MIAMI BEACH, Fla--Breast cancer litigation is "a world whose activity is sometimes built upon old science, no science, or junk science," said Kenneth Kern, MD, of Hartford Hospital and the University of Connecticut School of Medicine, Farmington. In a presentation at the 12th Annual International Breast Cancer Conference, Dr. Kern offered the audience a "road map" for entry into that world.
MIAMI BEACH, Fla--Breast cancer litigation is "a world whoseactivity is sometimes built upon old science, no science, or junkscience," said Kenneth Kern, MD, of Hartford Hospital andthe University of Connecticut School of Medicine, Farmington.In a presentation at the 12th Annual International Breast CancerConference, Dr. Kern offered the audience a "road map"for entry into that world.
Breast cancer has been the focus of litigation in many differentforms for more than 100 years, he said, and today half of allmalpractice suits for delay of diagnosis involve breast cancer.
In his "deconstruction" of the breast cancer litigationproblem, Dr. Kern described four time periods: First, an era of"traumatic" breast cancer from 1900 to 1950; then fromthe '50s to the '60s an era of technical misadventures; from the'60s to the '70s, an era of diagnostic delays; and today the eraof loss of chance for survival.
In 1897, there were some 2,000 scientific articles stating thatcancer was caused by acute trauma, Dr. Kern said. In 1910 a Britishstudy found 500 breast cancers that were preceded by an acuteinjury, and cancer, particularly breast cancer in female workers,became a legally compensable event in the workplace.
The United States followed suit in 1910, at which time 40% ofbreast cancers were said to be initiated by acute trauma. Thereasoning was that acute trauma activated a microorganism thatcaused the cancer.
Eventually, medical knowledge advanced and these traumatic breastcancer cases ceased sometime in the 1950s. For the next decade,most breast cancer lawsuits involved technical misadventures relatingto misread pathology.
Patients occasionally underwent single step radical mastectomiesfor what turned out to be benign disease or a different diseasealtogether. As the number of skilled pathologists increased andtwo-step surgeries became more common, this era too came to anend.
With the greater availability of mammography, delayed diagnosisleading to decreased survival became a more prominent cause ofbreast cancer litigation, Dr. Kern said. But in the '60s and '70s,courts generally took the view that such delays were importantonly in patients who had a greater than 50% chance of survival."If your chances for survival were extremely low, the delaywas not considered to have had an effect," he said.
But in the current era, the courts have seemingly rejected theidea of cancer as a systemic disease from the outset, adoptinginstead "the Halsteadian idea of breast cancer marching literallywith time in a predictable fashion from the breast to the lymphnodes to the systemic body," Dr. Kern said.
In 1977, the National Cancer Institute (NCI) said that immediatebiopsy of breast lesions is the standard of care, with the resultthat almost any delay in diagnosis could be considered fodderfor a malpractice suit claiming loss of chance for survival.
"The shortest delay I could find in probing court recordshappened in New Mexico in 1978," Dr. Kern said. A femalepatient with a lump in the breast was told to wait 28 days, forone menstrual cycle, after which a biopsy was performed that showedcancer. The patient eventually won her suit at the appellate levelbecause of the NCI statement.
Today, in delay of diagnosis cases in which the patient presentswith metastasis, the jury decides when the metastasis occurred,based on expert opinion. The law asks only that experts statewith a reasonably probability that a biological event can occur."In other words, a P value, not of .05, but of .50,"he said.
"Juries are free to ignore the kind of data from our studiesof litigated cases [see below] showing that delay in cancer diagnosisdoes not correlate with increasing tumor size or advancing diseasestage," he said.
"I'm not saying that there's no such thing as breast cancernegligence," Dr. Kern concluded, "only that the poolof potential liability cases is much larger than it should be."
He suggested that clinical studies to determine "what reallyis a harmful delay," clinical guidelines, and a scientificconsensus could provide a remedy to this situation.
He also pointed to a public relations problem: "The publicis constantly being told that early diagnosis is the secret tocure, but we all know that early diagnosis is not the secret toall cures. And maybe we should tone down the way we present ourmessage to the public."
"Problems with the delayed diagnosis of breast cancer aretruly not subtle problems," Dr. Kenneth Kern said in a presentationat the Miami Beach conference (see story above). He pointed tohis national study of more than 300 litigated cases involving13 types of cancer.
Mortality in patients with misdiagnosed breast cancer comparedto the normal population (from the SEER database) was no different."In other words, these patients are not dying any fasterthan normal breast cancer cases," he said.
Dr. Kern concluded that the misdiagnosed patients must have someother unique characteristics. Using these actual court cases,he found that such patients were much younger than the averagebreast cancer patient (about age 40 vs age 60), and 95% had stageII disease or greater, suggesting that these patients' tumorshave a more aggressive biology.
In 82% of cases, the lesion was found during a breast self-examinationand reported to the physician. In half of these cases, the physiciandid nothing, "and that's of course one big part of the problem,"Dr. Kern said.
In the other half, mammography was performed, but 80% came backnegative, a much higher false-negative rate than the 36% rateseen in the Breast Cancer Detection Demonstration Project. "Thisis a problem of technology applied to this young age group"he said.
In summary, Dr. Kern told the audience to be aware of the "triadof error"--young age, a self-discovered breast mass, anda negative mammogram--and warned physicians not to "label"these patients as having a benign condition "unless you havebetter evidence."