ONTARIO
SUPERIOR COURT OF JUSTICE
BETWEEN:
Janice Nicole Deboer, Kenneth Anthony Deboer, Kevin Daniel Deboer and Krista Lee Deboer
Plaintiffs
- and -
Dr. D. M. Kolyn, Dr. Keith Campbell Hankinson, Dr. R. Webb, Dr. T. Tsin and Dr. Pamela V. Cyr
Defendants
André I.G. Michael, Jill S. McCartney, and Kimberly N. Knight, for the Plaintiffs
Darryl A. Cruz and Katherine A. Booth, for the Defendants, Dr. Kolyn and Dr. Tsin.
HEARD: September 15,16, 19, 20, 21, 22, 26, 27, 28, 29, 30, October 3, 4, 2016
REASONS FOR JUDGMENT
Overview:
1Janice DeBoer was diagnosed with breast cancer on May 3, 2010 at the age of 46. Her cancer has metastasized to her bones and has become disabling. Until the summer of 2016, she had worked as a flight attendant for Air Canada for over 30 years. She has been married to Kenneth DeBoer since September 1988 and they have two children, Kevin and Krista.
2The plaintiffs allege that the negligence of the radiologist Dr. Tsin, and the general surgeon Dr. Kolyn, caused months of delay in diagnosing and treating Mrs. Deboer’s breast cancer. They submit the cancer was a highly curable Stage 1 breast cancer, had it been diagnosed earlier.
3The defendants submit that Mrs. DeBoer’s breasts appeared radiographically and clinically benign in July of 2009 and therefore, there was no reason to suspect cancer earlier. They also submit that Mrs. DeBoer’s prognosis would not have been different because Mrs. DeBoer’s cancer was biologically aggressive and had metastasized into her bloodstream at a microscopic level, prior to any potentially earlier diagnosis date.
4The action against the other defendants was dismissed prior to trial.
Background facts:
5Mrs. DeBoer first came into contact with Dr. Kolyn in 2001 when she was referred by her family physician, Dr. Keith Hankinson for what appeared to be a benign breast lump.
6For ease of reference, I will describe the location of the lumps hereafter referred to as if they were located on the face of a clock, as one looks at a clock, twelve o’clock being at the top of the breast, three o’clock being the right side and nine o’clock being on the left side and so on.
7Dr. Hankinson had imaging done and a right breast ultrasound confirmed that there was a fibroadenoma at approximately the ten o’clock position. Dr. Kolyn’s clinical notes on August 21st 2001 describe the lump as “very smooth, mobile palpable” and she decided to monitor it. In April of 2002, a new cyst or fibroadenoma was noted in the left breast. Mrs. DeBoer was keen to have the two masses removed. On May 30, 2002 the fibroadnenomas were removed under general anesthetic by Dr. Kolyn at the Cambridge Memorial Hospital.
8In mid-2009, at the age of 45, Mrs. DeBoer developed a right breast lump at about five o’clock. Her family doctor referred her for a mammogram and ultrasound. The defendant radiologist, Dr. Tsin, reviewed the imaging. His report dictated and typed on August 01, 2009 notes that “there were two additional views of the right breast”, that “Mrs. DeBoer’s breasts were dense”, and “there were coarse cluster microcalcifications in the right breast on the medial lateral view only along the inferior right breast adjacent to the chest wall and not seen on craniocaudal view”.
9Dr. Tsin’s report categorized his clinical assessment by using the American College of Radiology breast imaging and reporting data system known as BI RADS. The rating is from 0 to 5. 0 meaning “not yet determined”, 1 “negative”, 2 “benign”, 3 “probably benign”, 4 “suspicious” and 5 “highly suspicious”.
10Dr. Tsin’s found the imaging of Mrs. DeBoer to be BI RADS 3, meaning that her breast was “probably benign” and indicated that a follow up ultrasound was required in six months and a follow up mammogram in a year.
11On September 23, 2009, Mrs. DeBoer attended her family doctor’s office to review the results of the imaging. She wanted the lump removed because of the discomfort she felt. She was referred again to Dr. Kolyn the consultation request stating: “Lady with R sided breast lump that is causing some pain – your management please. Thanks”.
12Dr. Kolyn received this referral along with the imaging results from Dr. Tsin sometime after September 23, 20091. Dr. Kolyn testified that she reviewed the imaging report and relying upon its interpretation of “likely benign”, arranged for an appointment with Mrs. DeBoer on December 21, 2009.
13Mrs. DeBoer presented on December 21, 2009 with a breast lump that she reported to Dr. Kolyn as being “different than the fibroadnenomas that she had in the past”. This lump which Mrs. DeBoer had for over five to six months was “hard and lumpy”. After physical examination by Dr. Kolyn, the plan was to remove the lump under local anesthesia on February 16, 2010. Dr. Kolyn did not believe that further imaging was required, given the plan.
14Dr. Kolyn testified that she took Dr. Tsin’s imaging report “at face value” and given the plan, she did not believe that further imaging was necessary.
15In the meantime, Mrs. DeBoer was making inquiries about a possible breast augmentation with Dr. Kaila, a plastic surgeon.
16When Mrs. DeBoer presented on February 16, 2010 at the hospital, she told Dr. Kolyn about a new area of concern, located at about the seven o’clock position in the right breast. Dr. Kolyn examined the new area of concern and was able to feel it and palpate it. She decided to perform a Trucut needle biopsy of the new area at seven o’clock and to defer excision of the five o’clock lump pending pathology of the new area. Dr. Kolyn’s reasoning was that the new lump at the seven o’clock was deep and, if it required removal, she would want to remove both lesions under a general anesthetic.
