Pregnancy & SSRI Antidepressants: The Zoloft® Lawsuit

Zoloft® is a prescription drug that belongs to a class of medications called selective serotonin reuptake inhibitors (SSRIs). This type of medication is used to treat a variety of psychological disorders.

A woman with her hands folded in front of her
Many patients who were prescribed Zoloft® and other SSRIs have experienced severe complications.

Serotonin regulates mood, appetite, and sleeping patterns, and has some functions in cognitive processes, including memory and learning, as well. SSRIs work by preventing the reabsorption of serotonin, allowing the chemical to interact with synapses for an extended period of time. This process is thought to contribute to feelings of well-being and happiness.

The results of several recent studies have shown a link between women who took Zoloft® or other SSRIs while pregnant, and an increased incidence of their babies developing autism spectrum disorder and other birth defects.

The results of several recent studies have shown a link between women who took Zoloft® or other SSRIs while pregnant, and an increased incidence of their babies developing autism spectrum disorder and other birth defects. Many women who took these medications while they were carrying their child have already filed claims against the manufacturers in the Zoloft® lawsuit. If you were prescribed an SSRI while you were pregnant and your child suffered from birth defects, including autism, please contact an attorney to explore your legal options. An experienced defective products attorney can help you understand the current status of the case and advise you on the best way to proceed.

Who May Be Prescribed Zoloft® or Other SSRIs?

Researchers estimate that nearly 10 percent of the U.S. population is prescribed antidepressants by their doctors. Women are more likely to be prescribed these drugs, and as many as 25 percent of women in their 40s and 50s are currently on SSRIs or a similar type of medication. SSRIs are considered third-generation antidepressants, and they are thought to have fewer side effects than earlier formulations. SSRIs are commonly prescribed to treat depression, anxiety disorders, panic attacks, and certain personality disorders.

SSRIs that Have Been Named in Lawsuits

This class of medications has been linked to serious complications and side effects, leading to many lawsuits.


Zoloft® is an SSRI antidepressant manufactured and developed by Pfizer in 1990 that was intended to be a safer alternative to Prozac®. The medication was available in the United Kingdom before the U.S. Food and Drug Administration (FDA) approved Zoloft® for use in this country in 1997. It has been prescribed to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, and social anxiety disorder. Eight years after its introduction to the U.S. market, Zoloft® became one of the most frequently prescribed medications, and grossed nearly $2.6 billion for the manufacturer.


Prozac® was developed and marketed by Eli Lilly and Company in 1987 to treat depression, pediatric depression, OCD, bulimia nervosa, panic disorder, and premenstrual dysphoric disorder. Prozac® was the first SSRI to be developed and still remains one of the most frequently prescribed medications to treat psychological conditions.


Paxil® is an SSRI that was first developed by a British pharmaceutical company called SmithKline Beecham (now GlaxoSmithKline, or GSK) and was approved by the FDA for the U.S. market in 1992. Paxil® has been indicated for use in the treatment of major depression, panic disorder, OCD, social anxiety, generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), premenstrual dysphoric disorder, chronic headaches, and bipolar disorder. In 2007, Paxil® was one of the most commonly recommended antidepressant medications with nearly 18 million annual prescriptions.


Lexapro® was introduced by Forest Laboratories in 2002 to treat major depressive disorder in adults and adolescents over 12 years of age, and GAD in adults. In addition to the current litigation surrounding an increased risk of birth defects, Forest Laboratories has also faced lawsuits concerned with the risk of suicide in patients taking the drug. In 2010, Forest was ordered to pay more than $300 million for illegal marketing practices with Lexapro® and two of their other medications.


Celexa®, which is also marketed by Forest Laboratories, was approved by the FDA in 1998 for treating adults. However, as part of the 2010 court order to pay more than $300 million to settle civil and criminal complaints, it was alleged that Forest had illegally marketed Celexa® to children. Forest denied the accusations, but pled guilty to obstruction of justice and admitted that employees had lied to FDA officials.

Complications from SSRI Use During Pregnancy

Numerous recent studies have shown a link between SSRI use during pregnancy and an increased incidence of babies born with autism spectrum disorder. One such study collected data from the Swedish medical birth register and other public sources that screen for autism between 2001 and 2007, and concluded that mothers of autistic children were three times more likely to have taken SSRIs during their pregnancy. These findings do not show causal evidence, but do indicate the need for further investigation into the relationship. Similar studies, conducted in Quebec and Northern California, which were also concerned with the rise in prevalence of autism spectrum disorders, have come to similar conclusions about a correlational relationship between the disorder and SSRI use.


If you have been injured by a defective drug, Speak with an Attorney

In addition to an increased risk of autism, SSRI use during pregnancy has been linked to other serious birth defects, including:

  • Heart Defects - The most commonly reported heart conditions in babies are atrial septal defects and ventricular septal defects, which are perforations in coronary tissue that can compromise blood flow.
  • Cleft Lip or Palate - An orofacial cleft is an opening or gap that is left in the lip or roof of the mouth when babies’ facial structures are forming. These defects will typically require several surgeries to correct and can affect the baby’s ability to feed, breathe, and develop normal speech.
  • Persistent Pulmonary Hypertension of the Newborn (PPHN) - This condition affects the blood flow to an infant’s lungs immediately after the baby has been delivered. Typically, the blood pressure in the lungs drops when the baby is born so that the infant can breathe on their own. PPHN causes the baby to revert back to fetal circulation, and prevents the infant from breathing independently.
  • Respiratory Distress Syndrome - This type of breathing difficulty is attributed to underdeveloped lungs and is a symptom of Neonatal Adaptation Syndrome, which has been previously linked to SSRI use during the third trimester of pregnancy.

Scientific Studies and FDA Warnings

  • An article published in the British Medical Journal (BMJ) in April 2013 reported findings from the Swedish study concerning SSRI use and the incidence of autism spectrum disorders. The researchers conducting the study concluded that there is a strong correlation and that further study is recommended to better understand the relationship.
  • The February 2016 issue of the Journal of the American Medical Association (JAMA) Pediatrics featured the study conducted by Canadian researchers that also found a strong correlation in the use of SSRIs, especially during the second and third trimesters of pregnancy, and an increased risk of babies developing autism spectrum disorders.
  • In December 2011, the FDA issued a warning about SSRI use during pregnancy and the risk of babies developing PPHN. Additionally, the FDA requires a “black box” warning on all SSRI packaging to indicate the potential increase in suicidal thoughts while taking the medication.

Schedule a Complimentary Case Evaluation

If you were prescribed an SSRI medication during pregnancy and your baby suffered from any of the associated birth defects, contact an experienced attorney today to discuss your legal rights. Pharmaceutical companies have a legal and ethical obligation to develop safe and effective products that have been properly tested. When a company markets a dangerous drug without adequately warning the public, they must be held liable for any injuries that it causes.

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