Arkansas files suit against J&J and two subsidiaries

Risperdal is being prescribed to treat illnesses it isn't approved for. This one isn't a Whistleblower suit, but it could have been.
Arkansas Attorney General Dustin McDaniel filed suit Tuesday against health-care product manufacturer Johnson & Johnson Inc. and two of its subsidiaries, accusing the drug makers of illegally promoting a popular antipsychotic medication.
The lawsuit, filed in Pulaski County Circuit Court, says the drug, Risperdal, is being prescribed to treat illnesses it isn’t approved for and the manufacturers have been misrepresenting its risks to patients.
Risperdal is the most widely used antipsychotic medication of its kind in the world, sales in 2005 amounting to $ 3. 5 billion, the lawsuit states.
The 35-page filing before Circuit Judge Timothy Fox comes about two months after McDaniel told the Legislative Council he planned to sue three major pharmaceutical manufacturers over what he said was a “marketing scheme” for antipsychotic drugs paid for by the state Medicaid program. The other two companies are Eli Lilly & Co. of Indianapolis and a European company, Astra Zeneca.
The lawsuit seeks to recover state money paid out on behalf of clients of Medicaid, patients of the Arkansas Department of Human Services and state employees and retirees through the Arkansas Department of Finance and Administration’s employee benefits division.
The lawsuit claims the companies took advantage of state programs to promote the drug for nonmedically approved purposes and have also misled users about how well it works.
“Defendants have engaged in a direct illegal nationwide program of promotion of the use of Risperdal for non-medically necessary uses,” according to the lawsuit. “Defendants have conducted this program of promotion knowing that prescriptions for Risperdal are generally reimbursed by the state... programs even though such prescriptions may be written for non-medically necessary uses of Risperdal.
“ Defendants have falsely represented to the state, and to the public in general, that Risperdal is safer and more effective than less expensive, first-generation anti-psychotics.”
The medication is federally approved to treat schizophrenia and some symptoms of bipolar disorder. But the companies have pushed it as a treatment for such conditions as attention deficithyperactivity disorder, depression, anxiety, mood disorder and aggression associated with late-onset dementia, according to the lawsuit.
The companies also failed to adequately warn users that Risperdal’s side effects include diabetes, pancreatitis, hyperglycemia and cardiovascular complications, the lawsuit says. Further, the lawsuit says, the defendants have paid “key opinion leaders” to support the companies’ market claims for the drug.
The suit lists eight claims of action against the drug makers, including negligence, recovery of the cost of treatment for injuries caused by the drug and violations of the Arkansas Medicaid Fraud False Claims Act and the Arkansas Deceptive Trade Practices Act.
The lawsuit doesn’t say how much the state is seeking from the companies but notes that Arkansas has spent “millions” on the drug since its introduction in 1993.
The lawsuit is being handled by Bailey Perrin Bailey LLP of Houston, Texas. The firm, which is handling similar suits in six other states, will bear all the expenses in exchange for 15 percent of any award.