A pair of twins were born with congenital defects after their mother had been prescribed Depakote during pregnancy. Suffering from Bipolar disorder, the mother had checked with her neurologist to see whether she ought to continue her prescription while she was pregnant. The doctor allegedly confirmed that she should, and even decided to increase her daily dosage over the course of her pregnancy. When the twins were born with defects including hypospadias and cleft palates, the mother sued her doctor for negligence. During the trial, an expert in Food and Drug Administration regulation was asked to discuss the proper approval and labeling requirements for Depakote.
Question(s) For Expert Witness
1. Can you discuss the FDA Approval Process and Labeling Requirements for pharmaceuticals such as the drug in this case?
Expert Witness Response E-010153
I have served as an expert on cases like this and was deposed in a case involving the labeling requirements for drugs that treat heartburn. A number of things are puzzling about this case. Firstly, the doctor would certainly be liable if he used the drug contrary to its labeling; secondly, I am unsure why he would increase the dosage assuming the patient's weight gain was primarily attributable to the pregnancy. I would be happy to discuss this case to clarify these points and would be available to review the matter.
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