Law Commons^™

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Understanding Administrative Sanctioning As Corrective Justice, Eithan Y. Kidron

University of Michigan Journal of Law Reform

When should a regulator prefer criminal sanctions over administrative sanctions? What procedural protections should apply if a process is labeled civil but the sanctions are, in fact, criminal in type? And can the state justifiably conduct parallel proceedings for punitive sanctions against the same person or entity for the same conduct?

Throughout the years, judges and scholars alike have tried to understand and classify administrative sanctioning. Common to all of these conceptions is their failure to provide a complete normative framework for this unique body of law, which in turn makes it difficult to identify its practical limits and to …

Regulatory Standards And Products Liability: Striking The Right Balance Between The Two, Teresa Moran Schwartz

University of Michigan Journal of Law Reform

Common law courts have a long tradition of borrowing legislative and regulatory standards to define standards of care under the tort system. Treating such standards as setting minimum levels of care and safety under tort law, the courts uniformly have ruled that violations of standards constitute negligence per se, while compliance is merely evidence of negligence. Although critics of the tort system have urged legislatures and courts to adopt rules giving greater weight to regulatory compliance in products liability cases, the drafters of the Restatement (Third) of Torts: Products Liability have declined to do so. They have adopted instead an …

Reckless Endangerment Of An Employee: A Proposal In The Wake Of Film Recovery Systems To Make The Boss Responsible For His Crimes, Anne D. Samuels

University of Michigan Journal of Law Reform

This Note argues that the traditional regulatory, civil, and criminal mechanisms are both ineffective and inappropriate to deter or punish corporate decisionmakers for decisions that pose risks to the safety or health of employees in the workplace. The Note proposes a new criminal offense to prevent and punish culpable corporate decisionmaking that results in employee deaths or injuries. Part I explains the novel application of the traditional murder offense in Film Recovery Systems and demonstrates that the case fails to lay the foundation for a standardized response to employee endangerment. Part II analyzes the traditional responses of the regulatory and …