An Open Letter To The Executive Leadership of CRICO: Insuring Harvard’s Ongoing Gynecological Morcellation Practices Will Harm Patients.
Honorable Mr. Reynolds and Professor Sato,
I write this public letter in order to convince you, and your colleagues at CRICO, that your corporation is causing an unsafe gynecological practice to be sustained across flagship Harvard affiliated hospitals. Specifically, by continuing to provide malpractice insurance to the providers who are actively engaged in morcellating women’s uterine tumors, CRICO has left the door open to iatrogenic spread and upstaging of deadly cancers of the uterus, including soft tissue sarcomas.
I know that you are well aware of the details of the deadly ethical and legal negligence exhibited by the gynecological leaders at Brigham and Women’s Hospital (and, likely, other Partners affiliated hospitals), which caused the deaths of my wife and several other unsuspecting women by Power Morcellation of their tumors using a STORZ medical device. Of course, we shall leave these egregious acts of corporate negligence to the Suffolk County Court and the court of public opinion to adjudicate in the next 2 years.
My letter, here, is in part prompted by communication I received from yet another young woman whose “missed” uterine sarcoma was morcellated at Massachusetts General Hospital (MGH)in the last few months — in 2019.
Of course, MGH gynecologists’ medical malpractice insurance provider is CRICO, as you well know.
In this most recent negligent handling of a uterine sarcoma at MGH, the morcellation was performed manually in a containment bag so as to avoid the legal liability peril from tissue/cancer dissemination. This, in a setting where no real preoperative diagnostic judgement or biopsy was exercised by the clinician to rule out a cancer lurking where one was, indeed, present. And, while most GYNs within Partners Health system fully grasp the fact that morcellation in containment bags has an inherent high leak rate.
Of course, I communicated with you extensively about this new index case at MGH via email, and I encourage you to read my writings with care — as they are part of the formal record now in your possession, which will demonstrate your knowledge of this deadly hazard when other cases of iatrogenic harm arise in the future within the health systems you are insuring.
Today, I was further compelled to write this more public letter to you because I became aware of a recent study published by the minimally invasive gynecology division at the Brigham and Women’s Hospital — led by Drs. Jon Einarsson and Sarah Cohen.
You may review the abstract and results of this paper HERE.
In this article, Einarsson, Cohen and their team report that in the case of contained and manually morcellated uterine tissues, which are extracted via mini-laparotomy vs. trans-vaginally, close to 8% vs. 41% leak rates, respectively, occur.
This latest paper by Einarsson’s group is an astonishing one on so many levels.
To start, the fact that Einarsson and his crew seem totally unfazed and unabashedly advertise this FAILURE rate is striking. Their oblivious insistence on focusing the notion that “contained minilaparotomy and contained vaginal extraction methods are associated with similar patient outcomes and recovery characteristics” directly speaks to how radically blind they are from an ethical and clinical perspective. Surely they understand that a leak rate of up to 41% is unacceptably high. One is left with the conclusion that they must either: a)not accept the severe danger in spreading uterine cancers, or b) be over-confident in their assumption that hiding behind a “standard of care” argument will provide them with sufficient legal protection against liability when they do end up upstaging a missed uterine cancer— or both.
Moreover, it is simply mind boggling and shocking that any Harvard IRB would approve such an experimental protocol in women. Especially because everyone at Harvard and BWH fully recognizes that gynecologists do not make any reasonable attempt at preoperatively ruling out cancer in these uterine tumors using well-established tissue biopsy techniques.
So, really, the BWH IRB is giving a green light to the possibility of a missed cancer being spread and upstaged in these “experimental” patients. That should simply be a sobering and unacceptable fact to any medical malpractice insurer and Brigham surgical leader. The IRB process at BWH has failed to ensure safety amd ethical conduct in this care.
Of course, a bag leakage rate of 8–41% in the case of contained manual morcellation is far too high to be safe — particularly when the “leaked” material may be a deadly cancer that is not looked for preoperatively, and could be spread and upstaged when it is morcellated and leaks.
