On Sunday, June 11, 2017, Gymboree filed a voluntary petition under Chapter 11 of the United States Bankruptcy Code in the US Bankruptcy Court for the Eastern District of Virginia, listing $755.5 million in assets and $1.365 billion in debts.

In a widely anticipated move, the FDA announced this week that it will extend the July 2018 compliance date for the revision to the Nutrition Facts panel. The revised panel will display calories more prominently on the label, as well as list added sugars.

Earlier this month, the Health Care Industry Cybersecurity Task Force sent to Congress the Report On Improving Cybersecurity in the Health Care Industry.

Major regulatory changes in data governance recently went into effect in Japan and China that are likely to impact organizations doing business in these Asian markets.

Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. 

With little fanfare or explanation, US Secretary of Labor Alexander Acosta announced on June 7, 2017 the withdrawal of the US Department of Labor’s 2015 and 2016 informal guidance on joint employment and independent contractors.

The Supreme Court issued a stunning ERISA decision on Monday, overturning the law in the three federal circuits as to what constitutes a “church plan” that is exempt from ERISA’s requirements.

Following a recent trend that started in Massachusetts and the City of Philadelphia, New York City has become the latest jurisdiction to ban employers from inquiring about salary history for applicants.

The CPSC also alleged that Kawasaki knowingly made a material misrepresentation to CPSC staff by underreporting the number of incidents associated with one of the ROV models and failing to report any incidents regarding two others. 

Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices of their products are rising faster than inflation.

Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million.

On May 30, 2017, New York City Mayor Bill de Blasio signed into law Bill 1387-A, which prohibits covered retail employers from engaging in so-called “on-call scheduling,” a practice that is very common and in many cases critical to the industry.

The Supreme Court issued a stunning ERISA decision on Monday, overturning the law in the three federal circuits as to what constitutes a “church plan” that is exempt from ERISA’s requirements.

On May 30, 2017, the Supreme Court issued a landmark 8-0 decision holding that when a patentee sells one of its products, the patentee can no longer control that item through the patent laws.

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. 

This week, the Supreme Court unanimously rejected the Federal Circuit’s broad reading of the patent venue statute for domestic corporations in TC Heartland LLC v. Kraft Foods Group Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017).

Charges that investor-state arbitration is undemocratic, undermines national sovereignty, and prevents necessary regulations have prompted some states to develop new approaches to the field. Recent initiatives in Africa and South America aim to readjust the system in two very different ways.

In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.

Arent Fox has learned that the Office of the US Trade Representative announced it will hold a public hearing on June 27 to discuss next steps for NAFTA renegotiations. This will follow a public comment period that will end on June 12.

As a case that has lasted fifteen years reaches its likely conclusion, the Fourth Circuit Court of Appeals has clarified the “loss causation” standard applicable to claims of ERISA fiduciary breach involving non-employer stock.

This morning, in a letter dated May 18, 2017, the United States Trade Representative sent to Congress the long awaited formal notice that the Administration intends to enter into re-negotiations with Mexico and Canada. This signifies that the NAFTA renegotiations have been formally launched.

California’s “day of rest” rules generally require employers to give employees one day off in seven days.

In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth.

A watchdog organization known as Transparentem has uncovered dire working conditions in the heavily polluted tanneries located outside of Dhaka in Bangladesh.

Ransomware is old news, as we had previously written here. Its latest iteration, the currently circulating WannaCry ransomware, is no laughing matter.