Pfizer Inc. failed to properly warn about its Zoloft antidepressant’s health risks even though internal reports noted some women who took the drug produced babies with birth defects, jurors were told at the end of the first trial of more than 1,000 lawsuits over the drug.
Pfizer’s internal reviews found links between Zoloft and heart abnormalities in babies but the company didn’t update the drug’s U.S. safety label to alert doctors and patients, Shelley Hutson, a lawyer for a family suing the company, said Friday in closing arguments in St. Louis state court.
Drug companies “can’t stay silent,” Hutson told the panel before it began deliberations in the case. “You must tell people what’s going on. Labels have to be updated and doctors have to be told” about risks.
Families suing Pfizer over Zoloft alleged the company turned a blind eye to their own researchers’ findings the drug use could produce babies with holes in their hearts and lung problems.
Pfizer contends there are no credible studies showing Zoloft causes birth defects and the U.S. Food and Drug Administration continues to back the drug as safe and effective, Beth Wilkinson, one of the company’s lawyers, said in her closing argument.
“The FDA, doctors and independent researchers all came to the conclusion that Zoloft did not cause birth defects,” Wilkinson told the panel.
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.
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.
The family of Logyn Pesante contends 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.
Pesante had to undergo three open-heart surgeries to address multiple defects and had a pacemaker implanted a month after his birth, according to court filings. The boy, now 11, still suffers from lingering problems tied to the defects and may need a heart transplant, according to testimony in the case.
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 birth defects.
That warning “never made it” into Zoloft’s U.S. warning label, Hutson told jurors Friday.
Pesante’s family already had rung up more than $2.7 million in medical bills dealing with his heart issues and Hutson urged the jurors to award damages that were “triple or quadruple” that amount to compensate them and pay for the boy’s future care.
Wilkinson countered that Pfizer officials included warnings about Zoloft use during pregnancy that were approved by the FDA. Those warnings urged doctors to decide whether the benefits of treating depression outweighed any risks posed by the drug.
The case is Pesante v. Pfizer Inc., 1222-CCO-2441, Missouri Circuit Court, 22nd Judicial District (St. Louis).