The U.S. Food and Drug Administration (FDA) first approved the prescription antidepressant Celexa (citalopram) in 1998. The drug quickly became popular in the U.S., with 16 million prescriptions written each year. Forest Laboratories marketed Celexa as a safe and effective treatment for major depression, but studies show Celexa is associated with several side effects and risks, including major heart complications and an increased risk of suicide and birth defects.
Actavis PLC acquired Forrest Laboratories in 2014 for $25 billion. In March 2015, Actavis acquired Dublin, Ireland-based Allergan PLC for $70.5 billion, and three months later adopted Allergan PLC as the combined company’s name.
In 2002, Forest introduced Lexapro (escitalopram oxalate) which is similar to Celexa. Although generic versions of both drugs have been available for years, both are still prescribed today.
Celexa is FDA approved for adults only, but it was and still is prescribed for children as an off-label treatment for depression and anxiety.
After an investigation by the U.S. Department of Justice, Forest Pharmaceuticals Inc., a subsidiary of Forest Laboratories, agreed in 2010 to pay more than $313 million to settle criminal and civil complaints, including a claim that the drugmaker illegally promoted Celexa to children.
In 2014, the company settled a class-action lawsuit for similar claims for approximately $10.4 million.
Federal Investigation for Illegal Marketing
Before the Department of Justice got involved, the U.S. Attorney’s Office in Massachusetts led the Forest investigation, which began in 2003.
Criminal charges alleged Forest Pharmaceuticals was responsible for off-label marketing of Celexa to treat children and adolescents, along with publicizing the positive results of a study on the drug in adolescents while failing to report negative results from a similar study.
Federal prosecutors accused Forest of paying doctors and other medical professionals to prescribe Celexa. According to the civil complaint, from 1998 to 2005 sales representatives gave doctors “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services.”
Compensation items, according to the complaint, included:
- Tickets to St. Louis Cardinal games
- A $1,000 gift certificate to a gourmet French restaurant to a high-prescribing child psychiatrist
- Broadway theater tickets worth $400
- $2,276 worth of Red Sox baseball tickets used for doctors in the Boston area
- A deep-sea fishing trip in Cape Cod for a doctor and his three sons
Despite the $313 million settlement, Forest denied the allegations in the civil complaint. In the criminal settlement, Forest Pharmaceuticals agreed to plead guilty to one felony count of obstructing justice in connection to lying to FDA officials during a plant inspection in 2003.
The company also pled guilty to two misdemeanors, including marketing Celexa for use in children from 1998 to 2002. The second misdemeanor involved the illegal distribution of the thyroid drug Levothroid.
The federal government received more than $88 million as part of the civil settlement, while more than $60 million was distributed and shared by the states. Forest also agreed to pay a $150 million fine and $14 million in assets in the criminal settlement.
Settlement Reached for Improper Marketing of Celexa
In 2009, the federal judicial panel established a multidistrict litigation (MDL) in the District of Massachusetts for lawsuits alleging Forest Laboratories improperly marketed Celexa — before it was approved for patients 12 and older — to children. The MDL included lawsuits filed in Illinois, New York, California and Missouri.
In February 2013, Judge Nathaniel M. Gorton denied a request to certify a class action for these claims, but in January 2014 agreed to a class of Missouri purchasers based on claims brought forth under the Missouri Merchandising Practices Act, a half-century-old law that prohibits deceptive and unfair business practices.
The parties in the pediatric class action agreed to a settlement worth between $7.7 and $10.4 million in March 2014.
Plaintiffs alleged Celexa is no more effective clinically than a sugar pill when used to treat children and adolescents.
“The clinical trials show that any perceived benefit pediatric patients receive from taking Celexa or Lexapro in treating their depression is primarily explained by the placebo effect — the perceived efficacy of a drug based upon one’s belief that the drug works.”
- Stated in the lawsuit
The class action included all parents and third parties in Missouri who purchased Celexa for a patient under the age of 18 between Jan. 1, 1998 and Dec. 31, 2013.
Forest denied all allegations and legal claims, stating it decided to settle only because litigation would be drawn-out and expensive.
Just a month before the announcement of the settlement, drugmaker Actavis plc acquired Forest Laboratories for $28 billion.
Missouri Celexa Purchasers Get Refunds
Gorton ruled that under the Missouri Merchandising Practices Act, thousands of Missouri parents were entitled to refunds for Forest Labs antidepressants prescribed to children because the drugs were unapproved for the use in that age group.
The claims also alleged Forest misled the parents of the effectiveness of the drug in children.
“Parents have the right to be fully informed about the potential efficacy of a drug,” Brent Wisner, a Los Angeles-based attorney for the plaintiffs, said.
The court ruled that parents who purchased the antidepressants in the 1998 to 2013 timeframe were entitled to partial or full refunds, or $50 if the total amount spent on the drugs could not be determined.
