December 10, 2012 – The first cases brought over birth defects allegedly caused by Pfizer’s controversial antidepressant Zoloft are set to kick off in September 2014, according to a recent scheduling order issued by the federal judge presiding over the multidistrict litigation (MDL). To date, there are approximately 250 Zoloft birth defect lawsuits pending in the MDL, all of which were brought on behalf of children who were born with severe congenital abnormalities after their mothers took Zoloft during pregnancy. Birth defects linked to the maternal use of Zoloft have been reported to include heart and lung defects, persistent pulmonary hypertension of the newborn (PPHN), clubfoot, cleft lip, and many other congenital malformations.
What’s the problem?
According to a Pre-Trial Order issued last month by U.S. District Judge Cynthia M. Rufe, the first Zoloft birth defects trial date is tentatively set for September 14, 2014, so long as all appropriate discovery has been completed by that time. Rufe indicated that the first trial will not begin until at least eight months after the briefing of any challenges to expert testimony that may be offered. The parties have been directed by the judge to submit proposals for the Zoloft birth defect bellwether trials, which are scheduled to undergo case-specific discovery by January 11, 2013.
Manufactured and marketed by pharmaceutical giant Pfizer, Zoloft (generic: sertraline) is among the most widely-prescribed medications in the United States, and has been used by tens of millions of Americans since first being released in 1997. Yet despite its widespread success, Zoloft has recently been linked to a large number of serious birth defects when taken by expecting mothers during pregnancy (especially during the first trimester, a time when many women are still unaware they are pregnant). Congenital abnormalities associated with Zoloft have been reported to include:
- Atrial Septal Defects (ASD)
- Ventricular Septal Defects (VSD)
- Persistent Pulmonary Hypertension of the Newborn (PPHN)
- Tricuspid Valve (Ebstein’s Anomaly)
- Mitral Valve Prolapse
- Transposition of the Great Arteries (TGA)
- Transposition of the Great Vessels (TGV)
- Tetralogy of Fallot (TOF)
- Hypoplastic Left Heart Syndrome (HLHS)
- Hypoplastic Right Heart Syndrome (HRHS)
- Tricuspid Atresia
- Aortic Stenosis
- Pulmonary Atresia (PA)
- Patent Ductus Arteriosus (PDA)
- Coarctation of the Aorta
- Truncus Arteriosus
- Tricuspid Valve Stenosis
- Heart Murmur
- Pulmonary Stenosis
- Gastroschisis – abdominal wall defect
- Esophageal Stenosis
- Anal Atresia
- Spina Bifida
Zoloft birth defect lawsuits claim that Pfizer knew – or should have known – that the drug has the potential to cause birth defects, but that it was negligent for failing to warn both the public and medical communities about this risk. In a number of claims, Pfizer has also been accused of encouraging doctors to prescribe Zoloft to women of childbearing age, and that the company considers pregnant women to be one of their primary targets. In 2007, Zoloft became the most widely-prescribed antidepressant in the United States, with nearly 30 million prescriptions filled for the drug annually.