Zoloft General Information

Zoloft (Sertraline HCL) is manufactured by Pfizer Pharmaceuticals and was first introduced in 1990 in the United Kingdom. By 1991, Zoloft was approved by the U.S. FDA for the treatment of major depression. Zoloft was later approved by the FDA for the treatment of panic disorder as well as obsessive-compulsive disorder. Since its approval, it has grossed over $2 billion for Pfizer and was prescribed 30 million times in 2005.

Zoloft is in a class of drugs called SSRI’s (selective serotonin reuptake inhibitor). SSRI’s work by blocking the reabsorption of serotonin in the brain, and the result of blocking serotonin is that patients usually experience a boost in their mood. As with any drug, there are potential side effects to Zoloft, including nausea, dizziness, diarrhea, and loss of appetite.

Unfortunately, Zoloft has been in the news lately for other side effects: the possibility that pregnant women taking Zoloft could have babies born with birth defects. There have been recent studies suggesting that taking Zoloft during pregnancy could potentially cause ventricular septal defects, pulmonary stenosis, right ventricular hypoplasia, and complex congenital heart disease in babies. Unfortunately, there have not been enough studies performed on humans to confirm whether or not Zoloft is the root cause of the birth defects.

Though there has been no confirmation that Zoloft causes birth defects, over 250 lawsuits have been filed against Pfizer, all of which allege that the plaintiffs’ children were born with birth defects caused by taking Zoloft during pregnancy. During the discovery process, an internal document was found which suggested Pfizer was aware of the risks that birth defects that can be caused by Zoloft, but Pfizer argued that the emails were taken out of context.

In late 2014, the FDA urged Pfizer to update Zoloft’s warning label to add that recent studies have linked Zoloft to birth defects. Pfizer has refused the FDA’s request at this point, claiming that their own studies have shown there is no difference in major birth defect risks for pregnant women. Pfizer is contending that the FDA is unfairly targeting their company by “strongly urging” they change their label, because the relabeling request was part of an FDA plan to re-label pregnancy information on all prescription drugs, not just Zoloft.

Current State of Litigation
Beginning in 2012, lawsuits began to be filed against Pfizer as a result of women who took Zoloft and had babies born with birth defects. The lawsuits against Pfizer are alleging that Pfizer failed to warn the patients of the potential for birth defects, and that if they had known the risks they would not have taken Zoloft during their pregnancies.

Because of the number of lawsuits filed against Pfizer (more than 250), the lawsuits were consolidated in April 2012 in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania under Judge Cynthia Rufe. The lawsuits were consolidated to provide coordinated pretrial proceedings and to avoid inconsistencies between each lawsuit.

In April of 2015, a trial in state court in Missouri was heard involving a boy who was born with heart defects his mother believed to be caused by Zoloft. The plaintiff’s lawyers argued that Pfizer was aware of the risk of birth defects, and Pfizer countered that there are no credible studies that show a link between Zoloft and birth defects and that there were FDA approved warnings on the drug’s label. Ultimately, the jury found that Zoloft did not cause the boy’s heart defects.

In June of 2015, another Zoloft trial was heard in Pennsylvania. A mother sought over $2 million in compensation for her daughter who was born with heart abnormalities. Ultimately, the jury in the case found that Zoloft’s warning label was adequate enough to warn the mother of the potential risks, including the possibility that taking the drug during pregnancy could cause birth defects.

The first trials to be heard in the MDL are scheduled for March of 2016, and will be the bellwether trials. Bellwether trials are designed to let parties test their arguments and try to come to a resolution for all of the pending litigation. If the bellwether trials share similar results to the state court trials, Zoloft litigation might come to a swift end.