Death due to Amniotic Fluid Embolism - NCDRC gives relief to Gynaecologist, quashed state commission order

The court overruled the state commission's verdict observing that the blame of tragic misfortune for unexpected, unavoidable, unpredictable, unpreventable Amniotic Fluid Embolism ( AFE), most of the times the obstetrician is a scapegoat. Unfortunately in some cases, despite the doctor's best intentions, patients suffer injury or die, and the clinicians involved often become the secondary victims.

The case goes back to the year 2012 when the pregnant patient with contractions was admitted to the nursing home of the doctor. In spite of good labour pains, there was no progress of cervical dilatation and in view of foetal distress, the patient and relatives were informed of the need for lower segment cesarean section (LSCS). However, they were reluctant to give consent for the same.

It is only when they were told to either give consent or take the patient to another hospital did they relent and give their informed consent and the operation was commenced under spinal anaesthesia administered by an anaesthetist. A healthy female baby was delivered but soon after the patient suddenly developed cardio-respiratory arrest. CPR was initiated and the patient was intubated. Later, positive pressure respiration started. However, amniotic Fluid Embolism was suspected. The patient responded to the resuscitative measures and the operation was speedily completed.

The relatives were informed of these sudden happenings and the serious condition of the patient and the need to transfer the patient to a tertiary care hospital. Accordingly, the patient was shifted to the nearby Yashoda hospital in an ambulance accompanied by the doctor. The patient was put on ventilator support.

Subsequently, the patient did not recover from the cerebral hypoxia and continued to be comatose.

Thereafter the relatives filed a complaint before the UP State Consumer Forum alleging negligence and deficiency in service (including incompetence and lack of facilities in the Nursing home) and seeking a compensation of Rs 99 lakhs. The complainant also filed a complaint before the UP State Medical Council for disciplinary action.

On 16th May 2018, the State Commission, Lucknow held the doctor and Nursing home liable for negligence and awarded compensation.

Aggrieved with the forum decision, the doctor appealed against this judgment before the National Consumer Disputes Redressal Commission in Delhi.

During the hearing of the case before the bench of honourable Justice RK Agarwal as President and Dr SM Kantikar as a member, the counsel on behalf of the petitioner alleged as the patient suffered the cardiac arrest, the doctors unnecessarily wasted crucial time inside the operation theatre which later on worsened the condition of the patient. The counsel further submitted that one male person ( non-doctor) was present in the OT with the doctors till the shifting of the patient to Yashodha Hospital. The hospital has no facilities up to the mark. It was a failure in the duty of care from the doctor and the hospital. The counsel brought our attention to the order passed by U.P. Medical Council which observed that the facilities available in the hospital were not up to the mark.

In response, the counsel from the respondents (doctor, hospital) submitted that the doctor is qualified as MD (Obst. & Gynae) having 17 years' experience and performed many complicated deliveries and LSCS operations. The complainant failed to prove that the conduct of the doctor in her speciality fell below the standard of reasonable practice.

After taking note of all the submissions and contentions put forward by both the sides, the bench went on to make its observations on the case. It marked,

"On perusal of the medical record of hospital, it is apparent that on 04.11.2012 at 12.15 pm, OP-1 examined the patient and noted the cervix was closed and the head of fetus was high. The FHS was 170/minute, regular. The patient and her attendants were informed and advised for LSCS. The indication for LSCS mentioned as "non-progress of labour with fetal distress". The decision taken by OP-1 to do emergency LSCS cannot be faulted. The attendant gave the consent at 12.45 PM and then the patient was shifted to OT. As per the anesthetist note, the blood investigation like Hb%, TC, DC, the blood sugar, urea and creatinine were normal. The surgery was performed by the OP-1, it was assisted by Dr***, the anesthetist, Dr ***. The pediatrician, Dr *** was also present in OT. The LSCS was performed under spinal anesthesia; a full term female baby was delivered at 1.14 pm. The Injection Synto – 10 units in drip started and injection Prostodin 1 ampule (250 microgram) Suddenly, patient showed fall in BP (90/60 mm of Hg), bradycardia, feeble pulse and fall in SPO2 level (90%). The patient became unconscious started with labored breathing. The patient was immediately intubated with ET number 7.5 and connected to boils trolly with circuit and IPPR done with 100 % oxygen. The doctors in OT also gave injection Atropine, Termine and Adrenaline. The cardiac massage was also done. At 1.20pm, the patient was revived from the arrest, the LSCS was completed, and placenta was delivered. She was unconscious and having slow respiration. The ambulance was called and at 1.35 pm the patient was shifted to higher center with ventilatory support. The patient was responding to long painful stimuli."

