And Here's Another Reason....

...why medical monitoring often does not make sense.

In our posts on medical monitoring, we have pointed out that even in those jurisdictions which do recognize this type of claim/damages, plaintiffs typically must show that the proposed medical monitoring regime is reasonably medically necessary.  Some courts articulate the notion that the testing be consistent with the standard of care, while others require the monitoring be reasonably necessary according to contemporary scientific principles.

An essential result of this is that the screening cannot risk doing more harm than good.  While the pre-load of a typical jury pool may be that monitoring is always helpful, the reality is that many forms of screening have significant potential costs and risks, associated with the procedure or the inevitable follow-up response to a positive test finding --which may turn out to be a false positive finding.  If those (and other) costs are not outweighed by the decrease in disease mortality fostered by the testing, then the monitoring doesn't make sense medically, and should not be available in a legal setting.

That is why we read with some interest the recent reports that the U.S. Preventive Services Task Force, which studies health screening measures, is planning to downgrade its recommendation on a common form of prostate cancer screening (PSA).  The test now gets a "D," which wasn't good when MassTortDefense was in school, and actually means it recommends against the screening because there is moderate or high certainty that the screening has no net benefit or that the harms outweigh the benefits.

The Task Force recognized that high or increasing levels of PSA can indicate many things besides an increased risk for prostate cancer; PSA tests have resulted in high rates of false positives (10-15%) and thus over-treatment for small, slow-growing cancers that will never actually cause harm. Those treatments, surgery and radiation, are not benign. In contrast, the latest studies of those screened show no statistically significant benefit after 10 years.

The point here for our readers is that if a commonly used, widely accepted test can be shown after actual use to risk more harm than good, then how questionable are the new technologies, made-for-litigation screening programs that plaintiffs' hired experts concoct for a class action?

 

ACS Head Offers Different View of Medical Monitoring

Readers of MassTortDefense involved in the defense of medical monitoring cases will want to follow the ongoing debate occasioned by the New York Times story this week, quoting Dr. Otis Brawley, chief medical officer of the American Cancer Society, admitting that American medicine has over-promised when it comes to medical screening and that the advantages of screening have been “exaggerated.”

Medical monitoring, whether a remedy or cause of action, is a claim for the cost of medical screening for a plaintiff exposed to a toxic substance allegedly because of the defendant’s wrongful conduct and who is accordingly at risk of future disease. Medical monitoring is designed to early detect the disease and thus maximize the chances of a cure or beneficial treatment.

As a an advocacy matter, medical monitoring is presented by plaintiffs with the seemingly unchallengeable notion that early detection saves lives. Plaintiff attorneys rely heavily on juror pre-loads about the importance and benefits of screening; virtually every juror has had a Pap smear, or mammogram, or prostrate test, and they have all been inundated with messages from the American Cancer Society that screening is highly efficacious-- messages that ignore the risks of screening. Defendants fight an uphill battle when they try to get the jury to keep an open mind about the risks and benefits of plaintiffs’ experts' proposed screening program.

Reportedly, the ACS is now working on a message, to put on its Web site early next year, to emphasize that screening for breast, prostate, and other cancers can come with a real risk. Those risks include not only the risks of the screening procedures themselves (such as radiation), but the risks of false positives, and the follow-on risks of over-treating a nodule that would never have developed into life-threatening disease. On the flip side, many researchers point out that the prostate cancer screening test has not been shown to prevent prostate cancer deaths. Similar lack of benefit has been noted with chest x-rays and CT scans for lung cancer. If cancer screening was really as effective as plaintiffs assert, the cancers that once were found late, when they were untreatable or incurable, would now be found earlier, when they could be treated and cured. Thus, a large increase in early cancers found would be accompanied by a decline in late-stage cancers, and an improvement in mortality. That just hasn’t happened for many types of screening.

Whether the issue is the screening tool or the screening itself, plaintiffs should no longer be allowed to base their medical monitoring claims on a widely accepted misconception that all screening is good, and all early detection saves lives.  Defense attorneys may have a juror pool more receptive to the evidence-based argument that plaintiffs must be held to their burden of proof to show that a monitoring procedure exists that makes early detection of the disease possible; the prescribed monitoring regime is different from that normally recommended in the absence of the exposure; and the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.
 

 

Medical Monitoring: Evidence Of More Harm Than Good

MassTortDefense has posted about medical monitoring claims. One of the advantages plaintiffs may have with juries in such claims is the pre-loaded notion that early detection is "always" better; therefore, screening tests must be helpful, right? Jurors are inundated with messages from public health authorities, government agencies, insurers and others about getting this or that screening test. The latest we saw: get your husband a colo-rectal screening for Christmas.


Undoubtedly, preventive care is crucial, and early detection by some tests of some disease has been shown to save lives. But not every test regime conjured up by plaintiffs' attorneys or their experts for a class of litigants falls into the same category as tests recommended for specific populations by, for example, the US Preventive Services Task Force.

Defendants need to explore the argument that a proposed monitoring test may do more harm than good. Proposed tests have potential side effects, risks. For example, researchers are looking at the risks posed by CT scans.

Researchers from Brigham and Women's Hospital in Boston told a meeting of the Radiological Society of North America in Chicago last week that as many as 7 percent of patients from a large U.S. hospital system had enough radiation exposure from CT scans during their lifetime to noticeably raise their risk of cancer. CT scans help diagnosis of a variety of illness and injuries, and are routinely used to track the advance of cancer. But a number of recent studies have raised alarms about the potential cancer risks from the radiation. The BWH group studied all patients who had a CT scan in 2007 at Brigham and Women's Hospital, or at the Dana-Farber Cancer Institute, in Boston. Then they checked on prior CT scans from a database that includes 20+ years of patient history and calculated overall radiation exposure based on the type and location of the scan. This allowed them to determine a lifetime risk. They found about 7 percent of the patients did have a cancer risk that increased by at least 1 percent over the baseline cancer rate.


