LITTLE ROCK — A California psychiatrist testifying for the state conceded Wednesday that he doesn’t know any Arkansas physicians who have been deceived by the labeling of the antipsychotic drug Risperdal.
The second day of the attorney general’s Medicaidfraud case against Johnson & Johnson, the drug’s manufacturer, was spent on defense attorneys questioning Dr. William Wirshing of Los Angeles.
The state is seeking more than $1 billion in fines from Johnson & Johnson — based on the number of Risperdal prescriptions the Arkansas Medicaid program has paid for — arguing the company covered up the side effects of the medication, which is widely used to treat schizophrenia and mood disorders. The state claims the company used dishonest labeling and deceptive mailings to promote the drug to Arkansas physicians.
The medication can cause diabetes-inducing weight gain in patients — an average of 6 pounds in three months — and it has particular risks for very young and very old patients. It can cause serious reproductive abnormalities in children and increased risk of stroke and heart attack in the elderly.
Risperdal is a wonder drug for seriously ill patients, Johnson & Johnson’s defenders have countered, accusing state lawyers of distorting test results on the drug to pursue their accusations against the company. The state claims the company has violated Arkansas Medicaidfraud statutes and deceptivetrade laws.
With more than 50 potential witnesses to appear, the trial before Circuit Judge Tim Fox is set to last three weeks. Jurors will decide the guilt or innocence of the company, with the judge deciding on any fines. If the company is found guilty, the minimum potential fine as described by state lawyers is $1.25 billion.
Wirshing, the state’s first witness, was called to testify about what the company knew about Risperdal and spent Tuesday afternoon on the stand. He returned for an all-day crossexamination Wednesday by company attorney Laura Smith of Little Rock.
Wirshing, a psychiatrist and medical school instructor, testified about working as a consultant for Janssen Pharmaceuticals, the Johnson & Johnson subsidiary that created and marketed Risperdal. He continues to have a relationship with the company, he told jurors.
Questioned by Smith about his prescription practices, Wirshing testified he regularly prescribes Risperdal or a similar drug for his patients. He “rarely” prescribes it for children and elderly patients, he said, but occasionally does so, even knowing its potential dangers.
“The potential benefits outweigh the potential risks,” he said.
During questioning, Smith asked Wirshing to read individual sentences from Risperdal labels and describe how the federal Food and Drug Administration dictates how warnings on those labels, also called package inserts, are worded, down to mandating the size of the lettering.
Wirshing said he didn’t know any Arkansas doctor who has been deceived by the labels. Smith used the opportunity of Wirshing’s testimony to read to jurors admissions from the state acknowledging that no doctor has ever complained to the Arkansas Medicaid program or to the attorney general’s office that the company’s drug labeling or mailings have been misleading.
State lawyers counter that they don’t have to prove that any doctors were deceived by the drugmaker, only that the company lied about the risks of side effects of the drug and that a November 2003 company mailing to Arkansas physicians was false and misleading.
Arkansas, Pages 7 on 03/29/2012