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2016| April | Volume 9 | Issue 4
April 18, 2016
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Giving medical advice on telephone/WhatsApp/SMS/emails is a risky proposition today - More legal clarity needed
April 2016, 9(4):73-74
Giving advice on telephone/WhatsApp/SMS/emails must be avoided, except in cases of grave emergencies. Law in this aspect is not settled in India and needs more clarity. Under the Indian Medical Council Regulations, 2002, every doctor is bound to give medical advice after physically examining the patient. But in emergencies, if the doctor is unable to physically reach the patient, advice can be given using these services, but with a few precautions. The reason/s for the doctor's inability to be physically present must be specifically recorded; the doctor must try to physically examine the patient at the earliest; and the notes/records written on telephonic instructions must be seen by the doctor and endorsed when the patient is physically examined. But in this case, the court seems to be holding otherwise. The allegation was that the patient was never seen by the chest physician (OP) during his month-long hospitalization. This allegation was rejected by the court observing that "bare mention of 'advice on telephone from Dr. P. P. Roy' in the medical record will not constitute medical negligence." There are a number of reported and unreported cases where the doctors have been held negligent for giving advice on telephone.
In cases of medical negligence, both the patients and doctors are entitled to produce medical experts in court to support their case. These medical experts are doctors of the same specialty as the doctor accused of negligence. But many a times, forensic experts or so-called medico-legal experts, who are doctors of other specialties, are produced in court as medical experts and their evidence is outright discarded. In this case, the National Consumer Commission discarded the expert evidence of a gynecologist in a case involving a chest physician (OP). The court has further expressed its view on this issue thus: "In medical negligence cases, one problem with respect to experts surfaces frequently: cross-discipline testimony; whether an expert from one discipline may testify on the standard of care in another discipline. Till date, in our country, there are no strategies to regulate expert witness testimony in medical negligence case. There is a need to formulate the best strategies for improving the quality of medical expert witness testimony, which are strengthening the qualifications for serving as a medical expert and providing more specific guidelines for physician conduct throughout the legal process."
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"Cognitive error of 'anchoring' - A common one in emergency departments," observes National Consumer Commission
April 2016, 9(4):61-63
Assumptions beyond a certain point and relying too much on the facts/conclusions of other doctors are risky and must be avoided at all cost. "Anchoring" is one of the commonest reasons of medical errors and resultant mishaps. In this judgment, the court seems to blame this error of anchoring as the underlying cause for the negligent conduct of the surgeon (OP) for delayed diagnosis and surgery in a case of acute appendicitis. The opening paragraph of this judgment points out to this source of medical error thus: "Diagnostic assumptions and prior reasoning of others can be carried along unchallenged when the facts and conclusions of previous assessments are absorbed into subsequent diagnostic reasoning. This cognitive error of 'anchoring' is a common source of emergency department error, and error in medical care more generally. In the emergency department, conclusions and assessments of physicians, nurses, and other paramedics initiate assumptions about both acuity and diagnosis. An initial error can be propagated if not reassessed, leading to delayed recognition of serious disease or even mistaken diagnosis."
What is a medical emergency? While certain conditions like heart attack or a woman in labor are always categorized under emergency, even a minor condition could be a medical emergency if it poses immediate and imminent danger to the patient. In this case, the court has observed that "Even acute appendicitis, without any complications, needs immediate medical attention. It should be considered as a 'medical emergency,' as complications can arise suddenly and the patient's health may decline rapidly."
Patient care by remote control is always risky. Law does not expect a doctor to always remain physically present with a hospitalized patient, but certainly expects that the doctor should be physically present at the earliest when the the same is indicated/necessary, especially in emergencies. (In this case, the surgeon (OP) had stated in his defense that the patient was "being actively monitored, managed, and treated under his direct care, management, and advice." The court rejected this defense observing that the surgeon (OP) ought to have attended the patient "during emergency hours" and not after 12 h of patient's hospitalization).
