For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i] the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions ...
The most recent changes to the Stark Physician Self-Referral Law (Stark) and the Anti-Kickback Statute (AKS), described previously here, create a new lexicon and framework to guide healthcare providers from payment for volume-based services to payment for value-based healthcare. These value-based rules go into effect on January 19, 2021 ...
Dear Clients and Friends Drew Network Asia (comprising Drew & Napier LLC from Singapore, Makarim & Taira S. from Indonesia, and Shearn Delamore & Co. from Malaysia) is delighted to present a joint webinar with Omni Bridgeway, a leading global disputes finance company, on the enforcement of arbitral awards and foreign judgements in Singapore, Malaysia, and Indonesia. Details are set out below: Date: Thursday, 14 January 2021 Time: 3.00 pm to 4.30 pm (SG/MY time) 2 ...
The President recently signed into law the Criminal Antitrust Anti-Retaliation Act (S. 2258) (116th Cong. (2020)), which amends the Antitrust Criminal Penalty Enhancement and Reform Act of 2004. It grants stronger protections to employees who come forward with claims of antitrust violations. Specifically, the law prohibits employers from discharge, demotion, or suspension, as well as any discrimination against any employee who assists in a government antitrust investigation ...
When the scope of the COVID-19 pandemic became apparent in March 2020, an avalanche of articles appeared in which many insurers took the position that there was no coverage for losses associated with the SARS-CoV-2 virus due either to a lack of physical loss or damage to property necessary to trigger coverage under most commercial property policies, or to the effect of virus exclusions found in many such policies ...
Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital ...
This post discusses the Alberta Court of Appeal's recent decision in Hannam v. Medicine Hat School District No. 76,[1] which stands as an emphatic reminder that the Supreme Court of Canada has directed courts to grant summary judgment when a fair and just determination can be made without a trial ...
On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19 ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective ...
The City and County of San Francisco (SF) issued a COVID-19 surge-related travel and quarantine order (Quarantine Order) on Dec. 16, 2020, and an updated Shelter-In-Place Order (SIP Order) on December 9 (updated Dec. 30, 2020). Under those orders, every person who enters SF after having been outside the Bay Area within the last ten days must quarantine for 240 hours from the time of arrival in SF. However, two exceptions apply to those working on construction projects in SF ...
The underlying dispute relates to the MV «Cheshire» incident in 2017, where a cargo of fertiliser was subject to a major decomposition incident. The fertiliser that was carried on the vessel was damaged, and the vessel was declared a total loss. In February 2020, Oslo District Court ruled in favour of the cargo interests, holding the carriers liable for the cargo loss (approx. USD 25 million) (TOSLO-2017-180657-1). The carriers have appealed the judgement ...
The underlying dispute relates to the MV «Cheshire»-incident in 2017, where a cargo of fertiliser was subject to a major decomposition incident. The fertiliser that was carried on the vessel was damaged, and the vessel was declared a total loss. In February 2020, Oslo District Court ruled in favour of the cargo interests, holding the carriers liable for the cargo loss (approx. USD 25 million) (TOSLO-2017-180657-1). The carriers have appealed the judgement ...
The United States Court of Appeals for the Fourth Circuit recently decided that claims based on Article 2 of the West Virginia Consumer Credit and Protection Act ("WVCCPA"), including claims based on its FDCPA-like debt collection provisions, do not apply to transactions where the consumer pays at the point of sale. In Hinkle v. Safe-Guard Products Int'l, LLC, Hinkle purchased a new car at a local dealership ...
On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry ...
2020 was a busy year for trademark litigation, with three U.S. Supreme Court decisions and several high-profile lower court cases involving trademark law. But many folks are understandably eager to put 2020 in the rearview mirror. So too does this article focus on the future, with the following examination of key trademark litigation trends to watch for in 2021. Fallout From Fossil: Influx of Profits Awards? The Supreme Court's recent decision in Romag Fasteners Inc. v ...
The 2020 Investment Priorities Plan (2020 IPP) has been promulgated by the Philippine President under Memorandum Order No. 50 dated November 18, 2020 (https://www.officialgazette.gov.ph/downloads/2020/11nov/20201118-MO-50-RRD.pdf), and it became effective on December 6, 2020. The IPP is issued pursuant to the Omnibus Investments Code of 1987 (Executive Order No. 226), as amended (Omnibus Investments Code) ...
The Government Accountability Office (GAO) recently issued its Annual Report to Congress, which provides statistics concerning bid protest filings for Fiscal Year (FY) 2020, including the number of protests filed and sustained. The chart below, included in GAO's Annual Report, summarizes this information. Click here to view the summary table As shown above, most of the data points remained constant from the prior year ...
The International Court of Arbitration of the International Chamber of Commerce (‘ICC’) has issued a revised version of its Arbitration Rules. The 2021 Rules enter into force on 1 January 2021 and aim to make arbitration even more efficient, flexible and transparent ...
Last week, the Equal Employment Opportunity Commission (“EEOC”) updated its COVID-19 guidance to address workplace issues related to COVID-19 vaccines, including mandatory vaccination policies. According to the EEOC, employers may mandate vaccines, but must attempt to accommodate employees who refuse vaccination because of disability or a sincerely held religious belief, practice, or observance ...
Key Points In a rare move, the Ninth Circuit Court of Appeals published two opinions about subjects that are hardly ever discussed in the court's published National Environmental Policy Act (NEPA) decisions. For the first time in more than three decades, the court examined impacts to an old-growth redwood forest, and for the first time since 2016, the court examined indirect (downstream) carbon emissions. In Bair v ...
Moderator Adam Polk interviews Thomas Richie concerning the Eleventh Circuit's recent decision in Johnson v. NPAS, which categorically banned incentive payments ...
An important update to Georgia’s statutory lien waiver laws will take effect on January 1, 2021. This summer, Georgia enacted an amendment to O.C.G.A. § 44-14-366 (the Lien Waiver Statute), that alters the form for interim and final lien waivers. The new statute makes it clear that lien waivers only waive lien or bond rights against the property and do not waive the right to file a lawsuit for non-payment or other related claims ...
It behooves construction professionals, be they materials manufacturers, general contractors, or lower-tier subcontractors, to carry some form of commercial general liability insurance (“CGL Insurance”). Having such coverage alleviates some of the potential risk and financial exposure a construction professional carries on a particular project. That is, of course, unless the construction professional gets sued and the insurer refuses to pay ...
