The CervicalCheck Scandal
In 2014, CervicalCheck embarked on an audit, which by March, 2015, would comprise 1,067 cervical cancer patients, that had a screening history with the programme. The Cancer Review team of 3 staff reviewed all 1,067 cases and decided 300 cases of cancer required further review.
This review would primarily focus on cervical cytology (Pap smears).
Upon review of cytology, some of these women had results upgraded from negative.
One of those women, Vicky Phelan, brought a court case against the HSE and the Lab involved. That case was settled for €2.5 million, with no admission of liability. It became headline news and was soon clear there was many other cancer patients, whose cytology was upgraded on review.
Public outrage, resignations and apologies all followed.
It became known as the "CervicalCheck Scandal".
I'll try give people an overview of the scandal, from a different perspective than it generally gets talked about on social media; discussing topics hopefully with sympathy and nuance; viewing it from, at times, the different perspectives of patients, screening service, doctors and lab staff.
Given the sheer volume of complex medical terms under discussion, I'll write a brief summary of each chapter, and parts, in "Plain English", so that no expertise or knowledge is required to read this.
- Chapter 1 - What is Cervical Screening? Overview.
- Chapter 2 - Purpose of the CervicalCheck Audit.
- Chapter 3 - Disclosure of the CervicalCheck Audit.
- Chapter 4 - Doomed to fail?
- Chapter 5 - Dragging Vicky and other women to court.
- Chapter 6 - False negatives happen everywhere but only becomes a scandal in Ireland.
- Chapter 7 - European judicial approach to cervical screening failures: Non-fatal cases.
- Chapter 8 - American and Irish judicial approach to cervical screening failures: Fatal cases.
- Chapter 9 - What is Cervical Screening? Moral and Philosophical arguments on lawsuits and compensation for screening failures.
- Chapter 10 - Judge tenderly, if you must.
Chapter 1 - What is Cervical Screening? Overview.
Part 1: Benefits and Harms.
Many areas of healthcare involve diagnosis and management of existing disease, people with symptoms presenting to a doctor. Cervical screening invites women with no symptoms, to look for future risk of disease.
There's benefits and harms to inviting asymptomatic women to participate in screening for cervical cancer. Benefits must outweigh harms, by a considerable margin, for screening to be of value at a population level.
Plain English summary: Screening does far more good than harm, while still doing some harm.
Benefits:
-A negative result can provide peace of mind and reassurance.
-Early detection of risk of developing cancer
-When cancer is identified at the earliest possible stage, it leads to less radical treatment and higher survival rates.
Plain English summary: Screening saves many lives
Harms:
-False positives: Cytology may suggest abnormalities are present, that are not actually present.
This can lead to anxiety, depression, emotional distress and unnecessary treatment, that increase risks of complication during pregnancy.
-False negatives: Cytology may not detect abnormalities present, when there are abnormalities present.
Identifying risk of developing cancer is therefore missed, as is the opportunity for earliest possible intervention. This can increase the treatment required and lessen survival chances, relative to identification at earliest opportunity.
-Overtreatment in true positives: Not all pre-cancerous cervical abnormalities develop into cancer, some of them spontaneously regress and disappear. The treatment may be necessary or unnecessary.
Plain English summary: Screening causes harm to some lives.
Part 2. Why are false negatives unavoidable?
Sensitivity: Percentage of people with cervical abnormalities, who correctly test 'positive' for it.
Specificity: Percentage of people with no cervical abnormalities, who correctly test 'negative' for it.
I put positive and negative in air quotes because cervical cytology is not binary positive or negative; it's an ordinal scale with a dozen possible classifications, one of which is negative and the others are different grades of abnormalities.
To avoid false negatives altogether, any screening test would need to have 100% sensitivity and that would inherently come at the expense of specificity.
Renowned cytopathologist Richard DeMay (wrote the textbook used in US universities in 1990's) tried to simplify this concept, in a way lay people could understand, quote:
"We could achieve 100% sensitivity and eliminate false negatives simply by diagnosing every smear as "abnormal". But if every result were "positive", what's the point in being tested? In the real world, increased sensitivity comes at a price of decreased specificity."
In his analogy, intended to be absurd, you'd be left with this:
-ALL women with abnormalities are identified because you just said they're all positive, which must include women with true positives.
-ZERO women without abnormalities are identified, because you just said they're all positive and didn't find any negatives, despite there being many women with true negatives.
It's theoretically possible to devise a test that has 100% sensitivity and 100% specificity but such a test would be as useful as a chocolate teapot, in practice, because the thing you're testing for would be so feckin' obvious that you didn't need to test for it in the first place.
If the test can achieve perfection, in correctly identifying every true positive and every true negative, you could just use your eyes instead e.g. a test to ascertain if a patient has a nose, will have 100% sensitivity and 100% specificity but the test would be pretty dumb and a waste of money, when you can just use your eyes to see if they have a nose.
Plain English Summary: You can never avoid all false negatives in cervical cytology and any misguided attempt to do so would come at an expense of increasing false positives. The harms of false negatives can include death, for dozens of women in Ireland, so cervical screening aims for high sensitivity, but it can never be 100% because doing so would cause thousands of women in Ireland harms of false positives.
Part 3 - False negatives are not an American-lab problem.
It's a popular myth that a key reason for the false negatives and subsequent court cases was due to outsourcing to American labs.
Those labs were demonized on social media, often in xenophobic undertones, despite being among the best labs in the world for technological innovation and expertise.
Cillian de Gascun is the new Interim Director of the National Cervical Screening Laboratory (NCSL) in the Coombe and he recently moved to address this, by noting the performance of the new lab will, at best, be the same as Quest's Lab in New Jersey, because it'll be operating to the same sensitivity and specificity requirements.
