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Lawsuit Alleges that the Manufacturer of the Antidepressant Zoloft Failed to Warn of Known Risks of Birth Defects

Over the past 20 years, the use of antidepressants such as Paxil and Zoloft have increased by nearly 400 percent among patients between the ages of 18 and 44. The most commonly prescribed antidepressants contain serotonin reuptake inhibitors (SSRIs), which have been shown to increase the risk of birth defects. These birth defects include heart malformations, spina bifida, and persistent pulmonary hypertension (PPHN).

Recent lawsuit alleges heart defects in newborn resulting from mother’s use of Zoloft during pregnancy.

On June 13, 2013, a federal lawsuit was initiated against Pfizer, Inc. the manufacturers of the antidepressant, Zoloft. The lawsuit alleges that the antidepressant caused harm to the plaintiff’s unborn child. The woman took Zoloft as prescribed by her doctors as treatment for depression. She believed the product to be safe based on the advice of medical professionals as well as, the manufacturer’s marketing materials and warning labels. However, her child was born with congenital heart defects, which have required multiple heart reconstructive surgeries and other ongoing medical treatment.

According to the lawsuit, Pfizer manufactured and sold a defective product, and failed to warn consumers of the product’s known dangers. The lawsuit specifically points to studies linking the medication to a variety of birth defects including heart abnormalities and PPHN.

FDA has issued numerous warnings regarding the risks associated with taking SSRI antidepressants during pregnancy.

In 2005, the Food and Drug Administration (FDA) issued a safety communication that sought to educate the public regarding the increased risk of congenital heart defects among newborns when mothers took Paxil during the first three months of pregnancy. According to studies cited in the FDA’s safety communication, taking Paxil during the first trimester of pregnancy doubled newborns’ risk of heart defects, as compared to other types of antidepressants. Accordingly, the FDA asked GlaxoSmithKline, Paxil’s manufacturer, to change the drug’s warning label to indicate that it carried a known risk of birth defects to the human fetus.

In 2006, the FDA issued another public health advisory regarding birth defects, namely neonatal PPHN, linked to SSRI antidepressants. It cautioned medical providers and patients to consider the risks of SSRIs and to weigh them against stopping the patient’s treatment for depression during pregnancy. The advisory was based on a study published by the New England Journal of Medicine, which indicated that babies were six times more likely to be born with PPHN when the mother took SSRIs after the 20th week of pregnancy.

If you took an antidepressant during your pregnancy and your child was born with a birth defect, you should contact Goldstein & Hayes immediately. An attorney will be able to review the facts of your case and determine whether the drug manufacturer’s negligence, fraud, breach of warranty, or other misconduct caused your child’s injuries. If so, an attorney can help you seek the compensation you deserve, both for the cost of your child’s past and future medical expenses as well as, you and your child’s pain and suffering.