And that's for symptomatic patients using the scans. For them, the radiation exposure from CT scans may be worth the risk. But for non-symptomatic, healthy plaintiffs who claim some often unverified level of exposure to a toxic substance, getting repeated CT scans under a medical monitoring regime could raise their risk of a tumor. And certain groups are more likely to be harmed by radiation, including younger people whose growing tissues may be more vulnerable according to some studies.

A typical CT scan can deliver 50 to 100 times more radiation than a conventional X-ray, depending on the site being examined and the type of the machine. Some 62 million CT scans are done in the U.S. annually.

 

Preventive Services Task Force: Sometimes Risks Exceeds Benefits

The U.S. Preventive Services Task Force has released its recommendations for colon cancer screening, suggesting that most people over age 75 should stop getting routine colon cancer tests. In a decision at odds with some traditional views, the USPSTF opted not to give its approval to CT colonography, virtual colonoscopy, and the stool DNA test. (The 2002 guidelines did not give an age limit for screening.)

What is significant to readers of MassTortDefense is not the specific review of these tests, but the important recognition underlying the decision: that risks of screening at that age are too great to justify any possible benefit. After reviewing research on the tests, the government-appointed panel of independent medical experts concluded that the benefits of detecting and treating colon cancer decline after age 75 and the risks rise too much.

The U.S. Preventive Services Task Force (USPSTF), first convened by the U.S. Public Health Service in 1984, and since 1998 sponsored by the Agency for Healthcare Research and Quality (AHRQ), is perhaps the leading independent panel of private-sector experts in prevention and primary care. The USPSTF conducts rigorous assessments of the scientific evidence for the effectiveness of a broad range of clinical preventive services, including screening, counseling, and preventive medications. Its recommendations are considered in some circles the "gold standard" for clinical preventive services.
 

In medical monitoring claims, typically a plaintiff must prove that screening tests are reasonably medically necessary for plaintiffs because of the risks of the allegedly tortuous exposure. Despite plaintiffs’ typical theme about early detection always being efficacious, the reality is that many “routine” screening procedures have their own risks and potential side effects. As the Task Force said, “The risks and benefits of these screening methods vary.”  Where doctors must assess the risks and benefits, a powerful individual issue may emerge, affecting class certification. Even in a class setting, on the merits, the risks of procedures sought by the plaintiffs may outweigh the benefits. Thus, in this context, the Task Force noted, “The primary established harms of colorectal cancer screening are due to the use of invasive procedures initially or in the evaluation sequence. Harms may arise from the preparation the patient undergoes to have the procedure, the sedation used during the procedure, and the procedure itself.”  Colonoscopy is considered the gold standard but it is not perfect. A long, thin tube with a small video camera is snaked through the large intestine to view the lining and any growths are removed.
 

Defendants in medical monitoring claims will want to assess the state of the art recommendations of bodies such as the USPSTF, as well as the specific literature on the risks of proposed screening tests.

 

Mass Tort Litigation Screenings Exposed

Professor Lester Brickman, of Cardozo School of Law, has published a fascinating article entitled, "The Use of Litigation Screenings in Mass Torts: A Formula for Fraud?"

At MassTortDefense, we would simply remove the question mark.

Plaintiff lawyers obtain the "mass" for some mass tort litigation by conducting screenings to sign-up potential litigants. These "litigation screenings" have no intended medical benefit, and thus this entrepreneurial response to highly profitable opportunities that arise in certain mass tort litigation should not be confused with true medical screening. In a litigation screening, potential litigants are solicited by lawyers or their agents by use of mass mailings, television and newspaper advertisements providing “800” telephone numbers, and by use of web sites purporting to provide medical information about toxic exposures, drugs, devices, or specific diseases but which are, in fact, “fronts” for law firms to whom the web site visitor is referred.

Screenings can be held in motels, shopping center parking lots, local union offices, and even lawyers' offices. There, an occupational history is taken by persons typically with no medical training, a doctor may do a cursory physical exam, and non-doctor technicians administer tests, such as X-rays, pulmonary function tests, echocardiograms and blood tests. The sole purpose of screenings is to generate "medical" evidence of the existence of an injury to be attributed to exposure to or ingestion of defendants' products – all pre-planned. Usually a handful of doctors ("litigation doctors") provide the vast majority of the thousands of medical reports prepared for that litigation.

By the good professor’s count, at least 1,500,000 potential litigants have been screened in the asbestos, silica, fen-phen (diet drugs), silicone breast implant, and welding fume litigation. Litigation doctors found that approximately 1,000,000 of those screened had the requisite condition that could qualify for compensation under plaintiffs’ legal theory, such as asbestosis, silicosis, moderate mitral or mild aortic value regurgitation or a neurological disorder. He further estimates that litigation doctors and screening companies have been paid well in excess of $250 million – huge number, but a tiny fraction of the contingency fees earned well in excess of $13 billion by his estimates.

The professor concludes that approximately 90% claims generated from the screenings were based on "diagnoses" of the type that U.S. District Court Judge Janis Jack, in the silica MDL, found were "manufactured for money."

He also presents the case that bankruptcy courts adjudicating asbestos related bankruptcies have effectively legitimized the use of these litigation screenings.

Professor Brickman's areas of expertise include legal ethics, contingency fees, mass torts, and asbestos litigation. He notes the significant volume of literature about the use of junk science in the court, even today, especially to try to prove general causation in mass torts. But his analysis is particularly valuable because it turns an empirical light on the use of litigation screenings to try to prove specific causation.