Faculty Bibliography

Modern medicine faces many significant problems. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or developed. The second is the routine practice of physicians prescribing approved drugs for unapproved uses--so-called "off-label" uses. These problems seem very different. Failure to invest in potential new uses is an innovation problem: firms lack incentives to research and develop new uses of old drugs. The problem of off-label uses, on the other hand, is one of safety and efficacy: off-label uses are risky because they are not supported by the same level of evidence as approved uses. While descriptively accurate, this is not the only accurate description. Each of these problems is also one of information--a lack of information about the safety and efficacy of prescribing approved drugs for unapproved uses. Because all new uses of approved drugs are off-label uses, gathering safety and efficacy information about off-label uses, in effect, produces safety and efficacy information about many new uses. Not only that, but some off-label uses may be new: physicians may innovate by prescribing drugs off-label. Reframing these two seemingly disparate problems in terms of a common information deficit enables a single, information-based solution. This solution--which draws on the existing suite of innovation policy levers--incentivizes providers, rather than pharmaceutical companies, to generate the post-market information needed to address both problems.

Voice-based AI-powered digital assistants, such as Alexa, Siri, and Google Assistant, present an exciting opportunity to translate healthcare from the hospital to the home. But building a digital, medical panopticon can raise many legal and ethical challenges if not designed and implemented thoughtfully. This paper highlights the benefits and explores some of the challenges of using digital assistants to detect early signs of cognitive impairment, focusing on issues such as consent, bycatching, privacy, and regulatory oversight. By using a fictional but plausible near-future hypothetical, we demonstrate why an “ethics-by-design” approach is necessary for consumer-monitoring tools that may be used to identify health concerns for their users.

A person naturally owns the fruits of their intellectual labour; so goes the labour argument for intellectual property (IP). But what should happen when a creator gets ‘lucky’—such as the photographer who is in the right place at the right time or the scientist who accidentally discovers a new drug? IP law frequently awards ownership in such cases (what we call ‘Lucky IP’). Some argue, however, that the creators in such cases do not labour sufficiently to deserve ownership, and that Lucky IP merely demonstrates that IP law is not truly concerned about labour at all. Drawing on the philosophical literature of moral luck, we argue that this analysis is misguided. Nearly all intellectual creations involve some measure of luck and, in most cases, the creators still labour sufficiently to become the natural owners of their creations. Lucky IP does not, therefore, undermine the labour theory of IP law.