Did they or didn't they? In a trial pitting ex-Johnson & Johnson sales rep against the company, a former national sales director testified that reps were trained to avoid pushing drugs for off-label uses. But a sales-rep witness says he did promote off-label use, and that the company's training did not prohibit the sales approach he used.
Ultimately, the jury will have to decide who's telling the truth. But here are some details for your own weighing. Michael Walsman, the sales exec, told the court that reps were specifically trained not to promote the antipsychotic drug Risperdal as "augmentation therapy," or as an add-on to other drugs, because that use wasn't FDA approved. Matthew D. Thompson, however, testified that he freely promoted Risperdal for augmentation use and was never told not to. Thompson allowed that he "probably" knew promoting the drug this way was against the law. "I'm not saying the company tried to hide it, but we didn't think about augmentation in the realm of on-label or off-label at that time," he said (as quoted by Bloomberg).
The he said-he said testimony came up in the cast of Lynn Powell, an ex-J&J rep who was fired in February 2004. Powell claims she was axed for complaining about pressure to promote Risperdal off-label. The company says she was fired for the opposite reason: For engaging in off-label marketing.
Obviously, this is yet another legal wrangle over drugmakers' marketing of atypical antipsychotics. Eli Lilly's Zyprexa, AstraZeneca's Seroquel, and J&J's Risperdal have been at the center of liability lawsuits, government probes, and more. As you know, Lilly agreed to a $1.4 billion settlement of claims related to its mismarketing of Zyprexa and continues to battle suits over off-label sales. AstraZeneca just yesterday announced that it had reached a tentative $520 million settlement of probes related to off-label Seroquel promotions. And in addition to Powell's suit, J&J's Janssen unit is dealing with Justice Department and state-level probes into off-label marketing.
- read the Bloomberg story