Topamax Lawsuit Claims and Settlements

The anticonvulsant medication, Topamax, was manufactured by Janssen Pharmaceuticals to treat epilepsy. The Topamax lawsuit was started by the families of babies who were born with birth defects after their mothers took Topamax while pregnant.

There are many other claims against Topamax, ranging from hair loss to glaucoma. New data forced the FDA to escalate Topamax to a “Category D” drug for its potential harmful impact on unborn fetuses.

Continue reading for a history of Topamax as a drug as well as an update on the Topamax lawsuit. The drug has been around since its FDA approval in 1996, so millions of people have used it and are now potentially eligible for compensation under the terms of the lawsuit.

What is Topamax?

Topamax is the brand name of a compound called topiramate. It was approved by the FDA in 1996 as a migraine prevention drug. 

In 2012, it was reformulated with an extended-release capsule. The drug is an anticonvulsant, making it a useful therapy for epileptic adults and children. When combined with another drug called phentermine, it has become an approved weight loss therapy as well.

The drug belongs to a category of medications called carbonic anhydrase inhibitors. Due to the drug’s multiple uses, it is prescribed around 11 million times per year, making it one of the 60 most used medications in the United States.

What is Topamax commonly prescribed for?

Topamax is commonly prescribed for epilepsy in adults and children, including the rare child-onset epilepsy known as Lennox-Gastaut syndrome. It has been approved as an adjunct weight loss therapy, as well as a treatment for alcohol dependence.

The most common use of Topamax, however, is for migraines, for which it is prescribed millions of times per year. Other uses for Topamax that are currently being researched include treating binge-eating disorders, post-traumatic stress disorder, and dextromethorphan withdrawal.

What are the Side Effects of Topamax?

There are many listed side effects of Topamax. The most common include:

• Tingling or burning sensations
• Mental confusion
• Dizziness and double vision
• Blurred vision
• Drowsiness
• Memory problems
• Mood changes
• Speech problems
• Trouble concentrating

Less common side effects include depression, fever, irritability, stomach pain, chest pain, loss of appetite, and hearing loss. Rare side effects include kidney stones, increased blood ammonia levels, and thoughts of suicide.

Is There a Lawsuit Against Topamax?

Yes, the main Topamax lawsuit involves claims that it causes birth defects in unborn fetuses. New data has made the FDA increase its status from a Category C to a Category D drug, which means that there is positive evidence concerning the drug’s fetal risk.

This does not mean that Topamax is completely prohibited for expectant mothers, but a Category D drug should only be taken with knowledge of the risks, which the lawsuit claims that the manufacturer Janssen Pharmaceuticals had not provided.

Other than the birth defect claims, there are other potentially dangerous side effects as well. Topamax can cause mood destabilization, even leading to suicidal thoughts. Some of the cases against Topamax do not involve children born with birth defects but the families of people who killed themselves while taking Topamax.

Topamax Birth Defects Lawsuit Claims

As mentioned, the FDA changed the category of Topamax after learning of its risk in causing birth defects. However, this didn’t happen until 2011.

This means that Topamax had 15 years to potentially cause defects that women had no way of predicting. The Topamax lawsuit, therefore, has thousands of potential plaintiffs who took the drug while pregnant before the risks were known.

Topamax Linked to Cleft Lip and Cleft Palate

The Topamax birth defects lawsuit claims that the drug causes birth defects, namely a cleft lip or palate. FDA studies have now shown that taking Topamax while pregnant raises the risk of a child being born with a cleft lip over 21 times compared to just 3 times the risk if the mother used another branded anticonvulsant medication.

To make the claims even more condemning, birth defects resulting from the use of Topamax usually occur in the first trimester, meaning many mothers unwittingly caused these defects in their unborn children before even knowing they were pregnant.

Seizure Medications and Birth Defects

Anti-seizure medications used to treat epilepsy have a known link with certain birth defects, including not only cleft lips but also skeletal development issues, heart development issues, and neural tube defects.

While other epilepsy medications have a known risk for causing these defects, Topamax’s risk is 7 times greater than other branded anticonvulsants.

Since doctors often recommend continuing epilepsy treatment while pregnant if the benefits outweigh the risks, the unknown severity of the side effects of Topamax in comparison to other epilepsy medications went undocumented for years.

Topamax Lawsuits for Other Dangerous Side Effects

Topamax lawsuits have been filed for dangerous side effects other than birth defects, including memory loss, kidney stones, glaucoma, and more. Here’s a brief breakdown of the secondary claims in the ongoing Topamax lawsuit.

