1 Boring Old Man

J&J Should Pay Texas $579 Million for Risperdal, Jury Told
Bloomberg
By David Voreacos, Margaret Cronin Fisk and Jef Feeley
January 10, 2012

Johnson & Johnson should reimburse at least $579 million to the Texas Medicaid system for fraudulently promoting its antipsychotic drug Risperdal for uses not approved by U.S. regulators, a state lawyer told jurors. J&J, the world’s largest health care products company, is defending a lawsuit by Texas Attorney General Greg Abbott that claims the company and its Janssen unit overhyped and overcharged the state for the drug after its approval in 1993. J&J also promoted Risperdal for use by children before it got approval from the Food and Drug Administration, Texas claims. By making false claims about the drug’s superiority and minimizing its side effects, J&J persuaded Texas Medicaid officials to pay 45 times more for Risperdal than for older types of drugs, Assistant Attorney General Cynthia O’Keeffe told jurors in opening a trial today in state court in Austin. “This is a case about the systematic looting of money from the Texas Medicaid system by one of the oldest and largest drug companies in America,” O’Keeffe said. Texas joined a lawsuit filed by a whistle-blower, Allen Jones, a former investigator for the Pennsylvania Office of Inspector General. An award of $579 million as sought by the state could be tripled by jurors under Texas law. In addition, if the state wins the case, jurors will decide the number of violations and set a penalty of as much as $10,000 apiece.

An attorney for Jones, Thomas Melsheimer, told jurors that J&J made $34 billion in Risperdal sales over 17 years. J&J, based in New Brunswick, New Jersey, systematically minimized Risperdal’s health risks to establish it as a blockbuster drug, Melsheimer said. He said the company made “a series of illegal payments” to Dr. Steven Shon, the former medical director of the Department of Mental Health and Mental Retardation in Texas, that “effectively made him a salesman for Risperdal” who promoted the drug around the U.S.

J&J denies wrongdoing and never acted illegally, attorney Stephen McConnico told jurors in his opening statement. He disputed the state’s contention that Risperdal was not superior to other drugs, saying it succeeded in the market because it was an improvement over an earlier generation of antipsychotics that had debilitating side effects. He said doctors made the decision to prescribe Risperdal off-label, which is not illegal, because it worked so well. “The idea that we’re some kind of master puppeteer that can control doctors all over the country” to prescribe what J&J wants is “simply not common sense,” McConnico said. “What did the doctors do? You bet they prescribed it. We don’t run away from that. We admit it. Because it worked.”

From 1994 to 2009, the Texas Medicaid program reimbursed for 2.75 million prescriptions for Risperdal, he said. He said Risperdal has remained on the state’s preferred drug list even as the attorney general has investigated this case for several years. “Actions speak louder than words,” McConnico said. “They wanted doctors to give it, and doctors wanted to give it”…

The case is State of Texas ex rel. Jones v. Janssen LP, D- 1GV-04-001288, District Court, Travis County, Texas [Austin].

The opening arguments sound like they were business as usual – elementary school playground talk ["did too!" "did not!"]. Tomorrow, the plainiff’s case begins, and we plan to be there bright and early. I’m not here to be a cheering section. They throw you out for that kind of thing. I’m here because I want to hear the details, what the expert witnesses  who had access to the primary documents have to say. Did J&J really manipulate the TMAP program as much as it seems from what we already know? What was the extent of the ghostwriting program from Exerptia Medica? Who ultimately called the shots? Why did it run for six or seven years  before anyone got wind of TMAP’s underbelly? That kind of thing. Like I said [does it make a sound?…], I want to make it real.