Subsidiaries of Johnson & Johnson reached an agreement in which they’ll pay $2.2 billion to resolve a federal lawsuit involving the marketing for off-label use of the antipsychotic drug Risperdal. So far, this is the largest settlement in history involving a single drug, according to Zane Memeger, U.S. attorney for the Eastern District of Pennsylvania, where the case had been filed.
Consumers Misinformed about Risperdal’s Uses
Janssen Pharmaceuticals has agreed to plead guilty to one count of introducing the misbranded drug, Risperdal into interstate commerce. The anti-psychotic had been approved by the U.S. Food and Drug Administration for treatment of schizophrenia, but was also marketed by Janssen for use in elderly patients with dementia and in mentally-ill children.
Attorney Zane Memeger explained in a public statement:
“The Department of Justice takes the FDA procedure seriously; companies that decide to put profit over patients will be prosecuted.”
Under the settlement agreement, Janssen will pay $334 million as a criminal fine, $66 million as a substitute for forfeiture of the drugs, and it has agreed to a separate civil settlement with the federal government and several individual states for about $1.3 billion. Back in March of 2012, Johnson & Johnson agreed to pay $118 million to resolve similar claims about Risperdal in Texas, that amount is to now be included in the $2.2 billion total. The settlement is the largest ever recorded pertaining to a single drug / medication.
Prior Claims Leading Up to Record Settlement
Starting in 2004, relators began filing “qui tam” actions over the marketing of Risperdal. Four cases were consolidated in the U.S. District Court for the Eastern District of Pennsylvania. Janssen is a Pennsylvania-based corporation with a company headquarters in bordering New Jersey.
The agreement also recognized whistleblowers from the Eastern District of Pennsylvania to be awarded $112 million. Those individuals include Victoria Starr, the first to file a suit, who will receive $110 million from the federal government’s share of the Risperdal settlement. The second whistleblower, Kurtis Barry, will be awarded $2 million from the federal government’s share of the related Invega settlement component, according to the U.S. Attorney’s Office in Philadelphia.
Stephen Sheller, one of the attorneys representing the plaintiffs, said the following regarding the conduct of the drug companies:
“They targeted children and the elderly.”
Sheller represents Starr, specifically, and has a number of separate cases regarding Risperdal’s effects on children, which are still currently pending.
Thomas Sheridan, who represented Barry, noted how the size of the settlement was possible largely due to the massive sales volumes of Risperdal. At one point, sales figures confirmed Risperdal to be the number one prescribed antipsychotic drug on the market.
Barry had also contributed evidence that the sales goals set by the company for the drugs went beyond what could be mathematically possible from the schizophrenia market share alone, according to Sheridan. In a separate statement, Sheridan pointed out what he felt was most alarming about the case; that the pharmaceutical company marketed the off-label uses for its drug to the “most vulnerable members of society.”
