1 - Liability Implications of Direct-to-Consumer Genetic Testing

Summary

Direct-to-consumer (DTC) genetic testing has raised questions about the accuracy of the test results, which may raise potential novel liability issues. This chapter examines potential liability exposures relating to DTC genetic testing in two main contexts. The first is potential liability for the DTC provider itself for erroneous results. Key issues in such cases will be the validity and effect of the representations and disclosures that the DTC company provides, which often informs the consumer that the results should not be relied on for medical care, disclaim any liability for any harms that may result from such reliance, and require any disputes to be resolved by mandatary arbitration. The second potential type of case is against health care providers who are presented with DTC results by their patients. Providers will often be put in a “damned if they do, damned if they don’t” predicament by such results, as both ignoring or relying on the DTC test results could create potential liabilities in certain situations. While providers can usually protect themselves by requiring validation of the DTC results by an independent laboratory, time and economic constraints may make this infeasible in some cases.