ERCP Complications, ICU infections: Bengaluru hospital, HoD Critical care medicine, gastroenterologist slapped Rs 30 lakh compensation
Medical Negligence
Hassan: The District Consumer Disputes Redressal Commission (DCDRC), Hassan, recently directed a Bengaluru-based hospital and its two doctors to pay Rs 30 lakh compensation to the family of a patient who died after undergoing a surgery at the hospital.
In its recent order, the District Consumer Court directed the hospital, the HoD of Critical Care Medicine, and gastroenterologist, "The opposite party no.5, 6 and 8 are jointly and severally directed to pay total compensation of Rs.30,00,000/- (Rupees Thirty Lakh rupees only) to the complainant, within six weeks from the receipt of the copy of this order. In case of non-compliance of the order the entire amount shall carry interest @ 10% per annum from the date of complaint till its realization."
Case History:
The case goes back to 2023 when the complainant's mother, the patient, was suffering from abdominal pain. After having done the initial investigation, CT Abdomen, and pelvis pain study, the treating doctor, hailing from Hassan, diagnosed that she was suffering from Gall Bladder stone and choledocholithiasis and referred the patient to a higher centre for management. Accordingly, the patient got admitted to BMC & RI Super Speciality Hospital in Bangalore and was under the treatment of another doctor at the facility.
Again, the patient was referred for higher management to the Bengaluru-based hospital located at Sarjapur Road, Bangalore. At the hospital, the HoD of Critical Care Medicine treated the patient and discharged her after a few days. The patient underwent an ERCP procedure with stent placement by a doctor from the Gastroenterology Department and was infected with E. Coli and Stenotrophomonas Noso Comial Infection (antibiotic resistance bacteria) during the course of the treatment in the said hospital, alleged the complainant.
The patient had to be readmitted and remained under treatment for several days. Later, she developed acute respiratory distress and bronchospasm during her treatment and had to undergo tracheotomy on 21.01.2023. On 30.01.2023, early morning, the patient developed a sudden onset of acute respiratory distress and died due to pneumothorax.
Filing the consumer complaint, the patient's son alleged that his mother died due to the hospital-acquired infection, and it was an act of medical negligence on the part of the hospital management and also of the treating doctors. It was further alleged that the management and the treating doctor failed to treat the patient with the minimum required care and skill, resulting in her death.
On the other hand, the treating hospital and doctors denied any negligence and submitted that the patient was brought to the Emergency Department of the hospital with pain in the abdomen and vomiting for 2 days, associated with chills, cough, breathing difficulty on exertion for 3 months, and decreased urine output since Day 1.
The patient had a history of DM for 4 years, HTN for 10 years and pemphigus on steroids 4 years back. On examination, the patient was afebrile, tachycardia, tachypneic and hypoxic. The patient had jaundice, and an abdominal examination revealed diffuse tenderness. CT done from outside hospital on 04.01.2023, showed multiple radiodense calculi - cholellithiasis, mild to Mod IHBRD, CBD dilated CBD calculi. It is further submitted that a diagnosis of obstructive jaundice due to cholelithiasis/chiledocholithiasis/cholangitis was made. Pancreatitis, AKI and sepsis were suspected, pending further reports.
The patient was treated in the emergency room with intravenous fluids, antibiotics and analgesics. Gastroenterology advised ERCP procedure after stabilization. The patient was admitted to EICU and treated with antibiotics, fluids and vasopressors. On 06.01.2023, the patient was taken up for ERCP, which showed choledocholithiasis + cholangitis partial CBD clearance done with stunting. The patient was brought back to EICU and supportive measures were continued.
However, the patient developed fever, worsening respiratory distress, and wheeze, and appropriate medical care was given. She was discharged after her lung function improved.
Regarding the allegations of hospital-acquired infection, they argued that the patient presented with an infection of the biliary system. She had cholecystitis, choledocholithiasis, and cholangitis with sepsis. The bile pus culture grew a bacteria on 06.01.2023 E.coil which warranted antibiotics from day one. Patient had developed pneumonia during the ICU stay as shown in the culture report from her lungs sent on 17.01.2023 which grew proteus Mirabilis and Acinetobacter Baumanii. The infection she developed while in the ICU was after 10 days of stay in the ICU with a failed extubation from the ventilator twice. She had several risk factors for the development of multi-drug resistant pneumonia in ICU. Patient had ARDS at the time of admission which is a risk factor for hospital-acquired pneumonia. The patient was infected with drug resistant bacterial infections because of the above risk factors which was appropriately recognized and treated.
