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Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Former NSA Contractor Indicted for Theft of Government Property

The United States Department of Justice (DOJ) has announced that a former contractor of a defense contractor has been indicted for stealing over 75 percent of hacking tools belonging to the Nations Security Agency’s offensive...more

Dentons' pick of global regulatory trends to watch in 2017 - National security and foreign investment review

Focus on the US - Defense and national security - The 115th Congress will mark the first opportunity in a decade for a Republican-controlled House and Senate to work with a Republican president. In 2017, leading...more

Your Cyber Minute: Ransomware attacks and what you need to know [Video]

The conversation continues. Hogan Lovells Partner Harriet Pearson and Managing Principal of Hogan Lovells Cyber Risk Services Jeff Lolley address the threat around ransomware and the potential implications for companies that...more

First Circuit Affirms Summary Judgment for Defendant, Rejecting the Use of Aggregate Data to Prove False Claims and Clarifying the...

The First Circuit has issued an opinion affirming a complete grant of summary judgment for Pfizer, Inc. in United States ex rel. Booker v. Pfizer Inc., No. 16-1805 (1st Cir. Jan. 30, 2017), a False Claims Act (“FCA”) lawsuit...more

Problems Abound with DOD’s Proposed IRAD Rule

On November 4, 2016, the Department of Defense proposed a new rule applicable to major defense contractors who expect to use future independent research and development (“IRAD”) to perform DoD contracts. The proposed rule...more

First Circuit affirms Pfizer victory in False Claims Act case

The First Circuit has rejected an appeal in United States ex rel. Booker v. Pfizer, a False Claims Act (FCA) case alleging that Pfizer engaged in off-label promotion of the antipsychotic drug Geodon. In its ruling on...more

First Circuit Affirms Dismissal of FCA Off-Label Marketing Case for Failure to Meet 9(b) Particularity Requirement

In Lawton v. Takeda Pharmaceutical Co. et al., 842 F.3d 125 (1st Cir. 2016), the First Circuit affirmed the lower court’s dismissal of a False Claims Act (“FCA”) suit alleging a drug maker fraudulently marketed a product for...more

The Risks and Implications of Failing to Comply with U.S. Government Cyber and IT Requirements

This article summarizes some of the many risks and implications that are associated with failing to comply with U.S. government-unique cyber and information technology requirements. We are often asked by small and...more

POD Update: Physician Investor of Physician-Owned Distributor Sentenced to Nearly 20 Years in Prison

On January 9, 2017, a physician was sentenced in federal court in the Eastern District of Michigan to 19 years, 7 months in prison for his role in criminal health care fraud totaling $2.8 million. The settlement has some...more

Important Takeaways from DHS’s Proposed Rule on Controlled Unclassified Information

The Department of Homeland Security (DHS) has now officially entered the government data security fray with its own proposed rule (HSAR Case 2015-001; 82 FR 6429; Jan. 19, 2017) for safeguarding Controlled Unclassified...more

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission...

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to...more

The Department Of Homeland Security Proposes New Rules Affecting Federal Government Contractors

This week, the Department of Homeland Security (“DHS”) issued three proposed rules expanding data security and privacy requirements for contractors and subcontractors. The proposed rules build upon other recent efforts by...more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

PII Training Required for Government Contractors, Effective Jan. 19

Beginning January 19, federal government contracts will contain additional training requirements for contractors who deal with personally identifiable information (PII) or with a system of records....more

Alert: New Privacy Training Requirements for Companies with Federal Government Contracts

Effective January 19, 2017, companies awarded federal government contracts will be required to ensure that their employees receive annual privacy training if those employees (1) handle personally identifiable information...more

WCAG 2.0 AA Gains Prominence as Website Accessibility Standard

The U.S. Architectural and Transportation Barriers Compliance Board (Access Board) finalized a regulation this week that will make the Web Content Accessibility Guidelines 2.0 (WCAG 2.0) Level AA the design standard when...more

Top Legal Issues Facing the Automotive Industry in 2017

Foley’s Automotive Industry Team has prepared this report that examines what the litigation, enforcement, and regulatory landscape will look like in 2017. Inside, you will learn about: - Managing warranty, recall, and...more

First Circuit Rejects Whistleblower’s Fraud on the FDA FCA Theory

On December 23, 2016, the First Circuit held that a relator under the federal False Claims Act (“FCA”) failed to plausibly plead that defendant medical device manufacturers caused the submission of false claims for...more

Congress Revisits the Data Rights Statutes and Advances Modular Open Systems Architecture in the FY 2017 NDAA

Although there usually is great validity in the aphorism that “no man’s life, liberty, or property is safe while the Legislature is in session,” we might have to rethink that notion when it comes to data rights. Congress did...more

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims...more

Switches and Sweets: Belsnickel Brings Defense Contractors and Subcontractors New Cybersecurity Controls in Preholiday Revisions...

If you are aware of German Christmas folklore (and really, who isn’t?), you know that Belsnickel is a legendary companion of St. Nick who carries a switch with which to punish naughty children and a pocketful of sweets to...more

Healthcare Law Update: December 2016

Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more

Unfair and Unbalanced-Episode 14 [Video]

In this episode SCCE CEO Roy Snell and I continue are exploration of issues of import to the compliance profession. We consider the penalty assessed by the NCAA on Notre Dame for it use of two ineligible football players and...more

Ninth Circuit Rejects FCA Suit Alleging Medical Device Inaccuracies

In United States ex rel. Ruhe v. Masimo Corp., 640 Fed. App’x 666 (9th Cir. 2016), the Court of Appeals for the Ninth Circuit affirmed a grant of summary judgment for defendant Masimo Corporation, a medical device...more

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