Administration of trial drugs Strozagel, Nuravon sans licensing authority nod: Forum absolves Apollo Group affiliate hospital, 3 doctors of medical negligence charges

The case deals with a 72-year old patient who suffered a paralytic attack and was admitted to Abdur Razzaque Ansari Memorial Weavers Hospital (Apollo Hospitals Group) for emergency treatment in 2012. The patient was given tablet "Clopigrel", an alternative to 'Aspirin', as a standard treatment of stroke. Various medical tests were also conducted on the same day and they were found normal.

A couple of days later, the patient suffered acute myocardial infarction (heart attack) and respiratory failure. She was put on ventilator. The patient was later admitted to another Om Nursing Home & Research Centre where she died.

The deceased patient's son, who is a medical practitioner alleged that without prior approval of licensing authority under Rule 122 DA of Drugs and Cosmetics Rules, 1945, the hospital and the doctors administered trial drugs namely "STROZAGEL" and "NURAVON" to the patient. The patient was elderly, 72 years of age, having health problems like hypertension, diabetes and obesity. The treating doctor was allegedly aware of these problems and the act amounts to medical malpractice.

"Those drugs were still under research and experiment which have not been approved in the year 2012 for such clinical/Institutional trials/experiments on human beings. The Complainants alleged that there was breach of Regulation 7.22 of Indian Medical Council (Profession conduct, Etiquette and Ethics) Regulation, 2002 as well as the breach of ethical guidelines for Biomedical Research on Human Participants also known as the ICMR Code, 2006 and further non-observance of 'Inclusion and exclusion criteria'. Moreover, guideline mandates to perform trial of new drugs/research only with "Informed Consent" of the patients," he added.

Being aggrieved by the alleged gross medical negligence he filed the complaint and prayed for Rs. 6 Crores along with Rs. 1 lakh towards costs of litigation/miscellaneous expenses.

The learned counsel for the complainants argued;

" The hospital, the Neurologist, the Cardiologist, and the doctor treated the patient carelessly and committed medical negligence. He got the information through RTI application to the DGCI to inquire about the drugs in India which were administered to the patient during 02.03.2012 till 25.03.2012. He submitted that wrong drugs 'Ozagrel' and 'Edaravone' for the treatment of Acute Ischemic Stroke were prescribed during the treatment therefore the doctrine of Res ipsa Loquitur is applicable. He argued that the act of the hospital and the doctors was negligence per se, i.e. the conduct or the act of omission was contrary is statute. Moreover, it was the failure of duty of care from the treating doctors at the Hospital. The hospital is, therefore, vicariously liable for the act of doctors therein engaged or empaneled."

However, the Hospital and the doctors denied the allegations. Their counsel reiterated their evidence and the treatment aspects of the patient. He submitted that;

"No expert opinion was filed by the complainant to prove their allegation that the death of the patient occurred due to 'Stroragel' and 'Niravon'. As per several medical literatures, the risk factors for stroke and ischemic heart disease are the same like hypertension, diabetes mellitus, smoking, obesity and dyslipidemia. Therefore, the instant patient was prone for cerebral stroke and heart attack (myocardial infarction)."

He further submitted that the patient suffered sudden weakness on the left side i.e. left hemiparesis. It was suspected that it was due to Transient Ischemic Attack (TIA) (without infarct) or stroke (with infarct). Therefore, it was important to prevent further extension of the thrombus. Accordingly, the patient was given IV Ozagrel (Strozagel) and also IV Edaravon (Nuravon). Only absolute contraindication of IV Ozagrel is an active bleed or risk of such a bleed, therefore, considering the old age of the patient, IV Ozagrel was given in low dose (40 mg). At that point of time, the drugs were not trial drugs, however those drugs were available with chemist, thus already completed IVth phase of trial."

The counsel for the hospital also clarified that the hospital was affiliated to leading Apollo Group of hospitals and was functioning as per their standards and specifications.

It submitted; "There was no act of any omission or commission on the part of the hospital. The alleged grievances are related to prescription of drugs, which is exclusively domain of consultant doctors. Therefore the hospital is not vicariously liable. The doctors are duly insured by the Insurance Company."

