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2016| September | Volume 9 | Issue 9
September 15, 2016
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A literate patient signing consent form - The best safety net for doctors
September 2016, 9(9):149-150
Illiterate/less literate patients must be dealt with greater care and caution. Even mundane aspects need to be explained in detail and that too with greater care and clarity. It is advisable that consent of such patients is also attested by an independent witness. Such precautions are not that strictly required in case of literate patients. This case is an excellent illustration of the aforesaid. It was alleged that "consent was obtained from the patient and husband on the dotted line on a blank form." The court rejected this allegation observing that "It is pertinent to note that the complainant (patient) herself is an advocate and not an illiterate person, both have signed the consent form of their own volition."
For all endoscopic/laparoscopic procedures, open surgery is also an alternative. The patient must be informed about both the options and consent must also be taken for both. (In this case, one of the allegations was that "instead of laparoscopic surgery, the OP (surgeon) performed open cholecystectomy").
The patient must be given relevant information in comprehensible terms, given time to contemplate and take decision, and only then signature on the consent form must be taken. (In this case, one of the allegations was that "consent was obtained from the patient and husband on the dotted line on a blank form." The court found that the surgeon (OP) had "explained about surgery to the complainant (patient) and her husband in detail, thereafter both had signed the consent form" and hence rejected this allegation). ,
Failure of the patient to follow medical advice must be specifically recorded. This protocol is all the more mandatory when advice is given for corrective actions for post-surgery complications or for complications during the course of treatment. (In this case, the patient developed extra hepatic obstruction to the bile flow after cholecystectomy. The court drew adverse inference as the patient was advised re-exploration for the assessment of complication and corrective surgery but the patient refused to get re-admitted and instead chose to go to other doctors and that too after 3 weeks).
"Not all medical injuries are the result of negligence" observed the court in this case where the patient who had undergone cholecystectomy suffered post-surgery obstructive jaundice. The surgeon (OP) was not held negligent.
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Take consent of "the relatives whosoever is immediately available"
September 2016, 9(9):151-153
Take consent of the nearest relative of the patient who is present at that point in time. No hierarchy of relatives is legally prescribed for taking consent. (In this case, one of the allegations was that consent of the patient's minor son was taken instead of the wife. The court while rejecting this allegation stated that "as per general practice consent is taken from the relatives whosoever is immediately available. Doctor cannot wait for consent of a particular person and thereby allow the condition of patient to deteriorate").
The doctor must sign on the consent form although this judgment speaks otherwise. (In this case, admittedly the doctor had not signed the consent form, and this was pointed as an instance of negligence. The court while rejecting this allegation observed that "consent must contain signatures of relative of the patient and not of the doctors. Signatures of doctors are taken only as abundant precautions to prove the consent, if consent is disputed").
Risk-reward ratio must always be kept in mind in deciding the course of action, especially in complicated cases or when prognosis is poor. (In this case, the doctors (OPs) performed kidney biopsy which ultimately resulted in a large hematoma. The court agreed with their defence that "the vital information and clues towards the final diagnosis obtained by kidney biopsy far outweigh the potential risks and complications associated with the procedure").
Specifically record if the patient fails to come for follow-up and instead a relative/attendant comes for the same. The reason stated by the relative/attendant for the patient's failure to report must also be recorded. In appropriate cases, the relative/patient must be warned and strictly instructed to bring the patient for the next follow-up. (In this case, it was pointed in court that the patient had failed to report for review and instead his wife came and showed the biopsy report which showed poor prognosis).
Proper communication has become all the more necessary in an era where distrust between doctors and patients is increasing with each passing day. This case is an excellent example. The doctors (OPs), keeping in mind the poor financial condition of the patient, performed the kidney biopsy using a sample kit. The kit purchased by the patient was returned back to the hospital pharmacy and the money was refunded. Instead of being grateful, the allegation was that the sample kit was unsterilized resulting into septic and that the excuse given that it was done so to save cost of kit was "unreasonable."The doctors (OPs) had to clarify in court that the sample kit does not mean that "it is not of proper quality or standard. Rather sample kit is one which is provided by sales representatives to doctors for convincing the quality and effectiveness of the kit. It is generally considered that sample kit is better in quality and more effective." The court in fact lauded the doctors (OPs) for this humanitarian approach.
