Assistance in Response to COVID-19 Pandemic
Health Care and FDA
- Working with clinical laboratories as they develop coronavirus testing models and navigate through Centers for Disease Control and Prevention and FDA approval processes, as well as coding and payment issues that arise during product development.
- Advising on the coronavirus in the workplace and related privacy and HIPAA strategies.
- Advocacy with the executive branch on COVID-19 related guidance and implementation.
- Advising foreign and domestic pharmaceutical manufacturers on the implications of FDA inspection delays as a result of the coronavirus pandemic.
- Advising commercial manufacturers seeking to develop diagnostic test kits and personal protective equipment (PPE) for health care workers.
- Assisting FDA-regulated entities on emergency use authorizations (EUAs) for coronavirus test kits, hand sanitizers, and surgical masks.
- Assisting companies with personal data and health information in rolling out remote work policies and procedures during the coronavirus pandemic.
- Advising public hospitals and academic medical centers in establishing testing sites and coordinating additional hospital bed capacity for an influx of COVID-19 cases.
- Advising clients on the implications of state shelter-in-place, stay-at-home, or essential-business executive orders, with specific reference to whether they or their employees qualify as “essential” or as part of the “critical infrastructure” as defined by the Department of Homeland Security.
- Assisting health care providers and companies with advocacy for coronavirus-related legislative priorities and regulatory implementation.
- Advising lodging, hospitality, and timeshare industry clients on various business and legal matters related to the coronavirus pandemic.
- Responding to and managing communications related to employees and customers who are diagnosed with the coronavirus or display flu-like symptoms.
- Advising clients on questions related to insurance coverage during the coronavirus pandemic.
- Advising clients on the operational and financial ramifications of the coronavirus pandemic, including the availability and benefits of a potential bankruptcy filing and the ability to maximize and obtain recoveries for the benefit of creditors.
- Advising medical waste companies and residential waste companies with lifting weight and distance restrictions during the coronavirus pandemic.
- Advising companies on compliance with the EPA’s Emerging Viral Pathogen Guidance for Antimicrobial Pesticides.
- Advising hospitals and other health care providers on medical and hazardous waste characterization, management, transportation, and disposal; the Environmental Protection Agency’s (EPA) new Management Standards for Hazardous Waste Pharmaceuticals; Safe and Secure Drug Disposal Act compliance; and federal and state licensure matters and any special requirements that may arise due to the coronavirus.
Corporate Transactions, Securities and Governance
- Advising on the U.S. Securities and Exchange Commission’s recent request that U.S.-listed companies with operations in China disclose any coronavirus threats or risks in their financial reporting; assessing coronavirus risks and navigating disclosures pertaining to the virus in financial reporting.
- Advising public companies and their boards of directors on strategic decisions, risk oversight, governance, and SEC disclosure related to COVID-19.
- Advising clients on the impact of the coronavirus pandemic on financing and cross-border acquisitions, joint ventures, supply arrangements, and strategic partnerships.
Financial Institutions and Finance
- Assisting financial services companies and broker-dealers on governmental restrictions, industry guidance, and marketplace regulations during the coronavirus pandemic, including business continuity planning, regulatory relief, and examination and enforcement inquiries.
- Representing a non-bank lender in restructuring several commercial real estate loans secured by hotel and retail portfolios across the United States, with a total debt stack exceeding $239 million.
- Serving as U.S. structuring counsel to several large international financial institutions, in a competitive bid process relating to the post-acquisition financing of auto and equipment receivables originated by a subsidiary of an international banking group.
- Advising a non-bank lender in the U.K. on a defaulted loan secured over hotel properties
- Representing corporate trust departments in CLO warehouse lines due to asset managers seeing a buying opportunity for loans for future CLOs.
Antitrust, Cyber-Security, and International Trade
- Assisting clients with price-gouging concerns, advertising and claims substantiation, and other consumer-protection issues related to the coronavirus pandemic.
- Assisting companies in cyber preparedness for COVID-19 cyber threats (cyber scams, phishing, and cyber-attacks) and helping mitigate the increase in cyber risk with a review of incident response and business continuity planning.
