Pfizer Knew of Risk of Congenital Birth Defects from Zoloft: Lawsuits

Two couples from Louisiana have filed a lawsuit against Pfizer that alleges the drug maker intentionally hid the link between their popular antidepressant Zoloft and congenital birth defects when the drug is taken by pregnant women.

The two Zoloft birth defect lawsuits were filed in late January in the U.S. District Court for the Eastern District of Louisiana by Terry and Nelda Rolling and Joseph and Meg Mitchell.

Both complaints involve children born with congenital birth defects after the mother’s use of Zoloft during pregnancy.

A growing number of families throughout the country have filed a similar Zoloft lawsuit against the drug maker, raising allegations that use of the antidepressant during pregnancy caused children to be born with a variety of birth defects and malformations.

Zoloft (sertraline) was introduced by Pfizer in 1991 for the treatment of depression, obsessive-compulsive disorder and anxiety. By 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the United States. Zoloft belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRIs).

In recent years, a growing amount of research and adverse event reports have suggested that side effects of Zoloft use during pregnancy may increase the risk of serious and potentially life-threatening health problems for babies, including persistent pulmonary hypertension in newborns (PPHN), spina bifida, heart defects, lung defects, abdominal defects, cranial defects and other malformations.

Studies have suggested that Zoloft may increase the risk of birth defects when used as early as the first trimester of pregnancy, a time when many women do not even know they are pregnant.

As recently as last month, Swedish researchers published a study suggesting a link between PPHN and all SSRI antidepressants.

A study in July linked Zoloft and other SSRIs to an increased risk of autism, and a study from a year ago found that Zoloft and similar drugs could delay infant developmental goals if taken by the mother during pregnancy.

The lawsuits allege that data was available to Pfizer as early as 1996 that suggested their SSRI antidepressant may 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.

Between 2002 and 2006, evidence continued to mount that children given the drugs suffered higher rates of prematurity, lower birth weight and length, low APGAR scores and other problems, including some birth defects.

By 2007, the lawsuits claim, Pfizer knew or should have known that Zoloft and other SSRIs doubled the risk of septal heart defects when taken by pregnant women due to another New England Journal of Medicine study that year. Those results were confirmed in a 2009 study.

The lawsuits allege that Pfizer willfully failed to warn consumers of the risks in order to maximize profits, resulting in a negligent breach in its duties to the medical community, users of their medication and their unborn children.