LITTLE ROCK — The warning label for the drug Risperdal was inadequate in 2000 because it failed to disclose the possibility that users faced an increased risk of developing diabetes, even though two studies by the manufacturer showed patients taking the medication were more susceptible to the disease, an expert for the state told Pulaski County jurors Thursday.
Laura Plunkett of Texas, testifying as an authority on federal drug regulations and pharmacology, was the second witness to take the stand in the Arkansas’ Medicaid fraud and deceptive-trade lawsuit against drugmaker Johnson & Johnson and its Janssen Pharmaceuticals subsidiary, maker of the antipsychotic medication Risperdal. The drug is one of the most widely used medications for treating conditions such as schizophrenia and bipolar disorders.
Plunkett, a former researcher and professor at the University of Arkansas for Medical Sciences in Little Rock, also testified that federal regulators had cited Janssen Pharmaceuticals for misleading doctors in a November 2003 mailing, known as a “dear doctor” letter, about the effect of the drug on diabetes. The federal Food and Drug Administration described that letter as “false and misleading,” Plunkett said, and ordered the company to mail another letter with corrected information.
Arkansas Attorney General Dustin McDaniel, who made his first appearance at the proceedings Thursday, claims Johnson & Johnson concealed the drug’s dangerous side effects, like the increased risk for diabetes, for years, particularly in its marketing to children and elderly patients.
Arkansas is seeking at least $1.25 billion in fines, all of which would go to the state Medicaid program, against the New Jersey-based company, based on the number of Risperdal prescriptions the state program paid for over a period of about 4 1/2 years. Company lawyers said the state is basing its case on bad science by exaggerating a legitimate dispute between Johnson & Johnson and federal regulators.
On the trial’s third day, Plunkett told jurors that federal laws require drugmakers to revise their labeling to warn patients about possible side effects if the medication can be associated with a “serious hazard,” even if a link between the medication and that hazard has not been proved.
In May 2000, the federal Food and Drug Administration solicited the company and its competitors to research links between diabetes and Risperdal and similar medications, such as Zyprexa. In August 2000, according to a company letter shown to jurors, Janssen responded that it couldn’t find significant links to the disease, reporting that there had been no major studies comparing Risperdal to Zyprexa.
But the company had done two significant surveys, known as 113 and E.R.I., state attorney Fletch Trammell said,showing jurors those reports. Plunkett said those surveys showed that Risperdal users had a higher rate of diabetes than patients who used its competitors.
Results from those surveys were never disclosed to federal regulators, Plunkett said, while Janssen promoted a third study done about that same time that showed more favorable results for Risperdal.
Arkansas, Pages 9 on 03/30/2012