New York, New York

HomeNew YorkNew York

Email Eric T. Chaffin Eric T. Chaffin on Twitter Eric T. Chaffin on Facebook Eric T. Chaffin on Avvo
Eric T. Chaffin
Eric T. Chaffin
Attorney • (888) 480-1123

38 Plaintiffs Agree—Zoloft Manufacturer Advertised to Pregnant Mothers

Comments Off

In a lawsuit filed June 6, 2012, 38 plaintiffs claim that the antidepressant Zoloft (sertraline) caused their newborn children to suffer from birth defects. Like other plaintiffs who have filed similar complaints, the parents accused manufacturer Pfizer of failing to warn physicians and pregnant woman about the potential link between Zoloft and birth defects. The plaintiffs further accuse Pfizer of actually marketing Zoloft to pregnant women, when the company knew or should have known about the risks of birth defects.

2006 Study Links Zoloft with PPHN

The FDA first approved Zoloft as a treatment for depression in 1991. The drug has also been used to treat obsessive-compulsive disorder, panic disorder, anxiety, post-traumatic stress disorder (PTSD), and certain premenstrual disorders. Initial approval was surrounded by controversy. The FDA’s director of neuropharmacological products at the time stated the choice to approve Zoloft was a “tough decision.” Early clinical studies had shown the medication to create only ”modest to minimal” improvements in symptoms of depression.

In 2005, the FDA added a warning to the drug label identifying the risk of suicidal behavior in children. In 2006, Zoloft birth defects became public knowledge when a study published in the New England Journal of Medicine linked the antidepressant with Persistent Pulmonary Hypertension of the Newborn (PPHN). This condition restricts blood flow to the lungs, creating shortness of breath and an irregular heartbeat. Shortly afterward, the FDA issued a public health advisory alerting physicians to the risks.

Zoloft Birth Defects Lawsuits Increase

Following the 2006 study, other research confirmed a link between antidepressants like Zoloft and birth defects. For example, a 2007 study showed a significant association between Zoloft and omphalocele (abdominal defect) and septal heart defects, and a 2009 study linked Zoloft use during the first trimester with atrial septal heart defects.

These studies led to an increase in Zoloft birth defect lawsuits, with parents claiming Pfizer failed to adequately study the drug before launching it onto the market. So many lawsuits were filed that in April 2012, the U.S. Judicial Panel on Multidistrict Litigation consolidated them in the U.S. District Court for the Eastern District of Pennsylvania. Plaintiffs in this most recent case, however, filed in St. Clair County Circuit Court.

Plaintiffs Accuse Pfizer of Promoting Zoloft to Pregnant Women

Lead plaintiff James Tyler Schuhardt and 38 other parents claim their children were born with Zoloft birth defects including vascular malformation, cleft lip and palate, club foot, heart disease, holes in the heart, autism, facial dysmorphism, learning disabilities, multiple kidneys, infections, missing earlobes, and a hole in the back of the head. Had these parents known about the risks – in other words, had Pfizer adequately warned about them – they claim they never would have used Zoloft during pregnancy.

These parents also accuse Pfizer of blatantly promoting Zoloft to pregnant women. They state in their complaint that Pfizer's sales force presented literature and verbal presentations meant to convince doctors and patients that Zoloft was the best treatment for depression during pregnancy, while hiding the risks. Like other plaintiffs, they also claim the company failed to follow up after study results to alert the public to the dangers associated with the drug.

Some of these parents have paid the highest price – their children actually died of the birth defects.