17Thus, Dr. Kolyn performed a Trucut needle biopsy by taking three cores of the area in Mrs. Deboer’s right breast at the seven o’clock area. Dr. Kolyn did not use real-time ultrasound guided imaging to ensure this was the lump biopsied. However, she was confident she had indeed biopsied the seven o’clock lump.
18The pathology report from the Trucut biopsy described benign breast tissue without specific abnormality. The pathologist noted that “clinical and radiographical correlation is required to determine if the appropriate lesion has been biopsied”. Dr. Kolyn testified that she thought that this result fit with her impression that the seven o’clock lump was likely “thicken breast tissue because of menstrual cycle”.
19Dr. Kolyn’s plan was to have Mrs. DeBoer in to assess the lump clinically in order to conduct the correlation required as indicated in the pathology report. That assessment was to be done on March 23, 2010. When asked why she did not order any further imaging, she testified that “she was waiting to see her”.
20The March 23, 2010 appointment was rescheduled to April 22 for surgical removal of both lumps. Mrs. DeBoer does not remember cancelling any scheduled appointment with Dr. Kolyn. However there appears to be a sticky note in Dr. Kolyn’s records2 of Mrs. DeBoer requesting to get booked for the removal of both lumps. Dr. Kolyn testified that she cancelled the March 23, 2010 appointment and asked her secretary to book Mrs. DeBoer into day surgery.
21In any event, sometime on either April 1 or 11, 2010, Mrs. DeBoer called Dr. Kolyn’s office to enquire about the risks involved with breast augmentation surgery which was now planned for May 3, 2010. Dr. Kolyn’s secretary’s note states: “Having a breast lump taken off on April 22 – wondering risk of infection b/c she is having breast augmentation on May 3. Will she heal in time for her surgery?”
22Dr. Kolyn said that she viewed the augmentation procedure as too close to the April scheduled removal surgery on April 22, 2010 and therefore, rescheduled it to August 9, 2010. Dr. Kolyn did not advise against the breast augmentation surgery. Dr. Kolyn did not order any further imaging of the two lumps. Dr. Kolyn did not order a biopsy of the original lump.
23Feeling reassured by Dr. Kolyn that the two lumps were benign, Mrs. DeBoer proceeded to have breast augmentation surgery with Dr. Kaila on May 3, 2010. During surgery, Dr. Kaila removed the five and seven o’clock lesions and sent them in one container for pathology. The pathology report indicated that Mrs. DeBoer had invasive ductal carcinoma.
24Dr. Kolyn testified that she was shocked when she reviewed the pathology report from the breast augmentation surgery. She met with Mrs. DeBoer and her husband on May 20, 2010. She organized an ultrasound guided fine needle aspiration of the right axillary lymph node on June 1, 2010, which showed metastatic carcinoma. On June 17, 2010, an MRI indicated that there were enhancing nodules in all four quadrants and they were suspicious for multicentric malignancy.
25Dr. Kolyn performed a right modified radical mastectomy on June 30, 2010. Dr. Kolyn recommended the removal of the implants, but Mrs. DeBoer wanted them kept in, if possible. Dr. Kolyn encountered significant scar tissue from the previous breast enhancement surgery.
26The pathology report from surgery revealed that the cancer had spread. There were positive margins left at the time of the mastectomy. Mrs. DeBoer was referred to Dr. Chouinard, an oncologist and Dr. Gopaul, a radiation oncologist, for the continued management of her breast cancer.
27An examination of the cancerous tissues revealed that Mrs. DeBoer’s cancer type was hormone positive (meaning it was estrogen receptor and progesterone receptor positive) and HER2Neu3 was negative. Chemotherapy followed by radiation and anti-hormonal therapy was recommended.
28After receiving chemotherapy treatment, Mrs. DeBoer was advised to begin taking Tamoxifen an anti-estrogen therapy. She filled one prescription of 60 tablets on December 10, 2010 but only started taking it sometime in 2011 and only for a couple of weeks. The reason will become clearer later.
29Radiation therapy was undertaken in July of 2011 when a local recurrence occurred in the area where her right breast was. She elected 21 out of the 25 planned treatments.
30In November 2013, following an MRI of her back due to complaints of low back pain, Mrs. DeBoer was diagnosed with metastases to her bones. In 2014, cancer had spread to her ovaries. The ovaries were removed and pathology confirmed that the primary disease in the breast had spread.
31In April of 2016, imaging of Mrs. DeBoer’s left shoulder showed metastatic lesions. She received a course of radiation for her shoulder to alleviate the pain.
32In summary, Mrs. DeBoer has breast cancer, which has metastasized to her bones. Her cancer has become disabling and prevents her from working. It is incurable.
The parties’ positions:
33The plaintiffs claim that the defendants’ negligence caused months of delay before making a diagnosis and starting treatment of Mrs. DeBoer’s breast cancer; that she suffered the progression from highly curable Stage 1 breast cancer to incurable metastatic Stage IV cancer; and that her type of breast cancer was diagnosable, treatable and curable.
34The defendants submit that Mrs. DeBoer had a biologically aggressive cancer that metastasized into her bloodstream at a microscopic level prior to any potential earlier diagnosis date. Accordingly, they say her disease and the prognosis would, on the balance of probabilities, have been the same regardless of whether she was diagnosed earlier.
Standard of Care of the Radiologist:
35The only expert who testified on the standard of care of a radiologist was Dr. Sparrow, who was retained by the plaintiffs. In his 40 years of practice, most of it in London, but more recently in Stratford, Dr. Sparrow has had a varied experience in multiple modalities of imaging. As Program Director of Diagnostic Radiology from 1989 to 1995, he was responsible for ensuring physicians’ training to become radiologists, including appropriate exposure and experience with different modalities of imaging. Dr. Sparrow has been an Associate Professor at the University of Western Ontario since 1999. He was also a founding member of the Ontario Breast Cancer Screening Program, which began in 1991. From its inception in 1991 until recently, Dr. Sparrow has been a Mammography Lead for the Ontario Breast Screening Program, and he was the Chair of the Canadian Association of Radiologists Mammography Accreditation Program.
