Is it always negligent to miss a significant fetal anomaly on a routine ultrasound scan at 20 weeks?

Consumer Commission Order

Judges: Retired Justice Sunil Hali and retired District and Sessions Judge DK Kapoor

Complainants: Seema Kumari and her husband Atish Kumar

Allegations

Dr KC Sharma and his wife Dr Uma Sharma were running an ultrasound scanning centre and nursing home at Udhampur “without adequate qualification, expertise and recognition from Medical Council of India”.

Missed

Hydrocephalous; it could have been detected earlier, if the sonographers/sonologists were experienced and suitably qualified.

Expert’s opinion

Dr Manisha Langer, a qualified radiologist, told the commission that myelomeningocele can be detected by ultrasound within 15 to 16 weeks of pregnancy. The detection rate improves after 24 to 25 weeks.

Result of missed diagnosis

The pregnancy could not be terminated

Compensation awarded

Rs 20 lakh compensation to the couple for medical treatment; out of this, Rs 15 lakh to be kept in a fixed deposit for the child.  Rs 15 lakh was awarded as compensation on account of pain and suffering undergone by the parents, and Rs 1 lakh as litigation charges.

Discussion

Sonographic diagnosis of open spina bifida typically occurs during the second trimester of the pregnancy.

Modern ultrasound equipment is undoubtedly capable of producing images that allow diagnosis of anomalies such as open lumbosacral spina bifida or atrioventricular septal defect. However, such diagnoses can only be made if considerable operator skill is combined with knowledge and experience.

In most cases the diagnosis of clinically significant fetal anomalies is quite straightforward, but evidence suggests that false-negative results occur regularly.

For example, European Surveillance of Congenital Anomalies (EUROCAT) (Ultrasound Obstet Gynecol. 2005;25:6-11) quotes a prenatal detection rate for spina bifida of only 68%, whilst a recent systematic review (Health Technol Assess. 2000;4:1-193) reports a detection rate for AV septal defect of just 42%. So, 32% doctors can miss the diagnosis at 20 weeks.

Was missing the diagnosis negligence?

Is it always negligent to miss a small open lumbosacral spina bifida (below L3) at a routine 20-week scan without extenuating circumstances (obesity, oligohydramnios)?

• About 62% of experts state that it is not negligent to miss such a lesion.
• 24% say it is not negligent to miss a small spina bifida provided there is documented evidence of normal intracranial anatomy (absence of head signs).
• Only 4/29 experts will say that such an anomaly should always be detected.

Was termination the choice if the diagnosis would have been done before 20 weeks?

No. Spina bifida is a manageable condition. It is not an indication of termination by itself. Higher lesion level, larger segment span and an inter-pediculate distance greater than 10 mm are associated with poor recovery.

What was the cause?

Probably folic acid not taken by the mother before the conception

Legal points

• Doctors should take informed consent from the patient that ultrasound can miss the diagnosis.
• Was she and if not, why was she not given folic acid?
• If she was not on folic acid, then why was the ultrasonologist not alerted to specifically look for spina bifida?
• One expert cannot be relied upon, if other experts or opinion say it otherwise.

 Answer: This judgment should be challenged

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA