Zoloft PPHN | Zoloft Birth Defects Lawsuit

Birth Defects Lawsuit Against Maker of Zoloft Moves to Federal Court

Staff Writer | May 18th, 2012

A mother whose child’s death was allegedly caused by Zoloft side effects will have to argue her case in federal court pursuant to a notice of removal filed by Pfizer, Inc. The lawsuit was originally filed in the Pennsylvania Court of Common Pleas, Philadelphia Civil Division, on April 11, 2012. The suit was brought by Dottie Kyle, who used the prescription medications Zoloft and Paxil during her pregnancy to treat her depression. Kyle’s daughter, Crystal Crooks, was born with severe birth defects, including cardiac defects, allegedly caused by Zoloft and Paxil. Crystal Crooks died on April 11, 2011.

Infant’s death allegedly caused by Zoloft PPHN

Though the Zoloft birth defects lawsuit was filed in state court, Pfizer, the manufacturer of Zoloft, filed a notice of removal on April 26, 2012, which moved the case to the U.S. District Court for the Eastern District of Pennsylvania. The removal is not likely to impair Kyle’s claims. On her deceased daughter’s behalf, Kyle is seeking both compensatory and punitive damages against Pfizer and SmithKline Beecham Corp.

Drug makers downplayed risk of defects like Zoloft PPHN

Zoloft (sertraline) is a member of the class of drugs known as selective serotonin reuptake inhibitors or “SSRIs.” The drug was approved by the FDA in 1991 and is one of the oldest SSRIs available. Zoloft has been one of the most prescribed antidepressants in the U.S., with almost 27 million prescriptions dispensed. In 2005, Zoloft’s sales totaled $3.3 billion.

Many of the patients taking Zoloft are women who became pregnant while using the medication. Central to Kyle’s lawsuit is the claim that Pfizer knew that its product posed significant risks to fetal development, but failed to adequately warn either pregnant women or physicians of the dangers. Kyle’s Zoloft birth defects lawsuit alleges that preclinical animal studies performed by Pfizer prior to Zoloft’s approval showed significant harm to fetuses when Zoloft was administered during pregnancy, including increased mortality and cardiac malformations. Birth injuries associated with Zoloft side effects include life-threatening cardiac conditions, spina bifida, persistent pulmonary hypertension (Zoloft PPHN), and limb deformations.

A 2007 study, published in the in the New England Journal of Medicine indicated that the risk of cardiac defects in babies exposed to Zoloft in the womb was 50 percent higher than in babies not exposed. Kyle argues that despite this and subsequent evidence, Pfizer did not actively discourage the use of Zoloft by women who were, or may have become, pregnant.