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The Department of Justice Antitrust Division's (DOJ's) investigation into the generic pharmaceutical industry may be expanding. On March 15, 2015, a third generic manufacturer disclosed that it received a subpoena from the...more
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
On February 10, 2015, the U.S. Court of Appeals for the Seventh Circuit upheld the conviction of Dr. Kamal Patel for violation of the anti-kickback law, reinforcing a broad definition of “referring” under the statute (U.S. v....more
On December 31, 2014 Federal Law No. 532-FZ was enactedOn Amending certain Legislative Acts of the Russian Federation in Connection with Interdiction of Falsified, Counterfeit, Poor-Quality and Unregistered Medicines, Medical...more
Almost all healthcare providers and health plan administrators are familiar with the detailed requirements of the privacy and security rules under the Health Insurance Portability and Accountability Act (HIPAA). Violations...more
In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more
“I didn’t set out to commit a crime. I certainly didn’t set out to hurt anyone… I was kind of a hero, because I helped the company make its numbers every quarter. And I thought I was doing a good thing. I thought I was...more
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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 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
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