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A view on medical negligence and medical errors in india


Negligence is a failure to exercise appropriate and or ethical ruled care expected to be exercised amongst specified circumstances. The area of tort law known as negligence involves harm caused by failing to act as a form of carelessness possibly with extenuating circumstances. The core concept of negligence is that people should exercise reasonable care in their actions, by taking account of the potential harm that they might foreseeably cause to other people or property.

Someone who suffers loss caused by another's negligence may be able to sue for damages to compensate for their harm. Such loss may include physical injury, harm to property, psychiatric illness, or economic loss. The law on negligence may be assessed in general terms according to a five-part model which includes the assessment of duty, breach, actual cause, proximate cause, and damages.

Breach of Duty In English Law

In English tort law, there can be no liability in negligence unless the claimant establishes both that they were owed a duty of care by the defendant, and that there has been a breach of that duty. The defendant is in breach of duty towards the claimant if their conduct fell short of the standard expected under the circumstances.

Elements of Negligence Claims

# Some things must be established by anyone who wants to sue in negligence. These are what are called the "elements" of negligence.
# Most jurisdictions say that there are four elements to a negligence action
# Duty-the defendant has a duty to others, including the plaintiff, to exercise reasonable care,
# Breach-the defendant breaches that duty through an act or culpable omission,
# Damages-as a result of that act or omission, the plaintiff suffers an injury, and
# Causation-the injury to the plaintiff is a reasonably foreseeable consequence of the defendant's act or omission.

Duty of Care

In tort law, a duty of care is a legal obligation which is imposed on an individual requiring adherence to a standard of reasonable care while performing any acts that could foreseeable harm others. It is the first element that must be established to proceed with an action in negligence. The claimant must be able to show a duty of care imposed by law which the defendant has breached. In turn, breaching a duty may subject an individual to liability. The duty of care may be imposed by operation of law between individuals who have no current direct relationship (familial or contractual or otherwise) but eventually become related in some manner, as defined by common law
# Causation
# Injury
# Damages
# Proximate Cause

5.2 Million Medical Errors Are Happening In India Annually

The subject of clinical outcome is very important. Healthcare has not been the priority for India and government as they have more priorities.

Healthcare has still not come to that stage where they invest money. Thanks to the private sector starting from 1980 onwards, now we are able to have 5% investment of GDP in healthcare- 1% from government and 4% from the private healthcare.

A Harvard study by Prof Jha shows that 5.2 million medical errors are happening in India annually. Similarly the British Medical Journal quoted that India like any other developing country is recording a lot of medical errors. The reason behind this is that we have not trained doctors and nurses to measure the clinicaloutcomes.

Our main focus is to treat patient and that is why we have really not been able to come out with a national index of clinical errors or medical errors. Now the National Accreditation Board for Hospitals which I founded in 2005 is actually collecting data from 350 hospitals from past 3 years.

Once this data is compiled we will be able to have a National Index and the rest of the hospitals in the country can be asked to benchmark and then we can say where we are in terms of other developing or developed countries.

Our main focus is to treat patient and that is why we have really not been able to come out with a national index of clinical errors or medical errors. Now the National Accreditation Board for Hospitals which I founded in 2005 is actually collecting data from 350 hospitals from past 3 years.

Once this data is compiled we will be able to have a National Index and the rest of the hospitals in the country can be asked to benchmark and then we can say where we are in terms of other developing or developed countries.

What Are The Major Issues And Challenges That We Need To Focus On?

The issue now is that one rural sector is being dealt only by government because private sector is not in position to go to the rural side.

The shortage of doctors is the major issue and I am talking about the specialists. We have 50,000 MBBS graduates passing every year but we have only 18,000 post graduate seats, so every year these MBBS graduates compete for those 18,000 seats and remaining people keep on working as a junior resident.

Even the community health centre which is run by government has position of for specialists like MD, MS. So the government has to increase the post graduate seats which they are working on.

The other indicator is the Human Development Index in which we come somewhere around 188 world over and this is because HDI is based on education, healthcare and the capacity to earn.

Third and final issue is that hospitals and around 2/3rd medical colleges are in the south and western side of the India where only 1/3rd of the population resides. The 2/3rd population like UP, Madhya Pradesh, Orissa, West Bengal, Kashmir have only 1/3rd medical colleges.

So this is a big mistake we did for example in Tamil Nadu we have roughly 45 medical colleges in each state while in states like Rajasthan, UP and Bihar around 18-22. Here population is 2 times but the medical colleges are half so that is a big issue that we have not been able to take care of.

Why Is Affordable Healthcare Still A Very Distinct Target To Achieve?

All of us are today are taking about the affordability. Everyone is saying healthcare is very costly and this is because none of us budget for the healthcare.

Patient safety and affordability are linked but patient safety means good technology, good doctors, good medical protocols which we call standard treatment guidelines and these are missing in our healthcare scenario. So we must first focus on patient safety, we must measure hospital acquired infection rate, we must have surveillance on the infection and antibiotics policy and all doctors and nurses should be trained on infection control.
India sees millions of medical errors due to ‘less practice'.

As many as 5.2 million medical errors and adverse drug reactions have been noted in India according to a study by Harvard School of Public Health.

These medical errors are preventable, argues the study which stated that teaching hospitals did better in 1990’s and early 2000 but there has been a slip in the last decade which has seen an increasing number of errors.

Dr Vijay Mohan, professor at Osmania Medical College explained, “The increasing errors are due to less bedside practice. We need more and more practice and less study. Presently, a large pool of MBBS doctors are spending a lot of time studying for the post-graduate and other exams rather than practising medicine. This is the reason the scope of errors has increased.”

With the increasing patient load in both government and private hospitals it is becoming very important to keep pace with the demands of clinically examining patients and also ensuring that the diagnosis is correct.
According to senior doctors and also professors of medical colleges, whenever a young practising doctor is in dilemma they are sharing diagnosis reports on what’s app with seniors to clarify their doubts.

While there is nothing wrong and technology must be used at its best, there is proving to be a need to have clinical decision backed with proper diagnosis so that there is a uniform opinion and not different versions.
To ensure that medical errors are reduced and cost of healthcare brought down, there is a need being felt that there must be one standard protocol set through artificial intelligence which will help better diagnosis and also reduce medical errors.

Dr Srinivas G., senior general physician explained, “Digital technology can help to give prescriptions, refer for tests and other aspects but doctor requires spending time and personally examining the patient, listening to the heartbeat and also speaking to them about their medical history to understand what has gone wrong. Often there are people who come with symptoms due to underlying mental health conditions. In these cases, it is not the physical health which is a problem but the mental health. Hence, digital technology has its place in secondary diseases which have complications but for basic diseases it requires proper doctor evaluation.”

While evidence based medicine and setting of standard protocol for treatments are being pushed where all doctors speak in one voice so that the patients are not confused.

This is being welcomed but there is a need felt for more of bedside medical practice to understand patients better.

Medical negligence

- 70% of deaths are a result of miscommunication
Every year, about 5.2 million people die due to human errors in India. Even in the US, the figure is not less than 44,000 to 98,000. It is not lack of medical skill or knowledge of doctors, but that of team coordination and communication during an emergency said Dr Rakshay Shetty.

What Is Criminal Negligence?

Criminal negligence occurs when someone acts in a way that is an extreme departure from the way that a “reasonable” person would have acted in the same or similar situation. Criminal negligence generally involves an indifference or disregard for human life or for the safety of other individuals.

How Is Criminal Negligence Different From Civil Negligence?

Criminal negligence is different from civil negligence in that it involves more extreme behaviour or actions. It requires more than a mere mistake in judgment, inattention or ordinary carelessness and it refers to conduct that is so outrageous and reckless that it is clear departure from the way an ordinary careful individual would have acted.

Civil negligence occurs when a person’s conduct falls short of how a “reasonable” individual would act in the same or similar situation but the individual’s conduct may not be considered a drastic departure from the way a reasonable person would have acted.

The Level Of Proof

Also, civil negligence cases involve a lesser “burden of proof” compared to criminal negligence cases. The plaintiff in a civil negligence case only has to prove by a preponderance of evidence that the defendant was negligent.