"It's key that we don't get caught up in the misnomer that this laboratory will be be better than the US-based laboratories that currently process the bulk of our cervical screening tests. Women in Ireland can be assured that the quality of service they are receiving from laboratory in the US is equivalent to the service they receive here" - Cillian de Gascun
Moreover, court cases for False Negatives long preceded the formation of CervicalCheck in 2008 and Irish Labs will get caught up in this litigation culture, if it persists.
Anne Broderick's family was awarded €325,000 in 2006, relating to a False Negative in the Coombe on March 4th, 1993, deemed a factor in her death in 1998.
Only the other week, February 17th, 2023, an unnamed woman with terminal cancer settled a High Court action over a False Negative smear read in St. Luke's Hospital Lab, Dublin, on November 4th, 2004.
The only reason there wasn't hundreds of such court cases, from 1970 - 2013, is nobody ever audited invasive cancer patients screening histories, until CervicalCheck did it voluntarily in 2014; which also isn't a reflection on Medical Scientists in Ireland.
Our medical scientists are world class. 100% sensitivity is just impossible to achieve and it's good that Cillian is championing reasonable expectations for the public to have.
Plain English Summary: False negatives are not an American problem nor an Irish problem, they are the same problem in labs everywhere. Ireland and USA respond to them almost uniquely, in terms of legal approach and compensation amounts.
Part 1: Audit of Cancer Patients vs Quality Assurance
The primary goal of such audits is to improve the screening service.
Very few cervical screening services in the world conduct audits of cancer patients. Instead most rely on quality assurance measures to monitor the effectiveness of the service. The few countries that audit invasive cancer patients, generally cite 3 reasons for doing so.
1. It allows a comparison between the screening history of (a) cancer patients and (b) women who don't have cancer.
2. It can identify areas of screening that are working very well to identify risk of cancer and also areas that could be strengthened.
3. Focusing on cancer patients enables learning, in ways general quality assurance maybe can't. There might be certain themes or trends identifiable on a review of cytology of women with cancer and identifying those has big potential for learning.
Plain English summary: An audit that looks solely at women who have cancer can, over time, lead to fewer women having cancer.
Part 2: Why only further review 300 of the 1,067 cases of cancer? Why not 500 or 900?
For the period in question, September, 2008 - March, 2015, there was close to 3,000 women diagnosed with invasive cervical cancer but the audit would ultimately laser focus on 10% of those.
Many of the women couldn't be included in any review of screening because they had no screening history. Around the time, close to 50% of women diagnosed with cervical cancer in Europe had no prior smear and it's only possible to review screening history of women that had.
Other women had a prior smear via GP's in the period long before CervicalCheck existed and couldn't be included.
One element of this story that got completely glossed over by the media, politicians and the public, is exactly why only 300 of the 1,067 women with a screening history in CervicalCheck required further review in the first place.
What about the other 767 women, why weren't their cases deemed requiring of further review?
Some of them had normal smears on review, which is known as an interval cancer.
Some of the cancers were detected via screening pathways in the programme.
Some had no smears but were referred by GP's to CervicalCheck Colposcopy clinics, due to worrying symptoms.
In all the focus on false negatives, it became an afterthought or footnote in the media that many true positives were identified via CervicalCheck, out of the 1,067 women with cancer audited.
Moreover, survival chances were greatly improved by the empowered decision of those women to go for a routine smear and check for their risk of cancer. It's statistically certain that many are alive today in 2023, due to that decision.
Plain English summary: Many of those 1,067 lives were saved by screening and it gets lost in an understandable focus on the lives that weren't saved.
Part 1: How it was supposed to work, in theory.
2 key decisions need to be made, if a screening service embarks on an audit of cancer patients.
1. Do we inform patients of the review of their case? Yes/No.
2. How do we inform patients of the review of their case?
Given an audit of cancer patients is an optional exercise and contains retrospective information that can't prevent already-diagnosed cancer, screening services take different approaches to disclosure.
Canada utilizes these audits but screening services prohibited from informing cancer patients of the results.
Legislation guarantees the confidentiality of these audits (everywhere except Quebec, that do their own thing), in order to create an environment where the sole purpose is to improve the screening service and save more lives. It's illegal to tell women about false negatives, stemming from audit reviews.
England, Finland, Norway, Sweden utilizes these audits and inform cancer patients of the results. In all 4 countries, the screening service informs the consultant, who discloses the information to their cancer patients.
CervicalCheck chose to (a) disclose the results of the audit to women and (b) to follow the Anglo-Scandinavian model of disclosure: Write to the consultants, who were to then inform their patients.
Plain English Summary: They decided to tell cancer patients audit results, writing letters to 29 consultants between February, 2016 and July, 2017., for women under their care
Part 2: How it worked, in practice.
Why did some consultants resist disclosure of the information to women?
Bad reasons (opinion):
Consultants were in possession of these letters for 204 women, long before Vicky's court case, but only 43 women were informed by late 2017, with the other 161 women not informed.
There was some bad reasons offered for non-disclosure to these women and also outright misogyny in the subsequent disclosure, after Vicky's court case, including the horrible line from an unnamed consultant that "nuns don't get cervical cancer".
-I withheld the information from you, no reason offered.
-It got lost in the file.
-You already had a hysterectomy, I decided you didn't need to know.
Those reasons range from blasé indifference to paternalism, my understanding of which is people in authority making decisions on behalf of others, supposedly 'knowing' what's in their best interest.
Adults are very obviously capable of deciding what's in their own best interest and don't need other adults to make that decision for them.
