Zoloft Injury Lawsuit - SSRI Birth Defects in Children

Texas Mother Files Zoloft Injury Lawsuit

Staff Writer | April 1st, 2014

zoloft injury lawsuitAnother Zoloft injury lawsuit has just been added to the multidistrict litigation (MDL) in federal court in Philadelphia.  A Texas mother charges that her child was born in 2003 with life-threatening congenital birth defects due to the mother’s use of Zoloft during her pregnancy.

The mother asserts that the drug’s manufacturers, Pfizer and its subsidiary Greenstone, knew that Zoloft caused severe side effects in children whose mothers took the medication while pregnant.  But defendants concealed that information from the mother, her treating physicians, and the FDA, the mother alleges.  Had she been warned of the risks, the mother charges, she would not have used the drug during pregnancy.

Zoloft side effects in children

The FDA approved Zoloft to treat major depression in adults in 1991.  It quickly became one of the most frequently-prescribed drugs in the United States, with over 39 million Zoloft prescriptions written in 2012.  Many physicians prescribed Zoloft to women of child-bearing age, and continued to prescribe its use when those women became pregnant.

Some studies have shown that Zoloft use during pregnancy causes congenital birth defects.  A study of nearly 500,000 children born in Denmark between 1996 and 2003 found that infants were more than three times as likely to be born with heart defects when their mothers used Zoloft while pregnant.

A 2007 study in the New England Journal of Medicine found that Zoloft use during pregnancy was associated with a variety of serious birth defects.  Infants born to mothers who took the medication while pregnant were nearly twice as likely to suffer craniosynostosis (a growth defect of the skull that can affect brain development); twice as likely to be born with septal heart defects; and nearly six times as likely to be born with omphalocele (a birth defect in which the infant’s intestines stick out of the navel.)

In 2006, the New England Journal of Medicine published a study linking Zoloft during pregnancy to a birth defect called persistent pulmonary hypertension of the newborn (PPHN).

Zoloft injury lawsuits centralized under MDL

Over 420 Zoloft cases have now been centralized for pretrial handling in the MDL.  The lawsuits charge that Pfizer knew that Zoloft use during pregnancy caused congenital birth defects, but failed to notify the FDA, the medical community, and women who became pregnant while taking the drug.

The lawsuits assert a number of claims against Pfizer, including:

  • Failure to warn of Zoloft’s known dangers to developing fetus
  • Defective design, manufacture, and marketing of Zoloft
  • Negligence in Zoloft’s development, formulation, distribution and marketing
  • Negligent design of Zoloft
  • Fraud, misrepresentation, and suppression of adverse information regarding Zoloft’s dangers to developing fetus
  • Breach of express and implied warranties
  • Gross negligence and malice
  • Negligent infliction of emotional distress

Plaintiffs seek compensation for pain and suffering, past and future medical expenses, loss of future earnings capacity, loss of consortium, and other losses.  In addition, the victims allege that Pfizer acted with deliberate, wanton, willful, and conscious disregard for the safety of consumers.  Accordingly, the lawsuits seek punitive damages from Pfizer.

This Zoloft injury lawsuit was filed by the Texas mother on February 27, 2014.  The first trial in the Zoloft MDL is scheduled to begin October 28, 2014.


  1. Lars Henning Pedersen et al., “Selective serotonin reuptake inhibitors in pregnancy and congenital malformations: population based cohort study,” BMJ 2009 (September 23, 2009) http://www.bmj.com/content/339/bmj.b3569

  2. Louik C, Lin AE, Werler MM, Hernandez-Diaz S, Mitchell AA. “First-trimester use of selective serotonin-reuptake inhibitors and the risk of birth defects.” N Engl J Med http://www.nejm.org/doi/full/10.1056/NEJMoa067407

  3. IMS Health, “Top 25 Medicines by Dispensed Prescriptions (U.S.)” http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Corporate/Press%20Room/2012_U.S/Top_25_Medicines_Dispensed_Prescriptions_U.S..pdf