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Topamax Birth Defect Lawsuits

As of 2025, the U.S. Food and Drug Administration (FDA) continues to warn about the risk of birth defects associated with Topamax (topiramate). The FDA first issued a safety communication in 2011 based on data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry, which showed that infants exposed to Topamax during the first trimester of pregnancy faced approximately a threefold increased risk of developing oral clefts, such as cleft lip and cleft palate, compared to infants whose mothers did not take the drug. This risk is still recognized today, and Topamax remains under scrutiny by healthcare professionals and regulators due to ongoing reports and studies confirming its teratogenic potential. Topamax was first approved by the Food and Drug Administration in 1996 to prevent seizures. But, the medication has been used for a variety of illnesses.

If you or a loved one have suffered injuries or have had a child with birth defects by taking Topamax, contact our experienced mass tort attorneys today to schedule a one-on-one consultation. Our attorneys are available to help you every step of the way and offer free consultations where we will review all the circumstances surrounding your case. Contact us by phone or email to schedule your complimentary case evaluation.

What does the Topamax lawsuit allege?

Currently several individual lawsuits and mass tort actions are ongoing across multiple states against Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, regarding Topamax-related birth defects. While there is currently no formal class action certified, many claims are consolidated in multi-district litigation (MDL). Always consult an attorney for the most updated litigation status.. In this class action lawsuit, victims have alleged that Topamax should not have been on the medication market, or, Topamax should have had a warning label on the possibility of birth defects. Further, there has also been controversy with many doctors that prescribed Topamax for those who did not even have epilepsy or suffered epilepsy side effects. 

What side effects does Topamax have?

Several studies have shown that Topamax caused cleft lip and cleft palate deformities in children of pregnant women who were taking Topamax.

Other side effects include birth defects such as:

  • Limb deformities
  • Facial deformities
  • Heart defects

All of the above birth defects are considered to be serious and may require extensive medical treatment as the child grows. These types of birth defects will require medical bill compensation from the pharmaceutical company.

For a comprehensive list of adverse effects, refer directly to the FDA’s official Topamax label or speak with a qualified healthcare professional. This ensures you are aware of both the minor and serious risks associated with the medication.

What minor side effects does Topamax have?

Besides birth defects, there are also other minor side effects that have been reported by users of Topamax. These include:

  • Heartburn
  • Constipation
  • Leg cramps
  • Pain in breasts
  • Sweating
  • Muscles spasms 
  • Eye redness
  • Pressure in the eyes
  • Burning sensation
  • Fatigue 

Who is responsible for my Topamax birth defect lawsuit?

  • The pharmaceutical company is responsible for the injuries you have sustained by taking Topamax. Specifically, Topamax’s manufacturer is Ortho McNeil and Jannsen Pharmaceuticals. These two pharmaceutical companies placed the product in the market.
  • Also, In certain situations, doctors who prescribed Topamax “off-label” to women of childbearing age without fully informing them of the risks may be held liable under a medical malpractice claim. Off-label use is legal but must still meet the standard of care, especially when there is a known risk of birth defects. Pharmacists, too, may face liability if they dispense Topamax incorrectly or fail to provide appropriate medication counseling as required by pharmacy laws.
  • Pharmacists can also be responsible and held liable in the event that they have incorrectly provided Topamax to a patient that was not prescribed Topamax. Pharmacy errors fall under negligence liability.

What type of lawsuit is a Topamax lawsuit?

  • Product liability: Product liability is a specific type of lawsuit where an injured party holds the product manufacturer responsible for putting a defective product on the market. The defective product that has been placed on the market must have a specific defect, whether it is a design defect, manufacturing defect, or failure to warn defect. In this Topamax circumstance, the defect could be the failure to warn. Users may allege that the Topamax manufacturing company failed to warn users of the potential side effects of the drug.
  • Negligence: this is usually the case in medical malpractice lawsuits. In the event that the doctor prescribed Topamax without having a valid reason to do so, they may be held responsible in a Topamax lawsuit. 

To see whether you qualify for a product liability lawsuit or a medical malpractice lawsuit, we recommend that you speak to our highly qualified attorneys immediately. our attorneys are available to assist you 24/7.

What Compensation Can Victims Recover?

Victims of Topamax-related injuries may be entitled to compensation for:

  • Past and future medical expenses
  • Special education and rehabilitation costs
  • Pain and suffering
  • Lost wages or reduced earning capacity (for parents)
  • Emotional distress
  • Loss of consortium
  • Punitive damages (in certain cases)

The exact compensation depends on the severity of the injuries and circumstances of the case. Consulting with an experienced attorney can help you estimate the potential value of your claim.