36Dr. Sparrow testified that the interpretation of a mammography is an exercise in clinical judgment. Dr. Sparrow considered that Dr. Tsin failed to meet an acceptable standard of care for a radiologist, which required that Dr. Tsin describe the microcalcifications as suspicious, because they are coarse and heterogeneous. In Dr. Sparrow’s opinion, Dr. Tsin should have requested additional images, including supplemental and magnification views. In addition, a supplementary cranial caudal image was required to precisely locate the calcifications in the breast.
37Dr. Sparrow’s opinion is based on the distribution of the calcifications which he initially characterized as “linear” in his report dated February 16, 2016. When testifying at trial, he described the distribution as “segmental”, and explained in cross-examination that the use of the descriptor linear was a misnomer.
38Dr. Sparrow was provided the American College of Radiology breast imaging Atlas of 2003 (ACR BIRADS)4 which was in effect at the material time. He was of the opinion that the calcification distribution seen on Mrs. DeBoer’s imaging5 was consistent with the “segmental” calcifications distribution as described in the ACR BI-RADS.
39The defence did not call any radiologist expert. Instead, the defendants ask the court to review the ACR BIRADS and conclude that “the illustrated segmental distribution bears no resemblance whatsoever to the distribution that exists on the mammograms in this case”. In my view, the request is inappropriate. It is not the role of the court to interpret mammograms.
40Dr. Tsin’s testified that he does not consider the cluster of calcifications shown on Mrs. DeBoer’s imaging to be segmental but rather in a “regional” distribution. He is of the view that the cluster does not flow through the ducts toward the nipple, but rather flows downward against the chest wall.
41Dr. Sparrow explained that the two groups of calcifications visible on the July 22, 2009 imaging were close to the chest wall, they were not diffuse and they were not located in the left breast. This could indicate there is something “unusual” at that location. The calcifications were clustered into two groups within a small area of the breast.
42Dr. Sparrow further opined that benign calcifications usually appear as single calcifications or are widely scattered, often in both breasts. They tend to look the same in terms of size and shape, whether round or oval. When the shape is more irregular, such as those appearing in Mrs. DeBoer’s right breast, they have a higher association with breast cancer, particularly in women with dense breasts.
43In addition, Dr. Tsin testified that when he assessed Mrs. DeBoer’s imaging, no coned mag bilateral view was conducted. Nowhere in his reference materials was this annotation made. He only became aware of this annotation when, for the purpose of this litigation, he was asked to produce all of his file. The computer printout shows the box for a “coned mag bilateral 1 view each” was ticked which he says was likely done by a clerk at the lab by mistake.
44The imaging report that was provided to Dr. Kolyn included this annotation that a “coned bilateral mag view” had been conducted by Dr. Tsin, which was not accurate.
45Dr. Sparrow considered that Dr. Tsin fell below the standard of care of a radiologist when he concluded that the BIRADS score was 3. In Dr. Sparrow’s view the features of calcification on the mammogram of July 22, 2009 individually and collectively merited attention. He thought that a score of 4 was the standard of care because
. This was not a screening but rather a diagnostic mammogram
. Mrs. DeBoer was premenopausal and under 50;
. She had a palpable lump; and
. She had dense breast.
46This court finds that Dr. Tsin’s evidence that the distribution of the calcification was in a downward distribution cannot stand as reasonable. The only way that anyone can say that, would have been through further imaging particularly from a mag view which was not done.
47I prefer Dr. Sparrow’s opinion about the appearance of both clusters variable in size which appear to be segmental along a ductal pattern with a tendency to be oriented towards the nipple.
48Accordingly, Dr. Tsin breached the standard of care of a radiologist because he failed to request further imaging, including supplemental cranial caudal image and magnification views. It is reasonable to infer from all of the evidence that additional imaging ordered would have likely occurred within a reasonable amount of time of no more than within two to three weeks from July 30.
49This failure to meet the radiologist’s standard caused the first delay in Mrs. DeBoer’s diagnosis. Had further imaging and a subsequent biopsy been performed by the end of August 2009, Mrs. DeBoer would have been diagnosed almost eight months earlier, as her breast cancer was undoubtedly present in the summer of 2009.
50I will return to the implications of an earlier diagnosis in the discussion of causation below.
Standard of Care of the Surgeon:
The experts:
51Two experts were called on this issue: Dr. Holliday for the plaintiffs and Dr. Davison for the defence.
52Dr. Holliday practised for 36 years, largely in London, Ontario as a general surgeon. He was Chief of the Department of General Surgery at the London Health Care Centre. In the last ten years of his career, his practice has included extensive breast cancer diagnosis and management.
53Dr. Holliday is a Professor Emeritus at the University of Western Ontario, Department of Surgery. Throughout his career, Dr. Holliday has been involved in teaching medical students, interns, clerks, residents and fellows on a full spectrum of general surgical matters.
54Dr. Holliday served as Executive Director of the Canadian Association of General Surgeons’ Test Committee, which examined the educational standards of all general surgery residents across Canada and prepared a program for assessment of the progress of residents through their training. Dr. Holliday was involved in the preparation, administration, and evaluation of the program. He also has been the Executive Director of the credentialing committee of the Royal College of Physicians and Surgeons of Canada since 2008.
55Dr. Holliday has been involved with research for the Canadian Breast Cancer Research Institute and the National Cancer Institute of Canada. Finally, Dr. Holliday has treated between 1,500 and 2,000 patients for breast cancer over his 36 year career.
