First Topamax Trials

David Matthews of Matthews & Associates in Houston and Tim Goss of Freese & Goss in Dallas are scheduled to try the first Topamax trials in the country, in the First Judicial District of Pennsylvania – in Philadelphia – beginning the first week of September.

Both cases will be tried against Janssen Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson. Plaintiffs allege in both cases that their child was born with birth defects caused by their mother’s having taken Topamax during the first trimester of pregnancy. Both petitions accuse the company of failing to properly warn of the increased risk of birth defects.

One plaintiff, the mother of a child born with a cleft palate, is a 31-year-old woman from Milwaukee, Wisconsin; the other woman with an injured child is a 36-year-old from Killeen, Texas. The children of both women have already undergone several surgeries to treat their birth defects, and are scheduled for more.

Plaintiffs are currently in the discovery phase, performing research, securing company records of clinical trials’ designs and results, gathering history of the company’s communications with FDA regarding Topamax, depositioning Johnson & Johnson’s scientific experts, and hiring experts of their own, among other preparations.

“We think we’ve got the evidence we need to prove our cases and demonstrate Johnson & Johnson’s liability,” said attorney David Matthews. “They’ve got the deep pockets needed to roll the dice and take our clients on; so they are. We’ll be ready.”

While Topamax may be effective in the treatment of epilepsy or migraine headaches, side effects associated with the drug can be severe if it is taken during pregnancy. Birth defects include:

cleft palate

cleft lip

heart defects

lung defects

brain defects

arm and limb defects

Sleepiness, Fatigue, Lethargy

New York Times story  in March 2011 trumpeted FDA warnings of Topamax raising the risk of birth defects.