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Pfizer Knew of Zoloft Pregnancy Risk, Alleges Virginia Woman

A lawsuit filed on May 30, 2013 in the U.S. District Court for the Eastern District of Pennsylvania alleges the makers of antidepressant Zoloft are liable for the wrongful death of the plaintiff’s daughter. The woman had been prescribed the drug while pregnant. According to court documents, she was not made aware of the Zoloft pregnancy risk, which includes a variety of heart defects.

The plaintiff’s daughter died shortly after being born in Norfolk, Virginia in July 2005. Doctors diagnosed a hypoplastic left lung and bilateral hypoplasia using an ultrasound. The bereaved mother filed the lawsuit against drugmakers Pfizer, alleging the company knew or should have known of the Zoloft pregnancy risk. She had taken Zoloft from November 2004 until May 2005, two months before the birth of her daughter, who was born slightly prematurely at 36 weeks.

Despite a growing number of similar lawsuits alleging a link between Zoloft and birth defects, Pfizer continues to market the drug irrespective of whether or not a patient is pregnant.

Approved by the FDA in 1991, Zoloft is Pfizer’s branded version of sertraline, one of the most popular selective serotonin reuptake inhibitors (SSRIs) on the market. Before losing the patent for setraline in 2006, Pfizer averaged sales of 27 million each year. In 2005 alone, prescriptions worth $3.3 billion were written for patients with depression, anxiety, panic disorders and obsessive compulsive disorder.

SSRIs are the most commonly-prescribed antidepressant. Though their precise mechanism is not fully understood, they are known to be effective at treating severe depression. According to a number of studies, the widely-held perception that SSRIs have less serious side effects than other types of medication may not be the case.

Studies have shown the Zoloft pregnancy risk to include septal heart defects, neural tube defects, spina bifida, persistent pulmonary hypertension in newborns (PPHN) and autism. The risk is thought to be higher when the drug is taken during the last half of pregnancy.

Pfizer allegedly knew of Zoloft pregnancy risk

Numerous lawsuits have contended that Pfizer “knew or should have known” of the link between Zoloft and birth defects – which include heart problems and skull deformities – as early as 1991. Prior to the drug being released to market, Pfizer had allegedly established a causal link in clinical trials on animal fetuses, but failed to warn physicians, the public or the FDA.

Zoloft birth defects lawsuits consolidated

According to a recent update on the ongoing legal proceedings against Pfizer, 336 lawsuits are currently compiled in a multidistrict litigation (MDL 2342), and a further fifty cases are pending at the federal level. Several state courts including Missouri, New York, Illinois, West Virginia and Pennsylvania are waiting to hear at least 23 cases relating to the Zoloft pregnancy risk.

Created on April 17, 2012, the Zoloft lawsuit MDL, designed to speed up the legal process, is being overseen by Judge Cynthia M. Rufe at the U.S. District Court for the Eastern District of Pennsylvania.

Judge Rufe has chosen 25 potential cases for bellwether trials, which are intended to help predict the likely outcomes of future Zoloft birth defects lawsuits. The first case is set to be heard in October 2014.