This is an old page on Topamax birth injury lawsuits and side effects. Our law firm is not handling these lawsuits in 2024, but we leave up information for people who have an interest in the topic.
Topamax Birth Injuries
Topamax lawsuits are about to rise dramatically in light of new studies linking specific birth defects, namely cleft lip and cleft palate, to Topamax use by expectant mothers.
Our lawyers think the Topamax lawsuits are well-positioned to eventually lead to an MDL (which has happened since this was originally written in 2011). The Topamax class action lawsuit focuses on two key allegations: first, that Topamax should not have been released to the market or should have been recalled, and second, that it was often prescribed to patients who did not have the conditions the drug was intended to treat.
Topamax Not Have Been on the Market/Topamax Recall Should Have Occurred
First, Topamax’s manufacturer Ortho-McNeil, now partnered with Jannsen Pharmaceuticals, knew or should have known that Topamax would lead to cleft lip and/or cleft palate deformities in the children of pregnant woman taking Topamax. There is no reason why the studies that have been done which show the association between cleft lip/cleft palate injuries could not have been done before Topamax was commercially available.
One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects (most notably, cleft lips or cleft palates) compared to the risk in a background population of untreated women. Let’s pretend, without any evidence, that the study exaggerates the risk and it is half what the data indicates. That would mean that the children born to women on Topamax during pregnancy still have 10 times the risk of an oral birth defect. They should have known that moms taking Topamax during pregnancy were putting their unborn children at a ridiculously high risk of developing cleft lip and/or cleft palate.
Worse still is the fact that the injury occurs often before a woman even knows that she is pregnant. So it is not just women that know they are pregnant that are risk, any woman of childbearing age could get unexpectedly pregnant and have a child with a cleft lip/cleft palate.
Topamax Side Effects
Topamax (topiramate) is a widely prescribed medication primarily used to treat epilepsy and prevent migraines. While effective for these conditions, Topamax has been linked to a variety of side effects that range from mild to severe. Some of these side effects are well-documented and included in the drug’s labeling, while others have been the subject of litigation due to the serious risks they pose, particularly when used during pregnancy or for unapproved off-label purposes.
One of the most commonly reported side effects of Topamax is cognitive impairment. Patients frequently experience issues with memory, concentration, and overall mental clarity, often described as “brain fog.” These cognitive effects can be disruptive to daily life, as they interfere with tasks that require mental focus and decision-making. In some cases, these side effects persist even after the drug has been discontinued, raising concerns about the long-term impacts of Topamax on brain function.
Another significant side effect associated with Topamax is the increased risk of developing kidney stones. Topamax can reduce the amount of bicarbonate in the blood, leading to metabolic acidosis, a condition that changes the acidity of the body and can encourage the formation of kidney stones. This painful side effect may require medical intervention, including surgery in severe cases, making it one of the more concerning risks for patients on long-term Topamax therapy.
For those taking Topamax during pregnancy, the risks are especially serious. The drug has been strongly associated with birth defects, particularly cleft lip and cleft palate in newborns. The FDA reclassified Topamax as a Pregnancy Category D drug in 2011, indicating that there is positive evidence of fetal risk. Studies have shown that women who take Topamax during the first trimester of pregnancy have a significantly higher chance of giving birth to babies with these congenital defects, leading to numerous lawsuits against the manufacturer for failing to adequately warn patients and healthcare providers.
Topamax has also been linked to serious vision problems, including acute myopia and secondary angle-closure glaucoma, which can cause permanent damage if not addressed promptly. Patients have reported sudden decreases in vision and eye pain, often requiring immediate medical attention to prevent long-term damage. While these effects are certainly rare, they are severe enough to warrant regular monitoring of eye health for individuals prescribed Topamax.
In addition to these major concerns, there are a number of other potential side effects that patients may experience while taking Topamax. These include nausea, dizziness, fatigue, weight loss, and tingling sensations in the hands and feet. While many of these side effects are relatively mild and may subside with continued use, they can still impact a patient’s quality of life and should be monitored by healthcare professionals.
Pushing Topamax for Patients That Don’t Have Epilepsy
Okay, you might be saying, drugs come with risks. Topamax treats epilepsy, apparently with great success, and maybe there are some women who did not expect to get pregnant who used Topamax for epilepsy. I agree. I don’t think that particular class of cases is going to fare particularly well. (this is the fact pattern J&J will push to the top for an MDL bellwether trial.)
