Legal Matters

Safeguarding Against Legal Pitfalls

In this age of information and consumer rights, even a small mistake can make the radiologist-physician end up behind bars. By Sonal Shukla

Radiology seems to be a safer branch to practice as far as medico-legal issues are concerned. The occurrence of medico legal issues in radiology is less than five per cent. This is because a radiologist is not involved in treatment of the patient directly as any treating physician or operating surgeon would involve. "Treating physician or operating surgeon would decide which radiological investigations are to be carried out. Accordingly, patients are referred to a radiologist for the radiological investigations," explains Dr Milind Salunkhe, Advocate and Medico-legal Consultant and Chief, Symbiosis Medico-legal Cell, Pune.

Higher radiological investigations like CT scan or MRI scan are done as per the advice of the doctor. This is the main reason why medico-legal litigations are in small numbers as compared with the specialty branches like gynaecology, surgery, ophthalmology or anesthesia. One more reason can be the fact that patients come in contact with the radiologists for a very short time-span. Patients do not expect more from radiologist than to give correct reports. Patients getting dissatisfied in the radiology department are not as frequent as he may be in the wards or in private rooms during his/ her stay in the hospital.

However, increased awareness of the patient population about their rights and the rise in practice of invasive radiological procedures can lead to increase in medico-legal cases against radiologists. Thus, it is time to give a glance at the medico-legal aspects looming over this field.

The Problem Areas

According to experts, the key reasons for the occurrence of medico-legal cases in radiology are errors in reporting in diagnostic radiology, lack of informed consent, wrong labeling and issues created with the use of contrast media. Elaborates Dr Lalit Kapoor, Managing Trustee, Association of Medical Consultants (AMC), Mumbai and Founder of Medico-Legal Cell, AMC Mumbai, "Medico-legal issues in radiology could stem from allegations of not measuring up to the standard of care expected out of the radiologist, negligence and / or deficiency in service which leads to consequential damage to the patient and causing bodily injury and mental trauma to the patient, especially following diagnostic or therapeutic procedures conducted by the radiologist."

Agrees Dr Gopinath Shenoy, Obstetrician and Gynecologist, Medico Legal Consultant and Former Judge of the Consumer Court, "Medico-legal issues in the field of radiology are burning and more misused than used. It is misused because today at the drop of the hat patients run to the court. They feel that this is the easiest way to get money and there is harassment unnecessarily," says Dr Shenoy.

Experts believe that essentially the types of medico-legal issues occurring in field of radiology are no different than those occurring in any other branch of medicine. However, the fact that all reporting of findings is in writing (black and white) can often be an additional risk factor, thereby increasing medico-legal vulnerability.

Wrong Diagnosis

Wrong labeling of X-ray films has often resulted in consequent damage to the patient followed by claims for compensation. This type of case can be described as 'right diagnosis, wrong patient'. However, it can also be a case of 'wrong diagnosis, right patient.' "For instance, a radiologist missed a lung lesion in a chest X-ray. This was diagnosed by another radiologist subsequently. An X-ray of fracture talus was reported as normal. Such cases could lead to malpractice litigation," avers Dr Kapoor. In another instance, a sonologist missed congenital anamolies in antenatal USG and a malpractice claim followed.

Not just gathering good clinical information but also proper labeling of films is very important. An MRI technician wrongly labeled the site of lesion in a case of a spinal tumour. He marked L-2 vertebra as L-3. The radiologist reported accordingly and the neurosurgeon operated accordingly with predictable results. Patient had to be re-operated to remove the tumour at the correct level. Relatives filed a complaint in the consumer forum claiming compensation. "It is a human error but still the onus happens to be with the consultant radiologist," states Dr Bhujang Pai, Head- Radiology, PD Hinduja Hospital, Mumbai.

He feels that one should stress upon having double checks in place where the technician who is doing it will verify it properly. "We have an application in PACS system wherein when the patient comes with the voucher number, immediately his name is entered, so we are sure that it is only his history coming to us," Dr Pai adds further.

If adequate care is not taken while performing the procedure or reporting, it can be a case of deficiency in service/ negligence.

Pregnancy Matters

A newly married young lady was referred to a radiology clinic for X-ray of paranasal sinuses. Her urine pregnancy test done the same day had tested positive. The X-ray technician was made aware of that fact. Still, the X-ray was duly taken. Later on, a gynaecologist passed adverse remarks on such an X-ray being taken and advised termination of pregnancy in view of risk of foetal abnormalities due to X-ray exposure. The lady was devastated and reportedly suffered severe mental trauma following the Medical Termination of Pregnancy. The couple blamed the radiology clinic and claimed compensatory damages.

Experts emphasise that all radiology clinics need to sensitise their staff on this issue. If X-ray examination is inevitable, suitable safeguards should be adopted and even non-medical staff such as receptionists ought to be made aware. Says Dr Ravi Ramakantan, Prof of Radiology, KEM Hospital, Mumbai, "There are certain protocols that needs to be followed, before we examine ladies in the child-bearing age group. The registrar is supposed to know as to when she had her menstrual period and whether they are expecting a baby or not. If this is not done and there is inadvertent radiation to the abdomen, the patient can sue the radiologist saying that he/ she has produced harm to the foetus and she would be justified."

