Savio Freitas vs CEO, Lilavati Hospital And Research Centre & Anr

Dr. S.M. Kantikar, Presiding Member

This present Complaint was filed by Mr. Savio Freitas (hereinafter referred to as the ‘patient’) against the CEO Lilavati Hospital and Research Centre (for short, ‘Lilavati Hospital’ – OP-1) & Dr. Suresh V. Joshi (for short, the OP-2), alleging medical negligence causing severe burn injuries during the heart surgery and he suffered lifelong disability (foot drop).

On 06.02.2012, the Complainant Mr. Savio Freitas, aged about 34 years, admitted to JJ Hospital, Mumbai for the complaints of blackout. After 2D ECHO & CT Scan and other investigations, he was diagnosed as Type-I Dissecting Aneurysm with Aortic Valve Regurgitation (leakage), a very serious life threatening condition. Thereafter, he got admitted in Lilavati Hospital (OP-1) under care of the Cardio Vascular Thoracic Surgeon Dr. Suresh V. Joshi (OP-2). On 12.02.2012, the patient was operated for about 12 hours, it was an open-heart surgery consists of heart valve and aortic arch replacement. It was alleged that after the operation and before shifting the patient from operation theatre, blisters on both the lower limbs and superficial skin peeling of the left lower limb were noted. The OPs informed the patient that those were ‘superficial burns’ and it would heal on its own within 8-10 days. It was further alleged that the patient suffered serious third-degree burn injuries, but it was not mentioned in the post-surgical report. The whole incident was posed by OPs as “blisters” and “superficial skin peel”. It was mentioned in “Incident Report”. The Complainant alleged that the OPs used the out dated rewarming procedure, which led to leg burns after the surgery. Additionally, he suffered foot drop.  The hospital provided false information to the Complainant and their family members that initially nothing was mentioned about the injury.

The Complainant requested the OPs to compensate for the partial disability for his life as he was unable to do job / duties. He made written correspondences and attended meetings with Narendra Trivedi, CEO, Dr. Chulani, Medico Legal Consultant, Dr. Suresh Joshi, and other panellists, but no avail.  The hospital only after being pressurised agreed to provide plastic surgery. However, the OPs did not rectify the foot drop or compensation towards injury.

The Complainant further stated that, he underwent 13 surgeries for debridement and plastic surgery. He has to remain on potentially dangerous blood thinning because of artificial heart valve and aortic arch.  He needs strict monitoring and injections of Clexane, costing about Rs.900-1200/- per injection.

Being aggrieved due to the alleged medical negligence and deficiency in service of the Opposite Parties; the Complainant filed the Consumer Complaint under section 21 of the Consumer Protection Act, 1986 (for short ‘the Act, 1986) and prayed compensation to the sum Rs.2,21,35,592/- for the third-degree burn injury resulting lifelong disability suffered by the Complainant.

The Opposite Parties filed their respective Written Versions and denied the allegations of medical negligence. It is their case that Mr. Savio was of Marfan’s Syndrome, with thin and tall body structure.

Reply of Lilavati Hospital (OP-1)

7.1 The OP-1 denied all allegations of negligence during treatment of the patient. The complaint was filed with false allegations against a reputed hospital and doctor due to misplaced frustration and anger of the complainant. The complaint is not maintainable due to lack of pecuniary jurisdiction as the complainant failed to provide any documentary evidence to support his claim. The complaint is barred by limitation and defective for non-joinder of necessary parties, as it was the trust hospital, and it was mandatory to join the trustees as OPs. The OP-1 further submitted that the patient  had a serious heart condition, usually fatal. OP-2 performed the complex open-heart surgery that saved his life. The OPs took steps treat the side effects, but the complainant was unjustifiably blaming them entirely.

7.2 The OP-2 successfully performed the major operation and during surgery the process of hypothermia (cooling) was used. The re-warming method is an internationally recognized standard procedure. He denied that injuries were caused by the re-warming process. After discovering the injury suffered by the patient, the OPs took every possible step to mitigate the effects and to heal the same. He was treated by plastic surgeon, who performed as debridement, suction-assisted wound dressing, and skin grafting. The injuries were healing, and only a few raw areas remained to be healed. However, the complainant developed common peroneal nerve palsy, which was needed observation up to three months. The OP-1 submitted that the conduct of the complainant's relatives was unreasonable, and they pressurized the opposite party to foot the bills for the treatment.

