In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
As we indicated a few months ago, the partial reform of the intellectual property law continues its journey towards the Lower House of the Spanish Parliament. On Friday, February 14, the Cabinet approved the text of the preliminary bill, which must now get the green light from the consultative bodies and be debated in Parliament as a bill before its definitive approval. The main lines of the approved text are those we advanced in our previous post: 1 ...
In a landmark case in Australia that is a first of its kind (but undoubtedly will not be the last), damages have been awarded to New South Wales school teacher, Mrs Christine Mickle, for offensive and defamatory tweets and Facebook posts made by an ex-student of the school where she taught. The student, Andrew Farley, apparently held a grudge against Mrs Mickle for playing what he perceived as a role in the removal of his father from the position of head music teacher at the school ...
Following a period of consultation, the Government has confirmed that legislative changes will be made to ensure that “protected persons” will not be affected by the statutory amendment power being introduced as part of the abolition of defined benefit contracting-out ...
CMS recently announced yet another delay to the full implementation of “two midnight rule,” which revises its longstanding guidance to hospitals and physicians relating to when hospital inpatient admissions are deemed to be reasonable and necessary for payment under Medicare Part A. Specifically, this latest “delay” is the result of CMS’s extension of the “Probe & Educate Period,” a period of partial non-enforcement for the two midnight rule requirements, until September 30, 2014 ...
On January 27, 2014, the parliamentary secretary of the Canadian Minister of Foreign Affairs tabled five treaties in the House of Commons dealing with intellectual property, of which three relate to trademarks ...
The Affordable Care Act, in a largely overlooked provision, bestowed broad powers on the Centers for Medicare and Medicaid Services (CMS) to impose a moratorium on the enrollment of new Medicare or Medicaid providers, including whole categories of providers in certain geographic locations ...
The moniker "spam" for unsolicited and often indiscriminate electronic communications to multiple mailing lists, individuals, or newsgroups derives from a famous sketch in the British television comedy series Monty Python's Flying Circus. However, these days spam is no joke. It is a scourge on modern communications ...
St. Luke’s Health System’s 2012 acquisition of Saltzer Medical Group, Idaho’s largest independent multi-specialty physician practice group, violated federal and state antitrust laws according to a U.S. District Court holding issued on Friday, January 24, 2014. The Court ordered divestiture of the practice. The FTC and the Idaho Attorney General filed the Complaint seeking to block the sale on March 12, 2013. In response, St ...
Most marketers and retailers know that the consumer protection laws require that their advertising claims be substantiated, truthful and not misleading. But the new year is a good time to take stock of advertising campaigns, practices and procedures to make sure they pass muster under the Federal Trade Commission’s (FTC’s) latest guidance. The FTC’s recent enforcement actions provide a starting point ...
On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...
For more than twenty years, the federal government has attempted to limit the number of unsolicited phone calls consumers receive through the Telephone Consumer Protection Act, 47 U.S.C. § 227 (“TCPA”), which is perhaps best known for governing the famous “Do Not Call” list. Businesses, including banks and financial institutions, must understand the statute and stay abreast of its changes because the penalties for violating the TCPA are steep ...
Why Proportionality Should Be Considered As Part of the Preservation Parties have a general duty to preserve and produce relevant electronically stored information (ESI). This duty, however, is bounded by a proportionality requirement because e-discovery should not be allowed to be the tail that wags the dog. Courts and parties have been adept at applying proportionality requirements to the production of ESI, but they have struggled to apply proportionality to the preservation of ESI ...
We’ve written about the new Generic Top Level Domains (gTLDs) on more than one occasion. This refers, of course, to the process whereby companies and organisations can register names – generic words, geographical names, brand names - as top level domain names. So, in the same way that there’s long been .com, .net and .info, you can now have .bank, .google and .capetown. Some 1900 applications have already been filed ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
These days, it seems as if every passing week brings with it a new story in the press about the legal risks of engaging with social media. We have heard much recently about the dangers of defamation on Twitter.Earlier this year, Sally Bercow learned to her cost just how easy it can be to libel someone without explicitly accusing them of anything, after sharing a message about Lord McAlpine with her Twitter followers: "Why is Lord McAlpine trending? *innocent face*" ...
More than three years after first announcing that it was considering issuing regulations applying the Americans with Disabilities Act to websites, the US Department of Justice (DOJ) appears on the verge of announcing its proposed rules for website accessibility. While the DOJ originally stated that it anticipated issuing its Title II website accessibility rules for websites operated by state and local governments by November 2013, it now expects to issue these rules by the end of the year ...
In recognition of the increasing popularity in the market of asset-backed contribution arrangements (ABCs), the Pensions Regulator has issued detailed guidance for trustees considering using such a structure to fund their pension scheme. ABCs, in general terms, allow an employer operating a defined benefit pension scheme to use a non-cash asset to provide a regular income stream to the scheme without an outright disposal of the asset to the scheme ...
The 83rd Texas Legislature passed legislation to simplify the process by which physicians supervise and delegate to Physician Assistants (PAs) and Advance Practice Registered Nurses (APRNs). This article summarizes the rules recently adopted by the Texas Medical Board (TMB) to implement SB 406 (83R) ...
Starting in January 2014, everyone will be required to purchase health insurance. If you are someone whose company already provides you with insurance, you can probably skip this article. But if you are elderly, purchase your insurance privately, or are one of the 24.2 percent of Texans without health insurance, you might want to read on ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 22, 2013, the National Institute of Standards and Technology (“NIST”) issued the Preliminary Cybersecurity Framework (the “Preliminary Framework”), as required under Section 7 of the Obama Administration’s February 2013 executive order, Improving Critical Infrastructure Cybersecurity (the “Executive Order”). The Preliminary Framework includes standards, procedures and processes for reducing cyber risks to critical infrastructure ...
