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2014| October | Volume 7 | Issue 10
April 6, 2015
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Reducing consent to a "Signature Ceremony" - Three different procedures, identically worded consent
October 2014, 7(10):145-146
Filling the consent form in a mechanical fashion and getting signatures of the patient/attendants/relatives without proper counseling is negligence
. [In this case, the court found that the consent forms for the three procedures undergone by the patient (applying plaster cast, cast removal and fixation of metal plate, and skin grafting] were "identically worded." The court had, therefore, observed that the "only inference that can possibly be drawn is that none of the three procedures was specifically explained at the time of obtaining consent"].
Printed consent forms must have suitable and enough spaces to be filled while taking consent.
Medical negligence could be broadly divided into two parts: an improper decision/diagnosis/course of action and/or improper implementation of an otherwise proper decision/diagnosis/course of action. This case is an excellent example wherein the court held that "the choice of the line of treatment of the orthopedic surgeons (OPs) cannot be faulted for choosing the plate and screw method and not external fixation method. But having chosen the line of treatment, they failed to do it properly."
Doctors/hospitals must always contemplate and anticipate about the risks involved and must take the indicated action/s to prevent/minimize the same. The risk as well as the preventive action taken must be specifically recorded in the medical records. Failure to do so could be construed as negligence. (In this case, the court observed that the OPs "were fully aware of the risk of infection in a leg fracture with an open wound and yet failed to avoid it").
Doctors are bound to properly explain the line of treatment chosen by them to the patient/attendants/relatives.
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National Consumer Commission holds that an allopathic doctor can prescribe ayurvedic medicines - Legally incorrect proposition
October 2014, 7(10):143-144
Allopathic doctors cannot prescribe drugs of other pathies including ayurveda. In this case, the court, relying on the literature published by the ayurvedic eye drop manufacturer which stated that "it has good antimicrobial activity and no adverse effects, if administered as per the prescribed dosage," held that there was nothing wrong in the ophthalmic surgeon (OP) prescribing the said eye drops, even though it was an ayurvedic medicine. But this is not the correct legal position. An allopath does not have the requisite qualifications and skills to prescribe an ayurvedic drug in the same way as doctors of other pathies are legally incompetent to prescribe allopathic drugs.
Hospitals and nursing homes must duly preserve appropriate records of culture reports, fumigation reports, and such other activities that may be helpful in the court of law. (In this case, the court drew adverse inference as the hospital (OP) failed to produce the microbiology culture report of the swabs taken from the operation theater during the relevant period when the surgery was performed, fumigation register, or details of the other surgeries performed in the said operation theater).
Transfer note/summary must record a brief history of the patient.
Hospitals and nursing homes must ensure that they have the requisite licences and permissions from the appropriate regulatory authorities.
Non-cooperation of the patient in appropriate cases must be specifically recorded.
Give guarded prognosis to the patient/attendants/relatives.
Referral made to other hospitals/facilities/centers are approvingly looked upon by the courts.
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Failure to take into account small but "real" risks is negligence
October 2014, 7(10):151-154
Failure to take into account small but real risks is negligence
. (In this case, the court has very clearly pointed that the doctors (OP) had recommended angiography as a routine procedure, and had ignored and failed to appreciate the risks that were "real and as high as fatal in individual cases").
Illegal, immoral, or unethical demands made by the patients/relatives/attendants must be specifically recorded in the medical records. In appropriate cases, the police must also be informed about such demands in writing. (In this case, it was pointed in the court that this complaint for medical negligence was filed because the doctor in-charge and the Medical Superintendent of the hospital (OP) did not accept the demand made by the patient's brother who had come from the UK and had requested them to witness the fixation of the patient's thumb impression on a will when the patient was on the ventilator).
Preparing a comprehensive pamphlet/note about the common procedures giving explanation of the procedure, risks, and post-procedure precautions is advisable. This pamphlet/note can then be given to each and every patient who is to undergo that procedure, and acknowledgment of the patient having received the same must be taken. (In this case, one of the defenses was that the patient was handed over a pamphlet on the guidelines for angiography patients, wherein it was clearly stated that there was approximately 1% risk of serious complications including deterioration of renal function or cardiac condition).
Before opening the patient, surgeons and hospitals must contemplate whether the requisite consultants and/or infrastructure are in place and in working condition for that particular surgery/procedure and to deal with its common complications. (In this case, the court held the hospital (OP) negligent as it "had not kept the arrangements ready to meet with emergent conditions, which is clear from the decision of OP to shift the deceased to ICU, instead of conducting coronary artery bypass graft (CABG); even the surgeon did not come to examine the condition of the deceased at 07.20 pm, i.e. immediately after the incident"). ,
Overconfidence is dangerous and could at times lead to avoidable consequences. The court has very aptly observed in this case that the advice to the patient to undergo immediate angiography and, that too, without appropriate investigations was a wrong decision arising either "out of overconfidence" or "in anxiety not to lose a patient."
