Litigating the hype: the Lung Health Institute class action and its implications

The recent Lung Institute class action lawsuit is used as an example of patient-initiated lawsuits regarding unproven "stem cell" interventions. Current regulatory considerations for administration and advertisement of cell therapies are contrasted to gaps that occurred in this case. We discuss lessons for coordinated and multipronged enforcement and litigation strategies and the role of scientists as expert witnesses in cases involving deceptive or harmful claims for so-called "stem cell" interventions. This paper focuses specifically on US laws and regulations however the lessons learned can be extended to other regions worldwide. Global attention must be given to these issues as the propagation of unproven "stem cell" interventions continues to grow not only in countries with limited regulation and oversight but also, as shown in this paper, in countries with strong regulatory agencies.