J&J Fined $5,000 Per Sales Rep Visit for Risperdal Mismarketing

How bad could that Texas lawsuit against Johnson & Johnson for mismarketing Risperdal be? Try $5,000 per visit of a sales rep to a doctor.

That was the formula used in a West Virginia state court case in which the state attorney general sued J&J and its Janssen Pharmaceutica unit over false or misleading statements about Risperdal and Duragesic. The West Virginia judge assessed only $4.4 million in fines, but the formula he used -- $5,000 per visit of a rep to a doctor plus $500 per letter or brochure -- could have resulted in $22 million in fines.

The court noted in its order,

The defendants were twice put on notice by previous [FDA] warning letters that its promotional materials for Duragesic contained false or misleading statements; however ... the defendants then willfully sent the false or misleading Duragesic [brochure] to West Virginia health care providers to make its medication Duragesic more appealing for sale.

The wording of [the] November 2003 Risperdal letter was intentionally constructed to modify the FDA's warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients.

J&J faces a much bigger suit in Texas, where it has been accused of Medicaid fraud, kickbacks and improper marketing of Risperdal to children and the poor in that state.

The FDA's Risperdal warning letter is a big part of the Texas case, too.