Oral Order : (B.N. Rao Nalla, President)
This is a complaint filed under section 17 of the Consumer Protection Act, 1986 by the Complainant to direct the opposite party No.1 to pay Rs.25 lakhs towards compensation for the medical negligence; to direct the opposite party no.3 to pay Rs.10 lakhs towards costs for employing unskilled and unprofessional doctors etc., and costs.
2. The case, in brief, as made out in the complaint is that the complainant is the husband of Smt Janakamma consulted opposite party no.1 on 5.3.2011 for the treatment of rheumatoid arthritis and the said doctor after examining her advised for knee transplant surgery to both legs. The opposite party no.1 initially having opined that the right leg bones around knee being damaged recommended her knee arthoplasty for the left leg only and subsequently to the right leg also. Opposite party no.1 fixed the datge of operation on 11.03.2011 being an ' International Conference Day' earmarked for Total Knee Arthoplasty at a discounted package in Yashoda Hospital but when the complainant’s wife was admitted in the hospital surgery was postponed to 14.03.2011. Before the surgery the opposite party no.1 without any pre-operative tests and the risk factors about the surgery on 14.03.2011 performed surgery on both the knees of the wife of the complainant. The complainant being enticed by Mr.Manikya Reddy, Marketing Personnel working in Yashoda Hospital at the instance of the opposite party no.1 gave consent for the surgery on both knees of the wife of the complainant. After four hours of surgery on 14.03.2011 his wife was shifted to ICU for post-operative care and treatment. The complainant’s wife was found to be in oedematous and sedative condition with her body, face, lips got swollen. Complainant’s wife being under the post-operative care of opposite party no.1 assisted by the opposite party no.2 did not give proper medication and care to treat the manifestations such as oedema all over her body, incoherent speech, shortness in breath and drowsiness nor any investigation was done to rule out any such complications post TKA co-relatable to the condition of the patient having the antecedents of diabetes mellitus, obesity and varicose veins. Despite the complainant’s insistence to cure the said symptoms the opposite parties no.1 and 2 focused more on the physiotherapy and they started the physiotherapy from the third day of the surgery. She was made to walk daily two times though she complained of unbearable pain in her right leg.
3. On 22.03.2011 the opposite party no.2 along with physiotherapist came to the complainant’s wife and insisted her to walk despite herself pleading that her body is not permitting any movement. However, the opposite party no.2 without any evaluation of the patient’s condition, blindly and bluntly insisted her to walk however, after two steps the complainant’s wife collapsed resulting in fracture to her right femur bone over the operated area due to excessive physiotherapy done to her. Subsequently the complainant’s wife suffered very badly due to the fracture in her right femur and no known efforts were done to treat the already existing post-operative complications resulting in her death on 23.03.2011 due to pulmonary embolism.
4. Complainant alleges deficiency in service against the opponents on the following counts:-
a) It is alleged by the complainant that service to be rendered by a surgeon not only mean to perform the operation but also treat the patient post-operative. Opposite party no.1 claiming to be an experienced and competent surgeon having operated both the knees of the complainant’s wife without proper assessment of her body condition who was known to have the history of obesity, diabetes, varicose veins and chronic arthritis.
b) Second allegation is that the opposite party no.1 is also responsible for having not done the bone density test before choosing to operate both the knees at one time considering her ailment history and age factor
c) Third allegation is that both the opposite parties no.1 and 2 are culpable and guilty of totally neglecting the post-operative complications developed by the patient not taking physician advice.
d) Fourth allegation is that the opposite parties no.1 to 3 are responsible for ignorantly subjecting the patient to physiotherapy without proper assessment of her body condition already being suffered from the possible postoperative complications.
5. It is further averred that the complainant incurred an amount of Rs.2.10 lakhs and a refund of Rs.13,723/- was given as a solicitous discount on account of death of the patient. After death of his wife the complainant lodged a complaint in the Ramgopalpet Police Station, Secunderabad on 24.03.2011 but there has been no action and instead advised the complainant to approach the third opposite party who would certainly settle the matter. The complainant got issued a legal notice on 29.06.2011 calling upon the opposite parties no.1 to 3 to pay compensation for their negligent and deficient acts. Thereafter the complainant has filed this complaint alleging deficiency in service against the opposite parties no.1 to 3 claiming the reliefs as stated in para no.1 supra.
