Appeals court reverses J&J decision
A West Virginia appeals court has reversed a lower court ruling and $4.5 million penalty against Johnson & Johnson for having allegedly made misleading statements in communications to doctors on its antipsychotic drug Risperdal and Duragesic fentanyl patch. The penalty was applied to a 2003 Janssen letter to doctors on Risperdal and a 2003 14-page promotional file card on Duragesic. The appeals court found that the lower court erred when it relied on a CDER Division of Drug Marketing, Advertising and Communications Warning Letter as evidence the communications were false and misleading. Because Warning Letters do not constitute “final agency action,” they are not susceptible to judicial review, the appeals court said.
“Accordingly, the circuit court erred in giving preclusive effect to the FDA's determinations that Janssen had violated the FDCA through its statements and omissions” in the Risperdal and Duragesic communications.