Lawsuit Over J&J Risperdal Marketing Can Proceed

A Texas state court has ruled that a trial can proceed against Johnson & Johnson's Janssen unit for allegedly using false advertising and improper influence - such as grants, trips and other perks - to ensure its Risperdal antipsychotic was placed on the mandatory protocol for the Texas Medication Algorithm Project, a state system protocol for treating psychiatric disorders.

The original lawsuit was filed in 2004 based on evidence provided by Allen Jones who, at the time, was working as a fraud investigator with the Pennsylvania Inspector General’s Office. Both Jones and the state of Texas are plaintiffs and their lawsuit contends Janssen engaged in a widespread scheme to ensure state Medicaid officials would give preferential treatment to Risperdal on TMAP (you can read the lawsuit here). A lawyer who represents Jones says damages could exceed $1 billion, based on potential treble damages and penalties.

The back story: In 2001, as Pennsylvania was considering whether to adopt Texas guidelines, Janssen paid $4,000 to fly two state mental health officials to New Orleans, where they ate dinner at an upscale restaurant in the French Quarter, visited an aquarium and met with Janssen execs and Texas officials, The New York Times wrote. Janssen also paid two Pennsylvania officials $2,000 each for giving speeches at Janssen educational seminars for docs and nurses working in Louisiana prisons.

The payments were discovered by Jones, who was investigating why state officials had set up a bank account to collect grants from drugmakers. Later, though, Jones alleged that he was removed from the investigation and attributed the decision to influence from drugmakers. He was soon fired. Originally, 10 drugmakers helped fund the Texas effort that led to the TMAP guidelines, while Janssen and others allegedly paid for meetings in other states where officials were encouraged to develop similar programs.

However, the whistleblower lawsuit filed by Jones, which the Texas attorney general joined, contends that Risperdal was no safer or effective than similar meds, but was more expensive. The suit also charges Janssen marketed the antipsychotic for use in children, even though Risperdal was approved only for treating adult schizophrenia. Since Risperdal first became available, Texas has paid more than $500 million for the pill, according to the state.

“We are very pleased that a Texas jury finally will be able to scrutinize Janssen’s actions, which we allege have unfairly cost the state’s taxpayers hundreds of millions of dollars for a drug that was no better than older, cheaper medicines,” says Tom Melsheimer, the lawyer who represents Jones. As for Jones, he simply says that he is pleased with the decision. We await word from Johnson & Johnson. UPDATE: A spokesman sends us this: "Janssen is prepared to vigorously defend itself against these claims. We are committed to ethical business practices, and have policies in place to ensure that our products are only promoted for their FDA-approved indication."