6. Top of Form
The first opposite parties no.1 to 3 has filed written version denying the allegations made in the complaint and contended that the wife of the complainant was suffering from severe arthritis of both knees and in valgus, difficulty in walking and was average in weight. After detailed clinical and physical examination she was advised to undergo Bilateral Total Knee Replacement (TKA) as it also a Valgus deformity knee. Her diabetic condition was under control with the most suitable medication. She was not much obese and there was no varicose vein. The opposite parties expected the patient to recover at normal pace as many other patients similarly situated, recovered. The indications for TKA are Rheumatoid arthritis, Osteoarthritis, Post Traumatic Osteoarthritis, recurrence of operated High-Tibial Osteotomy, Patello femoral Osteoarthritis, the neuropathic joint. There are few absolute contraindications to knee replacement surgery like Bony Ankylosis, Septic Arthritis and Genu recurvaum. In the instant case as patient had no contraindications for this surgery in any form and hence decision was taken for TKA.
7. On 11.03.2011 the patient was admitted in the hospital and the surgery was planned to perform on 12.03.2011. Though she was the second patient to undergo surgery but the surgery had to be postponed to another working day due to certain problems with the instruments in the first TKA operated on 12.03.2011 on another patient. On the basis of OP report, PAC was done and the patient was found fit for the surgery and there was no contraindications for the surgery. CBP was done and found to have low hemoglobin blood transfusion was also done as a corrective measure. After all the investigations, on 14.03.2011 the surgery was done and the total duration of the surgery including anesthetic preparation and general preparation of the patient was three hours from 1 p.m. to 4 p.m. Following the surgery the patient was in the post-operative for about 2 hours as per the protocol of the Hospital. The patient did not require keeping in ICU since she was alright after the surgery. There was no edema, drowsiness in her mental state. She was fully alert and her conscious level was very good. There was no sign of swelling of lip, body or face. There was occasional use of analgesic postoperatively which is a routine matter as and when required for pain relief. As the patient was alright and planned to be discharged on 20.03.2011 but patient requested that she cannot go home as her arrangement cannot be made immediately. The allegation that it was sudden decision by the doctors to operate on both the legs and the consent was taken by persuasion etc., are not true. In many cases TKA was done on both the legs to avoid high expenses and delayed hospitalization and complainant and his wife agreed to the same. The physiotherapy treatment is a must for the patients operated upon for TKA to avoid further complications.
8. The opposite parties submitted that the patient was referred for physiotherapy for rehabilitation of post Bilateral TKA on 15.03.2011 and her physiotherapy session started from 16.03.2011 as per the instructions. The ideal of physiotherapy is to decrease the swelling, to decrease the pain to increase the range of motion of the joints and to increase the strength of the muscles. All these exercises do not cause any stress over the joints and instead help in strengthening the muscles surrounding the joints. On 17.03.2011 ambulation was advised and the patient was made to walk with the help of a walker. The patient was comfortable while undergoing physiotherapy from 16.03.2011 to 21.03.2011. On 22.03.2011 the patient has undergone bed side physiotherapy and after that while ambulating with walker, suddenly she felt pain in her right knee joint and immediately she was made to sit in a chair and examined by Orthopedecian and was advised for X-Ray, which revealed fracture in her right distal femur. There was no force to undergo physiotherapy but as a matter of fact and protocol physiotherapy sessions were done in her own interest, which is a must for TKA. If the physiotherapy sessions were not done there was a chance of Deep Vein Thrombosis and swelling, joint stiffness etc., and hence to avoid the same the physiotherapy is a must to the patient. The allegation that the physiotherapy was done in spite of the refusal by the patient is not true.
9. The opposite parties denied that because of excessive and forcible physiotherapy the patient had suffered fracture is not correct. Unfortunately, the patient developed fracture and after the fracture she again developed Fat embolism which is a fatal complication. The patient was alright even after the fracture and following the fracture of the femur in the Hospital, proper treatment was administered viz., splinting the femur, X-rays of the effected part etc., and the matter was discussed with her husband viz., the complainant and he was apprised of the complications.
