Topamax is the trade name of a prescription medication whose generic name is topiramate. Topamax was originally approved by the Federal Food and Drug Administration (FDA) as a seizure medicine. Topiramate is prescribed today as a treatment for seizures in adults and children who are at least 2 years old. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, manufactures and distributes the drug.
Topamax can also be used in combination with other medicines to treat certain special types of seizures, e.g., partial onset seizures, in adults and children who are 2 years and older.
Adults and teenagers who are at least 12 years old can also take Topamax to prevent migraine headaches. It is important to recognize that Topamax prevents migraines or reduces the number of migraines a person has. However, it is not an effective treatment for a headache that has already started.
Does Topamax Have Side Effects?
Topamax has several significant side effects. Among the most significant is that it can cause birth defects known as cleft lip and/or cleft palate if it is taken by a woman early in her pregnancy.
While cleft lip and cleft palate are not fatal, the repair of these conditions does require surgery early in a child’s life. Specifically, cleft lip repair surgery usually takes place within the first 3 to 6 months of an infant’s life. Cleft palate repair surgery takes place within the first 12 months of a child’s life, with earlier surgery being preferred. There are then likely to be additional follow-up surgeries between the ages of 2 and 18 to improve a child’s speech and the appearance of their face.
After the initial surgical repair of a cleft lip or palate, a person’s doctor may recommend follow-up surgeries to improve a child’s speech or the appearance of the lip and nose.
Other side effects of Topamax are as follows:
- Vision: Vision problems that must be treated quickly if they are not to become permanent. A person should call their doctor immediately if they have a sudden decrease in vision;
- Dehydration: A person can experience an increase in their body temperature and decreased sweating at the same time. This can cause life-threatening dehydration. Again, a person should contact their doctor if they develop hot, dry skin, a high fever, or decreased sweating;
- Suicidal Thoughts: Some people have thoughts about suicide while taking Topamax. A person should be aware of changes in their mood or thought patterns. A person wants to report any new mental health symptoms or symptoms that get worse to their doctor.
People are warned not to stop using Topamax suddenly because this could lead them to suffer increased seizures.
Who Can Be Liable in a Topamax Lawsuit?
In 2011, families of babies born with birth defects began filing lawsuits against Janssen, the manufacturer of Topamax. It was also in 2011 that the federal FDA required Janssen to put a warning in the prescription information that comes with the drug stressing the increased risk of cleft palate and cleft lip in infants whose mothers took Topamax during pregnancy.
The FDA mandated the new warnings because of its analysis of data that came from the North American Antiepileptic (NAAED) Pregnancy Registry. This program provides surveillance that monitors the safety of seizure medications. Data from the NAAED showed that the risk of an infant being born with a cleft lip or palate was 21 times more if the mother took topiramate in the first trimester of pregnancy.
As time went on, hundreds of people sued Janssen, claiming that the company had failed to adequately warn them that Topamax causes birth defects. In 2013 juries in the lawsuits that had been filed found that Janssen had failed to warn doctors and their patients about the birth defect risk of taking Topamax during pregnancy.
The juries also decided that Janssen’s negligence was a factor in causing injuries. Janssen challenged the verdicts by appealing and asking the courts for reconsideration, but Janssen was unsuccessful, and the verdicts against the company were held.
Meanwhile, Johnson & Johnson, the parent company of Janssen, settled 76 other Topamax cases that were pending in Philadelphia. The court closed the Topamax mass tort program in March 2016. There have been no new updates in this litigation as of 2022.
There has not been a class action suit associated with Topamax. However, there was mass tort litigation managed in the Court of Common Pleas in Philadelphia. It included 76 Topamax classes. Again, as noted above, it was reportedly closed in March of 2016.
There has never been a product recall of Topamax, and it is still on the market and prescribed for patients. The package now includes a warning to the effect that the benefit of preventing seizures may outweigh any risks posed by this medicine. Other medications may be safer for a person to use.
A person who has suffered a significant injury from taking Topamax may have a claim for medical malpractice against the doctor who prescribed the drug. A person would have to prove that the doctor who prescribed the medication either should not have prescribed it given the person’s medical history and condition, failed to warn the person of the risks associated with the use of Topamax, or failed to adequately monitor the person and appropriately respond when it was necessary.
A person who has suffered a significant injury from taking Topamax might also have a claim against the pharmacist who filled their prescription for Topamax. Again, if a person has suffered an injury because of taking Topamax, they might have a claim for pharmacy error or pharmacy malpractice.
A pharmacist might commit malpractice in the following ways:
- Dispensing the wrong dosage of the drug to a patient;
- Dispensing the completely incorrect medication to the patient;
- Failing to provide the correct directions as to dosage and other measures on medication;
- Failing to identify a possible drug interaction with a prescription that was filled with another prescription;
- Failing to warn a patient as required regarding possible side effects and drug interactions.
When taken with other drugs that make a person drowsy, Topamax can intensify this effect. A person should ask their doctor before they take other medications when they are taking Topamax. In addition, a person should alert their doctor and their pharmacist if they take any of the following:
- Zonisamide;
- Birth control pills;
- Divalproex, valproic acid;
- Other medications for glaucoma, including eye drops.
Other prescription and over-the-counter medicines, vitamins, and even some herbal products can interact with Topamax. So a person wants to be very careful about combining Topamax and any other medication.
What Are the Legal Remedies for a Topamax Injury?
A person who successfully sues the manufacturer of Topamax or a doctor who has prescribed it may win an award of compensatory money damages. A victim’s economic and non-economic damages are both reimbursed by an award of compensatory damages.
Economic damages compensate a victim for such losses as medical costs for all of the necessary medical treatment a person received. Damages would also compensate for lost wages, both past and future, as well as any loss of earning capacity that a person might have suffered.
In addition, compensatory damages cover a person’s non-economic losses for such things as the pain and suffering associated with their physical injuries. In addition, if a person is permanently disfigured by any of their injuries, they would receive compensation for this. If a person suffers scarring or disfigurement of a part of their body that is usually visible, such as the face, neck or hands, a jury is likely to view this as more harmful than scarring on other parts of the body that are not usually exposed to view.
Do I Need the Help of a Lawyer for My Topamax Issue?
If you have suffered injury because of the side effects of taking Topamax, or if your child has birth defects related to your use of Topamax during pregnancy, you want to consult a class action lawyer. Your lawyer can analyze your case and the nature of the injuries and help you determine if you have reason to sue the manufacturer, your doctor, or your pharmacist.
Given the FDA-required warnings on the packaging, a case against the manufacturer of Topamax could be challenging. Your lawyer would know how to identify the kind of expert witnesses you would need and how to use them to your best advantage.
