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Mother Sues Over False Negative Cystic Fibrosis Test

6 July 2009
Appeared in BioNews 515

A Scottish woman is suing Lothian Health Board for medical negligence after a cystic fibrosis (CF) test performed on her while pregnant produced a false negative result. The 41 year old woman from Edinburgh provided a mouthwash sample during her pregnancy in 1994, which tested negative for mutations in her CF gene. However, after her son was born in 1995, it was found that he had inherited the condition from her. Though the test was reported as negative, the claimant alleges that it was actually faintly positive and that due to the low quality of the sample the test procedure should have been repeated.

The mother seeks damages of £100,000 for harm caused by the hospital's mistake on the basis that, had she known that her son would suffer from the condition, she would have terminated the pregnancy. The original literature provided when the mouthwash sample was solicited stated that one person in 25 is a CF carrier, meaning they carry one copy of the defective gene but do not have symptoms of the condition; that where either parent identified as a carrier, further tests would be provided; and that 'If the result does show that the baby is going to have the disease, you may wish to consider termination'. In a procedural hearing last week Judge Lady Stacey stated that the fact that the leaflet had raised the option of termination, demonstrated the importance of the issue and the need for a full hearing.

The procedural hearing occurred as the board attempted to have the claim dismissed. As the test had been performed as part of a study by a scientist at the University of Edinburgh's Human Genetics Unit, and not by a member of staff at the Eastern General Hospital, the Lothian health board claimed that it had no responsibility for the false negative test result. The Edinburgh Court of Sessions, however, rejected this application on the basis that the hospital's responsibilities are not necessarily limited to those treatments it directly administers and the patient's expectations must be taken into account

While this sample had been analysed at the University, other samples in the program had been analysed by Lothian employees and it would 'be open to a patient to think the hospital, in offering a test, was offering to analyse any samples given'. The case will now progress to a full evidential hearing to ascertain whether the authority did owe the woman a duty of care in the provision of the test.

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