10. The opposite parties submitted that the fractures around the prosthesis are of three kinds, viz., Intraoperative, Stress caused by fall or other injuries. Most fractures result from fall. The mechanism of injury causing the distal femur fracture invariably involves minor trauma, usually tripping or slipping and falling on the floor. Such minimal force as twisting the leg in either a standing or recumbent position causes fractures. Many of these patients preoperatively were either non-ambulatory or minimally so and once an initially successful TKR has been performed they have become active. However, because of unsteadiness or residual weakness they are more susceptible to injury. Large series of elderly patients, more than 60 years old, in trauma demonstrate these complications like Fat Embolism, Adult Respiratory Distress Syndrome (ARDS), Phenomena, Sepsis, Myocardial infraction which are the significant risk factors for mortality in the Hospital. In this case, the patient developed fracture and after the fracture she again developed Fat embolism which is a fatal complication and this Fat embolism presented as Acute Cor Pulmonale (Pulmonary Embolism) leading to cardiac arrest. It is unfortunate that the patient who was about to be discharged and to go home after a successful surgery and rehabilitation was to meet cardiac arrest in the above circumstances. In spite of best surgery and consequent recovery but due to the fracture and the other complications, the patient died but not due to the negligence of the doctors or of the hospital. Femur fracture has a strong relationship with ARDS and increases the risk of mortality and pulmonary complications leading to sudden death. The unique relationship between Adult Respiratory Distress Syndrome (ARDS) and Femur fracture is a well-known entity in all major Hospitals around the world.
11. The opposite party denied the allegation that much against the wishes of the patient, the opposite parties no.1 and 2 have undertaken the surgery for both the knees at a time. In fact from the date of admission it was decided to have bilateral TKA. The opposite party no.1 doctor is well experienced and conducted many surgeries since past more than 20 years and he is well qualified having passed MS Ortho followed by qualification of physical Medicine and Rehabilitation. The Hospital, the staff and the doctors have taken sufficient care and the death of the patient is not due to the negligence of the doctors or the Hospital. The death is due to the above circumstances which are beyond the control of the doctors and the hospital.
12. The opposite parties denied that being the experienced doctors, the opposite parties no.1 and 2 had undertaken the operation and physiotherapy without proper assessment of the body condition of the patient. The patient was not counseling or the complainant regarding the possible complications and post-operative modalities to be followed and that suddenly decided to operate both the knees without evaluation of the risk factors is absolutely incorrect. To legal notice got issued by the complainant a suitable reply was given. There is no negligence on the part of the opposite parties no.1 to 3 and hence prayed for dismissal of the complaint.
13. The opposite party no.4 filed written version contending that there is no cause of action much less entitlement for the complainant or the opposite party no.1 to file the present complaint without there being an averment as to policy coverage and as to who is the insured and the insurance coverage under a policy issued by the opposite party no.4. The very complaint and impleading of the opposite party no.4 is premature and without any entitlement. The policy in question is alleged to be a Professional Indemnity Doctors Policy with policy No. 551802/46/10/8700000184 in favour of the opposite partyno.1 for the period from 17.09.2010 to 16.09.2011 and indemnity limit during the policy period is Rs.30 lakhs with indemnity limits for anyone accident is Rs.15,00,000/- subject to retroactive date; compulsory excess; terms and conditions, exceptions etc., and coverage which is to be evidenced through original policy document to prove the indemnity premium paid; and premium with limits of liability; further the policy coverage and persons and cause of actions entitled are all to be considered and any coverage is put to strict proof. The indemnity limit during the policy period will depend on with the insurable peril coverage. No intimation was given during the subsistence of the policy and there is no entitlement under the policy. There is no privity of contractual liability till it is established that a policy was issued covering the alleged cause of action. The opposite party no.4 is neither a necessary party nor a proper party to answer the complaint of the complainant much less liable to be impleaded. There is no contract of insurance covering any vicarious liability between the opposite party no.1 and the opposite party no.4. Hence, the opposite partyno.4 prayed for dismissal of the complaint.
