Topamax Makers on the Hook for Baby’s Cleft Lip

(CN) - A couple whose child had severe birth defects is entitled to $11.6 million in damages from the makers of Topamax, the Pennsylvania Superior Court ruled.

Haley Powell was 18 years old in 2005 when she had an epileptic episode and lost consciousness. A neurologist treated the South Carolina woman with three different drugs, including Topamax, which combats epilepsy and migraines.

When Powell and her husband learned that they were expecting a child in late 2007, the doctors weaned Powell off Topamax.

An ultrasound revealed that Powell's child, Brayden, had a cleft lip. He was also born with gum line defects.

Though the baby underwent surgery to repair the cleft lip, it left him with a scar from his nose to his lip. He also is missing a tooth, has a speech impediment and becomes frustrated when people cannot understand him. The child's future could include rhinoplasty and gum-graft surgery.

Haley and her husband, Michael Gurley, sued Janssen Pharmaceuticals Inc., the manufacturers of Topamax, for negligence in Philadelphia County, Pa.

They alleged that Janssen failed to warn them and their doctors about the risks of Topamax relating to pregnancy.

A jury awarded the family $10.62 million for noneconomic loss, as well as $335,000 for future health care costs. The court later awarded another $700,000 for delay damages.

Janssen appealed, but the Pennsylvania Superior Court upheld the award last week. "The testimony showed that Dr. Warner was unaware of Topamax's increased risk of cleft lip and/or palate in newborns when he prescribed the drug to Haley, and that knowledge of this risk would have deterred him from prescribing the medication to her," the March 16 ruling states.

In upholding the $10.6 million non-economic damages award, the court credited the finding that "Brayden Gurley's pain, suffering and loss were significant and demonstrated on the record throughout the trial."

Senior Judge William Platt wrote the decision on behalf of a three-judge panel.

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