Topamax Cleft Lip Lawsuit Results in $11M Jury Award

For the second time in the past month, Johnson & Johnson has been ordered to pay damages for birth defects caused by Topamax, after a Philadelphia jury found that side effects of the seizure medication used during pregnancy caused a child to be bron with a cleft lip, nasal deformities and other medical complications.

Johnson & Johnson and their Janssen Pharmaceuticals subsidiary currently face more than 130 Topamax lawsuits brought on behalf of children who have suffered birth defects or malformations, with the first cases now reaching juries in Pennsylvania state court.

Following an award of $4 million late last month, a second Philadelphia jury has awarded $11 million in damages in a case brought by Haley Powell, a stay-at-home mother whose son, Brayden, was born in 2007 with a cleft lip and other deformities that may require at least five surgeries before the age of 21.

According to allegations raised at trial, Janssen withheld important safety information abut the Topamax pregnancy risks and concealed information from consumers and the medical community.

On October 30, the first Topamax trial in the country ended with another jury ordering the drug makers to pay more than $4 million in a case filed by April Czimmer, whose son Blake was born in 2007 with numerous birth defects from Topamax. Czimmer alleged at trial that she took Topamax for roughly six months during her pregnancy and was never provided adequate warnings about the potential for the medication causing unborn children to develop malformations and birth defects.

Topamax (generic topiramate) was approved by the FDA in 1997, and it has been available as a generic since 2006. It is approved for the treatment of epilepsy, migraines and to promote weight loss.

Johnson & Johnson has maintained that adequate Topamax warnings were provided. However, in March 2011, the FDA issued a warning about the Topamax oral cleft birth defect risk among babies born to mothers who took the drug during the first trimester of pregnancy. The FDA has urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.

Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.

These early trial dates are designed to help the parties gauge how juries may respond to evidence and testimony that may be repeated throughout other cases, potentially facilitating further Topamax settlement negotiations to resolve the litigation without dozens of individual trials.