Years of marketing Risperdal for off-label uses have left manufacturers Janssen Pharmaceuticals and Johnson & Johnson with a tarnished history and sizeable monetary penalties.

Risperdal is the brand name for risperidone, a medication approved to treat schizophrenia, manic episodes of bipolar disorder, and irritability associated with bipolar disorder.

Since it was first FDA-approved for U.S. sale in December 1993, Risperdal has become particularly notorious for being linked to an abnormal development of breast tissue in men and boys, known as gynecomastia. The drug can cause an increase in prolactin, a hormone that stimulates breast growth. Gynecomastia allegedly related to Risperdal has been the subject of over a thousand claims already settled by J&J.

Risperdal Misbranding

From 2004 to 2013, the U.S. Justice Department investigated claims by eight separate whistleblowers from inside J&J. The whistleblowers alleged in part that the company had been marketing Risperdal for “off-label” uses – uses other than those approved by the FDA. While doctors have discretion to prescribe drugs for off-label use on a case-by-case basis, it’s unlawful for a pharmaceutical company to promote any drug for a non-FDA-approved use. The FDA refers to the practice of promoting a drug for off-label use as “misbranding.”

The whistleblowers provided evidence that J&J had misbranded Risperdal for use in elderly patients and in children from 1999 to 2005, during which time the drug was not approved for use in patients within those age ranges. The DOJ alleged in one of its complaints that J&J’s 2001 business plan provided for $340 million in Risperdal sales for use in children. One whistleblower said she worked for a time under a compensation plan that rewarded her for selling Risperdal off-label as a treatment for dementia. She said that her complaints to her manager were dismissed.

The investigation culminated in a settlement of civil and criminal charges costing J&J $2.2 billion in penalties. The whistleblowers were awarded as much as $29 million each.

Janssen said it accepted accountability for the criminal charges. However, J&J maintained the civil portion of the settlement was not an admission of liability, and it continued to deny the civil allegations.

Several state governments joined in the investigation, saying J&J’s misbranding caused them to overpay through Medicare or Medicaid. More recently, in April 2015, the Cherokee Nation filed its own claim over Risperdal misbranding. The tribe says it purchased Risperdal in 2002 and 2003, the same time that J&J and Janssen allegedly promoted the drug for unapproved use. They say the companies failed to properly warn the tribe about the risks associated with Risperdal, particularly the increased risk of stroke and diabetes in elderly patients. The tribe referred to the companies’ 2013 plea deal with the U.S. Justice Department, in which J&J and Janssen apparently admitted to the misbranding. They now seek compensation for the money they paid to purchase the drug.

The defendants removed the tribe’s Risperdal lawsuit from Oklahoma state court to federal court in July 2015. It’s now pending in the U.S. District Court for the Eastern District of Oklahoma under case no. 6:15-cv-00280.