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Posted by Marilyn McGoldrick on Nov 5, 2013 3:30:00 AM

Johnson & Johnson’s Janssen Pharmaceutical unit has been ordered to pay $4.02 million in a lawsuit claiming its anti-seizure drug Topamax was responsible for a child’s birth defect, a Philadephia jury said last week.

Jurors in the state court case found for the plaintiff, April Czimmer, who took the drug for six months while pregnant and gave birth in 2007 to a boy with a cleft lip. Czimmer took the drug from August 2006 until February 2007 to treat her migraines. This kind of birth defect, known as “oral cleft,” range from a small notch in the lip to a groove that runs the length of the roof of the mouth and nose.

Czimmer’s case is the first of about 134 Topamax cases pending in state court in Philadelphia . Another Topamax trial began this week in South Carolina, this time concerning a five-year-old boy who was also born with a cleft lip.

Topamax, approved by the U.S. Food and Drug Administration (“FDA”) in 1996, was one of Johnson & Johnson’s best-selling drugs before it lost its patent protection in 2009.

On March 4, 2011, the FDA warned that studies suggested Topamax could contribute to cleft palate birth defects in children born to women that had used the drug during pregnancy. The FDA asked J&J to update its label to reflect a stronger warning for the drug.

Only FDA approved for anti-seizure purposes, the lawsuits brought against Johnson & Johnson claim that Janssen and its predecessor, Ortho-McNeil Pharmaceutical, aggressively promoted Topamax for off-label, non-approved uses since at least 2001. Off-label uses include weight loss, treatment for anxiety, migraines, sleep apnea, diabetes and substance abuse, according to court papers.

Janssen aggressively advertised and sold Topamax for these off-label uses “without any valid scientific evidence” that supported the use of the drug for the treatment of such ailments, according to the master complaint. Janssen said it would appeal the jury’s verdict.

Thornton Law Firm attorneys represent victims of drug and chemical-related birth defects. Thornton Law Firm lawyers have spent decades representing children and families who have been injured by birth defects caused by pharmaceutical drugs such as Paxil, Prozac and other SSRIs, and exposure to toxic substances including glycol ethers, pesticides, and solvents that are hazardous to reproduction. If you have a question about your legal rights, call David Strouss or Marilyn McGoldrick at Thornton Law Firm 1-888-341-1405.