14. The opposite party no.5 filed written version contending that there is no cause of action much less entitlement for the complainant or the opposite party no.1 to file the present complaint without there being an averment as to policy coverage and as to who is the insured and the insurance coverage under a policy issued by the opposite party no.5. There is no whisper of the complaint being filed against M/s Dattachandra Hospital (P) Ltd., or M/s Yashoda Hospital and therefore alone the complaint against the opposite party no.5 is liable to be dismissed. There is no averment in the complaint with regard to deficiency in service or unfair trade practice against the said M/s Dattachandra Hospital (P) Ltd., or M/s Yashoda Hospital. There is no contract of insurance or any jural relationship between the opposite parties no.1 to 3 and the opposite party no.5. The policy in question is alleged to be a Professional Indemnity Doctors Policy with policy No. 611905/36/16/32/00000064 is in favour of Dattachandra Hospitals (P) Ltd., opposite partryno.6 for the period from 31.05.2010 to 30.05.2011 subject to retroactive date; compulsory excess; terms and conditions, exceptions etc., and coverage which is to be evidenced through original policy document to prove the indemnity premium paid; and premium with limits of liability; further the policy coverage and persons and cause of actions entitled are all to be considered and any coverage is put to strict proof. The indemnity limit during the policy period will depend on with the insurable peril coverage. No intimation was given during the subsistence of the policy and there is no entitlement under the policy. There is no privity of contractual liability till it is established that a policy was issued covering the alleged cause of action. The opposite party no.4 is neither a necessary party nor a proper party to answer the complaint of the complainant much less liable to be impleaded. There is no contract of insurance covering any vicarious liability between the opposite party no.1 and the opposite party no.4. Hence, the opposite partyno.4 prayed for dismissal of the complaint.
15. No counter/written version filed by the opposite partyno.6.
16. The complainant has filed his affidavit and the documents, ExA1 to A73. On behalf of the opposite parties no.1 to 3 , Dr.Sanjib Kumar Behera, the opposite party no.1 filed his affidavit, on behalf of the opposite partyno.4, the Dy. Manager and Authorized Signatory has filed his affidavit. The opposite parties no.5 and 6 did not file any affidavit nor documents. The opposite parties no.1 to 3 have filed the documents Exs.B1 to B4. As per the directions of this Commission the opposite partyno.1 was crossed examined by the Advocate Commissioner and filed his report.
17. The counsel for the Complainant and the Opposite parties had advanced their arguments reiterating the contents of the complaint and the written versions in addition to filing written arguments on behalf of Complainant and the opposite parties no.1 to 3 and 6. Heard both sides.
18. The points that arise for consideration are :
Whether there was any negligence on the part of doctors in conducting surgery?
Whether the complainants are entitled to any compensation?
If so, to what amount?
19. The case of the complainant is that the deceased Smt Janakamma aged about 63 years had consulted the opposite party no.1 on 05.03.2011 with a complaint of rheumatoid arthritis. The opposite party no.1 after examining her advised her to undergo knee arthoplasty first to the left leg and subsequently to the right leg. She was admitted in the hospital on 11.03.2011 for the surgery but it was postponed to 14.03.2011. On 14.03.2011 the opposite party no.1 performed surgery to both knees. After the surgery on 22.03.2011 the opposite party no.2 along with the physiotherapist made her to walk and in the process walking she collapsed resulting in fracture to her right femur bone and subsequently she died on 23.03.2011 due to Fat/Pulmonary embolism.
20. The case of the complainant is that the opposite party no.1 without proper assessment of her body condition who had the history of obesity, diabetes, varicose veins besides chronic arthritis performed surgery. He also alleged that the opposite party no.1 though first suggested surgery of one knee suddenly decided to operate both the knees without evaluating the risk factors of pulmonary embolism and cardiac myocardial infraction. The opposite party no.1 also not done the bone density test before choosing to operate both the knees at one time considering her ailment history and age factor. The opposite party no.1 also negligent in not administering anti-coagulants to the patient post-surgery and in not properly evaluating the post-operative symptoms.
21. On the other hand the counsel for the opposite parties no.1 to 3 contended that as the patient was suffering from severe arthritis of both the knees approached the opposite party no.1 and the opposite party after detailed clinical and physical examination advised her to undergo bilateral total knee replacement as it is also valgus deformity knee. Her diabetic condition was under control with medication. She was not obese and there was no varicose vein. There are few absolute contraindications to knee replacement surgery like bony ankylosis, septic arthritis and genu recurvaum and in the case of the complainant’s wife there were no contraindications for the said surgery in any form and hence the opposite party no.1 has taken for TKA. Following the surgery the patient was shifted to the post-operative ward for about two hours as per the protocol of the hospital. The wife of the complainant did not require keeping in the ICU, since she was alright after the surgery. There was no sign of swelling of lip, body or face and planned to be discharged on 20.03.2011 but she requested to stay in the hospital as her arrangement cannot be made immediately. In innumerable cases TKA was done on both the legs to avoid high expenses and delayed hospitalization and this is a routine practice throughout the world. Blood transfusion was given post-operative because patient lost blood and the physiotherapy treatment is a must for the patients operated upon for TKA to avoid further complications and for easy movement of the joints. The patient was referred for physiotherapy for rehabilitation of post bilateral TKA on 15.03.2011 and her physiotherapy session started from 16.03.2011 as per the instructions. All these exercises do not cause any stress over the joints and instead help in strengthening the muscles surrounding and joints. On 17.03.2011 ambulation was advised and the patient was made to walk with the help of a walker and the patient was comfortable even while undergoing physiotherapy from 16.03.2011 to 21.3.2011. On 22.03.2011 the patient has undergone bedside physiotherapy and after that while ambulating with walker suddenly she felt pain on her right knee joint after a tumble in the leg. Immediately she was advised x-ray which revealed fracture in her right distal femur. There was no force to undergo physiotherapy but as a matter of fact and protocol physiotherapy sessions were done which is a must for TKA. The fracture was not due to the physiotherapy. The patient developed fracture and after the fracture she again developed fat embolism which is a fatal complication and this fat embolism presented as acute pulmonary embolism leading to cardiac arrest. The unique relationship between Adult Respiratory Distress Syndrome and Femur fracture is a well-known entity in all major hospitals around the work.
