Jannsen Pharmaceuticals Pleads Guilty to Misbranding, Fined $344M

Johnson & Johnson subsidiary Jannsen Pharmaceuticals pleaded guilty to information charging it with introducing a misbranded drug into interstate commerce, the U.S. Attorney’s Office out of Pennsylvania announced Thursday afternoon.

Jannsen was charged with one count of introducing the misbranded drug Risperdal. Upon pleading guilty, Jannsen was sentenced to pay a $344 million fine and forfeiture of $66 million.

Risperdal is a drug approved to treat the management and manifestation of psychotic disorders, and in March of 2002, its use was narrowed to the treatment of schizophrenia exclusively.

Jannsen, based in Titusville, Mercer County, pleaded guilty to introducing the drug for a new, unapproved use. It introduced the drug to health care providers as a treatment for psychotic symptoms and associated disturbances exhibited by elderly, non-schizophrenic dementia patients. These uses were not approved by the Food and Drug Administration (FDA).

After a drug is approved, it cannot be introduced into interstate commerce for unapproved or “off label” use. Introducing the drug for a use not approved by the FDA shows the manufacturer intends to distribute the drug for unapproved use, also known as “misbranding,” according to the U.S. Attorney’s Office.

Earlier this week, Johnson & Johnson agreed to pay $2.2 billion to resolve criminal and civil liability charges associated with this case. It is the largest payout for misbranding and unapproved use in history, and the third largest payout involving a single company.