After hearing both the parties, the Commission observed;

From the medical literature, it is known that in patients with Acute Ischemic Stroke (AIS), platelets are activated in the acute phase, releasing neurotoxic, and thrombogenic eicosanoids, which may reduce the brain blood flow and cause brain damage. Sodium ozagrel (ozagrel), a thromboxane A2 synthase inhibitor, is one of the most studied drugs which may reduce the risk of neurological impairment and reduce the volume of brain damage. In Japan Ozagrel sodium, a thromboxane synthesis enzyme inhibitor was approved in January 1988 for the improvement of postoperative cerebrovascular contraction and accompanying cerebral ischemia. Thereafter an additional indication for improvement of motility disturbance due to acute cerebral thrombosis was approved in April 1992. USA may have their own guidelines in respect of certain medicines, but the same cannot be applied universally due to racial differences as well as differences in approved therapeutic agents, and disease sub-types between India and other countries. These stroke guidelines approved by the USA therefore, can not necessarily be directly adopted into clinical practice in India.

" It is pertinent to note that the drugs Ozagrel (Strozagel) and Edaravon (Nuravon) were available in the market with the chemist. The trial was in the 4th phase, which does not require any informed consent of the patient. The only phase which requires informed consent of the patient is 1st and 2nd phase. In that phase, the drugs are not available in the market with the chemist for sale. The mother of the Complainants was suffering from Hypertension (high Blood Pressure), Diabetes Mellitus (Sugar), and severe obesity. She was at risk of cardiac problems and she suffered stroke before admission in the Opposite Party hospital. The kidney injury was due to the consequences of several factors like long standing Diabetes, high BP and Infection. The patient was treated as per the accepted standard in medical protocol. The patient was recovered from renal insufficiency and serum Creatinine became within limits. Both Ozagrel and Edaravon well known drugs are used for treatment of stroke, and therefore there was no need of prior consent. The Complainants have misconceived them as trial drugs. The Complainants were attributing the causation of heart attack and respiratory failure to injection Ozagrel and Edaravon. In our view, Inj Ozagrel does not cause heart attack, but as an antiplatelet agent, it is considered to be beneficial for the treatment of ischemic heart disease. It acts like Aspirin and Copidogrel anti-platelet agents. Moreover, the drug Ozagrel is approved by DGCI for the treatment of acute bronchial asthma, one of the causes of respiratory failure. In the present case, the patient was suffering not only from hypertension, diabetes mellitus and severe obesity but also from hypothyroidism, which was diagnosed after admission. There was hypoproteinemia and lower respiratory tract infection noted by the doctor."

Clarifying on the inclusion and exclusion criteria raised by the complainant, the Commission noted;

"Inclusion and exclusion criteria are not part of any recommendation or guidelines of any official body or any expert body. These are simply part of research study. Any drug trial study needs Inclusion criteria — to include the patient for study, and Exclusion criteria — to exclude confounders (confounding factors) to have a homogeneous patient population in roughly the same stage and condition and also to exclude certain patients for ethical reasons — not including if the patient is improving, if the risks are very high etc. By projecting such study as guideline, the Complainants are misleading this Commission. The Office of DGHS has aptly replied that no permission was given for trial in respect of Edarvon. Ozagrel is an extensively used drug for ischemic stroke. Therefore, in our view, there was no malpractice or any violation of rules by the treating doctors."

Examining the claims of the complainant that the deceased patient was taking "all attention and care" of her autistic grandchild in USA. She was expected to live up to 86 years as per US data i.e. upto another 14 years, the apex consumer court expressed;

"In our view, it is surprising about the Complainants for such guess work that the 72 years old lady having multiple comorbidities would take care of autistic child for further 14 years. Thus the Complainants have deliberately attempted to claim an exorbitant compensation without any basis, which was, just, to come under the jurisdiction of this Commission."

It subsequently dismissed the complaint noting;

"Based on the foregoing discussion, we do not find any negligence or any mal practice on the part of the hospital and doctors. The Complaint lacks merit, hence dismissed."

To view original order, click on the link below:

http://cms.nic.in/ncdrcusersWeb/GetJudgement.do?method=GetJudgement&caseidin=0/0/CC/121/2014&dtofhearing=2022-08-26