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Plaintiffs in the Post-Genome Era

Proof by Genetic Assay in 2007


Point / Counterpoint

Will new susceptibility information really lead to more lawsuits and more pressure to ban certain chemicals? Here are two opinions:

Friends of the Earth (UK):
Chemical Industry Threatened by the Biomedical Revolution

UK Chemical Industries Association (CIA): CIA Finds Friends of the Earth Report Linking Genome Project to Calls for Chemicals Bans Contrived and Disappointing


The plaintiff sat nervously as the jury filed backed into the courtroom. This jury was about to announce an award that would have been inconceivable only five years earlier. There were over 8,000 others who had been exposed to the same contaminant as they had. Like the plaintiff, four of these others were afflicted with bladder cancer. Unlike the plaintiff they lacked a key piece of evidence connecting their cancer with the actions of the defendant. They lacked the genetic variant that rendered this successful plaintiff, Mike Harlan, highly susceptible to cancer following exposure to the arsenic that had appeared in the local drinking water.

This case began two years ago, in 2005, when Mike was diagnosed with bladder cancer. Like many people who are suddenly faced with a life-threatening illness, Mike wondered why this was happening to him. So he asked his doctor. Thanks to genetic technology, an answer could be found.

From a urine sample, cells from the lining of Mike's bladder were isolated. From these cells, the mRNA, the portions of Mike's genetic code which were then actively making proteins in the bladder, was isolated. Using new diagnostic equipment, the doctor was able to determine cheaply and quickly which genes were active in Mike's bladder cells and which variants of those genes Mike possessed.

A computer analyzed the data and reported that the pattern of active genes was consistent with arsenic exposure. Another urine sample was used to test for arsenic directly, and it also indicated that Mike had been and was currently being exposed to arsenic at moderate but elevated levels.

It did not take long to track down the likely source of the contamination. A nearby manufacturer of wood preservatives had shut down about five years earlier after a history of environmental violations and financial mismanagement. A site investigation revealed rusty storage tanks, some leaks, and high levels of arsenic in groundwater adjacent to the site.

Mike's genetic testing had revealed a variant of a certain gene that rendered him many times more likely than the general population to develop bladder cancer following arsenic exposure at the exposure levels. Given the background incidence of bladder cancer, this meant that there was an 80 percent chance that Mike's bladder cancer was due to arsenic exposure. In the minds of the jurors, this figure, even allowing for scientific uncertainty and other potential sources of arsenic exposure, was enough to convince them that it was more likely than not that Mike's cancer was caused by the company's arsenic releases.

After learning of Mike's situation, the rest of the small community near the abandoned plant also became concerned. Nearly all took their own genetic tests.

Luckily, the level of arsenic in the water supply was simply too low to create any significant risk of bladder cancer in the average person. Indeed the arsenic levels were not much above a level that had been considered safe thirty years ago. Even those in the community who had the susceptibility gene but did not have bladder cancer faced only a small risk of developing bladder cancer. To win damages for the increased risk of developing cancer that the company had caused, they would need to show that they would probably develop bladder cancer, a standard that they were, happily for all involved, unable to meet.

The four people in the community besides Mike who already had bladder cancer were negative for the susceptibility gene. Statistically there was only a slight chance that their cancers were caused by the contamination -- not enough to win a lawsuit.

The Promises and Perils of Genetic Proof

Before people like Mike had access to genetic technologies, proving that the company's arsenic release actually caused his cancer would have been nearly impossible. Minor releases like this one do not cause large, statistically significant cancer clusters. We may know that in the aggregate, exposure levels like the one produced by this corporation cause a marginal increase in cancer risk. However, no one case of cancer can be linked to the exposure with the requisite level of certainty. This quandary has made the tort system, the individualized method of regulation, inadequate on its own to protect the public from environmental contamination. The fact that some extreme cases are won does not produce the proper level of deterrence.

Instead regulators implement a variety of standards to determine the allowable levels of pollution. Cost-benefit regulations use statistical methods to determine how many people, without having to identify them, might be adversely affected at certain exposure levels. They then compare the costs of reducing pollution with the health benefits the reductions would achieve. Cost-benefit balancing, in a rough sense, seeks to prohibit levels of pollution in excess of what a rational corporation would emit if faced with paying for all of the health costs (and other costs that might be included in the balance) those emissions truly imposed on others.


Barriers to "Individualized" Environmental Protection Through Tort Law

  • Even with genetic information, many injured plaintiffs will not be able to prove causation resulting in under-deterrence.
  • Impact on flora and fauna is not easily litigated or monetized resulting in too little protection of overall environmental quality.
  • Plaintiffs may be unwilling to waive privacy rights by disclosing genetic information or may be concerned about the psychological impact of the information.
  • Regulations may better be able to reflect public values, especially as our ability to predict their consequences improves.

Will such regulations still be needed in a world where science is able to assign responsibility to polluters with far greater accuracy than is possible today? If polluters are forced to internalize all of the costs of the harms they create, will the proper level of deterrence be realized? The post-genome era does indeed promise to make individualized proof more available and more reliable. However numerous barriers will still exist preventing the tort system alone from ensuring a healthy environment. The barriers are both technical and ethical in nature.