22. In this connection it is relevant to look into cross examination of the opposite party no.1 and replies given by him are as follows:
The first consultation form is at page 113 marked as Ex.A21. Page 113 does not contain as to what medical records pertaining to the patient were seen by me. Witness adds: apart from the report seen on the OPD consultation which is bought by the patient’s attendant few extra tests are advised on the same day which is necessary for undergoing surgery. It is true, it is not mentioned anywhere in page 113 that I have verified any of the records bought by the patients attendant. ….. it is true in page 113 I have not recorded the past ailment history of the patient…. It is true I have not mentioned the basic things such as weight, blood pressure, etc. ….. Yes, as a surgeon it is incumbent on me to mention as to what are the ailments suffered by the patient in the past, treatment underwent in the past, surgery if any undergone by the patient. May be I do not know if the deceased patient was obese. Yes it is true at page 4 under para 10 physical examination of the initial assessment paper height, BMI, weight are blank.
Q. Basing on what record or report you have concluded in your evidence affidavit that the patient was of average weight?
Ans: Basing on observation recorded in page no.4 overleaf, column No.’C’ the shape of abdomen scaphoid which is suggestive of patient not obese.
Q. Do you agree with the recording of the anaesthetist at page 116 in physical examination column mentioned as obese.
Ans: Yes, it is recorded as obese.
Q. Basing on which of the marker, report, finding you have advised the patient to undergo bilateral total knee replacement (TKA)?
Ans: On basis of the X-ray which was advised on the primary consultation day she was bilateral surgery.
If any person is advised to have X-ray in our hospital he will be given a report along with X-ray. I have seenonly X-ray in this case and advised bilateral surgery. ….I have not consulted or co-ordinated with any other specialist doctor of other departments before I recommended bilateral surgery to the diseased patient, witness adds: it is on OPD basis no other consultation are necessary before deciding a surgery hence after admission of the patient she was taken consultation by cardiologist and endocrinologist as per her requirement and their advise is followed…..it is true transfusion was done only after surgery.
Medical investigations which have been advised to the patient preoperatively after her joining the hospital, the results of such investigations are not recorded in the doctors notes.
Witness upon seeing the records stated no blood transfusion was done as a corrective measures prior to operation. … It is true, time is not recorded on the consent from at page 104.
Q. Do you agree with me the most common complication of knee replacement surgery is dep vein thrombosis?
Ans: No, witness adds DVT in any surgery of leg is one of the rarest complication.
Q. I put it to you none of the records preoperatively discloses that I have taken preventive steps, measures, treatment to prevent the risk of DVT.
Ans: Yes. Witness adds DVT is not a common finding in all patients, particularly in her case. No signs and symptoms in her case. So no specific or prophylaxis or prevention pre-operatively.
Q. I put it to you pages-3 to 5 no where remotely indicate that you had attempted to evaluate or assess as to whether the patient had signs and sysmptoms of DVT?
Ans: No according to me DVT is a disease.
Q. Can you tell us what are the symtoms of DVT and when does it occur?
Ans. I have to refer book
Q. I put it to you, you have no proper understanding and proper knowledge about DVT?
Ans; It is not true. It is true we have not given an anticoagulants to the patient post operatively.