Plain English Summary: Doctors are people; the vast majority of people are kind and caring, some people are not.
Part 2a: How it worked, in practice.
Why did some consultants resist disclosure of the information to women?
Good reasons (opinion):
There was also fundamentally good reason(s) involved in some cases of non-disclosure, which got little-to-no media attention and really should have, in the interest of nuance.
One good reason stems not from aloof cancer doctors, making decisions about what a woman is entitled to know, but rather from women expressing deep concerns on the timing of such news.
Oncology nurses in Leicester Royal Infirmary were tasked with assisting consultants in disclosing audit results in 2001. This was during the Leicester Cervical Scandal, which was identical in nature to the Irish scandal; a review of cytology upgrading 84 results from negative.
Consultants in that hospital sat down, flanked by a nurse, and informed cancer patients there was a false negative smear and, if their risk of cancer was detected earlier, they may not be in the awful position they find themselves in now.
The women involved in the Leicester audit disclosure, who were still alive (some had died), reacted differently to the news.
Some were philosophical and aware screening was not 100% foolproof, one reportedly said "Oh well, C'est la vie", according to a consultant involved.
Some were angry at the 'mistake', that was robbing them of a chance to have children or to grow old.
Some were angry at being told of the 'mistake', adopting a "What bloody difference does it make now? Is it going to undo the cancer? I'd rather you never told me at all" attitude.
Subsequent to those disclosure meetings, nurses in Leicester Royal Infirmary witnessed a rapid deterioration in the mental and physical health of some of their cancer patients.
Those nurses felt that the timing of the disclosure of information, during ongoing treatment like chemotherapy or when their patient was only recently in remission, was, quote, "positively harmful" to their patients health.
It was subsequently viewed as unethical and indefensible to give a cancer patient retrospective information that actively harms their survival chances in the present.
What matters most in the present is giving a woman the best chance to live as long as possible, superseding that with any other consideration is abhorrent.
Both CervicalCheck and consultants in Ireland were very much aware of what happened in Leicester and some consultants refused to disclose the information, on that basis.
The most high profile being Vicky's consultant gynaecologist, Dr. Kevin Hickey, who explicitly gave that as his reason, in writing, for non-disclosure, quote:
"(Disclosure) would not confer any advantage to them in their clinical course and would only heighten anxiety"
To which the director of CervicalCheck. Dr Grainne Flannelly, compassionately understood those concerns and advised consultants to "use their judgement" on disclosure, to minimize the possibility of further harming cancer patients.
It wasn't just cut-and-dry paternalism; in many cases it was trying to avoid a repeat of what happened in Leicester; which demonstrated how harmful retrospective information can be to women with cancer and how it can even sadly cut their lives short.
Plain English Summary: When to give retrospective information to their cancer patient presented a significant ethical dilemma to doctors and nurses, trying their absolute best to save her life. The information in the audit was retrospective, disclosing it couldn't positively influence the prognosis nor ongoing treatment. All it could theoretically do is worsen survival chances.
That dilemma was glossed over in media reports.
Part 3: What mistakes did CervicalCheck make on disclosure?
From the screening service perspective, to follow the Anglo-Scandinavian model of disclosure was relatively straightforward.
- Undertake an audit
- Send letters to consultants with the results
However, there was a key difference between Ireland and those other countries:
This was the first ever Irish audit of invasive cancer patients, it was only straightforward for the others due to practice.
It's worth noting that all 4 of those countries (England, Finland, Norway, Sweden) made a mess of their first attempt at auditing cancer patients, too, resulting in dozens of court cases in England in 2001 and dozens of claims for compensation in Norway, some years later.
Implicit within being "the first ever", of anything of this sort, is you can't draw from previous experience.
Although it might sound like a straightforward exercise, it's a highly unusual exercise because it's attempting to disclose information from 5, 10, 15 years ago, that often was not even contemporaneously knowable.
What CervicalCheck perhaps should have done, therefore, is plan for disclosure with that in mind; that this was their first go at a very unusual exercise, that hardly any countries even attempt due to how problematic it can be, requiring an unusual level of coordination and potential for litigation.
- Involve consultants (treating clinicians) in a few more discussions on the upcoming audit and when/how to disclose information, or more relevantly, when to postpone disclosure to their patients, regarding those recently in remission or still undergoing treatment.
- Undertake an audit
- Send letters to consultants
Partially skipping that first step resulted in a year of impasse, confusion and arguing, on who should disclose the results. Simply because nobody involved had ever disclosed the results of a retrospective audit and none of them had experience of how to do it in practice, which is quite different from in theory.
Plain English Summary: Communication and planning on disclosure could have been better according to Dr Scally and that was surely a valuable lesson learned, though one that will benefit women in Ireland the future, when it comes to disclosure of audits.
"He told me about the story and that I was included in the audit. Straight away, to be honest, I was glad to hear from him because I was going through the cancer scare and explained I've a biopsy tomorrow and can you help me with this? He's a great doctor and he agreed to help me. I was pulled over at the side of the road and had the children in the car during this call and it's only when I stopped the car that it actually hit me. "Oh my God, I didn't even need to have cancer". I just walked straight into the house and Natasha (daughter) asked 'what's wrong?' and I said "I'm one of the women"
Part 5: Do's and Don'ts of how these audits should be disclosed.
I've gone through the very few countries that disclose audits, in order to compile what good practice looks like.
There will be heavy emphasis in these Do/Do't lists placed on the NHS approach, mostly as it's written in English and less possibility to get lost in translation.
