Above: The father of a three-year-old girl who allegedly died due to medical negligence protesting in Kerala/Photo: UNI
Do surgeries where swabs and instruments are left inside the body of a patient fall under the ambit of criminal negligence and how have courts adjudicated in such matters?
By Dr KK Aggarwal
Recently, two doctors at Nizam’s Institute of Medical Sciences in Hyderabad were booked under Sections 336 and 337 of the Indian Penal Code for alleged medical negligence after surgical forceps were found in the abdomen of a woman who had undergone surgery last year. The forceps were surgically removed. Such cases where swabs and scissors are left behind after an operation are often reported in the media. Is this willful negligence or carelessness?
A retained surgical instrument is any item inadvertently left behind in a patient’s body in the course of surgery. As a preventable medical error, it occurs more frequently than “wrong site” surgery and it incidence has a reported rate of 0.01-0.001 percent. Of these, swabs make up 70 percent of the cases and the remainder, surgical instruments. The consequences of retained surgical tools include injury, repeated surgery, excess monetary costs, loss of hospital credibility and in some cases, death of the patient.
These errors are more common after an emergency surgery, an unplanned intra-operative change of procedure, changes in theatre staff and failure to count swabs in and out. An operation by a single surgeon carries a greater risk than when a team is involved. Other situations are obesity and a sudden change during surgical procedure (such as a change of surgeon). Whatever be the situation, the occurrence of a retained swab should not happen, and is classified by the National Patient Safety Agency as a “never event” and are classed as medical negligence in court judgments.
It is preventable by performing more than one in and out swab count (double checking and reporting to ensure that all swabs have been removed); having an adequate number of experienced staff; replacing small swabs by laparotomy pads and thoroughly searching the abdomen before closure of the wound. In one study of successfully litigated cases, a correct count of swabs had been noted in 88 percent of cases. This led to a call for bar-coded swabs which can be scanned on entry and exit to avoid human errors which are clearly still too prevalent.
Why are there fewer convictions?
Despite medical negligence being widely prevalent, why are there few convictions? For criminal negligence, one has to prove either a wrong intent or knowledge on the part of the doctor that a particular action is likely to cause harm and was still done without consent. Informed consent in most cases is the bridge between a wrong act and an untoward event.
Any adverse event or non-criminal medical negligence will attract compensation under the law of torts or the Consumer Protection Act. Today, compensation is awarded in upto 5-10 percent of consumer cases, which is a significant number. The indemnity insurance by national insurance companies also acknowledges medical negligence as acceptable for compensation. To err is human and no treatment is risk-free.
However, criminal negligence is a different matter altogether. In 2005, the Supreme Court in the Jacob Mathew case said: “Negligence in the context of medical profession necessarily calls for a treatment with a difference. To infer rashness or negligence on the part of a professional, in particular a doctor, additional considerations apply. A case of occupational negligence is different from one of professional negligence. A simple lack of care, an error of judgment or an accident, is not proof of negligence on the part of a medical professional. So long as a doctor follows a practice acceptable to the medical profession of that day, he cannot be held liable for negligence merely because a better alternative course or method of treatment was also available or simply because a more skilled doctor would not have chosen to follow or resort to that practice or procedure which the accused followed. When it comes to the failure of taking precautions what has to be seen is whether those precautions were taken which the ordinary experience of men has found to be sufficient; a failure to use special or extraordinary precautions which might have prevented the particular happening cannot be the standard for judging the alleged negligence. So also, the standard of care, while assessing the practice as adopted, is judged in the light of knowledge available at the time of the incident, and not at the date of trial. Similarly, when the charge of negligence arises out of failure to use some particular equipment, the charge would fail if the equipment was not generally available at that particular time at which it is suggested it should have been used.
