Winnebago County, WIAn SSRI birth defects lawsuit filed at the start of the year in US District Court for the Eastern District of Pennsylvania alleges that the Selective Serotonin Reuptake Inhibitor (SSRI) antidepressant the mother continued to take while pregnant resulted in the death of a child.
In this case, the SSRI lawsuit centers on the Zoloft taken by plaintiff Justyne Eaton throughout her pregnancy. Depression affects upwards of 15 percent of women of childbearing age, many of whom have been prescribed SSRI antidepressants to combat the symptoms of depression. However, there are suggested risks associated with SSRI drugs and childbirth. The US Food and Drug Administration (FDA) has stopped short of pulling SSRI drugs from the market, noting the usefulness the class of drugs brings to the fight against depression - and that in many cases the benefits of treating serious depression outweigh any potential risks to an unborn fetus.
Tell that to plaintiffs Ryan and Justyne Eaton of Winnebago County. According to the Wisconsin Law Journal (1/18/13), their daughter came into the world with brain malformations, hydrocephalus and pulmonary hypoplasia. Aubrey Eaton did not survive, and succumbed, allegedly to SSRI side effects January 6, 2010.
The Eaton SSRI lawsuit is only the latest in a collection of lawsuits alleging harm at the hands of SSRI antidepressants. In the case of Zoloft, which is the SSRI drug involved in the Eaton lawsuit, there are no fewer than 270 other lawsuits that have been consolidated for discovery and bellwether trials this spring.
Evidence that suggests an association between SSRI antidepressants and birth defects goes back to 2006, when a paper published in the influential New England Journal of Medicine reported a significant association between PPHN (Persistent Pulmonary Hypertension of the Newborn) and selective serotonin reuptake inhibitors. The FDA responded with an alert suggesting a recommendation “that physicians carefully consider and discuss with patients the potential risks and benefits of SSRI treatment throughout pregnancy, including late pregnancy.”
However, in 2011, the FDA backpedaled somewhat, noting that out of five published studies on the issue, two found an association between SSRI drugs and PPHN, but three did not. The agency concluded that based on those findings, doctors and other healthcare providers had the FDA’s blessing to treat depression during pregnancy “as clinically appropriate.”
And while the FDA approved updated labeling for Zoloft this past December that references the need to notify a physician if a woman of childbearing age becomes pregnant or intends to become so - and also references the conflicted research outcomes - there appears to be no mention of increased risk for SSRI birth defects resulting from usage of Zoloft during pregnancy.
The Eaton’s 12-count SSRI lawsuit alleges strict product liability, failure to warn, defective design, negligence/malice, fraud, breach of warranties, a violation of the Wisconsin Consumer Fraud Act and wrongful death. Zoloft manufacturer Pfizer Inc. issued a statement, saying in part, “While we have great sympathy for all families dealing with birth defects, the Company stands by Zoloft and we intend to vigorously defend it.”
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