Managing Risk, Compliance & Litigation
Skillfully Navigating Risk
The current period of uncertainty and unprecedented disruption reinforces the critical importance of taking a proactive approach towards continuously assessing and managing key risks to the organization. Whether our attorneys are helping a company safeguard its data against external threats, providing guidance to ensure compliance with relevant regulatory bodies, or working with a client to implement an effective strategy to minimize litigation risk, we leverage deep experience to advise clients on a broad range of risk management and compliance matters.
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Viewpoints
FDA Issues Draft Device Guidance in Preparation for the End of the Public Health Emergency
December 27, 2021| Blog|
New York City Releases Private Employer Vaccine Executive Order
December 16, 2021| Blog|
News & Press
Our Approach
Mintz represents clients ranging from start-ups to Fortune 100 companies and nonprofits that operate in a variety of heavily regulated industries. All of these organizations have been severely impacted by the COVID-19 pandemic and are striving to simply remain in business, but companies must remain vigilant about compliance and reporting, especially those who have taken advantage of grants and loans available under the CARES Act and other government stimulus programs.
Civil and criminal government investigations as well as congressional scrutiny related to these COVID-19 related grant and loan programs are expected to increase significantly in the coming months and years, and many of these investigations will target companies that accepted grants or loans through the Paycheck Protection Program, the Main Street Lending Program, the CARES Act Provider Relief Fund, and various other COVID-19 related stimulus programs.
Our interdisciplinary team brings together attorneys from our health care, SEC, financial services, government investigations, and litigation practices, including our False Claims Act experts, to help clients detect and correct problems in an effort to mitigate future threats before the government becomes involved. When investigations, litigation, or congressional hearings do arise, we work with our clients to create a strategy that is singularly focused on protecting the long-term sustainability of their leadership and business operations.
- Advise clients on applying and qualifying for COVID-19 related grants and loans, the meaning of certifications applicants must sign and the associated risks, evolving agency guidance, use of grant monies and loan proceeds, eligibility for loan forgiveness, documentation and recommended compliance practices
- Review compliance programs and, where advisable, recommend new policies and procedures to reduce the risk of government enforcement and whistleblower actions brought under the federal False Claims Act and other civil and criminal laws
- Represent clients in state and federal investigations and litigation alleging violations of the federal False Claims Act and similar state laws, criminal laws prohibiting false statements and certifications and other types of fraud, and other applicable state and federal statutes and regulations
- Price gouging
- Securities litigation
- Insurers-side litigation
- Consumer class actions
- Directors & Officers litigation
- Insolvency & creditor rights litigation
- Contract review and dispute resolution
- Construction litigation, delay, and disruption
- Real estate litigation and commercial evictions
- M&A litigation including breach of contract and representation and warranties claims
- Government investigations including claims of insider trading, Ponzi schemes, and securities violations
- State and federal investigations alleging violations of the Anti-Kickback Statute and the federal False Claims Act, and other state and federal health care laws
- HIPAA / privacy
- IP due diligence
- Contract review
- Telemedicine guidance
- Unemployment advising
- Product liability assessments
- FDA related work / guidance
- Business continuity planning
- SEC reporting and compliance
- Workforce reduction strategies
- Clinical trials and research guidance
- Anti-financial crimes risk mitigation
- Insurance risk management and counseling
- Best practices for conducting virtual board meetings
- Privacy and cybersecurity concerns related to teleworking
- Regulatory approval guidance related to COVID-19 testing
- Real estate owner and operator guidance related to property maintenance and liability concerns
- Planning and risk management counseling (including patient safety and privacy) for health care providers treating COVID-19 patients while continuing to treat additional patient populations
- Center for Disease Control (CDC)