Topamax Memory Loss Lawsuit

Topamax’s primary action as a carbonic anhydrase inhibitor means that it controls how carbon dioxide is hydrated/dehydrated in the body. This can have a lasting impact on the user’s mood and memory since the brain relies on a balance of oxygen and carbon dioxide to function properly.

Memory loss, difficulty focusing, mood changes, and even loss of perception have been noted in some of the plaintiffs filing for compensation against Janssen for this dangerous side effect of taking Topamax. 

Topamax Kidney Stones Lawsuit

Some plaintiffs are filing for compensation against Topamax for enduring kidney stones while on the medication. Topamax is known to induce a condition called systemic metabolic acidosis, which in simpler terms alters the acid balance in the user’s body. 

This can lead to the formation of kidney stones, particularly in overweight users, which are painful and potentially expensive to deal with.

Topamax Glaucoma Lawsuit

The manufacturers of Topamax failed to market its potential to cause eye problems like glaucoma until 2006, leading to a Topamax glaucoma lawsuit. Both secondary angle closure glaucoma, as well as acute myopia, have been studied in connection to Topamax.

These diseases can lead to blurry vision, long-lasting eye pain, and even vision loss. The conditions could be reversed if the user discontinues their use of Topamax. However, prolonged use, such as in the decade before the public was aware of this potential side effect, could result in permanent eye damage.

Topamax Hair Loss Lawsuit

Studies have shown that Topamax can cause hair loss, leading to a Topamax hair loss lawsuit since its manufacturers failed to properly mention this side effect. Studies show that this hair loss is usually reversible once the drug’s use has been discontinued.

Note that hair loss is more common in users who bought Topamax for epilepsy compared to those who used it for migraines.

Topamax Lawsuit Settlements

Topamax manufacturers have been charged a total of $81 million in fines by order of the Department of Justice. The average product settlement amounts of individual cases have remained mostly undisclosed by the courts, but one woman received a million settlement after giving birth to a child with severe defects while another received $11.7 million in 2013.

These cases were both appealed by the manufacturer, but the judgments were upheld in a higher court, leaving dozens of additional cases to be resolved individually. While it’s impossible to know how much each case will be compensated, an experienced personal injury attorney can compare your situation to the current cases to determine whether you are eligible for compensation and how much you can expect to get.

Topamax Lawsuit for Off-Label Promotion

The Topamax lawsuit for off-label promotion in 2010 focused on the manufacturer’s use of a “Doctor for a Day” program to promote Topamax for non-FDA-approved uses. This program hired physicians to represent the manufacturer’s sales reps and visit the offices of other healthcare providers as well as attend industry dinners to promote the drug.

Under the False Claims Act, Janssen was ordered to pay $75.37 million in damages for the illegal promotion of Topamax using false claims about its uses. Part of this agreement also requires Janssen to enter a corporate integrity agreement with the Inspector General’s office to increase accountability for illegal pharmaceutical promotion and prevent future misconduct.

Who Qualifies for a Topamax Lawsuit?

You may qualify for a Topamax lawsuit if you took Topamax during pregnancy and your child was subsequently born with a birth defect like a cleft palate.

You may also be able to file an injury claim if you sustained eye damage, including acute myopia and glaucoma, or if a direct relative committed suicide while taking Topamax. You must have used Topamax before 2011 since this is when the FDA reevaluated its risks and reclassified it as a Category D medication with a greater risk potential.

Speak with an experienced personal injury attorney to learn if you qualify for a Topamax lawsuit settlement.

How to File a Topamax Lawsuit?

To file a Topamax lawsuit, you need to gather evidence linking you or your child’s injuries to your use of Topamax. This evidence must include the medical records and bills of both the mother and child, prescription records establishing a timeline for the use of Topamax to prove it was used during the pregnancy, if applicable, as well as any medical or personal accounts of your injuries.

The evidence you provide could include photos or videos documenting your injuries, your and your doctor’s testimonies, as well as bills proving the financial cost of managing the birth defect or injury.

Managing this evidence can be complicated. Since states each levy a statute of limitations on personal injury cases, it’s important to be aware of your eligibility for a Topamax lawsuit and speak to an experienced attorney as soon as possible.

Conclusion

Topamax lawsuits concern the FDA’s recent studies on the risks of taking this anticonvulsant therapy during pregnancy, which the manufacturer, Janssen Pharmaceuticals, failed to accurately market or report. The main claims associated with the lawsuit include birth defects caused by the mother’s use of Topamax as well as other symptoms such as vision loss, memory problems, and even suicide.

Contact an accredited personal injury lawyer to learn more about your eligibility for a Topamax lawsuit and how much you can expect to get in compensation.