Technical barriers will likely prevent many individuals who have actually suffered injury from environmental contamination from recovering damages. Consider the many people who may not be of a susceptible genotype yet who are in fact rendered ill by pollution. A simple genetic test will not provide the evidence needed to prove a high probability exists that their illness was caused by a certain contaminant. Indeed, such tests may put them in a worse position than they are today, since today's risk estimates were derived from studies which may have included those of susceptible genotypes. Perhaps new tests will be developed that yield information from the cancer cells themselves, but it is likely that there will continue to be cases where injured plaintiffs cannot obtain the scientific evidence needed to meet the burden of proof.

Second, by taking into account only monetized estimates of human health impacts, the tort system fails to protect other environmental values -- such as the health of wildlife, the continued existence of sensitive species, or aesthetics. This charge may be leveled equally at any cost-benefit regulation that is concerned only with human health. This issue will be taken up more fully in the next scenario.

Plaintiffs like Mike will surely be forced to disclose the genetic evidence on which their claims rely. According to one view, this would be a purely voluntary disclosure, since Mike is not forced to seek damages. On the other hand, Mike is entitled to be compensated for the injury he has suffered due to the wrongdoing of another. Moreover, Mike may be in great need of compensation, for his medical expenses and to support his family if he is incapacitated.

The genetic code Mike discloses may contain information that could be used against him by an insurer or an employer. Keeping the evidence sealed may be a partial solution to this problem. Still some plaintiffs may not wish to seek the evidence in the first place, fearful that they may learn about other predispositions or defects that may be incurable. Since the level of deterrence provided by the tort system depends at bottom on the number of successful suits brought, the system will depend entirely on individuals' willingness to seek genetic information and their willingness to live with the psychological consequences of its revelations.

Even with the superior, individualized evidence that genetic technologies provide, tort law alone will not be sufficient to protect the public or the environment. Studies of aggregates bolstered by knowledge of inter-individual variability will tell us with increasing accuracy how many people may fall through the cracks at given levels of environmental regulation. Comparative genetics may even yield additional insight into how pollution affects wildlife. With this new information we may be in a better position to translate public values into protective regulations.

The Plaintiff's Responsibilities?

Typically a plaintiff has a duty to take reasonable steps to mitigate damages. For example, a defendant does not have to pay for injuries that result from a plaintiff's unreasonable refusal to undergo medical treatments. Plaintiffs are not however expected to undergo risky treatments that have only a marginal chance of success. To the extent that a person's genes are responsible for the risks they face, what duty should they have to either alter those genes through genetic therapy, or alter their behavior to minimize their risk?

It appears that it may be some while before gene therapy to "correct" susceptibility genes becomes a safe procedure. Gene therapy in any form is still too risky and unreliable to become a standard course of therapy in the very near future, even for the most debilitating genetic defects. More difficult problems confront its use for susceptibility genes. Even if a genetic variant presents some increased risk of disease, altering that variant may have consequences that create other risks -- either by the introduction of errors or the alteration of biological pathways.

A classic example of the unintended consequences of eliminating a genetic variant is furnished by sickle cell anemia. One copy of the responsible allele confers protection against malaria. Two copies result in the disease. Ridding the human genome of the sickle cell allele would eliminate a useful trait in areas of the world where malaria is prevalent. No one knows how many similar examples exist in the genome.

Even if we were able to overcome the technical hurdles in a particular instance and were able to devise a safe genetic therapy for a susceptibility gene, should the therapy be a condition of recovery in a tort action? Doubtless, some will contend that the alteration of their genome is an alteration of their person. They may have religious, spiritual, or purely personal objections. Many states do not presently allow a person to recover for the injuries they suffer as a result of refusal of reasonable medical care, even if such refusal is based on religious objections. The limits of this doctrine are unclear, and gene therapy may put it to the test.

It also may be argued that a gene that is active only in the bladder and that creates a single protein cannot be said to define who a person is in any rational sense. Further it is true that there are already standard medical procedures that alter genes -- chemotherapy for one. Even the foods we eat, the air we breathe, and over-the-counter medications we take alter the expression of our genes. The present biological activity in a person depends on many factors, their underlying genome being only one. A tendency to equate human identity with genetic content has been referred to derisively as genetic reductionism.

If a person has no duty to "fix" their genes, should they at least have a duty to take reasonable steps to discover their genetic susceptibilities and take behavioral steps to minimize their risk? This will prove a difficult question in tort law as genetic screening becomes more widespread and the uses for genetic information more pervasive. The role of the individual as a risk analyzer and manager are explored further in the next scenario.


Next section: Grocery Store Genetics

Sections
Click here for text.
Sections
Rosetta Stone: Front Page
Introduction
Plaintiffs in the Post-Genome Era
Grocery Store Genetics
International Toxicity
Conclusion: Challenges and Opportunities in the Genomics Age
Slide Show
External Links
Gene Tools
Washington Post: The Promise of Precision Prescriptions 5/24/00
Wired News: Gene Tools Get Retooled 4/20/00
CNN: Have your genes sequenced online 5/24/00

Arsenic
Proposed Revision to Arsenic Drinking Water Standard
Arsenic in Drinking Water National Academy Press

Genetic Susceptibility
and Diagnosis

Genetic Suseptibility to Lung Cancer, Harvard Center for Cancer Prevention
Wired News: Following Cancer's Red Flags 7/10/00
Bioethics.net

Genetics 101

Glossary of Genetic Terms, with audio and video, NHGRI
Glossary and Acronyms, Environmental Genome Project
Genetics: The Basics, DOE
DNA from the Beginning, animated primer on the basics, Cold Spring Harbors Laboratory
Genome Gateway, a comprehensive genomics web resource.

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