Standard of care expected from a doctor is adjudged from the practice prevailing at the time of treatment among peers of the same speciality. (In this case, one of the defenses was that the medical expert who had deposed in court on behalf of the patient had stated that the treatment was not as per "contemporary" practice, instead of pointing out to the practice "prevailing" at the time of the treatment).
Staff members working in ICU, both medical and non-medical, have to be extra vigilant. (In this case, the court found that the patient's blood sugar level was 25 mg/dl at midnight, a severe hypoglycemic condition. The court questioned as to how this could happen despite 24 Χ 7 observation and services available in the ICU and held that the ICU staff was not vigilant in monitoring the patient).
Vitals must be checked and appropriate investigations must be carried out at indicated intervals and specifically noted in the patient's medical records. (In this case, the court drew adverse inference as the biochemical report chart did not show periodic blood sugar estimation done at the hospital (OP)).
Advising the patient to undergo a procedure/surgery immediately instead of a planned one must be done only on proper justification. Emergencies, of course, are the exceptions. (In this case, the court held that the advice given to the patient to undergo immediate angiography was wrong).
In all cases of mishaps/accidents/complications/intra-surgery problems, the services of senior and appropriate consultants must be requisitioned with a sense of urgency. (In this case, one of the allegations was that post-angiography when the patient suffered a heart attack, no alert was issued for senior doctors/cardiac surgeon). , ,
Perform the requsite pre-surgery tests and investigations. ,
In all cases where complications/unexplained events happen immediately after a surgery resulting in death, post-mortem must be recommended to know the actual cause of the death. (In this case, the patient had undergone angiography, suffered heart attack in the recovery room, and died about 9 days thereafter. One of the allegations was that autopsy ought to have been recommended but was not done).
Improper management even of an unanticipated complication could be termed as negligence. (In this case, one of the grievances was that post-angiography when the patient suffered heart attack in the recovery room resulting in brain death, which was an emergency, it was not tackled properly).
Hospitalized patients must be shifted from one place to another in appropriate mode of transport. (In this case, one of the allegations was that the patient was perhaps shifted from the cath lab on the first floor to the ICU on the fifth floor on a wheelchair and not on a stretcher).
Too many deletions/corrections/overwriting in medical records could be construed as an indication of panic, especially in cases of emergencies/accidents/mishaps.
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Difference between pardonable and unpardonable errors of judgment/mistakes
October 2014, 7(10):155-156
Law clearly differentiates between a pardonable and an unpardonable mistake. This case clearly brings out this differentiation. The radiologist (OP) had wrongly reported presence of gallstones and missed malignancy. Relying on this wrong report, the surgeon (OP) proceeded with surgery and on finding malignancy, he merely took tissues for biopsy and closed the abdomen. The court held the radiologist (OP) negligent and observed that his conduct was "not an error of judgment but it was a mistake and wrong diagnosis," whereas the surgeon (OP) was not held negligent though the allegations were that he ought to have called an oncologist.
Hospitals are generally held liable in all cases of medical negligence, but this case is an exception. The surgeon (OP) had performed surgery on the patient, relying on an incorrect report given by the radiologist (OP) wherein gall stones were diagnosed and malignancy was missed. The court had very specifically recorded, "The hospital (OP) had limited role in this case; we do not find any lapses or negligence by it." The radiologist (OP) was held negligent, whereas the surgeon and the hospital (OPs) were not held negligent.
Keeping a patient hospitalized for no justifiable reason/s is negligence
. (In this case, the allegations were that the patient who had cancer was kept hospitalized post-surgery for 9 days without giving any treatment of cancer. The court held that the hospital (OP) was justified in doing so as the histopathological report of the patient was awaited).
It is advisable that pathological laboratories and imaging centers must record the sensitivity/error of the particular investigation in the investigation reports, especially the critical/sensitive ones.
Patient's failure or neglect to come for follow-up when advised must be specifically recorded.
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Mixing of medicines while dispensing/storing - An area of concern
October 2014, 7(10):149-150
Hospitals/doctors/pharmacists must make conscious efforts to keep medicines whose covers/colors are identical separately. This is a potential source of error. In this case, the hospital (OP) had very specifically stated in its defense that "the diabetic drugs are kept in a separate rack."
An English literate patient is the safest one from a legal perspective. Usual allegations of the patient having been misguided or the patient putting signature by force or without having an opportunity to read and understand are rejected by the courts in case of an English knowing patient. Even in this case, the court rejected the allegations that wrong medicine was dispensed by the hospital's (OP) pharmacist, observing that the patient was not illiterate, could understand English, ought to have been vigilant, and was under the bounden duty to "check the medicines before or while leaving the pharmacy."
Patients must be instructed to show the medicines purchased to the doctor/nurse. This healthy practice has been approvingly recommended by the court in this case.
