Women who took Topamax during pregnancy and gave birth to a child with birth defects may be eligible to file a lawsuit and receive compensation for their injuries.
In March 2011, the Food and Drug Administration issued a warning that pregnant women taking Topamax are significantly more likely to give birth to a child with oral cleft defects, such as a cleft lip or a cleft palate. The use of Topamax while pregnant may also increase the risk of other side effects, including spina bifida, persistent pulmonary hypertension of the newborn (PPHN), genital birth defects, limb malformations, hypospadias and other congenital birth defects.
Because cleft lips and cleft palates occur during the first trimester of pregnancy, many women may have continued taking Topamax while they were unaware that they were pregnant, putting their child at an increased risk of birth defects. Although oral cleft defects may be correctable with surgery, children born with these birth defects may suffer problems speaking or eating, and may face an increased risk of ear infections.
After studies showed that Topamax users may be up to 21-times more likely to give birth to a child with cleft lip or cleft palate, the FDA upgraded the drug to its Pregnancy Category D. Drugs which are labeled Category D are known to increase the risk of birth defects when taken by pregnant women.
In March 2010, the manufacturers of Topamax were forced to pay $80 million to settle claims by the U.S. Department of Justice that they had illegally marketed Topamax for off-label uses, including bipolar disorder, weight loss and alcohol dependency. Other Topamax lawsuits filed against the companies have alleged some doctors were paid to promote the drug to other physicians for these off-label conditions.
If you or a loved one used Topamax while pregnant and gave birth to a child with cleft lip, cleft palate or other birth defects, contact the lawyers at Hissey Kientz, LLP for a free legal consultation about your case. You can reach us by calling toll-free at 1-866-275-4454, or by filling out the free case evaluation form located on this page.