Emory Corporate Governance and Accountability Review

Volume 5Issue 1
Voices from the Inside: Essays on a Broken Health System

A Practitioner’s View of Institutional Corruption Through the Lens of the Health Care System: An Essay

Reuben Guttman | 5 Emory Corp. Governance & Accountability Rev. 1 (2018)

I cannot say the root of my cynicism stems solely from my litigation against the healthcare industry. I spent years representing industrial and service unions and their members; the average working person—or hardcore union member—has no allusions about the power of institutions to corrupt. They often view their own employer and their union with the same gimlet eye. Yet, my litigation against the healthcare industry has, at the very least, been a policy laboratory for the understanding of institutional wrongdoing and deficiencies in compliance enforcement. While the lessons I have learned are in the first instance about “fraud, waste and abuse,” in the delivery of healthcare, they are transferrable and thus have meaning elsewhere.

Read More »

Don’t Fix What Ain’t Broken—Off-Label Marketing, the FDA’s Regulatory Regime, and the First Amendment

Loren Jacobson | 5 Emory Corp. Governance & Accountability Rev. 19 (2018)

This Essay posits that the FDA should protect the current regime put in place by the Kefauver-Harris Amendments and continue to prosecute drug and device companies and their employees for putting patient lives in danger by marketing their products for off-label use. The Essay focuses on the pharmaceutical companies, but device companies are subject to the same regulations. In fact, in 2015, the Department of Justice filed charges, including claims for putting misbranded and adulterated products in interstate commerce, against two Acclarent executives, William Facteau and Patrick Fabian, for the promotion of a device approved as a sinus spacer for unapproved use as a steroid delivery system. As this Essay makes clear, legislative efforts to allow broader off-label marketing are short-sighted, ignoring both the terrible consequences visited on patients prior to the Kefauver-Harris Amendments.

Read More »

The False Claims Act’s First-to-File Bar: Jurisdictional or Not?

Robert A. Magnanini & Jason S. Kanterman | 5 Emory Corp. Governance & Accountability Rev. 63 (2018)

While the general theory behind the First-to-File bar may appear relatively simple, properly and practically applying it is a difficult task. Though there are many complexities involved with First-to-File litigation, this Article focuses on the current disagreement among the various circuit courts of appeals as to whether the First-to-File bar is a jurisdictional bar to litigation. This Article is not intended to offer an exhaustive analysis or resolution to this issue, but rather, will simply introduce the current debate and offer initial thoughts on why the authors believe the First-to-File bar is a non-jurisdictional provision.

Read More »