A legal case based on the use of Tropamax during pregnancy resulting in a birth defect is based on multiple factors.
Two factors are mandatory:
- (1) Use of Topamax: For a case to be possible, the pregnant women had to have ingested Topamax (or the generic version topiramate) after conception and during the first trimester. Careful review is necessary as the actual date of conception can never be precisely determined.
- (2) Presence of Cleft Lip or Cleft Palate or other craniofacial malformation: The child has to be born with a cleft lip, cleft palate, or both. A cleft lip or cleft varies from small notches in the lip to clefts that extend through the ridge of the upper jaw and the floor of the nostril/palate. Any factor that disrupts the normal embryonic facial development could result in a cleft lip or cleft palate forming.
While these first two are mandatory for a case, there are also other considerations that are taken into account. These factors are considerations:
- (3) Other medications: It is important to know what other medications the mother was on during pregnancy, if any. Polytherapy, the use of more than one AED, increases the risk of birth defects. Further, other medications may react with Topamax and cause birth defects also.
- (4) Family History: Find out if there is a family history of cleft lip or cleft palate. There is no exact explanation for why children are born with cleft lips and cleft palates and it is possible there is a genetic link. Generally, the cause is seen as multifactor and involving heredity and environment.
- (5) Other Toxic Exposures: Find out other potentially toxic exposures the mother had during pregnancy. These include, but are not limited to, alcohol use, cigarette smoking, other antiepileptic drugs (phenytoin, valproic acid), thalidomide, dioxin (pesticide), and retinoic acid. Also, find out whether there is any evidence of malnutrition during pregnancy.
All of this information will help in understanding the strength of a case and in understanding how a cleft lip or cleft palate happened. The more known about the background of the pregnancy and what else may have been involved, the better the case will be.