Texas AG and Johnson & Johnson Battle in Opening Statements

by Janet Elliott, Contributing Writer

AUSTIN (January 10) – In opening statements today in the state’s $1 billion false drug marketing case against Johnson & Johnson, a lawyer for the company said he will present “real world” evidence that the antipsychotic Risperdal was widely used by medical professionals on adults and children because it works better than competing products.

Texas Attorney General Greg Abbott is suing Johnson & Johnson and its Janssen unit for fraudulently promoting Risperdal as the preferred drug for treating schizophrenia and other mental illnesses, at a cost to taxpayers of $4.57 a pill compared to 10 cents for a comparable, older drug. The state is seeking $579 million in money that Medicaid paid for Risperdal and another $500 million in penalties.

J & J’s lawyer, Steve McConnico of Austin’s Scott, Douglass & McConnico, told a Travis County jury that Risperdal was a step forward from the previous generation of antipsychotics that often caused debilitating facial tics, shuffling gaits and nervous mannerisms. Additionally, he said that the older drugs did not help with a lack of motivation that accompanies serious mental illnesses such as schizophrenia and bipolar disease.

The idea that Johnson & Johnson employees were “some kind of master puppeteers who could control all these doctors around the world and country does not make sense,” McConnico said.

Cynthia O’Keeffe, deputy chief of the Texas Attorney General’s Civil Medicaid Fraud Division, began opening arguments by describing Janssen’s “systematic scheme” to turn its drug into a blockbuster while downplaying serious side effects of weight gain and diabetes.

The state began investigating the marketing of Risperdal at the urging of whistleblower Allen Jones, a former investigator in Pennsylvania’s Office of Inspector General, who uncovered payments from Janssen to Texas state officials, University of Texas professors and mental health advocates. The AG’s Office joined Jones’ suit in 2006, alleging that the scheme to influence Texas decision- makers was so successful that Janssen exported it to other states.

Tom Melsheimer of Fish & Richardson in Dallas, who represents Jones, said Johnson & Johnson and its charitable foundation contributed more than $3 million to influence the state’s guidelines for treating mental illnesses to secure Risperdal’s position as the preferred drug. He said one of the key targets was the then-medical director of the Texas Department of Mental Health and Mental Retardation, Dr. Steven Shon.

“A series of illegal payments to Dr. Shon effectively turned him into a salesman for Risperdal,” Melsheimer said.

Melsheimer said the company promoted Risperdal for so-called “off label” uses to treat children and adolescents. In 2001 – five years before the drug was approved for limited use in children – a quarter of all prescriptions were for children, Melsheimer said.

McConnico, who is leading a team of lawyers from the Dallas office of Locke Lord Bissell & Liddell, denied the company had a policy to promote off label use, although he said there may have been some sales representatives who were overzealous. Doctors are allowed to prescribe medications for off label uses, and many psychiatrists chose Risperdal for their young patients because it was the best alternative to prevent them from harming themselves and others, McConnico said.

Risperdal remains on the state’s preferred drug lists. Between 1994 and 2009, Texas Medicaid reimbursed J&J for more than 2.75 million prescriptions of the antipsychotic, a fact that McConnico said shows that the state has “put no restrictions on this and now they want all their money back.”

State District Judge John Dietz is presiding over the trial, which is expected to last several weeks. Jurors were told that much of the testimony will be presented via videotaped depositions.