An Illinois couple has filed a lawsuit against Pfizer after a birth injury resulted in their son’s death. The plaintiffs assert that their son was exposed to the antidepressant Zoloft, manufactured by Pfizer, and that he suffered from syndactyly and hypoplastic left heart syndrome, which eventually led to his death.
The lawsuit was filed in the U.S. District Court for the Eastern District of Pennsylvania and names the distributors and manufacturer of Zoloft as defendants. The claims include negligence, wrongful death, design defect, breach of warranty and failure to warn. The plaintiffs request damages for medical expenses and other losses. The case is joined with other similar cases in the Zoloft multidistrict litigation (MDL).
The lawsuit claims that Pfizer had a duty to warn the medical community as to the safety of Zoloft, and that the generic version of Zoloft, known as sertraline, contained package inserts that omitted information and contained misleading and false statements. The lawsuit states that the defendants knew or should have known that drugs such as Zoloft have a greater risk of side effects in children, and that they should have provided a warning of the risks to the developing fetus if a pregnant woman takes Zoloft.
According to the lawsuit, women who took Zoloft during pregnancy have given birth to children with birth injuries, such as heart defects and persistent pulmonary hypertension of the newborn (PPHN). The lawsuit alleges that the defendants failed to disclose data to consumers, the medical community and the FDA.