J&J Pushed Risperdal for Kids Without Approval, Memo Shows

J&J Pushed Risperdal for Kids Without Approval
Johnson & Johnson logos are displayed for a photograph in Tiskilwa, Illinois. Photographer: Daniel Acker/Bloomberg

A Johnson & Johnson unit marketed its Risperdal drug in 2004 to doctors working with troubled children even though regulators hadn’t approved the drug for those patients, company records show.

Officials of J&J’s Janssen unit pushed salespeople in Texas to “flood clinics with Risperdal stuff” as part of a 2004 campaign to increase prescriptions for the anti-psychotic drug written for children and adolescents, according to an internal memo put into evidence today in state court in Austin, Texas. The U.S. Food and Drug Administration didn’t approve Risperdal for any pediatric use until 2006.

Texas officials contend New Brunswick, New Jersey-based J&J, the world’s largest health-care products company, defrauded the state Medicaid program by promoting Risperdal for uses not approved by U.S. regulators, including for children with psychiatric disorders. The state joined a lawsuit filed by a whistle-blower, Allen Jones, a former Pennsylvania health-care fraud investigator.

Lawyers for Texas Attorney General Greg Abbott are asking jurors to award the state at least $579 million from J&J and Janssen in damages over the companies’ marketing program for the anti-psychotic medicine.

Shane Scott, a former Janssen sales manager in Texas, testified he got a memo from his superiors in the summer of 2004 calling for a push to market Risperdal to treat attention-deficit syndrome in kids at the beginning of a new school year.

‘ADD Meds’

The campaign’s goal was to position Risperdal to compete with rival anti-psychotic drugs, such as AstraZeneca Plc’s Seroquel and Eli Lilly & Co.’s Zyprexa, Scott said.

“When kids are back in school, they are more likely to take their ADD meds,” Scott testified during a videotaped deposition that was played for jurors.

Salespeople who visited doctors in San Antonio and other South Texas areas were so successful in marketing Risperdal in 2004 that Scott’s district later was ranked for a time as the top seller out of the company’s 58 districts across the U.S., the manager testified. Scott said his superiors praised his performance in connection with the Risperdal sales.

Bruce Perry, a psychiatrist at Northwestern University Medical School who works with traumatized children, told jurors today that young people “are more vulnerable” to the side effects of anti-psychotic drugs.

Weight Gain

Those conditions include weight gain, drowsiness and sometimes-severe withdrawal symptoms, said Perry, a former head of psychiatry at the Texas Children’s Hospital in Houston. He testified as an expert for the state.

Texas is the fourth state to take claims over J&J’s and Janssen’s marketing of Risperdal to trial.

The states of Louisiana and South Carolina sued J&J partly over marketing letters the company sent to doctors in those states touting Risperdal as superior to rival drugs. Lawyers for the state argued those statements were false.

J&J lost a $327 million judgment in South Carolina in June after a jury found the drugmaker liable for damages. The company also lost a Risperdal case in Louisiana, where on top of a $257.7 million jury award, the judge ordered the company to pay $73.3 million in attorneys’ fees and costs.

A Pennsylvania judge threw out the state’s case against J&J and Janssen in June 2010.

J&J and the Janssen unit have also been sued over marketing practices by Alaska, Arkansas, Louisiana, Montana, New Mexico, Pennsylvania and Utah. The Arkansas case is set for trial in March.

The Texas case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).

Before it's here, it's on the Bloomberg Terminal. LEARN MORE