Did J&J Plan to Break Rules?

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In 2003, it approved Risperdal for bipolar disorder. Three years later the drug was cleared to treat symptoms related to autism in children and teens. Regulators also cleared it to treat bipolar children and teens in 2007. The drug was never approved for dementia.

Lawsuits tied to off-label marketing have proliferated in the past four years, and drugmakers have paid out some lush settlements. Last September, Pfizer (PFE) agreed to pay the U.S. government and various states $2.3 billion for off-label promotion of its Bextra painkiller and other drugs. For antipsychotics alone, off-label settlements against Pfizer, Eli Lilly (LLY), AstraZeneca (AZN), and Bristol-Myers Squibb (BMY) have mounted to more than $2.5 billion since 2006.

Resolutions reached in some of these cases do not bode well for J&J. Lilly's settlements with the U.S. government and more than 40 states for off-label promotion of its antipsychotic, Zyprexa, came to more than $1.6 billion over time. "It was this very conduct—marketing an atypical antipsychotic for dementia rather than for psychosis—that led to the $1 billion-plus settlement with Eli Lilly," says Patrick Burns of Taxpayers Against Fraud, a Washington organization that supports whistleblower suits.

A Marketer in the House?

In all, J&J made more than 5,000 pages of documents public. The filings show that Janssen executives felt a strong need to broaden their marketing efforts shortly after Risperdal won FDA approval. "Schizophrenia represents only 35% of [antipsychotic] prescriptions," Ivo Caers, a Janssen executive, wrote in a 1994 report included in court papers. "Aggressive expansion of Risperdal use in other indications is therefore mandatory."

Like other drugmakers, Janssen hired doctors to speak at continuing medical education, or CME, programs. But to drive sales, it armed them with slides extolling Risperdal's effectiveness. "The content of the Speakers Slide Kit is driven by marketing as they are promotional in nature," says a January 2003 e-mail sent by Jeni Bastean, a Janssen executive. At a 2003 meeting, another Janssen executive praised the use of coached questioners at programs, according to a transcript.

A doctor identified in the transcript as Randy told Janssen employees that he signed a letter agreeing he would talk only about permitted uses of Risperdal. But Randy had a way around this: "I always plant a shill, because if I get asked a question from the audience, I can then speak off-label." After this remark, Dr. Andrew Greenspan, an executive in Janssen's medical affairs department, said: "That's good practical advice."

CME meetings also aided Janssen's marketing of Risperdal as a geriatric drug, according to Lon Schneider, a psychiatry professor at the University of Southern California and a plaintiff's expert in the litigation. The common element to such meetings, Schneider wrote in his expert report, "was to promote the use of Risperdal and other Janssen products for elderly patients with dementia."

Margaret Cronin Fisk is a reporter for Bloomber in Michigan. Jef Feeley is a reporter for Bloomberg in Delaware. David Voreacos is a reporter for Bloomberg in New Jersey.