“The jurisprudential concept of negligence differs in civil and criminal law. What may be negligence in civil law may not necessarily be negligence in criminal law. For negligence to amount to an offence, the element of mens rea must be shown to exist. For an act to amount to criminal negligence, the degree of negligence should be much higher i.e. gross or of a very high degree. Negligence which is neither gross nor of a higher degree may provide a ground for action in civil law but cannot form the basis for prosecution.”
—By Dr KK Aggarwal
Let us understand “never” events: These are situations where deficiency of service and/or negligence is presumed, and no trial of expert’s evidence is necessary (IMA vs VP Shantha and Spring Meadows Hospital v. Harjol Ahluwalia). Such cases can be speedily disposed of (Nizam Institute vs P S Dhananka). In another apex court judgment, decided on January 16, 2012, in Jaswinder Singh vs Santokh Nursing Home, the Court endorsed the National Consumer Disputes Redressal Commission judgment that “in such a surgical procedure, the surgeon is assisted by other Doctor and para medical staff like nurses, etc. who also owe a duty to count the mops used during the surgical procedure to ensure that all the mops/swabs so used had been retrieved before the operated organ is sutured. However, the surgeon cannot abjure of his/her overall responsibility even in that behalf and cannot be allowed to take the plea that it was not his/her concern to ensure that no mop/swab was left in the abdomen”.
In Achutrao Haribhau Khodwa vs State of Maharashtra on February 20, 1996, the apex court observed: “In cases where the doctors act carelessly and in a manner which is not expected of a medical practitioner, then in such a case an action in torts would be maintainable.” A tort is a civil wrong which unfairly causes someone else to suffer loss or harm resulting in legal liability for the person who commits the tortious act, called a tortfeasor. Although crimes may be torts, the cause of legal action is not necessarily a crime.
The victim of the harm can recover his loss as damages in a lawsuit. In order to prevail, the plaintiff in the lawsuit must show that the actions or lack of action was the legally recognisable cause of the harm. Tort law is different from criminal law in that torts may be created due to negligent, but not intentional and criminal actions. Tort lawsuits have a lower burden of proof.
When can such negligence be criminal negligence? Four IPC Sections can be applicable in such cases:
Section 304A, IPC: Causing death by negligence—whoever causes the death of any person by doing any rash or negligent act not amounting to culpable homicide shall be punished with imprisonment of either description for a term which may extend to two years, or with a fine, or both.
Section 336: An act endangering life or personal safety of others—whoever does any act so rashly or negligently as to endanger human life or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to Rs 250, or both.
Section 337: Causing hurt by an act endangering life or personal safety of others—whoever causes hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to six months, or with a fine which may extend to Rs 500, or with both.
Section 338: Causing grievous hurt by act endangering life or personal safety of others—whoever causes grievous hurt to any person by doing any act so rashly or negligently as to endanger human life, or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine which may extend to Rs 1,000 or both.
In Dr. R.R. Rana vs State on May 31, 2012, the Delhi High Court upheld the trial court framing charges under Section 338 IPC on the grounds that “in the instant case, the nature of injuries suffered by the wife of the complainant is grievous. While treating a patient for medical termination of pregnancy, the nature of injuries which the wife of complainant allegedly suffered (perforation of uterus and bowel) at the hands of the petitioner are such that no professional or skilled person in his ordinary senses and prudence could have caused. It appears that the petitioner did not have even the ordinary skill to perform the MTP”.
For any criminal liability, it needs to be shown that it was a gross case of reckless negligence. A private complaint is not supposed to be entertained by the police unless the complainant has produced prima facie evidence before the court in the form of a credible opinion given by another competent doctor to support the charge of negligence on the part of the accused doctor. The investigating officer should also proceed against the accused doctor by obtaining an independent and competent medical opinion, preferably from a doctor in government service qualified in that branch of medical practice who can normally be expected to give an impartial and unbiased opinion regarding the facts collected in the investigation.
It is obvious that such cases are not easy to tackle and unravel.
—The writer is president, Heart Care Foundation of India, and President-Elect, Confederation of Medical Associations of Asia and Oceania