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.

Figure 1

The status of the “loss of chance” (LOC) doctrine Dark blue shading indicates the LOC doctrine has been adopted. Light blue shading indicates the LOC doctrine has been rejected. Grey shading indicates the LOC doctrine has been deferred or has not yet been addressed.

Figure 2

Jurisdictions in which genomic malpractice cases have been decided. Status is current through December 31, 2016.

Figure 3

Number of genomic malpractice cases decided within each jurisdiction Status is current through December 31, 2016. Grey shading indicates zero cases. Lavender shading indicates one case. Blue shading indicates between two and five cases. Green shading indicates between six and 10 cases. Yellow shading indicates between 11 and 15 cases. Peach shading indicates between 16 and 20 cases. Red shading indicates more than 20 cases.