A Pennsylvania appeals court recently ruled to uphold a $3 million verdict in a case against Janssen Pharmaceuticals, Inc., after a trial court found the drug manufacturer to have been negligent in warning doctors about the risks of Topamax and birth injuries. Drug manufacturers are responsible for informing doctors of any potential risks or side effects of drugs so that doctors can then advise patients and prescribe medications appropriately. Medication-related birth defects are serious, and can have lifelong consequences.
Birth Injury Case Background
The original lawsuit against Janssen, a Johnson & Johnson subsidiary, alleged that an infant’s birth injuries resulted from the mother having taken Topamax while pregnant. The little girl was born with a bilateral cleft lip and palate. The trial court ruled that Janssen failed to make adequate efforts to educate and warn doctors about the potential risks of Topamax, including birth injury risks. This verdict was just one more highlighting a serious problem facing the American healthcare system, where large pharmaceutical companies fail to uphold their duty to inform doctors and subsequently patients about potential risks.
Following the trial court’s ruling, Janssen filed an appeal claiming that they should not be held liable for failure to warn about potential risks due to the company’s inability to change the pregnancy warning on the label without permission from the U.S. Food and Drug Administration (FDA). The appeals court upheld the original verdict stating that labeling is a separate issue, and that as a drug manufacturer, Janssen still had a duty to warn doctors about potential risks.
Further, the court of appeals held that the evidence presented at trial did indicate that Janssen was aware of a causal relationship between Topamax and birth defects, including cleft palate. Even so, the company failed to disseminate that information to doctors, including the plaintiff’s, in order for pregnant patients to be adequately warned.
Topamax and Side Effects
Topamax is a prescription medication used to treat certain varieties of seizure, as well as migraines. According to current FDA guidelines, Topamax can be prescribed in capsule form to be taken as a pill, or opened to sprinkle on soft food. As with most prescription medications, Topamax has a risk of adverse side effects, including:
- Visual field defects
- Metabolic acidosis
- Suicidal ideation and behavior
- Cognitive dysfunctions
The birth injury case discussed in this article originated in 2008, when the child was born. While the court ruled that at the time of the pregnancy, Janssen was not adequately warning doctors about the risks during pregnancy, the FDA has since updated the labeling information. Section 5.7 of the FDA’s Prescribing Information lists “Fetal Toxicity” as one of the potential adverse effects.
According to the new FDA label, Topamax “can cause fetal harm when administered to a pregnant woman”. Further, the label suggests that Topamax exposure during pregnancy presents an increased risk for cleft palate or cleft lip. The label says that Topamax has been tested in a variety of pregnant animals, and the results indicated birth defects including craniofacial defects, structural malformations, and reduced fetal weight.
Because of these risks, the FDA warns that Topamax should only be used during pregnancy if the benefits clearly outweigh the risks. The updated label also states that if a woman taking Topamax becomes pregnant, she should be educated about the potential risk of birth defects prior to using the drug.
Dangerous Birth Defects
Birth injuries and defects caused by medications can have long-term, even lifelong effects on the entire family affected. In the case of the child represented in the above-mentioned birth injury case – since her 2008 birth, the little girl has undergone over 14 procedures, including surgeries to treat her birth defects. Based on her ongoing, and expected continued need for treatment, the $3 million verdict included $1.5 million awarded to her parents to cover anticipated healthcare costs, and $1.5 million to the child for non-economic damages associated with her injuries.
Her family has argued throughout the lawsuit process that their fight against Janssen is not about money, but rather about the pursuit of justice for their family and the hardships their child has gone through. It is critical that drug manufacturers educate doctors about specific risks, such as potential birth defects or complications of pregnancy, in order to protect patients and promote safe drug usage. Failure to follow these requirements is a clear violation of patient rights.
What to Do after a Birth Injury
If your child was born with a birth defect, and you believe that it was caused by a medication you took while pregnant, you likely have many questions, such as:
- What are my legal rights?
- Can I fight a pharmaceutical company?
- Who is responsible for warning me about medications?
- How can I protect my family?
To find answers and learn more about your legal rights, contact Brown Wharton & Brothers to discuss your situation. We proudly offer a free case review to every potential client. Further, our firm operates on a contingency fee basis, meaning that you owe us nothing out-of-pocket if we do not win your case. Our focus is our clients and securing the best possible outcome for each individual case.
If you have a birth injury case and choose to hire us, we will work with you step-by-step to help you pursue justice and security for your family. During such a difficult time, you can trust the confident, compassionate, experienced birth injury attorneys at Brown Wharton & Brothers.
To schedule your free case review, contact us today via our online form and we wil.