Alerts

The Health Resources and Services Administration, as administrator of the 340B Drug Pricing Program on behalf of the Department of Health and Human Services (HHS), published its proposed 340B Drug Pricing Program Omnibus Guidance on August 28, 2015.

Despite the setbacks in Maui last month during the last ministerial meeting of the Trans-Pacific Partnership (TPP)[1] many still believe that the negotiators will resolve all outstanding items so that an agreement can be signed by the end of 2015 and implemented in the Spring 2016.

Federal contractors and subcontracts have become the next group of employers who will have to provide paid sick leave. On Labor Day, September 7, 2015, President Barack Obama signed an Executive Order granting paid sick leave for Federal contractors and subcontractors.

Recently, the Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion issued a Warning Letter to drug maker Duchesnay, Inc., after reality TV star Kim Kardashian endorsed the company’s morning sickness drug, Diclegis, on her Instagram account.

Earlier this summer, Los Angeles hosted the Special Olympics World Summer Games at venues throughout the city. The games featured more than 6,400 athletes from 177 countries who competed in 27 sports, including aquatics, gymnastics, track and field, basketball, football, tennis, and volleyball.

Last week, in a sharply divided opinion, the National Labor Relations Board (NLRB or Board) reconsidered the long-standing standard for a “joint-employer” finding under the National Labor Relations Act (NLRA or Act).

Purchasers and restructurers of California companies can rest a little easier after last Thursday’s landmark ruling by the California Supreme Court.

David S. Greenberg co-authored an article published in Bloomberg BNA’s Medicare Report on the implications of the Centers for Medicare & Medicaid Services’ proposed revisions affecting long-term care facilities participating in Medicare and Medicaid programs.

In the past five years, few topics have dominated litigation over employment agreements quite as significantly as class-action arbitration waivers.

A federal judge in the Southern District of Ohio recently issued a temporary restraining order in a dispute between the National Association for the Advancement of Colored People (NAACP) and former members of the now-inactive NAACP, Cincinnati Branch (“the Cincinnati Branch”).

On May 20, 2015 the Bureau of Industry and Security (BIS) within the Department of Commerce (Commerce) published a proposed rule that will affect exports of products dubbed “cybersecurity items.”

Ever since football players at Northwestern University sought union certification in January 2014, their case has been closely watched by many in both the labor and sports arenas.

On August 5, 2015, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 15-11.

On August 7, 2015, the US District Court for the Southern District of New York issued a significant decision concerning FDA’s regulation of off-label promotion of approved drugs.

On July 22, 2015 the Bureau of Industry and Security (BIS) amended the Export Administration Regulations (EAR) to reflect the May 29, 2015 removal of Cuba from the list of state sponsors of terrorism.

The US Court of Appeals for the Third Circuit recently ruled that a suspension with pay generally does not constitute an “adverse employment action” under the substantive discrimination provision of Title VII. Jones v. Southeastern Pennsylvania Transportation Authority.

On August 3, 2015, the New York Attorney General announced settlements with five retailers who violated state law that prohibits the sales of realistic-looking toy guns. As part of the agreement, the retailers will halt sales of the violative products and pay more than $300,000 in penalties.

On July 28, 2015, Mead Johnson Nutrition Company, an Illinois-based pediatric food producer, settled FCPA charges brought by the SEC for over $12 million.

On Monday, a federal district court judge in New York issued a ruling that, if adopted broadly, will have a significant – and potentially nightmarish – impact on any provider who receives an overpayment from Medicare or Medicaid.  Kane v. Healthfirst, Inc. and U.S. v. Continuum Health Partners Inc. 

Major US credit card associations including Visa, MasterCard, American Express, and Discover have set October 1, 2015, as the deadline for merchants to implement the Europay, MasterCard, and Visa (EMV) standards.

On July 30th, the Department of Justice petitioned the US Supreme Court to reverse United States v. Newman, 773 F.3d 438, 438 (2d Cir. 2014), a high-profile insider-trading decision by the Second Circuit that curtailed tipper-tippee liability.

On July 27, 2015, the Food and Drug Administration published a Supplemental Proposed Rule (SPR) that amends its Proposed Rule on Nutritional Labeling published on March 3, 2014.

The following alert is the fifth installment from Birgit Matthiesen for a planned series of cross-border trade updates. 

The Fourth Circuit has recently made it more difficult for false advertising plaintiffs to survive a motion to dismiss where their claims are based on an allegation of “literal falsity.”

A recent court ruling is a good reminder to health care providers that bankruptcy may not (as is sometimes suggested) be a safe harbor for providers in danger of being forced out of business by the loss of their Medicare and Medicaid provider agreements.