Law Commons^™

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Risky Ventures: The Impact Of Irs Health Care Joint Venture Policy, Roger P. Meyers

University of Michigan Journal of Law Reform

IRS oversight of joint ventures between exempt and for-profit organizations has undergone substantial change over the past thirty years. This change has important consequences for the health care industry, where joint ventures have grown increasingly common. In the face of unclear guidance and aggressive enforcement of exemption-policing tools such as the private benefit doctrine and the control test, a hospital risks revocation of its tax-exempt status, or liability for unrelated business income tax, when it engages in a joint venture directly. It may be able to eliminate this risk by operating the same joint venture through a for-profit subsidiary; however, …

Establishing New Legal Doctrine In Managed Care: A Model Of Judicial Response To Industrial Change, Peter D. Jacobson, Scott D. Pomfret

University of Michigan Journal of Law Reform

Courts are struggling with how to develop legal doctrine in challenges to the new managed care environment. In this Article, we examine how courts have responded in the past to new industries or radical transformations of existing industries. We analyze two historical antecedents, the emergence of railroads in the nineteenth century and mass production in the twentieth century, to explore how courts might react to the current transformation of the health care industry.

In doing so, we offer a model of how courts confront issues of developing legal doctrine, especially regarding liability, associated with nascent or dramatically transformed industries. Our …