I've tried to incorporate a few elements of the Norwegian approach, also, and taken on board views of Irish patients, English patients and 28-year-old Maren Walvik Johnsen, in treatment for cancer in Norway following a false negative on audit review of her cytology.
Do...
-Ascertain the cancer patient wants information from a review of their case, at this moment in time.
-If a patient does not want the information right now, ensure it's made clear they can change their mind any time they like. The information is theirs: if or when they want it is their choice.
-Ensure patient is aware they can bring family or friends for emotional support, during disclosure.
-Give the information with compassion and empathy.
-Include an apology, if appropriate.
-Discuss the effectiveness and limitations of screening.
-Simplify complex medical terminology, to increase patient understanding.
-Allow ample time for the patient to voice her concerns and questions.
-Answer all questions transparently and honestly.
-Discuss how a review of cancer patients increases learning and can improve the screening service.
-Ensure a patient has access to information about any potential recourse to apply for compensation, such as the Norwegian Patient Compensation Board (Norsk Pasientskade Erstatning)
-Ensure a patient has information on access to counselling and other supports.
Plain English Summary: It's important for the disclosing clinician to facilitate the patients understanding of the information they have requested, and to respect her wishes if she doesn't want to know.
The following picture is part of the NHS Cervical Screening Review form, as an illustration of the above principles that a patient should always have a say, nor just in (a) what they want to know, but also, (b) when they want to know it.
The following picture is from an NHS flowchart on what the the process should look like from clinicians point of view:
Don't...
-Assume what information a patient would want to know.
-Blurt out retrospective information that may harm a patient in the present.
-Disregard their wishes by giving information they're not ready to accept.
-Speculate if a delay in diagnosis impacted prognosis, it's a complex counterfactual.
-Discuss any pending or future litigation, it's inappropriate to do so.
-Tell a patient over the phone, as happened to some of the women in the Irish audit.
-Belittle, demean, dismiss, mock their concerns, as happened to multiple women in Ireland.
-Evade a question to which the answer is knowable or known i.e. don't lie to people.
Plain English Summary: Disclosing results of an audit has potential to harm a patient. The right way to disclose it is the one where the patient's wishes and needs are respected.
"There are many indications that this was a system that was doomed to fail at some point" - Dr Gabriel Scally
That report made dozens of criticisms and 170 recommendations on how to improve the system, most of which were implemented, which led to the following comment in the Scally Implementation Review:
"In my view, women in Ireland can have confidence in and should take full advantage of the cervical screening programme" - Dr Gabriel Scally
Retracing steps on those comments, poses some interesting questions.
Part 1: What does success look like?
Implicit within that assertion, of being doomed to failure, is an objectively defined idea of success.
Success is often subjective in life, getting a 'C' in Honours Maths in the Leaving Cert may feel like abject failure to one person, believing they were capable of an 'A', or feel like complete success to another person, believing they were capable of a 'C'.
An 'F' is a true, objective determination of complete failure and an 'A' is a true, objective determination of complete success.
The stated goal of CerivcalCheck, and all centrally organized screening programmes, is to reduce the (a) incidence of cancer, and (b) deaths from cancer.
A stated goal is defining success, something that it is objectively measurable.
There's no obvious sign of an imminent 'F' in the trend of incidence of cervical cancer in Ireland between 2008 - 2015, it more closely resembles an 'A'.
That raises another pertinent question.
Part 2: Doomed to fail who?
When both the incidence of cervical cancer cases and mortality from cervical cancer is falling, after the introduction of Organized Screening, it can't be asserted the system was failing women.
After all the entire premise of introducing the system was to reduce those 2 incidences in the target population.
Who was it doomed to fail?
The answer to that question is speculative but I think Irish media and most of the public interpret it to mean it was doomed to fail Vicky Phelan, Ruth Morrissey, Emma Mhic Mhathúna, Lynsey Bennett and the other women who died, after false negatives in cytology.
Problem is - if that's the answer to the question - to my mind it's not far off asserting cervical screening is doomed to fail everywhere in the world and has little-to-no merit as a population-based intervention.
That's a view expressed by many cervical cancer screening sceptics who believe the harms of screening outweigh the benefits, when the disease burden is so low to begin with.
You don't even have to dispute a single criticism made by Dr Scally to arrive at this paradox, either. Who knows, maybe he's 100% correct that the entire ship was destined to sink in Titanic fashion; steered across the Atlantic in darkness, heading for icebergs, with not enough lifeboats on board.
But if the inevitability of failure is assessed by deaths, following false negatives in cytology, every screening service in the world is steaming towards icebergs.
Cytologists, cytotechnologists, cytopathologists - medical scientists more generally - are all geniuses. A quick way to feel stupid in this life is to talk to one of them for 5 minutes about what they do for a living, wouldn't recommend trying it at a party.
They still can't alter the reality of false negatives and false positives and there's zero evidence Ireland is unusual in those error rates, we do just fine and always did, both before (1968 - 2000's) and after contracts to American labs.
People know the names Vicky and Lynsey and always will but they'll never know the names of 100,000+ women that had abnormalities detected by screening.
That a cancer screening system is doomed to fail some women, is not inherently a failure of the whole system.
It's a feature of the limitations of the test, within the system.
Part 3: What difference will implemented reforms make in preventing other women dying, like Vicky, following a false negative?
Little-to-none, probably.
The biggest development in reducing the number of abnormalities missed was the advent of HPV-testing but the reforms, in and of itself, won't do much in this regard as testing will always be fenced in to the sensitivity/specificity conundrum.
The recommendations implemented covered a wide array of areas from governance to quality assurance, which will generally improve the service in many ways.
