Archives: U.S. Government Investigations and Compliance

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2016 Year in Review: MDR Reporting Enforcement

In 2016, the Office of Compliance at the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health issued a total of 17 warning letters to medical device manufacturers citing violations of its regulations under 21 C.F.R. Part 803 for adverse event and malfunction reporting and recordkeeping.  The 2016 warning letters inform current … Continue Reading

“Foreign Official” Under the FCPA: The First U.S. Appellate Court Weighs In

On May 16, 2014, in United States v. Esquenazi, the U.S. Court of Appeals for the Eleventh Circuit issued the first appellate opinion considering the scope of the term “foreign official” under the Foreign Corrupt Practices Act.  In the long-awaited opinion, the court concluded that a Haitian state-owned telecommunications company was a government “instrumentality,” and … Continue Reading

Conflict Minerals in Medical Devices: SEC Reporting Update

Conflict Minerals Update for Device Manufacturers Under the SEC’s conflict minerals rules, public companies must disclose in an annual Form SD and associated Conflict Minerals Report (a “CMR”) certain information regarding any tin, tantalum, tungsten, and gold (collectively “3TG”) that is “necessary to the functionality or production” of any products that they manufacture or have … Continue Reading

Another Medical Device Company is Cleared, Coming Off A Long List of Open FCPA-Related Investigations

For over five years, Medtronic, Inc. (Medtronic), a Minnesota-based medical technology company, had been the subject of open investigations by the US Securities and Exchange Commission (SEC) and the US Department of Justice (DOJ) under the US Foreign Corrupt Practices Act (FCPA).  This summer, Medtronic announced, in its annual report filed with the SEC on … Continue Reading

Challenged Airline Merger Carries Lessons for Medical Devices Acquisitions in New Era of Premerger Scrutiny

According to news and industry sources, healthcare mergers and acquisitions are on the rise in 2013. In fact, there have reportedly been at least 49 such transactions in the medical devices field alone so far this year. Companies seeking to enter into or expand their presence within this burgeoning marketplace should proceed carefully, however, because … Continue Reading

CMS Posts Responses to FAQs on Sunshine Act Compliance

With the Sunshine Act’s August 1 compliance date for data collection rapidly approaching, the Centers for Medicare and Medicaid Services (CMS) has set up a page of frequently asked questions (FAQs) on its Open Payments website.  CMS appears to be adding FAQs on a rolling basis, with the most recent round of updates loaded in … Continue Reading

Par Pharmaceutical Pleads Guilty and Agrees to Pay $45 Million to Resolve Off-Label Promotion Claims

On March 5, 2013, DOJ announced that manufacturer Par Pharmaceutical pleaded guilty to a criminal misdemeanor charge for misbranding with respect to its product Megace ES (megestrol acetate).  Par agreed to pay $45 million and entered into a five-year corporate integrity agreement.  The settlement also resolves the suit Par filed against FDA in 2011 concerning … Continue Reading

Anti-Corruption Developments in 2012 and What to Watch for in 2013

Covington recently released its annual Anti-Corruption Year in Review, highlighting enforcement activities in 2012 and offering our view on what to watch for in 2013.  Besides the release of the Resource Guide to the FCPA by the US Department of Justice and US Securities and Exchange Commission, there were numerous FCPA enforcement resolutions and enforcement … Continue Reading

Caronia Update: Government Does Not Appeal Significant Second Circuit Decision

The federal government will not appeal the decision of a Second Circuit panel in United States v. Caronia.  The government did not petition for rehearing by the panel or the en banc Second Circuit before the January 16 deadline.  Further, the Wall Street Journal and others are reporting that FDA officials have confirmed that the government … Continue Reading

Managing Your FCPA Risk: Lessons for the Device Industry from 2012 Enforcement Actions

Just as the start of a new year leads individuals to reflect on the year just ended and make resolutions for the year to come, the dawn of 2013 represents the perfect time for medical device companies to take stock of lessons learned in 2012 in order to adapt and strengthen their anti-corruption compliance programs.  … Continue Reading

OIG Finds Hospital’s Free Electronic Interface Arrangement Does Not Violate Anti-Kickback Statute

On December 12, 2012, the Office of Inspector General (OIG) issued Advisory Opinion No. 12-20, which concluded that the proposed arrangement—wherein a hospital would provide free access to an electronic interface to community physicians for certain services—would not violate the federal anti-kickback statute (or “the statute”). The anti-kickback statute ascribes criminal liability to parties who … Continue Reading

Device Companies Under Increased Government Scrutiny

Scrutiny of medical device companies by federal prosecutors is expected to increase in the coming years. As reported in a recent trade publication, Susan Winkler, a lawyer in the U.S. Attorney’s Office in the District of Massachusetts and former chief of that Office’s healthcare fraud unit, has stated that device companies have received less attention … Continue Reading

U.S. v. Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to off-label promotion.  The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for … Continue Reading

“TEST Act”: Newly Enacted Law Grants CMS Discretion for Sanctioning Referral of Proficiency Tests

On Tuesday, President Obama signed into law the “Taking Essential Steps for Testing Act of 2012,” H.R. 6118, granting the Centers for Medicare and Medicaid Services (CMS) discretion to choose appropriate sanctions for clinical laboratories that are found to have intentionally referred proficiency test samples in violation of the Clinical Laboratory Improvement Amendments (CLIA). In … Continue Reading

‘Tis the Season: Gifts, Travel, and Entertainment and the FCPA Resource Guide

The holiday season is quickly upon us—time to find the perfect gifts for family and friends, enjoy holiday parties, and remember to help those less fortunate.  In many cultures around the world, the holiday season also is a time to share tokens of appreciation with clients, service providers, and others in business relationships.  Such tokens … Continue Reading

“Modest Meals” Regulation Finalized In Massachusetts

On November 21, the Massachusetts Public Health Council adopted final regulations governing the definition of “modest meals” provided in connection with an educational presentation by a medical device or pharmaceutical company held outside of a physician’s office or hospital.  The regulations finalize emergency amendments adopted in October following changes to the Massachusetts Pharmaceutical and Medical … Continue Reading