Prozac Lawsuit

Prozac is an SSRI antidepressant that may cause serious side effects and birth defects. Drug maker Eli Lilly has faced multiple Prozac lawsuits filed by patients or loved ones of those who took Prozac and experienced serious injury, birth defects or death.

Quick Summary
Prozac Lawsuit

Since its introduction, Prozac (fluoxetine) has been the subject of ongoing investigations from reports of adverse effects associated with its use. Eli Lilly, the manufacturer of Prozac has successfully defended a number of lawsuits but has also settled multiple cases after claiming that the drug has an established efficacy and safety profile. Most Prozac lawsuits have been resolved or settled but a few cases may still remain in courts.

Prozac Lawsuit Claims

Over 300 Prozac lawsuits have been addressed by the court systems including 30 lawsuits that were settled for an estimated $50 million. These lawsuits had largely been filed by people who claimed the medication caused the user to commit or attempt to commit murder or suicide. An additional 75 federal cases and other cases in courts across the country were resolved by dismissal or private settlements.

In addition to early claims of suicide or homicide, one of the most common issues resulting in a lawsuit after using Prozac are claims for birth defects. Prozac lawsuits have also claimed developmental disorders, such as autism, were the result of being prescribed during pregnancy.

Prozac Lawsuit Overview

Prozac (fluoxetine) is a selective serotonin reuptake inhibitor, or SSRI antidepressant medication approved in 1987. It was the first of the SSRIs which were a “new” type of antidepressant, said to have fewer and less bothersome side effects than older medications. Though it may cause different or fewer side effects, SSRIs like Prozac have since shown a history of causing side effects in patients which may be unexpected or severe.

Since its introduction, Prozac has been the subject of ongoing investigations from reports of adverse effects associated with its use. The drug has been featured on a number of talk shows due to claims that Prozac was responsible for a number of high-profile murders and suicides. The FDA has issued several warnings about possible dangers of Prozac, some of which were discovered only after they may have resulted in shocking actions or events.

Eli Lilly, the manufacturer of Prozac has successfully defended a number of lawsuits but has also settled multiple cases after claiming that the drug has an established efficacy and safety profile. Most Prozac lawsuits have been resolved or settled but a few cases may still remain in courts.

Prozac Lawsuit Claims

Over 300 Prozac lawsuits have been addressed by the court systems including 30 lawsuits that were settled for an estimated $50 million. These lawsuits had largely been filed by people who claimed the medication caused the user to commit or attempt to commit murder or suicide. An additional 75 federal cases and other cases in courts across the country were resolved by dismissal or private settlements.

In addition to early claims of suicide or homicide, one of the most common issues resulting in a lawsuit after using Prozac are claims for birth defects. Prozac lawsuits have also claimed developmental disorders, such as autism, were the result of being prescribed during pregnancy.

Specific notable cases include:

  • In one Prozac lawsuit case, a SWAT team captain and police officer, Daren Alli, committed suicide after 4 days of taking Prozac. He had reportedly been suffering from mild symptoms of depression but Alli’s wife claimed that suicide was out of character for her husband. His wife also claimed that Alli would not have attempted treatment with the drug if he knew the possible risk of Prozac.
  • In one Prozac Birth Defect Lawsuit, a woman who took Prozac in 1996 during pregnancy gave birth to a son with a heart defect. The child required multiple cardiac surgeries over the course of several years, but the mother was unaware that the drug she had taken during her first trimester may have been responsible and did not file a lawsuit until 2013. Lilly unsuccessfully attempted to have the lawsuit dismissed in 2015 but the plaintiff was unsuccessful in court.
  • Prozac lawsuit claims have not been limited to the United States. In a Canadian Prozac lawsuit case, it was disclosed that Eli Lilly failed to report to the FDA about the findings of two studies about psychological instability resulting from Prozac. In this Prozac lawsuit case, it was disclosed that if the studies were presented to the FDA, health professionals would be better aware of patients’ risks.

People who have been harmed by Prozac have stated that they would not have agreed to treatment if they were aware of the potential issues. Eli Lilly has been accused of failing to warn the public about possible complications.

Prozac FDA Warnings

In 2004, Prozac was issued the first warning from the FDA that may have come partly as a result of Prozac publicity and lawsuits. The FDA began requiring that Prozac and all SSRI antidepressant medications include a black-box warning regarding the risk of suicide.

Prozac’s black-box statement warns patients and health care practitioners about the possibility of increases in suicidal thoughts and behaviors. It is particularly focused on use in children, adolescents and young adults and may be most prevalent when medication is first started or when dosing is changed. Medical professionals and caregivers are advised to closely monitor patient behavior in children, adolescents and young adults.

Prozac Side Effects

All prescription medications cause side effects and while Prozac was intended to have a reduced side effect profile, some of the medication’s effects can result in serious injury or harm.

Most of Prozac’s common side effects are similar to those of other SSRI medications including:

  • Nausea
  • Appetite loss
  • Insomnia or anxiety
  • Sexual dysfunction
  • Headache
  • Weight changes

Prozac Birth Defects

SSRI antidepressants like Prozac have been associated with an increased risk of birth defects when taken by pregnant women. Prozac was initially listed as a Pregnancy Category B medication but was upgraded to Pregnancy Category C in 2007, indicating that animal studies have shown fetal abnormalities, but human studies are inadequate. Doctors who wish to prescribe antidepressants to pregnant patients must weigh the benefits and risks of the medication against possible birth defects.

Birth defects from Prozac include:

  • Premature birth
  • Heart defects
  • Craniosynostosis
  • Anencephaly
  • Omphalocele
  • Gastroschisis
  • Lung or respiratory defects

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.