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   2015| January  | Volume 8 | Issue 1  
    Online since January 28, 2015

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Patients with poor prognosis - Advisable to take 'informed consent' even in non-interventions

January 2015, 8(1):15-16
In patients with poor prognosis two basic precautions must be taken by the doctor. First, the patient / attendants must be specifically informed, and that too in no uncertain terms, of the poor prognosis. Second, although not mandatory, it is advisable, that the patient's consent be taken, wherein, the poor prognosis is clearly recorded. Such a consent must be taken even if no intervention is contemplated. (In this case, the expert witness appreciated the surgeon (OP) for giving a poor prognosis, as the same was clearly recorded in the informed consent document signed by the patient).
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"Poor records mean poor defense, no records mean no defense" - National Consumer Commission

January 2015, 8(1):4-6
1. Write medical records completely, contemporaneously, and correctly. They have the most important role to play in cases of medical negligence, as observed by the court in this case. "Medical records form an important part of the management of a patient, to decide the issue of alleged medical negligence. The legal system relies mainly on documentary evidence, particularly, in a situation where medical negligence is alleged by the patient or the relatives". 2. Medical records are not questioned in a court of law subject to them being 'genuine and unbiased'. In this case, the court has commented on two very important aspects of medical records:
  1. "Medical records that are written after the discharge or hours after death do not have any legal value".
  2. "Erasing of entries is not permitted and is questionable in court. In the event of alteration, the entire line or word should be scored and rewritten with date and time".
3. Medical records of all indoor patient's must be maintained for a period of three years from the date of commencement of the treatment and any request made for medical records from the patient must be complied within 72 hours. 4. Clinical notes, surgery notes, and records of follow-up must be properly maintained and must have a detailed history of the patient. 5. Medical records must be legible. In this case the court has very specifically taken note of the fact that the drug prescription written by the surgeon (OP) was illegible. 6. Doctors going on leave with a hospitalized patient, especially surgeons leaving the patient who has undergone surgery under the care of another locum / substitute is a difficult proposition and must be handled with proper care and caution. (In this case, it was very specifically alleged that the surgeon (OP) had, on the fourth day of surgery, proceeded on leave, leaving the patient in the hands of inexperienced junior doctors). 7. Failure or delay in arriving at a proper diagnosis can be construed as negligence. (In this case the court observed that the surgeon (OP) had a casual approach toward the patient, as he had failed to diagnose the cause of fever for more than 10 days at the initial stage). 8. A doctor, while discharging his professional duties, has to be alert and prompt with each and every patient whether a relative, non-relative or a friend. (In this case the court has very specifically drawn adverse inference against the surgeon (OP) for "his approach to the patient was casual one, because the patient was his relative") 9. Emergency surgeries/procedures must be performed for justifiable medical reason/s and the reason/s for rushing in an emergency must be specifically recorded in the patient's medical records. 10. Appropriate investigations and consultations must be done prior to surgery to decide the status of fitness of the patient for the surgery. 11 Relevant specialties must be consulted when indicated especially in taking decisions, such as a decision to perform a surgery. (In this case the court questioned the surgeon (OP) for performing a hysterectomy without even consulting a gynecologist). 12. Hospitals that give medical services absolutely free or charge a nominal registration fee are the only ones exempted from the consumer courts. (In this case, the surgeon (OP) took a very specific defense that he had not charged the patient, as the patient was a close relative and the court did believe in this defense. But at the same time, the court held the hospital and the surgeon (OPs) negligent on the ground that the other doctors as well as the investigations done at the hospital were charged).
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Effect of the 11 crore judgment - 50,000 granted by State Consumer Commission enhanced to 10 lakh by National Commission for a bile-duct injury