Consultants need to take diagnosis/advice of family physicians seriously, especially in case of referrals. (In this case, the patient was referred by the family physician to the hospital with diagnosis of "acute appendicitis," but this diagnosis seems to be ignored, as surgery was delayed and this ultimately resulted in patient's death. The court, while holding that this was negligence, observed that "Family physicians play a valuable role in the early diagnosis and management of such condition").
Failure/delay in hospitalizing or providing appropriate care to a patient in need of emergency care is
negligence. Appropriate care must be extended by hospitals/doctors without insisting for fees. (In this case, one of the allegations was that the hospitalization of the patient was delayed by 1.5 h for want of money, as the patient's mother was only carrying a check).
Consultant/s must examine the patient, perform surgery, or take the requisite steps at the earliest in case of patients who need emergency care. Delay, if any, could be construed as negligence. (In this case, the patient was diagnosed with acute appendicitis. The court held the surgeon (OP) negligent for attending the patient after 12 h of hospitalization, for failure to perform emergency USG scan, and for "inordinate and unexplainable delay" of 17 h in performing the operation).
Failure to choose/perform the proper procedure is negligence. (In this case, the surgeon (OP) was held negligent for failure to perform a second incision for providing outlet tube to drain out the pus).
Record the steps taken during the course of surgery in the surgery notes. (In this case, the court held the surgeon (OP) negligent observing that "as per the OT record, no drainage tube was kept, despite knowing that infected fluid was present in RIF, it was gangrenous perforated appendicitis").
Take appropriate postoperative steps. (In this case, the surgeon was held negligent for post-surgery failure to monitor the electrolyte levels and fluid intake-output). ,
Take proper history of the patient. (In this case, one of the defenses was that the patient had concealed past history of taking antidepressant drugs for refractory schizophrenia and the same caused post-surgery complications).
Law expects greater care from tertiary care hospitals. (In this case, the court observed that the hospital (OP) was one of the tertiary care hospitals and that "highest care is expected than from other hospitals").
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Responding to an HIV patient in an emergency - The classical dilemma faced by every doctor/hospital
April 2016, 9(4):64-67
Patients with AIDS/HIV in need of emergency care pose a unique problem to healthcare providers. Take appropriate decisions/actions at the earliest with all the precautions that are required in such cases. Record carefully and completely. This is a textbook case of the dilemma faced by doctors/hospitals. The patient had suffered myocardial infarction (MI) a few days back, was hospitalized for performing angioplasty, but tested HIV positive. Testing by western blot method would have taken 3 days as the said facilities were not available in that city. The doctors (OPs) proceeded with angioplasty immediately, charged 15% more as the material used in case of seropositive patients was required to be destroyed, and sent the blood sample to another city on the next day for confirmatory test. The report was negative. The court, while rejecting all allegations of negligence, questioned, "which doctor would have waited and taken the risk for another 3 h or so to carry out the procedures which were required to be carried out at the risk of the complainant (patient) getting another heart attack? And who would have been answerable in case the complainant (patient) had suffered another heart attack during the said period?"
As soon as the seropositive status of the patient is confirmed, even provisionally, the following protocol is advisable:
The patient must be counseled to disclose this fact to his/her sexual partner. In case the patient fails to do so, the doctor must disclose this fact.
Healthcare workers who are involved or may be involved with the patient must be intimated about the patient's seropositive status.
Confidentiality of the patient's seropositive status must be maintained. (In this case, the hospital (OP) followed this protocol diligently. The patient's wife was intimated about his seropositive status. Patient was treated as seropositive according to the hospital's (OP) protocol which did "not reveal the exact nature of the illness, if any, but indicates to all those attending to the patient directly or indirectly that extra precaution needs to be taken in respect of such patients, but there is no disclosure of the illness, if any, suffered or suspected in respect of such patients and only indoor records of the hospital show the same").
