The Food and Drug Administration has warned the public of an increased risk of cleft lip and cleft palate in infants born to women treated with Topamax during pregnancy. This warning about serious adverse side effects to unborn children from the drug Topamax will have a definite impact on litigation. Ortho-McNeil’s Topamax is approved by the FDA for the treatment of epilepsy and migraines. It was reported that the incidences of cleft lip and cleft palate are 21 times the normal rate of those birth defects.
In March, the FDA issued a warning letter and placed Topamax in Pregnancy Category D, meaning that pregnant women who take the drug are at high risk for developing serious birth defects. Based on the number of folks diagnosed with oral cleft conditions and the number of Topamax users, I’m fairly certain that a large number of suits will be filed. Both Topamax and its generic alternatives have been widely promoted for off-label uses like weight loss and alcohol and drug dependency. As a result, it’s difficult to know exactly how many people actually used the drug. There are about a dozen generic manufacturers of this drug. Manufacturers are spread across the United States in states that include Florida, New Jersey and West Virginia.
Last year, Ortho McNeil’s parent company, Johnson & Johnson, pled guilty to a misdemeanor under the Food, Drug and Cosmetic Act and paid a $6.14 million criminal fine for promoting the off-label use of the drug for non-approved uses such as weight loss, alcohol dependence, eating disorders and mood and anxiety disorders. In addition, another subsidiary of the company agreed to pay more than $75 million in a False Claims Act suit alleging it illegally promoted Topamax and caused false claims to be submitted to the government for unapproved uses.
Source: Lawyers USA Online
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