Healthy Skepticism Library item: 16766

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Martin JP, Cronin Fisk M, Voreacos D
J&J Salesman Says He Sold Drug for Unapproved Uses (Update3)
Bloomberg.com 2009 Oct 28
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aizNbBG7bmZg

Full text:

A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.

Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.

“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.

Thompson was the third witness called in the case of Lynn Powell, 36, who claims she was fired in February 2004 for complaining within the company about pressure to promote Risperdal for children and bipolar disorder patients when it was approved only for adults with schizophrenia. Thompson was Powell’s supervisor when she was fired.

Attorneys for New Brunswick, New Jersey-based Johnson & Johnson deny the company condoned such practices. They said Powell was fired for violating its ban on off-label promotion.

Sales Training

The Janssen sales staff was trained specifically not to promote sales for augmentation therapy, said Michael Walsman, the unit’s former national sales director.

“We did not promote augmentation therapy,” Walsman testified today. “That was something we did not approve or do.” Walsman oversaw sales of Risperdal for more than a dozen years until his retirement in 2005.

The Powell lawsuit is the first Risperdal sales case to go before a jury. The Justice Department is investigating off-label marketing at Janssen and in the industry. Ten states sued Johnson & Johnson over Risperdal sales practices, including claims it violated a U.S. ban on off-label marketing. The Powell trial began in state court in Trenton, New Jersey, yesterday.

Thompson testified he was a sales representative in the Detroit area in 2002 for a Janssen sales force whose primary product was Risperdal. In one of his notes after a doctor’s visit, Thompson wrote that he was “working intently” to get the physician to try Risperdal in combination with another drug. In another, he wrote that he had “pushed” a doctor to prescribe higher levels of Risperdal in augmentation therapy.

‘Were You Aware?’

“In 2002, were you aware that making off-label claims was illegal?” Powell’s attorney, John Thurman, asked him today.

“I probably was,” Thompson replied.

Thompson was shown reports he filed after field visits with salespeople in 2003, including one describing a sales rep pressing a doctor for children and adolescents to consider Risperdal. Thompson commended the saleswoman for her skills in the sale, according to the report. He agreed under questioning that this was clearly off-label marketing.

“I did not think it was okay,” he said. He didn’t report her to superiors, he said.

Under federal law, drugmakers are barred from promoting drugs for unapproved, or off-label uses. Doctors are allowed to prescribe drugs for such uses.

Promoted in 2002

In late 2002, Thompson was promoted to a district manager in Raleigh, North Carolina, where Powell was one of his sales representatives.

Powell began selling Risperdal in 2000 in the Raleigh area and was trained to promote off-label use to doctors and hospitals, her lawyer said in opening statements yesterday.

Powell became uncomfortable with the practice in 2003 when she was told to sell Risperdal at a children’s psychiatric facility and one for the mentally retarded, Thurman said. She claims she was fired for objecting to such sales.

Walsman, the former Janssen executive, said sales representatives received extensive training each year that included warnings against promoting drugs for off-label uses.

Under questioning from J&J lawyer Thomas Scrivo, he read aloud portions of training manuals and a 2002 memo from Janssen’s then-President Alex Gorsky specifically noting that off-label sales were illegal and could compromise the company’s reputation.

“The issue of proper promotion of our products was a constant thing,” Walsman testified.

Top Salesperson

In 2003, Powell was honored as the top salesperson in her region, generating about $1.6 million in sales. She and her sales partner ranked 12th out of 250 teams nationally, Walsman said.

He said he was unaware of Powell’s concerns or the allegations against her until after she was fired.

“The only thing I knew was that she had been terminated for off-label promotion,” he said.

J&J fell 45 cents to $59.57 in New York Stock Exchange composite trading.

The case is Powell v. Janssen Pharmaceutica Inc., L-358-05, Superior Court of New Jersey, Mercer County (Trenton).