(Please note that Shouse Law Group has stopped accepting new Topamax cases. The discussion below is for public information purposes only.)
Topamax lawsuits are mass tort claims filed against the pharmaceutical company Johnson & Johnson and its subsidiary Janssen Pharmaceuticals for the side effects of the popular epilepsy and migraine pill Topamax. This drug has been linked to suicidal thoughts, as well as an increased risk for birth defects, like cleft lip or cleft palette, when taken by pregnant women. The lawsuits claim that the pharmaceutical companies failed to warn patients and doctors of the risks, and seek compensation for:
- Medical expenses of caring for the child and correcting their injuries,
- The child’s reduced ability to earn a living because of the setbacks caused by their condition, and
- The physical pain and mental suffering felt by both child and family.
- 1. What is Topamax?
- 2. Side effects of Topamax
- 3. Lawsuits over Topamax’s side effects
- 4. Compensation available for victims of Topamax’s side effects
- 5. What to do if you have suffered from Topamax
1. What is Topamax?
Topamax is a drug that has been approved by the U.S. Food and Drug Administration (FDA) to treat epilepsy and prevent migraine headaches.1 It was first sold commercially in the U.S. in 1996. Topamax works by suppressing the rapid brain activity that precedes epileptic seizures.
However, Topamax has often been prescribed “off-label” to treat conditions for which the FDA has not approved its use. Off-label uses of Topamax have included:
- Alcohol dependence and alcoholism,
- Cocaine addiction,
- Addiction to methamphetamines,
- Bipolar disorder,
- Borderline personality disorder,
- Obsessive-compulsive disorder, or OCD
- Binge eating, and
- Posttraumatic stress disorder, or PTSD.
Johnson & Johnson and Janssen Pharmaceuticals, the makers of Topamax, used to aggressively market the drug for off-label use, in violation of the FDA’s rules. In 2010, they were fined $81 million by the Department of Justice for their conduct.2
As a result, Topamax has been used by thousands of people who do not have epilepsy or who suffer from migraines.
2. Side effects of Topamax
Topamax comes with numerous side effects. Relatively minor side effects include:
- Mental haziness,
- Memory problems,
- Weight loss,
- Lack of appetite,
- Abnormal sense of taste,
- Paraethesia, or a tingling feeling in the extremities, and
- Lack of sensory feelings in the skin.
Topamax also carries the risk of far more severe side effects, as well, including:
- Suicidal thoughts,3 and
- Birth defects.4
When pregnant women take Topamax, the risks that their unborn child develops a birth defect increase dramatically. According to the FDA’s warning,5 the odds that a child would be born with a cleft lip or palette was 1.4% when their mother took Topamax while she was pregnant. This was more than 21 times the normal risk of a newborn having an oral cleft, and 3 times the risk of such a birth defect if the mother was taking an epilepsy drug other than Topamax.
Worse, these oral clefts happen in the first trimester of a pregnancy, often before a woman is even aware that she is pregnant. Women who take Topamax could have put their unborn child at risk of an oral cleft even before they knew they were expecting.
These side effects led the FDA to downgrade Topamax from a Pregnancy Category C drug, which meant there was insufficient data to say whether the drug posed a threat to pregnant women, to Pregnancy Category D, which meant there was fetal risk.6
However, the FDA’s warning did not come until 2011, 15 years after Topamax first entered the market and two years after the drug’s last patent expired in the United States. Thousands of women had taken the drug while pregnant, already.
3. Lawsuits over Topamax’s side effects
Numerous lawsuits have been filed against Johnson & Johnson and Janssen Pharmaceutical for the birth defects that Topamax caused. Others have also been filed against the companies for the suicidal thoughts that have been linked to Topamax. All of these lawsuits are based on the pharmaceutical companies’ failure to warn doctors and consumers of the serious side effects of Topamax.
Drug companies have a legal duty to disclose the dangers that come with taking their drugs. This legal duty, however, falls between two conflicting interests:
- The interests of doctors and patients, who want as many risks to be disclosed as possible so they can make informed decisions about their health and what prescriptions to recommend, and
- The interests of the pharmaceutical companies, who want to minimize disclosure so it seems like their drugs are extremely safe, in order to maximize their profits.
In many cases, pharmaceutical companies ignore or downplay serious side effects of their drugs, refusing to warn consumers because it would hurt their bottom line. This puts innocent people at risk, as they are kept from knowing important information about the side effects associated with the drugs they are taking.
