OBJECTIVES: Litigation in healthcare can arise for a variety of reasons, with major cost implications for providers. A particular concern are systemic issues where a programme of care may face litigation from multiple individuals. This study examined the impact of litigation and explored the issues associated with inclusion of litigation costs in economic evaluations.

METHODS: We use a motivating example of cervical cancer screening services in Ireland, which have recently been subject to multiple court cases. Reviews of negative screen results for women who were subsequently screen detected determined that some test results were equivocal and may be considered potential false negative results. We outline the potential consequences of litigation for a viable service and the potential impact of including litigation costs on an economic evaluation.

RESULTS: The successful litigations have been primarily directed at the laboratories that processed samples. The consequences of litigation include . Inclusion of litigation costs in an economic model may render the programme no longer cost-effective. If the risk of litigation is already incorporated through insurance costs (both in third party processing costs and in overheads), then explicit inclusion may lead to double counting and thus be inappropriate. Furthermore, the likelihood of litigation may be challenging to estimate. The issue of litigation also highlights the need for accountability and can impact beyond the health service and into the political sphere.

CONCLUSIONS: Inclusion of litigation costs in an economic evaluation is complex and potentially creates bias. There are many unknowns regarding litigation. These include the likelihood of litigation, the cost of litigation, the impact on service utilisation and, consequently, uncertainty about how all those issues impact on the estimated cost-effectiveness of a service.