Endo Health Solutions Inc. (EHSI) faced a significant legal outcome today as they were ordered to pay $1.536 billion in criminal fines and forfeiture for their involvement in distributing misbranded opioid medication. This marks the second-largest set of criminal financial penalties ever imposed on a pharmaceutical company for violations of the Federal Food, Drug and Cosmetic Act.
EHSI pleaded guilty to introducing misbranded drugs into interstate commerce, acknowledging their deceptive marketing tactics related to the opioid medication Opana ER. The company marketed the drug as having abuse deterrence and tamper resistance qualities without sufficient clinical data to support these claims.
Following the guilty plea, Principal Deputy Assistant Attorney General Brian M. Boynton emphasized the importance of holding accountable companies whose actions have contributed to the ongoing opioid crisis. DEA Administrator Anne Milgram condemned EHSI for prioritizing profits over the well-being of the public through intentional misrepresentation of opioid medications.
The investigation involved several agencies, including the FBI, DEA, HHS-OIG, FDA-OCI, VA-OIG, OPM-OIG, DCIS, and the Amtrak Office of Inspector General. The collaborative effort led to the discovery of EHSI's deceptive practices and their contribution to the opioid epidemic.
In response to the sentencing, Inspector General Robert P. Storch highlighted the impact of corrupt corporate practices on the healthcare system, emphasizing the need to protect individuals from harmful actions driven by profit motives. The resolution of the case was commended by Inspector General Michael J. Missal for the Department of Veterans Affairs, who expressed gratitude for the joint efforts in pursuing justice.
Inspector General Kevin H. Winters for Amtrak reiterated their commitment to safeguarding employees and retirees from risks posed by fraudulent activities, such as the misbranding of dangerous drugs. The FBI Miami Field Office's Special Agent in Charge Jeffrey B. Veltri condemned EHSI's disregard for patient safety through false advertising efforts aimed at concealing the risks associated with their product.
Christi A. Grimm of the HHS-OIG reaffirmed the agency's dedication to investigating companies that endanger public health for financial gain, emphasizing the importance of protecting federal healthcare programs and the individuals they serve.
Endo Health Solutions Inc. has withdrawn Opana ER from the market since 2017, and the imposed fines and forfeiture serve as a significant consequence for their misconduct. The case serves as a reminder of the legal repercussions faced by companies engaging in deceptive practices that jeopardize public health.