Pfizer Wins Dismissal in Zoloft Birth-Defect Warning Cases

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  • Nearly comprehensive order dismisses cases after three years
  • Women claimed Pfizer failed to warn them of risk to newborns

A federal judge in Philadelphia granted Pfizer Inc.’s request to dismiss more than 300 lawsuits attempting to link the antidepressant Zoloft to heart defects in newborns.

Pfizer was accused in lawsuits filed by hundreds of women in the U.S. of failing to warn pregnant mothers about possible birth defects. U.S. District Judge Cynthia Rufe in Philadelphia dismissed the vast majority of claims against Pfizer, ruling in the company’s favor without a trial. At least one case remains pending under Tuesday’s decision.

The ruling affirms that the plaintiffs failed to produce reliable scientific evidence that Zoloft causes the injuries the alleged, Pfizer said in a statement.

“There is extensive science supporting the safety and efficacy of Zoloft, and the medicine carries accurate, science-based and FDA-approved information on its benefits and risks,” the company said.

New York-based Pfizer reaped about $3.3 billion in Zoloft sales in 2005, making it the best-selling antidepressant on the market at the time. The company lost patent protection on the drug the next year and generic versions are now made by other drugmakers, including Mylan NV. Under U.S. law, the label on generic versions of the drug must contain the same warnings as Pfizer’s label.

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.

Mark Robinson, a lawyer for the plaintiffs, also didn’t immediately respond to phone and an e-mail messages seeking comment on the ruling.

Pfizer won two jury trials last year in cases brought by women making similar claims in Philadelphia and St. Louis. The cases demanded at least $2.4 million in damages for heart abnormalities in babies.

The case is In Re: Zoloft Products Liability Litigation, 12-md-02342, U.S. District Court, Eastern District of Pennsylvania (Philadelphia)