Is Topamax still on the market?

As of May 2023, the Food and Drug Administration has determined that Topamax capsules are still available for purchase because of their effectiveness in assisting those with epilepsy. This has sparked outrage and controversy in the medical community. 

Should I hire a Topamax lawsuit attorney?

Since there are several different legal theories involved in a Topamax lawsuit, we recommend that you have a highly qualified Topamax defective products attorney on your side. This is especially true when dealing with pharmaceutical companies with large legal departments. If you fight against these pharmaceutical companies unrepresented, you may not be able to recover as much compensation as you would have with an attorney.

If you suspect that you have had a child with birth defects because of taking Topamax, we recommend that you contact our lawyers immediately. 

Why hire our Topamax lawsuit attorneys?

  1. We work through a contingency fee basis, collecting zero fees upfront
  2. We have relationships with top-rated medical experts to prove your injuries
  3. We have decades of experience representing victims of defective medication
  4. We work closely with our clients to make sure that they understand every step of the way
  5. We fight aggressively against pharmaceutical companies to make sure that our clients get the justice they deserve
  6. We investigate the circumstances of the medication and the side effects to build a strong case 

Topamax and Suicidal Thought

In 2008, the Federal Drug Administration released a warning about Topamax and the side effects of causing suicidal thoughts amongst those who were taking the medication. But, the Federal Drug Administration did not add a black box warning. 

Topamax Controversy

In 2010, Topamax manufacturers pled guilty and paid around $80 million for marketing Topamax illegally with the United States Department of Justice. The pharmaceutical company hired third-party doctors to work as sales representatives and push the Topamax drug. 

How Long Do I Have to File a Topamax Lawsuit?

The statute of limitations varies depending on the state where you reside. Generally, you may have 1 to 4 years from the date you discovered the injury or reasonably should have discovered it. However, certain states may apply different rules when the injury involves a minor (such as birth defects affecting a newborn). It is crucial to speak with an attorney immediately to ensure you do not miss critical deadlines that could prevent you from pursuing your claim.

Topamax Birth Injury Attorney

Contact our experienced and highly qualified Topamax birth injury attorneys today for more information on how you could move forward with your lawsuit. We know that no single dollar amount could replace the amount of suffering that your family has gone through, especially if you are a mother to a child that has been born with birth defects because of Topamax.

Our caring and understanding attorneys will help you every step of the way to make sure that we hold the pharmaceutical company responsible. It is the least we can do and will provide closure and lift the financial burden off your shoulders. Also, we recommend that our clients file a lawsuit because it prevents other pharmaceutical companies from also making the same mistakes.

Frequently Asked Topamax Lawsuit Question

What birth defects are associated with Topamax?

Studies have shown that Topamax is linked to an increased risk of birth defects, especially oral clefts such as cleft lip and cleft palate. Other reported defects include limb deformities, facial abnormalities, and heart defects. These conditions often require long-term medical care and corrective surgeries.

Is there still a Topamax lawsuit in 2025?

Yes, as of 2025, lawsuits related to Topamax are still ongoing, primarily through individual claims and mass tort actions. These lawsuits allege that the manufacturer failed to adequately warn about the risk of birth defects. Many victims are seeking compensation for medical expenses, emotional distress, and other damages.

Who can be held responsible in a Topamax lawsuit?

The primary defendant is usually Janssen Pharmaceuticals, the manufacturer of Topamax. However, doctors and pharmacists may also be held liable if they prescribed or dispensed the medication negligently. In some cases, a combination of product liability and medical malpractice claims may apply.

What is the statute of limitations for filing a Topamax lawsuit?

The time limit to file a lawsuit varies by state but generally ranges from 1 to 4 years. In cases involving birth defects, some states allow the deadline to extend until the child reaches a certain age. Consulting with an attorney promptly is the safest way to protect your legal rights.

Is Topamax still on the market despite the risks?

Yes, Topamax is still available as of 2025, primarily for treating epilepsy and migraines. However, it carries a warning regarding the risk of birth defects when used during pregnancy. Patients are advised to discuss risks thoroughly with their doctors before using it.

Heidari Law is here to help you

There are a lot of controversies associated with Topamax, whether it is through the marketing means or through the birth defects that it causes. If you have taken Topamax, and have suffered injuries, give us a call today to discuss your options. We have offices located all around California and Nevada, and are available 24/7 for your convenience.