Dr. Suresh V. Joshi (OP-2)

The OP-2- Dr. Joshi denied all allegations. He submitted that the complaint was filed to defame his name and unnecessarily harass him. There was no negligence. His preliminary objections were same as of OP-1.  The patient came to the hospital in critical stage and everything was done to save his life, even with the inherent risk factors and potential complications.

The OP-2 further submitted that initially the patient was admitted to Dr. Singh's City Hospital in New Mumbai.  He was in the state of cardiogenic shock and unconscious.  He was put on Dopamine infusion to maintain blood pressure. The patient was subsequently transferred to J J Hospital and then brought to OP-2 at Lilavati Hospital. Though the OP-2 had to attend conference, he cancelled it and agreed to take-up the case.  He submitted that the patient was a case of 'MARFAN'S SYNDROME', with thin and tall body structure.  OP-2 had a detailed discussion with the patient and his family whereabouts the complexities and risks associated with the major operation. One day before the operation, the patient's relative signed the informed consent form.  The issues related to neurological damage were clearly mentioned. The total expense for the operation could not be predicted due to the complexity and emergent nature of the surgery. The patient's relatives delayed to deposit amount, therefore, operation was delayed.

The OP-2 submitted that on 12.02.2012, he performed a supra-major operation which involved changing a heart valve and two parts of a damaged blood vessel with an artificial vessel tube (Dacron Graft), connecting three blood vessels supplying blood to the brain and upper limbs to the graft, and connecting coronary arteries supplying blood to the heart itself to the graft. The patient's family was aware of the patient's condition before surgery, the nature of the operation, and possible complications. They had discussion with OP-2 and the anaesthetist Dr. Mrs. Reshma Motwani, who explained the details of the operation and possible major complications. According to literature there was risk of 5 to 20% to the life and about a 3 to 5% risk of serious neurological damage like hemiplegia.

The OP-2 submitted that the procedure of deep hypothermia and circulatory arrest with selective ante-grade cerebral perfusion involves connecting the body to a heart and lung machine, stopping the heart, and lowering the body temperature. Blood supply to only the brain is maintained through a technique called selective ante-grade perfusion, while the rest of the body is without blood supply for over an hour. During this time, a damaged aorta is replaced with an artificial tube and the brain and upper limb arteries are connected to the graft. Blood supply to the lower body is slowly resumed and body temperature is raised, with blood supply to the heart being restored later after a valve replacement and joining of the coronary arteries to the Dacron graft. Therefore, the operation took about 12 hours and was technically complete and successful. However, before the patient was shifted from the operating theatre, blisters were noticed on both lower limbs and superficial skin peeling of the left lower limb. OP No. 2 informed the patient's family that the operation was successful, but the patient would take a day or two to get out of danger due to the complexity and long duration of the operation.

The OP-2 submitted that the patient's family was happy with the result of the operation, but excessive bleeding due to disturbed clotting mechanism and fluctuation in blood pressure was the main life-threatening concern. The Intensivist Dr. Vaz and his team were directly in charge of the post-operative care and in touch with the family. Dr. Motwani, the anaesthetist, was also associated with ICU doctors. Despite being physically and mentally exhausted after a long and complex operation that lasted 12 hours, OP-2 gave guidelines for post-operative management to the intensivist on duty before leaving the hospital. The patient showed steady progress in the ICU but developed foot drop due to peroneal nerve palsy and pressure sores on the left leg. OP-2 further submitted that he was repeatedly disturbed throughout the night by the patient's relatives. The hospital allowed the family to seek a second opinion from their own neurologist, Dr. Wadia who concluded that the nerve injury was either due to the complexity of open-heart surgery or due to prolonged pressure but not due to burns.

