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Plan Ahead, Stay On Top of Government and Tech Changes, and Be Ready to Call the FBI: Key Lessons from the PHI Protection Network Conference
Late last week, the health care data security community gathered in Philadelphia for the PHI Protection Network Conference. The diverse group of speakers included in-house data security officers, technology consultants, academics, attorneys, and a variety of influential federal government representatives. I was in the audience. A handful of key themes were reiterated in various ways throughout the two-day gathering.
U.S. Sentencing Commission Engages on Conditions of Supervised Release and "Compassionate" Release
As an at large national appointee to the U.S. Sentencing Commission Practitioners Advisory Group (along with private bar defense counsel appointees from each federal circuit), I had a front row seat to Commission hearings last week concerning conditions of supervised release and probation and the criteria for a compassionate release or reduction in sentence from the Bureau of Prisons (BOP).
The Enforceability of FDA's Off-Label Marketing Restrictions Following the Amarin Decision
Today, February 17, 2016, AHLA's Journal of Health & Life Sciences published as its “Featured Article†our analysis of the enforceability of FDA's off-label marketing restrictions in the aftermath of the August 2015 Amarin Pharma, Inc. v. United States FDA decision. The article, entitled, “To Promote or Not to Promote? The Enforceability of FDA's Off-Label Marketing Restrictions Following Amarin,†traces the recent string of judicial decisions challenging the government's restrictions on drug companies, truthful and non-misleading off-label speech as violating the First Amendment's free speech protections.
The Government Pushes The False Claims Act Envelope; Government Contractors Push Back
In recent weeks, corporations have pushed back against Departments of Justice (DOJ) and Health and Human Service (HHS) efforts to expand False Claims Act (FCA) remedies to conduct beyond the FCA's explicit reach. Yet a huge incentive exists for DOJ to push the FCA envelope: DOJ's recently released 2015 Civil Division fraud recoveries - totaling over $3.5 billion - establish a six-year trend of recoveries in excess of $3 billion annually.
Two Points and a Lesson from PrivacyCon, FTC's Digital-Privacy Conference
Last week, on January 14, 2016, the Federal Trade Commission (FTC) convened PrivacyCon, a first-of-its kind conference bringing together policymakers, academics, and technology researchers to discuss the challenges surrounding online privacy as we navigate between a fixed-internet world, a mobile one, and the growing “internet of things.†I was in the audience, and I came away with two major points and a lesson for white collar defense lawyers and their clients.
DOJ's New Appetite for Prosecuting Food Companies and Their Executives
The DOJ, together with the FDA, is increasingly investigating and prosecuting food companies for the sale of adulterated food products. Coupled with the Yates Memo, the September 2015 memorandum by DOJ Deputy Attorney General Sally Yates announcing DOJ's emphasis on holding individual employees accountable for corporate misconduct, this puts food company executives, as well as food companies, at increased risk of being charged criminally for adulterated products.
U.S. Supreme Court to Decide the Viability of the Implied Certification Theory of False Claims Act Liability
On December 4, 2015, the U.S. Supreme Court agreed to consider a challenge to the federal government's hotly-contested and Circuit-splitting “implied certification†theory of False Claims Act (FCA) liability. The implied certification theory has been a versatile and lucrative tool for whistleblowers and for the government, and a Supreme Court ruling on the viability of this prosecution theory may provide clearer boundaries and more certainty for those who do business with the government.
A Conversation with Darpana Sheth of the Institute for Justice About Legal Challenges to Civil-Forfeiture Laws
The Philadelphia District Attorney's Office recently settled, in part, a federal civil-rights class-action lawsuit seeking declaratory and injunctive relief in regard to its civil-forfeiture policies. I had the opportunity to speak with Darpana Sheth, a lawyer with the Institute for Justice and the lead counsel for the plaintiffs, about this development.
FCC Takes on Hospitality Wi-Fi Management Again: More Sanctions, Unresolved Concerns
On Monday, November 2nd, the Federal Communications Commission (FCC) took more enforcement steps in its campaign against Wi-Fi blocking, "the practice of blocking unauthorized Wi-Fi hotspots that let consumers share mobile data access with other devices, like laptops and tablets" in hotels and convention spaces. This comes on the heels of a $750,000 settlement with Smart City Holdings over its Wi-Fi blocking at multiple convention centers, and a late-2014 settlement of $600,000 with Marriott over similar conduct.
HHS-OIG Senior Counsel Riordan Focuses on Kickbacks, Accountability, and the Role of Compliance in Pharma Compliance Congress Keynote
On Wednesday, October 22, 2015, the 16th Annual Pharma Compliance Congress in Washington, D.C., was kicked off by keynote speaker Mary Riordan, HHS-OIG Senior Counsel and perhaps OIG's most well-known face to the pharmaceutical industry. In her talk, Ms. Riordan laid out three hot button areas for company compliance professionals: kickbacks, individual accountability, and the role of compliance in business operations. We thought these were worth sharing, particularly because two of the areas -- a jump in kickback cases and individual accountability in the investigation and resolution of corporate investigations -- were themes also emphasized by the government speakers at the AUSA Roundtable panel.
A Conversation with UVA Law's Brandon Garrett About the DOJ's Swiss Bank Program
Recently I had the opportunity to speak with my former law professor, Brandon Garrett, about the DOJ's Swiss bank program. Professor Garrett is the Justice Thurgood Marshall Distinguished Professor of Law at the University of Virginia School of Law, and author of the recent book Too Big to Jail: How Prosecutors Compromise with Corporations. Professor Garrett has written and spoken extensively about white collar corporate prosecutions and the use of non-prosecution and deferred prosecution agreements in the corporate prosecution context.
Further Thoughts About The Yates Memo
Now and then, we enshrine Deputy Attorney Generals for DOJ policy memoranda issued in their name (e.g., the Ogden Memo on discovery). The white collar bar then dissects DOJ's policy rationale and any operational impact for the defense. Last month's Yates Memorandum regarding Individual Accountability for Corporate Wrongdoing is no exception.