Genomic medicine and the "loss of chance" medical malpractice doctrine.

ABSTRACT

As genomic medicine expands, interest in how medical malpractice law will apply to such questions as whether and when to return new or updated genomic results has grown. Given that access to some genomic results (such as those pertaining to minors or those for which scientific interpretations are unsettled) is delayed for years, the "loss of chance" (LOC) doctrine is of particular potential relevance. Yet it has received relatively little attention among scholars of law and genomics. We performed legal research to determine the status of this malpractice doctrine across the United States and consider its potential applicability to genomic medicine. We further examined known genomic medicine malpractices to assess whether this doctrine had yet been invoked in that context. We identified a trend toward adoption of the LOC doctrine, finding 29 states (58%) have adopted, 15 states (30%) have rejected, and six states (12%) have deferred or not yet addressed the doctrine. Attempts to invoke or apply the doctrine in the known genomic medical malpractice cases were also found. While our findings do not provide cause for substantial concern, the availability of the LOC medical malpractice doctrine is a potentially important factor to consider when making programmatic decisions for genomic medicine. Future research examining whether liability risks posed by this doctrine prompt defensive medicine practices would be useful.