Another sad story that could have possibly been prevented. Another family harmed due to a negligent pharmaceutical company? One family thinks so, and is therefore trying to hold them accountable.
The Louisiana family is blaming the makers of Zoloft for their child being born with birth defects. In their Zoloft lawsuit, Terry and Nelda Rolling accuse Pfizer of failing to adequately warn of the drug’s risks, and of concealing, suppressing, and failing to disclose dangers.
The family alleges that Nelda took Zoloft while pregnant, which caused congenital birth defects in their baby, the minor plaintiff, identified as K.R., said The Louisiana Record. The Rolling’s are suing Pfizer individually and as parents and natural guardians of their baby.
Their complaint alleges that as early as 1996, Pfizer had information suggesting Zoloft could increase the risk of problems for children when taken during pregnancy, yet the drug maker failed to provide adequate warnings to consumers or the medical community. Evidence that Zoloft could harm a developing fetus continued to mount between 2002 and 2006. By 2007, due to the publication of a study in the New England Journal of Medicine, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken during pregnancy, the lawsuit claims.
What is Zoloft?
Zoloft is approved by the U.S. Food & Drug Administration (FDA) to treat major depression (MDD), social anxiety disorder, posttraumatic stress disorder (PTSD), panic disorder, premenstrual dysphonic disorder (PMDD), and obsessive-compulsive disorder (OCD) in adults and OCD in 6 to 17 year olds.
Zoloft and similar drugs, known as selective serotonin reuptake inhibitors (SSRI) antidepressants, operate by raising levels of serotonin, which plays a role in the development of the fetus.
A number of studies have linked SSRI antidepressants, including Zoloft, to birth defects. In July 2006, the FDA warned that women who use the antidepressant Zoloft after the 20th week of pregnancy are six times more likely to give birth to a child with persistent pulmonary hypertension of the newborn (PPHN). The FDA issued this warning about Zoloft based on the results of a study in the New England Journal of Medicine that examined the risk of birth defects with Zoloft and similar antidepressants.
Just last month, a new study conducted at Sweden’s Karolinska Institute found that expectant mothers taking SSRIs could experience a doubling of the risk of giving birth to a baby born with a serious, life-threatening lung condition known as neonatal pulmonary hypertension (PPHN). The risk was seen in that study as two-fold when SSRIs were taken by the infants’ mothers during pregnancy. Researchers from Sweden, Norway, Iceland, Finland, and Denmark used data collected from birth registries in their countries as part of the study.
Other prior studies have also linked SSRI use during pregnancy to increases in other birth defects, such as skeletal and heart and limb deformities, cleft lip and palate.
The Rollings are one of a growing number of plaintiffs who have filed suit alleging Zoloft caused birth defects. Their lawsuit was filed on January 27 in federal court in New Orleans.