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.
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.
The FDA has only approved Celexa for use by adults, but it has long been prescribed for children as an off-label treatment for depression and anxiety.
After an investigation by the U.S. Department of Justice (DOJ), 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.
Celexa propelled Forest Laboratories to prominence among pharmaceutical manufacturers. By 2015, the company was absorbed by Allergan following a series of mergers worth more than $95 billion.
Federal Investigation for Illegal Marketing
The U.S. Attorney’s Office in Massachusetts launched an investigation into Forest over illegally marketing Celexa in 2003. It filed criminal charges accusing the company of off-label marketing of Celexa to treat children and adolescents. The DOJ also accused Forest of publicizing positive results from 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.
Forest agreed to plead guilty to one felony count of obstructing justice for lying to FDA inspectors during a plant inspection in 2003.
The company also pleaded 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. Forest also agreed to pay a $150 million fine and $14 million in assets in the criminal settlement.
The company agreed to settle a separate civil complaint from the DOJ for $313 million, while denying the accusations in the complaint.
The federal government received more than $88 million as part of the civil settlement, while more than $60 million was shared by the states.
Settlement Reached for Improper Marketing of Celexa
About the same time, patients who had taken Celexa and their families began filing lawsuits against Forest Laboratories claiming the company had marketed Celexa to children.
In 2009, the U.S. Judicial Panel on Multidistrict Litigation (JPML) combined many of these lawsuits into a multidistrict litigation (MDL) in a Massachusetts federal court. The MDL included lawsuits filed in Illinois, New York, California and Missouri.
In January 2014, Judge Nathaniel M. Gorton agreed to a class action for some Missouri plaintiffs. They had based their claims on a Missouri state law that prohibits deceptive and unfair business practices.
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.
The plaintiffs claimed Forest misled the parents of the effectiveness of the drug in children. Their lawsuits claimed 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
Two months after Judge Gorton certified the class action, Forest agreed to a settlement.
Missouri Celexa Purchasers Get Refunds
Judge 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 use in that age group.
“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 case included expert testimony from psychiatrists who said they also were misled by Forest Laboratories. 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.
In the settlement, Forest denied all allegations and legal claims, stating it decided to settle only because litigation would be drawn-out and expensive.
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.”