In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent.
A recent lawsuit filed against GNC serves as a reminder that companies need to ensure that prices listed as “regular prices” are substantiated.
The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.
Whether it is proprietary information regarding customers, pricing, sourcing, product design, or manufacturing methods, trade secrets provide a competitive edge in the market by virtue of the fact that it is not generally known.
Why does it matter? This seemingly inconsequential distinction may mean the difference between being able to prominently display your embroidered brand trademark on your jeans and being required to place a large “Made in China” marking next to the embroidered brand trademark.
Given the recent municipal bankruptcies and likelihood of more to come during the next recession, the author draws lessons from recent cases to determine what changes to Chapter 9 would be in the interest of the nation.
VA recently announced a significant policy change that will now require drug manufacturers to make drugs that are “covered drugs” under the Veterans Health Care Act (VHCA) available to the VA under the manufacturer’s Federal Supply Schedule (FSS) contract.
Arent Fox filed an amici brief on behalf of the Wisconsin Alumni Research Foundation, the Indiana University Research and Technology Corporation, and San Diego Intellectual Property Law Association. Our brief focused on the following three errors in the Federal Circuit’s rationale.
Theft of intellectual property, including trade secrets, costs US businesses more than $300 billion a year, according to a 2013 report by the Commission on the Theft of American Intellectual Property (a bipartisan group of high-ranking former US officials).
Covered entities and business associates subject to HIPAA Security Rule are closer to getting a benchmark for encryption standards with the release of the Standards and Guidelines Development Process in late March by the National Institute of Standards and Technology (NIST).
The Program Notice provides some guidance on how generic drug manufacturers are to calculate the new Additional Discount on generic drugs that will become part of the rebate due state Medicaid programs under the Medicaid Drug Rebate Program.
Buried among all the provisions arming the government with new enforcement tools in the Trade Facilitation and Trade Enforcement Act of 2015 are a handful of benefits which, if applied correctly and appropriately, could save importers money.
On April 14, 2016, the European Union formally adopted a new scheme – known as the EU General Data Protection Regulation (GDPR) – to protect the personal data of European residents.
J Crew Group Inc. was recently hit with a nationwide class action lawsuit alleging that the clothing retailer offers fictitious sales on the J Crew Factory store website.
On April 5, 2016, Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of a new web-based tool to assist developers of mobile health apps in understanding what federal laws they must comply with.
Today, the Department of Health and Human Services announced that it is re-opening the comment period on its June 17, 2015 proposed rule (the Proposed Rule).
Data breach notifications may be more common in Tennessee. Notably, the Governor recently signed into law a bill updating the current breach notification requirements by (a) requiring notice even where data is encrypted, (b) requiring notice within 45 days of discovery of the breach (barring a law e
On April 15, the World Bank released updated public disclosures of its suspension and debarment practices against companies that violate its compliance directives.
On April 13, 2016, the Article 29 Working Party released its opinion on the EU-US Privacy Shield.
The US Drug Enforcement Administration recently announced that it is evaluating whether to downgrade the classification of marijuana under the Controlled Substances Act, which could allow more research into its potential medicinal benefits. A decision is expected this summer.
On April 11, 2016, the Centers for Medicare and Medicaid Services (CMS) announced its Comprehensive Primary Care Plus (CPC+) initiative.
The Federal Trade Commission announced on April 12 that it reached settlement agreements with four companies that market skin care products, shampoos, and sunscreens online over charges that they falsely claimed that their products are “ALL NATURAL” or “100% NATURAL,” despite the fact that they cont
The producer of popular Netflix television series “House of Cards” has been sued in federal court on claims of trademark infringement for its use of the trademark HOUSE OF CARDS.
The Trade Facilitation and Enforcement Act of 2015 repealed the “consumptive demand” exemption to the ban on imports made by “forced labor.” The repeal became effective on March 10, 2016.