The Claimant, the child JT, alleged that inadequate warning had been given by the neurologists at the Newcastle Upon Tyne Hospitals NHS Foundation Trust who were treating JT’s mother in 1998 concerning the risks and benefits of the anti-epileptic drug, Carbamazepine, particularly as the drug was being given for facial pain rather than as an anti-convulsant.

However, the Court concluded that, in 1998, the only risks which ought reasonably to have been appreciated by a competent neurologist, and of which the mother should have been informed, concerned possible structural (midline) abnormalities such as spina bifida and further that, as the drug was being given at 12/13 weeks gestation, then that risk was very small. Overall, therefore, reasonable advice would have been reassuring in tone. The Court concluded that sufficient warning/information had been given.

In any event, even if no advice had been given concerning the effect of the drug on the unborn foetus, the Claimant’s mother would have accepted the very low risk of structural abnormalities given the magnitude of her pain.

The Claimant was born with a range of minor structural abnormalities, including a VSD which closed after 10 months, unilateral talipes which was corrected by 7 months of age, an occult spina bifida and an extra renal pelvis together with glue ear and suspected patchy developmental delay. The Court heard evidence from geneticists as to the extent to which the medical literature is capable of establishing a sufficient association between any of the Claimant’s structural or other abnormalities to enable the Claimant to prove causation on balance.

The Court concluded that no sufficient causative link was established with the Claimant’s in utero exposure to the drug and that, therefore, causation was not established. Further that save for the Claimant’s talipes, those abnormalities which were sufficiently established within the evidence were not capable of amounting to “injuries” as they were of no clinical or functional significance (Grieves/Johnston considered).