Pfizer is facing a lawsuit in the US over congenital birth defects linked to the use of its antidepressant Zoloft (sertraline) during pregnancy.
The lawsuit, filed on behalf of 18 children born with defects, claims that Pfizer failed to adequately warn doctors and patients of the drug’s risks.
As Zoloft is widely prescribed in the US and in Europe (as Lustral) for depression and related conditions, the lawsuit has the potential to trigger a widespread legal and sales backlash against the drug.
Zoloft is an SSRI approved by the FDA for treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, acute post-traumatic stress disorder, premenstrual dysphoric disorder and social anxiety disorder.
The lawsuit, filed in St. Louis Circuit Court, asserts state law claims against Pfizer of negligence; negligence of pharmacovigilance; strict liability; negligent design; failure to warn; and fraud. Actual and punitive damages are sought.
The plaintiffs claim that Pfizer knew, or should have known, of studies showing that children born to mothers who had taken SSRIs during pregnancy had a greater risk of serious birth defects such as atrial septal defect and multiple holes in the heart.
They further allege that Pfizer knew Zoloft was being prescribed to women of childbearing age but did not adequately warn doctors or the public of the risks.
“Since the 1990s, mounting evidence has shown that SSRIs, including Zoloft, are dangerous for pregnant mothers and their developing babies,” commented lawyer Jeffrey J. Lowe. “Unfortunately, Pfizer hid that information.”