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Johnson & Johnson Agrees to Fraud Resolution
On Nov. 4, the DOJ announced that it had reached an agreement with pharmaceutical manufacturer Johnson & Johnson (J&J) and its subsidiaries to resolve multiple health care fraud investigations (state and federal) relating to Invenga, Natrecor, and Risperdal, prescription drugs manufactured by the company. In a combination of civil and criminal actions across three states, J&J was accused of promoting the three prescription drugs for uses not approved as safe and effective by the Food and Drug Administration (FDA) pursuant to the requirements of the federal Food, Drug, and Cosmetic Act (FDCA), as well as paying kickbacks to doctors in connection with prescriptions for the same.
The financial component of the settlement, characterized by the DOJ as “one of the largest health care fraud settlements in U.S. history,” requires J&J to pay more than $2.2 billion. Beyond the monetary impact, J&J also agreed to a five-year Corporate Integrity Agreement (CIA) with the Office of Inspector General of the Department of Health and Human Services (HHS-OIG).
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