A month after nixing the “objectively reasonable interpretation” (Safeco) defense under the False Claims Act, the Supreme Court has vacated and remanded two other cases for further consideration of the defendant’s subjective state of mind when it filed payment claims with the government. The Fourth Circuit in Sheldon and the Eleventh Circuit in Olhausen will provide the first tests of the High Court’s newly minted FCA intent standard ...
In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and high technology), the Supreme Court yesterday refused to exempt so-called reverse payment (or "pay for delay") patent settlements from antitrust scrutiny. Prior to yesterday’s ruling in FTC v. Actavis, Inc., 570 U.S. ___ (2013), most of the circuit courts to have considered the issue (i.e ...
The Twenty-first Amendment—which repealed Prohibition—gives states broad authority to regulate alcohol within their borders. But can states impose residency requirements on alcohol retail licensees? The U.S. Supreme Court, by a vote of seven to two in Tennessee Wine and Spirits Retailers Ass’n v. Thomas, answered no. As state alcohol regulators adjust their licensing processes to comply with the ruling, retailers and wholesalers may see changes in the alcohol market ...
In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the physicians and medical associations who brought the case did not have the right to challenge the FDA's regulation of the drug. To have standing, plaintiffs must show they have a “personal stake” in the case ...
This week marks National Fertility Awareness Week in the UK. This annual event, organised by Fertility Network UK, a national charity dedicated to supporting individuals on their fertility journeys, aims to change perceptions and raise awareness for those undergoing fertility treatment. The theme for this year is "Forward4Fertility," emphasising progress and inclusivity in the journey towards parenthood. The staggering fact that over 3 ...
The Federal Ministry of Transport and Digital Infrastructure (BMVI) is providing EUR 50 million annually until 2023 to promote computer games in order to strengthen Germany as a location for developers. In the first phase,de minimis funding will be provided with grants of up to EUR 200,000. In a second phase larger-scale funding will also be possible ...
In a rare bipartisan and bicameral compromise, Congress has passed the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act,” shortened to the “SUPPORT Act.” The bill was signed by President Trump on October 24, 2018 ...
Tackling rising prices within the parameters of public procurement. One of the main symptoms of the current economic crisis is rising prices, for individuals and businesses. Brexit and the Russian invasion of Ukraine are just two contributory factors in fuelling increases in prices across the supply chain in the UK, particularly the cost of raw materials, labour and transport ...
Summary On September 9, 2021, President Biden issued his Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors (the “Executive Order”) that, when implemented, will require most federal contractors to comply with all guidance for federal contractor and subcontractor workplace locations published by the Safer Federal Workforce Task Force (see www.saferfederalworkforce.gov) ...
In the early hours of Saturday, March 14, 2020, the United States House of Representatives passed the Families First Coronavirus Response Act (FFCRA), which is designed to expand relief in response to the COVID-19 outbreak, through access to free testing, enhancing food assistance, increasing Medicaid funding, and providing paid sick leave and unemployment benefits to workers ...
In a recent case involving a health care facility, the NLRB issued a 3-1 decision that significantly changed a successor employer's bargaining obligations before imposing the initial terms and conditions of employment on a unionized workforce. While seemingly favorable to employers, the decision also serves as a reminder to companies that they should act cautiously and consult with counsel before they take over a business with a unionized workforce ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
The presence of a small amount of undeclared sesame in a particular product may seem trivial but, for those who are allergic, it can provoke a major reaction. Such was the predicament faced by Pret a Manger in July 2016, following the death of Natasha Ednan-Laperouse that same month due to the undeclared presence of sesame in a Pret baguette ...
Dinsmore's Chris Cashen, Anne Guillory, Chris Jackson, and Kyle Bunnell were published in dri Strictly Speaking, Vol. 18 Issue 1. Their article, "States’ COVID-19 Immunity Statutes and Product Liability Claims Related to COVID-19," examines states’ COVID-19 immunity statutes for product designers, manufacturers, and distributors concerning COVID-19-related lawsuits. An excerpt is below ...
A minority of states have enacted statutes and taken other action to protect business owners from claims by persons who allegedly were infected by COVID-19 on their premises.1 The purpose of this article is to compare these statutes and discuss some of the differences between them. This article addresses statutes in effect as of October 27, 2020. The article does not address pending legislation ...
The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan ...
On March 18, 2020, the State Medical Board of Ohio (“Board”) held a special meeting, which resulted in the temporary suspension of certain regulatory enforcement activities in response to the COVID-19 pandemic. Telemedicine Effective immediately, the Board will suspend enforcement of any regulations requiring in-person visits between providers and patients ...
Following the passage of House Bill (HB) 122[i] and its corresponding expansion of telehealth services by Ohio health care providers, the State Medical Board of Ohio (Ohio Board) has released proposed administrative rules in furtherance of the recent legislation ...
The State Medical Board of Ohio recently proposed amendments to the existing regulations governing light-based medical devices (lasers), which will significantly impact the provision of laser services in Ohio. While the proposal adds a new category to existing delegation authority, it also imposes new regulatory requirements to existing delegation authority which will impact Ohio physicians providing laser services ...
Following the passage of House Bill 122 last year, the State Medical Board of Ohio (“Ohio Board”) has released final administrative rules governing the provision of telehealth services by Ohio physicians and certain other provider types.[i] The final rules, which became effective February 28, 2023, continue the recent trend of regulators, such as the Drug Enforcement Agency,[ii] largely reverting back to pre-pandemic telehealth restrictions ...
Medicaid providers will be subject to new audits by Medicaid Recovery Audit Contractors (RACs), beginning in January 2012. These new audits will be in addition to existing audits being conducted by Medicare RACs, Medicaid Integrity Contractors (MICs) and Zone Program Integrity Contractors (ZPICs), among others.1 The Medicaid RAC audits, mandated as part of the 2010 Patient Protection and Affordable Care Act (the Health Reform Act), are expected to result in the recovery of $2 ...
State Attorneys General across the nation are warning consumers about price gouging during the COVID-19 pandemic and offering easy online tools to report violations. Consumers have gotten the message. Texans, for example, have sent over 10,000 complaints of price gouging to the state AG’s office during the pandemic.1 Price gouging laws have been enacted by nearly 75 percent of states ...
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 ...
