Narrow Construction of Food & Drug Act Undermines FDA Regulation, Class Actions A divided panel of the Second Circuit Court of Appeals in New York overturned on First Amendment grounds the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce, an offense more commonly referred to as off-label marketing. The decision, United States v. Caronia, No. 09-5006-cr (2d Cir. Dec ...
On October 15, 2012, Spilman Thomas & Battle, PLLC filed suit in the D.C. Circuit Court of Appeals on behalf of the Independent Petroleum Association of America (“IPAA”) and six other state-level oil and gas associations (PA, WV, OH, KY, IL, IN), (referred to herein as “the Associations”) challenging the U. S. Environmental Protection Agency’s (“EPA”) New Source Performance Standards (“NSPS”) promulgated for the oil and natural gas industry on August 16, 2012 ...
On November 26, 2012, the Department of Health and Human Services’ Office of Civil Rights (“OCR”) published guidance on the two methods for de-identifying protected health information (“PHI”) in accordance with the HIPAA Privacy Rule ...
The rapid growth of the hospice industry has attracted the attention of Congress and federal and state healthcare regulatory and enforcement agencies. The Patient Protection and Affordable Care Act (the “ACA”), signed into law by President Obama on March 23, 2010, included several provisions aimed at hospice providers ...
On November 15, 2012, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) issued a report titled “Personal Care Services: Trends, Vulnerabilities, and Recommendations for Improvement,” which included a response from the Centers for Medicare and Medicaid Services (CMS) ...
Skilled nursing facilities (SNFs) billed one-quarter of all claims in error in 2009 – resulting in $1.5 billionin inappropriate Medicare payments – according to a report released by the Department of Health and Human Services’ Office of Inspector General (OIG) on November 9, 2012. The OIG noted that the majority of the inappropriate claims were upcoded, and many involved claims for so-called “ultrahigh therapy ...
On October 15, 2012, IOGA-WV, the Independent Petroleum Association of America (“IPAA”) and five other state-level oil and gas associations filed suit in the D.C. Circuit Court of Appeals challenging the U. S. Environmental Protection Agency’s (“EPA”) New Source Performance Standards (“NSPS”) promulgated for the oil and natural gas industry on August 16, 2012 ...
As Denmark is situated between the North Sea and the Baltic Sea, the prevailing weather conditions suggest that wind power should constitute a major part of the country's total power production. While onshore wind turbines have dominated the Danish landscape for decades, offshore wind turbine parks have been erected in Danish waters in recent years ...
The General Medical Council has issued definitive guidance on doctors' duties when they fear a child in their care is suffering from abuse. The GMC's 2012 Guidance on Child Protection came into effect on 3 September 2012 after a two-year working group - chaired by a senior family court Judge, the Right Honourable Lord Justice Thorpe - listened to evidence given by child protection experts ...
On 15 October 2012, the Federal Government announced the appointment of an expert panel to review pharmaceutical patents in Australia (Review). The Review will focus particularly on the extension of term provisions in Chapter 6, Part 3 of the Patents Act 1990 (Cth). Those provisions currently allow the extension of pharmaceutical patents up to five years beyond their standard 20-year term ...
B.C. Environment Minister Terry Lake and Energy, Mines and Natural Gas Minister Rich Coleman refused to issue an Environmental Assessment Certificate (“EAC”) to Pacific Booker Minerals Inc. for its proposed Morrison Copper/Gold Mine project near Smithers, at the headwaters of the Skeena River ...
Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent Lithuania’s bank bankruptcy story would not repeat itself. Sometimes people still associate the term “bank” with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are widespread in the EU and other countries of the world ...
BackgroundIndustrial activities are of great importance to Europe’s financial wealth. Industrial emissions, however, cause environmental pollution and industrial emissions constitute a major part of Europe’s total emissions to air, water and soil. Consequently, there is a need for regulation of industrial operations at an EU level.In view hereof the so-called IPPC Directive (Integrated Pollution Prevention Control) was adopted in 1996 ...
Even a cursory review of relevant news stories today reveals that hydraulic fracturing (“fracking”) is one of the most hotly debated subjects in the energy sector. Both environmentalists and regulators are keeping concerns about fracking at the forefront of their agendas. Since late May of this year, there have been a number of key legal developments related to the issue that merit the attention of the oil and gas industry ...
On September 17, 2012, the Department of Health and Human Services (“HHS”) announced a $1.5 million settlement with the Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (“MEEI”) for potential violations of the HIPAA Security Rule ...
As of January 1, 2013, Quebec and California will emerge as the first two Western Climate Initiative (WCI) Partners to create a carbon market that imposes binding targets on businesses identified as major greenhouse gas (GHG) emitters ...
The Federal Trade Commission’s increased focus on the antitrust implications of healthcare mergers and acquisitions has been widely publicized. While scrutiny has largely been directed toward hospital and health system transactions, a recent case in Nevada indicates that the FTC is now taking an interest in relatively small provider combinations in highly concentrated markets ...
There have been two important developments in British Columbia’s wind energy sector in June. The first was the release of BC Hydro’s Draft Integrated Resource Plan (Draft IRP) for public consultation. The Draft IRP recommends building new clean generation resources to ensure sufficient future capacity within the system ...
Pursuant to statutory changes enacted in its 2011 Sunset Review, the TCEQ has created a website that allows companies and persons subject to its regulations to review the agency’s proposed compliance history rating, for a 30-day period prior to that rating being made available to the public ...
In what has been described as a “sweeping victory” for the U.S. Environmental Protection Agency the United States Court of Appeals for the District of Columbia Circuit issued a decision on June 26, 2012 in lawsuits that challenged various aspects of the Agency’s regulatory scheme for greenhouse gases (GHGs). EPA’s challenged actions stem from a decision by the U. S. Supreme Court in 2007 in the case of Massachusetts v ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
The D.C. Circuit Court of Appeals has rejected the petitions of numerous states and industry groups that challenged several rules EPA issued to control greenhouse gas emissions from stationary and mobile sources.1 Following the United States Supreme Court’s decision in Massachusetts v ...
The Supreme Court makes clear that a party that has started to clean up contamination caused by another party is also deemed to be a business operator. This gives rise to joint and several liability for the original contamination. The fact that remedial work was intended to reduce the environmental impact is of no importance. Background A company which was later incorporated into JM Värmdöstrand (“JM”) operated a casting works from the 1940s to the 1980s on a site in Oxelösund ...
If you are in the oil and gas industry and you’ve experienced the recent onslaught of enforcement actions, particularly in the Appalachian basin, by the U. S. Environmental Protection Agency (“EPA”) you may take comfort in the aphorism: “You’re not paranoid if they really are out to get you!” A simple Google search of “EPA III Enforcement” and a click on the “Natural Gas Extraction/Marcellus Shale” link at the EPA Region III website should cause any company concern ...
New amendments to the Regulation on Health Conformity of Dietetic Products have entered into force on 28 May 2012. Here are some of the most significant changes that are prescribed by these amendments to the Regulation. As a reminder, this is a regulation that introduced the obligation of the registration of dietetic products (including supplements) in July 2010, and is a regulation that regulates the issues of labelling and the composition of these products in details ...
