BROOKLYN (CN) – Forest Laboratories suppressed a clinical study that showed increased suicide risk among children who took the anti-depressants Celexa and Lexapro, and showered child psychiatrists with gifts in “a rampant scheme” to persuade them to prescribe the drugs, though they were not approved for children, according to a federal RICO class action. Pfizer and Warner Lambert also are named as defendants.
A 2001 clinical trial showed a “significant” heightened suicide risk for patients who took the drug versus those who took a placebo, according to the named plaintiff, the New Mexico UFCW Union’s and Employers’ Health and Welfare Fund.
“Defendants misled physicians and the medical community at large by promoting the results of a positive study on pediatric use of Celexa while failing to disclose the negative results of a contemporaneous study for the same pediatric use,” the complaint states. “The contemporaneous study found Celexa no more effective than a placebo, yet more young patients taking Celexa attempted suicide or reported suicidal ideation than those taking only placebo. The suppressed study was later relied upon by the FDA in its decision to mandate that Forest add a ‘black box’ warning to both Celexa and Lexapro labels, cautioning against pediatric use.”
The complaint adds: “This fraud was compounded by a rampant scheme to induce doctors to become high prescribers through various forms of illegal remuneration, including cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment, and other valuable goods and services.”
The UFCW claims the defendants unleashed a marketing blitz for off-label use. The union claims the pharmaceutical company “arranged for … kickbacks, such as restaurant gift certificates for physicians, lavish entertainment of physicians and their spouses, and grants to individual physicians.”
Forest Labs sales reps offered tickets to St. Louis Cardinals and Boston Red Sox games, a $1,000 gift certificate to New York restaurant Alain Ducasse, a deep sea fishing trip off Cape Cod, a salmon fishing charter cruise, $400 in Broadway theater tickets, and “social dinners” at high-end restaurants in North Carolina and Louisiana to reward doctors who wrote the most prescriptions, according to the complaint.
The class demands damages for consumer fraud, unjust enrichment, RICO conspiracy and deception.
Lead class counsel is Justin Bloom with the Murray Law Firm of New Orleans.