Texas court begins trail of $1b Risperdal marketing suit

AUSTIN, Texas — Texas prosecutors want jurors to award the state $1 billion in a lawsuit that accuses Johnson & Johnson of overstating the safety of an anti-psychotic drug and influencing its use in the state's Medicaid program. The company, facing similar claims in other states, is promising to vigorously defend itself when both sides lay out their cases during opening statements Tuesday.

The lawsuit accuses Johnson & Johnson and several of its subsidiaries of fraud by making false or misleading statements about Risperdal and the drug's safety, cost effectiveness and superiority in the 1990s. Risperdal is a pill for schizophrenia and bipolar disorder.

The trial is expected to last two weeks.

The suit was originally filed in 2004 by whistle-blower Allen Jones, a former employee with the Office of Inspector General in Pennsylvania, and Texas later joined the case. Jones has said he learned of Johnson & Johnson's actions in Texas while investigating similar claims in Pennsylvania.

The suit is among dozens of pending state and federal cases alleging illegal marketing practices and kickbacks in an effort to boost Risperdal over competing drugs. And a verdict against the company wouldn't be the first.

Last year, a South Carolina judge ruled that Johnson & Johnson must pay a $327 million civil penalty after a jury found it guilty of overstating the safety and effectiveness of Risperdal. In 2010, a jury found that the company violated Louisiana's Medicaid Fraud Act and was fined about $258 million in damages.

Johnson & Johnson has denied the claims in Texas's lawsuit and said it follows U.S. Food and Drug Administration rules.

"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. If questions are raised about adherence to our marketing and promotion policies, we act quickly to investigate the situation and take appropriate disciplinary action," the New Brunswick, N.J.-based company and its subsidiaries said in a statement.

Jones' attorney and Texas Attorney General Greg Abbott's office, which is representing the state, declined comment before the trial began.

Risperdal and similar antipsychotic drugs have been linked to increased risk of strokes and death in elderly dementia patients, seizures, major weight gain, onset of diabetes and potentially fatal high blood sugar.

Jones accuses several doctors who were state officials in Texas' mental health department of giving Risperdal preference over other antipsychotic drugs. One is accused of accepting honoraria from Johnson & Johnson to urge doctors in other states' Medicaid and mental health programs to use Risperdal.

The drug company and its subsidiaries are also accused of promoting misleading interpretations of research studies and paying millions of dollars - much of it to decision-makers - to influence the creation of state mental health medication guidelines favoring Risperdal.

The company also is accused of falsely saying the drug was safe to use with children and other populations when federal regulators had not approved its use with those groups.

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source: Seattle Times (AP, 1/10)