They claimed that the hospital-acquired pneumonia, especially ventilator associated pneumonia is one of the most common hospital-acquired infections in the ICU and can range from 5-40% with high mortality. The risk factor for VAP is the same. Since the patient had several risk factors for developing VAP, that too with multi drug resistant bacteria, the hospital-acquired infection is not a medical negligence.
Consumer Court's Observations:
After going through the entire medical record, the submissions by both parties and the evidence on record, the District Consumer Court observed that the specific allegation of the complainant was that while performing the ERCP procedure, his mother was infected with E.Coli and stenotrothomonas, gram-negative sepsis, hyper tension due to which his mother died and therefore, the act of the treating hospital and the doctors was medical negligence.
At this outset, the Commission noted that the endoscopy report showed an ERCP procedure was performed on 06/01/2023 at 12.32 pm and stent was placed. Under endoscopic diagnosis, it was mentioned that "choledocholithiasis with cholangitis ERCP and partial CBD clearance done CBD stunting done".
In the said document, it was also revealed that on 08.01.2023, the patient developed respiratory distress, tachypnea, desaturation, developed severe bronchospasm, and she was treated for the same.
Meanwhile, the Discharge summary dated 10.01.2023 reflected under the head of course in ICU that on arrival to MICU from EICU she was conscious, stable vitals, on PRVC more of mechanical ventilator support, she was continued antibiotics, in view of ARDS she was sedated and paralysed for a day, her pus cultures grew E-coli, antibiotics was optimsed, she was transfused 1 unit of PRBC for low hemoglobin, she was in PRVC mode of ventilation, conscious, making adequate urine output and she was getting discharged for insurance purpose.
"So, this document clearly proves the Op 6 (HoD critical care medicine) notices the development of E-Coli in the patient on early 06/01/2023 itself," noted the Commission.
Referring to Medical Literature, the Commission further observed that E.coli is a bacterium commonly found in the gut of warm-blooded organisms, and it causes various diseases including pneumonia, urinary tract infections and diarrhea. Symptoms may appear 3 to 4 days after being exposed to the bacteria. However, symptoms may appear as early as 24 hours or as late as 1 week later.
The Commission noted that the patient was readmitted on 11.01.2023 and she was shifted to MICU with complaint of Shortness of breath and Generalized weakness.
At this outset, the Commission observed, "On perusal of contents of affidavit evidence of Op No. 6 and 8 (gastroenterologist) it clearly proves that after ERCP procedure of 6/1/2023 the patient developed multiple bacterial infections in the ICU and MICU of 5th Op hospital."
Holding the treating hospital and its doctors liable for the worsening condition of the patient, the Commission observed,
"E-coli developed in the patient and same was noticed by Op.6 and 8 (doctors) on 06/01/2023 itself. Being doctors they well know the risk factor of the above said bacterial infections. Such being the case, the Op.6 and 8 should have taken steps early to perform Tracheostomy. But when the condition of the patient became worst then only they had taken decision for Tracheostomy on 21/01/2023. Ops should have taken early steps to perform Tracheostomy to facilitate_early weaning and prevent complication. The Ops should have taken extra care in the immediate ERCP procedure keeping in view of the patient is diabetic. Delay in Tracheostomy proved it to be no use after development of severe bacterial infections as it was too late to intervene. If proper care and attention was taken, the complication like Hospital acquired pneumonia could have been avoided."
"The Ops 5, 6, and 8 failed to take appropriate precautions while the deceased was on ventilator. They did not proactively look for ventilator associated pneumonia and the Ops should have known that chances of pneumonia was certainly high in case of those who was diabetic and infected patient," it further noted.
It was observed by the Commission that the HoD of the Critical Care Medicine Department admitted in his cross examination that when he met the patient in 09.01.2023, she was on the endotracheal tube, controlled mode of ventilation and she had severe hyposia, possibly moderate to severe acute respiratory distress syndrome sepsis and septic shock. He also admitted that on 09/01/2023 itself he noticed breathing difficulty in patient. But he denied that due to improper insertion of tube vocal card edema occurred.
