Women who gave birth to children with birth defects have filed Topamax lawsuits against Johnson & Johnson and Janssen Pharmaceuticals, the division that makes the anti-seizure drug. Topamax, which is the generic drug topiramate, was approved by the U.S. Food and Drug Administration (FDA) in 1996 to treat epilepsy and migraines.
What was not well-known at the time, according to plaintiffs in lawsuits, is that taking it during pregnancy could have serious consequences. If you took this medication during pregnancy and don’t feel you were warned of the risks, you could have a valid case to make against Johnson & Johnson.
What is Topamax?
This medication was developed and made by Janssen Pharmaceuticals of Johnson & Johnson. It was designed as an anticonvulsant, a drug that prevents and treats seizures. The FDA approved it for the treatment of seizure disorders like epilepsy as well as for migraine headaches. Children as young as two may be prescribed the drug for a rare seizure disorder called Lennox Gastaut Syndrome, and for migraines, adolescents may use it.
Off-label, doctors may prescribe Topamax to treat alcohol and drug addiction, anxiety disorders, eating disorders, and obesity caused by weight gain from using antipsychotic medications. As an anticonvulsant, Topamax is thought to work by calming down excited neurons in the brain. This may also explain why it can help with migraines, anxiety, and addiction. It may also dilate blood vessels, which can relieve pain associated with migraines and other conditions.
Topiramate has also been combined with a drug called phentermine to make the brand name drug Qsymia. This medication is approved to treat obesity, but only in certain patients. It is indicated for people who need to lose weight because of a health condition like type 2 diabetes or high blood pressure.
Birth Defects and Pregnancy Complications
Any drug that contains topiramate may increase the risk of complications and birth defects when taken during pregnancy. This is the main reason that lawsuits have been filed against Johnson & Johnson and Janssen over Topamax. Although the medication has been on the market since it was approved in 1996, the FDA only officially announced it was associated with these risks in 2011. That means that for decades women may have taken the drug during pregnancy, not understanding the possible outcomes.
The warning from the FDA came from two sources of evidence: adverse event reports and research studies. The 2011 warning included specific data showing that topiramate use during pregnancy increases the risk of a child being born with a cleft lip or palate. The agency included the recommendation that any woman who could possibly become pregnant consider other treatment options before taking topiramate products.
It is especially important for women who have any chance of getting pregnant to avoid Topamax because the particular birth defects it may cause occur very early during pregnancy. Cleft lip and cleft palate are defects that cause the palate in the mouth or the tissue above the lip to fail to join together. They can be corrected with surgery, but often require multiple treatments. These defects also cause complications like ear infections and delayed speech.
Another possible source for Topamax lawsuits is over the increased risk of suicidal thoughts and behaviors. The FDA announced in 2009 that makers of anti-seizure drugs, including Topamax, must include updated labeling information regarding the risk. Clinical trials showed that patients taking any of these drugs could experience suicidal thoughts immediately upon starting the medication course and that the effects could last for up to six months. Four suicides occurred during trials of Topamax.
Topamax Lawsuits and Failure to Warn
As soon as the FDA warning about birth defects came out in 2011, women and families who had been affected by cleft lips and cleft palates began filing lawsuits against Johnson & Johnson and Janssen Pharmaceuticals. Some of the earliest cases were resolved in 2013. One family received $11 million in a settlement, while another got $4 million.
The plaintiffs in these cases argued that Johnson & Johnson and Janssen failed to warn the public, patients, and doctors about the full extent of the risks of taking topiramate while pregnant. They even claimed that the companies knew about these birth defect risks early on, as early as 1997, and not only didn’t warn patients or doctors, but actively concealed the information that came from studies, clinical trials, and safety reports.
Johnson & Johnson and Janssen denied all of these claims during the cases, but the jury verdicts sided with the plaintiffs. The juries found that the companies did fail to warn doctors about the risks of giving Topamax to women who were or could become pregnant. The juries also determined that the companies were negligent in the development of the birth defects. Janssen appealed the decisions, but the findings were upheld in appeals courts.
Suing over Topamax
Many more people have sued Johnson & Johnson and Janssen over topirmate products like Topamax and Qsymia. Some of these plaintiffs have described the terrible effects cleft palate and lip defects have had on their children. In one case a young man born with a cleft lip had five surgeries throughout his childhood and adolescence because of serious malformations in his lip and nose. Other plaintiffs have described similarly life-altering consequences of being born with these types of defects.
If you have also been affected by Topamax, whether you are the parents of a child born with a defect or the child who has had to live with the consequences of a birth defect, a lawsuit may be a way you can seek compensation for your expenses, pain, and suffering. The companies responsible for this medication have already been found negligent in some cases of birth defects. Juries have found that the medication was a major cause of cleft lip and cleft palate in some individuals. This means that if you have a similar story, you too could be eligible for compensation. Let a lawyer advise you and help you decide if you should take the next step.