56Dr. Davison is a general surgeon practicing in a community setting in Brampton, Ontario. He has privileges at William Osler Health Centre, a community hospital in Brampton. He has been in practice since 1991. His practice includes seeing a few hundred patients each year related to breast issues, which makes up approximately 20 to 25 percent of his total practice in general surgery. Of those few hundred breast cases, approximately 40 to 50 cases involve patients who are diagnosed with breast cancer. Dr. Davison has performed hundreds of mastectomies, lumpectomies and Trucut biopsies in his 25 year career.
57Dr. Davison does not teach. He has no academic appointments. His publications do not relate to breast cancer and his most recent publication dates back to the 1990s.
Analysis on the standard of care:
58Dr. Holliday testified that the management of breast lumps must follow a common standard, whether the general surgeon is practicing at a tertiary care center or in a community based center. In other words, every surgeon (academic, non-academic, or community based) must keep apprised of the common practices of investigation and standards of care for surgery. Dr. Davison agreed.
59Dr. Holliday testified that Dr. Kolyn failed to meet the requisite standard of care during and subsequent to Mrs. DeBoer’s February 16, 2010 appointment by failing:
. to use image localization;
. to act on discordant findings; and
. to follow up on the five o’clock lump.
60In his view, Dr. Kolyn failed to obtain an appropriate tissue diagnosis of the breast lump at the seven o’clock location, by failing to use real-time ultrasound guided imaging to biopsy the lump. In Dr. Holliday’s opinion, it is very difficult to biopsy a small deep lump without image localization because the biopsy needle can push the lump away rather than penetrate it.
61Dr. Holliday further concluded that Dr. Kolyn failed to meet the standard because she did not order further imaging of the five o’clock lump. Six months had passed since diagnostic imaging was conducted of that lump.
62In contrast, Dr. Davison testified that Dr. Kolyn’s decision to obtain a tissue diagnosis of the new lump by performing an immediate Trucut biopsy without image guidance was a reasonable one.
63Dr. Davison also considered that it was reasonable for Dr. Kolyn to await receipt of the pathology report before deciding to remove the lumps. This was particularly so given Dr. Kolyn’s reliance on Dr. Tsin’s radiological report.
64The pathology report received by Dr. Kolyn from the Trucut biopsy showed benign breast tissue only and no microcalcifications. The report further indicated “clinical and radiographical correlation is required to determine if the appropriate lesion has been biopsied”.
65In Dr. Holliday’s opinion the results were “discordant findings”, because they showed only benign breast tissue and no microcalcifications. There were no features of suspicious tissue nor the distinctive features of a fibroadenoma. Therefore Dr. Holliday concluded that Dr. Kolyn ought to have been alerted to the possibility that she may not have biopsied the lesion. For Dr. Davison, the pathology results “make sense” because they confirmed Dr. Kolyn’s clinical impression that she would get benign breast tissue.
66Dr. Holliday said that Dr. Kolyn breached the standard of care by not performing any further imaging or biopsies to confirm her suspicion of a fibroadenoma.
67I pause here to note that, Dr. Kolyn testified that she actually thought that the new lump was “hormonal thickening”, which explains why the pathology results showed just benign breast tissue. But Dr. Kolyn testified that she has no independent recollection of the events in question and relies solely on her notes. In the February 16, 2010 record, Dr. Kolyn noted twice “new lump” and her discharge diagnosis is “breast lump”. Nowhere in her notes does she refer to “breast thickening”. Nor is there any note of a history of menstrual related or hormonal related problems with the breasts.
68In my view, Dr. Kolyn’s evidence at trial that she considered the lump to be hormone related is suspect. It is more likely than not given in hindsight as an explanation for the discordant findings in the pathology report.
69If Dr. Kolyn suspected “breast thickening” or “hormonal related lump” she undoubtedly would have noted it. Instead the word “lump” is used three times and not “thickening” or “hormonal”.
70During cross examination, Dr. Holliday was asked about Dr. Kolyn’s testimony that she believed that the new lump was “hormonal thickening”. He responded: “that does not compute”.
71With respect to the five o’clock lump, it appears that Dr. Kolyn’s attention was diverted to the new lump, notwithstanding her obligation to manage the original one. The issue is whether she should have been suspicious even in the face of the radiologist’s report. Dr. Kolyn’s uncritical reliance on Dr. Tsin’s report meant that she did not further investigate by ordering new imaging or conducting a biopsy to confirm her clinical judgment that the lump was a fibroadenoma.
72As Dr. Potvin (Medical Oncologist called by the Plaintiff on causation) indicated, because Dr. Kolyn identified the lump in December of 2009 as “irregular” and “quite prominent”, and was now dealing with a new lump in the same breast in February 2010, she ought to have been prompted to order new imaging. Physical examination does not reliably or accurately distinguish a cancerous lump from a benign one, even when the examiner is very experienced.
73The fact that the pathology results reported simply benign breast tissue, should have alerted Dr. Kolyn that she might not have biopsied the lump in question.
74Dr. Kolyn failed to meet the standard of care expected of a general surgeon for the following reasons:
The Trucut biopsy results were discordant; and
The five o’clock lump was not investigated after July 2009 by either further imaging or biopsy;
75Dr. Kolyn’s knowledge of the impending breast augmentation surgery should have caused Dr. Kolyn to seek further imaging prior to that scheduled surgery in order to provide the correlation required from the discordant results.
76Had imaging been done in February or early March 2010, changes consistent with evolving malignancy would have been revealed and Mrs. DeBoer’s course of management would have been altered. It certainly would have avoided the false reassurance that came from the results of the blind biopsy.
Causation:
The experts:
77Two experts were called on the issue of causation, Dr. Potvin for the plaintiffs and Dr. Fine for the defence.