January 2015, 8(1):1-3
1 A surgeon who has to proceed on a planned leave / absence immediately after a surgery or during the post surgery period, especially when the patient is hospitalized must ideally not accept such patients. Unforeseen emergency where the surgeon may be absent during the post surgery period is a legally valid exception. However, in case the patient has to be accepted (except any high-risk elective surgeries) three basic precautions must be taken:
  1. Appointing a suitable locum / substitute to take care of the patient during absence
  2. Informing the patient specifically the fact of leave / absence well in advance
  3. Duly recording the aforesaid in both the consent form and the admission form and also taking a written declaration from the patient of insistence to undergo surgery.
(In this case, on the fifth day of the surgery, the surgeon (OP) proceeded on a planned leave and the court held that this was failure of duty to take care of the patient. The surgeon's (OP) defense that he had clearly informed the patient and relatives 'about his travel plans at the time of consultation and the surgery was performed with their full consent, and that another surgeon would look after the case in his absence if needed' and that he had 'offered to undertake the surgery after his return, but the patient requested him to perform the surgery as soon as possible because the patient was having a lot of pain and they did not want to wait till his return' was rejected by the court). , , 2. The doctor in-charge of the patient must ensure that the locum / substitute attends regularly and manages the patient properly. (In this case, one of the allegations of the patient was that the locum / substitute appointed by the surgeon (OP) during his absence examined the patient 'once a day in a casual manner'. Perhaps this was one of the reasons for the patient feeling dissatisfied and the court holding the surgeon (OP) negligent). 3. For scheduled elective surgeries / procedures, if there is any inordinate delay in starting the intervention, the reason/s thereof must be specifically recorded in the medical records and surgery notes, and the patient / relatives / attendants must also be informed of the same. (In this case, the surgery was scheduled at 1:30 pm but started at 7:30 pm and this delay was one of the prominent allegations made by the patient in the court. This allegation was rejected by the court). 4. In case the surgery is taking an unusually long time to complete, the reason/s thereof must be specifically recorded in the surgery notes. 5. Hospitals are always liable and responsible for the negligent conduct of their nursing staff, other employees, doctors, and anesthetist. In the case of doctors and anesthetists it is not relevant whether they are permanent or temporary; resident or visiting; whole time or part time.
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Failure / delay to diagnose in case of difficult / challenging / confusing indications - Error of judgment, not negligence, holds court

January 2015, 8(1):7-8
  1. Courts accept that at times arriving at a provisional / definitive diagnosis may be a Herculean task. Law merely mandates that the requisite steps be taken by the doctor, when indicated, and that too in a scientifically approved manner, to arrive at a diagnosis. (In this case, the court has very specifically held that "distinguishing sarcoidosis from pulmonary tuberculosis can sometimes be a great challenge to physicians" and that the failure of the doctor (OP) to diagnose sarcoidosis in this case "was an error of judgment, and not negligence"). , ,
  2. A doctor relying on the investigation reports of another qualified radiologist / sonologist / pathologist and acting accordingly is not negligence. (In this case, it later transpired that the initial diagnosis of Pulmonary Tuberculosis given by the doctor (OP) was wrong, but the court did not hold him negligent, observing that his approach was reasonable as he relied and acted on the report given by a qualified radiologist).
  3. Follow-up of the patient periodically and when indicated is viewed favorably by the courts.
  4. A patient must be referred to a higher center when indicated, especially when the treatment is not showing appropriate results or the patient has suffered some complications. Courts draw favorable inference for such referrals.
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A judgment call taken by the surgeon after opening the patient - Court refuses to question

