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Court sides with Topamax victims

Topamax_Birth_Defects.jpgA judge at Pennsylvania's Philadelphia County Court of Common Pleas recently affirmed a March 2014 jury verdict in favor of a child suffering from Topamax birth defects and her family. The ruling is but one instance in which Topamax victims prevailed over the maker of the drug, Janssen Pharmaceuticals.

The parents in Topamax lawsuits allege generally that their children suffer from birth defects that were the result of the mother's use of the prescription antiepileptic and migraine-treatment drug while she was pregnant.

In this case, one doctor or another prescribed Topamax for the mother's migraines throughout 2006 and 2007, while she was trying to get pregnant. The mother discovered that she was pregnant on the day after Christmas in 2007. A couple of days later, one of her doctors prescribed Topamax for the duration of the pregnancy. The couple did not know that their daughter had bilateral cleft lip and cleft palate until she was born in August 2008.

"Ever since her birth on August 17, 2008," the judge's ruling reads, the child "has undergone multiple surgeries to try to correct her birth defect, which affects her jaw, nose and lips. She has also had procedures involving hearing loss and has speech problems. She has been bullied in school because of her speech and appearance."

The couple filed a suit in Pennsylvania in December 2011 for negligent failure-to-warn and related causes of action. The suit alleged, among several claims, that the mother's use of Topamax while pregnant caused her daughter's birth defects. Moreover, the manufacturer failed to issue adequate warnings about the birth defects risk. The jury trial took place in early 2014.

The jury in March 2014 returned a verdict in favor of the plaintiffs, awarding $1.5 million to the minor for non-economic damages and $1.5 million to her parents to cover health care expenses through age 18.

Janssen appealed the verdict, attacking the failure-to-warn claim and asserting that one of the prescribing physicians should have known about the birth defects risk.

This is interesting because the mother testified that she was "unaware of the full extent of the risk of cleft lip and palate birth defects associated with Topamax use by pregnant women."

That makes sense. Frankly, although the U.S. Food and Drug Administration approved Topamax in 1996, the FDA did not even know about the risks to humans until years later. Science, not the drug maker, confirmed the birth defects risk in humans; hence, the FDA in 2011 announced, "New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy." The agency further would require commensurate changes to the drug's medication guide.

The jury in this case seemingly caught the manufacturer red-handed in not divulging what it should have known.

The judge who upheld the jury verdict wrote that the prescribing physician knew that "some birth defects had been reported in animal studies but there was no known birth defect risk of cleft lip and palate in humans. Ultimately, the jury believed that Janssen failed to disseminate known test findings in humans associating Topamax use by pregnant women with direct risk of birth defects."

The judge further wrote this: [The doctor] testified that she routinely studied medical periodicals in her professional practice and had seen no reports linking Topamax to birth defects for cleft lip and palate in humans at the time [the mother] became pregnant. She also testified that she would have read and respected Dear Doctor letters, journal articles and oral or written warnings from Janssen representatives telling her of the birth defect risk associated with Topamax among humans. She testified that no such information was given."

A mother who used Topamax while pregnant and had a child with cleft lip or cleft palate may want to discuss her legal options with an attorney. A law firm skilled trying pharmaceutical injury cases against drug companies is an option. 

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