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Full-Text Articles in Law
Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard
Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard
Georgetown Law Faculty Publications and Other Works
Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …
Reining In The Rogue Squadron: Making Sense Of The "Original Source" Exception For Qui Tam Relators, Dayna Bowen Matthew
Reining In The Rogue Squadron: Making Sense Of The "Original Source" Exception For Qui Tam Relators, Dayna Bowen Matthew
Publications
The qui tam provision of the Civil False Claims Act effectively serves to expand the government’s capacity to combat fraud, but also invites abusive prosecution against blameless public contractors. Although the public disclosure jurisdictional bar is designed to permit worthy claimants to proceed as whistle blowers while precluding parasitic opportunists from unfairly imposing litigation costs and reaping undeserved awards, the inconsistent judicial interpretation of the original source exception threatens predictable and just law enforcement. Christopher Alexion’s note categorizes the approaches courts have taken as ranging from permissive, to “middle ground” to restrictive based on the timing of the relator’s disclosure, …
Materiality: A Needed Return To Basics In False Claims Act Liability, Monica P. Navarro
Materiality: A Needed Return To Basics In False Claims Act Liability, Monica P. Navarro
Monica P. Navarro
This article discusses the creation and failures of the express and implied certification constructs developed by federal courts to analyze falsity under the False Claims Act and advocates for the retirement of these judicial constructs in favor of the adoption of a materiality regime for deciding falsity under the Act.