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Federal Prosecutors Charge NECC Employees with Second Degree Murder: A Shot Across the Bow to Healthcare Companies Navigating...

Federal prosecutors charged the head pharmacist and the president of New England Compounding Center (NECC), a now-bankrupt Massachusetts compounding pharmacy, with second-degree murder and racketeering in the U.S. District...more

Vascular Solutions Inc. and its CEO Face Criminal Charges for Selling Unapproved Medical Devices

Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more

Vascular Solutions Indicted

The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical...more

Red Notice Newsletter - October 2014

Welcome to the October 2014 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. - This month on the anticorruption front, a Texas company agrees to pay more than $5 million to settle allegations...more

The Pain Drain - The Continuing Impact of Pain Management on Health-Care Providers

Over a hundred million Americans suffer from chronic pain. To combat this epidemic, health-care providers have increasingly turned to opioid analgesics. As a result, opioid analgesic use has risen dramatically over the past...more

Face video scan can trigger data protection breach?

Data protection breaches of health related sensitive data might occur through a mere video scanning an individual’s face according to a recent research....more

FBI Warning to Health Care Sector Holds True

In April of this year, the FBI issued a Private Industry Notification (PIN) to the health care industry warning of the “likely increase [in] cyber intrusions against health care systems.” In the same month, and into June of...more

Federal Prosecutors Bring Criminal Charges against Individual for Alleged HIPAA Violation

Federal prosecutors in the Eastern District of Texas recently brought criminal charges under the Health Insurance Portability and Accountability Act (“HIPAA”) against a former East Texas hospital employee. The former...more

Los Angeles County Sues Hospital Owner for False Surgical Implant Claims to County Workers’ Compensation Program

On July 18, 2014, the County of Los Angeles (“the County”) filed a lawsuit in Los Angeles Superior Court again Michael D. Drobot, Sr., his son Michael R. Drobot, Jr. and their controlled entities, Pacific Hospital of Long...more

DEA Schedules Tramadol As A Schedule IV Controlled Substance

On July 2, 2014, the Drug Enforcement Administration (DEA) published its Final Rule placing tramadol into Schedule IV of the Controlled Substances Act (CSA). Tramadol is a synthetic opioid analgesic used in the...more

Hospital Executive Indicted for Allegedly Lying about Meaningful Use of Electronic Health Records

A hospital executive was recently indicted for allegedly submitting a false attestation regarding a hospital’s “meaningful use” of electronic health records (“EHR”) technology through the Medicare EHR incentive program. This...more

Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

China Introduces New Health Care Sector Anti-Corruption Regulations

China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and Family Planning...more

New UK Pharmaceutical Packaging Warnings: Lucy in the Sky with Directions for Marketing Authorisation Holders

This client alert looks at the impact of a new drug driving offence in the UK which will come into effect during 2014 as part of The Crime and Courts Act 2013 (the “CCA 2013”). It is relevant for UK Marketing Authorisation...more

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

In late December, China’s National Health and Family Planning Commission ("NHFPC"), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013...more

"Health Care and Life Sciences: Affordable Care Act Rollout to Impact M&A and Enforcement Activity"

Health care and life sciences companies face a variety of issues in 2014, including further difficulties with the Affordable Care Act (ACA) rollout because of legal and logistical challenges, the potential dampening of...more

Healthcare Fraud Recoveries at All-Time High Since 2009

Fiscal year 2013 marked the fourth consecutive year in which the Department of Justice has recovered at least $2 billion from cases involving charges of healthcare fraud. Make no mistake: these record-setting yields were no...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...more

The Anti-Kickback Statute And The Affordable Care Act: A Law Enforcement Tool Suddenly Goes Missing

With the aggressive pursuit of cases against the pharmaceutical and device industries (including the recent $2.2 billion settlement with Johnson & Johnson), the implementation of Medicare Fraud Strike Forces in major cities...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

White Collar Watch - October 2013

In This Issue: - Small businesses beware: IRS deploys “big data” to scrutinize cash transactions - Google’s scanning of emails may constitute wiretapping: Federal District Court denies Google’s motion to dismiss...more

Computer Crime Insurance Coverage: Can It Cover Fraudulent Entries Submitted by an Authorized User?

In a recent decision, New York's appellate court considered whether a "Computer Systems Fraud" insurance policy rider (Policy) covered losses that Universal American suffered as a result of fraudulent claims electronically...more

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