Q. Your record shows no nebulization was given to the patient immediately after the surgery on 14th until 19th March 2011
It is true no investigations for electrolytes, urea, creatinine, ABG were done immediately after surgery until 22nd March 2011 found at page 74. Witness adds that this is not a routine investigation to be done on every day basis after the surgery. It is only performed when it is absolutely necessary.
It is true that investigations for electrolytes, urea, creatinine, were only done after the patient suffered cardiac arrest. Witness adds: this investigation done after the cardiac arrest to felicitate further management.
23. Reply to the cross examination indicate that the opposite partyno.1 failed to do pre-operative preparation on the wife of the complainant. As the knee arthoroplasty is a major surgery, pre-operative preparation must be done immediately following surgical consultation and lasts approximately one month.
24. In Campbell’s Operative Orthopedics Volume one, Ninth Edition, edited by S.Terry Canale, M.D., the importance of pre-operative preparation is stated as follows:
Knee arthoplasty is major surgery. Pre-operative preparation begins immediately following surgical consultation and lasts approximately on month. Patient is to perform range of motion exercises and hip, knee and ankle strengthening as directed daily. Before surgery is performed, pre-operative tests are done: usually a complete blood count, electrolytes, APTT and PT to measure blood clotting, chest X-rays, ECG, and blood cross-matching for possible transfusion. About a month before the surgery, the patient may be prescribed supplemental iron to boost the hemoglobin in their blood system. Accurate X-rays of the affected knee are needed to measure the size of components which will be needed. Medications such as warfarin and aspirin will be stopped some days before surgery to reduce the amount of bleeding. Patients may be admitted on the day of surgery if the pre-op work-up is done in the pre-anesthetic clinic or may come into hospital one or more days before surgery. Some hospitals offer a pre-operative seminar of this Surgery.
Post-operative hospitalization varies from one day to seven days on average, depending on the health status of the patient and the amount of support available outside the hospital setting. Protected weight bearing on crutches or a walker is required, until the quadriceps muscle ha healed and recovered its strength. Continuous passive Motion is commonly used, but a Cochrane review concluded that the evidence was weak and the magnitude of its effect was small. Patient typically undergo several weeks of physical therapy and occupational therapy to restore motion, strength and function. Often range of motion (to the limits of the prosthesis) is recovered over the first two weeks (the earlier the better) At six weeks, patients have usually progressed to full weight bearing with a cane. Complete recovery from the operation involving return to full normal function may take three months, and some patients notice a gradual improvement lasting many months longer than that.
There is increased risk in complications for obese people going through total knee replacement. The morbidly obese should be advised to lose weight before surgery and, if medically eligible would probably benefit from bariatric surgery. ………
Deep vein thrombosis
According to the American Academy of Orthopedic Surgeons (AAOS), deep vein thrombosis in the leg is ' the most common complication of knee replacement surgery….. prevention…. May include periodic elevation of patient’s legs, lower leg exercises to increase circulation, support stockings and medication to thing your blood'
Per prosthetic fractures are becoming more frequent with the aging patient population and can occur intraoperative or postoperatively.
25. Deep vein thrombosis is a blood clot in a deep vein, most commonly in the lower leg or thigh. The clot can block blood flow and cause pain, swelling and skin discoloration. In the most serious cases, deep vein thrombosis can lead to a pulmonary embolism – when part of the blood clot breaks loose and travels through the bloodstream to the lungs, where it can block a lung artery, causing damage to the lungs or other organs from lack of oxygen. Common signs and symptoms of DVT include pain or tenderness, swelling, warmth, redness or discoloration and distention of surface veins, although about half of those with the condition have no symptoms.
26. The counsel for the complainant argued that the information regarding performing of surgery on both the knees was only informed to the complainant on the morning of 14.03.2011 just before the surgery when the complainant’s wife was already taken into the operation theatre and a consent for knee arthoplsaty on both the knees was obtained from the complainant through one Manikya Reddy an agent of the opposite party no.1 who cajoled and coaxed complainant for his consent despite the fact that the patient was mentally prepared only for operation on the left knee.
27. The learned counsel for the opposite parties no.1 to 3 denied the said allegation and submitted that it was not a sudden decision and in innumerable cases TKA was done on both the legs to avoid high expenses and delayed hospitalization and this is a routine practice throughout the world and in many hospitals and his wife agreed to the same.
28. Now the point is that whether the opposite parties are negligent in performing surgery on the patient without obtaining the valid consent of the patient in writing, though the deceased patient was an adult and was in a condition to give consent or otherwise for the surgery on both knees to be performed on her?
