Topamax Lawsuit 2022 | Topamax Birth Defects Lawsuit

Topamax Lawsuit Overview

Topamax (generically named Topiramate) is an anticonvulsant medication used by patients to treat epilepsy, nerve pain, seizures and to prevent migraine headaches.

The Topamax Lawsuit (specifically the Topamax Birth Defects Lawsuit) alleges that Janssen Pharmaceuticals, the manufacturer, failed to warn women and doctors about the drug’s risk for causing birth defects and other side effects.

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Children of pregnant women who used Topamax, particularly during the first trimester of pregnancy, have an increased risk for the development of oral clefts and other potential birth defects.

If you or a loved one used Topamax or Topiramate prescriptions while pregnant, and the child subsequently developed a cleft palate or other birth defects, you may qualify for a Topamax Lawsuit.

Contact TorHoerman Law for a free consultation or use the chatbot on this page to see if you qualify for legal action instantly.

Frequently Asked Questions

Topamax is a prescribed medication for the treatment of epileptic seizures and other certain types of seizures.

Topamax has also been used to treat bipolar disorder and prevent migraine headaches.

Minor Topamax side effects may include, but are not limited to:

  • Tiredness
  • Drowsiness
  • Dizziness
  • Loss of coordination
  • Confusion
  • Trouble concentrating
  • Memory problems
  • Weight loss

If taken by pregnant women, Topamax can present an increased risk of cleft lip and other oral clefts, as well as other potential birth defects.

There is also scientific research on the incidence of metabolic acidosis resulting from Topamax use.

Metabolic acidosis is the build-up of acid in body fluid, which can lead to several dangerous medical conditions.

Other serious side effects include, but are not limited to:

  • Kidney stones
  • Rapid breathing
  • Irregular heartbeat
  • Bone pain
  • Loss of consciousness
  • Unusual bleeding and bruising

Though there are risks associated with Topamax use, the potential benefits for patients in treating epilepsy and seizures are enough for a medical professional to prescribe the medication.

Table of Contents

Topamax Birth Defects Lawsuit: What Birth Defect Risks are Related to Topiramate Prescriptions?

Scientifically positive evidence has linked Topamax to certain birth defects.

If you took Topamax while pregnant, and your child suffered birth defects, you may qualify for a Topamax Lawsuit.

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According to a 2008 study published in Neurology, babies of pregnant mothers taking Topamax suffered birth defects at rates 11 times higher than average.

Topamax Birth Defects: Risk of Oral Clefts in Infants Exposed to Topiramate Drugs

Infants exposed to Topiramate in utero experience an increased risk of developing Oral Clefts (also known as a Cleft Lip or Cleft Palate).

Oral clefts, cleft palate or cleft lip are birth defects that occur when a baby's lip and mouth do not form correctly during pregnancy.

Oral clefts occur early on in pregnancy, even before a woman discovers that she is pregnant.

Cleft palate refers to a split in the roof of the mouth and is sometimes not forwardly visible.

Cleft lip refers to a split in the top lip.

In 2011, the U.S. Food and Drug Administration released a warning on Topamax and the risk of cleft palate in developing babies.

The FDA originally labeled Topamax as a pregnancy category C drug, meaning that clinical trials on animals indicated potential risks for fetal injury, but they were not yet known for humans.

Now, Topiramate is labeled as a pregnancy category D drug, as new data shows risks for development of cleft lip, cleft palate and oral clefts generally.

The following guidance was released alongside the FDA Drug Safety Communication on cleft palate risks:

  • Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking topiramate. Women should talk to their healthcare professionals about the best kind of birth control to use while taking topiramate.
  • Before you start topiramate, you should tell your healthcare professional if you are pregnant or are planning to become pregnant. Healthcare professionals may discuss other treatment options with you.
  • You should tell your healthcare professional right away if you become pregnant while taking topiramate. You and your healthcare provider should decide if you will continue to take topiramate while you are pregnant.
  • Topiramate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping topiramate suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.
  • If you become pregnant while taking topiramate, you should talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect additional information about the safety of antiepileptic drugs during pregnancy.