But you can't prevent false negatives by asking people to resign or firing people, you can't prevent them with quality assurance or audits, you definitely can't prevent them by pundits in the media creating unrealistic expectations and undeliverable demands.
If you dragged someone in off the street and showed them 10,000 slides under a microscope, saying they are all either (a) benign immature squamous metaplasia, and (b) pre-cancerous high grade dysplasia, all they'd be able to tell you is "nice colours!" and "they all look the same!".
Now put someone trained just for the job in front of that microscope and they'd correctly identify most of them, despite how closely benign cell changes visually mimic precancerous ones. It takes incredible skill to get most of them right.
Give it 7 more years and a funeral of one those women, whose test they didn't interpret correctly, might be on the news. Could well be a young woman after tragically dying from cervical cancer in her late 30's and leaving behind small children.
That tragedy is felt not just by family and friends, and by the wider public; it's also felt by medical scientists and screening staff.
Meanwhile thousands of unnamed women, who will never be considered newsworthy, will go on to have children or long lives, after abnormalities detected by the same staff, in that same lab and treated by doctors, if necessary.
Nobody can 'fix' false negative 'failures', not unless pursuing a harebrained attempt at 100% test sensitivity, which will always come at a price of reduced test specificity and all of the harms false positives bring.
All anybody can try do is encourage others to stop viewing anything less than perfection as a failure of a test and encourage everyone to view it as a feature of the test.
Plain English Summary: CervicalCheck was "doomed to fail" got a lot of media headlines. Every cervical screening programme in the world is "doomed to fail" some women, yet "destined to help" most women who participate in it, whether by detection of abnormalities or reassurance provided by the absence of them.
Chapter 5 - Dragging Vicky and other women to court.
Part 1: Why make a dying woman go to court in the first place?
There's no scenario wherein a stressful, deeply personal court case was beneficial to Vicky's clinical outcome and you can say the same for Ruth and others.
It's often said since, that women were:
"dragged through court"
While that is unquestionably true, there is one good reason I can see for why both the NHS and HSE pursued this deeply unpopular legal strategy.
NHS dragged 3 women (Sandra Penney, Helen Palmer, Lesley Cannon) to the Court of Appeal in 1999 and the HSE dragged 1 woman (Ruth Morrissey) to the Supreme Court in 2020.
The good reason is counterintuitive and somewhat perverse but the truth is they probably dragged those 4 women to the higher courts to try save women's lives.
If every false negative in cytology led to millions in compensation, when cancer becomes invasive and leads towards death, a screening service will become financially unviable and collapse.
In such an event, it would revert from centrally Organized Screening (by invitation at regular intervals) back to regional Opportunistic Screening (GP's at irregular intervals), the latter of which is known to be inferior.
It would almost certainly result in lower population coverage, an increase in cancer cases in women, more radical hysterectomies, more deaths and essentially that's all bad news for women.
Both the NHS and HSE were well aware of this and were between a rock and a hard place, with few having understanding, let alone sympathy, for their predicament.
Dragging sick women to court is universally viewed as a contemptuous, heartless approach.
Not only that but legal history has shown it's nearly impossible to 'win' those cases, even if defendants wholeheartedly believe in their innocence. A jury's sympathy will rightly always be with a dying woman and not with multi-billion $ labs and health services, insured to the hilt.
Not dragging dying women to court, can paradoxically result in more cancer and more death, especially if the net result of eventually settling all cases out-of-court is a de facto expectation of 100% accuracy in cytology, which is impossible.
False negatives are unavoidable, for reasons I already discussed, so if that becomes the legal expectation, it'd be the end of Organized Screening and also deter Opportunistic Screening participation.
NHS and HSE both lost their appeals but got what they were looking for by taking it to the higher courts: a legal precedent that expressly states not all false negatives are negligent.
The NHS got that in the Court of Appeal in [Penney & Ors v East Kent Health Authority, 1999], with Lord Woolf explicitly stating negligence can't be established merely by a woman unfortunately developing cancer, after an "incorrect" negative result.
The HSE got that in the Supreme Court in[Morrissey v HSE & Ors, 2020], with Chief Justice Clarke stating negligence "will necessarily depend to a significant extent on the facts of the case" (case by case basis).
Plain English Summary: The higher courts in England and Ireland ruled in favour of the women but made clear not all false negatives in cytology are negligent, which possibly saved screening from outright collapse.
In that respect, millions of women in England and Ireland benefited from the stressful ordeals of 4 women, who very sadly got dragged through the courts of appeal, in Ruth's case near the end of her life.
Part 2: Why did they insist Vicky sign an NDA?
The question involves understanding who "they" is referring to and an analysis of the traditional legal approaches of the defendants.
The HSE does not pursue a general approach of NDA's, you can see that from the volume of clinical negligence cases on the 6 o'clock news in the last 15 years.
Many families stood outside the Four Courts giving interviews, after being awarded damages, for one error or another. HSE clearly doesn't demand NDA's, as a matter of course, to try prevent them all from speaking up.
There's a denial from the HSE that they ever sought any NDA from Vicky and from my perspective there's one incontrovertible reason to believe them, a reason the media didn't even mention, let alone flesh out in detail.
Internal communications released showed CervicalCheck were well aware, in 2015, of potential litigation, if they disclosed the results of this audit.
If their concern was lawsuits and multi-million € payouts in the future, there was a super simple solution to that problem back in early 2016:
Don't disclose the results...
Most countries don't do these audits and hardly any (5) disclose results to women.
International best practice is not to do audits and not to tell women; on top of that there was no legal obligation in Ireland to disclose retrospective information of screening history. They had every basis they could wish for, to justify non-disclosure.
