A woman who took Topamax recently won a $4 million jury award against Johnson & Johnson after her child was born with a cleft palate, which she argued was caused by her prescription. The jury found J&J negligent in failing to warn physicians and patients of the extent of Topamax’s birth defect risks. Topamax attorneys at Pintas & Mullins Law Firm hope that this case spurs momentum in the right direction for Topamax victims.
Topamax, also known as topiramate, is an anticonvulsant to treat migraines and epilepsy, and is produced by Johnson & Johnson’s unit Janssen Pharmaceuticals, which controls over 20% of the epilepsy drug market. In March 2011, the FDA revealed that infants born to mothers who took Topamax during pregnancy were about 21 times more likely to be born with oral cleft palates than infants whose mothers did not take the medication.
The FDA based its notification on an abundance of human data, subsequently labeling Topamax as a Pregnancy Category D drug. This means that there is positive scientific evidence that fetuses can be harmed by the drug, however, will remain on the market because of its potential benefits in some users despite the fetal risk. The labeling and patient medication guides were also changed in March 2011 to reflect this new data.
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Although the FDA required a label change in 2011, studies confirming this risk started emerging as early as July 2008. At that time, a study was published in the medical journal Neurology disclosing the very real and severe birth defects in Topamax newborns. An abstract of this study may be found here.
Since neither doctors nor patients were adequately warned about the dangers of Topamax, a slew of lawsuits have been filed against Janssen by mothers whose children now suffer from oral birth defects. Birth defects often require extensive surgeries and expensive medical treatments to correct, and families may be eligible to receive compensation for these medical expenses through a Topamax lawsuit, which, as we have seen, are succeeding in high numbers.
This most recent verdict was awarded to a woman who took Topamax for six months before giving birth to her son, who suffered a cleft palate. In her complaint, the woman argued that Janssen not only failed to warn her about the risk of birth defects, but also engaged in extensive marketing programs to promote Topamax for off-label use. Janssen actually paid the federal government over $80 million in 2010 due to similar off-label marketing claims.
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For women, a prescription to Topamax can be a double-edged sword, because it both decreases the effectiveness of contraceptives (such as oral birth control), and Topamax is most harmful during the first trimester of pregnancy, which is when many women have not yet realized they are pregnant. This makes Janssen’s knowing disregard to warn doctors and patients about the risks of birth defects particularly malicious and unconscionable.
If you were prescribed Topamax during pregnancy and had a child with any type of birth defect, a Topamax attorney can help guide you through the process of filing a legal claim and obtaining compensation for your medical bills, lost wages and emotional distress. Topamax lawsuits send Janssen a clear message that knowingly placing patients at risk to increase profits will not be tolerated.