CervicalCheck

” The devil can be in the detail”

Ref http://www.bailii.org/ie/cases/IEHC/2019/H268.html

By way of background Ruth Morrisseys smear was read by Quest Diagnostics  in August 2009 in one of its laboratories located in Grand Rapids Michigan in the United States and her August 2012 smear was read by the third named defendant/respondent, Medlab Pathology Limited (―Medlab‖) in one of its laboratories situated in Co. Dublin.

Ms. Morrissey was diagnosed with cancer in 2014 and Judge Cross held, on the balance of probabilities, that the HPV infection was present for at least ten years before that diagnosis. The High Court held the negligent misreading of both the 2009 and 2012 slides (inadequate number of cells < 5000) were found to have caused the entirety of the Morrisseys‘ claims for injuries and loss.

More focus is required to the American Society of Cytopathology (ASC) Guideline identified in the Ruth Morrissey judgment set out below which is self serving and attempts to give the Labs an effective waiver over missing AGC/ASCUS cells in a PAP smear (borderline abnormalities) that some experts for labs in Ruth Morrissey High Court said could be put in a “waste basket”. This seems to form a major plank in the defence of this cases by the labs and seems hard to reconcile now with the ruling of the High Court and Supreme Court of Ireland in Morrissey that “absolute confidence” must exist in the mind of the screener before classifying these AGC/AGUS cells as normal (negative).

Judge Cross held that certain abnormal features of cells were visible on the August 2009 slide, and thus the trial judge had no doubt that the cells on the slide were AGC/AGUS. In this regard, he accepted the evidence of the Morrisseys‘ expert witnesses, Ms. Tan and Dr. McKenna, and the conclusions of those who conducted the audit.

Insofar as this provision proposes that it is not negligent to report a finding of ASC-US or AGUS cells as a normal or clear result, it was roundly rejected and criticised by Cross J. who considered that this attitude towards the categorisation of ASC-US and AGUS cells was prevalent amongst Quest‘s American expert witnesses. One of Quest‘s expert witnesses, Prof. Austin, was involved in the drafting of the ASC Guidelines, while another expert witness, Mr. Feit (cytotechnologist based in Wisconsin), referred to the high degree of inter-observer variability in respect of ASC-US and AGUS categories and stated that the categories are not used at all in the U.S. for proficiency audits or examinations of cytoscreeners. 

“99. Ms. Stowe (a cytotechnologist based in Wisconsin) on behalf of MEDLAB PATHOLOGY LIMITED described the ASCUS/AGUS category as being a ” waste basket “. The categories certainly describe ” indeterminate ” cells which are abnormal if not cancerous or pre-cancerous. As we have seen there is an obligation for the screener in cases of ASCUS/AGUS to have the patient rescreened within a short number of months. As I remarked earlier, I fear that such descriptions as given by Dr. S. result from the Guidelines of the American Society’s view that atypical cells can, in effect, be ignored when discussing liability, a proposition specifically endorsed by Prof. Pitman (the lead consultant cellular pathologist) Medlabs expert.”

This category of cells are probably the most uneconomical to search for as they take more time and are more difficult to identify and from a cynical perspective these ASC guidelines are drafted by the experts in this field of cytology who would have a superior knowledge of the “interpretative” pitfalls of reading a PAP smear and knew this was a particularly dangerous category to miss particularly for women under 40 years as where these atypical glandular cells present early intervention is absolutely crucial.