January 2015, 8(1):9-10
  1. A surgeon is free to take appropriate decisions after opening the patient, but all such decisions must be acceptable to medical science, for bonafide reasons, and in the best interest of the patient. Courts usually do not interfere with professional / medical decisions taken by doctors. (In this case, although two parts of surgery were planned, namely, bladder augmentation and appendicular vesicostomy, after opening the patient, the surgeon (OP) performed only the former. The court held that this was not negligence as the surgeon (OP) had "reasonably explained that it was his professional judgment that he did not choose to perform the second part of the surgery, looking at the anatomical and physiological condition of the patient".) ,
  2. In case two different procedures have to be performed during an intervention, this fact must be specifically informed to the patient, and consent must very specifically record both the procedures. If any deviation is anticipated, the same must also be informed to the patient and recorded in the consent. (In this case, the allegation was that the surgeon (OP) had performed only the bladder augmentation and appendicular vesicostomy was not done, whereas, it was agreed that both the procedures would be performed).
  3. In all cases where specific decisions have to be taken after opening the patient, this fact must be specifically disclosed to the patient and recorded as such in the consent form.
  4. Specialized hospitals like pediatric, maternity, and so on, must avoid accepting patients outside their area of expertise. Emergencies would be an exception. (In this case, one of the allegations was that the hospital (OP) was a pediatric hospital for treatment of children up to the age of 15 years, and hence, the fact that the surgeon (OP) had performed surgery on the patient who was above 18 years was negligence. The surgeon (OP) very specifically stated in defense that the hospital (OP) gave special permission for carrying out the surgery. The court accepted this defense). ,
  5. Consent must be taken from the patient and none else if the patient is an adult, conscious, and oriented. Taking consent of the spouse, parents, children, and other close relatives of the patient, which is very common in India, is per se negligence. (In this case, all the other allegations made by the patient were rejected by the court except the allegation that though he was an adult, the consent of his mother was taken).
  6. Requisite presurgery investigations must be performed. Failure to do so is negligence per se.
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Not insisting on complete / correct history of a patient in an emergency is legally insignificant

January 2015, 8(1):13-14
  1. History and that too a complete and correct history must be taken of all patients including those in an emergency. The doctor must specifically record if the patient is not giving correct / complete history. However, in case of an emergency patient failure to take history or incomplete history taken by the doctor is not considered as negligence or deficiency in service. The only precaution that must be taken in such cases is to specifically record the fact that it was an emergency and the reason/s for recording an improper history. (In this case, the patient had come to the gynecologist (OP) in an advanced stage of delivery. The gynecologist (OP) in her defense had very specifically stated that the patient had not disclosed ' how many doctors had treated her and what treatment was given to her during pregnancy'. The court did not hold this as improper).
  2. Deviating or not following the standard protocol in emergencies for bonafide reason/s and in the patient's interest is generally overlooked by the courts. (In this case, the patient made allegations that no presurgery tests were performed, but as the patient was brought in an emergency the court did not pay heed to any such allegations).
  3. Even in emergencies, if possible, the patient / attendants / relatives must be informed, explained, and counseled, and consent must be taken.
  4. In case of emergency patients, especially critical ones, the patient's attendants / relatives must be regularly informed of the patient's condition. In case of any complication or abnormal findings, the same must also be immediately disclosed. (In this case, the patient, who was brought in an advanced stage of labor, in an emergency, was examined by the gynecologist (OP) and immediately the patient's husband was informed of the necessity to perform a Cesarean section).
  5. No consent of the patient / attendants is required to transfer a hospitalized patient to another hospital, if indicated. (In this case, the patient's husband alleged that no consent was taken by the gynaecologist (OP) to transfer the patient to another hospital, but the court did not hold this as negligence).
  6. The patient must be referred to another hospital when indicated and the reasons for the same must be specifically recorded in the medical records. (In this case, post delivery the patient went into respiratory depression and needed ventilator support, which was not available anywhere in that city, and hence, the patient was referred to another hospital. The court approved this transfer).
  7. Helping the patient in arranging an ambulance or providing such other help is always viewed favorably by the courts. (In this case, the court lauded the gynecologist (OP) for arranging an ambulance observing that this showed 'the bonafide' of the gynecologist (OP)).
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Proceeding by a wrong method / preference is not necessarily negligence