On 20.02.2012 the patient was transferred out of ICU and underwent several tests, which confirmed the satisfactory condition of the heart, blood vessels, and heart valve function. The blisters on the right leg had almost healed, but the pressure sores on the left leg required tissue excision and skin grafting. The patient also developed foot drop due to peroneal nerve palsy, for which a splint was given. OP No. 2 took personal responsibility for the payment of the advance deposit, and after the operation, requested the patient's relatives to pay the remaining deposit money, only because the billing department was insisting on it.  Despite the patient's wife and relatives praising him for the successful operation and saving the patient's life. However, complaints were made against OP No. 2 to the CEO The patient's wife made contradictory claims against the behaviour of OP-2 and threatened to go to the press to malign his reputation if treatment was not made free.

Arguments on behalf of Complainant

The Complainant in person argued the matter. He narrated the hospitalization and the negligence of the hospital and treating doctor. He reiterated the facts stated in the complaint. He further submitted that he was seeking compensation for leg injury and future disabilities expenses. His disabilities also affects his capability of earning livelihood, therefore he deserve heavy compensation.

Arguments on behalf of OP-1:

The learned Counsel for the OP-1 reiterated their evidence. He submitted that the Complainant owes Rs.6,69,427/- to the OP-1 hospital.

Arguments on behalf of OP-2:

The learned Counsel for the OP-2 reiterated the evidence. Dr. Joshi- OP2 was present during argument was permitted to argue. He submitted that the complainant was suffering from an extremely serious heart condition, which is fatal under normal circumstances. OPs successfully performed an extremely complex open-heart surgery, which literally saved his life. He narrated the surgical details. On 10.02.2012, the complainant was examined in the Department of Cardiology of OP No. 1, found that the complainant had Aneurysm  Dilated Ascending Aorta (a condition which can lead to rupture or dissection of Aorta) and his Aortic Arch was dilated.  The complainant was admitted to OP No. 1 as a semi-emergency and his situation was so critical that OP No. 2 had to be urgently summoned from Kolkata to immediately operate upon him.  The patient and his family members were duly informed about open heart surgery for total replacement of his aortic arch. The risks and the possible complications of the supra-major surgery were duly explained, they gave their consent.

He further submitted that in such supra-major surgery was conducted in deep hypothermia where the body temperature is brought down between 15-18 degree Celsius and is maintained at that level for hours until surgical correction is done. After this, the body is gradually rewarmed to normal. During the operation of the patient  Electro-cautery unit used did not suffer from any defects and was regularly under maintenance. It  was used with REM Polyhesive Adult Patient Return Electrode, which is an adhesive patient return electrode that does not slip even in case of movement during surgery. This prevents burns due to possible displacement of a metal element electrode. Unfortunately, despite utmost care and all precautions having been taken by the OPs, the complainant suffered a foot drop and developed burn like injury to his lower limbs.  Dr. Joshi denied that injuries suffered by the patient were due to out-dated process of re-warming, as alleged by the Complainant. The rewarming method is an internationally recognized standard method used after performing such complex surgeries.

The learned Counsel for OPs argued that the OPs were not negligent in any manner, and took due care of the complainant.  All precautions were taken to avoid any complication. The complainant has not paid the bills, therefore he  be directed to pay Rs. 6,69,427/- to the OP-1  with interest from 11.05.2012 till the date of actual payment.

Findings and Discussion:

I have carefully perused the entire medical record, the evidence filed by both the parties and took reference from the medical literature and standard text books on Cardiothoracic surgery.

The case of complaint that the blisters present on both the lower limbs were because of cautery burns / thermal injury. However, it was denied by the OPs and according to them the blisters were due to ischemia and prolonged pressure and these ulcers are also known as pressure sores / trophic ulcers. It is also the case of the Opposite Parties that the foot-drop was also due to ischemia and prolonged compression of the peroneal nerve that takes place during a 12 hour long surgery where there is ischemia due to complete circulatory arrest and where the patient is in one position (prone) continuously for over 12 hours.

The Complainant attributed it initially to cautery burns and later improved his case and attributed it to (a) the possibility of leg catching fire due to heater aimed towards painted leg or water balloons (gloves) bursting due to excessive heat or other causes. (b) The leg being painted and a heater being used was circumstantial evidence of hazardous material in the OT. (c) So much heat on a human body, the heater blanket, the room heater, the heart lung machine and so many heat sources to bring up the adequate temperature. A human body could well have caught fire and was not responding in time.

In my opinion, the Cautery burns can occur by faulty or incorrectly applied cautery pad which can cause burns around the area where it is applied, however in this case the cautery pad was never applied to leg, where the injury had occurred, but was applied behind the back, which was not damaged, as recorded in OT notes. The other mechanism of cautery burn is when bare skin of any body part directly touches metallic part of operation table, thus creating a short circuit but in this case both legs up to ankle were surgically prepared and painted and draped in sterile area, as done in most open heart procedure for saphenous vein harvesting and particularly in this case as, upper part of left leg had a surgical incision for femoral artery incision. Thus, there was no contact of legs with any other unsterile area or metallic part of operation table for a short circuit.

In the instant case the patient developed pressure sores similar to bedsores, due to prolonged immobilization in one Position during surgery.  It was due to prolonged ischemia (reduced blood supply to tissue due continuous pressure). In this major surgery, the blood flow to lower body as a part of complex operative procedure was stopped during process of deep hypothermia and Circulatory Arrest. Such injury is more severe to skin, in debilitated or thin person with less fat, as in present case. It is evident that  injury to left leg was more severe although the blisters initially also appeared on right leg, because left leg received reduced blood supply even after restoring blood supply to lower body, due to retrograde Femoral artery cannulation.

At the time of operation, the REM mechanism cautery of Valley lab was used. It was system of Return Electrode Monitoring (REM) was introduced in 1980 by some of the advanced cautery/Diathermy companies.  The REM mechanism does not allow the cautery machine to function if there is no adequate contact of the cautery pad and gives a loud alarm — thus preventing the most common cause of burns at the site of cautery pad. Also, it detects if there is short circuit by way skin contact to other body parts with metallic parts of operation table and does not allow the cautery machine to function. Thus, as Valleylab cautery machine was used for this patient at inter-scapular region (back). The accidental burns at the site of cautery pad did not occur.

The OP- 2 was aware of the possibility of pressure sores, and hence proper padding of both feet was done and a soft pillow was kept under left thigh for even support, as well as monitoring both core and peripheral temperature. After the 12 hours of marathon operation, OP - 2 spoke to the wife and mother of the patient, and told them that the operation is successful but there were blisters on the legs and the same would heal in due course. On next day 13.02.2014 OP-2 saw the patient at 8 a.m., again informed the relatives about the patient’s condition and once again specifically mentioned about the blisters on legs, which appeared superficial at that stage. The blisters right leg showed rapid improvement but the ones on left leg worsened on 16.02.2012. In spite of pressure sores, patient was able to walk with some help. Thus, the relatives were constantly kept informed about the condition of patient.  The allegation of complainant about no information given was incorrect.

On 16.02.2012, foot drop was identified. Immediately, OP-1 consulted Dr. V. Chauhan - Neurologist and also Dr. Kumta - Plastic surgeon for the management. As patient’s relatives wanted second opinion from their own Neurologist Dr. P. Wadia, who after examination  clearly mentioned in his conclusion that the nerve injury is either due to the complexity of open heart surgery or due to prolonged pressure and not due to ‘burns.’ It is a known that Peroneal nerve palsy is complication due to prolonged pressure. Thin persons are more prone, as  the nerve being compressed by head of Fibula bone and same was also suggested by Dr. P. Wadia. According to Dr. P. Wadia the injury to perineal/popliteal nerve was due to complexity of surgical procedure consist of Deep Hypothermia and Circulatory arrest. Thus, the foot drop was not because of burns.

According to the medical literature, both the pressure / ischemic sores and incisional hernia are inherent risk factors and well documented complications with the surgery undertaken by the OPs. It can be encountered in spite of taking all the care and caution even in the best centers in the best of the Hospitals anywhere in the world[Repair Of Incisional Hernia after Median Sternotomy by B R Davidson and Anr.].

