By Justin D. Green
A few significant ways the US Food and Drug Administration protects public health is through facilitating product recalls or market withdrawals and issuing safety alerts. But when bad actors circumvent the system, the FDA Office of Criminal Investigations (OCI) enters the scene to ensure the safety of American food, medical products, and other FDA-regulated products.
Partners are essential to OCI’s ability to meet its mission and can include local and state police, federal law enforcement agencies like the Department of Homeland Security’s Customs and Border Protection and Homeland Security Investigations, the Drug Enforcement Administration, the Department of Justice, the US Postal Inspection Service, and foreign governments.
Whether it’s circumventing the FDA regulatory process, distributing counterfeit or misbranded prescription drugs or other FDA-regulated medical products, engaging in illegal diversion of prescription drugs, selling fraudulent products with claims to prevent, treat, or cure diseases, or jeopardizing patient safety, OCI works closely with jurisdictional and regulatory partners to investigate crimes and protect public health.
OCI’s work sends a strong message that those who criminally endanger the public health will be pursued with the full force of the law and will be held accountable for their actions. OCI’s work is not only about accountability -it’s also about justice. It’s about standing up for the victims, giving them a voice, and restoring faith in our legal and healthcare systems. We take pride in the dedication and hard work of OCI agents in protecting the public health, ensuring accountability, and bringing justice to victims. This includes the more than 200 special agents on the frontlines of the FDA’s field operations unit who executed over 290 arrests and more than 300 convictions in fiscal year 2023 alone.
For more than 30 years, OCI investigators have been conducting and coordinating criminal investigations of suspected illegal activities involving FDA-regulated products, arresting bad actors, and referring cases to the Department of Justice for prosecution.
A recent tampering case in Dallas, Texas demonstrates OCI’s contribution. Agents from OCI’s Dallas Resident Office were the lead investigators in this case. Raynaldo Riviera Ortiz Jr., a Dallas anesthesiologist had tampered with IV bags at Baylor Scott & White Surgicare North Dallas by injecting them with dangerous drugs, causing numerous cardiac emergencies in patients at the facility.
On August 24, 2022, the FDA received an emergency complaint from Tenet Healthcare – the company that operates Surgicare North Dallas – about a potential tampering. The next day, OCI agents contacted the administrator of the Surgicare concerning the notification and obtained evidence of the potential tampering.
Working together with the Dallas Police Department, OCI agents moved swiftly to identify the source of these critical events. They began by identifying more than 250 personnel who had access to the facility, pinpointing suspicious behaviour and potential motives.
The investigation uncovered five separate instances between May and August 2022 in which Ortiz had tampered with IV bags of saline, surreptitiously injected them with bupivacaine (a nerve-blocking agent), epinephrine (a stimulant) and lidocaine (an anesthetic) and waited for them to be used in colleagues’ surgeries, causing repeated cardiac emergencies and a death. All the patients survived, but an anesthesiologist who worked at the facility died after using an IV bag to treat herself for dehydration.
Based on these findings, Ortiz was arrested on September 14, 2022 – just three weeks after OCI was alerted of the suspected tampering. His medical license was suspended, and he was detained while the case was pending.
OCI’s investigation led to the conviction of Ortiz in April 2024 on four counts of tampering with consumer products resulting in serious bodily injury, one count of tampering with a consumer product and five counts of intentional adulteration of a drug. On November 20, 2024, he was sentenced to 190 years in federal prison.
On October 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency, including creating a unified Human Foods Program and new model for the agency’s field operations, which was renamed the Office of Inspections and Investigations (OII). While the reorganization did not directly impact OCI, the office continues to be a part of the agency’s field force (OII) and serves as the agency’s criminal law enforcement arm.
Operating across six field offices covering all 50 states, San Juan, Puerto Rico; London, United Kingdom; and the Hague, Netherlands, OCI will continue to collaborate with our federal, state, local, and international law enforcement partners to investigate crimes related to FDA-regulated products and seek new and innovative ways to conduct investigations. OCI’s commitment to helping the FDA fulfill its public health mandate will remain the cornerstone of our work.
