PHILADELPHIA – On Friday, March 7, after a four-week trial interrupted by several winter storms, a 12-person jury awarded a 5-year-old girl $3 million for a severe bilateral cleft lip and cleft palate caused by the drug Topamax. The little girl has so far undergone 14 procedures, including four surgeries, to correct her birth defects.

The manufacturer of the drug, Janssen, a Johnson & Johnson company, argued that Topamax doesn’t cause birth defects, but that if it caused this one, the company had warned the infant’s mother, Kelly Anderson, that the drug may cause birth defects.

“Translate that,” said Kelly and Brian Anderson’s attorney, David Matthews, who gave closing argument. “J & J claimed they warned about something which they also said is not a problem. We didn’t buy any of that and neither did the jury.”

After the verdict, one juror spoke for many, if not all, “If you see signs during the sale of the drug that it is causing birth defects, you need to let doctors know.”

Topamax was prescribed to Kelly Anderson for migraine prevention.  All drugs have a pregnancy risk category that doctors use for prescribing medicines.  Although there were multiple red flags that Topamax caused birth defects in humans, Janssen did nothing to change the risk category, and doctors continued to prescribe the medication to women of child-bearing years. The FDA required Janssen to update Topamax’s warning label in 2011, three years after the Anderson child’s birth.

Janssen made more than $2 billion annually on Topamax, and lawyers for the Andersons  argued that profit was the motivation for the lack of a label change.

“This is justice for Kelly Anderson and her little girl,” said Mr. Matthews. “We proved to the jury that Johnson & Johnson knew the risks of Topamax and yet failed to warn her doctor of its dangers. We’re grateful that the jury was able to see through Johnson’s smoke-and-mirrors defense.”

The Case

Re Topamax Litigation Kelly Anderson and Brian Anderson v. Janssen Pharmaceuticals, Inc., F/K/A Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Topamax Jury Verdict for $3 Million – Wall Street Journal