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 ...
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 ...
In a decision issued on February 13, the New York Court of Appeals ruled that a policy’s contractual limitations provision requiring suit to be filed within two years of a loss is “unreasonable and unenforceable” when the insured’s property cannot be reasonably replaced (as necessary to fulfill a separate condition of coverage) within the two-year limitations period ...
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 Friday, January 17, 2014, the Texas Supreme Court issued its opinion in Ewing Construction Company v. Amerisure Insurance Company - holding that “a general contractor who agrees to perform its construction work in a good and workmanlike manner, without more, . . . does not ‘assume liability’ for damages arising out of its defective work so as to trigger the Contractual Liability Exclusion ...
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13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of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 ...
Last December 23, the Supreme Court of Canada partially overturned the decision of the Quebec Court of Appeal in the case of Cinar Corporation v. Robinson1 and reinstated most of the conclusions of the Quebec Superior Court. BACKGROUND In the 1980s, Claude Robinson (“Robinson”) developed a project for a television series entitled “The Adventures of Robinson Curiosity” (“Robinson Curiosity”). He partnered with Pathonic to whom he had presented his project ...
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 ...
A recently unsealed decision from the United States District Court for the District of Maryland demonstrates that insurers cannot hide behind the attorney-client privilege and work-product doctrine to shield claim files from discovery. The court made clear that involving counsel in claim handling does not operate to make either doctrine automatically apply. Charter Oak Fire Ins. Co. v. Am. Capital Ltd., No. 8:09-cv-100 (D. Md. Nov. 6, 2013) ...
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 ...
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 ...
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 ...
As the fiscal year came an end at midnight on September 30, the House and Senate were unable to reach an agreement to fund the federal government and avoid a government shutdown. As a result, the White House Office of Management and Budget (OMB) has issued the order to implement the shutdown of the federal government. Although essential functions such as public safety and benefit payments will continue, the shutdown impacts all agencies funded through the annual appropriations process ...
Whether you call it a “shutdown” or a “slowdown,” the lack of a fully-funded federal government is impacting more than the 800,000 federal workers furloughed since October 1.1 According to economic consulting firm, IHS Global Insight, the federal budget debacle will cost $1.6 billion per week in lost gross domestic product ...
After two years of operations, the SEC’s whistleblower program announced its first multimillion dollar award - a record $14 million payment to an anonymous tipster. The award is the largest of three announced since the program’s inception and emphatically signals the SEC’s continuing emphasis on its whistleblower program ...
When bankers and First Amendment lawyers encounter each other at cocktail parties, they can struggle to find common interests. Here is something to break the ice. In July 2010, President Obama signed into law the Dodd-Frank Act, the most comprehensive series of financial regulatory reform measures since the Great Depression. Just one year later, the United States Supreme Court issued Sorrell v. IMS Health, Inc., 131 S. Ct ...
Following a period of consultation, the Government has published regulations in relation to bridging pensions which will come into force on 1 October 2013. A number of pension schemes contain provisions dealing with bridging pensions, where a greater pension is paid from the scheme until the member reaches state pension age. As the state pension age is due to be increased over time the original provisions may no longer be appropriate ...
On March 1, the Fifth Circuit Court of Appeals ruled that $750 million of primary and excess coverage issued to Transocean Holdings, Inc. (“Transocean”) “imposes no relevant limitations upon the extent to which BP [BP American Production Company] is covered” as an additional insured in connection with the Deepwater Horizon incident in April 2010 ...
