A Chicago woman born with a cleft lip and cleft palate alleges the antidepressant, Zoloft, is to blame, and has filed suit against Pfizer Inc. According to the Madison St. Clair Record, Angela Rife was born in 1991 with multiple birth defects, including oral clefts. Rife’s mother had been prescribed and used Zoloft during her pregnancy with Angela.
Zoloft, a selective serotonin reuptake inhibitor antidepressant (SSRI) 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 was approved in 1991, and by 2007 there were nearly 30 million prescriptions, making it the most prescribed antidepressant in the U.S.
However, a growing body of research has tied Zoloft and other SSRI antidepressants to an increased risk of birth defects when they are used in pregnancy, especially the earliest stages when many women are unaware that they are pregnant. In July 2006, the U.S. Food & Drug Administration (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. Since then, more evidence has accumulated linking Zoloft to birth defects, including a study published last month by researchers in Sweden linking SSRI antidepressants to PPHN, and another published over the summer that linked Zoloft and other SSRIs to an increased risk of autism.
Rife’s lawsuit charges Pfizer with acting in a “willful, wanton and outrageous manner and with evil disregard for the rights of patients.” According to the complaint, Pfizer knew of the dangerous side effects associated with taking the drug while pregnant, failed to properly test the antidepressant and failed to warn patients of the risk of serious birth defects. The lawsuit further alleges the drug manufacturer knowingly hid — and continues to hide — available information from patients about Zoloft’s risks.
Rife’s lawsuit was filed December 5 in Illinois’ St. Clair County Circuit Court. She is asking for more than $75,000 in actual damages in addition to punitive damages “in a fair and reasonable amount to deter Pfizer and others from engaging in the wrongful conduct.”
According to Pfizer, there are currently more than 50 lawsuits involving Zoloft pending throughout the country which involve common claims and questions of fact, namely that children were born with birth defects due their mothers’ use of the drug during pregnancy. Last month, the drug maker filed a motion with the U.S. Judicial Panel on Multidistrict Litigation to have Zoloft birth defect lawsuits transferred to the Southern District of New York, where Pfizer is headquartered. Pfizer also suggested that, as an alternative, the Northern District of Mississippi, the Southern District of Mississippi, or the Northern District of Ohio could also be suitable for the proposed Zoloft birth defect litigation.