But the reality is that while you can make a lot of money selling a good epilepsy drug and a lot more money making an ever broader appeal. The FDA approved Topamax as an anti-epileptic drug not for any psychiatric use. But Topamax was criminally marketed to expand the reach of sales of Topamax far beyond the limited conditions for which the drug was approved. An assertion like this sounds like plaintiffs’ attorney hype to gin up lawsuits but, unfortunately this is fact, not fiction.
Ortho-McNeil’s Criminal Guilty Plea
The government filed criminal charges that alleged that Johnson & Johnson, through its subsidiary Ortho-McNeil, promoted Topamax for off-label uses beyond its FDA-approved indication for epilepsy, including psychiatric disorders, weight control, and addiction treatment. To support this scheme, Ortho-McNeil organized conferences and paid physicians through its “Doctor for a Day” program to promote these unapproved uses. Despite FDA warnings in 2001 about serious risks like acute myopia and glaucoma, and a 2004 warning about the dangers of Topamax in pediatric patients, off-label marketing continued.
Ortho-McNeil pled guilty to introducing Topamax into interstate commerce for uses that were not approved by the FDA, which is a violation of U.S. law. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims). The U.S. government said that Ortho-McNeil promoted Topamax with the oldest trick in pharmaceutical sales: hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.
What’s the motivation here? A lot of money has been made selling Topamax. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States. Ortho-McNeil has made a fortune off of Topamax. No matter how the Topamax lawsuits turn out, this fact is not going to change. But maybe Ortho-McNeil/Johnson & Johnson will be required to give some of that money back to children who are going to suffer from the trauma of dealing with these birth injuries, including the surgical costs for the corrective surgery that very young children – infants, actually – have to undergo because their mother was prescribed Topamax while she was pregnant.
Topamaz Litigation History
Timeline of Topamax Litigation
1996 – Topamax FDA Approval
- December 24, 1996: The FDA approves Topamax (topiramate) for the treatment of partial-onset seizures in adults with epilepsy as an adjunctive therapy.
2001-2003 – Off-Label Promotion
- During this period, Ortho-McNeil Pharmaceuticals, a subsidiary of Johnson & Johnson, promotes Topamax for unapproved uses, including bipolar disorder and alcohol dependency. This leads to future legal scrutiny for off-label promotion.
2008 – FDA Warning on Suicidal Thoughts
- The FDA issues a warning that anticonvulsant drugs, including Topamax, increase the risk of suicidal thoughts and behavior.
March 2011 – FDA Birth Defects Warning
- The FDA issues a safety alert that Topamax use during pregnancy increases the risk of birth defects, particularly cleft lip and cleft palate in newborns. Topamax is reclassified as a Pregnancy Category D drug, indicating positive evidence of fetal risk.
2011 – First Wave of Birth Defect Lawsuits
- Following the FDA’s warning, lawsuits begin to be filed by families alleging that Topamax use during pregnancy caused birth defects like cleft lip and palate.
- Claims assert failure to warn of the risks to pregnant women and inadequate labeling by the manufacturer.
2012-2014 – MDL Formation
- 2012: Plaintiffs push for the consolidation of birth defect cases into a Multidistrict Litigation (MDL) to streamline pretrial proceedings.
- 2013: MDL No. 2738 is established in the U.S. District Court for the Eastern District of Pennsylvania, centralizing hundreds of federal cases alleging that Topamax caused birth defects.
2014-2015 – Settlements
- 2014: Jury verdicts in some bellwether trials (test cases) lead to multi-million-dollar awards for families, such as a verdict of over $11 million to a family affected by Topamax-related birth defects.
- 2015: Janssen Pharmaceuticals (a division of Johnson & Johnson) agrees to settle a large number of Topamax birth defect claims for confidential amounts. This results in the resolution of many cases, though the terms remain undisclosed.
2017 – Continued Settlements
- Most of the birth defect cases in the MDL have settled by this point, although some individual cases may still proceed in state courts or other jurisdictions.
2020-2023 – Other Topamax Litigation
- Although the birth defect MDL is largely (or completely) resolved, lawsuits involving other Topamax side effects continue in various courts.
- Janssen Pharmaceuticals also faces ongoing legal challenges related to the off-label promotion of Topamax.
2024 – Topamax Litigation Status
- By 2024, the Topamax MDL has effectively concluded with most cases either settled or resolved through verdicts. Our law firm is not handling Topamax lawsuits and we are unaware of any lawyers that are.