Home | Business News | Browse by Publication | T | Trial

Genetic tests are testing the law: the fast-growing field of genetic testing has raised new legal questions: who is responsible when a child is born with a severe genetic defect? And what theories, standards, and choice of law apply to these new technologies?

Article Excerpt
Modern genetic testing is routinely used to determine whether prospective parents are at risk for passing on genetic diseases to children, to find out whether a fetus has a genetic disorder, and to identify certain genetic conditions in newborns. Recently, genetic testing has been used to screen embryos created through in-vitro fertilization (IVF) to select the ones that will be implanted.

This rapidly evolving area of medicine increasingly pushes the limits of both science and the law. With little regulation of genetic testing or IVF practice in the United States and few professional guidelines for health care providers, legal standards about proper use and interpretation of these tests are just emerging.

Genetic testing gives would-be parents more hope, more information, and more choices than ever. At the same time, testing, testers, or communicators of test results can fail with sometimes tragic consequences. Plaintiff lawyers, who are more and more likely to handle a case involving these tests, need to know how genetic testing works and what legal precedents for such claims exist.

Understanding the science

A genetic test is a laboratory analysis of a tissue sample that detects DNA or chromosomal alterations, or proteins or other metabolites indicative of a genetic disorder. Today, it can be done directly on a tissue sample taken from a cheek swab, blood cells, amniotic fluid (through amniocentesis), placental cells (through chorionic villus sampling, or CVS), or a single cell of an embryo created through IVF technology.

While genetic testing can be performed at any time, it is often used by couples thinking about starting a family. "Carrier testing" screens the prospective parents either before or during a pregnancy for potential genetic mutations. Certain types of carrier testing are offered depending on racial or ethnic background: For example, professional guidelines recommend cystic fibrosis (CF) screening for all white couples and say it should be available to all populations. (1)

Testing of a developing fetus during pregnancy can identify a genetic alteration linked to current or future disease. Cytogenic testing detects changes in chromosomal number or structure (which could indicate, for instance, Down syndrome); biochemical genetic testing measures proteins and metabolites (which could signal, for example, phenylketonuria, or PKU); molecular genetic testing uses nucleic acid probes to identify alterations in DNA sequences that can predict early-onset diseases such as CF and late-onset illnesses such as Huntington's disease.

Recently, IVF, along with advances in genetic testing, has made it possible to test an early-stage embryo through preimplantation genetic diagnosis (PGD). Developed a little over a decade ago and still not routinely performed, PGD allows physicians or embryologists to identify embryos carrying specific genetic alterations that can cause disease. A couple can then choose to transfer to the woman's uterus only those embryos that don't show these alterations.

PGD has most frequently been used by couples with known genetic risks, who may already have an affected child. Worldwide, at least 2,000 babies have been born after PGD testing discovered that the embryos they developed from had no disorders like cystic fibrosis, Tay-Sachs disease, Marfan syndrome, muscular dystrophy, sickle cell and Fanconi anemia, and thalassemia. (2)

The use of PGD for other purposes--such as to test the embryo's sex, to create a child to be a tissue match for a sibling, to detect late-onset disorders such as Alzheimer's disease, or to discover genetic susceptibility to diseases like hereditary breast cancer--is controversial. (3)

Today, genetic tests are clinically available for 1,000 diseases; several hundred more are available in a research setting? More than a hundred have been used in prenatal testing and PGD, and there is no technological...

View this article FREE - Now for a Limited Time, try Goliath Business News
Free for 3 Days!