Zoloft MDL judge rules, birth defects cases dismissed

Zoloft MDL

A Pennsylvania federal judge last week dismissed more than 300 lawsuits against Pfizer Inc. that had alleged its antidepressant Zoloft caused birth defects in children born to women who took the drug during pregnancy.

U.S. District Judge Cynthia Rufe in the Eastern District of Pennsylvania said that plaintiffs, whose cases were consolidated in federal court, had not produced enough evidence to scientifically link the drug and birth defects. The decision comes after previous decisions that excluded testimony from key plaintiff expert witnesses. There had been two trials involving Zoloft birth-defect claims in state courts in Philadelphia and Missouri, both of which Pfizer has won. Those cases demanded at least $2.4 million in damages for heart abnormalities in babies.

Judge Rufe wrote in her opinion: “The court recognizes that the final scientific verdict as to whether Zoloft can cause birth defects may not be delivered for many years…Nevertheless, plaintiffs chose when to file their cases, and the court concludes that for the plaintiffs who have continued to pursue their claims, the litigation gates must be closed.”

Zoloft is part of a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. Pfizer has denied acting improperly and said that a number of major medical groups, including the American Heart Association, have supported its position, while Plaintiffs said that the company played down the birth-defect risks of the popular drug in order to boost sales.
New York-based Pfizer earned about $3.3 billion in Zoloft sales in 2005.

The company lost patent protection on the drug the next year and sertraline, the generic, is now made by other drugmakers, including Mylan NV. The drug currently generates about $375 million in revenue for the company or about 0.8 percent of the company’s total sales in 2015.