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Insight: Loss of Chance and Proportionality Issues Related to Cancer

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Insight: Loss of Chance and Proportionality Issues Related to Cancer

By Marc B. Garnick, MD, Beth Israel Deaconess Medical Center

Related to: Diagnosis, Emergency Medicine, Primary Care, Nursing, Obstetrics, Surgery

The recent legal decision by the Massachusetts Supreme Judicial Court, to award proportional monetary damages based upon statistics that rely upon clinical stage considerations, is concerning. It does not give due consideration of the complicated biologic processes that determine cancer behavior. Claims arising out of an alleged delay in the diagnosis of cancer should take into account a) the intent of clinical staging of cancer, b) the importance of genetic profiling of an individual’s cancer, and c) the inherent biology of cancer. Advances in scientific knowledge of the nature and progression of cancer may have a significant impact on the recovery of “loss of chance” damages in the courts.

A typical case arises from a claim that the physician either failed to diagnose a patient’s cancer, or delayed in establishing a cancer diagnosis, thus, diminishing the patient’s statistical likelihood of a better medical outcome. Under the new rule of law, plaintiffs may obtain proportional monetary awards if they can establish that a physician’s negligence resulted in a statistical loss of chance. Massachusetts law now allows for the recovery of monetary damages on a proportional scale, even if the patient was not likely to survive his/her cancer diagnosis.

This new legal consideration does not comport with either established or emerging medical and scientific data that underscore the predictors and genetic components that govern the behavior of an individual’s cancer. It mistakenly promulgates misinterpretation of clinical cancer staging and applied population-based staging statistics to an individual’s cancer. The primacy of outcome is now placed on the timing of diagnosis, rather than the genetic makeup or response of the cancer to intervening treatment(s).

The founding fathers of cancer staging clearly identified the differences between clinical stage and pathologic stage. The introduction to the “Bible” of staging manuals, the AJCC Cancer Staging Manual, states that clinical staging is a useful modality to compare differing treatments of a necessarily heterogeneous group of patients. Pathologic staging, on the other hand, provides prognostic information, and enables evaluation of comparative treatment results.

Clinical staging includes a physical examination, laboratory results, and radiographic findings. Pathologic staging includes surgical removal of the primary tumor and the regional lymph nodes, and biopsy of other anatomic areas, with microscopic review by a pathologist. The pathologic stage of a cancer underscores the deficiency of our currently available clinical diagnostic methods, as the extent of the cancer that is determined by microscopic analysis often shows more advancement of the cancer than that demonstrated by clinical evaluations. Now, and in the future, we will be adding genetic characteristics or genomic profiles of the cancer and reflect it in staging conventions. Future editions of staging manuals will likely provide three differing types of cancer stage; clinical, pathologic, and genetic/molecular. Each stage will provide increasingly precise information about cancer behavior and prognosis.

As the science underlying the understanding of cancer advances, a very different picture of cancer behavior is evolving. Discoveries abound about the genes that allow cancer cells to become metastatic; the biochemical components that allow a cancer cell to nourish itself; how these errant cells establish a “home” in distant organs; and, just recently, which cells will respond to differing types of treatment.

None of these marvelous discoveries has anything to do with either the clinical stage of the cancer or the actual timing of the diagnosis. These intricately complicated processes are part of the make up of the individual patient’s cancer, determined well before the cancer is ever detectable by currently available methodologies. Were it a simple matter of the timing of diagnosis, we would be substantially ahead of winning the war on cancer than we are today.

While the American Cancer Society has put forth a large effort on “early” diagnosis of cancer, the unfortunate truth is that by the time “early” comes around; the cancer has existed for a long time. In some instances, 75-80 percent of the cancer’s natural history has already elapsed. What clinicians call “remission” is actually describing a clinical state where as many as one billion cancer cells, or more, can still remain in the patient. Unfortunately, we currently lack the sophisticated means or diagnostic tools to detect these cells. 


November 10, 2009
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