Seven women who say they screamed at the operating table due to 'excruciating' pain because a nurse tampered with their pain medic...
Seven women who say they screamed at the operating table due to 'excruciating' pain because a nurse tampered with their pain medication sued Yale University on Wednesday, accusing it of failing to properly safeguard its supply of fentanyl.
The women underwent painful and invasive procedures for in vitro fertilization and were supposed to receive the opioid at a Yale fertility clinic in Connecticut last year.
They got saline instead, but their complaints were dismissed even as they 'screamed' during the surgeries and reported feeling 'torturous pain' afterward, according to a lawsuit filed in state court in Waterbury by the women and their spouses.
The nurse responsible, Donna Monticone, was sentenced to just four weekends in prison in May, along with three months of home confinement and three years of supervised release.
Prosecutors say 75 percent of the fentanyl given to patients during a five-month period was diluted with saline.
Nurse Donna Monticone was sentenced to four weekends in prison in May after she tampered with the fentanyl supply at the clinic for her own use
Prosecutors say that a DEA investigation found that 75 percent of the fentanyl given to patients at the clinic from June to October 2020 was adulterated by saline
The seven women were having their eggs retrieved as part of the in vitro process at the Yale Reproductive Endocrinology and Infertility clinic in Orange, Connecticut, above
The affected women were all at patients at Yale's Reproductive Endocrinology and Infertility clinic in Orange, Connecticut.
Their names are Melissa Cowan, Alyssa Gargiulo, Brianne Mcloughlin, Leah Mirakhor, Dilay Nacar, Awo Osafo-Addo and Nicole Walsh.
According to the lawsuit, they all underwent 'excruciating' oocyte retrievals, which require a surgeon to maneuver 'a thick needle through the vaginal wall, ovarian ligament, ovary, and ovarian follicle to aspirate mature eggs.'
Oocyte retrieval is the second of five steps of in vitro fertilization, according to the Mayo Clinic. After the eggs are retrieved, they are fertilized outside of the body and inserted back inside the female patient.
The entire procedure at Yale ranges from $15,000 to $30,000 and is not covered my most insurance plans, the lawsuit states.
The lawsuit says staff was alerted to a problem in the supply of fentanyl, a synthetic opioid used as a painkiller, through 'patients intraoperative screams and postoperative reports of torturous pain.'
'It was more pain than I could ever imagine,' one woman told a local news station back in March.
'I remember screaming in the middle of the procedure from pain,' another patient said.
They were allegedly told their pain was due to the lack of anesthesiologists on site on Saturdays and Sundays.
The women argue that Yale 'never investigated these reports' and that their pain was minimized as 'normal.'
They also say that, in early 2020, Yale sought to save money by 'bulk ordering' mass quantities of fentanyl for on-site storage after moving its fertility clinic to Orange, about seven miles from the Yale-New Haven hospital.
The person in charge of the shipments was none other than the 'nurse who subsequently admitted to diverting fentanyl form the REI clinic,' the suit claims.
The lawsuit accuses Yale officials of failing to follow mandated pharmacy protocols and allowing vials of fentanyl to be vulnerable to tampering.
The suit also alleges Yale violated state and federal laws by keeping more than 175 vials of fentanyl in an unsupervised and unlocked area, and failed to implement safeguards including drug testing staff with access to opioids.
'Yale's failure to develop and implement safety measures mandated by state and federal law to secure drugs like fentanyl resulted in these patients being traumatized,' Joshua Koskoff, a lawyer for the women, said in a statement. 'What should have been a time of hope for these women and their families became one of unimaginable suffering.'
The lawsuit accuses the clinic of using cost-cutting measures that left vials of fentanyl open to tampering
A look inside of the clinic where fertility patients say Monticone diluted their fentanyl with saline solution, causing them to 'scream' during surgery
Yale spokesperson Karen Peart Peart said university officials will not comment on the lawsuit.
The lawsuit is seeking undisclosed damages.
Nurse Monticone no longer works for the clinic and pled guilty to one count of tampering with a consumer product. She was sentenced to four weekends in jail and three months of home confinement in May instead of a recommended five year jail sentence.
The New Haven Register reported that the judge weighed the testimony of people who experienced incredible pain because of Monticone's actions with the fact that she cooperated with the investigation.
Monticone, 49, started using the drugs during a painful divorce and amidst a years-long custody battle for her children, the outlet reported, though the judge said the court was not able to determine the full scope of her familial problems.
Attorney Josh Koskoff, who represents dozens of clients from the fertility center in the case, said that his clients were 'sensitive to the idea that this is a single mother,' according to CBS2’s Tony Aiello.
Monticone apologized to the affected patients during her sentencing hearing.
The fact that Monticone had no prior criminal record played a part in her light sentencing, as well, the Register reports.
Prosecutors say that an investigation by the Drug Enforcement Agency found that 75 percent of the fentanyl given to patients at the clinic from June to October 2020 was adulterated by saline.
Wednesday's lawsuit includes civil allegations of medical assault and battery and medical malpractice. It says hundreds of patients potentially were unknowingly treated with saline instead of fentanyl at the clinic last year.
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