With affected families urged not to let Topamax manufacturer Ortho-McNeil, a subsidiary of Johnson & Johnson, get away for not issuing an early warning about the birth defects linked to the anticonvulsant, Topamax lawsuits are expected to be on the rise. This would not be the first time for Johnson & Johnson should the lawsuits reach the court, as last year it paid a fine of $81.5 million after pleading guilty to promoting Topamax for unapproved uses. As
Ortho-McNeil faces charges of illegal marketing practices for another drug, Topamax may be the least of Johnson & Johnson’s problems.
For issuing a warning on the drug’s potential for fetal risk only March this year, roughly 15 years after Ortho-McNeil began marketing Topamax for epilepsy treatment, Topamax lawsuits could hinge on this fact. Since 2007, more than 32 million Topamax prescriptions have been filled, according to the data from the FDA. Unfortunately, millions of women may have taken Topamax during pregnancy in the 15 years that the anticonvulsant was listed as a Pregnancy Category C medication, without knowing the associated risks.
The
US Food and Drug Administration (FDA) had elevated the classification of Topamax to Pregnancy Category D, which means there is positive human evidence of the drug's potential to cause serious harm to a fetus when taken during pregnancy. The change in classification was prompted by several studies suggesting that pregnant women undergoing the Topamax treatment is exposing their infants to the risk of developing birth defects such as:
* cleft palate
* cleft lip
* heart defects
* lung defects
* brain defects
* arm and limb defects
What prompted studies in the US was a similar data from the United Kingdom Epilepsy and Pregnancy Register which was published in the journal Neurology in 2008, which according to the FDA supported the US findings. However, instead of taking notice, Ortho-McNeil and Johnson& Johnson waited for FDA promptings only this year to update the warning label on the Topamax packaging to include the birth defects risk. Patients who have taken Topamax during pregnancy may be eligible to receive compensation to cover medical expenses, pain and suffering resulting from medication-related birth defects via a
birth defects lawsuit or a Topamax lawsuit.
