Legal Considerations in a World of Comparative Effectiveness Research

In this chapter, Dr. Paul Kalb, Esq. draws on his expertise in the area of health care fraud and abuse in discussing legal considerations relating to comparative effectiveness research (CER). He describes barriers to CER dissemination by manufacturers as well as use of CER in various litigation settings. Dr. Kalb talks about these issues with Paul Greenberg and Crystal Pike, economists at Analysis Group with whom he has worked on many legal cases involving off-label promotion and kickback allegations. They discuss recent developments concerning: (a) what can be communicated by manufacturers based on different standards of scientific evidence (e.g., substantial, competent and reliable, truthful and non-misleading); (b) to whom different types of product claims can be communicated (i.e., where the sophistication of the audience may matter); and, (c) who can do the communicating (i.e., where the expertise of the spokesperson may matter). In addition, they talk about managing company risk in an environment where some communications may be seen as off label and others may be seen as false or misleading. Finally, they talk about specific examples in which CER has been used effectively in litigation.