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Corporate Investigations and White Collar Defense - August 2016

Spotlight on the False Claims Act - Why it matters: This month, we review a recent Ninth Circuit case that allowed a qui tam relator’s action against various Medicare Advantage organizations to proceed, holding that the...more

Corporate Investigations and White Collar Defense - July 2016

“Official Acts”—What They Are… and Are Not - Why it matters: On June 27, 2016, the Supreme Court decided McDonnell v. U.S., holding that, for purposes of the federal public corruption statutes, an “official act”...more

The Supreme Court - June 2016 #4

The Supreme Court of the United States issued decisions in three cases on June 16, 2016: Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7: Yarushka Rivera, a teenage beneficiary of...more

On May 4, 2016 changes to the procedure for applying the “third one is out” rule in state procurement of medical devices entered...

RF Government Resolution No. 102 of February 5, 2015 approved a list of certain types of foreign-manufactured medical devices (the “List” and “Devices,” respectively) in the procurement of which state and municipal customers...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Corporate Investigations & White Collar Defense - January 2016

The FCPA in 2016: DOJ and SEC Focus on International Cooperation and Investigation of Individuals - Why it matters: As we reported in our December 2015 newsletter, both SEC Enforcement Director Andrew Ceresney and DOJ...more

Expect Focus – International, Summer 2015

In This Issue: - TTIP’s Impact on U.S. and EU Trade Relations - Proposed Innovation Box Legislation - Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014 - Rules...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Blog: The Trade Agreements Act and Sales of Medical Devices to the U.S. Government

Does your company sell medical devices to the U.S. Government, either directly or through a reseller or distributor? Are those devices or supplies manufactured at least partly in a country other than the U.S.? ...more

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

Catching Up on the False Claims Act

From a corporate risk perspective, if your company is in the financial industry, healthcare, or defense industry, your greatest legal and compliance risk has to be the False Claims Act....more

Medical Device Manufacturer Settles Trade Agreements Act Suit

A whistleblower alleged that the manufacturer knowingly violated the Trade Agreements Act’s country of origin requirement. Government contractors must agree that the products they sell to the U.S. government under...more

2013 Enforcement Predictions

I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more

New Excise Tax on Certain Foreign Contractors

Section 5000C of the Internal Revenue Code (the Code) was added by the James Zadroga 9-11 Health and Compensation Act of 2010 (the Act) on January 2, 2011. This new provision imposes a 2 percent excise tax on “Federal...more

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