Hundreds of lawsuits and a warning from the U.S. Food and Drug Administration (FDA) have linked the anti-seizure drug Topamax to an increased risk of birth defects like cleft palate and cleft lip when taken during pregnancy.
If you took Topamax during your pregnancy to treat seizures or migraine headaches and your child suffered birth defects, you may be able to file a Topamax lawsuit to pursue compensation for your child’s current and future medical bills and other damages.
O’Connor, Acciani & Levy’s defective drug lawyers are prepared to manage every aspect of the legal process to help you obtain the compensation you deserve and to hold the manufacturer accountable. We offer a free, no obligation legal consultation and do not charge legal fees unless you obtain compensation at the end of the legal process through a favorable verdict or settlement.
FDA WARNING ABOUT TOPAMAX
Topiramate, also known by the brand name Topamax, is in a class of drugs called anticonvulsants, which are used to treat seizures. Topamax is used to treat the following types of seizures in adults and children two years old and older:
- Partial onset seizures
- Primary generalized tonic-clonic seizures
- Seizures associated with Lennox-Gastaut syndrome
Topamax is also prescribed to treat migraine headaches in people 12 years old or older.
From January 2007, through December 2010, more than four million patients filled topiramate prescriptions and approximately 32.3 million topiramate prescriptions were dispensed.
However, the drug can have severe, potentially life-changing side effects, such as birth defects. On March 4, 2011, the FDA released a drug safety communication alerting doctors and consumers that Topamax could increase the risk of cleft lip or cleft palate in infants born to women who took the drug during pregnancy.
The communication also alerted patients and doctors that the drug would now be classified as a pregnancy category D drug, since there was positive evidence of a risk to the fetus.
The drug safety communication cited statistics from the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The NAAED data revealed that 1.4 percent of infants exposed to topiramate during the first trimester of pregnancy were born with oral clefts. This is compared to between 0.38 percent and 0.55 percent of infants exposed to other antiepileptic drugs and 0.07 percent of infants whose mothers were not being treated for epilepsy.
According to data from the pregnancy registry, infants who were exposed to topiramate have a 21.3 percent risk of oral clefts compared to a background group of women who were not treated for epilepsy.
The United Kingdom Epilepsy and Pregnancy Register also reported 3.2 percent increase in oral clefts among infants exposed to topiramate. This is a 16-fold increase compared to the risk in the background population of untreated patients.
FDA ADVICE TO PATIENTS AND DOCTORS
The FDA communication says women who are taking topiramate and not planning a pregnancy should use effective birth control. They should also talk to their health care provider about the best kind of birth control to use while taking topiramate – birth control containing estrogen could have decreased effectiveness in women who are taking topiramate.
Women who are pregnant or planning to become pregnant should tell their doctor before taking this medication. This way you can discuss other treatment options and the benefits and risks of taking this medication during pregnancy.
Patients should not stop taking Topamax before talking to a health care professional because it could cause serious problems. Failing to treat epilepsy during pregnancy can cause severe harm to women and their fetuses.
The FDA communication tells doctors to inform patients of the research on the increased risk of oral clefts, particularly patients who are of childbearing age.
If you took Topamax before this warning came out and your child had cleft palate or another type of oral cleft birth defect, contact our attorneys about filing a Topamax lawsuit.
The FDA warning led to more than one hundred lawsuits against Janssen Pharmaceuticals, Inc., the manufacturer of Topamax. These lawsuits claimed the company failed to adequately warn doctors and patients about the risk of birth defects, particularly because the drug can decrease the effectiveness of contraceptives.
Many of these Topamax lawsuits were filed in the Philadelphia Court of Common Pleas’ mass tort program. By 2013, there were more than 130 pending lawsuits in the Topamax docket.
The first case to go to trial was filed by a mother who took Topamax for migraines during her pregnancy. Her son was born with cleft lip and cleft palate.
In October 2013, the jury held Janssen Pharmaceuticals liable for failing to warn about the risk of birth defects. The child was awarded approximately $4 million in damages, including $562,184.68 for future health care costs and $3,440,000 for pain and suffering. This ruling was upheld on appeal in 2015.
The next month, another case resulted in a verdict of approximately $11 million for a boy born with a cleft lip that caused nasal malformations. This verdict included $10,620,000 for non-economic losses and $335,000 for future health care costs. Janssen appealed the verdict, but it was upheld on March 16, 2015.
In 2014, Johnson & Johnson, the parent company of Janssen Pharmaceuticals settled 76 pending lawsuits in Pennsylvania state court involving birth defects caused by Topamax. The terms of the settlement were not made public.
When the settlement was announced, there were still approximately 60 cases in the Topamax docket in the Philadelphia Court of Common Pleas. This docket was officially closed on March 17, 2016.
If your child suffered birth defects because of Topamax, contact our attorneys about filing a Topamax lawsuit to pursue compensation.
SCHEDULE A FREE LEGAL CONSULTATION TODAY
Drug manufacturers are legally obligated to make safe products that do not pose an unreasonable risk of severe injuries or side effects. If a company puts a potentially dangerous drug like Topamax on the market, it must provide sufficient warning to doctors and consumers so they can make an informed decision about whether to take it.
When companies fail in their legal obligations, victims may be able to file a defective drug lawsuit to pursue compensation for all the damages they have suffered.
Our attorneys can help you pursue a Topamax lawsuit against the manufacturer for producing a dangerous drug and failing to properly warn you about it.