If your child was born with a birth defect, and you believe Prozac may be to blame, you may be eligible to file a lawsuit against the antidepressant’s manufacturer. Several studies have established a direct link between the use of Prozac while pregnant and an increased risk of having a baby with birth defects. Prozac has been linked to different types of birth defects, including cardiac, developmental, respiratory, and digestive defects. Multiple Prozac lawsuits have been filed in the past due to the drug’s severe side effects, such as violent behavior and suicidal actions or thoughts. Keep reading to learn more about filing a lawsuit against Prozac for birth defects.

What Is Prozac?

Prozac, known generically as fluoxetine, is a popular antidepressant belonging to the selective serotonin reuptake inhibitor (SSRI) class of drugs. SSRIs work by blocking serotonin reabsorption, boosting the levels of serotonin in the brain. Increased serotonin levels have been shown to boost mood. Manufactured by Eli Lilly & Company, Prozac was approved by the Food and Drug Administration (FDA) in 1987. It’s prescribed for patients suffering from:

  • Major depressive conditions
  • Eating disorders
  • Panic attacks
  • Obsessive-compulsive disorder

Pregnant women were prescribed Prozac to help with the anxiety and depressive disorders that can come with pregnancy.

Prozac’s Link to Birth Defects

Since Prozac’s introduction, there have been complaints and reports of adverse effects linked to the use of the drug. Eli Lilly has faced several lawsuits linked to Prozac side effects. Most of these lawsuits have been filed due to claims that Prozac caused users to commit or attempt to commit suicide or murder. The company paid tens of millions to settle some of these lawsuits, while others have been resolved by dismissal. A few cases are still in court. The FDA has issued several warnings about Prozac’s possible dangers.

Since 2005, there’s been information emerging about Prozac potentially causing birth defects. Numerous studies have found a link between Prozac taken by pregnant mothers and a higher risk of birth defects. In 2007, the FDA upgraded Prozac from a Pregnancy Category B to Category C medication, meaning the drug has been found to have adverse effects on animal fetuses, but there are no adequate studies of its impact on humans.

In July 2015, researchers from the Centers for Disease Control and Prevention published an analysis of birth defect risks and the use of SSRIs during pregnancy. The researchers found that a number of antidepressants were not linked to birth defects. However, two of them — Prozac and Paxil — were found to have a link to birth defects. The researchers published the analysis in the British Medical Journal.

Prozac has been associated with the following birth defects:


Persistent pulmonary hypertension (PPHN) is a serious health condition in newborns that occurs when blood doesn’t flow to the lungs to get oxygen. This birth defect causes low-oxygen blood to circulate throughout the baby’s body, which could lead to brain damage, heart defects, and lung damage.

A study that was published in February 2006 showed that the risk of PPHN in newborns was six times more if mothers took an SSRI like Prozac during pregnancy. A few months after the New England Journal of Medicine published this study, the FDA released a health advisory cautioning women on the risk of newborns suffering serious lung problems if their mothers took these antidepressants while pregnant.

Septal Defects

A septal defect is a hole in the walls of the baby’s heart that causes improper circulation of blood throughout the body. The condition forces the heart to work harder than necessary to pump blood. A study published in the British Medical Journal in 2009 showed increased septal heart defects among children whose mothers had taken SSRIs during early pregnancy.

Obstetrics and Gynecology published another study in 2011 that found Prozac use during pregnancy to be associated with an increased risk of children developing isolated ventricular septal defects. The risk of this birth defect was double that among children whose mothers hadn’t taken the antidepressant while pregnant.


In June 2007, the New England Journal of Medicine published a study that found a link between the use of SSRIs like Prozac during pregnancy and craniosynostosis, as well as other defects like omphalocele and anencephaly. Craniosynostosis occurs when the bones in an infant’s skull fuse prematurely, changing the skull’s shape and growth pattern. Omphalocele is a birth defect in which the intestines or other abdominal organs stick out of the baby’s belly button.

Anencephaly causes a baby to be born without parts of the skull or brain. Babies with anencephaly are usually stillborn or die soon after birth.


A study published in the Archives of General Psychiatry July 2011 issue suggested a link between SSRI use and an increased risk of giving birth to a child with autism spectrum disorder. According to the study, the risk of having a baby diagnosed with autism doubled if the mother had taken an SSRI one year before giving birth. Women who took an SSRI in the first trimester of pregnancy had a four times greater risk of giving birth to a child with the disorder.

Prozac has been associated with many other birth defects, including:

  • Respiratory defects
  • Digestive defects
  • Anal atresia
  • Clubfoot
  • Spina bifida
  • Diaphragmatic hernia

How to File a Lawsuit Against Prozac

Birth defects can severely affect a child and his or her family. Raising such a child can be expensive and stressful. These defects may cause lifelong health conditions, significant medical expenses, loss of income from time off work, and emotional trauma. They may cause physical or intellectual disabilities, making it necessary to apply for disability for a child. Recovering financial compensation may be essential to you and your child having the best quality of life possible.

If you or a loved one took Prozac during pregnancy and delivered a child with a birth defect, you may be eligible to file a lawsuit against Prozac’s manufacturer. Filing a Prozac lawsuit may enable you to obtain compensation for the congenital defect’s financial, physical, and emotional effects.

The first step you should take is finding out whether you’re eligible to pursue compensation by setting up a Prozac claim evaluation with a defective drug lawyer. A Prozac lawyer will evaluate your claim and help determine whether you have grounds for filing a lawsuit, discuss your legal options, and let you know whether a class action or individual lawsuit suits you best.

In a class action lawsuit, you’re grouped together with other people to collectively bring a single lawsuit against the drug manufacturer, regardless of the severity of your child’s birth defects. Any settlement or award from the lawsuit will be shared equally among the plaintiffs. Generally, individual lawsuits are the most appropriate for birth defect cases, especially if Prozac caused defects that left your child severely injured. Such lawsuits are filed, presented, and assessed individually. An individual lawsuit helps you maximize your financial recovery.

A mass tort lawyer can combine your case with other similar cases into one trial. In mass torts, your case will still be treated individually, unlike in a class action lawsuit. Mass tort lawsuits help you and other plaintiffs pool legal resources, saving time and money.

Your Prozac lawyer will help you file a lawsuit and manage all aspects of the legal process, including carrying out investigations, representing you at trial, and negotiating compensation. The lawyer will help you build a strong case by gathering the necessary medical records and working with medical experts to show how the birth defects resulted from the drug use.

In Chicago, your lawyer will likely raise the failure to warn theory in your Prozac birth defect case. When drugs pose risks of harm, drugmakers must give adequate warnings. Eli Lilly failed to warn patients and doctors of the possible adverse consequences for babies. If Eli Lilly had made people aware of Prozac’s potential effects, mothers might have avoided taking the drug during their pregnancies.

In recent cases, drug companies have been held liable for failing to warn of the risks and side effects. You could be entitled to receive compensation from Eli Lilly for failing to adequately warn about the risk of birth defects. Other causes of action upon which lawsuits involving Prozac and other SSRIs have been based include:

  • Design defect
  • Negligence
  • Breach of implied warranty

A pharmaceutical injury lawyer will help you determine the best course of action for pursuing compensation. A successful lawsuit will help you recover compensation for damages like medical expenses, loss of wages, loss of ability to work, scarring or deformities resulting from the defect or treatment, and pain, suffering, and mental anguish. If your child dies because of a birth defect linked to Prozac use, you can also recover compensation for funeral expenses and the pain and suffering before the child’s death and after losing the child.

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