The phrase “preponderance of evidence” means that it was more likely than not that the defendant acted negligently. But in a criminal negligence case, the prosecutor is required to prove “beyond a reasonable doubt” that the defendant is guilty.

“Beyond a reasonable doubt” is the highest standard of proof and it means that the evidence is so strong that there is no other logical explanation besides the fact that the defendant acted with criminal negligence.

Who Files The Case?

Also, criminal cases are tried differently compared to civil cases. It is the state that is filing the claim against the defendant in a criminal case. This is because the conduct is considered to be sufficiently disruptive or damaging in order to justify a punishment by the state.

But a civil negligence claim is filed by one private citizen against the other and the focus in a civil claim is to reimburse the victim for their losses rather than to punish the defendant. Also, the penalties are different for civil cases and criminal cases.

The Punishment For Criminal Vs Civil

A person who is liable in a civil case only has to pay money damages while a person convicted in a criminal case can go to jail. Criminal negligence can also be punished by fines, probation supervision and mandatory community service.

Once the sentence imposed by a court has been served, the individual who was convicted of criminal negligence would probably have a criminal record which could make it difficult to find a job

What Is An Example of Criminal Negligence?

Criminal negligence typically refers to conduct that leads to a risk of major bodily injury or death to another individual. One major example is someone driving under the influence of drugs and alcohol and causing someone’s death because of their operation of a motor vehicle. Most statutes would define this conduct as criminally negligent homicide.

What Is An Example of A Law on Criminal Negligence?

In the state of California for example, in order to convict someone of criminal negligence, it is necessary for the prosecutor to prove three elements:
# That the defendant acted so recklessly that they created a high risk of death or major bodily injury.
# That the defendant’s actions showed a disregard for human life or an indifference to the consequences.
# That a reasonable person in a similar situation would have known that the actions would have probably resulted in harm to other individuals.

Cases of Criminal Negligence

When a person is driving a car and texting at the same time, and in the meanwhile breaks someone else’s car, he is criminally negligent because the criminal laws of the land, do not allow texting and driving.
Similarly, in a case where a person is drinking and driving, and kills someone on the road, he can be held criminally negligent. The reason is that killing is a crime and similarly drinks and driving is also a crime, therefore he can be sued and held criminally liable.

When a nurse in a nursing home forgets to feed the patient and the patient dies because of the negligent act of the nurse that is when the nurse can be held criminally liable because it is because of her criminal negligence that the patient is put forward for a risk to life.

# caregiver in a hospital who is not paying attention and who provides someone with a deadly dose of medication could be considered criminally negligent.
# person who is supposed to be a caretaker of the nursery and fails to take care, in lieu to which someone takes away child of another, can be held criminally negligent.
# doctor who prescribes additive drugs to a patient knowing that he is allergic to it can be held criminally negligent.
# doctor in lieu of making money from the services he provides, if exchanges the lungs of a person during a surgery or leaves a tool or any hazardous substance inside his patient’s body, is criminally negligent.
# parent who leaves their child of two years, at home for going to a pub can be held criminally negligent. This is because it is their breach of duty to take care which is exposing the child to substantial risk.

Procedures And Best Practices Involved In Filing of A Criminal Case

So, now that we have seen certain cases where negligence can turn into a criminal act, we need to know how to file a criminal case.
File an FIR - Make sure that you file an FIR with the police at the police station after the happening of the criminal event with you.

Vakalatnama - Once you have filed an FIR, know that the Vakalatnama has to be filed because the lawyer or the advocate will need to represent you on your behalf.

Investigation- the process of investigation starts after the cognizance of the case to the court and sometimes even before that if the nature of the offence is serious in nature.

Laying of charges - If the crime is heinous then the police will frame the charges in the police diary and then report the same to the court. The court will then decide whether to prosecute based on the witnesses and the statements provided in the court.

Enquiry - Inquiry will be conducted by the court to determine the guilt of the offender and if no such guilt is found, then the statements will be recorded under the Section 164 of the CRPC, where the accused will be required to say whether he feels he is guilty or not and he can admit the guilt.

Trial- The process of trial starts when the investigation is over and the court now needs to decide upon the facts and the evidences upon whether the accused is guilty of the offence or not.

