Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
The H-1B visa filing frenzy is upon us once again! Because of the chronic shortage of nonimmigrant visas for foreign workers in the specialty occupation category (H-1B visas), employers seeking to hire new H-1B workers must file their petitions on April 1, 2014 for work beginning October 1, 2014 ...
On March 2, 2017, the California Supreme Court issued its much anticipated decision in the City of San Jose v. Superior Court of Santa Clara County case. In short, the Court determined that when a public official or employee uses a personal account to communicate about the conduct of public business, the writings are subject to disclosure under the California Public Records Act, if those writings are not otherwise exempt from the disclosure requirements ...
The February 14 decision in a closely watched Fourth Circuit False Claims Act (FCA) case did not, as initially anticipated, address the issue of the validity of statistical sampling to establish FCA liability. However, it did address another question that has split the circuits—whether the U.S. Department of Justice has the unreviewable right to veto FCA settlements in cases in which it has declined to intervene. See United States ex rel. Michaels v. Agape Senior Community, et al ...
On March 2, 2017, the California Supreme Court determined that when a public employee uses a personal account to communicate about the conduct of public business, the communications are subject to disclosure under the California Public Records Act (CPRA), if those communications are not otherwise exempt from disclosure. In a unanimous opinion, the Court in City of San Jose v ...
The Trump Administration has signaled its intent to roll back the scope of federal jurisdiction under the Clean Water Act in an Executive Order issued on February 28. The Executive Order directs U.S. EPA and the Corps of Engineers to consider rescinding or revising the "Clean Water Rule," which defines when the Clean Water Act applies to wetlands, ponds, intermittent streams, and other water bodies that have a "significant nexus" to "navigable waters ...
The February issue of the International Financial Law Review (IFLR) includes an international briefing article by SyCipLaw partner Aaron Roi B. Riturban entitled “Philippines: Promoting foreign investment”. The article focuses on Republic Act no. 10881, which lifts the foreign investment limitations found in laws governing adjustment companies, lending companies, financing companies, and investment houses. Read the article online at the IFLR website ...
The Latest News from the Canadian Infrastructures Market Defense Construction Canada Issues a Request for Expressions of Interest for Energy Performance Contract Defense Construction Canada (DCC) has issued a Request for Expressions of Interest, dated December 20, 2016, for improvements in energy efficiency contracts covering nine military facilities across Canada (Québec, Ontario, Alberta, Nova Scotia and New Brunswick) ...
View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
ARIPO Developments: Amended Harare Protocol on Patents and Industrial Designs The African Regional Intellectual Property Organization’s (“ARIPO’s”) amended Harare Protocol on Patents and Industrial Designs (the “Protocol”), came into effect on 1 January 2017 and includes some important changes ...
The Mauritian Limited Liability Partnerships Act, 2016 – what you need to knowDo LLPs have independent legal personality? The Mauritian Limited Liability Partnerships Act, 2016 (the “Act”) came into force on 3 January 2017, and provides for the establishment of limited liability partnership (“LLP”) structures in Mauritius. The LLP is a welcome and awaited addition to the various types of vehicles that can be created in Mauritius ...
The SEC’s Office of Compliance Inspections and Examinations recently announced its 2017 examination priorities for broker-dealers, investment advisers, and investment funds. OCIE, which serves as the “eyes and ears” of the Commission, identified the current staff’s priorities as a focus on (i) matters of importance to retail investors, (ii) risks specific to elderly and retiring investors, and (iii) assessing market-wide risks ...
On January 20, 2017, in a case of first impression among the appellate courts, a panel of the Ninth Circuit concluded in Syed v. M-I, LLC (Case No. 14-17186) that an employer violates the Fair Credit Reporting Act (FCRA) when its background check disclosure/authorization document includes a sentence that releases the employer, the consumer reporting agency (the vendor), and their agents from liability for any violations of the FCRA ...
The False Claims Act, 31 U.S.C. §§ 3729, et seq. (FCA) continued to be a significant focus of government and whistleblower activity in 2016. ThisYear in Review highlights several key developments, including: The U.S. Department of Justice is continuing its strong enforcement of the FCA, including recovering more than $4.7 billion in settlements and judgments in FCA cases in 2016, as well as continuing its focus on individual culpability ...
In its most important constitutional judgment ever, the UK Supreme Court has this morning confirmed that the UK Parliament in Westminster, rather than the British Government, must decide on the UK’s withdrawal from the European Union (EU). The Court has in this respect upheld the decision of the High Court as reported in our “Brexit Update ...
The Board of Supervisors unanimously approved legislation on December 13, 2016 to provide developers of market rate projects with 24 or fewer dwellings with the option of contributing the required fees for off-site affordable housing (under the Inclusionary Housing Program) to a Small Sites Fund administered by the Mayor's Office of Housing and Community Development ("MOHCD") ...
The election of Mr. Donald J. Trump as President of the United States has resulted in much consideration by corporates of existing strategies with respect to Iran. Mr. Trump’s lack of experience in public office and some of his election campaign statements continue to cause anxiety. Will Mr ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year. Employers also must provide copies of the reports to their full-time employees ...
The December/January issue of the International Financial Law Review (IFLR) included an international briefing article entitled “Philippines: Competition Law Updates”. The article was contributed by SyCipLaw partners Franco Aristotle G. Larcina and Arlene M. Maneja. The article discussed the new merger form issued by the Philippine Competition Commission on August 31, 2016. Read the article online at the IFLR website ...
On January 1, 2017, most public works projects in California will be subject to new procedural requirements applicable to claims from contractors ...
The Serbian Parliament has recently adopted amendments to the Criminal Code. The amendments include a significant overhaul of the legal framework for white collar crimes, touching upon the rules relevant for antitrust enforcement as well. While the Serbian Criminal Code previously penalized antitrust infringements spearheaded by the responsible managers, the relevant provision was relatively vague and targeted chiefly dominance abuse ...
