Topamax Linked to Birth Defects

What is Topamax/Topiramate?

Topamax, the brand name of topiramate, is an anti-seizure drug. One of 

the more common causes of seizures is over-active brain cells that cause an excess of brain activity. Topamax and topiramate suppress excessive brain activity by blocking certain neural pathways and chemicals. By the year 2008, Topamax controlled close to 20% of the seizure medication market, and grossed over $2.7 billion in sales.

The manufacturer of Topamax, Janssen Pharmaceuticals, is a subsidiary

of Johnson and Johnson. In 2010, just two years after the drug hit its peak sales, Janssen Pharmaceuticals paid out over $80 million in fines and penalties for illegally marketing the drug and failing to warn of several side effects, including birth defect. Both Janssen Pharmaceuticals and Johnson and Johnson also settled numerous cases in 2010 in which mothers claimed that Topamax or topiramate caused birth defects in their babies.

Topamax has since been elevated from a Category C drug, which

indicates a drug that has not been shown to be harmful to unborn human babies, to a Category D drug, which has positive evidence of human fetal risk. Category D drugs should be used by and prescribed to expectant mothers only when there are no safer alternatives, and only when the benefits of taking the specific Category D drug outweigh its risks.

Common Topamax/Topiramate Side Effects

Topamax has a long list of side effects. The most common side effects of

Topamax are pretty standard, however the more severe symptoms include: eye damage, metabolic acidosis (kidney failure), changes in consciousness, increased risk of suicide, hyperthermia (overheating due to insufficient sweating), language problems, reduced efficiency of hormonal birth control, and birth defect.

The Topamax/Topiramate Lawsuits

Janssen Pharmaceuticals has been sued due to birth defects caused by

Topamax. Women who took Topamax while pregnant claim that their babies suffered birth defects including, but not limited to:

• Pre-term delivery
• Lung abnormalities
• Skull abnormalities
• Skeletal abnormalities
  
• Low birth weight
• Cleft lip
• Learning disabilities
• Deficiencies in motor coordination
• Spina bifida
• Persistent pulmonary (lung) hypertension (high blood pressure)
• And more.
• 
  

According to the lawsuits, women were not instructed to stop taking

Topamax or reduce their dosage while pregnant. This, despite the fact that a 2008 study by the American Academy of Neurology revealed that women who took Topamax or topiramate while pregnant were 16x more likely to give birth to a baby with birth defects than those women who did not take the drug while pregnant. In addition, many women were not warned of the possible side effects of the drug.

The birth defects that Topamax and topiramate have been shown to

cause are anything but minor. Many of the above birth defects are permanent, and others require numerous painful surgeries to correct. These surgeries strip a baby of their childhood before it even begins. Instead of being free to run and play, the victims of Topamax will be forced to undergo multiple excruciating surgeries that, in some cases, will extend even into adulthood.

Janssen’s Legal Duty to Warn Consumers

Pharmaceutical manufacturers have a legal duty to warn consumers

of any known side effects of their products. The catch is that manufacturers do not have a duty to warn of unknown dangers. The cases regarding Topamax or topiramate and birth defects will turn on whether or not Janssen can show that they did not have any knowledge that their product would cause birth defects, or that it might put pregnant women at a higher risk of having babies with birth defects. While Janssen may be able to argue that they were unaware of the 2008 study, it is unlikely that any court would ignore the fact that they were warned about, and even fined for, their omission of several known side effects, including the risk of birth defect, in 2010.

Topamax was not listed on California's Proposition 65 database as a drug

that is known to cause birth defects until November 27, 2015.

Status of Topamax/Topiramate Birth Defects Lawsuits

By 2013, more than 130 cases alleging that Janssen had failed to warn

consumers of the risks of birth defects were pending in Philadelphia. At this time, Topamax had been on the market for over 15 years with no warnings provided as to the potential for the drug to cause birth defects if consumed by pregnant women, or women who were trying to get pregnant. This issue has risen to the level of a mass torts action. What this means is, hundreds of people have already filed claims, and thousands are expected to file in the coming months.

From January 2007 to December 2010 alone, more than 32.3 million

prescriptions for Topamax or topiramate were dispensed, and approximately 4.3 million patients filled those prescriptions. There are now lawsuits that have been filed against the manufacturer in 51 out of 52 U.S. states. In Texas, there have been numerous lawsuits filed, with most settling outside of court for confidential amounts.

What Type of Compensation Can I Expect If I Have a Case?

In October of 2013, a jury awarded $4 million in the first case to go to trial

against Janssen and Johnson and Johnson. The baby was born with a cleft palate and it was decided that the company’s negligence was a substantial factor in causing the child’s suffering. The jury held that the manufacturer and its parent company failed to adequately warn both physicians and patients about the birth defects that had been associated with the medication.

In November of 2013, a second Topamax case resulted in a jury  verdict of

$11 million for a child who had also been born with a cleft palate as a result of Topamax. The parents in this case argued that the manufacturers failed to warn both doctors and the FDA of the potential harms of Topamax and its connection to birth injuries.

In 2016, a Pennsylvania Court of Appeals upheld a $3 million verdict  in

favor of the victim in a Topamax case. In that case, the child was born with a bilateral cleft palate and cleft lip. The child had to undergo over 14 surgeries and procedures in an effort to remedy the birth defect. The child’s parents were awarded $1.5 million to go towards future medical expenses, and the child was awarded $1.5 million in non-economic damages (an award for pain and suffering).

The average of these three huge verdicts is roughly $6 million. Does  this

mean that every Topamax case is worth millions? The short answer is no. While the drug may be the same, the facts of each individual case vary. Every case is different, so every verdict will be different. As seen above, all three cases were about the specific birth defect of cleft palate, and yet we see 3 vastly different verdicts in terms of final award. The value of your specific case will vary based on the facts of your case and the individual harms suffered as a result.

Do I Have a Topamax/Topiramate Case?

If you or someone you love took Topamax or topiramate while

pregnant, and the baby was born with any of the above complications or defects, you may have a case. If the baby was born with a complication other than the ones listed, you still may have a case. If your doctor never warned you about the potential side effects of taking Topamax or topiramate, and you or your baby suffered as a result, you may have a case.

If you think you may have a Topamax case, you should call us right away.

What Should I Do If I Have a Case? How Can You Help Me?

If you think you have a Topamax or topiramate case, you should call us

today. Our wolf pack is ready to fight for you to get the justice you deserve. If you hire us for your Topamax or topiramate case, we can file a claim for you against Janssen Pharmaceuticals and Johnson and Johnson in an effort to get you compensation.

There is no up-front cost to you, and you will only pay us if we win the

case for you. The fee for our services will come out of any settlement or verdict directed to you.

We will hold the responsible parties accountable for the damage they

have done to you and your family.

Disclaimer: The information provided in this blog post is for general informational purposes only and should not be construed as legal advice. Consult with an attorney for professional advice tailored to your specific situation.