78Dr. Potvin is a medical oncologist who specializes in breast cancer and genitourinary cancer. She is engaged in academic research, including issues relating to breast cancer. She serves as an investigator for clinical trials performed at the London Health Science Centre. She has involvement in evaluating the effectiveness of different forms of cancer treatment. She has served as both co-principal and principal investigator for clinical trials. She has been published in peer-reviewed journals, authoring papers on the various forms of anti-hormone therapies, such as Tamoxifen. She has reported on the response to Tamoxifen and effectiveness for the patient, as well as assessments of chemotherapy.
79Dr. Potvin is an Associate Professor and has served as co-director for the undergraduate medical education program from 2005 to 2007, which included weekly teaching of students rotating through her clinics and formal teaching sessions to undergraduate medical students on cancer topics.
80Since 2007, Dr. Potvin has been the Program Director of the medical oncology residency program, which involves training of physicians after three years of internal medicine training for specialization in medical oncology. She is responsible for curriculum development that meets national standard and ensuring that residents receive all the required training experiences.
81Dr. Potvin has been on the Breast Cancer Tumour Board for more than a decade, which involves weekly meetings between physicians of different specialties including surgeons, diagnostic imaging radiologist, radio-oncologists, medical oncologist, pathologists, researchers, and nursing staff.
82Dr. Potvin sits on a sub-committee for national standards with the Royal College of Physicians and Surgeons. She has been involved with the development of competency based medical education since 2007.
83As part of her training and experience, as a clinical physician and researcher, Dr. Potvin is routinely involved in the assessment of imaging, surgical findings and interpretation of pathology reports.
84Finally, Dr. Potvin has been Chair of the National Canadian Association of Medical Oncologist for the past four years.
85Dr. Fine is a medical oncologist practicing at the Carlo Fidani Peel Regional Cancer Centre with more than 30 years’ experience in the care and management of patients with breast cancer. He has served as Chief of the Department of Oncology at Credit Valley Hospital from 2002 to 2012 and was the Regional Vice President of Cancer Services for the Mississauga Halton area for Cancer Care Ontario during this time period.
86Dr. Fine has been lecturing since 1983 as an Assistant Professor with the Department of Medicine at the University of Toronto. Dr. Fine was appointed to the Canadian Cancer Society Ontario Division Board in May of 2011 to 2015 and was involved with Cancer Care Ontario for many years.
87Clearly, both experts were well qualified to give their opinions. Dr. Fine has been qualified as an expert in courts before, while it was the first experience for Dr. Potvin.
88Both experts agreed that a delay in diagnosing breast cancer can impact someone’s life expectancy. While Dr. Fine considered that the difference in outcome was minimal in this case, Dr. Potvin said that even a one percent difference is significant.
89The defence submits that while a one percent difference in ten year survival might be material for a patient, it does not rise to the level of a balance of probabilities.
90While statistical evidence may be helpful in the medical oncological field, it is less helpful in determining causation on the balance of probabilities. I say this because, where statistical evidence does not rise to a scientific balance of probabilities, causation in law may nonetheless exist where evidence in the case supports such a finding.6
91Both experts agree that it was highly likely that Mrs. DeBoer had Stage I cancer in July of 2009 with a T1 tumor and no nodal involvement. The uncontroverted evidence is that Mrs. DeBoer’s cancer was Stage II by the time of her diagnosis in May of 2010.
92Dr. Fine assumed for the sake of his calculation of life expectancy ‘as the crucial inquiry’, that in December of 2009, Mrs. DeBoer was still at Stage I cancer. In his view, the difference in survival rate is minimal whether she was diagnosed in the summer or fall of 2009 or even in early 2010, compared to May of 2010. Dr. Fine is of the opinion that Mrs. DeBoer is likely to survive the ten year mark, given that she is still alive seven years post diagnosis. The result is an exceedingly small difference on life expectancy on a balance of probabilities.
93Accordingly, the defendants submit that the loss of chance of ten percent or less of a better outcome does not meet the balance of probabilities. It is a loss of chance which is not compensable.
94Dr. Fine’s opinion is founded on his belief that Mrs. DeBoer’s cancer carries with it a certain biology. In other words, in his view Mrs. DeBoer more likely than not had micrometastatic disease as far back as July 22, 2009. This is because the recurrence in 2011 was too soon if her cancer lacked aggressive characteristics. Accordingly, her outcome would have likely been the same, regardless of the timing of diagnosis and her staging.
95Dr. Potvin opined that had Mrs. DeBoer’s lumps been removed in the early fall of 2009 or early 2010 through appropriate oncological surgery followed by adjuvant treatment such as chemotherapy and anti-estrogen therapy, thereby minimizing any local recurrence, her long term outcome would have been greatly improved and in fact she likely would have been cured.
96In Dr. Potvin’s opinion, the delay in diagnosis resulted in increased tumour size, lymph node involvement and complications in her treatment because of Mrs. DeBoer’s breast augmentation surgery, including positive margins and ineffective systemic treatment. Additionally, in her opinion, the delay until surgery (eleven months from July 22, 2009 and four months from February 2010) is an independent factor that increases risk of recurrence and decreased survival rates.
97In fact, Mrs. DeBoer has gone on to have a local chest wall recurrence, metastatic disease and now is suffering from advanced Stage IV breast cancer with all of the attendant pain and other disabling features. Sadly, she will likely die from breast cancer.
Location of the cancer:
98The defence submits that establishing in which of the two lumps cancer was located is important to causation. The plaintiffs submit that it was located in either one or both of the lumps.
99Dr. Kaila’s surgical report states that the “two small lumps that were identified and spoken about prior to surgery were removed and sent to pathology.” The two small lumps identified by the pathologist refer to “right breast lump at five o’clock position and at seven o’clock position”.