Admittedly the Complainant did not opt for surgery at two Hospitals, of which one J.J. was topmost teaching Govt. Hospital in Mumbai. He was not operated at these places as he was in very critical condition that he might not survived from the surgery. Therefore, the contention of Complainant that, per-operatively he was active does not hold any merit.

It is not acceptable that the Dept. of Cardio-Vascular Surgery was ill-equipped. The Lilavati Hospital Mumbai is known for its utmost infrastructure having well equipped facilities and well qualified, experienced departments including Dept. of Cardio Vascular Surgery. The Complainant failed to point out the deficiency. Just mere allegation has no ground without evidence.

Moreover, the Complainant refused treatment at JJ Hospital and on his own volition approached Lilavati Hospital which had all facilities and experienced OP-2, one of the topmost cardio-thoracic surgeon in India.

All the patients who undergo such Metallic heart valve replacement operations have got to be on “blood thinners” for the rest of their lives. In the instant case the OP-2  has performed very complex major surgery, it also includes changing of one heart valve (Aortic Valve) along with changing the first two parts of ‘the’ main blood vessel (Ascending and Transverse Arch of Aorta till beginning of third part -namely descending Aorta) with artificial blood vessel tube (Dacron Graft). Thus the Complainant has to take lifelong blood thinners. Though the Complainant suffered lasting physical damage, but on the contrary, he got lease of life today only because of the efforts put in by the OP-2.

In my considered view, OP-2 was neither negligent nor failed in his duty of care. The Complainant claimed imaginary expenses.  There is the evidence of OP-2 that he received several telephonic threats by variety of relatives and friends of patient to malign his reputation by going to press if treatment is not made free. In one of the complaints, patient’s wife had also made similar threats to CEO including making a criminal complaint. In fact, patient approached several newspapers and DNA Times published adverse reports against OP -2 and maligned his reputation.

Conclusion:

In C. P. Sreekumar (Dr) M S (Ortho) v. S. Ramanujam[ (2009) 7 SCC 130] case, it was observed that:

“Mere averments in the complaint, when denied, cannot be said to be evidence by which the case of complaint can be proved.

In every case where the treatment is not successful or no complete cure or the patient dies during surgery, it cannot be automatically assumed that the doctor or hospital was negligent. This view fortifies from the case Devarakonda Suryasesha Mani v Care Hospital, Institute of Medical Sciences[IV (2022) CPJ 7 (SC)], it was held by Hon’ble Supreme Court as below:

“..2. Unless the appellants are able to establish before this Court any specific course of conduct suggesting a lack of due medical attention and care, it would not be possible for the Court to second-guess the medical judgment of the doctors on the line of medical treatment which was administered to the spouse of the first appellant. In the absence of any such material disclosing medical negligence, we find no justification to form a view at variance with the view which was taken by the NCDRC. Every death in an institutionalized environment of a hospital does not necessarily amount to medical negligence on a hypothetical assumption of lack of due medical care.”

Thus in my considered opinion, the manifestation of an inherent risk factor or a known complication is not necessarily negligence. It can manifest in-spite of all the care and caution exhibited by the treating doctor. The Hon’ble Apex Court in Kusum Sharma & Ors v Batra Hospital & Medical Research Centre & Others[(Civil Appeal No. 1385 of 2001)] observed as below:

51….xx…

Medical science has conferred great benefits on mankind but these benefits are attended by unavoidable risks. Every surgical operation is attended by risks. We cannot take the benefits without taking the risks. Every advance in technique is also attended by risks. Doctors, like the rest of us, have to learn by experience; and experience often teaches in a hard way."

Similarly, the Hon'ble Supreme Court in the case of Jacob Mathew v State of Punjab[(2005) 6 SCC 1] held that:-

It is known that in a critical and emergent situation, the medical practitioner is always left between the devil and the deep sea where the decision to be taken then and there. The medical practitioner faced with such an emergency always tries his best to redeem the patient out of his suffering. No sensible professional would intentionally commit an act or omission which would result in loss or injury to the patient.

Based on the discussion above, I don’t find any deficiency or dereliction in the duty of care from the OP-1. The OP-2 performed very complex heart surgery. No negligence is attributable to the Opposite Parties. The Complainant failed to prove his case.

The Complaint is dismissed.