January 2015, 8(1):11-16
  1. Courts generally do not interfere with the medical decisions taken by a doctor unless the same is patently wrong or done for some dishonest purpose. Even a wrong method / decision is not necessarily conisidered as an act of negligence. (In this case, on the next day of surgery, after observing that there was swelling, the orthopedic surgeon (OP) simply slit the plaster and did not opt for the other available option of performing fasciotomy. The court has very aptly observed that, 'even if it is held that opponent Dr. Bhandari (orthopedic surgeon - OP) choose wrong method of treatment applying plaster scab in preference to other available method i.e. fasciotomy, on this ground only it cannot be inferred that he acted negligently and his conduct fell below that of the standards of reasonably competent practitioner in his field).
  2. Every hospitalized patient must be given a proper discharge card, briefly recording the summary of treatment, precautions to be taken, and instructions for follow-up. (In this case, the patient made a very specific allegation that he was not given any medical records except a discharge card and the court observed that this allegation was meritless as a 'discharge card giving brief of summary of treatment was issued').
  3. In all cases where a patient seeks discharge or transfer to another hospital contrary to medical advice, a proper 'discharge against medical advice declaration' must be taken from the patient, clearly explaining the risks of any such step. (In this case, contrary to medical advice the patient sought transfer to another hospital about 400 km away. This transfer obviously resulted in complications, but the orthopedic surgeon (OP) was able to point out that the said transfer was done contrary to his medical advice.) ,
  4. Refusal of the patient to perform or follow medical advice should be specifically noted in the medical records. Courts draw adverse inference against the patient in such cases. (In this case, the plastic surgeon had advised a 'cross leg flap' surgery, but the patient declined the same and instead insisted on being shifted to a hospital about 400 km away. The court drew adverse inference against the patient for the aforesaid).
  5. Indian courts follow the English law, which is pro-professional. In all cases of medical negligence the patient has to positively prove in the court that the doctor was negligent. (In this case, the court has observed that the patient was unable to discharge the initial burden of proving medical negligence; it was for the patient to make efforts to collect medical records from the doctor / hospital; and the doctor / hospital were not bound to produce medical records in court or give copies thereof to the patient on their own).
  6. A hospitalized patient seeking a second opinion must be provided all the help in getting a second opinion. Courts draw positive inference in favor of the doctor / hospital.
  7. The accepted medical practice expected from doctors by law is the 'knowledge of medical practice and the procedure available at the time of the operation and not on the date of trial'.
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The correct protocol after failure / non-completion of a treatment / intervention

January 2015, 8(1):17-18
This is a text book case of the legally correct manner in which a doctor should act. In this case, admittedly, the procedure performed by the gynecologist (OP) could not be completed, but the court endorsed each and every action of the gynecologist (OP).
  1. Qualifications - the very first step expected from a doctor is to ensure that he / she has the requisite qualifications to accept the patient. (In this case, the court has very specifically observed that the gynecologist (OP) had the requisite qualifications to perform tubectomy).
  2. Accepted Medical Practice - every medical act must be performed in accordance with medical science and the practice prevalent among peers. (In this case, the gynecologist (OP) performed tubectomy using the Pomeroy's technique, a standard procedure that is widely followed by other gynecologists. The court specifically took note of both these aspects). ,
  3. Failure / complications - a doctor is well within his / her rights in performing only a part of what was agreed and abandoning the rest if such a course is in the patient's interest and for bonafide reason/s. (In this case, the gynecologist (OP) could not identify the fallopian tube on the right side due to dense adhesions in spite of prolonged efforts, hence, tubectomy of the right side was not done. The court held that this was not negligence). ,
  4. Post failure / complications / mishaps - the patient / attendants must be informed about the same at the earliest. (In this case, tubectomy of the right side could not be done by the gynecologist (OP) and this fact was immediately informed to the patient's husband and relatives on the same day and to the patient on the very next day). ,
  5. Recording in the patient's medical records - every important aspect of patient management must be recorded in the medical records of the patient. (In this case, the fact that the patient was advised to do a hysterosalpingogram (HSG) after three months, as tubectomy was incomplete, was specifically mentioned in the case sheet of the hospital and the court did take cognizance of the same). ,
  6. Alternatives / other options - the patient must always be advised, counseled and explained of the other options and alternatives that are available. (In this case, after tubectomy failed, the patient's husband was specifically advised about the other option of undergoing vasectomy in the future). ,
  7. Post surgery advice / follow up - the patient must be given appropriate and complete post surgery advice and the schedule for follow-up. (In this case, the patient, on discharge, was advised to do a HSG after 3 months, to assess the patency of the tubes as the gynecologist (OP) was admittedly unable to perform tubectomy of the right side).
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