Yale University has entered into a civil settlement agreement with the Department of Justice (DOJ) under which it was to pay $308,250 to resolve allegations that it violated recordkeeping and other provisions of the Controlled Substances Act (CSA).

The university entered into the settlement agreement on behalf of the Yale Fertility Center, a fertility medical practice located on Yale’s West Campus in Orange, Connecticut, the government announced Oct. 4. The center is operated by Yale Medicine, the clinical practice for the university’s School of Medicine.

Tampering with Fentanyl Stockpiles

According to the Office of the U.S. Attorney for the District of Connecticut, in November 2020 Donna Monticone, a nurse responsible for ordering and inventorying stockpiles of controlled substances at the fertility facility, was discovered to have tampered with vials of fentanyl kept at the center for patient use during outpatient surgical fertility procedures.

A criminal investigation revealed that between June and October 2020 Monticone had stolen fentanyl from the stockpiles for her personal use by withdrawing the substance from vials in which it was stored, reinjecting saline into the vials, and returning the vials to the center’s store for use during surgical procedures. Monticone later acknowledged that she initially injected herself with fentanyl while working at the clinic and later took the vials home, where she made the saline substitutions.

About 75 percent of the fentanyl give to patients at the clinic during this period was adulterated with saline, with some of the vials containing diluted fentanyl and others containing saline alone.

In March 2021, in an appearance before the U.S. District Court for the District of Connecticut, Monticone pleaded guilty to one count of tampering with a consumer product in violation of 18 U.S.C. §1365(a)(4) (United States v. Monticone, No. 3:21-cr-00031-JCH (D. Conn.)).

The following June, she was sentenced to four alternating weekends in custody, three years of supervised release, and a restitution payment of $637.56. She had faced the possibility of a maximum sentence of imprisonment for 10 years.

Monticone has surrendered her nursing license.

DEA Investigation

A related civil investigation identified 685 incidents of violations of the CSA’s recordkeeping requirements by Yale University.

A DEA audit of an inventory conducted at the Yale Fertility Center uncovered discrepancies in 665 units of controlled substances, including vials of fentanyl 100 mcg, ketamine 10 mg, and midazolam 2 g.

“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,” the DOJ said.

U.S. Attorney Vanessa Roberts Avery stressed the importance of compliance with the CSA’s recordkeeping mandates. “Health care 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,” she said.

The DEA’s Office of Diversion Control conducted the investigation.

The university did not immediately respond to a request for comment on the settlement.