100The pathology report revealed the following: “multiple breast tissue pieces without orientation”. This was because the breast augmentation surgery was not done from an oncological view therefore there was nothing to denote which was the five o’clock versus seven o’clock mass.
101Invasive breast cancer was identified with the largest focus measuring 1.7 x 1.6 x 1.0 cm, along with ductal carcinoma in situ (DCIS). As described by Dr. Potvin DCIS is a pre-malignant growth in breast tissue that can turn into invasive cancer, and is almost always present with invasive cancers. Both Dr. Potvin and Dr. Fine explained that pathologists will describe the tumour size generally by its largest diameter.
102In this case, the pathology report7 specifically describes two specimen lumps from the right breast at 5 and 7 o’clock received in one cassette. The pathologist describes the specimen type as multiple breast tissue pieces without orientation and goes on to describe the measurement of three pieces, the largest being 1.8 x 1.7 x 1.6. The findings are invasive ductal carcinoma; microcalcifications present in DCIS and present in invasive carcinoma. Also important, multiple margins are positive with invasive carcinoma.
103When the mastectomy took place two months later, on June 30, both Dr. Potvin and Dr. Holliday agreed that all of the cancer was located between three o’clock and six o’clock. The pathology of the breast was divided into 28 sections and examined for cancer. The cancer itself was found in the area of blocks A10 to A16, all on the medial side of the breast between three and six o’clock.
104The calcifications that were seen best on the imaging8, in July of 2009 were located between seven o’clock and nine o’clock. The pathology from the mastectomy detected calcifications in the seven to nine o’clock region along with DCIS.
105Based on the pathology from Dr. Kaila’s removal of the lumps at five and seven o’clock, during the breast augmentation surgery, at least one of those lumps contained invasive ductal carcinoma. Although the typed portion of the report appears to be identical for both lumps, it is reasonable to assume that if one of the two specimens was benign or did not contain invasive carcinoma and DCIS, then the pathologist would have reported it.
106Even if only one tumour from the augmentation had invasive pathology, the fact that the pathology from the mastectomy showed there was a 1.0 cm invasive carcinoma found in the area of three to six o’clock position, means there were either two cancers of over 1.0 cm each in the three to six o’clock position, or there was one 2.7 cm tumour in that location.
107If invasive cancer was found in both specimens taken during augmentation surgery, there was likely cancer in the seven o’clock lump. That is because no benign tissue was found in the samples. It is unlikely that the pathologist only analyzed one lump since two lumps were sent for analysis.
108It is also significant that the mastectomy specimen revealed DCIS at, among other locations, the nine o’clock position, which is close to the chest wall, where the calcifications were seen on mammogram.
109Accordingly, even if the cancer was likely located only in the three to six o’clock region, it was more likely than not from the five o’clock lump, which was pathologically found to be cancerous.
110The defendants submit that it is more likely than not that the fibroadenoma located during the mastectomy would have been the one biopsied. As a result, no further imaging would have been considered necessary. Therefore, the cancer would have not been diagnosed.
111The submission must be rejected. The defence’s submission suggests that a fibroadenoma only would have been found had further imaging been conducted either in the fall of 2009 or at the latest in February of 2010. The fact that a fibroadenoma was removed from this location during the mastectomy does not mean that no cancer would likely have been found had a proper investigation been conducted.
112Had Dr. Tsin properly reported a BIRAD 4 it is more likely than not that the following would have occurred:
Further imaging of Mrs. DeBoer would have been required;
Dr. Kolyn would have seen Mrs. DeBoer earlier than December 21, 2009;
Dr. Kolyn would have caused further imaging and biopsy; and
Mrs. DeBoer would have been diagnosed with breast cancer in the early part of the fall of 2009 at the latest.
Breast augmentation surgery complications:
113Dr. Davison and Dr. Holliday agreed that the breast augmentation surgery complicated the management of Mrs. DeBoer’s breast cancer because it made the mastectomy more difficult because of scar tissue.
114In her operative note, Dr. Kolyn recorded that there was an extreme amount of fibrosis (i.e. scarring and thickening of tissue due to injury and repair), and adherence of the breast tissue to the capsule of the implant. What that could mean is that it is likely that positive surgical margins were left behind, imparting a high likelihood of residual cancer cells on the chest wall.
115Although Dr. Kolyn testified that in her opinion she removed all of the scar tissue, there is very little comment about scar tissue in the mastectomy specimen’s pathological analysis nor in her operative notes.
116While Mrs. DeBoer’s anatomy is one of extremely low body fat, which has the potential for positive surgical margins, according to Dr. Holliday, this would be less likely had the mastectomy occurred before the augmentation surgery caused additional scarring and technical challenges.
117Dr. Holliday explained as well that had the mastectomy occurred before augmentation surgery, the risk of positive surgical margins would have been managed by removing fascia and pectoral muscle to ensure there were no positive margins.
118Further, Dr. Potvin testified that systemic chemotherapy requires an adequate blood supply to reach tumor cells in a high enough concentration to have a tumoricidal effect. Scarring and fibrosis from the augmentation surgery, compounded by the mastectomy, results in a very poor blood supply. The main benefit of adjuvant systemic chemotherapy lies in killing circulating cancer cells, and the prevention of distant metastases.
119Accordingly, according to Dr. Potvin, the breast augmentation surgery complicated the management of Mrs. DeBoer’s breast cancer. It made the mastectomy more difficult because of the scar tissue caused by the previous surgery. Systemic therapies, such as chemotherapy and Tamoxifen, were made less effective because blood supply to the tumour was cut off.
120Had augmentation surgery not occurred, the tissue planes would have been more visible and identifiable. Tissue could have been removed more easily with an absence of adherent scar tissue, particularly in a very thin women. As Dr. Kolyn described, when the implant was put in, the muscles weakened and spread apart, which allowed the scar tissue to adhere to the muscle, as well as to the actual implant.