"Admittedly when the patient got admitted to Op.5 hospital on 05/01/2023 there was no complaint of vocal card edema. But Op.6 failed to explain for what reason vocal card edema occurred in the patient while she was in ICU. In the affidavit as well as written version of the 6th Op it shows that they have intubation and extubation many times definitely which may cause infection," the Commission observed at this outset.
"Moreover, prior medical conditions of the patient were known to the Ops 6 and 8 even before ERCP performed. The patient was suffering from chronic disease and was also susceptible to complications on account of her weak condition but at the same time what aggravated the same is the hospital associated infections that seems to have compounded the worsening situation of the patient. So, worsening of the deceased patient's condition after the ERCP was the result of deficient service by 5th Op hospital which thus contributed the patient death," it held.
The Commission observed that the treating doctors and hospital did not produce any documents to prove that while admitting the patient to the treating hospital, she was suffering from respiratory infection. Meanwhile, the records revealed that the patient died due to "Tension pneumonia, inter pulmonary haemorrhage, hospital acquired pneumonia, gram negative sepsis and hyper tension."
"The diabetic patients are prone to infections after surgery or procedures and adequate preventive steps should have been taken by the Op.6 and 8 to prevent infections. If proper care and attention was taken, the complications like infections and speticaemia could have been avoided. In the 5th Op Hospital after ERCP procedure initially complication was started with poor infections. At that time proper care should have been taken immediately. It was not done," the Commission observed in this regard.
The Consumer Court also took note of the report prepared by the expert committee of HIMS, which noted that "as per the record patient was examined in triage and advised admission. But patient was shifted to St.John's medical college, Here patient is not admitted, but treated on outpatient basis. No invasive procedures are done that may lead to development of hospital acquired infection."
However, in this regard, the Commission noted, "As against this statement, the medical record produced by the complainant as well as Ops it clearly reflected that as per the advice of 2nd Op, patient was taken to 4th Op on 05/01/2023, he advised for ERCP, but against his advice, patient was taken to 5th Hospital on the same day and admitted her without any delay. Hence we cannot agree with the opinion of experts made in their report. Further all the medical record produced by the parties proves that after ERCP the patient developed infections and there was a delay in treating the patient properly. In para 3 of the said report it is stated that "Stenotrophomonas species bacteria grown in BAL sample taken on 23rd January. As this event occurred around 17 days after hospitalization, this infection can be considered as hospital acquired infection"."
"All the documents produced by parties prove that the infections occurred during the stay of the deceased at the 5th Op hospital. On the other hand, there is nothing to show that the bacterial infections law outside the hospital. Thus there is preponderance of possibilities of the infection having been acquired in the hospital itself. Consequently, in the light of the evidence produced by both parties, the patient condition after the ERCP from 06/01/2023 onwards deteriorated due to the hospital associated infections which is a clearly defiant in the part of Ops.5, 6 and 8. The deceased died due to tension pneumonia, inter pulmonary haemorrahage, hospital acquired pneumonia, gram negative sepsis on account of failure of the Op.6 and 9 to prevent infection. Hence we hold that Ops.5, 6 and 8 have committed medical negligence while treating the patient and their negligence caused the death of patient," it concluded.
Observing that the doctors have a legal duty to comply with the applicable ethical and legal regulations in their daily practice, the Commission noted that "Ignorance of law and its implications will be detrimental to the doctor, even though he treats the patient in good faith for the alleviation of the patient's suffering...Res ipsa loquitur is a rule of evidence which in reality belongs to the law of torts. Inference as to negligence may be drawn from proved circumstances by applying the rule if the cause of the accident is unknown and no reasonable explanation as to the cause is coming forth from the defendant."
The Commission referred to the Supreme Court orders in the case of Poonam Verma and in the case of Jacob Mathews and NCDRC order in the case of Deep Nursing Home versus Manmeet Singh Mattewal and others and noted, "Admittedly Op.6 and 8 had treated the mother of complainant in 5th OÑ€ hospital. As per the legal maxim & rule of vicarious liability, an employer i.e., 5th Op is liable for the negligence of its employees. So, the hospitals become legally liable for any medical malpractice case done by its doctor or any other medical practitioner who has been on roll with the hospital."
With this observation, the Commission directed the hospital and the treating doctors to pay Rs 30 lakh as compensation to the patient's son.
To view the order, click on the link below:
https://medicaldialogues.in/pdf_upload/bengaluru-consumer-court-rs-30-l-309747.pdf
