Dangerous Drugs

Lawsuits Allege Zoloft Can Cause Birth Defects

This Alert Affects:

Women who took Zoloft while pregnant and delivered children with birth defects.

Birth defects including heart, abdominal, and cranial defects. These injuries include cardiac defects, spina bifida, and other problems.
Pfizer, Inc.
What is Zoloft?
Zoloft is used to treat depression, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder. It belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
FDA Warning
In 2006, the FDA published a Public Health Advisory citing a study that found an increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants whose mothers took SSRIs such as Zoloft during their pregnancies.
Type of Lawsuit
Mass Tort

Hundreds of women have taken legal action against Pfizer Inc., the manufacturer of Zoloft, after delivering infants with congenital birth defects and malformations. These lawsuits allege that use of the antidepressant during pregnancy can put a fetus at risk for serious medical problems, some of which are life-threatening.

Did you deliver a child with a birth defect after using Zoloft? If so, Class Action lawyers would like you to know that there is still time to join the hundreds of women who have filed lawsuits against Pfizer. To find out if you can collect financial compensation for your child’s injuries and medical needs, fill out our free case review form today.

How Much Does a Lawyer Cost?

Contingency fees are usually the preferred method of payment for defective drug lawyers. When an attorney works on a contingency-fee basis, it means that he or she will only collect payment for work done on the case if it is successful. With this arrangement, the lawyer will typically request one-third of the award as his or her fee.

Is This a Class Action Lawsuit?

Although some believe the Zoloft lawsuits are a class action, they are actually being handled through a procedure known as multidistrict litigation (MDL). This means that a single judge is overseeing all federally-filed lawsuits involving Zoloft. Unlike a class action, each plaintiff in the MDL will retain his or her right to an individual award, trial, and attorney. An MDL ultimately helps to save time and money for all parties involved and ensures consistent rulings throughout the litigation.

Why Are Lawsuits Being Filed?

More than 400 women have accused Pfizer of releasing a defective drug into the marketplace, hiding the information it found during pre-market testing for Zoloft, and failing to provide adequate warnings for the antidepressant.

Some lawsuits have been filed on behalf of infants who died from complications allegedly associated with their mothers’ use of the drug during pregnancy; others are seeking compensation for medical costs and household renovations that were needed to accommodate their children, many of whom are suffering from permanent birth defects.

One plaintiff claims she took Zoloft throughout her pregnancy and delivered a baby with numerous heart defects that led to the child’s death just 17 days after being born. Infants have reportedly suffered from complicated internal organ defects including omphalocele (where the intestines or other organs protrude from the navel) and craniofacial defects, such as cleft lip and palate.

According to court documents, Pfizer has known since 2005 that Zoloft would cross the placenta and pose risks to an unborn fetus, and others have reported that the manufacturer knew of the birth defect risk as early as the 1990s. Plaintiffs claim that even pre-market tests performed by Pfizer showed malformations in non-human mammals, yet the manufacturer failed to disclose this information to women taking the drug.

What Birth Defects Have Been Associated With Zoloft?

Mothers taking Zoloft during pregnancy have reported delivering infants with the following birth defects:

  • Anencephaly (absence of a large part of the brain or skull)

  • Craniosynostosis (skull malformation)

  • Tetralogy of Fallot (problems with the heart’s structure)

  • Truncus arteriosus (one large blood vessel leads out of the heart, instead of two)

  • Pulmonary valve atresia (failure of the pulmonary valve to develop)

  • Ventricular/atrial septal defect (a hole in the wall that separates the heart’s lower chambers)

  • Patent foramen ovale (a hole in the heart)

  • PPHN (high-pressure in the lungs)

  • Transposition of the great arteries (the two main arteries leaving the heart are reversed)

  • Omphalocele (intestines or other organs protrude from the navel)

  • Craniofacial defects (cleft lip or palate)

  • Limb defects (club foot)

  • Anal atresia (closure of the anus)

Several studies published in the NEJM, the British Medical Journal, and the Journal of Clinical Epidemiology showed that mothers who used SSRIs such as Zoloft while pregnant had an increased risk of delivering children with birth defects. An additional study from the NEJM found that SSRIs doubled the risk of septal heart defects in children. SSRIs have also been linked to delays in motor skills and increased tremors in children ages six months to three years, according to a news article from The New York Times.

Attorneys are currently offering free case evaluations to all women who used Zoloft or another SSRI while pregnant. If you delivered a baby with birth defects, please fill out our free case evaluation form today. You may be entitled to compensation for your losses.

Nov 7, 2013
Dangerous Drugs

After Lawsuits Over Lexapro, Zoloft, New SSRIs Released & Approved For Use

by Staff

In July 2006, the FDA issued a warning that selective serotonin reuptake inhibitors (SSRIs), including Lexapro and Zoloft, carried a risk of persistent pulmonary hypertension in children born to mothers… More

Sep 7, 2012
Dangerous Drugs

More Lawsuits Filed for Zoloft Birth Defects

by Staff

Pfizer, the nation's largest pharmaceutical company, has had nineteen defective drug product liability cases brought against it over the past several weeks.… More

Jul 19, 2012
Dangerous Drugs

Pfizer Marketed Zoloft to Pregnant Mothers, Says Lawsuit

by Staff

In June 2012, 38 plaintiffs filed a lawsuit claiming that the antidepressant Zoloft caused birth defects in their newborns.… More

Jan 27, 2012
Dangerous Drugs

New Study Highlights Risk of SSRI Use During Pregnancy

by Staff

A new study from Sweden shows that the use of certain antidepressants during pregnancy could greatly increase the risk of persistent pulmonary hypertension (PPH) in newborns.… More

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Case Resources

Hagan et al. v. Pfizer Inc. Complaint
Case number 11-cv-7583, U.S. District Court for the Southern District of New York
In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation Transfer Order
MDL number 2342, U.S. District Court for the Eastern District of Pennsylvania
FDA Drug Safety Communication, July 2006
The FDA warns that taking SSRIs including Zoloft after the 20th week of pregnancy can greatly increase the risk of delivering children with a life-threatening lung condition known as pulmonary hypertension in newborns (PPHN).
New England Journal of Medicine Study, June 2007
Researchers find that the use of Zoloft during pregnancy may be linked to an increased risk of the following birth defects: omphalocele, anal atresia, limb reduction defects and septal defects.