Patient’s valid consent is a must for surgeries: State Consumer Disputes Redressal Commission
Written consent from a patient is mandatory for any Out Patient Department (OPD) or In-Patient Department (IPD) surgical procedures, ruled the State Consumer Disputes Redressal Commission (SCDRC) while dealing with a complaint of medical negligence.
The commission, headed by Justice AP Bhangale and member Dr SK Kakade, and in consonance with the regulations of the Indian Medical Council (IMC), has also set rules for doctors to ensure transparency.
The commission was hearing a complaint filed by Dr Ramesh Kulkarni, a surgeon from Nashik, against Dr Amit Maydeo, an endoscopy surgeon in Mumbai. Kulkarni alleged that Maydeo did not take his consent before operating on him, and also claimed that he was negligent in post-operation care.
In April 2006, Kulkarni was detected with silent gallstones that became symptomatic in the month of December. He had consulted local doctor Dr Ramesh Patil who identified the issue with the common bile duct and referred him to Maydeo for further diagnosis and treatment.
On January 5, 2007, Kulkarni, in his complaint, claims that he had consulted Maydeo, whereafter, Maydeo performed endoscopic ultra sonography and endoscopic retrograde cholangiopancreatography on him at his Institute of Advanced Endoscopy in Mumbai.
During the examination, Maydeo detected roundworms in Kulkarni’s common bile duct and removed them endoscopically. While doing so, Maydeo performed wide biliary sphincterotomy and after complete ductal clearance, zentel suspension was used as drug to clear the roundworms. He also inserted a stent of the size of 10 French Size (Fr) in the common bile duct, claimed Kulkarni.
Kulkarni claimed that for this OPD procedure, his consent was not obtained and he was not explained the complications of the said procedure. He further claimed that within 12 hours of the procedure, he got abdominal pain from January 6, 2007. He tried to contact Maydeo but received no response. Kulkarni later consulted a doctor in Nashik and a CT (computed tomography) scan of the abdomen was done on January 15, 2007.
The diagnosis revealed that the common bile duct stent was displaced. Thereafter, Kulkarni, following the advice of Maydeo, got admitted at Jaslok hospital on January 16, 2007, where he was treated by Dr KP Balsara. Kulkarni was operated the next day and an exploratory laparotomy was performed on him. Kulkarni alleged that because Maydeo had wrongly performed the endoscopic wide sphincterotomy with metal stenting of the common bile duct, the stent had migrated causing him pain and a need to go through a laparotomy.
As per the commission’s rules for medical negligence, an opinion of an expert from JJ hospital was sought. The hospital did not find any medical negligence in the treatment given to Kulkarni.
The commission, after viewing the records and opinion of JJ hospital, stated that “the correctness of the treatment of the complainant in respect of diagnosis and the actual endoscopic procedure is the matter of subject experts. The court need not decide the correctness of the treatment when different schools of thought advise different lines of treatment.”
The bench also observed that “if a medical professional treats a patient without valid consent, then he will be liable under both tort and criminal law. Consent may be inferred from the general submission by a patient to orders given by a doctor during clinical diagnosis. If there is a need to undergo an invasive examination such as an incision on the body; written consent of the patient is ideally required.”
The commission ruled that there is a deficiency in the service provided by Maydeo. “Performance of such invasive procedure was an unauthorized interference with the complainant’s body, which amounted to a tortious act of assault and battery, and also, a deficiency in service. Also, he (Maydeo) has not documented the communication to the complainant about the likely complications and hence did not instruct the complainant regarding likely possibility of the displacement of the stent and further plan of management of such complication,” the commission observed.
The commission has now asked Maydeo to pay ₹10 lakhs within three months from the receipt of the order to Kulkarni for causing mental agony.
Rules of Assent
• Pre-operative consent for OPD surgical procedures is essential. As per the guidelines of any surgical intervention that involves risk of complications, even though minor and OPD procedure, consent of the patient is important. Absence of which is considered as “act of omission – negligence”.
• Section 7.16 Indian Medical Council of ethics regulations, 2002, states that,” before performing an operation on the patient, the doctor should obtain in writing the consent from patient himself or the husband or wife, as the case may be.”
• The informed consent of the patient is necessary for any OPD or IPD surgical procedure.
• Since the legal duty of medical professional starts with patient consultation, the same includes preoperative and postoperative care and formal communication with patient with documentary proof of the same.
• Legal duty also includes post-surgical procedure care of the patient. Foreseeing the known complication and taking steps proactively to avoid as well as treat any complication is also part of “duty of care” by the medical professional.