Have you noticed that toxic tort and drug and device cases often involve disease states or medical syndromes that are poorly defined and don’t represent valid medical conditions at all? Examples in the last 30 years include the following:

• Silicone-Associated Connective Tissue Disease (allegedly caused by silicone breast implants)
• Sick Building Syndrome (allegedly caused by some sort of alleged toxic agent associated with a building)
• Multiple Chemical Sensitivity (allegedly caused by exposure to certain chemicals)
• Gulf War Syndrome (allegedly caused by exposure to chemicals used in the Gulf War)
• Welding-Related Parkinsonism (allegedly caused by exposure to welding fume)
• WTC Syndrome (allegedly caused by exposure to fumes from the World Trade Center attack)
• Popcorn Lung (allegedly caused by exposure to specific additives to microwave popcorn products)

In his paper “The Blame-X Syndrome: Problems and Lessons in Nosology, Spectrum, and Etiology” (2001), Alvan Feinstein discusses the problems with attempting to define a disease state or new medical syndrome based only on an exposure. Using Feinstein’s points as a springboard, we provide below specific strategies for challenging plaintiff experts who describe questionable medical conditions in their testimony.

The syndromes listed above have the following characteristics in common: (1) they lack of a set criteria defining them; (2) they are defined by exposure to the alleged causal entity; (i.e., an individual cannot have the disease unless they have been exposed to the alleged causal agent; and (3) the symptoms typically associated with these entities tend to be nonspecific (e.g., myalgias, dry mouth, insomnia), subjective (e.g., headache, lethargy), and relatively common (e.g., fatigue, diarrhea, lower back pain).

Despite these weaknesses, plaintiffs in toxic tort and drug cases may claim they suffer from a “Blame-X” syndrome. To effectively challenge such a claim, we recommend the following strategies:

1.) Unlink the symptoms from the exposure.

Requiring exposure to be part of the syndrome is referred to as “incorporation bias,” as explained in the following citation about breast implants:

First, the requirement of the inclusion of the putative cause (silicone exposure) as one of the criteria does not allow the criteria set to be tested objectively without knowledge of the presence of implants, thus incurring incorporation bias (27).

When faced with incorporation bias, the most important step is to “unlink” the signs and symptoms of the syndrome from its proposed etiological cause. You can accomplish this by eliciting testimony from the expert indicating the signs and symptoms can occur in the absence of exposure. For example, a cluster of respiratory symptoms might be diagnosed as WTC Syndrome in an individual who was at Ground Zero on 9/11, but the same symptoms might be diagnosed as chronic obstructive pulmonary disease or asthma in an individual who was not at Ground Zero.

2.) Reveal the lack of a precise disease definition.

When confronting an expert who posits the existence of a new disease, challenge them to provide the precise diagnostic criteria necessary to diagnose the condition. How many signs or symptoms are necessary to meet the criteria? How long must the patient exhibit the signs or symptoms? Can the syndrome recur and remit or must it persist over time? By defining the clinical characteristics of the disease, you can determine which legal cases will fit the syndrome and which will not, and therefore rule out plaintiffs who fail to meet the criteria.

The importance of explicit and precise disease criteria is illustrated in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Despite the existence of this tome (which has been highly scrutinized and has undergone numerous revisions over the years), there is still debate about the definitions provided. For example, the medical community has debated for decades whether the diagnostic criteria for fibromyalgia support the existence of a well-defined clinical entity. As a result, the diagnostic criteria for fibromyalgia has evolved and changed over time.

3.) Address the criteria’s sensitivity and specificity.

When the medical community seeks to define a new clinical syndrome, it measures two specific characteristics of the criteria: sensitivity and specificity. These characteristics are quantified in terms of a percent value.

• Sensitivity refers to how well the criteria capture individuals who meet the disease diagnosis. If a set of criteria are highly sensitive (say 90% sensitive), then they are very good at capturing all individuals who actually have the syndrome.

• Specificity refers to how well the criteria exclude individuals who don’t have the disease. If a set of criteria are highly specific (say 90% specific), then they are very good at excluding individuals who do not have the disease.

Determining the sensitivity and specificity of a set of disease criteria increases our confidence that the criteria are meaningful and that they are defining a real clinical entity. Pointing out that an expert is not using mainstream medical techniques to define a clinical entity casts doubt on the reliability of their testimony.

4.) Determine whether the syndrome is unique or if it has a background rate.

When questioning the expert positing the syndrome, clarify whether the syndrome occurs only in the presence of the exposure or if it can occur in the absence of the exposure. A proponent of a new syndrome will often assert that the syndrome is entirely unique and does not occur in the general population. Individual signs or symptoms associated with the syndrome can occur in the general population, but when presenting in a certain manner they are unique to the new syndrome.

Examples of unique exposure-related syndromes that appear to have a high degree of scientific and medical support are vinyl chloride-associated angiosarcoma of the liver and asbestos-induced mesothelioma of the lung. While neither of these conditions is entirely unique to the exposure, they are both exceedingly rare and tend to be tightly associated with the exposure of interest.

If an expert asserts that a certain set of signs and symptoms is part of a unique syndrome, they should be pressed to distinguish those signs and symptoms from well-established medical entities (i.e., exactly what makes the syndrome unique).

The flip side of an entirely unique syndrome is a set of signs and symptoms that have a well- recognized background rate. For example, sometimes a cancer or cardiovascular event is not alleged to have any unique clinical characteristics. But the disease entity is alleged to be a syndrome associated with the exposure merely because the exposure is part of the disease criteria.

If the expert acknowledges that the signs and symptoms are not unique to the syndrome (i.e., there is a well-recognized background rate), it is important to consider controlled studies evaluating the frequency of the symptoms in exposed individuals compared to unexposed individuals. If the cluster of symptoms exists in the general population independent of the exposure, then they must occur at a higher frequency in exposed individuals if the syndrome is to be considered real.

5.) Determine if the syndrome is recognized by the medical community.

If the scientific and medical community has not accepted and recognized the syndrome as valid, it will strengthen your argument. Has the syndrome been recognized by independent medical societies? Has it been proposed and defined by scientists or physicians who are not involved with litigation? Have there been serious challenges to the existence of the syndrome by mainstream scientists or physicians? Pressing the expert to acknowledge the lack of support for the syndrome from the scientific community bolsters your case.

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