About Topamax – What is Topamax?
Topamax is the brand name of topiramate, which is an anticonvulsant drug. It is prescribed to help control convulsions, otherwise known as seizures. One of the more common causes of seizures is over active brain cells that cause an excess of brain activity. Topamax suppresses 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. Both Janssen Pharmaceuticals and Johnson and Johnson also settled numerous cases in 2010 in which mothers claimed that Topamax caused birth defects in their babies.
Topamax has since been elevated from a Category C drug, which means it 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 the benefits of taking the specific Category D drug outweigh its risks.
The attorneys at Herrman & Herrman, P.L.L.C. are ready to fight for you if your baby suffered a birth defect due to taking Topamax. Our compassionate product liability attorneys recognize that you are going through a difficult time and want justice. You need compassion, support, and trusted guidance. Our Topamax attorneys are committed to the principle that manufacturers should be held accountable when they produce unsafe products and when they fail to warn of known dangers. Manufacturers that fail to provide adequate warnings of the risks of using their product can be held accountable through product liability lawsuits. Herrman & Herrman PLLC is currently accepting clients who have birth defects after using Topamax. Filing a lawsuit against the manufacturer of a defective product may provide you compensation to pay for your medical bills and relieve financial distress. We can handle the legal issues while you focus on your family. A lawsuit also can draw attention to a public safety concern and prevent others in Texas, Corpus Christi, Corpus Christi South Side, Brownsville, McAllen, San Antonio, Houston, Ft. Worth and the Rio Grande Valley from suffering similar harm. If we represent you, we will handle your case on a contingency fee basis, so you will not have any upfront costs.
Common Topamax Side Effects
Topamax has a long list of side effects. The most common side effects of Topamax include blurred or double vision, unsteadiness or clumsiness, dizziness or drowsiness, trouble with thinking and concentration, paresthesia (tingling, numbness, or other skin sensations), diarrhea, unusual weight loss, taste change, nervousness, appetite loss, and infection of the upper respiratory tract.
While these side effects are the most common, the drug can cause more serious symptoms. 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, and birth defect.
About the Topamax Lawsuit
Janssen Pharmaceuticals has been sued due to birth defects caused by their product, 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 lawsuit, 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 while pregnant were 16x more likely to give birth to a baby with birth defects than those women who did not take Topamax while pregnant. In addition, many women were not warned of the possible side effects of the drug. The birth defects that Topamax has 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.
These are just some of the reasons for the lawsuit against Janssen Pharmaceuticals. In addition to these reasons, the FDA had to issue several warnings in the past due to the fact that many of the more serious or life-threatening side effects were not even listed on the label. The FDA eventually had to mandate that all Topamax labels not only list the potential side effects, but also provide a clear warning as to their severity. Despite numerous studies conducted prior, along with the aforementioned fines and settlements of claims in 2010, the FDA did not issue a warning for birth defects caused by Topamax until 2011.
The U.S. Department of Justice has also accused Janssen of illegally promoting the drug for off-label uses. These uses include treatment for, bipolar disorder, alcohol use disorder, weight loss, and more. Janssen also failed to warn both doctors and consumers that Topamax reduces the effectiveness of hormone-based birth control methods. Thus, the company has come under a lot of heat for causing potentially unwanted pregnancies. Pregnancies that could ultimately lead to a newborn with birth defects, and a life-long financial commitment for the unsuspecting mother who now has to pay for multiple corrective surgeries for her child.
Janssen’s “Legal Duty to Warn Consumers” & Birth Defect Warning & Illegal Marketing
Pharmaceutical manufacturers have a legal duty to warn consumers of any known side effects of their products. The catch is that manufacturers to not have a duty to warn of unknown dangers. The cases regarding Topamax 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 in 2010.
Some courts however, have said that this duty to warn does not extend to potential patients, but rather to their medical providers. Under this legal analysis, Janssen may have had a duty to warn consumers of the side effects and possibility of birth defects, or they may only have a duty to warn the prescribing doctors. This would put the onus onto the doctors to then advise their patients of any potential risks, and make the decision that is most appropriate for their patient’s unique medical situation.
Under Proposition 65, a California state law, all drug manufacturers are required to have a warning label on any products known to cause birth defects. Even though this is a California state law, it requires that any product that causes exposures to any individuals in California have a specific consumer warning that clearly states the risk of birth defects so that consumers can make an informed choice. This ultimately leads to a benefit for all states, as any product that is intended to be marketed to the whole nation must contain that warning under California law.
Topamax, or topiramate, had no such warning label. This left both providers and consumers in the dark about the risks of birth defects associated with the drug. Despite the numerous settlements by Janssen, the fines they were required to pay, and three very public and costly lawsuits, the company still did not comply with Proposition 65. Topiramate or Topamax was not listed on the Proposition 65 website as a drug that is known to cause birth defects until November 27, 2015.
In 2010, the U.S. Attorney’s office released a statement saying that Janssen Pharmaceuticals plead guilty to a misdemeanor for the misbranding of Topamax or topiramate in violation of the Food, Drug and Cosmetic Act. The U.S. Food and Drug Administration had only approved Topamax for anticonvulsant and anti-epileptic use, not for any psychiatric use. As a result, the manufacturer was required to pay a $6.1 million criminal fine, as well as over $73.5 million to resolve numerous civil claims by consumers who were prescribed Topamax for a litany of psychiatric uses that were never approved by the FDA, but were actively promoted as acceptable uses by Janssen Pharmaceuticals and, by proxy, Johnson and Johnson.
Status of Topamax 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’s Topamax docket. At this time, Topamax had been on the market for over 15 years with no warnings provided on the bottle or in the enclosed packet 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.
Topamax Verdicts: What Type of Compensation Can You Get If You Have a Case?
In October of 2013, a jury awarded $4 million dollars 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 wildly 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.
In summation, your case may be worth millions, and if you think you have a Topamax case, you should call us today so that we can help you get the justice you deserve.
Do I Have a Topamax 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.
How Can a Topamax Lawyer Help Me?
If you think you have a Topamax case, you should call us today. Our lawyers are ready to fight for you to get the justice you deserve. When you hire a lawyer for your Topamax case, they can file a claim for you against Janssen Pharmaceuticals and Johnson and Johnson 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.
Contact Texas Attorneys Investigating Topamax
If you have questions about birth defects caused by Topamax, call us for a free initial consultation and explanation of your legal rights. The attorneys at Herrman & Herrman P.L.L.C. offer more than 100 years of legal experience in representing people who have been harmed by unsafe products. Our legal team is ready to fight hard for the full compensation that you deserve. Our firm has offices in the following locations: Corpus Christi, Corpus Christi South Side, Brownsville, McAllen, San Antonio, Houston, and Ft. Worth, TX.