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How Illegal Marketing of Lexapro May Have Harmed You and Your Child

David W. Hodges
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Partner at Kennedy Hodges LLP practicing pharmacy error, medical malpractice and personal injury law

Lexapro is a drug that relieves depression by increasing serotonin in the brain. Known as a selective serotonin reuptake inhibitor (SSRI), this drug was approved in 2002 by the U.S. Food and Drug Administration (FDA) to treat major depressive disorder (MDD) and generalized anxiety disorder in adults. In 2009, the FDA approved its use for treating MDD in children ages 12 to 17. Lexapro has become one of the most frequently prescribed antidepressants.

However, there has been some controversy about the FDA’s approval of this drug for use by children. Its decision came just weeks after the U.S. Department of Justice (DOJ) charged its manufacturer, Forest Laboratories, with illegally marketing and promoting this drug for use by children and paying kickbacks to doctors who prescribed Lexapro to patients. 

Overview of the Lexapro Lawsuits

Many lawsuits have been filed against Forest Laboratories. Some allege the drug created a risk of suicidal thoughts and violent behavior. At least two class action lawsuits target the marketing of the drug; and some have sued about the potential risk of birth defects in infants born to women who took Lexapro.

In 2010, Forest Laboratories paid out over $300 million under the False Claims Act, pleading guilty to a charge of illegal marketing and a felony count of obstruction of justice.

Another lawsuit in 2014 alleges that Forest purposely misled the medical community about the safety of its antidepressants for use in children and illegally promoted them for FDA non-approved uses. The complaint sought class action status for people who purchased Lexapro. The claim alleges that Forest:

  • Engaged in “deceptive and unlawful marketing” designed to intentionally deceive the public about the safety of Lexapro for children in order to sell Lexapro it knew had those safety issues.
  • That Forest rigged clinical trials, bribed doctors, and unlawfully marketed Lexapro to have it prescribed for children.

The lawsuit states: “By using fundamentally misleading drug labels, the ‘endorsements’ of paid opinion leaders, gerrymandered clinical trials, and a legion of specially trained sales personnel, Forest misled consumers and the medical community about Lexapro’s efficacy in treating pediatric depression. The clinical trials that examined whether the antidepressant Lexapro is effective at treating adolescent MDD indicate that Lexapro is no more effective clinically than a sugar pill.” 

Lexapro and Birth Defects

In 2006, the FDA warned that SSRI antidepressants, including Lexapro, were associated with a higher risk of persistent pulmonary hypertension of the newborn (PPHN)—a life-threatening disorder. The New England Journal of Medicine released a study that supported an association between the use of SSRIs in late pregnancy and newborns with PPHN.

Further investigations found possible connections between other serious congenital defects and women who took Lexapro while pregnant, along with other complications when it was taken during the first trimester. It’s possible that if a woman used Lexapro when pregnant and her baby was born with birth defects, she may be eligible for compensation. Here are some of the other birth defects and complications that could qualify for compensation:

  • Premature birth
  • Miscarriage
  • Clubbed foot
  • Delayed development
  • Enlarged heart
  • Septal heart defects
  • Left outflow tract heart defects
  • Macrocephaly
  • Craniosynostosis
  • Neural tube defects
  • Spina bifida

Other Possible Lexapro Side Effects

With nearly all SSRIs, there is a risk of side effects, and the FDA published a guide that warns that suicide is a major risk of taking Lexapro. This guide states that it “may increase suicidal thoughts or actions in some children, teenagers or young adults within the first few months of treatment or when dose is changed.”

Also, some people may experience “serotonin syndrome” when taking Lexapro. Symptoms of this condition can include hallucinations, coordination problems, changes in blood pressure, and vomiting. Other possible side effects of Lexapro can include abnormal bleeding, seizures, and severe allergic reactions. But of all the potential side effects, the most dangerous is the increased risk of suicide.

Filing a Lexapro Lawsuit

Many people have been harmed by Lexapro, especially those whose family member may have committed suicide due to this drug. Many of these lawsuits cite Forest’s continued marketing of Lexapro to teens and young adults even with the known risks of suicide and violent behavior.  

If you, a family member, or your child suffered injuries while taking Lexapro, you may have a claim against the makers of this drug. Let the attorneys at Kennedy Hodge help you. We make it our job to fight against product marketing that disregards health concerns. Please call us today at 888-526-7616, or contact us through this website to see if you’re eligible for compensation.