Eight sets of parents have filed suit against Pfizer Inc. over the antidepressant, Zoloft. Their lawsuit, filed last month in Illinois’ St. Clair County Circuit Court, claims Zoloft caused their children to be born with various birth defects including heart defects, neural tube defects, gastroschisis, omphalocele, craniosynostosis, cleft lip, club foot, anal atresia and limb reduction defects.
According to a report from the Madison-St. Clair Record, the mothers of the children named in the lawsuit all took Zoloft while pregnant. The lawsuit claims the mothers only took Zoloft because they believed it to be safe in pregnancy.
The lawsuit alleges that Pfizer should have known that Zoloft crosses the placenta, which could have important implications for the developing fetus. Despite knowing of Zoloft’s pregnancy risks, Pfizer failed to warn the public. Even now, Pfizer continues to market Zoloft as a safe drug to take during pregnancy, the complaint alleges.
“Pfizer’s sales force blitzed doctor’s offices with literature and verbal presentations designed to convince doctors and consumers that Zoloft was a superior drug for treatment of, among other things, depression during pregnancy,” the suit states. “Pfizer aggressively promoted Zoloft as an improvement over other antidepressant drugs on the ground that Zoloft was less likely to cause side effects if taken during pregnancy.”
The Zoloft birth defect lawsuit seeks unspecified compensatory damages, plus statutory remedies, a disgorgement of profits, pre-judgment interest, costs and other relief the court deems just. It charges Pfizer with strict products liability, breach of express warranty, negligence, misrepresentation by omission, negligent misrepresentation, fraud and misrepresentation, fraud by concealment, violation of consumer protection laws and breach of implied warranties against Pfizer.
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 dyphoric 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.