Newfoundland Injury Law Blog

Breast Cancer Testing: How Will the Cameron Report Impact the Class Action?

The members of the Breast Cancer Testing Class Action are seeking significant money damages for their injuries, and would seem to have a lot riding on what the Commissioner says in her report.  Or do they?

 The Report of the Cameron Inquiry into Hormone Receptor Testing will be released to the government this weekend, and made public on Monday, March 2^nd, 2009.

The Cameron Commission Report will likely have an impact on pathology practice and the safety of health care both in Newfoundland and Labrador and worldwide, but whether Eastern Health was negligent and must pay damages to injured breast cancer patients is not an issue with which the Inquiry is directly concerned. The Inquiry will be careful to avoid expressing any opinion on civil damages claims and will avoid applying civil standards such as negligence.  But it remains true that the fact findings of an Inquiry can have a powerful influence on the perceptions of parties to civil injury claims as to the strength of their respective cases.

 I expect the Commission will do an excellent job of investigating and reporting on the issues of patient safety with which it was charged.  And I expect that indirectly, the findings in the report will assist civil damages claimants and not assist the defence of Eastern Health.

 But in my view as Class Counsel, the weight of testimony at the Inquiry was so damning to Eastern Health’s conduct, that the civil case on liability and damages would remain strong no matter what the report says.  Eastern Health was massively, stupendously negligent, as the evidence at the Inquiry time and again disclosed.

 At the hearings, I cross-examined one of the leading world experts on Hormone Receptor Testing, and here’s what he said; so judge for yourself. (Everything the expert said “yes” to, Eastern Health wasn’t doing.)

CROSBIE, Q.C.:

Q. Would you say that it’s mandatory to use a  negative control?

 DR. DABBS:

A. Yes.

CROSBIE, Q.C.:

Q. Would it have been so in 1997?

 DR. DABBS:

A. Yes, it should have been.

…

CROSBIE, Q.C.:

Q. … The first one, I wrote these out last night, so the first one I have here is that in your view adoption of the 30 percent cutoff in 1997 was ill advised and not reasonable. Is that correct or incorrect? 

DR. DABBS:

A. I think based on the information that I have that that antibody that was published in that paper was actually not in use here. If I’m correct in that, then the answer to your question would be correct, I would agree with it.

CROSBIE, Q.C.:

Q. And it seems that in 1997 the adoption of the IHC technique was probably not appropriately validated, is that correct?…

A. Yes, I agree with that.

CROSBIE, Q.C.:

Q. I believe you told us that IHC is now considered to be a component of general pathological or pathology practice, is that correct?

 DR. DABBS:

A. Correct.

CROSBIE, Q.C.:

Q. It’s part of your standard armormentarium?

DR. DABBS:

A. Yes.

CROSBIE, Q.C.:

Q. And has been so since 1997 or even before that?

DR. DABBS:

A. Before that, yes.

CROSBIE, Q.C.:

Q. And then you characterized one of the practices of Eastern Health, in particular, the absence of an SOP as a recipe for disaster?

DR. DABBS:

A. Yes.

…

CROSBIE, Q.C.:

Q.  …But you would expect the pathologists themselves to undertake an investigation if they realized there was a dramatic change in result?

 DR. DABBS:

A. Yes.

CROSBIE, Q.C.:

Q. I also understood that you were of the view that Dr. Ejeckam’s … analysis of the problem in the lab failed to recognize the extent of what you characterized as a global problem?

 DR. DABBS:

A. … Yes, I agree, right, I agree. 

CROSBIE, Q.C.:

Q. I took it that the lab here would have been closed down if inspected during the subject period, 1997 to 2005 to standards prevailing  in the United States. Is that a correct understanding?

DR. DABBS:

A. I think that’s a correct statement.

CROSBIE, Q.C.:

Q. And when asked about acceptable error rate, your reply was that the lab, your lab is dissatisfied with anything two percent or greater of tests which have to be repeated and then you investigate the problem?

DR. DABBS:

 A. Well, just to clarify that, the two percent cutoff is for just repeats in immunohistochemistry. This would be a result of tissues that need to be reprocessed or stains that come back and there’s a part of the tissue that is not there. Usually these relate to tissue processing issues and not to false negatives or false positives. That goes into a whole new realm.

…

CROSBIE, Q.C.:

Q. Did you characterize the test failures here in your view as being largely technique failures?

DR. DABBS:

A. To the best of my knowledge, yes.

CROSBIE, Q.C.:

Q. You stated, as well, that a negative invasive lobular would provoke deep concern in your institution?

DR. DABBS:

A. That’s correct. And that’s the type of event  that I would consider to be a serious or sentinel event, something that needs to be thoroughly investigated because of the rarity of that result. It would be cause for concern to look at the testing, the fixation and how the specimen was handled and how the specimen, in fact, was interpreted.

CROSBIE, Q.C.:

Q. And I got an overall sense of validation as something that should be done in house, as it were?

 DR. DABBS:

A. Correct.

CROSBIE, Q.C.:

Q. And I think you said that variability for this particular test should be no greater than for any other path lab procedure?

 DR. DABBS:

A. The variability in ER testing?

CROSBIE, Q.C.:

Q. Um-hm.

DR. DABBS:

A. Correct.

CROSBIE, Q.C.:

Q. Is it mandatory for a lab to have QA when undertaking this kind of testing?

DR. DABBS:

A. Yes, it is.

CROSBIE, Q.C.:

Q. Would that be true in 1997?

DR. DABBS:

A. Yes, it would.

CROSBIE, Q.C.:

Q. Is constant optimization mandatory?

DR. DABBS:

A. Yes, it is.

(For a transcript of Dr. Dabbs’ “wake up call” interview with the press after he finished testifying, click here.)

The Cameron Commission Report is likely to have an impact on pathology lab practices and the safety of health care both here and worldwide, but the facts grounding the negligence of Eastern Heath and the liability to pay damages were put on public record of the testimony time and again throughout the hearings.breast cancer civil damages hospital negligence medical malpractice pathology injury