Tumour biology:
121Consistent with Dr. Fine’s opinion, the defendants suggest that Mrs. DeBoer’s cancer was “occult metastatic cancer”, which had metastasized even in July of 2009 and was just not detectable.
122The evidence is clear that Mrs. DeBoer’s cancer, based on immunohistology testing, was estrogen and progesterone receptor positive (“ER+PR+”). Being ER+PR+ is a positive for patients. It is a type of cancer that is treatable because it responds well to anti-hormonal treatment, such as Tamoxifen.
123Indeed, when Mrs. DeBoer actually took Tamoxifen in 2013 after metastasis, it was effective to suppress the cancer.
124In addition, Mrs. DeBoer’s cancer was HER2neu negative. That too is a positive for her, because that means her cancer is not that type of aggressive cancer.
125As Dr. Potvin described, the fact that the metastases did not occur until two years later is evidence that those cells came from the local recurrence. This is important because it demonstrates the underlying growth rate of Mrs. DeBoer’s cancer.
126Her local recurrence has been well controlled since she received radiation treatment and continuous anti-estrogen therapy since 2013. Dr. Potvin explained that biologically aggressive tumours tend to be resistant to radiation and systemic therapies, leading to death within the first couple of years following diagnosis. The fact that Mrs. DeBoer is still alive and responding well to treatment is evidence that her cancer is not the biological aggressive type that Dr. Fine described.
127Dr. Fine appears to speculate about the biology of Mrs. DeBoer’s cancer. No Onco-Type DX (genetic evidence of the cancer) testing was done in this case.
128The defence submits that had Mrs. DeBoer obtained the Onco-Type DX test, it is likely that her biological cancer score would have been high. The testing was not done by either party. Although the onus remains with the plaintiff to prove on a balance of probabilities causation, the law permits this trial judge to draw an adverse inference from the failure by the defendant, whose theory could have been supported by the testing, to conduct such a test. It was within their power to do so. Dr. Fine’s opinion on causation is largely based on his speculative assumption that Mrs. DeBoer’s biological cancer was aggressive.
129Dr. Fine admitted in cross examination that there was no evidence of metastasis until November of 2013, more than two years later. Also Dr. Fine agreed that it is possible to have a histological grade 3 with a low Onco-Type DX score.
130Interestingly, Dr. Potvin opined that aggressive cancers frequently metastasize to the vital organs, while hormone sensitive cancers tend to go to the bones. In this case, seven years post diagnosis, Mrs. DeBoer’s cancer has spread to the bones but not her vital organs. There is no evidence of cancer spread outside her bones.
131For all of these reasons, Dr. Fine’s assertion that Mrs. DeBoer had a highly aggressive type of cancer is not supported on a balance of probabilities.
Analysis on causation:
132The experts all agree:
a) that passage of time is very important in the outcome in breast cancer because it is a disease of growth;
b) the stage of cancer is directly related to prognosis. The recurrence rates increase and survival rates decrease as a person progresses from Stage I to IV;
c) it takes years for DCIS to become cancer, but that once there is active cancer, the cancer can grow and spread in a matter of months;
d) cancer cells spread through the lymphatic systems to lymph nodes and then to other parts of the body, as well as directly through the blood stream; and
e) a delay that exceeds 3 months, independent of any other factors respecting the tumour itself, decreases survival.
133Breast cancer is a common affliction that is diagnosed daily. Cumulatively the overall evidence demonstrates that it is almost a certainty that had Mrs. DeBoer been properly diagnosed in the summer or early fall of 2009, she would have had Stage I, node negative, hormone receptor positive breast cancer – a highly curable cancer.
134She would have had an uncomplicated mastectomy with clear margins and no lymph node involvement. She would have been treated with chemotherapy and anti-estrogen therapy. Her type of cancer would have responded well to anti-estrogen therapy. She would not have had augmentation surgery in a breast with cancer.
135Instead, Mrs. DeBoer was diagnosed nine months later, with Stage II, multifocal, lymph node positive breast cancer. Her mastectomy was complicated by the intervening breast augmentation procedure. It left scar tissue and resulted in a difficult tissue dissection and cancer cells left behind. The scar tissue also reduced the effectiveness of systemic therapies. The pectoral muscle was splayed and there was an extreme amount of adherent scar tissue. She had positive margins and developed “recurrence” in the chest wall.
136Mrs. DeBoer’s cancer was diagnosable, treatable, and curable in 2009 or early 2010. But for the defendants’ negligence, Mrs. DeBoer would not be suffering from cancer metastases in her bones. She would still be working at the job she loved. She would not die prematurely from this disease.
Post-cancer diagnosis clinical course:
137Mrs. DeBoer’s oncologist, Dr. Chouinard, prescribed chemotherapy. It was administered until completion in November of 2010. Mrs. DeBoer experienced side effects, including hospitalizations for pain and infection complications from chemotherapy. She was fatigued and became significantly depressed.
138Prior to Mrs. DeBoer’s cancer diagnosis, she had suffered from some symptoms of depression and anxiety for a number of years. She began taking anti-depressant medication after her children were born in the early 2000s. Mrs. DeBoer was also seeing her family doctor and sought counselling to address her feelings of low self-esteem and marital issues.
139Initially, Dr. Chouinard advised Mrs. DeBoer not to start Tamoxifen because it could aggravate her symptoms of depression, a recognized side effect in women with a history of depression.
140On October 4, 2010, Mrs. DeBoer saw her radiation oncologist, Dr. Gopaul. Given the positive margins and one lymph node involvement, radiation was recommended post chemotherapy.
