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A riveting podcast series (The Retrievals) highlights the stories of women who visited the prestigious Yale Fertility Clinic. Their allegations. For egg retrieval procedures, they received saline instead of fentanyl for pain.
The vials said fentanyl. Unbeknownst to everyone, a nurse was feeding her own habit, leaving the vials with no active ingredient.
When the egg retrieval procedures were performed, the patients had less sedation/analgesia than most dental procedures.
Yale settled with the Department of Justice. And lawsuits now abound.
Egg retrieval is not a particularly complicated procedure. With ultrasound guidance, a needle pierces the vaginal wall to access the ovaries. The eggs are removed by gentle suction. The procedure is described as relatively painless “and takes 20 to 30 minutes under twilight anesthesia.”
Relatively painless.
In ‘The Retrievals’, a dozen victims describe feeling ‘gut-wrenching pain’ during the procedure; many had asked for more medication, but all were told that they had already been administered the maximum dosage.
‘It was bad instantly,’ says a woman named Leah. ‘And it shouldn’t really be bad instantly, like you shouldn’t wake up and be in horrific nightmarish pain. But I woke up and it felt like someone had been inside me and gutted me.’
‘It was like someone had been inside me, scraped me hollow, and it was burning.’
Another patient, Laura says, ‘I remember thrusting my hips up and saying, “I feel everything!”‘
After the procedure, one patient texted her sister-in-law, baffled, and told her: ‘I could drive myself home right now, I’m that alert.’
“I was thrusting my hips and telling these people, like wide awake speaking to them, “I feel everything you’re doing!”‘
‘I just remember texting them that it’s hard to believe that we have a fentanyl epidemic where people are addicted because it did nothing to me.’
And on and on.
As many as 200 patients were alleged to have received saline, instead of fentanyl. The patients were told they’d be receiving midazolam for drowsiness, and fentanyl for pain.
Over a five-month period, Donna Monticone, a nurse at the clinic was stealing fentanyl and replacing it with saline.
In October 2020, after months of patients complaining that they suffered unimaginable pain during their surgeries, an anesthesiologist working at the clinic noticed that a cap came off a vial fentanyl too easily.
Within three days, Donna Monticone was questioned by authorities and denied taking the fentanyl at first. She later came clean when her drug test came back positive.
She confessed to stealing vials of fentanyl from the storage room and injecting herself in the bathroom at work up to four times a day. Then she took the empty canisters home to fill them with saline solution, she swears that she used a clean needle every time.
She estimated that she tampered with 75 per cent of the fentanyl given to patients at the clinic. Some of the vials contained pure saline and some were a mix.
Monticone lost her job. The Department of Justice (DOJ) was notified. DOJ sent letters to ~200 patients explaining they were potential victims in a federal case.
Lawyers for plaintiffs believe the number of affected patients is even higher.
As for Monticone, she was a divorced mother of three in a custody battle with her ex-husband.
‘I was overwhelmed by the sense that I would never be free,’ said Monticone in court records. ‘That I would have to take more time off of work, find more money to pay the lawyer and engage in yet more litigation, I suddenly couldn’t see or think straight anymore.’
It was around this time that she resorted to stealing drugs from the clinic.
Monticone’s sentence was much more lenient than you’d expect.
Monticone was sentenced to just four weekends in jail instead of a recommended five year jail sentence.
U.S. District Court Judge Janet C. Hall also sentenced her to three months of home confinement and three years of supervised release.
The civil case against Yale is gathering steam. And whether Yale’s Fertility Center will be able to re-establish its reputation remains to be seen.
What do you think?
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"Can Medical Justice solve my problem?" Click here to review recent consultations...
- Former employee stole patient list. Now a competitor…
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- Just received board complaint…
- Allegations of sexual harassment by employee…
- Patient filed police complaint doctor inappropriately touched her…
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- Patient “extorting” me. “Pay me or I’ll slam you online.”
- My carrier wants me to settle. My case is fully defensible…
- My patient is demanding an unwarranted refund…
- How do I safely terminate doctor-patient relationship?
- How to avoid reporting to Data Bank…
- I want my day in court. But don’t want to risk my nest egg…
- Hospital wants to fire me…
- Sham peer review inappropriately limiting privileges…
- Can I safely use stem cells in my practice?
- Patient’s results are not what was expected…
- Just received request for medical records from an attorney…
- Just received notice of intent to sue…
- Just received summons for meritless case…
- Safely responding to negative online reviews…
We challenge you to supply us with a medico-legal obstacle we haven’t seen before. Know you are in good hands. Schedule your consultation below – or click here to visit our booking page.
Jeffrey Segal, MD, JD
Chief Executive Officer and Founder
Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.
Dr. Segal was a practicing neurosurgeon for approximately ten years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases.