Arguments- both the lawyers put forth their arguments for the determination of the guilt of the accused.

Judgement- The judgment is given on the basis of the arguments put forth and taking into consideration the result of all the steps involved in a criminal case.

Procedures For Filing A Civil Suit on Negligence

Filing of a suit or a plaint-This means that you actually take down time and everything involved in the civil action that happened against you, in the above context, negligence. Then you write and give a written statement of the facts and whatever happened.

Vakalatnama-In vakalatnama what happens is that the person filing the suit authorises the advocate on behalf of the person to file a suit and in civil cases, this is not really necessary. This is done as the requirement of the time and the need is. The person can himself go and file the case and fight the case as well, the requirement of the vakalatnama, therefore is not a compulsion.

Filing-In this step what happens is that you file your plaint which is a written statement with the Chief Ministerial Officer or any other officer as the requirement may be and pay the prescribed fee for filing and the procedural fee and get going with the following steps. The fees may be different according to the officers you approach to.

Hearing-In this stage of hearing what happens is that the judge will listen to what you want to say and what the other party wants to say and then it will ask for substantial documents supporting the case and then fix a date.
Written statement-Written statement means that the statement by the judge that is given for the hearing on the next date. Also, within that period of time the defendant is required to record his written statements proving himself to be free of whatever charge the plaintiff has put against him.

Replication by plaintiff-Replication by the plaintiff means, that the person who has put the charges against you of any civil nature, he will reply to the recorded written statement of the defendant substantiating himself in the court of law of the various practices and actions that prove himself to be the right and the defendant to be actually guilty of the charge of the civil action against him.

Filing of other documents-Filing of other documents mean that the other documents required to substantiate the arguments by each of the parties involved. Both the parties collect and give the collected documents for substantiating their arguments and prove that they are rightful in the court of law.

Framing of issues-Framing of Issues means that once the documents have been put forth across the table, the judge will now consider the issues and the parties will have to fight their case upon the issues so framed according to the substantiated documents and evidences.

List of witnesses-List of witnesses means that the documents that substantiated by the parties, need also to be accomplished by a witness who will prove in the court that he saw or witnessed the event happening for which the case has been filed.

Final Hearing-Once the witnesses, documents and issues are looked into, the judge decides as to in whose favour the judgement should be and acts as an empire in the adversary system of the Indian Courts. The judgement is either given in the form of paying damages, compensation, injunction or remuneration for the losses suffered.

According to the English language, a professional is a person doing or practicing something as a full-time occupation or for payment or to make living and that person knows the special conventions, forms of politeness, etc. associated with a certain profession. Professionals are subject to professional code and standards on matters of conduct and ethics, enforced by professional regulatory authorities and they enjoy high status and respect in the society.

Professional Liability
It covers all aspects of professionals to follow codes of conduct when providing care or services in their field. In the event of the failure to adhere to the professional codes of ethics by the service provider a professional liability claim can be filed for.

Negligence By Professionals
In law of negligence, professional such as lawyers, doctors, architects and others are included in the category of persons professing some special skill or skilled persons generally. A professional may be held liable for negligence on one of the findings of two: one, either he was not possessed of the requisite skill which he professed to have; or two that, he did not exercise, with reasonable competence in a given case, the skill which he did profess.

Negligence By Medical Professionals
A person who holds himself out as ready to give medical advice or treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose. Such a person, whether he is medical practitioner or not, who is consulted by a patient, owes him certain duties, namely a duty of care in deciding whether he undertakes the case; a duty of care in deciding what treatment to give and duty of care in his administration of that treatment. A breach of any theses duties will support an action for negligence by patient.

Degree of Negligence
The Delhi High Court laid down in 2005 that in civil law, there are three degrees of negligence:
# lata culpa, gross neglect
# levis culpa, ordinary neglect, and
# levissima culpa, slight neglect.

Every act of negligence by the doctor shall not attract punishment. Slight neglect will surely not be punishable and ordinary neglect, as the name suggests, is also not to be punished. If we club these two, we get two categories: negligence for which the doctor shall be liable and that negligence for which the doctor shall not be liable. In most of the cases, the dividing line shall be quite clear, however, the problem is in those cases where the dividing line is thin.

