Genetic injury in toxic tort cases: what science can and cannot prove.

• Author: Cepelewicz, Barry B.
• Position: Health Care and the Law

IN THE past several years, courts have compensated plaintiffs who allege that they were exposed to some substance that increased their risk of developing disease in the future, although at the time of trial they were free of injury. When asserting these claims, plaintiffs may allege any or all of three causes of action:

* Fear of future disease, under which they seek compensation for the emotional distress allegedly caused by the fear that they may someday contract a disease, usually cancer, as a result of the exposure.

* Increased risk of future disease, under which theory they seek compensation for all probable manifestations of a disease that they are deemed likely to contract in the future if they can demonstrate a sufficiently enhanced risk of contracting the disease.

* Medical monitoring claims, under which they seek to recover the costs they will incur as a consequence of having to be monitored for early manifestations of a disease that is associated with their exposure.

The problem with these theories is that they are very speculative. Courts routinely have required that a claim be genuine, serious and reasonable before allowing a recovery for a speculative claim.(1) Some courts will grant medical monitoring on the basis that the need for the monitoring is a present compensable economic injury. Other courts, however, have required that plaintiffs prove the existence of a present physical injury.

In determining whether a physical injury exists, some courts have expanded the definition of what constitutes "present physical injury." In some instances, they have found sufficient physical injury when a plaintiff who alleges exposure to a toxic substance presents complaints of headaches, nausea, dizziness or cramps.(2)

Courts also have found that "subcellular" damage can be a present physical injury. "Subcellular" markers of disease are widely accepted in the medical community to demonstrate present injury. For example, elevated liver enzymes and elevated bilirubin counts are seen in patients exposed to hepatotoxic substances. The main issue, however, is whether genetic abnormalities, which are a type of subcellular damage, is acceptable as an indication of present injury or risk of future injury.

In an increasing number of instances, plaintiffs have argued that exposure to a toxin created a change in their chromosomes, thereby increasing their risk of some disease, usually cancer, in the future. Courts have held that chromosomal breakage is sufficient to satisfy the present physical injury requirement. Although the terms "chromosomal injury" and "genetic injury" are used interchangeably in the case law and in this article, they are not the same. For example, a chromosome is made up of many genes. Chromosomal breakage refers to gross breakage of a chromosome, irrespective of a specific gene. Genetic damage refers to damage of a specific gene.

This article discusses current case law with respect to claims alleging that exposure to a product has resulted in chromosomal damage and seeking medical monitoring or damages for increased risk of disease or fear of disease. The article also presents a general overview of certain concepts in molecular biology and studies that have been documented in the medical literature to determine if one can conclude with a reasonable degree of medical certainty that damage to a gene will more likely than not predispose an individual to an increased risk of a disease warranting the award of damages.(3)

RELEVANT CASE LAW

For years, the prevailing law was that the claim of a subclinical injury was held insufficient to constitute a "present physical injury." In Schweitzer v. Consolidated Rail Corp.(4) the Third Circuit noted that a subclinical asbestos-related injury prior to manifestation may be of interest to a histologist and of vital concern to liability insurers and their insureds, but the court held that such an injury did not constitute the actual loss or damage to the plaintiff's interest required to sustain a cause of action under generally applicable principles of tort law. The court stated that no tort cause of action exists until the plaintiff has sustained an identifiable, compensable injury. The court feared that any other holding would result in unwarranted speculation and inequitable results. This decision appears to have been eroded, however, by an increasing number of later cases in which courts determined that they could not rule as a matter of law that a plaintiff's alleged injuries were not real because they were subcellular in nature.

The case cited with greatest frequency on the issue of whether chromosomal injury constitutes a "present physical injury" is Brafford v. Susquehanna Corp.(5) This 1984 case is significant because there were some plaintiffs who claimed no actual injury beyond undetected gene damage caused by the radiation.

