Most genetic testing is currently conducted by test manufacturers, in-house. In-house testing is not subject to liability for product defects because it is considered a service, not a product. However, changes in the regulatory climate and increasing demand for genetic tests will likely result in increasing numbers of genetic tests being sold for use by others, as kit products.
The author argues that genetic test kits should be subject to negligence liability and to liability for product defects, including manufacturing, design and instruction or warning defects. The special rules for medical products that essentially exempt them from design defect liability should not apply to genetic test kits because: (1) genetic tests are not unavoidably unsafe; (2) as with other durable goods, alternative safer designs for genetic test kits may exist or be feasible; (3) genetic tests may not be regulated to the same extent as prescription drugs; and (4) the public cannot rely on physicians as effective gatekeepers for determining the safe and appropriate use of genetic tests because physicians' training in genetics is inadequate.
