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A Louisiana jury has issued a $257.7 million verdict against Johnson & Johnson for making misleading claims about its antipsychotic drug Risperdal in letters sent to hundreds of thousands of doctors.
The pharmaceutical giant had been charged with defrauding Louisiana’s Medicaid system through its advertising claims in a November 2003 promotional letter that was sent to about 700,000 doctors nationwide. The letter went to 7,604 Louisiana doctors as well.
The letter claimed that Risperdal was safer than other antipsychotic drugs and sparked a warning letter from the FDA for making unsubstantiated claims and minimizing the risk of Risperdal side effects. Johnson & Johnson sales representatives also made more than 27,500 sales calls to Louisiana in 2003 and 2004, which the jury found to be in error as well.
Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.
This is not the first time that Johnson & Johnson has gotten into hot water over how it has marketed Risperdal. The Department of Justice is currently engaged in a whistleblower lawsuit against the company for allegedly taking part in a nursing home drug kickback scheme intended to get facilities to push Risperdal onto elderly patients.
The DOJ filed a civil False Claims Act compliant against Johnson & Johnson (J&J) on January 15, saying that the company paid millions to Omnicare, Inc. as kickbacks for prescribing its drugs to nursing home patients. Last year, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.
Last year, Risperdal marketing tactics earned the company a $4 million judgment from a judge in West Virginia. The company is appealing that decision.
Louisiana jurors cited Johnson & Johnson for 35,542 violations of the Louisiana Medical Assistance Programs Integrity Law and fined the company $7,250 for each violation. The state had asked for $10,000 for each violation, which would have cost the company more than $355 million.
Johnson & Johnson has indicated that it will appeal the ruling, saying the jury was not properly instructed and that critical evidence was wrongfully barred from the trial.