Yale Paid $308K after violating the Controlled Substances Act: The United States Attorney for the District of Connecticut announced on October 4, 2022 that Yale University, on behalf of Yale Medicine and the Yale Fertility Center, has entered into a civil settlement agreement with the federal government in which it will pay a total of $308,250 to resolve allegations that it violated civil provisions of the Controlled Substances Act.
The Yale Fertility Center is a fertility medical practice located on Yale University’s West Campus, in Orange, Connecticut. The Yale Fertility Center is operated by Yale Medicine, the clinical practice for the Yale School of Medicine, and a component of Yale University (collectively, “Yale”). The settlement resolves allegations that Yale failed to maintain complete and accurate records concerning the controlled substances it purchased and dispensed at the Yale Fertility Center, and failed to provide effective controls and procedures to guard against theft and diversion of controlled substances.
In November 2020, Donna Monticone, a nurse responsible for ordering and inventorying controlled substances at the Yale Fertility Center, was discovered to have tampered with vials of fentanyl. The fentanyl was kept at the Yale Fertility Center for patient use during out-patient surgical fertility procedures. A criminal investigation revealed that Monticone stole the fentanyl for her own use. She withdrew the fentanyl from the vials, reinjected saline into the vials and reintroduced the vials into the stock of the Yale Fertility Center to be used during surgical procedures.
In March 2021, Monticone pleaded guilty in federal court to tampering with a consumer product. A related civil investigation identified 685 separate occasions in which the record-keeping requirements of the Controlled Substances Act were allegedly violated by Yale. The DEA’s audit of the Yale Fertility Center’s inventory of controlled substances revealed discrepancies of 665 units of controlled substances, including vials of fentanyl 100mcg, ketamine 10mg, and midazolam 2mg. The investigation also found that Yale failed to maintain an initial inventory, failed to keep a record of destruction of controlled substances, and was unable to readily produce DEA e222 forms, which are required records for purchase and sale of Schedule II controlled substances.
Congress, with the passage of the Controlled Substances Act, took steps to create “a closed system” of distribution for controlled substances in which every facet of the handling of the substances – from their manufacture to their consumption by the ultimate user – was to be subject to intense governmental regulation. This mission was taken against the backdrop of trying to prevent the diversion and abuse of legitimate controlled substances, while still ensuring that an adequate supply of those substances meet the medical and scientific needs of the United States.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publicly known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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