J&js Janssen Unit Marketed Risperdal Off-label, Ex-workers Say
J&J tried to promote Risperdal for conditions beyond schizophrenia, its approved use until December 2003, according to sworn statements among almost 1,000 pages of documents in the case in Trenton, New Jersey. To boost sales of the medicine, J&J urged doctors to prescribe Risperdal for conditions such as bipolar disorder and depression, the declarations say.
“We (sales representatives) were directed to grow share in these off-label populations,” ex-saleswoman Kristel Kellner said in a statement as part of the lawsuit filed by Lynn Powell, one of the former salespeople. Powell claims J&J fired her in 2004 for complaining about such practices, violating a law shielding workers from retaliation.
Risperdal was J&Js fourth-biggest seller in 2008. It was its biggest in 2007, before a patent expired.
The declarations, which are exhibits in Powells suit against the company, contradict the companys statement in a court filing that any so-called off-label promotion “was and is strictly prohibited by Janssen.”
The Justice Department is investigating such practices at Janssen and in the industry. Nine states including Louisiana have sued J&J, claiming it violated a federal bar to off-label marketing, according to company regulatory filings.
Powells firing “demoralized me and my peers because all of us were selling in the same manner,” a former salesman, Matthew Fontaine, said in a statement. A trial of the lawsuit, filed in February 2005, is set for March 30.
Company Response
Janssen says it didnt do off-label marketing and wont comment on specific claims in the lawsuit for reasons of employee privacy, a company spokesman, Srikant Ramaswami, said in an e-mailed response to questions.
“Janssen has a system in place to ensure that our marketing and promotion policies are followed,” he said. “If questions are raised about adherence to these policies, we act quickly to investigate the situation and take appropriate disciplinary action.”
Risperdal generated $3.4 billion in sales in 2008, or 5.4 percent of sales for J&J, based in New Brunswick, New Jersey. Janssen is a division of J&Js Ortho-McNeil-Janssen Pharmaceuticals unit.
Drugmakers have paid billions of dollars to resolve litigation and government investigations over marketing of medicines for conditions not approved by the U.S. Food and Drug Administration.
Pfizer Inc., the worlds largest drug company, said Jan. 26 it would pay $2.3 billion to end a marketing probe over the painkiller Bextra and other drugs. Eli Lilly & Co. said Jan. 15 it would pay $1.42 billion over promotion of its antipsychotic Zyprexa.
Risperdals competitors include Zyprexa and AstraZeneca Plcs Seroquel.
“Off-label marketing is a sort of skinflint, cheap way of promoting drugs without doing the research needed to get the approval of the FDA for new uses,” said Sidney Wolfe, director of Public Citizens Health Research Group, a Washington-based advocacy organization. “Companies that do this place patients at risk because there is no assurance that the benefits outweigh the risks.”
While drugmakers arent allowed to urge off-label uses, doctors can prescribe medicines for conditions not approved by the FDA. Dr. Jeffrey Lieberman of Columbia University Medical Center said off-label prescribing “is done all the time in the practice of medicine in a very rational and useful way.
Pushing Boundaries
“Researchers are pushing the boundaries of trying to determine how a therapeutic agent can be effectively applied,” said Lieberman, the psychiatry department chairman. “The process of getting FDA approval is a lengthy, complicated and expensive one.”
Almost 1,000 pages of documents in the Powell case, available in Trenton, include salespeoples descriptions of marketing pitches, articles provided to them on studies of new uses and details on the hiring of medical leaders to talk to other physicians about the drugs benefits.