The Apex Court has specifically laid down the following principles for holding doctors negligent:
“Gross medical mistake will always result in a finding of negligence. Use of wrong drug or wrong gas during the course of anaesthetic will frequently lead to the imposition of liability and in some situations even the principle of res ipsa loquitur can be applied. Even delegation of responsibility to another may amount to negligence in certain circumstances. A consultant could be negligent where he delegates the responsibility to his junior with the knowledge that the junior was incapable of performing of his duties properly. We are indicating these principles since in the case in hand certain arguments had been advanced in this regard, which will be dealt with while answering the questions posed by us.”

In A.S.Mittal Vs State of UP, AIR 1989 SC 1570 an irreparable damage was done to the eyes of some of the patients who were operated at an eye camp organized by the government of Uttar Pradesh. Some of the patients who underwent surgery could never see the light of the day, i.e. whatever little vision they had even that was lost. The apex court coming heavily on the erring doctors held that, “the law recognizes the dangers which are inherent in surgical operations and that will occur on occasions despite the exercise of reasonable skill and care but a mistake by a medical practitioner which no reasonably competent and a careful practitioner would have committed is a negligent one.” The compensation was awarded.

In one of the most recent decision in Kusum Sharma v. Batra Hospital, the Hon’ble Supreme Court has settled the law relating medical negligence. Mr. DalveerBandari J scrutinizing the cases of medical negligence both in India and abroad specially that of the United Kingdom has laid down certain basic principles to be kept in view while deciding the cases of medical negligence.

According to the court, while deciding whether the medical professional is guilty of medical negligence the following well-known principles must be kept in view:
1. Negligence is the breach of a duty exercised by 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.
2. Negligence is an essential ingredient of the offence. The negligence to be established by prosecution must be culpable or gross and not the negligence based upon the error of judgment.
3. The medical professional is expected to bring a reasonable degree of skill and knowledge and must exercise a reasonable degree of care. Neither very highest nor a very low degree of care and competence judged in the light of the particular circumstances of each case is what the law requires.
4. A medical practitioner would be liable only where his conduct fell below that of the standards of a reasonably competent practitioner in his field.
5. In the realm of diagnosis and treatment there is scope for genuine difference of opinion and one professional doctor is clearly not negligent merely because his conclusion differs from that of the other professional doctor.
6. The medical professional is often called upon to adopt a procedure which involves higher element of risk, but which he honestly believes as providing greater chances of success for the patient rather than a procedure involving lesser risk but higher chances of failure. Just because a professional looking to the gravity of illness has taken higher element of risk to redeem the patient out of his/her suffering which did not yield the desired result may not amount to negligence.
7. Negligence cannot be attributed to a doctor so long as he performs his duties with reasonable skill and competence. Merely because the doctor chooses one course of action in preference to the other one available, he would not be liable if the course of action chosen by him was acceptable to the medical profession.
8. It would not be conducive to the efficiency of the medical profession if no doctor could administer medicine without a halter round his neck.
9. It is our bounden duty and obligation of the civil society to ensure that medical professionals are not unnecessarily harassed or humiliated so that they can perform their professional duties without fear and apprehension.
10. The medical practitioners at times have to be saved from such a class of complainants which use criminal process as a tool for pressurizing the medical professionals/hospitals, particularly private hospitals or clinics for extracting uncalled for compensation. Such malicious proceedings deserve to be discarded against the medical practitioners.
11. The 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. The interest and welfare of the patients have to be paramount for the medical professionals.

In Criminal law, negligence or recklessness must be of such a high degree as to be held gross. The apex court in Jacob Mathew v. State of Punjab, has explained that; “the expression „rash and negligent act‟ occurring in section 304-A of the I.P.C should be qualified by the word „grossly‟. To prosecute a medical professional for negligence under criminal law it must be shown that the accused did something or failed to do something which in the given facts and circumstances no medical professional in his ordinary senses and prudence would have done or failed to do. The hazard taken by the accused doctor should be of such a nature that the injury which has resulted was most likely imminent.” From the above it may be inferred that the distinction between civil and criminal liability in medical negligence lies in the conduct of the doctor which should be of gross or reckless or of a very high degree.

