Risperdal trial: Sales rep cites pressure from above

A former Janssen Pharmaceuticals sales representative who was promoted because of his success in selling the antipsychotic drug Risperdal told a Philadelphia Common Pleas Court jury Monday that he and his team followed orders from the top of the company in promoting the drug for uses not approved by the U.S. Food and Drug Administration.

Janssen is a wholly owned subsidiary of health-care giant Johnson & Johnson, which has headquarters in New Brunswick, N.J., and divisions elsewhere in the region.

"Janssen wanted Risperdal to be a $1 billion drug, and that led to how we would communicate with our customers," said Tone Jones, referring to doctors who would prescribe the drug to patients. Jones was a sales representative for Janssen and Risperdal.

The jury of eight men and four women will decide whether J&J owes money to the family of a 17-year-old from Texas who was prescribed the drug when he was 5 and started growing breasts at age 12. Judge Mark Bernstein told the jury he expected the case to last about three weeks.

J&J faces hundreds of individual lawsuits alleging harm to patients, but it also faces - or has paid to settle - multiple state and federal cases involving inappropriate promotion of Risperdal.

The drug was approved in 1993, but only to treat adults with schizophrenia and bipolar disorder, which have small populations, and that makes generating huge profits difficult. Doctors can legally prescribe anything, but drug companies can't promote a drug for anything not on the official FDA-approved label. The allegations across all the suits is that Janssen did just that.

J&J attorney Laura Smith dismissed that idea and encouraged jurors not to view the case as one of a multinational corporation ignoring federal law and patient safety in pursuit of profit, but as a case of a boy with multiple mental problems who was genuinely helped by the drug and had minimal side effects.

"Risperdal was a very good choice" for the boy's three physicians, Smith told the jurors.

Smith later told the jury that if any Janssen personnel had been found promoting drugs for unapproved uses, they would have been fired.

That set up a direct contradiction when Jones took the stand. The plaintiff's attorney, Bob Hilliard, in his opening statement, had shown a group photograph that included Jones and then-Janssen president Alex Gorsky, who is now chief executive officer of J&J.

Hilliard asked Jones whether he knew of anybody who got fired for selling Risperdal off-label.

"No," said Jones, who started four years at quarterback for Oklahoma State and then spent about 10 years working for Janssen.

Did you get bonuses based on selling Risperdal off-label? Hilliard asked.

"Yes," said Jones.

Earlier in the day, Hilliard and Philadelphia lawyers Stephen Sheller and Brian McCormick formally asked Judge Arnold New to reconsider his decision Thursday that Gorsky could not be compelled to testify. New gave no reason for his decision. Gorsky's assistant had said in an affidavit that he would be in Asia. The boy's attorneys said New was setting a terrible precedent because every corporate leader would suddenly find the need to be out of the country when subpoenaed by opposing counsel.

"A decision to quash the subpoena of Mr. Gorsky would result in denial of the rights of ordinary citizens, such as Plaintiffs, and would favor large businesses over the interests in a trial by jury," the plaintiff's attorneys wrote.