Johnson & Johnson’s Janssen unit marketed its antipsychotic Risperdal to children and adolescents despite warnings by the U.S. Food and Drug Administration not to do so, a witness told jurors in Austin, Texas.
Janssen’s marketing to children began after the drug’s introduction in 1994 and continued until the FDA’s first approval for pediatric uses in 2006, jurors heard today from attorney Arnold Friede, an expert witness for the state. Texas seeks at least $579 million from J&J, claiming it defrauded the state Medicaid program by hyping Risperdal and overbilling.
Friede explained company documents and FDA letters as lawyers for Texas seek to show Janssen repeatedly disregarded agency admonitions to not market Risperdal beyond its initial approved use for psychotic disorders including schizophrenia.
Friede, a consultant who once worked at the FDA and Pfizer Inc., said Janssen disregarded the drug’s label. From December 1993 to October 2006, it said: “Safety and effectiveness in children have not been established.”
Texas joined a whistle-blower lawsuit filed in 2004 by Allen Jones, a former Pennsylvania state investigator. An attorney for Jones told jurors in his opening statement this week that J&J made $34 billion in Risperdal sales over 17 years.
In questioning today, Friede reviewed a 1994 business plan for Risperdal that discussed “seeding the literature and, if appropriate, changing current labeling” for uses including sales to children.
Friede said company policy stated “seeding” studies or those with “limited scientific value generally designed to promote product utilization are prohibited.”
He reviewed an FDA letter that denied a 1996 application by Janssen to allow use in children. The Janssen application never said “for what child or adolescent psychiatric disorders Risperdal would be intended,” the FDA said.
“Your rationale for proposing this supplement appears to be simply that, since Risperdal is being used in pediatric patients, this use should be acknowledged in some way in labeling,” according to the FDA letter in September 1997.
Typed notes by Janssen sales representatives of their calls on doctors showed they discussed the use of Risperdal with children, Friede told jurors.
Friede also reviewed FDA admonitions to Janssen to avoid saying that Risperdal was superior to an earlier class of antipsychotics.
The drug agency sent J&J a warning about its Risperdal marketing practices in 1999. It followed with a stronger warning after the company sent a letter on Nov. 10, 2003, to 700,000 doctors in the U.S.
J&J wrote to tell the doctors that the FDA wanted all makers of so-called atypical antipsychotics, including J&J, Pfizer Inc., and Eli Lilly & Co., to warn in product labels of the risk of hyperglycemia and diabetes mellitus.
J&J said research “suggests” that Risperdal “is not associated with an increased risk of diabetes” compared with an earlier class of antipsychotics. It also said evidence “suggests” Risperdal is “associated with a lower risk of diabetes than some other studied atypical antipsychotics.”
An FDA warning letter sent in April 2004 said the J&J missive failed to disclose new data on diabetes in the warning label; “minimizes the risk of hyperglycemia-related adverse events” that can lead to coma or death; fails to recommend glucose control monitoring for patients; and “misleadingly claims that Risperdal is safer than other atypical antipsychotics.”
J&J then sent a corrective letter to doctors.
The states of Louisiana and South Carolina, in suing J&J and Janssen, relied heavily on those company letters to doctors and on the FDA response. J&J lost a $327 million judgment in South Carolina 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.
The case is Texas v. Janssen LP, D-1GV-04-001288, District Court, Travis County, Texas (Austin).
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Saturday, January 14, 2012
J&J Marketed Risperdal to Children Despite U.S. FDA Warnings, Jurors Told - Bloomberg