I am sure that as a physician, the Chief Medical Officer at CRICO, Dr. Sato, fully appreciates what the oncological implication of this high leakage rate in the case of “contained manual morcellation” is — particularly when a cancer diagnosis is “missed”, as it was recently at MGH.
To be clear, the consequence of such leakage during contained manual morcellation of a “missed” uterine cancer is the catastrophic spread and upstaging of a deadly, but otherwise potentially curable cancer: That, is the very definition of an iatrogenic mortality risk, severe harm and negligence.
Please try to understand that CRICO risk managers are continuing to make a grievous error in judgement by covering these reckless practitioners who unabashedly continue to perform such oncologically catastrophic procedures — even “experimentally” with IRB approval.
Perhaps, CRICO leaders believe that gynecologists like Einarsson and Cohen are following a “standard of care” and are, therefore, legally protected. But this is an extremely short-sighted perspective that will do harm to susceptible patients.
If CRICO’s calculus with respect to morcellation has been delivered to you by expert gynecologists, I suggest that you immediately seek the advise of a multi-disciplinary group of surgeons from Thoracic Surgery and Surgical Oncology. I am quite certain that every self-respecting general or oncological surgeon would readily admit that a41% leak rate for a tumor with malignant potential is much too high a mortality risk for any reasonable insurer to accept. And I assure you that CRICO ought to start being reasonable in its calibration of gynecological morcellation practices.
You, as CRICO’s leaders, ought to seriously consider the following: that if/when other unsuspecting women’s “missed” uterine cancers are spread and upstaged using this rhetorical gimmick Partners gynecologists now label “contained manual morcellation”, the legal definition of corporate negligence will, again, have been met.
I found it paradoxical and disturbing to read CRICO’s slogan, online: “Protecting Providers. Promoting Safety.”
Mr. Reynolds and Dr. Sato, do you truly believe that CRICO is “promoting safety” by continuing to insure providers against the possibility of iatrogenic uterine cancer upstaging in the setting of an up to 41% leak rate with “contained manual morcellation”? Do you really believe that continuing to defend negligent gynecology leaders like the ones at BWH, responsible for causing the death of my wife and others, is sound risk management judgement? I think not!
Or, perhaps you are awaiting the court’s judgement on the massive level of negligence committed by these gynecologists before you do anything reasonable to prevent further harm and to bring your activities back into morally and legally sound space? How short-sighted!
Consider, that by continuing to provide malpractice coverage to practitioners like Drs. Einarsson and Cohen, who seem insistent on resurrecting and sustaining the oncologically dangerous practice of uterine morcellation, CRICO is promoting an unsafe and deadly surgical practice in women — particularly in women whose cancer diagnoses are being missed pre-operatively, as it was in the recent case at MGH.
Your organization’s purpose is to defend the financial integrity of Harvard hospitals and physicians from liability — and in so doing you have enormous influence over what practices are systemically adopted, and therefore on patient safety. But in the case of CRICO’s continued coverage of uterine morcellation practices, not only is your organization insuring against unreasonable liability, but more importantly, you are empowering the perpetuation of a totally avoidable iatrogenic cancer mortality risk in women.
I am hopeful that as a Harvard physician, Dr. Sato if not Mr. Reynolds, is able to see that in the case of uterine morcellation, CRICO’s “Protecting Providers” is NOT “Promoting Safety”.
No malpractice insurer, including CRICO, would ever insure a physician whose practices are known to be dangerous and unreasonable. In the same vein, you ought not insure practitioners for a specific practice, which is known to pose an unreasonable and totally avoidable iatrogenic cancer mortality risk to women — no matter how academically decorated these practitioners may be in the Harvard system.
Mr. Reynolds and Dr. Sato, CRICO and the Harvard affiliated hospitals and gynecologists have got this practice’s risk calculus and the magnitude their responsibility to women’s safety all wrong.
It’s time to stop this insanity. You can!
Sincerely,
Hooman Noorchashm MD, PhD (For Amy and the others).
