Topamax is an FDA-approved medication designed to treat epileptic seizures and prevent migraines. Manufactured by Johnson & Johnson subsidiary Ortho-McNeil Neurologics, Topamax has been available to consumers since 2006.
Like most prescription drugs, the intention behind Topamax seems admirable: to relieve dangerous or uncomfortable health conditions and improve quality of life. However, in the case of Topamax, some pregnant women who took the drug during their baby’s formative first trimester now have children with serious oral cleft birth defects. Topamax is also implicated in cleft palate, cleft lip, spinal bifida, and other limb or facial malformations.
As of 2011, based on data linking the use of Topamax to significantly increased risk for oral cleft birth defects, the FDA began requiring new warnings on Topamax packaging and urging doctors to avoid prescribing the drug to pregnant women or any female of child-bearing age. However for some women, the warnings from Ortho-McNeil and the FDA came too late.
A pattern of negligence has been established. This isn’t the first time the pharmaceutical company has run into trouble with the Topamax product. In 2009, the drug manufacturer was fined $81 million in a lawsuit concerning false statements and “off-label” promotion of the medication (marketing the drug for uses outside of those implicitly stated on packaging).
Douglas & London has a history of representing innocent children injured in utero. Firm partner Stephanie O’Connor has successfully litigated cases of children born with limb reduction deficits linked to a pre-natal diagnostic test known as chorionic villi sampling or “CVS.” Because of her significant expertise in this litigation, Ms. O’Connor was admitted pro hac vice in several jurisdictions across the country, including Illinois, Minnesota, Oregon and California.
Additionally, Ms. O’Connor along with firm partner, Michael London, have extensive experience representing women injured and/or rendered infertile as a result of their exposure in utero to the devastating effects of Diethylstilbestrol (DES), a medication prescribed for women during pregnancy from the 1940s through 1971 which was conclusively linked to the development of a rare form of uterine cancer in fetuses as well as reproductive tract anomalies that interfere with a woman’s ability to conceive and carry a child to term.
Ms. O’Connor and Mr. London have also been actively involved in representing infants born with birth defects as a result of their exposure in utero to antidepressants, such as Paxil, Prozac and Zoloft.
If your child has suffered from an oral cleft-related birth defect as a result of Topamax use, there may be cause to file a Topamax Lawsuit. Call us to review your rights in this important pharmaceutical drug case.