Johnson and Johnson 2013 Settlement and Corporate Integrity Agreement

On November 4, 2013, the Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and its pharmaceutical subsidiaries signed settlement agreements to pay more than $2.2 billion to resolve criminal and civil investigations into unapproved, or "off-label," promotion of three drugs and alleged kickbacks to physicians and nursing home pharmacies over a ten-year period. In 2012, we reported on the largest health care fraud settlement in U.S. history: $3 billion paid by GlaxoSmithKline.  According to the Associated Press, the J&J global settlement is the third-largest health care fraud settlement in U.S. history, and it includes a five-year Corporate Integrity Agreement (CIA) between J&J and the Department of Health and Human Services Office of the Inspector General (HHS-OIG). Key implications of the CIA for continuing medical education and compliance managers are outlined below. Summary of Criminal and Civil Agreements The global resolution includes criminal fines and a forfeiture of profits totaling $485 million and civil settlements arising under the False Claims Act totaling $1.72 billion, paid out to federal and state governments as reimbursement for improper Medicaid payments. The criminal complaint, prosecuted in the Eastern District of Pennsylvania, charged that J&J subsidiary Janssen Pharmaceuticals introduced the antipsychotic drug Risperdal into the interstate market for non-FDA-approved uses targeting the elderly and childr...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs