Pfizer Wins First Trial Over Zoloft Birth-Defect Claims

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Pfizer Inc.’s Zoloft
Pfizer Inc.’s Zoloft antidepressant didn’t cause a boy’s birth defects, a jury concluded in the first trial of more than 1,000 lawsuits over what was once the U.S.’s most popular mood-altering drug. Photographer: JB Reed/Bloomberg

Pfizer Inc.’s Zoloft antidepressant didn’t cause a boy’s birth defects, a jury concluded in the first trial of more than 1,000 lawsuits over what was once the U.S.’s most popular mood-altering drug.

Jurors in state court in St. Louis Friday rejected arguments that Pfizer should be held liable for Logyn Pesante’s heart abnormalities. The boy’s family sought more than $2.7 million in compensation for three surgeries to deal with his multiple defects and having a pacemaker involved a month after his birth.

The case was the first against Pfizer to go to trial over claims officials knew Zoloft, once the U.S.’s most-prescribed antidepressant, could cause birth defects and failed to update safety warnings to protect billions of dollars in sales. The company faces similar suits in federal and state courts in Philadelphia seeking damages for children born with congenital defects.

“While we have great sympathy for families affected by birth defects, this verdict affirms that Zoloft did not cause the conditions alleged in this case,” Neha Wadhwa, a Pfizer spokeswoman, said in an e-mailed statement.

First Win

Winning the first trial in a mass-tort case can help a company manage what could develop into a sprawling litigation, said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

“It’s always important to set the tone when you are facing thousands of cases,” Tobias said in an interview. “The first win casts doubt on the strength of these Zoloft cases.”

New York-based Pfizer pulled in about $2.6 billion in Zoloft sales in 2005, making it the most popular antidepressant on the market. Pfizer lost patent protection over the medication the following year and generic versions are now made by Roxane Laboratories Inc.

The birth-defect allegations against Zoloft mirror claims against GlaxoSmithKline Plc over its Paxil antidepressant. The London-based drugmaker agreed in 2010 to pay more than $1 billion to settle more than 800 suits accusing the drugmaker of ignoring the birth-defect risks.

Glaxo also agreed to pay more than $3 billion to resolve criminal and civil allegations that it illegally promoted prescription drugs such as Paxil and failed to properly report safety data to regulators. The settlement included a criminal fine of almost $1 billion, prosecutors said.

Heart Hole

Some researchers contend the class of antidepressants that includes Zoloft and Paxil poses a greater risk of heart and lung defects in newborns than other mood-altering drugs.

Pesante’s family argued in court filings the boy was born with a hole in his heart and other congenital defects after his mother took Zoloft to treat depression during her pregnancy. Doctors testified in the case Pesante may need a heart transplant later in life.

The family’s lawyers argued that before Pfizer put the drug on U.S. market in 1991, company researchers noted in Zoloft’s “Core Data Sheet” that women who weren’t on birth control shouldn’t take Zoloft because of the risks of defects.

That warning never made into the drug’s U.S. safety label, Pesante’s attorneys said. They also argued multiple studies showed links between heart-defects and Zoloft use among pregnant women.

Pfizer’s lawyers countered there were no credible studies that found Zoloft caused birth defects and that the company included warnings about Zoloft use during pregnancy that were approved by the U.S. Food and Drug Administration.

The case is Pesante v. Pfizer Inc., 1222-CCO-2441, Missouri Circuit Court, 22nd Judicial District (St. Louis).

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