1. The complainants, Shri Unnikrishnan and Smt. Sajitha, are the parents of Baby Midhila Krishnan, 9 years of age (since deceased referred herein as "patient") expired during operation for the correction of squint in her right eye at Amritha Institute of Medical Sciences/OP1. It was performed by a team of doctors/OPs 3 to 6 attached to OP1/Hospital. The complainants alleged that the death of their child was due to negligence caused during anesthesia administration, without taking any pre-operative precautions. No proper consent was taken. It was further alleged that the medical records relating to surgical procedure were manipulated. Therefore, the complainants filed a complaint before the District Forum, Ernakulam and claimed Rs.20 lakhs, as compensation.
2. The District Forum allowed the complaint and awarded a compensation of Rs.6 lakhs with interest @ 12% per annum from the date of the order, to be paid by OP No.7/New India Assurance Co. Ltd..
3. Aggrieved by the order of District Forum, the OPs filed first appeal before the Kerala State Consumer Disputes Redressal Commission, Thiruvananthapuram (for short, ''the State Commission''). The State Commission dismissed the appeal.
4. Aggrieved by this, the OPs filed this revision petition.
5. We have heard the learned counsel for both the parties. The OPs resisted the complaint on the ground that it is a charitable institute and its service is free. The patient was attended on OPD basis. The OP denied any negligence or deficiency in service, on the following grounds:
(i) the special risk factors involved in the squint surgery were explained properly to the
parents/complainants 1 and 2,
(ii) informed consent was taken for the surgery,
(iii) the OPs/petitioners conducted all pre-operative tests,
(iv) Glycopyrolate was administered to the patient before the surgery to prevent any
possibility of Occulo Cardiac Reflex(OCR),
(v) there were no latches, lapses or negligence on the part of the petitioners in
resuscitative steps to revive the normalcy of the patient,
(vi) the expert committee not reported any negligence or deficiency in service on the
part of petitioners and
(vii) since there is no conclusive finding as to the cause of death, no negligence can be
attributed on the part of opposite parties.
6. We have perused the evidence adduced before the District forum including the expert report
and the post mortem (PM) report. The counsel for the OP submitted that the operation was
performed with the ''informed consent''. On 4.4.2007, the surgery was started with general
anesthesia at 8:30 A.M., under monitoring of qualified Anesthesiologist and pre-medication.
Towards the end of surgery, at 10.20 AM, when the last few stitches were being taken, the patient
developed cardiac asystole. Patient was resuscitated successfully, given injection ''atropine'' and
''adrenaline''. Thereafter, again, patient was having intermittent episodes of bradycardia and
asystole at 10.30 AM. All the events were explained and the progress of the case was informed
periodically to the complainants. The entire team consisting of Cardiologist, Anesthesiologist and
Ophthalmologists, made their efforts to treat the complications. A pacing wire was placed under
fluoroscopic guidelines, at 2.40 PM, but patient''s condition did not improve. The patient, again,
had ''asystole'', while shifting from cath lab and was massaged, brought back to ICU but the
patient''s condition did not improve and was declared ''dead'' at 6.10 P.M..
7. In this case, the post-mortem report from Trichur Medical Hospital, revealed that the death was due to "hypoxia, following induction of anesthesia". It appears to be a vague report; it leads us nowhere, because, every cardiac arrest will cause hypoxia. Even the inquiry committee gave the expert opinion that there was no negligence.
8. In this context, the State Commission''s observation, made in para 10 of its impugned order, is more relevant, which is reproduced, as below:
"DW-1 is the sixth opposite party and was the head of department of
anesthesiology in the first opposite party hospital. He explained that at page 31 of
Ext.A-7, the medicines administered previous to surgery are mentioned. The
medicine glycopyrolate is one among them. But it is written as glycol because of
lack of space. The suggestion was from the word glycol alone, it cannot be said for
sure that it is glycopyrolate. DW-1 claimed that glycoporate has sialoguguic effect.
The suggestion was that the said medicine is mainly used to reduce secretion from
mouth. He answered that it is also used for drying up secretion. He admitted that
glycopyrolate has less vagolytic effect. He further admitted that to control occulo
cardiac reflexes atropine is more effective than glycopyrolate. The reasons for not
giving atropine before surgery was that it has its own side effect like severe
increase in heart rate which can cause problem for the surgery. He claimed that
glycopyrolate is not inferior to atropine as a pre operative medicine in squint
surgery ."