- Assisting companies in responding to new cyber-attacks as a result of COVID-19.
- Advising companies on how to mitigate the cyber risk resulting from an increase in employees working remotely, including through implementing policies and technical controls and employee communication strategies.
- Assisting clients on trade regulations during the coronavirus pandemic, including U.S. border cargo operations, tariff suspensions, import and related regulatory requirements for personal protection equipment (PPE) and medical devices, and critical infrastructure status for manufacturing supply chains.
- Advising clients on federal tax issues arising from the coronavirus pandemic, including the tax impact of new federal legislation designed to mitigate the economic effects, business disruption issues, and tax considerations for insolvent and troubled businesses.
- Advising clients on federal tax issues related to the effect of the coronavirus pandemic on supply chains, including deductibility of expenses, shutdown issues, net operating losses, and the impact on advance pricing agreements.
- Assisting clients with questions related to mandated provisions in pending legislation and how it relates to health benefit plans during the coronavirus pandemic.
Previous Related Experience
- Assisting clients, managing litigation and regulatory investigations, and/or serving as coordinating counsel on the panoply of insurance issues in the wake of catastrophes such as 9/11, hurricanes, and SARS, including business interruption and potential general liability issues resulting from underlying lawsuits.
- Advising a health system on board responsibilities for oversight of the system’s policies and preparedness plans for public health emergencies, among other areas of risk, including federal and state laws regarding admissions and discharges, end-of-life issues, and other critical matters for hospital operations.
- Advising on the Food and Drug Administration’s (FDA) Emergency Use Authorization, including representing medical product manufacturers that utilized the FDA’s emergency powers to develop vaccines, drugs, and devices for the Department of Defense and the Strategic National Stockpile.
- Assisting clients with congressional and agency outreach and communications.
- Preparing for and reacting to previous pandemics, including SARS and H1N1 influenza.
- Advising a large national company on its response to previous concerns about Ebola transmission, including communications to employees.
- Advised a hospital on an industry-level analysis of the swine flu crisis.
- Advising on the public health aspects of bioterrorism, including epidemics and pandemics such as SARS, with particular attention to the laws of quarantine, isolation, and privacy.
- Reviewing and diagnosing commercial shipping interruption and its ramifications that could trigger force majeure provisions in business contracts.
- Litigating the application to business contracts of the doctrines of impossibility of performance and commercial impracticability.
- Litigating the application of force majeure, material breach, and repudiation provisions in business contracts.
- Preparing for or avoiding drug shortages and shortages of active pharmaceutical ingredients (API), whether in the U.S. or abroad.
- Guiding corporate communications for evolving updates; providing input for written policy and procedures and communicating with employees.
- Advising on environmental requirements and issues related to the import, manufacture, labeling, sale, distribution, and use of disinfectants and other antimicrobial or antibacterial products, including Federal Insecticide, Fungicide, and Rodenticide Act rules for pesticides and devices and the EPA’s Emerging Viral Pathogen Guidance for Antimicrobial Pesticides. Counseling on maintaining environmental compliance during a pandemic flu.
- Communicating with the EPA and state environmental and public health regulators on your behalf.
- Advising on nonretaliation for raising concerns about safety and health conditions; worker safety requirements, such as the Occupational Safety and Health Administration’s (OSHA) General Duty Clause and Cal/OSHA’s aerosol transmissible disease standard; and standards and requirements for personal protective equipment and hazardous chemicals used for cleaning/disinfection.
- Advising on employment issues such as the Family and Medical Leave Act, paid sick leave, and other related labor and employment issues.
- Advising on federal and state quarantine regulations and requirements.
- Advising employers on health and welfare benefit plan compliance issues, including HIPAA privacy matters related to reporting.
- Advised a CDC survey contractor on contractual obligations following a suspension notice from the agency.
- Worked with a major supplier of surgical masks on relationships with international agencies, NGOs, and the Department of Defense.
- Advising U.S. and global entities on the temporary and permanent movement of people over borders, creating and overseeing entity migration policies, providing practical preparedness guidance in light of frequent abrupt changes to government policies, and assessing risks—including unintended discriminatory practices—within compliance efforts and other critical matters for international operations and/or international assets.