29. The answer is that the consent for the surgery on both the knees was not signed by the patient and it was signed by her husband, which is not valid.
30. In the general consent form of Yashoda Hospital dated 11.03.2011, it is clear that consent form was signed by her husband S.Gopala Krishna, time was not mentioned. In Samira Kohli vs. Dr. Prabha Manchanda & Anr. In Civil Appeal No. 1949 of 2004 2008 AIR 1385, the Honble Apex Court has held as follows:-
We may now summarize principles relating to consent as follows:-
(i) A doctor has to seek and secure the consent of the patient before commencing a treatment (the term treatment includes surgery also). The consent so obtained should be real and valid, which means that: the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what he is consenting to.
(ii) The adequate information to be furnished by the doctor (or a member of his team) who treats the patient, should enable the patient to make a balanced judgment as to whether he should submit himself to the particular treatment or not. This means that the Doctor should disclose (a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any, available; (c) an outline of the substantial risks; and
(d) adverse consequences of refusing treatment. But there is no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment.
Similarly, there is no need to explain the remote or theoretical risks of refusal to take treatment, which may persuade a patient to undergo a fanciful or unnecessary treatment. A balance should be achieved between the need for disclosing necessary and adequate information and at the same time avoid the possibility of the patient being deterred from agreeing to a necessary treatment or offering to undergo an unnecessary treatment.
(iii) Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure. The fact that the unauthorized additional surgery is beneficial to the patient, or that it would save considerable time and expense to the patient, or would relieve the patient from pain and suffering in future, are not grounds of defence in an action in tort for negligence or assault and battery.
The only exception to this rule is where the additional procedure though unauthorized, is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay such unauthorized procedure until patient regains consciousness and takes a decision.
(iv) There can be a common consent for diagnostic and operative procedures where they are contemplated. There can also be a common consent for a particular surgical procedure that may become necessary during the course of surgery.
(v) The nature and extent of information to be furnished by the doctor to the patient to secure the consent need not be of the stringent and high degree mentioned in Canterbury but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field. It will depend upon the physical and mental condition of the patient, the nature of treatment, and the risk and consequences attached to the treatment.
31. The Honble Apex Court in the Judgment quoted (supra) has further held that as there was no consent by the appellant for performing hysterectomy and salpingo-oopherectomy, performance of such surgery was an unauthorized invasion and interference with appellants body, which amounted to a tortuous act of assault and battery and therefore a deficiency in service.
32. (In the above cited case, the appellant was the patient) In this case, it is crystal clear that the patient was conscious and in a fit stage to give consent or otherwise. The treating doctors have not taken her consent. The opposite parties no.1 to 3 have admitted in their written version that only after the patient and the husband of the patient agreed they did surgery. But when the patient was in conscious and fit state to give consent they ought to have taken the consent of the patient also in the consent form. On the other hand, they only took the consent of the patient’s husband, which cannot be by any stretch of imagination construed as a valid and informed consent. Hence this itself is a deficiency in service on the part of the treating doctors and the hospital concerned.
33. Now the next point is whether the opposite party no.1 had performed the surgery without proper assessment of her body condition and pre-operative tests who had the history of obesity, diabetes, varicose veins and chronic arthritis.
34. Ex.A21 is the copy of form of complaints with duration and history dated 5.03.2011 which does not contain the history of the patient. The opposite party no.1 also admitted in the cross examination that he has not recorded the past ailment history of the patient and he also adds that it was not necessary to record all past ailment history on the primary consultation on OPD basis in the Osteo arthritis patient. Contrary to that he further deposed that it was incumbent on this part to mention what are the ailment suffered by the patient in the past, treatment underwent in the past, surgery if any undergone by the patient. The opposite party no.1 also deposed the he was not aware that the deceased patient was obese. Ex.A24 is the pre-Anesthetic Evaluation wherein in their evaluation report it was noted as the patient had history of Hysterectomy 20 years back and she was obese.
35. In the book of Campbell’s Operative Orthopedics it is clearly mentioned that there is increased risk in complications for obese people going through total knee replacement. The morbidly obese should be advised to lose weight before surgery and, if medically eligible, would probably benefit from bariatric surgery.
