Sunday, June 14, 2015 - A jury ruled in favor of Pfizer on June 11 in the second bellwether trial looking into the connection between the pharmaceutical giant‘s depression medication Zoloft and the occurrence of birth defects in the children of pregnant mothers who took the drug. The decision was the second consecutive win for Pfizer, which faces in the neighborhood of 1,000 lawsuits claiming that Zoloft was the culprit in the development of crippling birth defects for children of mothers who took Zoloft.
Plaintiffs suing Pfizer claim that the company intentionally withheld warnings detailing the drug‘s connection to birth defects. The jury found that the warnings provided on the label by Pfizer were sufficient in warning patients about the possible risks of taking the drug. The decision in favor of Pfizer is expected to stifle the growth of new lawsuits joining the MDL pending against the company.
Zoloft, which brought in more than $3 billion for Pfizer at its peak in 2005, and generics like it received a warning from the FDA in 2006 in connection with the medication‘s risk for birth defects. Plaintiffs in the bellwether trial were able to produce documents from within Pfizer that warned of the potential link to birth defects, recommending a tougher warning label. A 1998 report on the drug commissioned by Pfizer was also presented at the trial which listed more than a dozen birth defects that may or may not have been related to the mothers taking Zoloft.
Both of the plaintiffs in the bellwether trials have been children suffering from birth defects their representatives claim were caused by Zoloft. Both of the children in the trials were both with abnormalities of the heart and suffered since birth from cardiac complications. The child at the center of the first trial had already undergone a series of open-heart surgeries in connection to his birth defects. The question however remains not whether the drug caused the ailments, but rather whether the warning labels provided were thorough enough for doctors and patients to make a sound decision when deciding to use them.
Pfizer has maintained throughout the trials that the warning labels already affixed to Zoloft contain more than enough information for physicians to make a sound decision before prescribing the medication. The two juries that ruled in favor of Pfizer thus far have found this to be the crux of the issue, and not whether the drug itself is linked to birth defects. The company has also produced recent regulatory reports that show the link between Zoloft and birth defects may not be as strong as plaintiffs are claiming.
Though the first two verdicts have come back positive for Pfizer, there is still the chance of large settlement looming in the future in connection with the MDL. GlaxoSmithKline‘s depression medication Paxil was one of the main medication at the heart of the company‘s massive $3 billion settlement in conjunction with a federal investigation, with an additional $1 billion paid to settle lawsuits against the company.
The first federal trials relating to the Zoloft lawsuits are slated to begin in January of 2016.