On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
In the latest ruling from the contentious Gloria’s Ranch case (Gloria's Ranch, L.L.C. v. Tauren Exploration, Inc., 2018 La. LEXIS 1694), the Supreme Court of Louisiana reversed the lower courts’ decisions that held Wells Fargo Energy Capital, Inc ...
The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules ...
The English High Court issued its judgment in the case ofSeadrill Ghana Operations Limited v Tullow Ghana Limited1on 3 July 2018 in respect of a dispute under a long-term drilling contract between Seadrill and Tullow regarding the use of the semi-submersible drilling rig “WEST LEO” for operations offshore Ghana. The contract was signed in 2012 and its term was due to continue through to June 2018 ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
The South African Minister of Mineral Resources, Gwede Mantashe, published a notice in the government gazette on 28 June 2018 stating that there will be a restriction, in terms of section 49(1) of the Mineral and Petroleum Resources Development Act, 2002 (“MPRDA”), on the granting of applications for technical co-operation permits, exploration rights and production rights in terms of section 76, 79, and 83 of the MPRDA, from the date of publication of the notice (28 June 2018
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
2018 Summer Associate Molly Barham contributed to this alert. Two years ago, right after crude oil prices hit rock bottom in the middle of the worst downturn for U.S. producers since the 1980s, the Office of the Comptroller of the Currency (“OCC”) revised its Handbook for Examination of Oil and Gas Exploration and Production Lending (“E&P Handbook”) ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
On 15 June 2018, exactly one year to the day after the publication of the previous draft, the new South African Minister of Mineral Resources, Gwede Mantashe (the “minister”), published for public comment the Draft Broad-Based Black Economic Empowerment Charter for the South African Mining and Minerals Industry, 2018 (the “Draft 2018 Mining Charter”) ...
On June 14, 2018, Mexico’s Ministry of Economy (Secretaría de Economía) published in the Official Federal Gazette amendments to Articles 73 and 129 of the General Law of Commercial Companies (Ley General de Sociedades Mercantiles) (the “Law”), imposing a new requirement to provide notice in the Ministry of Economy’s electronic system regarding entries made in the Shareholder and Member Registry Books of Corporations and Limited Liability Companies (t
In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B ...
A New Development on the Subject (Update as of June 15th) Click Here to Read » A flurry of rulings during the last two weeks of May has generated enormous confusion regarding the status of California's two-year-old End of Life Option Act ("EOLOA"), the law that allows a terminally ill adult with a six-month prognosis to obtain aid-in-dying drugs from a physician, subject to numerous safeguards ...
The first upscale exploration of oil and gas in Montenegro started in 1914, when King Nikola Petrovic approved the National Assembly's decision for oil exploration around Lake Skadar. The first well in the area of Crmnica dates back to 1922 - although it produced nothing of significance. In later researches of the Montenegrin offshore, the existence of geological structures with the potential for hiding hydrocarbon deposits was confirmed ...
The Montenegrin Government plans to publish a tender for the lease of state land for the purpose of constructing a solar power plant in the municipality of Ulcinj. According to the announcement, the tender envisages a total of 6,621,121 square meters of land for the planning, construction, exploitation, and maintenance of a solar power plant at Briska gora, in the very south of Montenegro ...
As Lord Sumption’s leading judgment of the Supreme Court inRock Advertising Limited v MWB Business Exchange Centres Limited[2018] UKSC 24 states, it is rare that modern litigation raises truly fundamental issues in the law of contract. This case, however, raisedtwosuch issues, although as a result of the Court’s decision on the first issue, it was not necessary to decide the “difficult” second issue ...
Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc ...
The Administrative provisions that set forth the guidelines for comprehensive management of waste requiring special management in the hydrocarbons sector (the “Guidelines”) were published in Mexico’s Federal Official Gazette on May 2, 2018 and became effective the following day ...
The National Hydrocarbons Commission (“CNH”) announced on April 26, 2018, the so-called “farmout” bid process CNH-A-C6-7 Asociaciones/2018. This new bid round comprises seven onshore conventional blocks for exploration and production that are located in the states of Veracruz, Tabasco and Chiapas, covering collectively 4,580.8 km2. CNH estimates these blocks have conventional prospective resources of approximately 405.1 million barrels of crude oil equivalent ...
Earlier this year, Prime Minister Theresa May said the government wanted to, “secure broad energy cooperation with the EU”, including by, “exploring options for the UK’s continued participation in the EU’s internal energy market” ...
EPA Administrator Pruitt recently issued another policy to help streamline the New Source Review (NSR) Program. After receiving comments from many industry sources that the NSR Program should be reformed given its heavy time and cost burden, the Trump EPA has made reforming the NSR Program a priority ...
Earlier this year, Mexico´s Senate approved the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (“CPTPP”) formerly known as the Trans-Pacific Partnership ("TPP"). The CPTPP will enter into force once six of its members ratify the Treaty pursuant to their internal legal procedures. Mexico is the first member to ratify the Treaty ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