141At the end of November 2010, both Mrs. DeBoer and her husband attended with Dr. Gopaul to discuss her options with respect to radiation. Dr. Gopaul advised them that he considered her at high risk for local regional recurrence, particularly given her young age, her premenopausal status, multifocal microscopic positive margin, and her grade 3 histology with one node involved. Dr. Gopaul’s records show that Mrs. DeBoer was not convinced that she needed to proceed with radiation therapy notwithstanding his recommendation. Dr. Gopaul further noted that Mrs. DeBoer “is placing a lot of value in being able to maintain her implants. She would also like to be over with treatments and have to very carefully weigh the benefits of radiotherapy with the possibility of side effects.”9
142In early January 2011, Dr. Chouinard discussed the role of anti-estrogen with Mrs. DeBoer. However, he advised her not to take it yet, given her symptoms of depression. He would reassess her in two to three months.
143In March 30, 2011, Dr. Chouinard noted Mrs. DeBoer had experienced a major depressive episode and was still quite fearful and indecisive. He again advised her that she needed to start Tamoxifen soon.
144On July 11, 2011, Mrs. DeBoer was diagnosed with recurrence to her right chest wall. Mrs. DeBoer underwent a course of radiation treatment to the area of recurrence. She took Tamoxifen as directed, but only for a couple of weeks, because of the side effects.
145During the year 2012, Mrs. DeBoer did not take Tamoxifen, contrary to Dr. Chouinard’s advice.
146It is clear from the evidence that Mrs. DeBoer understood the advice she received about the importance of taking the anti-estrogen treatment, but nevertheless she declined to take it.
147Mrs. DeBoer developed back pain in 2013 and an MRI demonstrated bone metastases and superior end plate fractures within her spine. She was prescribed Denosumab, which is a medication used to keep the bones strong and to prevent further bone fracture or complications.
148In November 2014, Mrs. DeBoer had her ovaries removed.
149Mrs. DeBoer started Tamoxifen in 2013. Her cancer showed good control and her symptoms improved until 2015, when evidence of increasing tumour markers were detected in her blood. In April 2015, Mrs. DeBoer had a procedure to fill in where the break in her bones of her spine area was and to help stabilize the bone and alleviate pain. This is a recognized palliative procedure.
150In July 2016, Mrs. DeBoer was switched from Tamoxifen to Letrozole. Recently and before the trial, she was switched to Fulvestrant, which is a different anti-hormone therapy.
151Dr. Potvin and Dr. Fine agreed that while Mrs. DeBoer may not die imminently, her quality of life has been forever and dramatically altered.
Damages:
152Mrs. DeBoer testified about the importance of her work as a flight attendant for Air Canada. She enjoyed her work and loved being around people, travelling and discovering new places.
153Because of the diagnosis, Mrs. DeBoer resigned from the job she loved in the summer of 2016. Left shoulder pain and limited range of motion made it impossible to do her job. For example, she was unable to close overhead bins or do heavy lifting. Mrs. DeBoer has lost all sense of purpose or accomplishment.
154Before 2009, she was an active individual, playing volleyball, running, biking and being “outdoorsy”. Her quality of life is now diminished.
155Over the course of her battle with cancer, she undergone chemotherapy, radiation, and multiple surgeries. She has been prescribed medication with uncomfortable side effects, and she must live with the chronic pain that metastatic cancer has caused.
156Even though Mrs. DeBoer suffered from mild depression before her diagnosis, she was active and able to enjoy life. This unpromising dismal diagnosis has perhaps, not surprisingly, exacerbated her depression.
157For these reasons, Mrs. DeBoer’s non-pecuniary general damages for pain and suffering, and loss of enjoyment of life, are assessed at $275,000. This court discounts the general damages by 18 percent for her failure to mitigate her post diagnosis consequences by choosing not to listen to her doctors’ advice when urged to do so. Accordingly, the general damages awarded are $225,500.
158For the purpose of calculating Mrs. DeBoer’s past and future losses, the parties have agreed:
She would have retired at age 63;
Her normal life expectancy is 86;
Her reduced life expectancy is five years from trial;
She would have been unable to work because of the mastectomy and cancer treatment for 18 months (August 2009 to March 2011) if diagnosed earlier. No loss of income claim is advanced for this period.
Mrs. DeBoer’s past income loss from 2010 to trial is $30,000;
Mr. DeBoer is not advancing any claim for income loss;
Pre-Judgment interest applies only to past income loss;
Mrs. DeBoer’s future income loss is $650,260 calculated as follows:
Total employment income loss from trial to assumed life expectancy:
$290,935
Total employment income loss from assumed life expectancy to assumed retirement:
$140,000
Total pension income loss from assumed retirement to assumed normal life expectancy :
$229,325
159The Ministry of Health subrogated claims are for past care of $40,000 and for future care of $60,000.
160The evidence from the DeBoer family with respect to their Family Law Act claims focuses on the customary loss of companionship and care that Mrs. DeBoer would have provided had there been no negligence.
161This court assesses Mr. DeBoer’s claim at $50,000 and the children’s claim at $15,000 each. The fact that Krista, the daughter did not testify does not, in this court’s view mean that her claim cannot be assessed. There is no good reason that Krista should be treated differently than Kevin.
Costs:
162If the parties are unable to agree on the issue of costs, a hearing may be scheduled through the trial coordinator.
“Justice J. N. Morissette”
Justice J. N. Morissette
Released: December 23, 2016
Footnotes
- Exhibit 3, Vol. #1, tab C, pg. 32.
- Page 130 of exhibit 1.
- A gene known as a human epidermal growth factor receptor 2.
- Exhibit 13 at pg. 124.
- Exhibit 1 R MLO 32.
- Laferriere v. Lawson, [1991] 1 SCR 541, at para. 164.
- Exhibit 1, tab 6.
- Exhibit 2: R MLO view 32.
- Exhibit 1, tab 22.