The plaintiffs sued a defendant whose subsidiary, Susquehanna Western Inc., owned and operated a uranium milling factory. They alleged they were exposed to radiation levels in excess of those permitted by the United States government's regulatory standards. They sought damages for present physical injury, increased risk of cancer and other diseases, present and future medical costs, and mental anxiety.

The federal district court explained that in order for the plaintiffs to recover for increased risk of cancer, there must be an accompanying definite physical injury. The plaintiffs argued that the radiation resulted in present, permanent and irreparable genetic and chromosomal damage, which is a type of present injury that can give rise to a claim for future risk of cancer. The defendants argued that chromosomal changes are at best a subcellular expression of increased risk, and that allowing the plaintiffs to recover under such a theory would allow any plaintiff in the future to recover for exposure to any known carcinogen. The defendants also argued that subcellular changes cannot be seen, measured or documented.

The court found that because there was a high level of exposure, the plaintiffs' medical experts, who were of national renown, could conclude with a reasonable degree of medical probability that there was chromosomal change or damage caused by the exposure. The experts testified that the damage had been done, resulting in the "trigger" of a cancer change or a deprivation of normal immune response. The court concluded that "chromosomal damage is itself a present injury that can give rise to a claim for future risk of cancer," and it allowed the finder of fact to determine whether such subcellular damage satisfied the requirement of actual injury.

In Werlein v. United States(6) the plaintiffs alleged that they were exposed to trichloroethylene. Their experts testified that exposure to contaminated air and drinking water resulted in chromosomal breakage and damage to the cardiovascular and immune systems, thus creating an actual physical injury. They further testified that the present injuries were the cause of an alleged increased future risk of disease.

The federal district court held that subcellular injuries in and of themselves do not prevent injuries from being considered "real" and that the effect of volatile organic compounds on the human body is a subtle, complex matter. As a result, the defendants' summary judgment motion was denied. The court held that it was up to the trier of fact to evaluate the medical testimony and to determine if the plaintiffs had suffered present harm.

In Anderson v. W.R. Grace & Co.(7) the administrators and family members of miners who had died of leukemia allegedly caused by exposure to water contaminated with several chemicals, including trichloroethylene and tetrachloroethylene, and others who alleged other illnesses, sued for wrongful death, pain and suffering, emotional distress, recovery for illness and increased risk of developing future illnesses. With respect to the non-leukemic plaintiffs' emotional distress claim, the defendants argued that their alleged harm was "subcellular" and not the type of harm required to support a claim for emotional distress.

The federal district court explained that the plaintiffs' harm need not be immediately apparent as long as it could be "objectively evidenced." Because the harm was not obvious, the court required expert medical testimony, in addition to the victim's complaints, in order to substantiate its existence.

The court was influenced by the fact that the plaintiffs provided affidavits by physicians stating that there were changes in the plaintiffs' bodies caused by exposure to the contaminated water and listing non-specific ailments such as shortness of breath, decreased visual acuity, frequent waking, hoarseness, muscle aching, fatigue, chest pain, sore throat, respiratory infections, stress incontinence, tingling, numbness, joint stiffness and aching, dry sensitive skin, rashes, cold sores, red burning eyes, headaches, vomiting, abdominal distress, post nasal discharge, nasal congestion and nosebleeds. In one affidavit, the physician stated that the "clinical manifestation of [the cellular changes] is a function of the host.... Some individuals will manifest this damage as skin rashes and arthritis, while others will manifest the same damage as cancer."

The court held that even though the affidavit did not identify each illness suffered by each plaintiff nor state that the plaintiffs suffered more ailments than the average person, it was sufficient evidence of harm, and that subcellular harm affecting the immune system is sufficient to support a claim for emotional distress.

Potter v. Firestone Tire & Rubber Co.(8) was an appeal from a toxic exposure case brought by four landowners who lived adjacent to a landfill where Firestone disposed of toxic wastes. The landowners...