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Keeping you afloat amidst the rising sea of regulations

Is DOJ Changing Its Approach to Enforcement? What Regulated Entities Need to Know

Three Department of Justice memoranda recently emerged that shed light on DOJ enforcement policies—two published memos that restrict DOJ’s use of agency guidance, and one leaked memo that directs DOJ attorneys to consider moving to dismiss meritless qui tam (i.e., whistleblower) complaints brought under the federal False Claims Act.   

Another One Bites the Dust: Court Tosses Nearly $350 Million False Claims Act Verdict Under Escobar

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act (“FCA”) award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court in United States ex rel. Escobar v. Universal Health Services, 136 S. Ct. 1989 (2016). Together with the Fifth Circuit’s recent decision in United States ex rel. Harman v.

DOJ Reports $3.7 Billion in False Claims Act Recoveries in FY 2017

The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017. That number brings DOJ’s total FCA recoveries since FY 1987 to more than $56 billion, and its total since 2009 to nearly $34.5 billion.

What the Department of Justice Expects in a Compliance Program

In early February, the Department of Justice’s Criminal Division, Fraud Section, published a document titled, Evaluation of Corporate Compliance Programs. A must-read for any person responsible for a compliance program, regardless of industry, the document identifies common questions that DOJ may ask when making individualized determinations about a compliance program’s effectiveness.

Mylan Agrees to $465 Million Settlement with DOJ Over EpiPen Medicaid Drug Rebate Reporting Classification

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.),  an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).