3.1 Topamax lawsuits over suicidal thoughts
A few Topamax lawsuits have involved the suicidal thoughts that the drug has been connected to.
Despite the fact that four people committed suicide during trials of epilepsy drugs like Topamax,7 it was not until 2009 that the FDA forced Topamax’s warning label to include the risks.8
However, people taking Topamax only suffer from an increase in suicidal thoughts for up to six months after they stop taking the drug. Therefore, these lawsuits are now very rare.
3.2 Topamax lawsuits over birth defects
The vast majority of lawsuits involving the epilepsy drug Topamax are for birth defects in children who were in utero while their mother was taking the drug. Nearly all of these lawsuits have involved children who were born with a cleft lip or a cleft palette – birth defects that occur in the first trimester of a pregnancy, and often before a mother knows she is pregnant.
These birth defects can lead to:
- Multiple corrective surgeries,
- Dental work,
- Delayed speech development and the need for speech therapy,
- Feeding problems,
- Hearing problems,
- A heightened risk for ear infections, and
- Potentially permanent disfigurement.
The first of these lawsuits ended in 2013. They included:
- An $11 million jury verdict in Philadelphia against Johnson & Johnson and Janssen Pharmaceutical for a boy who was born with a cleft lip,9 and
- A $3 million verdict in Philadelphia for a boy who was born with a cleft lip after his mother was prescribed Topamax for her migraines while she was pregnant.10
After that, dozens of lawsuits against Janssen and Johnson & Johnson were filed in state court in Pennsylvania and were consolidated into one case for pretrial proceedings.11 That consolidated case was settled and closed in March 2016 for an undisclosed amount,12 though individual lawsuits have likely continued.
4. Compensation available for victims of Topamax’s side effects
Both children and parents suffer from birth defects, so both deserve compensation if they have been the victim of Topamax’s side effects. This compensation should cover:
- Medical expenses, including the costs of anticipated future care,
- A parent’s lost wages while helping their child,
- A child’s reduced earning capacity from their medical condition,
- Physical pain suffered by the newborn, and
- Mental suffering and anguish caused by the oral cleft and its disfigurement.
5. What to do if you have suffered from Topamax
If you were taking Topamax while pregnant and your child suffered a birth defect like an oral cleft, or if you were born with a birth defect because your mother was using Topamax, you may have legal options. While the statute of limitations in most states requires a victim to file a lawsuit within two years, many states toll this window if the victim was underage. In many of these states, children who have suffered from an oral cleft because of Topamax can still file a lawsuit until they are 20 years old.
Talking to a lawyer if you have been hurt by Topamax’s side effects can help you recover from your injuries without sacrificing your financial well-being. Call the defective drug lawyers at the Shouse Law Office.
- See Topamax Warning Label, 2017.
- Department of Justice, “Two Johnson & Johnson Subsidiaries to Pay Over $81 Million to Resolve Allegations of Off-Label Promotion of Topamax,” (April 29, 2010).
- See note 1. See also Mula M, Hesdorffer D, “Suicidal Behavior and Antiepileptic Drugs in Epilepsy: Analysis of the Emerging Evidence,” Drug, Healthcare and Patient Safety 3:15-20 (June 2011); Mula M, Trimble MR, Lhatoo SD, Sander JW, “Topiramate and Psychiatric Adverse Events in Patients with Epilepsy,” Epilepsia 44(5):659-63 (May 2003).
- See note 1. See also Green MW, Seeger JD, Peterson C, Bhattacharyya A, “Utilization of Topiramate During Pregnancy and Risk of Birth Defects,” Headache 52(7):1070-84 (July 2012); Margulis AV, et al, “Use of Topiramate in Pregnancy and Risk of Oral Clefts,” American Journal of Obstetrics & Gynecology 207(5):405e1-e7 (November 2012).
- FDA Drug Safety Communication: Risk of Oral Clefts in Children Born to Mothers Taking Topamax (Topiramate).
- See note 5.
- See Gardiner Harris and Benedict Carey, “F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications,” The New York Times (February 1, 2008).
- Topamax Warning Label, 2009.
- See Sophia Pearson, “J&J’s Janssen Loses $11 Million Jury Verdict Over Topamax,” Bloomberg (November 18, 2013).
- See Tom Moylan, “Janssen Settles Some Pa. Topamax Birth Defect Cases, Will Appeal $3M Verdict,” LexisNexis Newsroom (March 11, 2014).
- In Re: Topamax Litigation, No. 110602131 (Pa. Ct. Com. Pl. filed June 23, 2011).