Earlier this month, a federal appellate court issued an opinion upholding a lower court’s verdict in favor of a mother whose child was born with a cleft palate and lip. According to one news source covering the case, the young girl suffers from hearing loss and speech problems, and she has undergone approximately 14 surgeries to correct the condition. The plaintiffs claim that the girl has also been subject to teasing and bullying as a result of her appearance and speech.
The case was brought against a subsidiary of a drug manufacturing giant, Johnson & Johnson, and it alleged that the company failed to warn doctors that pregnant patients may experience a heightened chance of birth defects if they take Topamax during the first trimester of pregnancy.
A Drug Manufacturer’s Duty to the Public
In general, manufacturers of over-the-counter and prescription drugs have a duty to warn people who may take a drug of any potential serious side effects. Of course, not every side effect of a medication is known at the time of manufacture, so only those potential complications that are known about must be disclosed. However, if a company fails to warn patients or prescribing physicians of potential dangers associated with the medication, the manufacturer may be held liable for injuries caused as a result.
In this specific case, the manufacturer of Topamax argued that it should no be held liable because it was unable to change the drug’s warning label without approval from the Food and Drug Administration. However, the federal appellate court hearing the appeal disagreed with the manufacturer and determined that there was still a duty in place to warn patients through their prescribing physicians of the potential dangers associated with taking Topamax during the first trimester of pregnancy.
Topamax Increases the Risk of Certain Birth Defects
Topamax is prescribed to help those who suffer from frequent migraine headaches, as well as those who suffer from certain types of seizures. However, it has been shown that there is a 3.8% prevalence of oral birth defects in those born to mothers who took the medication during the first trimester of pregnancy. The two most common birth defects are cleft palate and cleft lip. Both of these disorders are known to begin in early development, before the mother may even know that she is pregnant.
Was Your Child Born with a Preventable Birth Defect?
If you have recently given birth to a child who suffers from what you believe to be a preventable birth injury, your child’s injury may have been caused by the negligence of either a medical provider or the manufacturer of a medication that you took during pregnancy, unknowing of the potentially devastating effects it could have. To learn more about birth injury cases, contact a dedicated Maryland personal injury attorney at the law firm of Lebowitz & Mzhen, LLC. The skilled personal injury attorneys at Lebowitz & Mzhen have decades of experience helping their clients pursue compensation in all types of medical malpractice and birth injury cases. Call 410-654-3600 today to set up a free consultation.
More Blog Posts:
Pharmacists Try New Approach to Reduce Medication Errors, Focusing on Increased Communication, Pharmacy Error Injury Lawyer Blog, May 13, 2016.
600,000 Bottles of ADHD Medication Recalled for “Impurity”, Pharmacy Error Injury Lawyer Blog, April 22, 2016.