ASC GUIDELINE ” Equivocal interpretive categories including atypical squamous cells (ASC) and atypical glandular cells (AGC) have poor inter‐ and intra‐observer reproducibility. Therefore, most cases of ASC and AGC do not represent consistently identifiable abnormalities and a reasonable basis for allegations of practice below a reasonable prudent practitioner standard of care. “

I am not a medical person but have read numerous scholarly and other articles on this subject and have gleaned a sufficient understanding to appreciate the risks of putting AGC (atypical glandular cells) cells in a waste basket.

https://cdn.ymaws.com/cytopathology.org/resource/collection/75A4FB3E-BE73-4755-84EA-54214443AE0E/Guidelines-for-Review-of-GYN-Cytology-Samples-in-the-Context-of-Investigations-EB-approved-5.3.151.pdf

One of grounds of appeal to the Supreme Court was lack of engagement of Irish High Court Judge Cross with the case of the defendants. It is difficult to see how Judge Cross (from a family of medical professionals) could have engaged more with this 36 day hearing. In my opinion he has done the women of Ireland a great service in the Ruth Morrissey 2019 judgment.

Whilst Ruth Morrissey was deprived of far too many  “lost years” of her life in my opinion her court case contributes hugely to the advancement of women’s rights and women’s health on this island. I for one salute her and her family. Her brave and fearless legacy hopefully gives her family some comfort in their darkest hours.

Relevant extracts

“However, it is noteworthy that among women <40 years with diagnosis of AGC, all clinically significant lesions were HSIL. Among women ≥40 years with a diagnosis of AGC, the majority of 69% (9/13) were …”
ref: https://smw.ch/journalfile/view/article/ezm_smw/en/smw.2007.11928/a4ee4f679b1a35de3847382c9ec87e3ac59433aa/smw_2007_11928.pdf/rsrc/jf

” The term atypical glandular cells of unknown significance (AGUSwas first introduced into The Bethesda System(TBS) in 1988. It is defined as endocervical or endometrial glandular cells exhibiting changes beyond reactive or repair, but lacking unequivocal features of invasive adenocarcinoma (ADCA)”

ref: https://smw.ch/journalfile/view/article/ezm_smw/en/smw.2007.11928/a4ee4f679b1a35de3847382c9ec87e3ac59433aa/smw_2007_11928.pdf/rsrc/jf

In 2001 TBS revised to differentiate a separate category of AGC.

“Prof. Pitman, as previously stated, having given her evidence as the necessity for blind review confirmed that as far as she was concerned even had there been a blind review and the reviewers had consistently reported ASCUS/AGUS that she would not have held the laboratory negligent as she supported the Guidelines of the American Society referred to above. These Guidelines suggested that any misreading of ASCUS/AGUS cells should generally not be classed as negligent. I believe that Prof. Pitmans evidence accordingly, must be treated with caution though I fully accept her belief in what she has said, I fear that she did from time to time depart into the realm of an advocate rather than an expert.


If and insofar as this paragraph suggests that a finding of ASCUS or AGUS can generally be reported as normal without legal criticism it is entirely unacceptable and wrong. Yet, that is the apparent and genuinely held view of the American Society of Cytopathology, all of whose members must attest to follow these guidelines as drawn up by Prof. A. It certainly was the opinion of Dr. P. on behalf of MEDLAB (the third named defendant) who stated that even had blind reviewers consistently revealed a finding of ASCUS or AGUS that she would not deem it a breach of duty or negligence on the part of the original laboratory to find that slide as negative

ref: https://www.statpearls.com/ArticleLibrary/viewarticle/17991

” high incidence of significant clinical disease associated with a cytologic diagnosis of AGUS, an aggressive management approach that begins with a second reading of the cervical smear, followed by colposcopic evaluation, cervical biopsy and endocervical curettage is warranted. Conization should be performed for any AGUS Pap smear suspicious for neoplasia. In special circumstances, other adjunctive tests, such as endometrial biopsy, should be performed to exclude other carcinomas. Further cytologic differentiation may provide some guidance in the future, and HPV testing seems likely to be helpful. Additional recommendations may also be forthcoming from the Bethesda and American Society for Colposcopy and Cervical Pathology conferences this year. ” ref https://www.aafp.org/afp/2001/0601/p2239.html

https://www.bmj.com/content/352/bmj.i276

https://www.cancervic.org.au/cancer-information/types-of-cancer/cervical_cancer/cervical-cancer-overview.html