Record specifically in history if the patient had or is taking medicines of other pathies or quacks. (In this case, the fact that the patient had history of taking Ayurvedic medicines was specifically pointed to the court in defence).
Adopt humanitarian and ethical approach. At times it would be painful, especially when inspite of going out of the way to help the patient,the patient misconstrues the same. This case illustrates the aforesaid. The doctors (OPs), keeping in mind the financial hardship of the patient, admitted the patient even though he was unable to deposit the complete amount; provided the sample kit to perform biopsy and the kit purchased by the patient was returned to the pharmacy; and even biopsy was conducted free of cost. However, after the patient's death the doctors were sued, and it was alleged that the sample kit used was substandard. The doctors were forced to state in court that "if having a sympathetic attitude towards financially weak person is a sin, it is not clear as to how the medical profession would survive." Fortunately, the court took into cognizance the aforesaid and commended the doctors (OPs) for their compassionate and ethical approach.
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Dealing with tricky treatment/interventions and knotty patients
September 2016, 9(9):155-157
In appropriate cases, especially cosmetic therapies, the following is advisable:
The patient should be asked to draw figures or state in writing his/her expectations from the treatment. The doctor must also counsel and explain the treatment and the possible outcomes with the help of photos, figures, drawings, etc., and the patient's endorsement must be taken on a copy thereof. Both of the aforesaid must be duly preserved with the medical records of the patient.
Explain the prognosis and risks in clear terms. Do not give any false assurances and promise only what is medically possible and indicated.
The prognosis, risks, and behavior/expectation of the patient must be specifically recorded in the medical records as well as consent.
Refusing to accept at the outset or continue treating a patient who insists on something that is not medically possible or indicated is one option in such cases. (In this case, the patient, a TV serial actor, had handed over a note to the doctor (OP) indicating what he wanted from the surgery. The doctor (OP) initially refused to perform the surgery but performed it later perhaps on patient's insistence. The patient was not only unsatisfied with the outcome of the surgery and successfully sued the doctor (OP) for negligence, but thereafter consulted 7 doctors in 13 medical institutions and underwent 5 operations and still remained unsatisfied).
Extra care and caution is required with patients suffering from psychiatric disorders/conditions. (In this case, the doctor (OP) blamed the patient's psychiatric condition for the patient's problems. He pointed that the patient was suffering from body dysmorphophobia, a body image disorder in which the patient is not happy with his looks. The doctor (OP) further pointed from an authoritative medical text that "the patient can become very unhappy if the results of the surgery are criticized by family or close friends in the immediate postoperative period. It is not rare to see a patient soon after the surgery who is ecstatic on one visit and deeply depressed on the next. If the surgeon decides to operate on a perfectionist patient, he or she must accept a certain risk that the patient may not be happy or may arrive at some measure of acceptance only after many weeks and a good deal of annoyance and irritation to the surgeon and his or her staff").
The discharge summary of a patient who has undergone a procedure/surgery during hospitalization must briefly record this fact and the requisite details such as the exact scientific name of the intervention and intra/post-intervention complications. (In this case, the court held the doctor (OP) negligent as the discharge summary did not mention whether the L-shaped graft was performed on the patient or not).
The doctor/hospital is bound to provide operation notes to the patient as these are integral part of medical records.
Patients not following medical advice must be suitably warned, and this fact must be duly recorded. In appropriate case, the doctor can also withdraw from such patients. (In this case, three specific instances of the patient failing to follow medical advice were pointed in defence - the patient was obsessive with the shape of his nose and fiddled with his nose too much inspite of specific advice not to do so; the patient refused proper drainage and washout under general anesthesia of his infected nose and decided to continue with the antibiotics; and the patient did not turn up for any follow-up treatment as advised).
Follow the standard and acceptable medical practice. (In this case, the court held the doctor (OP) negligent as the standard of medical practice clearly stipulated that L-shaped grafting was the best procedure for the patient's correction surgery but the same was not performed").
Do not give false assurances. (In this case, the doctor (OP) admitted in court that he had agreed to perform the surgery without leaving any scars, but the post-surgery prescription of another doctor clearly recorded the presence of scar. The court drew adverse inference from the aforesaid).
Consulting many doctors and multiple hospitals is the new trend. It clearly points out to the increasing trust deficit between doctors and patients. (In this case, one of the defense taken by the doctor (OP) was that the patient was "treated by 7 Doctors in 13 Medical Institutions and underwent 5 operations, which did not satisfy the patient").
