April 9, 2015 — The first of more than 1,000 lawsuits involving Zoloft is currently in trial, and Pfizer is accused of failing to warn women that they should use contraceptives to avoid having a baby with a heart defect.

Today, attorneys made opening arguments on behalf of 31 year-old Kristyn Pesante, who took Zoloft during pregnancy and had a son with several heart defects. The boy, now 11 years old, had three open-heart surgeries to address multiple defects and still suffers from complications.

According to Bloomberg, attorneys said Pfizer included the contraceptive recommendation in Zoloft’s “Core Data Sheet,” but did not include those recommendations in the U.S. safety label.

The lawsuit accuses Pfizer of hiding evidence linking Zoloft and birth defects so it could be marketed as superior to other antidepressants. Pfizer made $2.5 billion off Zoloft in 2005, the last year before it lost patent protection.

The Pesante case was filed in Missouri Circuit Court. Another state-court trial involving Zoloft birth defects is set for trial in Philadelphia at the end of May, brought by plaintiff Mia Robinson.

The outcome of the state-court litigation has high stakes for Pfizer and hundreds of women who have filed lawsuits after having children with heart defects. About 545 lawsuits have been centralized at the federal level in Pennsylvania, in Multi-District Litigation (MDL No. 2342). Dozens more lawsuits are pending in state-courts around the nation.

In 2011, the FDA issued a Safety Communication to warn about evidence linking Zoloft and a serious heart and lung defect known as Persistent Pulmonary Hypertension of the Newborn (PPHN). Since then, several studies have linked Zoloft with heart defects, skull defects, and more.


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