Other Topamax Birth Defects

Taking Topamax during pregnancy may be associated with birth defects other than oral clefts and cleft lip/palate.

A study published in the National Library of Medicine found that Topiramate and other antiepileptic drugs such as Zonisamide can lead to low birth weight and small for gestational age (SGA), which is defined as weight below the 10th percentile for gestational age.

Do Seizure Medications or Other Antiepileptic Drugs Pose a Human Fetal Risk?

Seizure medications have been linked to congenital heart defects, urinary tract defects and neural tube defects in babies of mothers who took them while pregnant.

Research on the association between birth defects and seizure medications include the following:

  • National Library of Medicine: Epilepsy drugs and effects on fetal development: Potential mechanisms
  • Neurology: Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs
  • National Library of Medicine: Influencing clinical practice regarding the use of antiepileptic medications during pregnancy: modeling the potential impact on the prevalences of spina bifida and cleft palate in the United States

Department of Justice Forces Janssen Pharmaceuticals to Pay for Off Label Promotion

In 2010, Janssen Pharmaceuticals (formerly Ortho McNeil Janssen Pharmaceuticals) was ordered to pay $81 million to resolve criminal and civil liability arising from the illegal promotion of Topamax.

The Johnson & Johnson subsidiaries allegedly engaged in off label promotion of Topamax, hiring outside physicians to visit healthcare professionals and healthcare providers to market the drug for psychiatric conditions.

Filing a Topamax Lawsuit: Do I Qualify?

If you used Topamax to treat seizures and migraines during pregnancy, and your child was born with a cleft lip, cleft palate, or oral clefts, you may qualify for a lawsuit.

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Evidence in Topamax Lawsuits

Evidence is key in any personal injury lawsuit, but it is especially important in lawsuits involving dangerous medications.

Evidence in a Topamax lawsuit may include:

  • The mother's medical records and bills
  • The child's medical records and bills
  • Prescription records
  • Proof Topamax was used during pregnancy (specifically during the first trimester of pregnancy)
  • Any communication between healthcare providers and patients
  • Personal accounts of injuries and written testimony
  • Photos or videos of birth defect
  • Proof of costs associated with birth defect or injury

Damages in Topamax Lawsuits

Damages are the total losses, both non-economic and economic, that an injured party incurs as a result of their injury.

In many personal injury lawsuits, the injured party will choose to file for both compensatory damages and punitive damages.

After assessing all damages that you incurred, your Topamax attorney will file a complaint demanding compensation to repay your damages.

Common damages in Topamax Lawsuits include:

  • Medical expenses resulting from injuries
  • Future medical expenses resulting from the injuries
  • Pain and suffering or post traumatic stress disorder, both physical and mental, caused by the injuries, treatment, and recovery period
  • Wage loss, loss of earning capacity
  • Other costs associated with our injuries
  • Loss of enjoyment of life resulting from damages
  • Punitive damages against the manufacturer

Infants born with a cleft lip, cleft palate, or oral clefts typically must undergo surgical intervention during childhood.

This can be financially and emotionally costly for children and their mothers.

TorHoerman Law: Accepting Clients for Topamax Lawsuit (Topamax Birth Defects Lawsuit)

TorHoerman Law attorneys are accepting clients in all 50 states for Topamax lawsuits.

Our team understands the difficulty of coping with an unexpected medical condition at no fault of your own.

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We've secured over $4 billion in compensation for people harmed at no fault of their own.

Our prior results speak to our team's expertise, and we're here to help you get the compensation you're owed for the trauma you've endured.

Contact TorHoerman Law for a free consultation or use the chatbot on this page to see if you qualify for legal action instantly. 

Tor Hoerman

Tor Hoerman

Owner & Attorney - TorHoerman Law

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