It's a logical paradox to suggest a cover-up of information they were under no obligation to even (a) gather (b) share, to begin with.
That they knew all of that and still chose to inform the women flies in the face of any theory they wanted to keep it hidden, to try avoid paying out millions in the future.
It seems far more likely they chose to tell women because they generally believe in the principles of disclosure.
However, the other defendant in Vicky's case was Clinical Pathologies Laboratories, Texas and it has a lengthy history of NDA's in US court settlements. Their Australian-based parent company, Sonic Healthcare, makes billions in annual revenue, with a big chunk of that in the US market.
Wealthy corporations, more used to the American legal approach, think sweet feck all of demanding NDA's. It's not much of a secret that a longstanding, favoured American approach to defending medical negligence is "Cool so here's the deal: We'll pay up, if you shut up? Take it or leave it..."
The money doesn't seem to bother healthcare giants; they could have paid out €10 million to Vicky and not made the slightest difference on any balance sheet. It's the potential for floodgates to open that unsettles them and if they can keep floodgates closed, they will.
Plain English Summary: It's unknowable what happened in that confidential mediation but I believe the HSE's denial of asking for an NDA. Multi-billion $ international companies pay fortunes to lawyers to fight for their own best interests. They're not paid to worry about the best interests of one very sick woman in Limerick - regardless of fault.
Part 3: What if Vicky signed an NDA? Story never emerges?
It's almost now a matter of fact, in the public consciousness, that Vicky's was the first court case and the story would never have became public, if not for Vicky's refusal to sign an NDA; which was very brave and altruistic from her perspective and seeking to help other women.
However, it's not very widely known that Vicky was by no means the first legal action to commence and the story probably would have emerged, regardless.
The first lawsuit in relation to the CervicalCheck audit actually began 2 and a half years before Vicky's court case, when solicitors representing Rachel O'Brien filed a Memo Entry of Appearance in the High Court on November 19th, 2015.
This was in relation to the very sad death of Rachel's mother, Miriam, in 2013, whom had a result upgraded from negative, in the audit review of her cytoloygy.
Other lawsuits stemming from the audit followed in 2016 and 2017, Cathal Curtis filed a Memo Entry of Appearance in the High Court on April 24th, 2016, shortly before his wife Michelle died in June, 2016.
Rachel O'Brien was just 14-years-old when solicitors representing her filed that lawsuit over the death of her mother and she never gets any credit in the media for being the first. It must have been a very intimidating and stressful prospect for a bereaved teenage girl, going through heartbreaking loss and grief.
I wish she got even a fraction of the public support given to adult women.
Vicky's was simply the first case publicly settled in April, 2018 because her condition was terminal and she couldn't wait for the slow march of justice; as Rachel, Cathal and others had to do, because their loved ones were already dead and there was no time-sensitive, life-or-death pressure to hear those cases.
If Vicky signed an NDA, it still would have come out. It wouldn't have taken Sherlock Holmes deduction to notice so many High Court cases filed against the HSE and Labs contracted by CervicalCheck, long before any NDA's get placed on a table.
There was cases pending in the High Court and more on the way to the High Court for it not to have come out. It may have come out too late to benefit Ruth and others.
They reaped the benefit of Vicky's bravery.
Plain English Summary: It makes for a compelling social media narrative to allege a conspiracy to hide the truth via NDA's; and Irish institutions of Church and State have a shameful history of doing stuff just like this.
CervicalCheck scandal however is very different; conducting the audit was voluntary, disclosure was optional and they sent the letters to clinicians, knowing the potential for litigation.
Chapter 6 - False negatives happen everywhere but only becomes a scandal in Ireland.
Part 1: Media misunderstanding of what a false negative is.
Richard DeMay said this in 1996 and it remains true in 2023.
"Reading Pap smears is a difficult and complex human endeavour in which mistakes are inevitable, and therefore, normal."
False negatives in cytology are unavoidable and any effort to make them avoidable could result in colossal harm caused to thousands of women via false positives.
What happened to Vicky, Miriam, Ruth and the entirety of the audit group happens in every country in the world, that has centrally organized screening progammes.
Over 50 countries, poor ones in Africa and Asia mostly, don't have cervical screening at all and it's sometimes lost on people that these services are a privilege of national wealth.
It only became a scandal in Ireland, though, and the reasons for that are simultaneously very simple and very complex. The most simple reason is few in Ireland, from media to politicians, understood what cancer screening is.
It's quite easy to view it as a scandal, if under the false belief women got a "wrong result" for a test with 100% sensitivity or that it was a diagnostic test for the presence of cancer, which it isn't.
Technically speaking, at the time of disclosure of the audit, none of the women got a wrong result because that implies the right result was possible under the initial conditions in the lab, at the time of their smear.
For it to be termed a 'wrong result' or 'misread smear' requires a court verdict or an admission of liability in a court settlement, which has occurred in very few cases.
The correct terminology is neither "wrong result" nor "misread smear", those are determinations that can only be made by Judges and Juries, based on particular facts of a given case, or by a defendant settling a case with admission of liability.
The correct terminology is "upgraded result on review", which doesn't necessarily imply any failure on the part of the cytotechnologists who read the slides in the first place.
This nuance was badly missed in frenzied media reporting around the breaking story in 2018.
Plain English Summary: Irish media universally reported women had smears "misread" or were given the "wrong result" and still do, to this day. That isn't just technically false, it's wholly false. There's no implication, inherent in upgrading a result, that it was possible to identify the same result initially.
Part 2: How does Ireland's audit review of cytology compare?
A review of the cytology (smear) of cancer patients is biased by the knowledge cancer developed, subsequent to a smear. The reviewer knows the woman was diagnosed with invasive cancer.
