Off-label Use and the Medical Negligence Standard Under Minnesota Law

Who decides whether a drug can be used off-label and under what circumstances? If a physician decides to prescribe a drug off-label, what legal issues, if any, should the physician be aware of? With the increased practice of prescribing drugs for off-label use, coupled with a somewhat dated and incomplete medical negligence standard in Minnesota, the intersection of the off-label use doctrine with Minnesota’s medical negligence standard is ripe for review. This article examines the off-label use doctrine and the medical negligence standard under Minnesota law. First, the article examines what the phrase “off-label use” means. Next, the article explores the cases that have arisen in Minnesota which address medical malpractice claims arising, at least in part, because of off-label uses. Finally, the article concludes with the author’s observations about whether off-label use should be a cause for concern. In part, the author considers whether increased off-label use presents new legal issues for physicians, patients, and attorneys