Inspections, Compliance, Enforcement, and Criminal Investigations
Criminal Investigations Case Activity
Examples of the types of criminal investigations OCI investigates.
- Counterfeit drugs: Beginning in 2005, an OCI counterfeit drug investigation has resulted in the indictment of three businesses and 24 individuals for their involvement in a $42 million conspiracy to manufacture and sell counterfeit, Lipitor® and other drugs which they manufactured in a Costa Rican lab. To date 17 have been convicted.
- Health Care Fraud: OCI, working with several other agencies, uncovered a massive conspiracy to overcharge Medicare, Medicaid and other providers for a drug for prostate cancer. The company paid more than $291 million in fines and restitution to U.S. and state governments.
- Illegal schemes for Serostim: After OCI's Special Agents discovered a conspiracy to commit health care fraud by bribing doctors and using other illegal methods to market a treatment for AIDS, the company paid $704 million in criminal fines and restitution to the U.S. Treasury.
- Illegal promotion for OxyContin: A major pharmaceutical company and three executives were convicted for having falsely labeled, promoted, and illegally marketed a potent pain reliever. The company paid fines and restitution totaling more than $600 million.
- Misbranded Drugs: On April 12, 2006, two men were sentenced in the Southern District of Indiana Federal Court to 77 months incarceration after pleading guilty to introducing a misbranded drug into interstate commerce. Dextromethorphan (DXM), a cough suppressant, was sold over the internet through their Web site. This case started in 2005 when five young people died after ordering and consuming DXM from the Web site.
- Clinical investigator fraud: An investigation by OCI and the Veterans Affairs (VA) Office of Inspector General resulted in the conviction of a VA physician who falsified documentation of a clinical drug study and recklessly enrolled patients who did not qualify under the study protocol. The physician's criminal negligence caused the death of one patient by falsely documenting the results of blood chemistry analysis. The physician was prosecuted and sentenced to 71 months federal incarceration.
- Food contamination: The president of a cold storage distribution company was convicted and sentenced to one year of federal incarceration. The company paid hundreds of thousands of dollars in restitution for re-boxing and relabeling food tainted by an ammonia leak at the cold storage facility. The contaminated food was delivered to an Illinois elementary school, causing approximately 43 students and staff to become hospitalized.
- Illegal drug diversion: In 2006, father and son owners and operators of a Florida pharmaceutical wholesale distributorship were sentenced to 18 years and 25 years incarceration, respectively. They also paid more than $27 million in restitution for their involvement in an illicit diversion scheme to buy and sell millions of dollars of illegally obtained medications used to treat AIDS, cancer, hemophilia, and other ailments. This scheme defrauded the Medicaid and Medicare programs of more than $45,000,000.
- Faulty surgical devices: OCI agents were instrumental in securing the conviction of two company executives who had fraudulently sold surgical sterilizing devices that caused eye damage in 18 patients, one of whom lost sight in one eye.
- Unlicensed flu vaccine: In 2005, OCI agents arrested a person in Texas who administered counterfeit influenza vaccine. Agents also brought about a federal conviction of a smuggler who tried to sell the foreign, unlicensed flu vaccine to hospitals.