Food and Drug Law Commons^™

Prejudice Standards In Washington’S Appellate Courts, Andrew B. Van Winkle

Seattle University Law Review

When an appellate court finds an error to have occurred during a proceeding, the error is not yet subject to correction. In order to merit a remedy, the error must have been sufficiently prejudicial to the aggrieved party’s case. Drawing the line between correctable and non-correctable errors is not an easy task, for it often requires guessing at what was in the minds of jurors and trial judges. To cope with this task, courts have devised various rules and tests for deciding whether an error was likely prejudicial or not. These standards often go by names such as “harmless error,” …

Real-World Consequences For Online Actions: The Case For Expanding Employee Harassment Protection Via Employers’ Rights Of Action, Alexander Barnes

Seattle University Law Review

This Note argues for expanding employers’ access to legal remedies that allow them to recoup the costs of protecting their employees from swatting, doxing, and other online harassment arising from their employees’ professional activity. Part I provides a brief description and history of the online harassment problem and its potentially deadly dangers. Part II describes employers’ legal responsibility to take action to protect their employees from harassment aimed at their employees within the scope of their employment. Part III explores common legal remedies that are currently available to employers, using the state of Washington as an example. Part III also …

Foreseeability And Duty In Washington Negligence Law: Leaving The Road Less Traveled By, Leo Linder

Seattle University Law Review

Washington negligence law is a confusing labyrinth of foreseeability that not even Ariadne’s string could guide plaintiffs out of. Foreseeability is implicated in four distinct analyses, several of which overlap considerably. Doctrines that were once questions of law are now questions of fact, and vice versa. Something needs to change.

Washington has taken the novel approach of bifurcating the duty element into two parts—duty’s mere existence, which is a question of law for the court to determine; and duty’s scope, which is a question of fact handed off to the jury to determine. Foreseeability impacts both of these assessments, but …

Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder

Articles, Book Chapters, & Popular Press

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai

Faculty Scholarship

This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs’ complexity, meeting the regulatory requirement of ‘high similarity with no clinically meaningful differences’ will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in …