a higher degree. Knowledge of the mere possibility that the act may cause death is  not  the  knowledge  envisaged. Viewed from the nature of the evidence adduced, it can safely be concluded that the accused did not have  the  degree  of knowledge to the extent that their act may likely cause the death of the patient. That apart, I have already found that the prosecution failed to prove gross or culpable negligence on the part of the accused. In these circumstances, section 304 of IPC is also not attracted.

 

This judgment is very important. As it has dealt with many issues which Doctors may face daily.

With kind regards

 

Adv. ROHiT ERANDE.©

Pune.


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