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Medical Monitoring and Medical Standards



Taking a short break from premises liability.... I recently filed briefs in three medical monitoring cases where the plaintiffs had no manifestation of physical injury. In the first, Meyer v. Fluor , the plaintiffs were children in Herculaneum, Missouri, who might have been exposed (even in utero) to lead contamination in the water supply. The Missouri Supreme Court decided to treat the request as one of remedy rather than a cause of action and held that medical monitoring is an acceptable potential remedy. In Sinclair v. Merck & Co., now pending in the New Jersey Supreme Court, the plaintiffs took Vioxx and now seek monitoring for "silent" heart attacks that may have occurred without the plaintiffs' knowing about it. Finally, in Lowe v. Philip Morris, pending in the Oregon Supreme Court, the plaintiffs are smokers who want to be monitored for adverse health consequences of smoking.

In researching these cases, I was dismayed, but not astonished, to discover the huge disconnect between the medical approach to monitoring for illness and the plaintiffs' approach. For example, the U.S. Preventive Services Task Force does not recommend using treadmill exercise testing, resting electrocardiograms, or electron beam computerized tomography to screen for heart disease in low-risk adults who do not have any symptoms of heart disease. The Task Force found that while treadmill testing, EKG, and electron-beam computerized tomography could identify persons at higher risk of heart disease, no evidence thus far exists to show that tests to screen adults has the result of improving health outcomes. Furthermore, the Task Force concluded that using these three technologies to screen for heart disease in low-risk adults could cause more harm than good because of the frequency of false-positive and false-negative results.

Potential harms of screening asymptomatic patients for coronary heart disease include unnecessary invasive testing (e.g., coronary angiography) and "labeling" of those who have had false-positive test results. In low-risk asymptomatic populations, most positive ECG test results occur in those who will not have a coronary heart disease event in the next 5 to 10 years. While the yield of screening is low in those at low risk for coronary heart disease, there is a high potential for harm from false-positive tests. The Task Force judged that the benefits of screening people at low risk for coronary heart disease would not outweigh the potential harms.

False-positive tests are common among asymptomatic adults, especially women, and may lead to unnecessary diagnostic testing, over-treatment, and labeling. Another study explains that false-positive results, in addition to causing a patient psychological stress and anxiety, often lead to invasive tests, such as coronary angiography or treatment with unnecessary medications. Although coronary angiography�a test in which a catheter is inserted into the patient and a dye injected�is considered generally safe, complications, such as internal bleeding, stroke, or infection, and even death, can occur. A positive result on exercise tolerance testing may also impel a patient to begin the use of therapies such as aspirin or statins to over-treat persons who would not otherwise require treatment. Meanwhile, false-negative results can mislead those with heart disease and result in delayed treatment. Both false positives and false negatives can be expected to result in psychological stress.

As I explained in Pacific Legal Foundation's brief in the Lowe case, the same concerns exist with regard to using CT scans to monitor for lung cancer. Here, too, the Preventative Task Force recommends against screening for most of the same reasons (e.g., the high incidence and consequences of false-positives and false-negatives). Perhaps most compellingly, the sad fact is that early detection does not improve the patient�s prognosis. Lung cancer kills. Even with modern advances in therapy, the average 5-year survival rates are less than 15% for all those with lung cancer. Five-year survival ranges from 70% for patients with Stage I disease to less than 5% for those with Stage IV disease. Standard medical practice is to refrain from monitoring (and the inherent risks of that monitoring) when the result makes no difference to the ultimate outcome for the patient. The American Cancer Society notes that "no organization recommends routine screening for lung cancer either among the general adult population or in individuals who are at higher risk due to tobacco or occupational exposures."

We'll see how the Oregon and New Jersey courts deal with these inconsistencies. The courts may well decide that the better part of valor is to punt to the states' legislatures, allowing representatives to take testimony from the array of interested parties and then balance the competing public policies.

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Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.