Not blinding the review was very much a design of these audits, in the few countries that undertook them, to increase learning opportunities.
Screening programmes wanted to know if there's areas of improvement they can make at any step of the screening process, from smear-taking, cytology, colposcopy and histology.
One way they can do that is by assessing if anything stands out between the audit cohort (cancer patients) and everyone else (women with screening history, who don't have cancer).
- Concordance in a review of a slide means the original classification was confirmed on review.
- Discordance in a review of a slide means the original classification was amended on review, commonly upgraded but can be downgraded.
Given only a few countries conduct these audits and publish results, it's only possible to compare with two countries.
This is the proportion of negatives that showed concordance (remained negative on review):
Irish (RCOG) review of slides (2019): 55.1% (108/196)
English audit of slides (2013): 51.1% (2,800/5,480)
Norwegian audit of slides (2017): 45.0% (54/120)
Plain English Summary: In this type of audit of cancer patients, it seems normal for roughly 50% of slides to differ from the original classification of cytology, due to the fact reviewers are aware women have been diagnosed with cancer. Classifications that may have originally looked benign may, with benefit of hindsight, be interpreted differently.
Part 3: What would have happened if they lived in England?
Given false negatives are unavoidable, expected and normal, it raises a simple question.
"How do other other countries approach them?"
The easiest way to demonstrate this is by imagining an identical cohort of women in England; same age, identical Pap smear slides, same review conditions, same health outcomes, ranging from excision to hysterectomy to death.
NHS screening programme classifies false negatives, upon review of cytology, into 3 categories:
- Satisfactory - the review confirms the initial result
- Satisfactory with 'learning points' - the review finds abnormalities that were not easy to identify.
- Unsatisfactory - the review finds abnormalities that were easy to identify and shouldn't have been missed.
Duty of Candour (2008) in England is their Open Disclosure legislation and it covers the mandatory responsibility of clinicians to be open and honest when a mistake was made in a patients care. Similar legislation on mandatory Open Disclosure in Ireland is passing through into law soon.
NHS Cancer screening programmes are insulated from full application of Duty of Candour, because cancer screening is different to other forms of healthcare.
- A failure to correctly diagnose disease, in a person with obvious symptoms, can be clinical negligence.
- A failure to correctly diagnose risk of future disease, in a person with no symptoms, has to be treated differently.
The mandatory obligation to be open, honest and apologise to women about false negatives, only applies to the following false negatives.
"Unsatisfactory - the review finds abnormalities that were easy to identify and shouldn't have been missed. Apology made."
There is no mandatory obligation to inform nor apologise to women about the following false negatives; rather an offer is made to read the review, which will not come with any apology:
"Satisfactory with 'learning points' - the review finds abnormalities that were not easy to identify. No apology offered."
Plain English Summary: NHS Cancer Screening programmes are treated differently in the application of mandatory Open Disclosure to patients. 'Unsatisfactory mistakes' must be disclosed and apologised for. 'Satisfactory mistakes' lead to an invitation to read the review but no apology is made.
Part 3a: Which false negatives are deemed acceptable by NHS?
The NHSCSP very helpfully and explicitly states which false negatives are expected and normal i.e. "satisfactory with learning points".
Doing so reduces the risk and volume of litigation to near zero because women are aware which kind of mistakes are expected and which ones are unexpected.
It also reduces false positives, which cause enormous harms of their own.
Lab staff in England are freed from the risk of litigation, which makes women safer. When staff are worried about landing their Lab in court and on the 6 o'clock news for a false negative, there is a natural tendency towards false positives, to cover their backs.
This increases potential harm to women.
The NHSCSP list of expected false negatives is contained in the picture below.
Plain English Summary NHS Cervical Screening Programme sets out which mistakes in cytology are expected and acceptable, to advance public understanding on the limitations of screening.
Part 3b: How many women in the Irish audit would England's Duty of Candour have applied to and would have received an apology?
It's impossible to say for certain because very few of the Irish audit cohort introduced evidence in court, as to the classification of the review of their cytology, and that would be necessary to answer the question specifically.
NHS generally expect 95% of reviews of invasive cancer patients to fall under either 'Satisfactory' or 'Satisfactory with learning points' and the remaining 5% to fall under 'Unsatisfactory'.
Applying that to the Irish audit, 1,097 cases of cancer, would leave 55 unsatisfactory reviews of cytology, approximately half of which would be expected to have involved a delay in treatment.
At those proportions, roughly 27 of the original 209 women in Ireland would have been mandatorily informed of a false negative and given an apology.
The other 182 women, if they lived in England, would have merely been given an option to read their review but no apology would come for the False Negative because their false negatives are deemed 'Satisfactory with Learning Points'.
Approximately 50% of cervical cancer patients in England, with a prior screening history, take up the offer to read their review, in such cases.
The 27 women who would have been given an apology could pursue legal action but the rest of them would likely be unsuccessful in doing so, because their false negatives fell under 'satisfactory mistakes', expected in all cervical screening programmes.
- €6,720 for permanent functional deficit (post-hysterectomy)
- €6,000 for emotional distress
- €5,000 for sexual damages
- €3,795 for temporary functional deficit (pre-hysterectomy)
- €3,000 for permanent disfigurement
- €1,000 for temporary disfigurement
"You suspect there is a gold treasure buried on your farmland. You grab a metal detector and carefully comb the farm but find no gold. A long time later, another farmer comes along with a tractor to help plough the land and he finds the treasure. You looked very carefully and didn't find it but it was there all along."
