FDA announced it will open a public docket and hold an Immunology Devices Panel meeting to deliberate the potential for patients who receive medical device implants that contain select metal or metal alloys to develop immune and inflammatory reactions. The panel may provide input on scientific information the FDA should consider as part of premarket review and postmarket surveillance of metal-containing implants and dental amalgams ...
As early as September 23, 2019, the United States House of Representatives is expected to vote on the widely anticipated Secure and Fair Enforcement (SAFE) Banking Act ...
On Thursday, September 12, the Third Circuit decided United States ex rel. Chang v. Children’s Advocacy Center of Delaware, No. 18-2311. In a precedential decision, the panel held that when a relator has not requested a hearing on a government motion to dismiss a federal False Claims Act (FCA) qui tam action, the court is not required to hold an in-person hearing before dismissing the action ...
For the past few decades, Panama has established public-private partnerships (“PPPs”) in projects as diverse as toll roads, water treatment plants, ports, telecommunications networks and the generation and distribution of electricity ...
On Monday, Sept. 9, 2019, the National Labor Relations Board (NLRB) issued its decision in The Boeing Company and International Association of Machinists and Aerospace Workers, adopting a three part test for determining whether a bargaining unit is appropriate under the analysis set forth in PCC Structurals, Inc., 365 NLRB 160 (2017) ...
The two financial centres have long been considered twins, but where do the similarities end and the differences begin? Hong Kong, now entering its 15th week of protests, has been filled with increasingly incendiary rhetoric and escalating violence. This past weekend saw protesters lighting fires at an MTR station entrance, just outside the uber-luxe Bulgari boutique in Central ...
The Association of Fire Prevention Enterprises of Cambodia (“AFPE”) in conjunction with the National Quality Inspection Centre for fire Safety Systems (“NICS”) hosted a seminar on 9 September 2019 on the introduction of the National Standard Book on Fire Safety Systems – Building Design Code ...
The rapid development of technology in the modern era has required more effective and efficient case and court administration services. In addition, Article 2 (4) of Law Number 48 of 2009 on Judicial Powers requires the justice system to be simple, quick and low cost. For this reason, the Indonesian Supreme Court saw a need to reform the administrative and justice system in order to overcome the existing obstacles and challenges of administering the justice system ...
The Cape Town Convention on International Interests in Mobile Equipment of 16 November 2001 (the the “CTC”) and its Protocol on Matters Specific to Aircraft Equipment has since its adaption in 2001 grown to be the overruling legal framework in the aviation industry, providing banks, airlines and leasing companies with an international unified regime on acknowledgement and enforcement of security interests in aircraft ...
For the first time, the Irish High Court has been asked to make a blocking order in regard to the illegal live streaming of Premier League games. Instead of watching Premier League games through legitimate and licensed services, some people were seeking to do so free of charge ...
The High Court of Justice held that travel agents are not permitted to sell insurance products for outside of Israel. This is in accordance with the decision of the Ministry of Finance’s Commissioner of Capital Markets, Insurance and Savings. In July 2019, the High Court of Justice rendered its decision in the matter 2969/19 The Israel Association of Travel Agencies and Consultants v. The Commissioner of the Capital Markets, Insurance and Savings Authority ...
As of August 7th, 2018, the amendments of the Consumer Protection Law (CPL), which includes for the first time, the consumer protection in the field of electronic commerce (e-commerce), taking that as the contracting process or the goods, services and commercial information trading through data communication webs ...
CalPERS Announces New Administrative Fees for Section 218 Agreements The California Public Employees' Retirement System (CalPERS), the California State Social Security Administrator (SSSA), announced in July that it will begin charging new administrative fees to public agencies for Section 218 Agreements to pay the cost of administering the SSSA program ...
The German Federal Ministry of Justice and Consumer Protection (BMJV) has submitted its long-awaited proposal for a Corporate Sanctions Act (VerSanG). When corporate crimes are committed, it is making provisions for independently prosecuting the entire organization in addition to prosecuting single perpetrators ...
Frithjof Herlofsen of Simonsen Vogt Wiig successfully represented an Italian shipowner in a loss of hire cover dispute against Gard. The rushed response of the Nordic Plan Revision Committee to include "Anti-Hamburg" wording in the revised 2019 Commentary to the Nordic Plan raise several concerns. Overview ...
In what appears to be a first under the False Claims Act, a case based on flawed cybersecurity has been settled, for nearly $9 million. On July 31, 2019, the Attorney General of New York announced that, alongside the U.S. Department of Justice, New York, eighteen other states, and the District of Columbia have reached an $8.6 million settlement with Cisco Systems, Inc. (“Cisco”) over sales of surveillance video software allegedly vulnerable to hacking ...
On September 1, 2019, AB2342 and its new timing requirements for issuing certain eviction notices and for answering eviction lawsuits go into effect in California. AB2343 amends California Code of Civil Procedure Sections 1161(2) and (3) regarding 3-day notices to pay or quit and 3-day notices based on neglect or failure to perform other conditions or covenants of the lease or agreement ...
The Bureau of Cannabis Control recently published two new fact sheets on its website as a resource for industry stakeholders, licensees, and the general public. The facts sheet help everyone better understand the different responsibilities of the cannabis distributor (Type 11) and the cannabis distributor transport only (Type 13) licensee by providing a list of required procedures and guidelines for various distribution activities ...
If, in the course of an in-depth assessment, the EU Commission finds that an unlawfully granted aid is incompatible with the internal market, it is obliged under Article 16 of the Procedural Regulation 2015/1589 to order the recovery of the aid by the Member State. On 23 July 2019, the Commission published an updated notice on recovery (2019/C 247/01) ...
Although under the Treaty on the Functioning of the European Union, the European Commission has limited power regarding infrastructure policy, which remains a Member state competence, recent rulings of the ECJ regarding ports and airports have allowed it to extend its role in this area by applying the State aid rules to infrastructure financing ...
On August 6, 2019, the Fifth Circuit Court of Appeals issued a panel opinion in the case of Texas v. EEOC at al., Case No. 18-10638 (5th Cir. August 6, 2019), that looks to significantly impact the way employers may choose to treat employees or applicants with criminal backgrounds. Background In April 2012, the EEOC issued “Enforcement Guidance on the Consideration of Arrest and Conviction Records in Employment Decisions Under Title VII” (Guidance) ...
Financing in the shipping industry has changed and will continue to change in the following years. The new IMO 2020 Regulations on low sulphur fuel and the IMO strategy on greenhouse gas emissions (GHG emissions) put more pressure on the shipping industry in the aftermath of the worldwide financial crisis. The need for the development of new financial structures in the shipping industry was therefore profound ...
