A whistle-blower lawsuit has been filed against drug manufacturer Janssen Pharmaceutica, alleging that the company misled Texas officials about its antipsychotic drug Risperdal in order to maximize profits. Unsealed documents in the Risperdal lawsuit claim that Janssen, a subsidiary of Johnson & Johnson, used deceptive marketing practices that caused Texas to overspend on Risperdal last year at the risk of mental-health patients.

The lawsuit is just one of several currently filed in several states against makers of antipsychotic drugs which accuse drug companies of engaging in deceptive marketing practices by overstating effectiveness while understating risks. Some lawsuits also claim that drug companies have promoted the drugs for unapproved or “off-label” uses.

The Texas lawsuit focuses on the state’s prescription drug program guidelines, which require doctors to give priority to newer drugs in the state-funded treatment of mental-health patients. This program, known as the Texas Medication Algorithm Project (TMAP), began in 1996 with the premise of standardizing prescription of medication to state mental patients. However, the whistle-blowing complaint alleges the Texas health department received as much as $6 million in contributions from Janssen and other parties to implement TMAP guidelines and increase profits of antipsychotic drugs.

According to the lawsuit, after the guidelines were adopted, Janssen “experienced a significant increase of sales of Risperdal” in Texas. Janssen successfully worked with other states to adopt similar programs, including Pennsylvania.

The whistle-blowing complaint was initiated in 2004 by Alan Jones, a former investigator for Pennsylvania’s Office of the Inspector General, who was fired after questioning the system of drug guidelines in Pennsylvania and divulging information about his investigation without permission.

Since the inception of the program in Texas and other states, Risperdal has become the most commonly prescribed antipsychotic medication in the United States, with domestic sales totaling $10 billion from 2001 to 2005, according to IMS Health Inc.

The whistle-blower lawsuit comes as Janssen is preparing to market a new antipsychotic drug: Invega Extended-Release Tablets, the first schizophrenia prescription treatment approved by the FDA since 2003. Invega, which is derived from Risperdal, was approved by the FDA on December 20, 2006.

Sources: Rob Waters, “Suit: Janssen Pharmaceutica misled Texas officials on drug,” Bloomberg News, December 29, 2006, accessed January 4, 2007; Miranda Hitti, “Invega Extended-Release Tablets Include a Newly Approved Chemical,” WebMD Medical News, December 20, 2006,accessed January 4, 2007.