Medical Negligence And Hospitals
Hospitals in India may be held liable for their services individually or vicariously. They can be charged with negligence and sued either in criminal/ civil courts or Consumer Courts. As litigations usually take a long time to reach their logical end in civil courts, medical services have been brought under the purview of Consumer Protection Act,1986 wherein the complainant can be granted compensation for deficiency in services within a stipulated time of 90 -150 days.

Cases, which do not come under the purview of Consumer Protection Act, 1986 (e.g., cases where treatment is routinely provided free of cost at non-government or government hospitals, health centres, dispensaries or nursing homes, etc.) can be taken up with criminal courts where the health care provider can be charged under Section 304-A IPC for causing damages amounting to rash and negligent act or in Civil Courts where compensation is sought in lieu of the damage suffered, as the case may be.

Medical Profession -Whether Under Consumer Protection Act
In one of the earliest significant ruling in Vasantha P. Nair v. Smt. V.P. Nair, the National Commission upholding the decision of Kerala State Commission had held that a patient is a “consumer” and the medical assistance was a service and, therefore, in the event of any deficiency in the performance of medical service the consumer courts can have the jurisdiction. It was further observed that the medical officer’s service was not a personal service so as to constitute an exception to the application of the Consumer Protection Act.

In Indian Medical Association v. V.P. Shantha and Ors., the apex court has put an end to this controversy and has held that patients aggrieved by any deficiency in treatment, from both private clinics and Government hospitals, are entitled to seek damages under the Consumer Protection Act, 1986.

A few important principles laid down in this case include:
1. Service rendered to a patient by a medical practitioner (except where the doctor renders service free of charge to every patient or under a contract of personal service) by way of consultation, diagnosis and treatment, both medicinal and surgical, would fall within the ambit of “service” as defined in section 2(1) (o) of the C.P. Act.
2. The fact that medical practitioners belong to medical profession and are subject to disciplinary control of the Medical Council of India and, or the State Medical Councils would not exclude the service rendered by them from the ambit of C.P. Act.
3. The service rendered by a doctor was under a contract for personal service rather than a contract of personal service and was not covered by the exclusionary clause of the definition of service contained in the C.P.Act.
4. A service rendered free of charge to everybody would not be service as defined in the Act.
5. The hospitals and doctors cannot claim it to be a free service if the expenses have been borne by an insurance company under medical care or by one’s employer under the service conditions.

The book is relevant to medical practitioners and patients, in that it raises the issue of medical errors. It provides a platform for an open discussion on the reporting medical errors between healthcare workers and patients. The suggestions offered in the book, though few in number, are practical and applicable in any healthcare setting. The tools that the authors offer as a way to minimise errors, like the use of checklists, digitalization of data, departmental audits, mortality conferences etc., are indispensable. Probably, computerizing the medication process system in hospital settings and pharmacological education of prescribers and nurses could help to reduce ME.

The issue was decided in the Supreme Court in the case of [1]Jacob Mathew vs State of Punjab. The court directed the central government to frame guidelines to save doctors from unnecessary harassment and undue pressure in performing their duties. It ruled that until the government framed such guidelines, the following guidelines would prevail: A private complaint of rashness or negligence against a doctor may not be entertained without prima facie evidence in the form of a credible opinion of another competent doctor supporting the charge. In addition, the investigating officer should give an independent opinion, preferably of a government doctor.[2] Finally, a doctor may be arrested only if the investigating officer believes that she/ he would not be available for prosecution unless arrested.

1. Statutes
2. The Constitution of India
3. The Consumer Protection Act, 1986
4. The Medical Council Act, 1956
5. Indian Penal Code, 1860
6. negligence-70-of-deaths-are-a-result-of-miscommunication/articleshow/51235466.cms
9. 24 (2005) 6 SCC 1
10. Smt. Madhubala vs. Government of NCT of Delhi; Delhi High Court, 8 April 2005, Citation: 2005
11.DEL 209 = 2005 (118) DLT 515
12. In Spring Meadows Hospital &Anr.VsHarjol Ahluwalia & Anr.30 (1998) 4 SCC 39 at 47,
16. ml

[1] Jacob Mathew vs State of Punjab.

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