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Privileging in emergencies
September 2016, 9(9):154-154
Law is very accommodating with doctors/hospitals attending an emergency patient. One such aspect is privileging. Accepting and attending an emergency patient who may not be strictly within the expertise of the doctor/hospital is not negligence; however, in non-emergencies the aforesaid could very well be construed as negligence. Efforts must be taken to transfer an emergency patient outside the expertise of the doctor/hospital to another appropriate doctor/hospital at the earliest. [In this case, the main allegation was that the consultant physician (OP) should not have accepted the patient as it was a case of neurology. The court rejected this allegation observing that the patient was admitted in an emergency when the consultant physician (OP) was "on emergency duty" and he attended the patient in "emergency" as per standard norms].
Failure to diagnose may not always be negligence. Law takes into account that there are ailments/conditions that are difficult to diagnose. (In this case, the court has specifically observed that the condition Herpes Simplex Encephalitis "is clinically difficult to diagnose").
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Defensive medicine - Now advocated by medical texts
September 2016, 9(9):158-159
The rising threat of medicolegal problems is forcing doctors to resort to defensive medicine, an open secret. Now even medical texts are advocating similar action. In this case, the court has referred to Mercer's Textbook of Orthopaedics and Trauma, wherein under the Chapter "Amputation" it is clearly stated that "A second opinion is immensely helpful especially in the present era of increasing litigation should be considered." Science has perhaps bowed down to the harsh reality of life.
Courts in India have repeatedly stated that, in case of an emergency patient, the doctor/hospital must remain focussed only on the treatment and not on the procedural aspect. In this case, the court has drawn favorable inference in favor of the doctor/hospital (OP) for starting treatment even before registering the patient.
Take separate consent for each type of intervention and each time an intervention is performed. (In this case, the orthopedic surgeon (OP) amputated the patient's legs twice and each time obtained fresh consent. The court approvingly observed that "consent was taken at every occasion, it was an informed consent").
In case of non-interventions where consent is not legally mandatory and therefore not taken, but the consequences could be serious, explain to the patient/attendants and take their endorsement on progress sheets or such other internal records. [In this case, the orthopedic surgeon (OP) pointed to progress sheet in the medical record wherein the details were recorded on day-to-day basis with signatures, specific date, and time].
Consent must be preceded by disclosure of information and counselling. Higher the risk, greater is the responsibility of the doctor/hospital, and more detail consent is required. Taking consent in a routine manner is negligence.
Delay in starting treatment or performing an intervention, when indicated, could be construed as negligence. (In this case, it was pointed by the patient that medical texts advised that debridement ought to be carried out within 6 hours of the accident, however, the same was not done. The court rejected this allegation as medical records showed that debridement was carried out within 4 hours).
Miscommunication often leads the patient/attendants towards misinformation, misapprehension, and ultimately to the court. Proper communication is the key to reduce medicolegal problems. (In this case, one of the defences of the orthopedic surgeon (OP) was that "it was the misconception of the complainant (patient) that OP undertook amputation three times" whereas it was done only twice. Proper communication could have perhaps avoided legal recourse).
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Performing two distinct surgeries/procedures in one sitting - Extra care and caution required in communicating with the patient/attendants
September 2016, 9(9):160-161
Communicate, counsel, and explain the reason/s for performing a scheduled surgery/procedure to the patient/attendants. The aforesaid protocol must be followed with greater care and caution in situations when two or more surgeries are planned together. (In this case, the patient underwent two surgeries together, one for removal of gall bladder and the other for piles. The patient approached the court alleging that performing two surgeries was unnecessary, gall bladder was unnecessarily removed, and that she also suspected that her kidneys were removed. Proper communication with the patient would perhaps have dissuaded the patient from approaching the court. The court has very aptly observed "In the instant case, it appears as a misconception of the patient and her relatives about two operations").
In case any scheduled surgery/procedure/investigation has to be postponed, it is advisable that the patient/attendants are duly informed about the same well in advance with reasons thereof. (In this case, one of the allegations was that aspiration planned at the hospital (OP) was postponed "without assigning any reason").
A doctor can choose a course of treatment of his/her choice but the same must be acceptable to medical science. (In this case, the patient had challenged the surgeon's decision to perform surgery for removal of gall bladder and piles together. The court rejected this allegation holding that performing both the operations in one sitting under single anesthesia was as per medical ethics and norms and was necessary for the healthy life of the patient).
