A report from the associate director in Pfizer’s Worldwide Safety Strategy unit warned company executives last year about a potential link between the anti-depressant drug Zoloft and birth defects. The report recommended changes to the medication’s warning label.
The report, introduced as evidence last week in a Philadelphia trial, could complicate Pfizer’s efforts to defend itself in lawsuits from parents of children with malformed hearts and was successful in a St. Louis trial in April, Bloomberg Business reports. The family in the Philadelphia case is seeking at least $2.4 million to cover the child’s future medical expenses.
More than a thousand lawsuits allege Pfizer sold Zoloft knowing it could cause cardiac abnormalities in newborns. The company successfully defended itself against a birth defect claim in the first lawsuit to go to trial in April, but this was before the report’s last week in Philadelphia, Bloomberg Business reports. Attorney Jim Morris, who has tried product-liability cases against Pfizer, though none involving Zoloft, said that now the report has surfaced, “I don’t see how they could go before a jury with a straight face” and argue that there is no link.
In a1998 report introduced into evidence in the Philadelphia trial, Pfizer researchers acknowledged more than a dozen birth defect reports for which Zoloft use could not be ruled out as a cause. But Pfizer said the internal review had been mischaracterized by plaintiff’s lawyers. Company spokeswoman Christine Rogen Lindenboom said plaintiffs’ attorneys had “cherry-picked” data from the review of adverse event reports and ignored conclusions that contradicted their testimony. Lindenboom said recent filings with U.S. and European health regulators support Pfizer’s contention that no credible link has been found between Zoloft and birth defects.
Pfizer hopes to persuade the Philadelphia jury to reject the claim that the girl’s birth defects, including a hole in her heart, were caused by her mother’s use of Zoloft, according to Bloomberg Business. In April, the jury in a state court in St. Louis, rejected arguments that Zoloft caused a boy’s heart defects. He needed three open-heart surgeries and had to have a pacemaker implanted.
Francesca Kolitsopoulos, of the epidemiology group of Pfizer’s Worldwide Safety reviewed published studies that showed an association between Zoloft and cardiac malformations, “which could be causal.” The April 2014 review concluded that researchers had found links between Zoloft use and septal heart defects, a congenital disorder that features a hole in a baby’s heart. Research also reported ties between the Zoloft and the birth defect omphalocele, in which the intestines or organs form outside the body. Kolitsopoulous proposed modifying Zoloft’s warning label to indicate that researchers had identified potential links to birth defects, according to Bloomberg Business.
The 1998 report shows that Pfizer safety monitors reviewed 50 side-effect reports from pregnant women who had taken Zoloft. Twenty-five cases involved “congenital abnormalities” or other adverse events “possibly related” to Zoloft use. In 16 of the cases, Bloomberg Business reports, “there was no obvious cause” for the defect other than the mother’s use of the anti-depressant.