This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
In a win for policyholders relying on multiple coverage layers, the Fifth Circuit held on June 23, 2014 that an excess liability insurance policy could be triggered by exhaustion of a “retained limit” - equal to the limits of underlying insurance - even if the amounts paid to meet the “retained limit” were not covered by the excess policy. Indemnity Insurance Co. of N. Am., et. al. v. W & T Offshore Inc., -- F.3d --, No. 13-20512 (5th Cir. June 23, 2014) ...
On 26 March 2014, the Minister of Law and Human Rights (“Minister”) issued Regulation No. 5 of 2014 on Validation of Foundations (“Regulation”). Briefly, the Regulation redefines the procedures and requirements for securing approval for the name of a foundation and its validation by the Minister ...
The Supreme Court of the Republic of Indonesia has issued Circular Letter No.2 of 2014 regarding Case Settlement in the Court of First Instance and Appeals in 4 (four) Justice Fields. The Supreme Court considers that since an electronically based management case system now exists in the courts of first instance and high courts, cases should be examined and ruled on quickly ...
An employer faces a difficult situation when a temporarily disabled employee who cannot perform his or her essential job functions requests an accommodation. This situation becomes significantly more complicated when the employee receives the “accommodation,” but never recovers enough to resume performing the essential job functions ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
On 1 April 2014 amendments to the Contributions Act increasing the general rate for health insurance contributions from 13% to 15% came into force. The new contribution rate will be applied to salaries beginning in April 2014. Receipts related to previous periods will be grandfathered in at the previous applicable rate. Unused vacation for 2013 will be calculated at the 13% contribution rate and the new rate will apply to unused vacation in 2014 ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
It seems every week, there is a new story about a company being impacted by a major data breach and the consequences that follow from such breach, including the inevitable lawsuits, public relations nightmare, and governmental investigations. These breach stories are then followed by articles about the high costs to deal with these breach events, including costs to notify consumers, to identify the source of the breach, to pay for credit monitoring, among many other costs ...
Texas operators and service companies need to carefully consider how a recent trend in Texas law affects the availability of insurance coverage - for themselves and their counterparties - for contractual liability. Most general liability policies, which insure claims for bodily injury and property damage, exclude coverage for liability assumed under a contract, unless the liability either exists in the absence of the contract or was assumed in a defined “insured contract ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
On the market since the late 1990s, cyber insurance is nothing new. But as the Internet spreads deeper into people's lives, cyber risks continue to grow and evolve well past simple data loss or compromise ...
On March 28 2014 Law 642/2013 - a milestone of the government's anti-corporate raider policy - entered into force. Revival of the bill, which had previously gathered dust in parliamentary committees for several years, was a response to numerous calls from the international community to take measures to counter illegal takeovers and acquisitions of businesses ...
On April 9 last, the Superior Court of Québec issued its judgement1 on a motion for a declaratory judgment pertaining to trademarks in the English language on public signs and posters. The applicants, Magasin Best Buy Ltée, Costco Wholesale Canada Ltd, Gap (Canada) Inc., Old Navy (Canada) Inc., Corporation Guess? Canada, la Compagnie Wal Mart du Canada, Toys “R” Us Canada Ltée and Curves International Inc ...
On January 16 last, the Supreme Court of Canada refused to grant leave to appeal by Lombard following a judgment rendered on June 20, 2013 by the Ontario Court of Appeal.1 This decision deals with the issue of overlapping excess and umbrella policies. THE FACTS In January 1995, an apartment building was destroyed by fire. Six people died and many others were injured ...
Following the Supreme Court’s decision in Bridge Trustees in 2011 (see further here), the Government announced that it would legislate to directly counteract the effect of the judgement and make it clear that benefits under a pension scheme cannot be regarded as money purchase benefits if it is possible for a funding deficit to arise in respect of any of those benefits ...
The new EU Procurement directive was published in the Official Journal of the EU today (28 March 2014) and will come into force on 17 April 2014. This article summarises some of the key changes from the new Directive which are likely to be of interest to both the public and private sector. The UK will have 2 years to implement the Directive but the government has suggested that it will be implemented in a shorter timescale ...
The Executive Branch announced days ago the 3 main investment projects which will be promoted under the Public-Private Partnership regime in Paraguay. With the enactment in the month of March of the Regulatory Decree of the Public-Private Partnership Law (Law 5102/2013), the projects are expected to be advanced immediately ...
On March 20, 2014, the Supreme Court of Canada granted Réjean Hinse leave to appeal a decision involving an action in damages he brought against the federal authorities, represented by the Attorney General of Canada. In 1964, Mr. Hinse was wrongly convicted of taking part in an armed robbery and ordered to serve fifteen (15) years in prison. He was acquitted by the Supreme Court of Canada in 1997, thirty-three (33) years later. After he was acquitted, Mr ...
NEW CVM DECISION SIMPLIFIES TRANSACTIONS INVOLVING PRIVATE INVESTMENT IN PUBLIC EQUITY (PIPEs) At a meeting held on January 7, 2014, the majority of the Brazilian Securities and Exchange Commission (“CVM”) Board (Colegiado) accepted the appeal lodged by João Fortes Engenharia S.A., within the context of CVM Proceeding No ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
On 3 March 2014, the Government presented the bill ”Enhanced competition supervision” (Sw: “Förbättrad konkurrenstillsyn”) (Governmental Bill, prop. 2013/14:135) which contains several suggested changes to the Swedish Competition Act which relate, inter alia, to leniency and the possibility to suspend time limits during merger control assessments ...
A year ago, President Obama issued Executive Order 13636, or "Improving Critical Infrastructure Cybersecurity." The order concerned "critical infrastructure," which it defined as "systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety or any combination of those matters ...