There can be many reasons why the initial search for gold was unsuccessful, without implying an incompetent search. Maybe it was buried beyond the 10cm - 20cm depth of the metal detector. Perhaps the mineral composition of the soil further reduced detection depth. Maybe a few square inches of grass were overlooked in many acres of land.
Some cervical abnormalities are difficult to spot, with fewer than 50 abnormal cells in a slide of 50,000 cells. A competent analysis of 50,000 cells can't be taken to mean analyzing every cell, to attempt to do so would make screening so time-consuming to become unviable and useless.
Cytology is an interpretative skill, a skill that saves many lives.
As with anything open to interpretation, there will be differences of opinion on what constitutes normal and abnormal. It's not positive or negative, it's an ordinal scale with many classifications.
That's reflected in a study showing wide discordance (disagreement) when 4 cytopathologists in hospital labs in Norway analysed the same 100 slides.
When the consequences of good faith mistakes can cost their Lab tens of millions of dollars or euros in compensation payouts, or being named-and-shamed for a mistake leading to the death of a young woman, it scares young people off pursuing it as a career.
"I'd encourage women to continue getting their smears because it's very important, even though it failed me, it does save many, many lives" - Ruth Morrissey
"Cervical screening is absolutely essential, I'd encourage women to keep going for their smears, even though it failed me. I don't want to see more numbers developing invasive cervical cancer, it's a horrible cancer to get, for younger women in particular. I'm lucky I have my 2 children but I've met women who weren't able to have children, as a result of cervical cancer" - Vicky Phelan
"Why are these people entitled to millions for cancer, but my family is not?"
My father died from lung cancer at 61-years-old, he died penniless after a difficult life of addiction, depression, mental health problems, homelessness.
He wasn't entitled to bring court cases or secure millions to leave to his children because there's no screening for his cancer.
Even if there was screening for his cancer; because it's far more common than cervical cancer, lawsuits for False Negatives would instantly collapse any theoretical lung cancer screening programme.
Why does a 22-year-old man, with Stage 1 skin cancer, not get to apply for tens of thousands in compensation? Why does a 34-year-old woman with terminal pancreatic cancer get absolutely nothing, to leave behind to her young children?
Screening is, after all, not a diagnostic test for cancer.
A screening failure is commonly describing a failure to identify risk of disease.
A screening service failing to identify risk of disease applies to all non-cervical and non-breast cancer patients because there's no screening to begin with, to succeed in identifying risk.
Plain English Summary: On a philosophical level, patients with other types of cancer may feel it's not very fair that cervical cancers get singled out like this and that they too could do with some money to leave their children.
Chapter 10 - Judge tenderly, if you must.
"Judge tenderly, if you must. There is usually a side you have not heard, a story you know nothing about, and a battled waged that you are not having to fight." - Traci Lea LaRussa
"Judge tenderly, if you must"
Glenda Mixon was also a vibrant young women, who got out of bed one beautiful summer day in 2008 and went to work. Among dozens of slides she read that day, was Darian's slide. Her interpretation of that slide was later deemed negligent and she was held 75% responsible for Darian's death.
"There is usually a side you have not heard"
By using her expertise in cytology and reading tens of thousands of slides accurately, Glenda helped thousands of women; whether giving them reassurance, preventing abnormalities progressing to cancer and even saving their lives.
"A story you know nothing about"
Nobody knows how heavily that weighed on Glenda because nobody ever asked her. No journalists asked did she lose friends or professional opportunities, nobody enquired did she have a support network of friends and family, nobody asked if she's even ok.
Nobody knows anything about her, beyond the fact a jury of non-experts decided they preferred one team's expert testimony, over another team's expert testimony.
Nobody knows if Glenda even made a mistake that day, it's all subjective opinion.
Nobody knows or cares.
Those are not easy shoes to walk in, either.
Part 3: A battle waged, that you are not having to fight.
Dr Grainne Flannelly arguably did more than any person in the history of Ireland to reduce the incidence and mortality of cervical cancer but throw her name into a google search and see if that's the impression you'd be left with. I reckon you'd get an opposite impression.
Cervical Screening has been embroiled in a battle for its very existence in Ireland, over the last 5 years, with emphasis very much on the word 'screening'.
This isn't about CervicalCheck, the organized screening service, nor about criticisms made on non-disclosure or governance of the programme.
Even if Organized Screening dissolved entirely in the aftermath of the scandal and Ireland reverted to Opportunistic Screening, via GP's, the concept of screening would remain under assault.
It's a battle few of us have to face and the people facing it aren't getting a whole lot of support.
The HPV test can never achieve 100% sensitivity, it will at best detect 18-of-20 abnormalities; yet the impossible expectation put out there, in the public consciousness, is that it should be able to detect the other 2.
There will always be false negatives, always be Vicky's, Emma's, Ruth's, who pay the heaviest price for the limitations of the test yet people expect it to never happen again.
Then you have lawyers making a pretty penny from it all, just waiting for the slightest mistake in a lab to result in turnover of millions and the added bonus of looking like the good guys.
Cervical cytology isn't just a difficult and imperfect science.
It's a difficult and imperfect science, with huge potential to cause harm.
Screening is the most delicate balancing act between sensitivity and specificity.
If litigation culture continues to punish sensitivity and lab staff consciously feel pressure to increase it; many women in Ireland would pay a heavy toll for resulting decreased specificity and unnecessary procedures for false positives.
"Botched tests"
"Judge them tenderly, if you must"
- The screening service undertook a voluntary audit and made a choice to disclose results.
- The lab staff, in England, Ireland and USA, none of them were shown as incompetent.
- The doctors often had good reason for non-disclosure, to try protect their patients.