- Centers for Medicare and Medicaid Services (CMS)
- Department of Justice (DOJ)
- Commodity Futures Trading Commission (CFTC)
- Department of Homeland Security (DHS)
- Department of Labor (DOL)
- Department of Treasury
- Financial Industry Regulator Agency (FINRA)
- Food and Drug Administration (FDA)
- National Health Institutes
- Occupational Safety and Health Administration (OSHA)
- Office of Civil Rights (OCR)
- Office of Inspector General (OIG) for the Department of Health & Human Services
- Securities Exchange Commission (SEC)
- Small Business Administration
- State attorneys general
- Various state and local public health agencies
Our Team
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Member / Co-chair, Energy & Sustainability Practice
Member / Co-chair, White Collar Defense and Government Investigations Practice
Member / Co-Chair, Health Care Enforcement Defense Practice
Member / Managing Member, Los Angeles Office
Member / Co-chair, White Collar Defense and Government Investigations Practice
Member / Chair, Technology Practice; Co-chair, Venture Capital & Emerging Companies Practice
Member / Co-Chair, Financial Services Practice
Member / Co-Chair, Health Care Enforcement Defense Practice
Member / Co-chair, Venture Capital & Emerging Companies Practice
Member/Managing Member, Boston Office; Chair, Corporate, Tax, Private Client & Immigration Division
Member / Chair, Antitrust, Employment, and Litigation Division
Member / Co-chair, Venture Capital & Emerging Companies Practice
Member / Chair, Antitrust, Employment, and Litigation Division
Member / Managing Member, New York Office & Chair, New York Corporate Practice
Other COVID-19 Business Issues
Liquidity & Capital Management
The severe business and societal disruption caused by COVID-19 has resulted in decreased demand for most products and services across the gamut of industries. Many companies are facing liquidity issues as they look to maintain operations. The ability for businesses to meet financial obligations is still evolving and will ceate opportunities and challenges for businesses and their investors.
Operational Resilience & Supply Chain
COVID-19 has emphasized the importance of business agility for companies handling sudden and extremely adverse operational events. Many companies have been forced to alter their business model as a result of the virus, which presents new risks and opportunities, while the exposed vulnerability of the global supply chain will trigger a host of contractual and vendor disputes. The intense pressure on supply chains has also led to recent legislation and enforcement actions aimed at preventing fraud and unfair or unlawful practices. The ability for companies to weather the current storm and emerge as more resilient organizations depends on their ability to quickly adapt while also effectively managing risks.
Navigating Federal, State & Local Government Responses
The current COVID-19 pandemic has generated a host of government responses to mitigate the impact of the virus, including Presidential Orders, state and local orders, enforcement actions and the sweeping stimulus packages. Keeping a finger to the pulse of government responses and their potential impacts before they happen can offer critical time for planning or the ability to more quickly access much needed relief for your business.
Workforce & Human Capital Management
The COVID-19 pandemic has dramatically altered the way that we live, work, and interact in a very short time. Understanding the diverse and multi-jurisdictional challenges created by containment efforts, while ensuring the safety and well-being of your employees and attempting to minimize risk and business disruption, can be a daunting task. Our experienced attorneys assist clients with navigating the legal considerations of these complex workforce issues, while keeping your organization and its most important resource – its people – front of mind.
Navigating Capital Markets & Public Company Reporting
The current COVID-19 pandemic has generated a host of issues for public companies. The SEC, NYSE, Nasdaq, and others are taking actions that impact access to capital markets, financial reporting, and disclosure obligations. Navigating the legal and practical implications of the pandemic is crucial to ensuring compliance with the securities laws and keeping investors fully informed.
Related Practices
- Employment Litigation & Arbitration
- Privacy & Cybersecurity
- Securities & Capital Markets
- Clinical Trials & Research
- FDA Regulatory
- Health Care Compliance, Fraud & Abuse, and Regulatory Counseling
- Class Action
- Insurance and Reinsurance Problem-Solving & Dispute Resolution
- M&A Litigation
- Real Estate Litigation
- Securities Litigation
- White Collar Defense & Government Investigations