Therefore, in our view, pre-operative administration of glycopyrolate, instead of ''atropine'', is an
acceptable method of anesthesia. The doctor can adopt any accepted method for treatment, it is
not negligence. This view dovetails from the case of Dr. Laxman Balkrishna Joshi vs . Dr.
Trimbak Babu Godbole and Anr. , AIR 1969 SC 128 and A. S. Mittal vs . State of U.P. , AIR
1989 SC 1570.
9. We have perused the observations made by the fora below about the deficiency in the
service on the part of the OPs. There was no informed consent and the special risk factors
involved in squint surgery were not explained to the parents of the child before obtaining the
consent. The State Commission and the District Forum observed that the consent obtained was a
routine one. No attempt was made to explain the special risks, involved in the squint surgery like
occurrence of OCR and subsequent complications. The evidence of DW1 (OP6), Dr. Suresh G.
Nair, admitted that special risk factors were not explained to the parents, but it was further added
that in case of administration of any anesthesia, risks are involved and everybody knows this. The
District Forum observed, as follows:
The treating doctors have failed in securing an informed consent from the parents
of the deceased after explaining to them the special risk involved in the surgery.
The consent registered at page 26 of Ext.A7 obtained from the mother of the
deceased looks ritualistic. Hence, conclusion is irresistible that 2 nd OP has failed
in obtaining informed consent from the guardian of the patient.
10. It was admitted by DW1 that ''atropine'' was administered, when cardiac arrest occurred. He
has stated in his deposition that ''atropine'' was not administered at the pre-operative stage,
because it has its own complications. Also, he has asserted that in lieu of ''atropine'',
''glycopyrolate'' was administered at the pre-operative stage, which is also effective in reducing
mouth secretion.
11. It is also pertinent to note in this case that, whether, Retrobulbar block was given in the instant case or not? It was deposed by DW1 that, retrobulbar block was given at 8:30 AM before the microsurgery commenced. He added that in Ext.A7 there will be no indication to show this fact and he stated that it was administered by the surgeon. He also disclosed that retrobulbar block is essential to prevent cardiac arrest. He explained that this is only a routine procedure especially for squint surgery. In the version filed on behalf of the opposite parties, it is stated that retrobulbar block was administered. On the reverse page of case Record of the Department of Anaestheology it is stated the names of medicines administered at 8:30 A.M.. Nothing is specified regarding retrobulbar block. Physician''s Progress notes also is blank with regard to retro bulbar block. At many places it is mentioned that the surgery was performed under general anaesthesia. We have perused the ophthalmology operation record where we have not found any noting regarding retrobulbar block. In that view of the matter, the conclusion is inescapable that before the commencement of the operation, no retro bulbar block was effected. Keeping in view the admission that retro bulbar block was inevitable to avoid cardiac arrest, it is crystal clear that the operating team has failed in that respect. It is not clear whether the duty is that of the surgeon or the anesthesiologist to administer the same. Also it is pertinent to take into account the opinion of DW1 stating that retrobulbar block is a routine process for every patient and especially for squint surgery.
12. Therefore, it is clear that, Medical record had lot of discrepancies. No doubt, OP1 is one of the best and reputed institutes in India. The team of doctors made their efforts to treat the complications of OCR, during squint surgery, but the child did not survive. We accept that ''glycopyrolate'' can be used, instead of ''atropine''; it was the decision of the anesthetists, as per their expertise. It was submitted during oral arguments that the word ''glyco'' was mentioned in the operation theatre (OT) record, which appears to be incomplete. Use of such abbreviation is misleading to the consumer fora. There are several meanings for ''glyco''. Thus, use of confusing abbreviations in the medical record is another deficiency in service. It is further surprising to note that, the petitioner had not placed any medical record pertaining to pre-anesthetic check-up, OT records, to prove that glycopyrolate was administered prior to operation. The enquiry report given by the experts (Annexure P4) is also silent about administration of injection ''Glycopyrolate''. It just mentions about " Routine premedication administrated ". Thus, if no documentation or improper documentation means "No proof" thus "Care is considered as, not done..!"
13. We are of considered view that, there are several lapses and deficiencies committed by the OPs-doctors, who are working in OP1-institute, like not-maintaining the proper record, no pre-anesthetic check-up, etc.. There was no ''informed'' consent, which clearly amounts to medical negligence and short of standard of care. Therefore, on the basis of the foregoing discussion, we are not inclined to interfere in the orders of both the fora below, accordingly the revision petition is dismissed.