The case included expert testimony from psychiatrists who said they also were misled by Forest Labs. Dr. Joseph Glenmullen of Harvard Medical School said, “Forest misrepresented both the efficacy and safety of Celexa and Lexapro use in children and adolescents, misled physicians and deprived patients of the benefit of their health care providers’ independent professional judgment.”
By July 2014, Celexa was prescribed to 8,069 Medicaid participants under the age of 18 in Missouri, according to the St. Louis Post-Dispatch.
Celexa carries an FDA black-box warning for an increased risk of suicidal thoughts and behaviors for patients 24 and younger. The National Institutes of Health warns, “Children younger than 18 years of age should not normally take citalopram [Celexa], but in some cases, a doctor may decide that citalopram is the best medication to treat a child’s condition.”
Birth Defect Lawsuits
Increasingly, plaintiffs include women who were assured Celexa was safe for use during pregnancy but weren’t warned about the risk for congenital birth defects.
On July 11, 2014, Sophie Cowan was born with atrioventricular canal defects. These are serious birth defects that involve a hole between the heart’s chambers. It creates life-threatening problems with the valves that normally regulate blood flow through the heart. The little girl died less than month later on August 7.
Sophie’s mother, Erica Akinson, had been prescribed Celexa and Lexapro during her pregnancy starting in 2010. Akinson became filed a lawsuit against Forrest Laboratories in August 2013. It was one of dozens of lawsuits being filed around that time alleging the company’s antidepressant drugs had contributed to birth defects.
Plaintiffs alleged that Celexa is responsible for a variety of congenital birth defects, including:
- Hypoplastic Left Heart Syndrome: Underdeveloped structures on the left side of the heart.
- Spina Bifida: Underdeveloped spinal cord.
- Anencephaly: Baby born without a large part of the brain, skull or scalp.
- Craniosynostosis: Fibrous joints in skull fuse together.
- Omphalocele: The baby’s bowels remain in the umbilical cord after birth.
- Club Foot: Baby’s foot is twisted out of shape or position.
- Persistent Pulmonary Hypertension of the Newborn: PPHN occurs when the circulatory system doesn’t switch over to breathing air, which damages the heart and lungs.
By the end of 2013, Forest Laboratories reported that it was facing at least 182 lawsuits claiming its antidepressants – both Celexa and Lexapro – used during pregnancy led to birth defects. The majority of the cases had been consolidated in a Missouri state court. At least 19 cases were pending before a federal court in New Jersey and one more case was awaiting trial in California state court.
In 2014, at least 15 of the lawsuits from the New Jersey federal court were sent back to the various state courts where they were originally filed.
The company said at the time it annually maintained $140 million in product liability coverage in case it lost lawsuits or decided to settle claims against its products.
By 2017, the company, now part of Allergan, Inc., reported it still faced 179 lawsuits over birth defects caused by its antidepressants. It said it had settled five of the cases in 2016, but did not disclose the amounts of any of the agreements with plaintiffs.
The federal judicial panel has not yet established an MDL for Celexa and Lexapro birth-defect lawsuits. Instead, individual lawsuits can be filed on behalf of the children affected by Celexa.
Suicide Lawsuits over Celexa
In April 2004, Andrew Tradd attempted to commit suicide by hanging himself. He died seven days later from a brain injury suffered in the attempt.
The 13-year-old Massachusetts teen had been taking Celexa for two years.
His family filed a lawsuit against Forrest Laboratories claiming the company knew about multiple studies showing an increased risk of suicidal behavior for patients taking Celexa and other SSRIs, but didn’t try to warn physicians or patients of the risk.
The Danish firm that first developed Celexa, H. Lundbeck, had placed suicide warnings on labels for the drug sold in Europe for years prior to Tradd’s death. The warning did not appear on U.S. labels until the FDA required it in 2004.
Lundbeck had conducted a four-year trial that found Celexa was no better than a placebo in treating teens with depression. The results of the trial were known in 2002, but the results were not released until 2004.
Other lawsuits filed over Celexa’s injuries and deaths involving teens included:
- Danielle Henrickson, age 14: Danielle hanged herself in July 2004. Her parents claimed in their lawsuit her mental health worsened after taking Celexa for just a few weeks.
- Rachel Weiss, age 16: Rachel had been taking Celexa for nine days when she had a panic attack at school. She threw herself down a stairway causing permanent spinal injuries.
Forrest settled the cases involving Tradd, Henrickson and Weiss for undisclosed sums in 2010.
In 2006, a judicial panel transferred federal Celexa suicide risk lawsuits to the U.S. District Court for the Eastern District of Missouri.
Ultimately, 57 cases involving both Celexa and Lexapro were transferred to MDL No. 1736, of which 32 settled. In July 2013, the presiding judge ruled that enough progress had been made in the MDL to send the remaining cases back to their originating courts.
In 2015, there were at least ten lawsuits alleging Celexa or Lexapro had caused or contributed to patients committing suicide or attempting suicide. Allergan, which now owned Forrest Labs, reported it had tentatively reached settlements in four of the cases and that a court had stayed one other suit. Five cases were awaiting trial in New Jersey state court.