Dr. Segal holds a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.
In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.
Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2023 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With over 50 combined years of experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.
With 30 years of operating room experience, this sadly is not the first time that I have seen this happen.
Seeing it affecting this many patients without any consequence is appalling and suggests personnel were asleep in not recognizing that patients were in pain.
Did this same scenario happen to me? Yes in my first year in practice decades ago, We had an anesthesia tech that was taking fentanyl out from syringes that we had drawn up and laid out, and substituted saline. We complained that the generic fentanyl was not working. We noted that on a day when we stayed in the OR after syringe draw up, before we went out to preop the first patients in the morning, and after the OR nurses arrived back in the OR to complete their set up, the anesthesia tech was behaving strangely.
Back in the day it was routine to leave fentanyl syringes out, after draw up, and leave them on top of the anesthesia cart. On that one day, because we were late getting out of the OR and the nurses were early coming back, the anesthesia tech did not have the opportunity to come in and make off with fentanyl. He was behaving strangely. The OR nurse manager observed him, on that day and other days. He would come out of the bathroom glassy eyed. She found an near empty bottle of saline in his locker. He was fired. Our generic fentanyl, not working problem abated.
I would bet this occurred in many operating rooms.
What is bizarre about this case is that in the operating room environment that has existed for the past 20 years, fentanyl is not in a storage room. It is in a Pyxis pharmaceutical dispensing machine in the operating room that only the anesthesiologist or nurse anesthetist can access. Even before the Pyxis came to our operating room, we had locking tackle boxes in the OR that were locked except when the anesthesiologist or CRNA was right next to them.
If this truly happened recently then Yale was not following proper narcotic management procedures established more than 20 years ago.
The fact that this happened to 200 patients, with the patients complaining of pain and the anesthesia personnel (assuming that they were involved) not recognizing this or having an index of suspicion about this, is unbelievable.
The normal sentencing for narcotics addicts, from what I have seen, is typically light, in today’s environment. It is felt that they have a disease and that they need treatment not punishment especially for a first offense. While I don’t feel the sentence is appropriate, long jail time more than 2-5 years is also not appropriate.
The civil suits should be directly targeted at the hospital with inadequate controls, inadequate monitoring, and lax procedures and reporting. They should pay a hefty price.
I have seen other instances of substance abuse or narcotic theft in the OR.
In one case, the anesthesiologist never had correct narcotic counts and was loathe to explain them to the pharmacy. I always returned narcotics to the OR properly logging them, and if a count was wrong, I brought it up with the pharmacist, immediately. None of the addicted personnel that I saw, ever did that. They all reported their narcotic counts late and when there were discrepancies they would not own them.
I had heard of one instance of an anesthesia provider having white power on his nose, above his mask, noted by OR personnel.
There is a reason that there is one word on the shield of the American Society of Anesthesiology.
That word is vigilance.
Aren’t CRNAs supposed to be supervised by anesthesiologists? Didn’t the people harvesting the ova notice that a lot of patients were in agony? Had that happened with a patient of mine, I would have sent for the MD posthaste. Had it happened more than once with the same CRNA, I would have refused to let him or her work in my OR again. And that happened more than once, albeit for different reasons.
I’m no great fan of Yale, but I don’t see why the institution is culpable. The doctors harvesting the ova, yes; the nurse, definitely—criminally and civilly. The anesthesiologists supervising (apparently ~not~ supervising), for sure. But why the institution?
Joe:
1)There is no evidence in the story that this was a CRNA. It was a nurse. That is all the story said.
2)We know that an anesthesiologist noted that a lid was loose on a fentanyl vial. So in that case the anesthesiologist would have been administering the fentanyl. Except he correctly reported it.
3)We do not know what other reporting took place.
4)We do know that this happened 200 times. I do not know what type of sedation they were using.
Assuming that this was some fentanyl + some propofol, without the fentanyl they would have needed a lot more proprofol. But the fact that these patients were described as being awake and aware, it suggests that they were not on propofol, just on “sedation”.
If I were at the head of the table, as soon as a patient started moving, I’d be administering more medication, not saying
“many had asked for more medication, but all were told that they had already been administered the maximum dosage. ”
This sounds from the description like they just were in a clinic setting, not an OR, and that they were just getting old fashioned versed (midazolam) and fentanyl, on some pre proscribed dosage, perhaps by a nurse in the clinic. That doesn’t sound like an anesthesiologist or CRNA was at the head of the table.
The facility is major league culpable because fentanyl was on a shelf in a storage room. Not under lock and key. Record keeping was deficient. Control was deficient. Policy and procedures covering office clinic settings was deficient.
The doctor harvesting the ova, not culpable unless he was the supervising physician over a nurse. Then there is vicarious liability.