In case the patient/attendants want to get an investigation done/confirmed at another facility, sample must be given to the patient/attendants. But this is not a substitute and the indicated investigations must be performed by the doctor/hospital, especially in emergencies or where the reports are critical. (In this case, the hospital (OP) gave one blood sample to the patient's wife to get it tested at a laboratory of his choice and sent another sample to a laboratory of the hospital's (OP) choice for confirming HIV by western blot method. The court approved this conduct).
Disclose specifically and record the fact that an investigation/diagnosis is only provisional and needs further confirmation. (In this case, the doctors (OPs) stated that the patient and his wife were informed that the HIV tests could be false positive and needed confirmation, but the same was nowhere recorded. The court specifically took note of this defeciency).
Seropositive patients can be charged more than a normal patient in view of the extra expenses incurred for such patients. (In this case, the patient who tested HIV positive and underwent angioplasty was clearly told that the procedures would cost 15% more than the normal charges since all the material and equipment which was to be used was required to be destroyed. The court upheld this extra cost).
The patient/attendants must be immediately informed about the results on receiving critical investigation/diagnostic reports. (In this case, the patient had initially tested HIV positive, and later his blood sample was sent for testing by western blot method which showed negative result. The fact that the patient was immediately informed about the results was specifically pointed in defense).
Investigation reports must specifically record the method used in performing an investigation, especially if there are more than one acceptable method. (In this case, the court has adversely commented on failure of one of the pathology laboratories to state which of the three methods was used to investigate the patient's blood).
Courts in India trust doctors and generally rely on their words and documents. In this case, the patient alleged that he was informed that he was conclusively HIV positive, whereas the doctors (OPs) denied this fact. The court has observed that "the question here is of credibility …. We are inclined to believe both the doctors (OPs) rather than the complainant (patient) whose version is not corroborated and otherwise opposed to the probabilities of the case."
There is a pressing need to address the growing trust deficit between doctors and hospitals. In this case, the hospital (OP) had charged 15% more than the normal charges from the patient who underwent angioplasty, as he had tested HIV positive. Post-surgery investigations revealed that the earlier report was incorrect. The hospital (OP) volunteered to refund Rs. 10,500/- plus costs of Rs. 10,000/- to the patient's widow, even after the court held that there was no negligence in this case and this was permitted by the court. Such compassionate acts will certainly go a long way in bridging the doctor-patient trust deficit.
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What should be done when the patient/attendants refuses to sign?
April 2016, 9(4):75-76
Refusal of patient/attendants to put their signatures/acknowledgments/endorsements on the consent form or medical records is a big problem with no foolproof solution. In such cases, this fact must be specifically recorded in the prescription, discharge card, bed-head ticket, and such other medical records. Hospitals having video-recording facility should use the same in such situations. (In this case, the patient had alleged that the doctors (OPs) had not given any referral letter while referring the baby to the medical college. The doctors denied this stating that the referral slip was handed over to the attendants, but they refused to sign on the carbon copy and that the baby was admitted to the medical college based on their referral letter. A copy of the said referral slip which the attendants had refused to sign was produced in the court. The court rejected the allegation).
It is advisable to get a handwritten letter from the patient/attendants, in appropriate cases, declaring that the doctor/hospital will not be liable for adverse consequences arising out of their failure/refusal to follow medical advice or to give consent. But a doctor/hospital will not be protected by such letters for an erroneous medical decision/action that is contraindicated under medical science. Hence, greater caution and discretion must be exercised in insisting or acting upon such letters. (In this case, the baby's attendants were advised by the doctors (OPs) to hospitalize the baby in the medical college for further treatment as the prognosis was poor, but they refused to do so and insisted that the baby should be admitted there. Hence, they were asked to give in writing that the baby was in serious condition and the doctors (OPs) would not be held guilty if anything untoward happens. This was specifically stated in defense).
Failure or refusal of the patient/attendants to follow medical advice must be specifically recorded. This will at least ensure that the doctor/hospital is not punished for the wrongs committed by the patient/attendants. (In this case, one of the defenses was that on the third post-discharge day, when the baby came with the complaint of pain and cough, treatment was advised for 5 days, but the mother did not bring the baby for repeating the doses on the same evening, next day morning, and next day evening, and this ultimately resulted in the baby becoming critical on the third day).
