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 ...
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 ...
Many California courts, politicians and regulators seem intent on attacking trucking and transportation companies. The California Supreme Court‘s, Dynamex Operations West Inc. v. Superior Court (Case No. S222732) decision is the latest example of this assault on the industry ...
Earlier this year, the National Agency of Waterway Transports (ANTAQ) published Normative Resolution No. 20, which approves new rules for the authorization for the construction and exploration of private-use terminal (TUP), cargo transhipment station (ETC), small-size public port facility (IP4) and tourism port facility (IPTur), revoking Resolution No. 3,290. The new rules aim at adjusting the requirements and proceedings applicable by ANTAQ to the changes introduced by Decree No ...
Earlier this year, the Congressional Budget Office (CBO) released its report on the direct spending and revenue effect of H.R. 1628, the American Health Care Act of 2017 (AHCA), as passed by the House of Representatives. CBO made this estimate in conjunction with the Joint Committee on Taxation ...
Not long after President Trump announced that the U.S. would impose tariffs on steel and aluminum, the Department of Commerce launched an investigation that may lead to additional duties on imported vehicles and automotive parts. Effective, the Department will now examine whether imports of vehicles and auto parts threaten U.S. national security ...
Getting the Deal Through – Shipbuilding is part of the series of Getting the Deal Through law guides published by Law Business Research that provide an overview of specialist areas of the law in a variety of international jurisdictions. It is published annually and the seventh edition, covers 13 jurisdictions. Leading practitioners from each jurisdiction answer the same key questions ...
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 ...
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 ...
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 ...
The hits keep coming to plaintiffs’ attorneys seeking to invalidate nursing home arbitration agreements. Last year, the plaintiffs’ bar could smell victory when the Centers for Medicare & Medicaid Services (CMS) announced its new rule banning arbitration clauses in nursing home admission contracts ...
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 ...
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 ...
Since 2013, the demand for aircraft ABS (asset-backed securitisation) transactions has gone from strength to strength. Last year saw a record number (14) of ABS deals close and 2018 is on course to at least match that number. For many aircraft lessors, access to the capital markets is a crucial component of their capital structure ...
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 ...
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 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 ...
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 ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
What are some of the exciting developments we're seeing in transport? How can these be practically applied? We were delighted to host a Fast Track session as part of our sponsorship of Amplify, AMP’s innovation festival, where we explored how innovative high speed transportation systems will impact our future. But how can these new technologies be introduced into society? High speed transportation systems Long commutes could soon be history ...
With the recent enactment of Bill 165, An Act to amend the Highway Safety Code and other provisions1, the driving of autonomous vehicles in Quebec is finally regulated, although a number of uncertainties remain. Indeed, the driving of autonomous vehicles of automation level 3, such as Tesla’s model X equipped with an improved guidance system, is now permitted in Quebec ...
I COMMERCIAL OVERVIEW OF THE SHIPPING INDUSTRY With Ireland having the European Union’s third-largest ocean area, the Irish government plans to double the state’s ocean wealth by 2030 and, in the interim, make Ireland an attractive location for international shipping activities. The changes brought about by Brexit may help to enhance Ireland’s position further in the maritime sphere ...
The skilled nursing sector has seen a significant number of facility divestitures and closures in the last few years. Quite frankly, this negative trend is due in part to a reluctance by some operators to implement clinical-based care standards and a lack of honest self-evaluation to improve the clinical care provided at skilled nursing facilities. Outdated operating models – solely meeting the basic needs of patients – does not bode well for SNF operators to survive ...
"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets ...
The Autonomous Bus and Minibus Pilot Project 1 (the “Pilot Project”) came into effect in Quebec recently. The project provides guidelines for the regulated driving of the first autonomous vehicles on Quebec’s roads ...
