Zoloft Lawsuit - SSRI Use Linked to Birth Defects
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Zoloft Lawsuit

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The Sanders Firm product liability lawyers represent clients nationwide whose newborns suffer from birth defects, including heart defects, cleft palate, and other problems after Zoloft use during pregnancy.

If you believe that your child’s congenital birth defects may have been caused by prenatal exposure to Zoloft (sertraline), you may be eligible to hold the drug company liable for damages. Parents who want to explore their options for legal recourse are invited to call The Sanders Firm for a free case evaluation.

Zoloft overview

Zoloft is used to treat depression, obsessive-compulsive disorder, panic attacks, post-traumatic stress disorder, and social anxiety disorder. It is also used to relieve the symptoms of premenstrual dysphoric disorder. Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.

SSRI antidepressants during pregnancy

Increased risk of birth defects including congenital heart deformities have been linked to antidepressant medication such as Zoloft when taken by women who are pregnant. Women who take Zoloft or other selective serotonin reuptake inhibitors (SSRIs) at any point during pregnancy, especially during the third trimester, have a greater risk for having children with life-threatening health issues, studies suggest.

Other SSRIs that may have negative effects on the baby in utero include:

  • Celexa
  • Fluvoxamine
  • Lexapro
  • Paxil
  • Prozac
  • Symbax

Generically available as sertraline, Zoloft is listed as a Pregnancy Category C medication by the U. S. Food and Drug Administration (FDA), which rates drugs based on their inherent risks of fetal injury. Category C medications have been shown to have adverse effects on animal test subjects, but lack substantial human trials to determine such risks.

Studies & FDA alert consumers about birth defect risks

Early research suggested that prenatal exposure to some SSRIs, including Zoloft, in the latter half of pregnancy put infants at increased risk for persistent pulmonary hypertension of the newborn (PPHN), in addition to life-threatening septal heart defects. One of the first such studies was published in 2006 in the New England Journal of Medicine, and indicated that mothers who took SSRIs after their 20th week of gestation were six times more likely to have a baby with PPHN – a serious lung disorder that often necessitates surgical intervention.

In fact, the FDA issued a drug safety communication in 2006, alerting healthcare providers and consumers about the risks of depression treatment during pregnancy with prescription antidepressants, citing findings of the birth defect risks associated with SSRI use.

In 2009, further studies on antidepressant and pregnancy risks was conducted by Danish researchers who determined that both Zoloft and Celexa, when taken early in the pregnancy, were tied to a small increased risk for certain heart defects. In 2011, the FDA released an updated safety communication regarding Zoloft, indicating that more studies are needed to confirm an association between SSRIs and PPHN, as some trials have yielded conflicting results.

Zoloft and birth defects

According to parents who’ve pursued legal remedies through the courts, Zoloft use during pregnancy is the direct and proximate cause of a range of health complications and birth defects.

Some of the health issues & birth defects attributed to Zoloft during pregnancy include:

  • Atrial septal defects (ASD)
  • Ventricular septal defects (VSD)
  • Persistent pulmonary hypertension of the newborn (PPHN)
  • Omphalocele
  • TOF (tetralogy of fallot) with pulmonary atresia
  • Craniosynotostosis
  • Cleft palate
  • Neural tube defects, causing spina bifida
  • Club foot/feet
  • Low fetal birth weight and low APGAR scores

At The Sanders Firm, we realize the emotional and financial tolls placed on families whose children are diagnosed with serious and potentially fatal congenital defects.  If you were prescribed Zoloft while pregnant and later delivered a child with heart defects or malformations, our team will evaluate your situation and establish whether you have a viable claim for damages against the manufacturer of Zoloft, Pfizer.

In addition to offering expert litigation advice and decades of winning trial experience against pharmaceutical giants like Pfizer, you can count on our personal injury attorneys to offer compassionate assistance and support during this difficult time in your life.

Allegations leveled in Zoloft lawsuits

When filing a claim against Pfizer involving alleged side effects of Zoloft, plaintiffs may sue on multiple causes of action, including failure to warn, negligence, fraudulent misrepresentation, breach of warranties and defective design. At the core of Zoloft litigation against Pfizer is the charge that women of childbearing age were not adequately warned about risks to their unborn child, despite prior studies that suggested otherwise.

To more efficiently handle pretrial proceedings and perhaps encourage settlement agreements, all federal Zoloft lawsuits alleging birth defects were centralized as multidistrict litigation (MDL No. 2342) under the guidance of Honorable Judge Cynthia M. Rufe. The Zoloft products liability litigation contains nearly 700 cases, with bellwether trials scheduled to begin in March 2016. Something of a test case, the outcome is meant to assist other plaintiffs and counsel in determining how juries are likely to react to legal arguments, expert testimony and other evidence.

Zoloft birth defect lawsuits have also been filed in state courts nationwide, with some reaching resolution. In 2015, a jury in St. Louis, Missouri found that Pfizer did indeed issue sufficient warnings about birth defect risks in its labeling and that the plaintiffs did not establish that Zoloft was the direct cause of the birth defects observed. In June of the same year, a Philadelphia jury cleared Pfizer of liability in the case of an 8-year-old born with serious heart defects, finding that the drug maker provided ample warning of each patient’s need to carefully assess risks and benefits before taking the medication while pregnant.

Learn more about your legal options

For over 46 years, The Sanders Firm has fought for the rights of those harmed by pharmaceutical companies that have placed profit over public safety. We are particularly dedicated to pursuing justice on behalf of the most vulnerable among us, including young children battling the effects of devastating birth defects. Not only will we seek full and fair compensation for the injuries sustained and the lifetime of supplemental health care that may be required, we are committed to securing corporate accountability from those responsible.

Hundreds of women who were unaware of the health risks associated with taking antidepressants during pregnancy have since discovered that their child’s heart defects or other birth complications could be directly linked to Zoloft. Contact a personal injury lawyer at The Sanders Firm to arrange your confidential legal consultation. Let us put our experience to work for you in recovering maximum compensation for your child’s pain and suffering. Call today toll-free at: 1 800 FAIR PLAY (800.324.7752).


  1. U.S. District Court, Eastern District of Pennsylvania, MDL No. 2342 https://www.paed.uscourts.gov/documents2/mdl/mdl2342

  2. FDA, Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies  https://www.fda.gov/Drugs/DrugSafety/ucm283375.htm

  3. British Medical Journal, Selective Serotonin Reuptake Inhibitors in Pregnancy and Congenital Malformations: Population Based Cohort Study https://www.bmj.com/content/339/bmj.b3569

  4. WebMD, Study Shows Small Risk of Heart Defect From SSRIs Taken During Pregnancy https://www.webmd.com/baby/news/20090924/antidepressants-linked-to-birth-defect