The doctor/hospital transferring the patient to another hospital is responsible for the patient during transit and till the time the patient is accepted by the other hospital. (In this case, it was pointed in defense that the doctors (OP) continued oxygen and manual respiration with Ambu bag during travel).
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Relevance and necessity of checking instructions in drug inserts
April 2016, 9(4):68-70
It is absolutely necessary to read and follow the instructions in the literature accompanying a drug, as deviation therefrom could be held as negligence. In this case, it was alleged that a rheumatologist and not the orthopedic surgeon (OP) was competent to prescribe the drug "Arava" and literature accompanying the drug was produced in court wherein it was warned "Schedule H Drug: Warning: To be sold by retail on the prescription of a Rheumatologist only." The court rejected this allegation for other reasons. But let us not forget that in the landmark case where Rs. 11.5 crore was granted as compensation, one of the reasons for holding the doctors negligent was their failure to follow the instructions given in the literature accompanying a drug.
Doctors must always keep in mind whether they are privileged or not to give a particular drug, perform a particular surgery, accept a particular patient, and so on. Accepting a patient or performing an act outside expertise or specialization is negligence
. (In this case, it was alleged that the orthopedic surgeon (OP) was not authorized to prescribe Arava and at the initial stage only, the orthopedic surgeon (OP) should have referred the patient to a Rheumatologist. The court rejected this allegation holding that "rheumatology is also one of the specialties included under orthopedics" relying on the certificate issued by Indian Orthopaedic Rheumatology Association (IORA) and medical literature).
It is always advisable to physically examine the patient at each stage of the treatment. (In this case, it seems that the orthopedic surgeon (OP) had advised the patient to consult a physician without examining the patient in person, as the patient had suffered a drug reaction. The lower court held that this was negligence, but the same was overruled by the National Consumer Commission).
Take appropriate steps to deal with complications during the course of treatment. (In this case, when the patient suffered a drug reaction, the orthopedic surgeon (OP) informed the patient to stop all the drugs and advised her to consult a nearby physician. The court drew favorable inference from the aforesaid).
Consent of the patient is legally required only in cases of interventions. But in cases where a particular course of treatment or a drug may be risky for the patient, the patient must be counseled; pros and cons of the proposed treatment/drug must be clearly disclosed along with the commonly occurring complications; precautions must be discussed and explained; and the aforesaid must be specifically recorded in the medical records. (In this case, the court rejected the allegation that failure to take informed consent of the patient prior to prescribing the drug which had side effects was negligence. The court drew favorable inference as before starting a steroid, the orthopedic surgeon (OP) had counseled the patient about the beneficial effects and contraindications of the drug, directed the patient to consult him regularly every month, prescribed the drug along with supportive treatment, and advised physiotherapy in order to avoid progress of joint stiffness).
Patients who consult after a very long time may have misplaced or forgotten to bring old medical records. If the old records are relevant, the fact that they have not been brought by the patient must be specifically recorded in the prescription, admission sheet, OPD card, and so on. (In this case, the orthopedic surgeon (OP) had very specifically stated in defense that the patient had misplaced her old medical records).
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Precautions in a multi-stage surgery
April 2016, 9(4):71-72
In multi-stage surgeries, the patient must be specifically informed about the said fact and the same must be specifically recorded in the prescription, discharge card, consent, and such other medical records. Failure to do either of these could be construed as negligence. (In this case, the patient had a fracture of the shaft humerus. The orthopedic surgeon (OP) performed surgery of the fractured bone by fixing of plate. Three months later, another doctor performed bone grafting. The orthopedic surgeon (OP) stated in court that he had planned for surgery in two stages, namely, surgery of the fractured bone by fixing of plate and bone grafting, and had informed the patient accordingly, but the patient on his own approached another doctor for bone grafting. The court rejected the defense that the patient was informed of the second surgery, as it was not mentioned in the case papers. The court further reasoned that the patient would not have approached another doctor for bone grafting if the patient was informed about the same).