In emergencies, especially when a critical patient is hospitalized at odd hours, a doctor can give instructions to another doctor/RMO/nurse on telephone. But the instructing doctor must make every effort to reach and physically examine the patient at the earliest. It is also important that the medical records where telephonic instructions are noted must be checked and countersigned by the doctor who had given such instructions. (In this case, the doctor (OP) had very specifically taken the defense that the patient's treatment was started by the RMO on his telephonic instructions as he was getting delayed due to a traffic jam).
Hospitals having their own pharmacies must ensure that the same are manned by a duly qualified pharmacist.
Consultants/facilities must be made available at the earliest to a patient in an emergency. (In this case, one of the allegations was that when the patient was hospitalized in a critical condition, the doctor (OP) was not available for more than 2 h).
A doctor can dispense drugs only to his/her patients and not to any outsiders.
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Dealing with drugs/consumables brought by the patient but not used
October 2014, 7(10):147-148
Drugs/consumables brought by the patients/attendants/relatives but not used must be returned back to the patient after taking a proper receipt. Failure to do so may be construed as negligence and deficiency of service. (In this case, the patient was asked by doctors at PGIMER to bring a vial of contrast medium and the same was loaded in the injector before he was taken for the computerized tomography (CT) scan. Plain CT was done and the contrast was not required. The patient was given the option of taking back another unopened vial brought by the next patient, but he refused and went to the court. The court directed PGIMER to refund back the purchase price of the contrast vial of Rs. 581.13/- to the patient). ,
Patients are going to court for seeking refund of inconsequential amounts such as Rs. 581.13/- and for trivial reasons such as not giving back an unused contrast vial, as in this case.
Stringent action must be taken against patients/attendants/relatives who shout, abuse, or misbehave with the hospital staff. In appropriate cases, the matter must be reported to the police.
Courts treat government/public hospitals leniently. This aspect becomes very clear from the observations of the court in this case - "There is hardly any doubt that there is great rush for such services in the PGIMER, Chandigarh, and the staff and doctors are tremendously under pressure to carry out their duties."
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Consumer Courts not bound to accept findings of Medical Council of India/State in totality - National Consumer Commission
October 2014, 7(10):159-160
Courts are not bound by the findings/observations/decisions of the Medical Council of India (MCI) and can take a completely contrary view. But orders of regulatory bodies like the MCI do have a bearing on the decisions taken by courts, including the Consumer Courts.
Before finalizing a surgery/procedure, contemplate and anticipate post-intervention complication/s, especially the common ones, and whether the requisite facilities to manage the same are available or not. (In this case, a specific allegation was made that the hospital (OP) ought to have anticipated the post-surgery complication of pulmonary embolism which requires intensive management and advanced cardiopulmonary facilities, and that the said facilities were not available with the hospital (OP)).
After the 11 crore judgment passed by the Supreme Court, patients' expectations of compensation have risen to unrealistic heights. This is a dangerous trend. In this case, the patient's husband claimed compensation of Rs. 6,30,60,000/- (1 crore - mental agony, distress, permanent loss of companionship, breakdown of family life; 1 crore - mental agony, distress, torture caused to the mother-in-law for loss of daughter-in-law; 1.5 crore - mental agony, emotional distress, torture caused to four children on loss of their mother; and 1 crore - time loss and loss of professional prospects of his daughter as a result of this shocking development, as she was preparing for medicals at that time). The court dismissed this complaint outrightly and observed that "The Consumer Courts are not a lottery center or game of Russian roulette."
Specifically check the date of expiry of blood before transfusing.
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Could a consent taken even before the procedure is finalized be termed as "informed consent"?
October 2014, 7(10):157-158
Consent is not at all taken seriously by doctors/hospitals in India, although allegations of improper consent are the single biggest cause of concern for the medical fraternity in cases of medical negligence. This case is a monumental example of this attitude. The patient underwent delivery and 2 days thereafter, tubectomy. The decision to undergo tubectomy was taken by the patient on the next day of delivery. Yet, in the court, the hospital (OP) had the audacity to state that the patient's consent for delivery should be considered as informed consent for tubectomy. The court had rightly questioned as to how a patient could give consent for a procedure which was not even finalized by the patient by that time.
Consent of a conscious and oriented adult patient can be given only by the patient and no one else, not even the patient's closest relative. (In this case, the defense was that the brother-in-law of the patient had given consent, but this was held invalid by the court).
It is advisable that name and relationship of the person accompanying the patient should be specifically recorded in the admission form when the patient is hospitalized.
Patient's request for a particular course of action will never act as a doctor's defense if such a request is contrary to medical science and practice. The doctor has to apply his own judgment in the facts and circumstances of that case and then take a call on the course to be adopted. (In this case, one of the defenses was that the patient had requested for general anesthesia).
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