36. Therefore, the opposite party no.1 without observing the past history, physical examination and without conducting pre-operative preparation had chosen to operate on the patient. According to the said book, pre-operation preparation for the surgery should ideally commence at least a month before the date of surgery so that any possible issues or concerns can be identified and corrected in advance. This exercise increases the success rate of the surgery and reduces the incidence of complications. About one to two weeks before your procedure, the patient will likely undergo pre-admission testing, referred to as 'PAT.' This includes a physical exam, a detailed questionnaire, a complete blood count-which checks for everything from diabetes to anaemia, a coagulation test(Partial Thromboplastic Time/ Activated Partial Thromboplastic Time (PT/APTT) Test) to determine whether her blood will clot normally, and a baseline metabolic analysis of your kidneys ( Creatinine Blood Test), liver, and pancreas. She may also have an EKG or ECG to verify the health of your heart. Other test includes, CRP Test(C-Reactive Protein is a protein made by the liver and released into the bloodstream within a few hours afte
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r tissue injury, the start of an infection, or other cause of inflammation). High levels of CRP are caused by infections and many long-term diseases. This test will identify and keep track of infections & diseases that cause inflammation. Apart from that pre-surgery exercises were also will aid in rehabilitation by making the patient body stronger and able to heal better. 37. Exs.A2 and A3 which are copies of hematology and biochemistry tests of the patient. Except the said tests the opposite party no.1 had not done coagulation test to determine whether the patient’s blood will clot normally, and a baseline metabolic analysis of your kidneys ( Creatinine Blood Test), liver, and pancreas. Other test includes, CRP Test(C-Reactive Protein is a protein made by the liver and released into the bloodstream within a few hours after tissue injury, the start of an infection, or other cause of inflammation). High levels of CRP are caused by infections and many long-term diseases. This test will identify and keep track of infections & diseases that cause inflammation. Had he done all these tests before the surgery as part of pre-operative check-up, he had found out that patient was not ready for surgery on the said date and might have postponed the surgery to another date when the patient was ready for surgery. 38. It is also seen that there is increased risk in complications for obese people going through total knee replacement. Had he seen the physical condition of the patient, he might have advised the patient to lose weight before surgery and, if medically eligible, would probably benefit from bariatric surgery. It is also nowhere mentioned that the patient and her husband thoroughly briefed regarding the diseased condition, surgical risk and other risks involved. 39. Now the another point is that if everything being in place, what was the main cause of injury or death? Whether the injury or death was the result of pre-operative or post-operative or condition environment-oriented deficiency? 40. In order to absolve oneself from the charge of medical negligence or lack of post-operative care onus is on the medical professional or the hospital. We may point out that the question of deciding as on whom the onus lies is directly related to the person who has the full knowledge or technical knowledge and not upon the person who is a gullible person as against those who are well qualified and well aware of the field they are practicing in. 41. The main defence of the operating doctor is that the complication occurred after the operation during the physiotherapy the patient developed fracture and after the fracture she again developed Fat embolism which is a fatal complication. 42. For this purpose a reference is made to Review Article relevant portion whereof is as under: The seriousness of fat embolism syndrome is not generally appreciated and the diagnosis is often overlooked. During the first week following major trauma, the causes of respiratory insufficiency include pulmonary contusions, fat embolic syndrome and shock lung. Pulmonary Changes Pulmonary findings usually are the earliest signs of the syndrome. Pulmonary insufficiency occurs in 75% of patients with fat embolism syndrome, and presents commonly as tachypnoea, dyspnoea and cyanosis. Rales and rhonchi can be heard. Hypoxaemia may be detected hours before the onset of respiratory symptoms. Approximately 10% of these patients progress to respiratory failure. Treatment of Fat Embolism Syndrome Careful monitoring of blood pressure, urinary output, and possibly pulmonary wedge pressure is helpful for management of shock. Over aggressive fluid resuscitation may worsen the patients pulmonary status ; if a perfusion can be maintained, judicious use of diuretic may be helpful. Analgesia often is overlooked in the treatment of fat embolism syndrome. Adequate analgesia is important to limit the sympathomimetic response to injury. Respiratory support is the mainstay of the treatment of fat embolism syndrome. Early and frequent monitoring of respiratory function, either by pulse oximetry or arterial blood gases, is advocated for patients at risk of fat embolism syndrome. Respiratory support can range from the use of nasal canula to mechanical ventilation. Peltier suggested that immediate administration of oxygen (40%) via face mask or nasal canula may be all that necessary. However, if persistent worsening hypoxemia (PaO2