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Pfizer Accused of Downplaying Zoloft Pregnancy Risks

A lawsuit filed in the U.S. District Court for the Eastern District of Pennsylvania alleges the makers of antidepressant Zoloft are liable for heart defects present in the plaintiff’s baby. The woman, from Iowa, had been prescribed the drug while pregnant. The case is the latest Zoloft birth defects lawsuit to be added to the multidistrict litigation proceedings being undertaken against drug maker Pfizer (MDL No. 2342).

Zoloft pregnancy risks cited in lawsuit

The plaintiff’s child was born in September 2003, and was diagnosed with a number of serious birth defects shortly thereafter. The conditions suffered were:

  • Double Inlet Left Ventricle
  • Pulmonary Stenosis
  • Transposition of the Great Arteries
  • Ventricular Septal Defect

The child has had to undergo multiple surgeries. Pfizer allegedly knew of the risk of congenital birth defects caused by taking Zoloft during pregnancy, but failed to adequately label these risks or warn mothers.Pfizer continues to market Zoloft to pregnant mothers, despite a growing number of lawsuits making similar allegations.

Depression is a major health challenge, and antidepressants a huge source of revenue for the pharmaceutical industry. In 2005 alone, prescriptions worth $3.3 billion were written for patients with depression, anxiety, obsessive compulsive disorder and panic disorders.

First approved for sale by the FDA in 1991, Zoloft is Pfizer’s branded version of sertraline, one of the most common selective serotonin reuptake inhibitors (SSRIs) on the market. When Pfizer lost the patent for setraline in 2006, Zoloft was averaging annual sales of $27 million.

SSRIs are the most commonly-prescribed type of antidepressant. Though Pfizer admits they do not fully understand how SSRIs work, they are known to be extremely effective at treating severe depression. According to various studies conducted over the past two decades, SSRIs are no safer than older treatments for depression.

The Zoloft pregnancy risks we now know about include septal heart defects, neural tube defects, spina bifida, persistent pulmonary hypertension in newborns (PPHN) and autism. The risk is thought to increase if the drug is taken during the latter stages of pregnancy.

Pfizer allegedly knew of risks

Numerous Zoloft birth defects lawsuits have contended that Pfizer “knew or should have known” of the link between their product and a range of birth defects. Some claim they knew of the risks as early as 1991. Before Zoloft was released, Pfizer had allegedly established a causal link in clinical trials on animals, but they failed to warn physicians, consumers or the FDA.

Zoloft birth defects lawsuit added to MDL

The lawsuit filed by the Iowa couple joins the products liability MDL against Pfizer. Created on April 17, 2012, the MDL is designed to expedite the legal process and serve the convenience of all parties. The proceedings are being overseen by Judge Cynthia M. Rufe in the U.S. District Court for the Eastern District of Pennsylvania.

Judge Rufe has chosen 25 out of hundreds of cases for bellwether trials. These early hearings are designed to help predict the likely outcomes of Zoloft lawsuits and avoid conflicting rulings. The first case is set to be heard in October 2014.