Topamax is an anticonvulsant medication manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The drug is prescribed to patients as a treatment for epilepsy and as a method of preventing migraines. The drug accounts for approximately 21 percent of epilepsy medications prescribed and sold to patients and had U.S. sales in excess of $10 billion by 2008.
Unfortunately, while Topamax promised many benefits to patients in its marketing products, including benefits for treatment of off-label uses such as bipolar disorder and dependency on alcohol, the drug has turned out to also have some very serious side effects. When women take Topamax while pregnant, it can have an adverse impact on fetal development and cause serious birth defects in infants. Patients who believe that they should have been warned about these risks and whose children developed birth defects have filed Topamax lawsuits to try to recover compensation for their losses. Topamax attorneys at the Law Offices of Jeffrey S. Glassman can help you to make a claim for damages.Topamax and the Risk of Birth Defects
One of the most common birth defects developed by infants exposed to Topamax during fetal development is an oral cleft palate. In March of 2011, the FDA released a warning, alerting those taking Topamax to the fact that their children had a 21 percent greater risk of an oral cleft palate if the drug was taken during pregnancy as compared with children born to mothers who did not take Topamax.
Topamax may also be linked to other birth defects as well, including:
- Defects in lung development
- Heart problems
- A penile defect called hypospadias
- Malformation of limbs
- Spina bifida
Janssen Pharmaceuticals knew or should have known about the risk of birth defects due to Topamax use at least as far back as 1997, when animal studies suggesting an increased risk of oral cleft palates. In 2008, a study in the Neurological Medical Journal also raised the issue of birth defect dangers. However, even after mounting evidence came to light on the risks to fetal development, Janssen did not provide accurate and adequate information about Topamax. Instead, the company chose to mount an aggressive campaign encouraging doctors to prescribe the drug off-label for non-approved uses.
In 2010, Janssen Pharmaceuticals, which was known as Orth-McNeil at the time, pled guilty to this illegal off-label marketing and paid fines exceeding $80 million, including a fine of around $75 million to resolve a case pending under the Federal False Claims Act.
While this settlement may have resolved Janssen Pharmaceuticals problems with the federal government for its marketing practices, there were still many patients who had children with birth defects because of Topamax use. Patients who use the drug began to file lawsuits against Janssen Pharmaceuticals and many were successful, including several families awarded multi-million dollar verdicts in late October and early November of 2013.
Plaintiffs who seek compensation from the pharmaceutical company will have the burden of proving that Topamax was the direct cause of the birth defects their children experienced. Janssen Pharmaceuticals continues to deny responsibility and claim that cleft palates are simply common defects with no link to the use of the medication.
At the Law Offices of Jeffrey S. Glassman, we know that defective drug cases like those involving Topamax birth defects can be complicated cases to win. Our attorneys have a network of medical professionals and other industry experts who can testify on your behalf and help prove your case. Our attorneys also have extensive experience representing those injured by all different types of defective drugs, including Topamax.
Call or contact us online today at (617) 367-2900 to learn more.