Ultrasound

When a radiologist does an ultrasound, no matter how careful he or she is, there are certain anomalies which are not seen or are difficult to be seen, for example- missing part of finger, or baby with extra thumb. "Some defects are not always seen even if they are present. So, normally we will put a disclaimer in the report that though no anomalies are seen on this scan at this time - that does not mean that there is no anomaly. But the court usually does not accept this disclaimer," laments Dr Ramakantan.

The types of medico legal issues occurring in the field of ultrasound are mainly related to misinterpretations and misdiagnosis. This occurs mainly in obstetrics scans for foetal anomalies. "This often happens because patients come at wrong gestational age for scanning and fail to realise the limitations of this technique," shares Dr Nitin Chaubal, Consultant in Ultrasound, Jaslok Hospital, Mumbai.

Agree to Disagree

A number of medico-legal problems have occurred because of lack of informed consent and incomplete pre-procedure explanation to the patient. "If the informed consent is not properly obtained then in that case, the patient can sue the doctor," opines Dr Suganthi Iyer, Assistant Director -Medical, PD Hinduja Hospital.

As shared by Dr Kapoor, a radiologist did a transvaginal sonography without taking informed consent and without explaining the procedure. He received a legal notice from the patient making several allegations. In another instance, a radiologist had to face litigation because he did transvaginal USG in an unmarried patient without proper consent.

The risks in interventional radiology are absolutely the same like any other surgery and in addition there is a radiation issue. Informed written consent is required in procedures like MR, CT scan with contrast,Form -F under PNDT Act for USG in pregnant women and section of DSA. Under the Indian Contract Act, if it is an invasive procedure, a written consent should be taken. "In invasive procedures like CT scan, MR where there is a contrast media used or if there is an image-guided intervention under USG/CT where a procedure is to be performed like biopsy,aspiration,FNAC,etc., consent is mandatory as such procedures can result in adverse reactions and complications. While in minor procedures like plain X-ray and plain ultrasound, a verbal consent is definitely required," shares Dr Iyer.

Allegations of sexual molestation

A number of radiological procedures are done in a dark room. Radiologists sometimes face allegations of sexual molestation of female patients. This generally occurs if radiologists do not take the precaution of having a female attendant whilst doing the procedure.

Matters of Negligence

"Higher degree of care and caution is expected from the medicos while rendering medical services to the patients. It is the legal duty of every doctor to provide medical services to the patient with utmost diligence and care, otherwise it would amount to negligence," shares Dr Salunkhe.

Medical negligence basically has two elements - omission and commission. In the case of the latter, it means that a medical practitioner would have done something in the same circumstance which a prudent doctor would not have done so. While in omission, it means a medical practitioner would not have done something in the same circumstance, which a prudent doctor would have done. "If adequate care is not taken while performing the procedure or reporting, it can be said to be deficiency in service - negligence," says Dr Iyer. An aggrieved or affected patient or his relatives can approach Criminal Court directly against the concerned doctor, if a negligence occurs which can be gross or severe in nature.The aggrieved patient can approach Criminal Court or consumer forum at the district level or at State or National Commission, depending the quantum of compensation claimed from the negligent doctor.

Anaphylactic Reactions

Radiologists ought to be prepared for emergency situations whereby patient gets anaphylactic reactions to contrast media, in spite of such cases being rare. "When you inject this contrast, patients can get severe reaction to that, so it becomes very important that we use non-ionic contrast media vis-a-vis ionic contrast media. Ionic is a cheaper version and non-ionic is a costly version. Ionic has got higher percentage of reactions as compared to non-ionic. Therefore, by rule almost all institutes now use non-ionic contrast media. We explain to the patients that it is in their interest because it is much safer, but that does not again mean that it is 100 per cent safe," explains Dr Pai.

Basically, contrasts are substances that are used to enhance the contrast of structures or fluids within the body in medical imaging. They are commonly used to enhance the visibility of blood vessels and the gastrointestinal tract. Interventional radiologists could face problems similar to surgeons or other invasive specialists due to possibility of iatrogenic complications.

Related to The PNDT Act

The Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st January, 1996, in order to check female feticide. Radiologists who contravenes the provisions of this Act is punishable with imprisonment and fine. "Radiologists need to exercise maximum caution in doing antenatal USGs. Provisions of the Act are draconian and could cause numerous medico-legal hassles," says Dr Kapoor.

On a Positive Note

Today, the advent of advanced technology in the field has made the results more accurate. Availability of high-end ultrasound machines and awareness of carrying out sonography at the right time in pregnancy has improved diagnostic accuracy. "Human error is bound to happen but the issue is that when you have good quality X-rays, good clinical information to support you, then it will go a long way in minimising the issues in radiology," concludes Dr Pai.

sonal.shukla@expressindia.com