Perform the indicated pre-intervention investigations.
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Breast enhancement surgery - Court suggests that both the patient/doctor ought to have measured the breast's size before the procedure
September 2016, 9(9):165-166
In certain treatments/procedures/surgeries where the outcome is subjective, especially aesthetic/cosmetic therapies, it is advisable or rather mandatory, to clearly document the patient's condition before as well as after the intervention/treatment. Take photographs in appropriate cases. (In this case, the patient had undergone breast enhancement surgery. Admittedly, the cosmetic surgeon (OP) did not record the actual dimension of the breast before performing the surgery. The patient pointed this shortcoming while alleging that the surgery was a failure as the expected results were not achieved. The court dismissed this allegation relying on the photographs in which the position before and after the operation was clearly shown; the photographs showed that there was considerable gain in the size of the breast of the patient. It would have been still better if the cosmetic surgeon (OP) had also recorded the size of the patient's breasts before and after the surgery).
Law is still not settled on the liability of hospitals that make their facilities available to doctors on rent. A written endorsement from the patient acknowledging and accepting the aforesaid arrangement is advisable. (In this case, the defence of the doctor-owner (OP) of the hospital where the cosmetic surgery was performed was that the patient had not consulted him and that he had merely provided his operation theatre (OT) to be used by the cosmetic surgeon (OP). The court has not commented on this aspect).
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Rising incidents of failure to screen pre-term babies for ROP (Retinopathy of Prematurity)
September 2016, 9(9):162-164
Ensure that premature babies are tested for retinopathy of prematurity (ROP) at the indicated period/interval. Record the aforesaid specifically. In this case, the court has defined the roles of doctors as: "It is the responsibility of the caring paediatrician to initiate screening (for ROP) by referring to an ophthalmologist and it is the responsibility of the ophthalmologist to do correct screening and treatment." On one hand, the Supreme Court has in one such case directed a government hospital to pay compensation of approximately2 crores, and on the other hand, such cases are on rise. Extra caution and vigilance is required in such cases.
Inform and caution the patient/attendants specifically regarding the potential risks/complications, especially the serious ones that may cause loss of life/limb. A general warning will not suffice. Greater the risk, greater is the responsibility of the doctor, and more detailed counselling is required. The fact that the patient was informed and explained about the risks must be written in the prescription, consent, discharge card, and such other medical records. (In this case, one of the allegations was that the patient's parents were never cautioned about the "risk of ROP before or after the delivery," whereas in defence, it was stated the patient's parents were regularly informed about the critical condition of the baby and possible neuro development, visual, and hearing sequel).
Progress sheets/bed-head tickets of indoor patients must record every detail of patient management. Failure to do so is negligence. (In this case, the court expressed doubts whether ROP screening was done or not. The court reasoned that "the progress sheet is devoid of details about ROP examination viz. who performed it, the method, instruments used and drugs (midrates/tropicamide)/anaesthesia used during ROP testing. The doctor has not mentioned any details of dilatation of pupil and findings of indirect ophthalmoscope findings, the intra ocular or extra retinal findings. Thus, it was a casual approach of OPs towards premature baby").
Nursing homes/maternity homes can perform delivery without having a neonatal unit. However, in critical cases patient should be referred to a higher centre for delivery. (In this case, the patient had delivered a 32-week-old premature baby and one of the allegations was that the gynaecologist (OP) was negligent as he had performed caesarean in his nursing home having no neonatal unit. The court rejected this allegation).
Failure to keep a paediatrician present in every case of delivery is not negligence.
Referral/transfer note must have the requisite details regarding treatment/hospitalization.
Provide complete medical records to the patient within 72 hours of receiving any such request.
Advise proper follow-up. This is all the more necessary in risky and critical patients.
Write medical records in legible handwriting. (In this case, the court drew adverse inference against the ophthalmologist (OP) and specifically observed about "some illegible handwriting noting").
The fact that free treatment was given to a victim of medical mishap is not very relevant in deciding medical negligence. (In this case, the hospital (OP) very specifically pleaded that free treatment of Rs. 50000 was provided to the patient, however, this fact was concealed from the court by the patient. The court was neither impressed by this contention nor did this have any bearing in holding the hospital (OP) negligent).
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