On Monday, the United States Attorney General announced that Johnson & Johnson will pay $2.2 billion to end civil and criminal investigations into kickbacks to the marketing of pharmaceuticals for off-label uses and to pharmacists. This will be one of the largest health care fraud settlements in the United States history.
This resolution came after several years of the case involving the marketing of anti-psychotic drugs Invega and Risperdal, along with the heart drug Natrecor.
Between 1999 and 2005, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. were promoting Risperdal for unapproved uses. This drug is used to control anxiety and aggression in elderly patients suffering from dementia, to treat behavioral disturbances in children, and disturbances in individuals with disabilities.
This would result in extreme costs to the United States government insurance programs in uncovered claims. In this settlement, Janssen Pharmaceuticals Inc. will plead guilty to a misdemeanor violation for its promotion of the drug Rispersdal.
The FDA reported that it had delivered multiple warnings to Janssen regarding “misleading marketing messages” to doctors, and later initiated a criminal complaint.
During this settlement, allegations regarding Johnson & Johnson’s subsidiary, Scios Inc., was also resolved. In this case, the company Scios Inc. marketed Natrecor for off-label uses which were not approved by the FDA and were not covered by federal healthcare programs.
Over the past decade, many large drug manufacturers have paid major fines to the United States government and states for alleged use of improper marketing of medicines.
In 2010, Pfizer Inc. paid $2.3 billion to settle allegations that it marketed 13 drugs incorrectly, which included kickbacks to healthcare providers.
In 2012, Great Britain’s GlaxoSmithKline Plc. agreed to pay $3 billion to resolve criminal charges regarding the targeting of children to use its Paxil depression treatment, and sold its Wellburtrin antidepressant for unapproved uses, while failing to inform United States regulators of safety risks seen with its Avandia diabetes drug.