In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment.
The new partnership tax audit rules enacted by Congress on November 2, 2015 could have a dramatic impact on partnerships and their partners (including limited liability companies taxed as partnerships (“LLCs”) and their members).
On August 31, 2016, California took a long-awaited step in publishing new major changes to the Proposition 65 warning regulations; the first of such amendments in more than a decade.
FDA continues to maintain an aggressive enforcement stance against cosmetics/personal care product companies and has already issued a record 19 Warning Letters to such companies so far in 2016.
Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs).
Employers who do business in Montgomery County, Maryland, should be ready to comply with the requirements of the County’s Earned Sick and Safe Leave Law, which becomes effective October 1, 2016.
The US Food and Drug Administration published a Final Rule in the Federal Register on September 6, 2016, which establishes that Over-the-Counter consumer antiseptic wash products containing one of 19 specific active ingredients (listed below) can no longer be marketed.
As Congress returns from its summer recess and begins wrapping up its work for the remainder of 2016, one of the many outstanding issues is FDA regulation of cosmetics and personal care products.
On August 29, 2016, the Equal Employment Opportunity Commission (EEOC or Commission) issued its Final Enforcement Guidance on Retaliation and Related Issues (the Guidance).
The Supreme Court case involving Spokeo and Thomas Robins, a consumer whose information was included in the search engine's reports, highlights the limitations to a consumer's ability to enforce their rights under the Fair Credit Reporting Act (FCRA).
In a 2-1 decision, a panel of the National Labor Relations Board (NLRB or Board) held that a confidentiality provision in a settlement agreement did not violate Section 8(a)(1) of the National Labor Relations Act (NLRA or Act).
Non-profit organizations that utilized tax-exempt bonds to finance their facilities have, since 1997, been confronted with somewhat complex and highly formulaic Federal tax rules governing how they may engage third parties to manage their facilities, commonly known as the Management Contract Rules.
On August 2, 2016, the IRS issued long-awaited proposed regulations that apply to valuation discounts for transfers of ownership interests in family-controlled entities.
This survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes.
In a 2-1 decision, a panel of the US Court of Appeals for the Ninth Circuit became only the second appeals court to agree with NLRB that class action waivers in employee arbitration agreements violate the National Labor Relations Act, adding greater uncertainty to this area of the law.
A new duty evasion investigation process, implemented through interim regulations issued by Customs and Border Protection on August 22, has the potential to be a game changer for a lot of importers.
Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state.
On August 12, 2016, the Health Resources and Services Administration published a proposed rule setting forth the requirements and procedures of the administrative dispute resolution process applicable to all covered entities and drug manufacturers participating in the 340B Drug Pricing Program.