A new lawsuit filed against Janssen Pharmaceutica and its parent company Johnson & Johnson again pits state-level judgment about a drug's safety and efficacy against FDA's. The suit, filed by Arkansas Attorney General Dustin McDaniel, seeks to recover money paid by the state to purchase the antipsychotic Risperdal (risperidone) as well as money the state claims it spent to treat people injured by the drug.
The suit focuses on several areas:
Off-label promotion The state's lawsuit documents claim that Janssen marketed Risperdal, an atypical antipsychotic, for "medically unnecessary" uses, including ADHD, depression, bipolar disorder, and aggressive behavior in late-onset dementia.
Safety The state argues that Janssen didn't adequately test the drug. "[P]rior to marketing Risperdal, defendants should have been concerned about Risperdal causing neurological problems, weight gain, diabetes, pancreatitis, hyperglycemia, cardiovascular complications, and cardiovascular syndrome," the filing reads. "And yet Risperdal's original label, and all label changes since, have not adequately warned of these adverse effects."
The state, in effect, argues that Risperdal should have had a different label—a point that raises the currently contentious issue of FDA preemption, which is working its way toward the Supreme Court on several fronts.
False advertising The state is in better sync with FDA in pointing out that the agency had soundly critiqued some Risperdal advertising for making unproven claims, minimizing risks, and printing warnings in out-of-the-way locations in tiny, pale-colored text.
This suit is similar to the one filed by New York State against Merck in September. New York argued that it was owed money for Vioxx prescriptions that were covered by state-funded insurance providers. New York City Mayor Michael Bloomberg, who was listed as a plaintiff in that suit, also cited false or misleading advertising. The suit is still outstanding.
In April 2004, Janssen received a warning letter from FDA noting that a "Dear Doctor" letter sent from the manufacturer to physicians was false or misleading in its risk assessment of Risperdal. The drug is scheduled to go off patent later this month.
"We are prepared to vigorously defend ourselves against these claims. Janssen routinely informs and fully discloses all appropriate information about Risperdal to the medical community, government agencies, and other payers, and this includes clear, FDA-approved information about the product's efficacy and safety profile," Janssen spokeswoman Ambre Morley stated in a release to Pharm Exec.