On the occurrence of Amniotic Fluid Embolism, the bench observed:

We have gone through the literature on Amniotic Fluid Embolism from the various published Articles the and medical text from William's Obstetrics (23 ed). It is stated therein rd that Amniotic fluid Embolism is a rare but often fatal complication of pregnancy and its onset can neither be predicted nor prevented. AFE is an infrequent, unpredictable, and the catastrophic complication of pregnancy in which amniotic fluid, fetal cells, hair, or other debris enters into the maternal pulmonary circulation, causing cardiovascular collapse. AFE is a syndrome typically occurs during labor, soon after vaginal or caesarean delivery, or during second-trimester dilation and evacuation procedures. It is virtually impossible to predict which patients are at risk for AFE. Diagnosis must be based on a spectrum of clinical signs and symptoms and by exclusion of other causes. Most cases of AFE are associated with dismal maternal and fetal outcomes, regardless of the quality of care rendered. Early recognition of AFE with prompt intervention is paramount to a successful outcome. Management is resuscitative, geared toward maintaining vital signs and treating hemodynamic and coagulopathy derangements as they occur. A team approach among obstetrician, anesthesiologist and intensivist is necessary for a successful outcome. Despite early intervention, maternal and fetal mortality remain high. Thus, owing to its uncertain etiology, varying symptoms, rapid onset, and high fatality rate the AFE is one of the most challenging obstetric emergencies leading to cardiac arrest.

The Cardiac arrest is a devastating event. Despite improving resuscitation practices, mortality is high with many survivors being left with severe neurological impairment. However, some do make a good recovery and return home to a meaningful quality of life. The pathophysiology of hypoxic ischemic brain Injury encompasses a heterogeneous cascade that culminates in secondary brain injury and neuronal cell death. The long-term consequences will depend on the severity of the cerebral anoxia and on how much irreversible damage has occurred in the brain. If there has only been mild or short-lived anoxia, there may well be recovery back to a normal or near normal level of functioning. However, if the anoxic injury has been more marked the outcome is less certain and there are likely to be long-term effects. The nature of these problems will vary from person to person, depending on the severity of the injury and the brain areas affected. Accurately predicting those who will achieve a good neurological outcome in post-arrest comatose patients is difficult

The bench then noted that the UP Medical Council has not held the doctor for procedural lapses or negligence while performing LSCS and held:

AFE is an unpredictable complication, and it was managed by the doctor efficiently and made timely reference to the higher centre for further management. Thus, any failure in duty of care from the treating doctor is not visible.

Further, the bench emphasised the aspects of medical negligence allegations and said:

In order to succeed the claim in medical negligence case three requirements need to be met. One the accidental nature of the misconduct on the part doctor, second the existence of proven damage and third its direct relationship. The doctor shall put in place all necessary measures as to the current scientific knowledge. We note the doctor performed her duty with reasonable standards and as per accepted practice. The patient was appropriately referred to the higher centre

Concluding the case, the bench set aside the order of the state consumer commission while allowing the appeal made by the doctor and held:

The doctor is qualified as an obstetrician and experienced one. LSCS was performed as per standard procedure, but unfortunately, the patient suffered cardiac arrest due to unpredictable Amniotic Fluid Embolism (AFE). Though immediately resuscitative steps were performed by the doctors in OT, but the patient suffered cerebral hypoxia. It was not due to negligence or deficiency while conducting the LSCS or management of AFE. The State Commission has erred in law to hold it as a medical negligence