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 ...
In the context of a dispute between a Turkish agent and a Belgian principal, the Commercial Court of Ghent (Belgium) referred a request to the Court of Justice of the EU (CJEU) concerning the legal protection of a Turkish agent under Belgian/EU law. The agent and principal had expressly agreed that their agency agreement was subject to Belgian law ...
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") ...
'Close of business' is a term many people use in their day to day working life without much thought. But what does it actually mean and should the term be used in contractual documentation? Agreeing to get something done by 'close of business' is a phrase often used when flexibility is required as to the time a task will be completed. It makes it clear the task will be done that day, but not by a particular time ...
In a decision rendered on December 1, 2016, the Superior Court of Québec had to rule on a situation which, until that time, was completely novel, and to determine whether lawyers can act in a court action against former employees of a client whom they still have to work with in connection with another related proceeding. The Court declared that the lawyers were disqualified ...
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 ...
The superintending and reforming power of the Superior Court of Québec over the decisions of the Court of Québec is indisputable. It is furthermore confirmed by article 34 of the Code of Civil Procedure1, which grants to the Superior Court powers to judicially review decisions made by the Québec courts, with the exception of the Court of Appeal ...
In its recent judgment of 21 December 2016, the Tournai Commercial Court (‘Court’) declared it did not have jurisdiction to deal with a dispute concerning the termination of an exclusive distributorship that the parties had agreed to submit to arbitration. This judgment was based on the new definition of arbitrability in the Belgian Judicial Code, which entered into force in 2013, and marks a new era for the arbitrability of Belgian distributorship law disputes ...
Disclosure is an essential part of litigation and arbitration under English law as it usually provides both parties with access to the contemporaneous documents which support or adversely affect a party’s case. The exponential growth in recent years of the number of electronic documents created during the course of a project has increased the size and, as a result, the cost of the disclosure exercise ...
It is becoming increasingly common to see allegations of misrepresentation made in shipbuilding and offshore construction disputes ...
accounts throughout Europe with one single order. EU Regulation 655/2014 of 15 May 2014 establishing a European Account Preservation Order procedure to facilitate cross-border debt recovery in civil and commercial matters (‘EAPO Regulation’) came into force on 17 July 2014 and applies from 18 January 2017 ...
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 ...
November 2016: In the recent Singapore High Court decision of The Enterprise Fund II Ltd v JongHee Sen [2016] SGHC 259, Judicial Commissioner Hoo Sheau Peng (the "Judge") considered whether “withoutprejudice” privilege ("WP Privilege")applied to certain communications between the parties and, consequently,whether those communications could be received into evidence ...
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 ...
On December 22, 2016, in Augustus v. ABM Security Services, Inc., Case No. S224853, the California Supreme Court issued a split decision on rest periods. In a decision in which four justices concurred, and two concurred and dissented, in part, the Court held that employers “must relieve their employees of all duties and relinquish any control over how employees spend their break time ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
A federal appeals court has rejected two challenges to the environmental review of the Los Angeles County Metropolitan Transportation Authority's (Metro's) planned subway expansion in Downtown Los Angeles. The "Regional Connector" project, approved in 2012, will create a three-station, underground link through Downtown that will allow passengers to travel from points on the Metro Gold Line to the Blue and Expo lines without having to transfer trains ...
The November 2016 issue of the Asian Legal Business (ALB) includes a regional update article entitled “Evidentiary Issues in Arbitration”, contributed by SyCipLaw Partner Ramon G. Songco and Associate Arvin Kristopher A. Razon. The article enumerated and discussed the laws that aimed to address concerns in resolving disputes in arbitration, such as how evidence is presented, assessed for relevance and competence, and protected during arbitration proceedings ...
Although neither of the parties objects to solving the dispute in the state court, the Supreme Court of Lithuania sends the parties to arbitration after it discovers a prior written agreement to arbitrate. The issuer of a promissory note (Claimant) requested the state court to declare the promissory note null and void ...
Article 257 of the UAE Penal Code (Federal Law No. 3 of 1987) was recently amended by Federal Law No. 7 of 2016 to introduce the concept of criminal liability for arbitrators, experts, and translators who issue decisions and opinions ‘contrary to the duties of impartiality and honesty’ ...
Much has been written regarding the enforcement of foreign arbitral awards in China, but relatively little consideration is given to the treatment in U.S. courts of awards entered by the China International Economic and Trade Arbitration Commission (CIETAC), or to the enforcement of CIETAC arbitration agreements. In fact, CIETAC arbitral awards are rejected by U.S ...
1. Pharmaceutical market players mostly deal with two regulators These are the Ministry of Healthcare of Ukraine (MOH) and the State Administration of Ukraine on Medicinal Products and Narcotic Drugs Control (SAUMP). The MOH is responsible for state registration of medicines, while the SAUMP deals with licensing, evaluation of good manufacturing practice (GMP) compliance, control over quality of medicines, and regulation of medical devices. 2 ...
Arbitral institutions strive to provide the parties they serve with a fair and impartial dispute resolution process that results in an unassailable final award. Since “evident partiality” in the arbitrators is one of the limited means to attack an award, the selection of unbiased arbitrators is fundamental to that goal, and most arbitral institutions have some requirement or guidance on arbitrator disclosures ...
On August 28, 2016, the Israeli District Court of the Central District issued a decision regarding the right of publicity under Israeli Law (In re Fundacio Gala Salvador Dali v. V.S Marketing (Israel 2005) Ltd.). The right of publicity is the right of a person to financially exploit his name, picture or voice ...