But did he have a duty to be complaining to the anesthesia personnel when patient after patient were writhing in pain. Yes.
The institution employs the doctors and nurses and anesthesiologists and is liable with vicarious liability.
Their policies and procedures, incident investigations, handling of narcotics were all deficient.
That is why the institution is culpable.
The hospital also has deep pockets, so they are going to be included in any suit.
Again, from the story, I doubt that there was an anesthesiologist in the room supervising.
It sounds, reading between the lines that the anesthesiologist was responsible for drawing up the fentanyl but it sounds like a nurse (not a CRNA) was administering the drugs.
This is what used to happen in gastro suites (nurse not CRNA administering), but not with propofol. In decades past it was Demerol and Valium, in the gastro suites, without pulse oximetry monitoring, leading to many disasters that I have heard about.
Listen to “The Retrievals”
Then comment.
No Pyxis.
Appears no oversight and/or checks on the Nurse manager – who ironically petitioned the court for leniency and the tone deaf, seemingly incompetent judge accepted BECAUSE SHE IS A MOTHER!
If they heard from multiple patients over a long period of time, then it appears the institution, doctors, CRNA’s, and whoever else was told in no uncertain terms that the anesthesia was not working could be culpable for not listening and consequences.
In my own Medicare Certified Surgical Center, most of our surgery (bone, joint and implant procedures) were done under sedation and local anesthesia I administered myself.
Obviously I also performed hospital based surgery. There is a lot of finger pointing going on here.
When multiple patients are writhing in pain during surgery, no matter where it is performed, “there is a problem in River City” to quote that famous line in a famous musical.
There is no excuse to allow this to continue even for a short time. Those who have responsibly need to investigate and act.
And yes, the hospital is also responsible. We doctors who use hospitals lose a lot of autonomy by using it.
The institution also has a responsibility to us.
Michael M. Rosenblatt, DPM
It saddens me that some of my colleagues are turning this issue into an anesthesiologists vs. CRNA (Certified Registered Nurse Anesthetists) conflict. Unfortunately, over my 25 years in the operating room (OR), I’ve witnessed instances where anesthesiologists, CRNAs, anesthesiologist assistants, nurses, and surgeons were involved in diverting opioids and other drugs due to addiction.
In this particular case, the procedure was performed using conscious sedation with medications like Versed and fentanyl. Conscious sedation doesn’t necessarily require the presence of anesthesia personnel. A proceduralist issued orders to an RN to administer the sedation. It’s puzzling to understand why the level of discomfort experienced by the patients was tolerated.
While patients do have varying pain perceptions, the fact that approximately 200 patients experienced pain should have raised a red flag for the physician who performed these procedures. Another concerning issue is the shortage of personnel. We often find ourselves settling for less competent providers due to this shortage, which may lead to overlooking certain clues and ultimately jeopardizing patient care.
200 patients seems to be too many not to have raised suspicion, although not of a person at first. My first question would have been was it all from a batch of anesthetic – was there a problem there? In this case, yes, indeed. So the anesthetic should have been checked well before over 200 patients c/o incredible pain. I absolutely understand some pain die in agony if you so much as look at them cross-eyed. But even 50 patients complaining should have raised flags. And, yes, the hospital is the ultimate “one” in charge of all of its employees, so vicarious liability falls on their shoulders.
Even one patient suffering is too many.
IF I had been at the head of the table, I would have done something immediately, NOT tell the patient they already had the “maximum dose”.
That is something an RN following a sedation protocol would have done.
But this also why anesthesia personnel need to be at the head of the table.
Hard to believe that in an esteemed learning institution like Yale, with a proud anesthesia history in patient safety Nicholas Greene with spinal anesthesia, Jan Ehrenworth with OR fires, among a host of other contributions of those two anesthesiologist among others, that this type event would have occurred not just once but 200 times. I would love to get the opinion of the current chair of Anesthesia at Yale about this story.
Listen to the podcast. You’ll be appalled if you have a drop of empathy. Largely narrated by the patients themselves, the medical minimization of their pain and gaslighting— denigrating their ability to handle pain or even to interpret the sensations of their own bodies (by everyone to whom they complained) is simply rampant gender discrimination.
I can’t imagine 200 men undergoing sperm retrieval without anesthesia, and there are far fewer layers there to traverse with a sharp instrument.
Then Yale sent letters to all suspected victims assuring them that they will be relieved to learn that “no harm was done!” While some women were refusing to continue with IVF, even foregoing childbearing, some actually considering suicide, and all suffering PTSD.
Without naming the levels of culpability, Yale bears ultimate responsibility for the damages it condoned through rampant medical sexism. I hope Maya Dusenbery writes her next book (after DOING HARM) on this shameful episode in the annals of medical history.