The eye is a delicate part of the body and any medical issues related to it must be handled with the utmost care as any damage to the eye may lead to long-term and serious consequences for a patient. Hence medico-legal cases are not uncommon due to the significant impact ophthalmological surgery can have on patients’ lifestyles. Majority of the cases of Medical Negligence in ophthalmology are due to two reasons:
Improper Medical Records
Unexpected outcomes following laser, cataract and lens exchange surgery – one of the precipitating factors are dissatisfaction with the consent process
Failures and delays to diagnose – these include alleged missed retinal detachment, delay in referral for diagnosis of glaucoma and alleged failure to diagnose the cause of deteriorating vision
Poor manner and attitude during a consultation – these include being unhappy with their ophthalmologist’s manner and attitude, rudeness during the consultation and receiving inappropriate comments made by their specialist
It is defined as “Voluntary agreement, compliance, or permission for specified act or purpose”. The Indian contract Act Section 13, states “two or more persons are said to consent when they agree up on the same thing in the same sense”.
Medical practitioners should sign consent before examination and treatment. If they treat or operate without consent will be considered as an internal interference with the patient's body without legal sanction. This in turn is equivalent to assault for which patient can legally claim for damage
Consent is to be obtained from conscious, mentally sound adults, or from the parent of a child who is less than 12 years of age. Consent is not necessary if the patient is in coma and need emergency treatment
A medico legal case referred by a court of law for examination also doesn't need consent
For a consent to be called as valid it should be free, voluntary, clear, intelligent, informed, direct & personal
A consent is said to be as informed when the following points has been explained to the patient by the treating doctor in the language he/she understands:
1. About disease he/she is suffering 2. How the disease was/will be diagnosed 3. Details of the treatment plans 4. Possible side effects & risks involved 5. Approximate cost of the treatment 6. Alternative methods of treatment other than what is planned
When the doctor has explained all the above points, it is very important to take either patient's signature or his/her thumb impression on the consent form
Doctors should take consent only in written form and not as oral as in unexpected cases it will be like a documented evidence in the court of law. The concept of obtaining general consent (Blanket consent) from the patient at the time of admission in the hospital is wrong and it has no value in the court of law if suppose any litigation arises. Consent must be specific for every procedure
Medical record is a document, chronologically mentioning the patient details, history and complaints, examination findings, investigations result, medication and day to day progress report. In the hospital setup it is the responsibility of the treating doctor, nurses and medical record section to safely maintain the patients' medical record.
Under the directorate general of health services guidelines published in hospital manual the responsibility of hospitals to keep safely the medical records is a) For Outpatient Department Patients: 5 years b) For Inpatient Department Patients including Medico-legal Cases: 10 Years
Without the patient's consent, findings from the medical record should not be used for educational conferences or publications. Only for statistical purpose the hospital has the right to use the patient's record finding even without the 6 consent of the patient
Nothing should be omitted from the patients' medical record and no tampering should be done
Any Correction should have the corrector's initials
Original documents should never be given to the patient on his/her demand instead a copy of medical record can be given at the cost of copying charges
Police do not have right to demand for the medical record except when there is statutory provision for such requisition
SECTION 320 IPC IN OPHTHALMOLOGY
Section 320 of Indian Penal Court defines grievous hurt. The following kinds of hurt only are designated as “grievous”: 1. Emasculation 2. Permanent privation of the sight of either eye 3. Permanent privation of the hearing of either ear 4. Privation of any member or joint 5. Destruction or permanent impairing of the powers of any member or joint 6. Permanent disfiguration of the head or face 7. Fracture or dislocation of a bone or tooth 8. Any hurt which endangers life or which causes the sufferer to be during the space of twenty days in severe bodily pain or unable to follow his ordinary pursuits
Points to Remember
To call a hurt as grievous it is not necessary that both the eyes should be affected at a time as Section 320 uses the word “either eye”
Hurt should be permanent and it does not always mean that the victim should be blind with 100% loss of vision after the injury. Even when the sight becomes 6/9 from 6/6 as a result of some hurt, it will be called as grievous hurt
TIPS TO MINIMIZE RISK
Ensure your surgical technique is regularly updated and in line with current best practice
Understand the patient’s concerns and expectations
Be honest and let your patient know if the surgery can give them the result they want or not
Explain what the procedure will involve, the likely results, and pot treatment advise and follow-ups
Discuss the possible benefits and risks of all potential treatment options
Explain what you would do to correct complications, or if you failed to meet their expectations
The patients should be given clear information about the costs involved
Never pressurise or rush patients into giving consent to have surgery
Double-check that the information has been understood and decisions are fully informed
Clearly document all the steps to provide evidence of a detailed interactive discussion; this is vital for legal purposes
Perform pre-surgical, verbal ‘time-out’ checks against medical records of:
the eye to be operated on
the proposed procedure
(for implants) implant make, model and dioptric power and spherical equivalent refractive target
(for laser refractive surgery) the programmed treatment sphere, cylinder, axis and spherical equivalent refractive target
FACTS: A patient who was treated by Dr. Sunil for trouble with his right eye in December 2015 and January 2016. During the administration of the second injection, the patient complained of pain and vision loss.
CLAIM OF THE COMPLAINANT: Claiming negligence on the part of the doctor, the patient approached the consumer forum alleging that the needle penetrated in the patient’s eye deeper than necessary, causing temporary vision loss.The patient alleged before the Court that the doctor was engrossed in a conversation with the anaesthetist present in the operation theatre while injecting his eye, hence leading to the injury. He further claimed that the doctor had given him Avastin injection despite Avastin being banned by the central government during the time. He alleged that his other eye was also affected by the use of Avastin.
DEFENSE OF THE DOCTOR: Denying the allegations, the doctor asserted that the patient was actually suffering from cataract. He contended that the patient was also mistaken about the use of Avastin after the Nagri Hospital episode. The doctors maintained that the trouble did not occur due to the Avastin injection but due to the vitreous haemorrhage, as a blood vessel may have been damaged, and the patient was treated for the same.
COURT HELD: The Court held that the doctor admitted that the vitreous haemorrhage had been caused due to the deeper penetration than necessary penetration of the needle, which amounts to negligence and deficiency in service. The forum then directed the ophthalmologist to pay a compensation amount of Rs. 1 lakh with 8% interest to the patient along with legal costs of Rs. 5,000 for the pain and extra expenditure incurred.