Yale Settles Controlled Substance Act Violations With $300K Fine: Feds

NEW HAVEN, CT —Yale University has entered into a civil settlement agreement with the federal government in which it will pay $308,250 to resolve allegations that it violated civil provisions of the Controlled Substances Act, the U.S. Attorney for CT said.

The settlement resolves allegations that Yale, Yale Medicine and the Yale Fertility Center, failed to maintain complete and accurate records on controlled substances at the fertility center, Vanessa Roberts Avery said. Further, Yale "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, federal prosecutors said. The fentanyl was kept at the Yale Fertility Center for patient use during out-patient surgical fertility procedures, it's noted. A criminal investigation found that Monticone stole the fentanyl for her own use by withdrawing the drug from vials and then re-injecting them with saline, Avery said. Those vials, with saline not fentanyl, were put back on the shelves to use during surgical procedures, Avery said.

In March 2021, Monticone pleaded guilty in federal court to tampering with a consumer product.

According to the Justice Department, this was not the first time there was an issue with controlled substance record-keeping by Yale.

A related civil investigation identified 685 separate occasions in which the record-keeping requirements of the Controlled Substances Act were allegedly violated by Yale, per Justice.

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, Avery said.

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, per Avery.

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.

“This settlement highlights our office’s efforts to ensure compliance with the Controlled Substances Act,” Avery said. “Healthcare providers’ obligations to keep accurate records and safeguard access to controlled substances are key to prevent diversion of these powerful drugs, and to ensure the safety of our community.”

This investigation was conducted by the Drug Enforcement Administration’s Office of Diversion Control.

“The DEA is committed to ensuring that all registrants are in compliance with the required regulations, which are enforceable through the Controlled Substances Act,” said Special Agent in Charge of the Drug Enforcement Administration for New England Brian D. Boyle. “Failure to do so increases the potential for diversion and jeopardizes public health and public safety. DEA pledges to work with our law enforcement and regulatory partners to ensure these rules and regulations are followed.”

The case was prosecuted by Assistant U.S. Attorney Sara Kaczmarek.