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A civil investigation found that Yale failed to properly manage its controlled substances, including fentanyl and ketamine, at the Yale Fertility Center. 65 women are suing Yale for medical malpractice and medical battery, among other allegations.

Yale agreed to pay $308,250 to the Department of Justice earlier this month in a bid to resolve allegations of violations of the Controlled Substances Act. The settlement agreement — which stems from allegations that Yale failed to maintain complete and accurate records of its narcotics and provide effective controls against their theft — is the result of a years-long investigation into tampering accusations at the Yale Fertility Clinic, which is operated by Yale Medicine.

 “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,” U.S. Attorney Vanessa Roberts Avery said in a press release.

In November 2020, it was discovered that Donna Monticone, whose role as a nurse included the management of controlled substances at the clinic, had for several months tampered with its narcotics supply — replacing the fentanyl in the clinic’s vials with saline to be used for surgical procedures.

According to the DOJ, approximately 75 percent of vials of fentanyl given to patients at the clinic during surgical procedures contained saline. Victims testified to the physical pain they experienced during surgical procedures to the court.

Last year, Monticone pled guilty to tampering with a consumer product, and was sentenced to four weekends in prison, as well as three months of home confinement and three years of supervised release. 

“Yale deeply regrets the distress suffered by some of its patients when a former nurse at the Yale Fertility Center diverted pain medication intended for patient procedure,” Karen Peart, University spokeswoman, wrote to the News. “After Yale discovered the nurse’s misconduct, it removed her from the Center, alerted law enforcement agencies and notified patients who might have been affected. The Center also reviewed its procedures and made changes to further oversight of pain control and controlled substances.”

When asked for the specific changes made to improve oversight, Peart said that the University had nothing further to add to the statement.

A related civil investigation which arose from Monticone’s case found that Yale had violated the record-keeping requirements of the Controlled Substances Act on at least 685 separate occasions. 

When the U.S. Drug Enforcement Agency audited the clinic, they found discrepancies in hundreds of units of controlled substances, including fentanyl, ketamine and midazolam. The clinic also failed to keep a record of the destruction of controlled substances and failed to show records related to the purchases and sales of these substances.

65 women are moving forward with a lawsuit against Yale, claiming they suffered through “the most painful fertility surgeries and procedures” without proper analgesia, according to the initial complaint filed in November 2021. 

“Several women were complaining about their pain and … were ignored and dismissed and gaslit,” Kelly Fitzpatrick, the lawyer representing the women, said. “The opioid crisis has been going on for many years now … these medical institutions are supposed to have controls in place that prevent diversion and [Yale] didn’t.”

Drug diversion refers to the abuse or illegal distribution of prescription drugs for purposes outside of the original purposes established by the prescriber. 

The plaintiffs’ lawsuit claims that the University “prioritized profits over patient safety” by violating required pharmacy protocols.

The clinic employed a cost-reduction strategy entailing bulk ordering opioids used for pain management. Hundreds of vials of fentanyl were stored in an unlocked room, which Monticone was able to enter unmonitored. 

It was “deeply troubling,” Fitzpatrick said, that complaints of pain from patients at the clinic were repeatedly ignored. The plaintiffs were undergoing procedures wherein their eggs were extracted from their ovaries. Typically, patients in these procedures are either put under anesthesia or are kept conscious but given strong sedatives. These women had to stay “completely awake” without receiving fentanyl. 

Despite complaints of pain, the clinic only found out about the diversion after a colleague noticed a loose cap on a fentanyl vial.

“All of these women were complaining about pain and were ignored … how many people was it going to take for them to look under the hood and figure out what was going on?” Fitzpatrick said. “The message [of this complaint] is patients should feel safe when they seek medical treatment.”

The plaintiffs also claim that Yale failed to implement safeguards against opioid diversion, such as a drug-testing program for staff who have access to opioids. 

Fitzpatrick revealed that 8 separate lawsuits have been filed against Yale, and will be consolidated into one multi-plaintiff case in the Stamford Superior Court. The lawsuit is currently in the discovery stage — during which parties gather and exchange evidence — and is about to have a scheduling order issued, after which a timeline will be delineated. 

“Yale has informed patients that there is no reason to believe that the nurse’s action harmed their health or the outcome of their treatment,” Peart said in a previous statement after Monticone’s ruling. “The Fertility Center routinely uses a combination of pain medications during procedures and modifies the medications if there are signs of discomfort.”

The Yale Fertility Center is located in Orange, Connecticut.