Delay in performing the indicated act is negligence. (In this case, the orthopedic surgeon (OP) was held negligent for the delay in bone grafting in a case diagnosed as fracture of shaft humerus).
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Doctor makes a choice between the devil and the deep sea - Court refuses to interfere
April 2016, 9(4):77-78
Serious contemplation is required in choosing a course of treatment or a drug having serious side effects, but without any other equally efficacious alternative. Take greater care and precautions in advising/administering the same. Consult other doctors, especially senior and experienced ones, in appropriate cases. Record specifically the reason/s for opting for such a drug/course. (In this case, it was alleged that the patient's diabetic status and heart problems were ignored by the doctors (OPs) before starting steroids and this caused complications and ultimately death. The court refused to intervene observing that "for optic neuritis, the steroid is a drug of choice").
Important and critical instructions must be explained to the patient orally and must be specifically written on the prescription, discharge card, and such other medical records. Furthermore, higher degree of care is required in carrying out the said instructions, especially if the doctor/facility advising and performing these instructions is different. (In this case, the patient who had high blood sugar and was prescribed a steroid was specifically advised to take the said injections under medical supervision. The court drew favorable inference and specifically observed that the said injection was administered to the patient "under the supervision of a qualified physician" and that the patient was monitored properly).
Side effects of drugs that can seriously harm the patient must be specifically disclosed to the patient. (In this case, it was alleged that the patient requested the physician (OP) to check the side effects of the injection before giving it, but he injected it saying that "there was no need to worry").
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National Consumer Commission holds hospital deficient for failing to produce records pertaining to the date of manufacture and date of expiry of stents
April 2016, 9(4):79-80
Preserve non-medical records for a longer period, especially in cases where legal trouble is expected, though this is not legally mandatory. In this case, the court held PGIMER Chandigarh (OP) deficient as it failed to produce in the court records of purchase of stents or to point out any entry in the stock register regarding the same. It was alleged that the stents used were substandard as the patient died within a month of being stented, and therefore, details of purchase of stents were sought by the patient's relatives. This is not a binding precedent, especially for non-government hospitals. But, nevertheless, in a case where the patient makes a similar allegation even against a non-government hospital, the hospital will have to produce such records for defense.,
Follow proper protocols to ensure that the drugs, implants, disposables, and so on are within the expiry period. (In this case, it was alleged that the stent used by the hospital (OP) had passed its date of expiry. The hospital (OP) was held deficient in service as it was unable to produce the requisite documents to disprove this allegation. The court has taken a very strict view observing that "the patient cannot be allowed to suffer on this account as they would never be sure about the authenticity and quality of treatment").
Contemplation is required in taking decision to hospitalize the patient. Even this aspect is slowly becoming contentious. At times, it is alleged that the patient was unnecessarily hospitalized, while at other times, the allegation is that the patient ought to have been hospitalized but it was not done. Similar allegations are surfacing regarding transferring the patient to ICU. (In this case, two specific allegations were made. The first one was that post-discharge when the patient was brought for follow-up, she was not admitted, though her condition was serious. The second one was that the patient who was diagnosed with sepsis was not admitted in the ICU, though such patients are usually treated in the ICU. Both were rejected by the court).
Every medical action must be performed when indicated, neither early nor late. (In this case, it was alleged that the patient ought to have been stented when she was admitted, rather than doing so on the third day).
Courts in India are hesitant in interfering with the professional decisions taken by a duly qualified doctor. In this case, the timing of stenting the patient and the decision not to admit the patient in ICU were questioned. The court, while rejecting both, has very aptly observed, "So far as the biliary stenting is concerned, it will depend on the assessment of the treating doctor when it is to be done, and therefore, the assertion of the complainant cannot be accepted that stenting was done in a delayed manner" and "Another lapse that has been pointed out by the complainant is the non-admission in ICU on 29.07.2007. Here also I am of the view that the treating doctors' assessment and judgment may have to be respected until proved contrary."
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