Risperdal Manufacturer Hit with Massive $2.2 Billion Penalty

Washington, DCOne can well imagine the rush to file a Risperdal lawsuit following the release, back in the fall, of a damning report by the US Food and Drug Administration Office of Criminal Investigations (FDAOCI) that resulted in a $2.2 billion judgment against pharmaceutical giant Johnson & Johnson (J&J). At issue were allegations that J&J actively marketed Risperdal for uses that circumvented the approved uses as mandated by the FDA.

Risperdal wasn’t the only issue at play in the criminal and civil investigation. Allegations also focused on two other drugs in J&J’s quiver of medicinal arrows. However, Risperdal played a major part in the matter. Risperdal lawyers were busy.

According to an official release by the US government, J&J subsidiary Janssen Pharmaceuticals Inc. (Janssen) promoted Risperdal for use in elderly patients suffering from dementia from March 3, 2002 through December 31, 2003. Further, there were allegations that the manufacturer attempted to downplay and mitigate study results that suggested an increased risk for stroke in elderly patients, by combining the study results with other studies to make it appear that the risk for Risperdal stroke was lower than it really was.

In similar fashion, Janssen stood accused of downplaying the risk for Risperdal diabetes.

From 1999 through 2005, according to the investigation, Janssen is also alleged to have promoted Risperdal for use in children and individuals with mental disabilities. The problem is that Risperdal - approved only to treat schizophrenia in 1993 - was not approved for short-term treatment of bipolar 1 disorder for adults until 2003. And it wasn’t until 2006 that the FDA gave Janssen its blessing to the treatment of irritability associated with spectrum disorders in children and adolescents 5 to 16 years of age.

In so doing, Janssen is alleged to have jumped the gun in spite of frequent overtures from the FDA that doing so would be in contravention of the approved uses for Risperdal.

While doctors have the medical and legal authority to foster use of drugs and medicines for uses other that those approved according to the needs of the patient and their own professional opinion surrounding treatment protocols, manufacturers are prohibited from promoting their products to doctors and health care professionals for uses other than those specifically approved by the FDA.

Janssen, and by association J&J, was also accused of paying speaking fees to doctors with the view of prompting increased Risperdal prescriptions to their colleagues. There was also an allegation that speaking fees to doctors were dependent on the doctor’s willingness to increase Risperdal prescriptions.

Amongst the numerous allegations, J&J was accused of paying millions of dollars in kickback payments to Omnicare Inc., the largest dispensary of drugs to nursing home patients in the US, under the guise of market share rebate payments, grants, educational funding and data-purchase agreements.

The investigation and subsequent settlement went all the way to the Office of the US Attorney General, who commented on the matter in a statement.

“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”

The potential link between Risperdal and diabetes is of concern for otherwise symptom-free individuals without any family history of diabetes or other risk factors. And yet, Risperdal blood sugar problems could throw them into a lifetime of dealing with diabetes.

Beyond the $2.2 billion in penalties, the pharmaceutical giant is now subject to stringent requirements under a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General.

The wide-ranging investigation of practices involving Risperdal, Invega and Natrecor resulted in criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and various states totaling $1.72 billion.