Insights

Since the November 2022 release of ChatGPT, generative AI has been a regulatory accelerator for governance of AI writ large. Individuals, organizations, industries, and governments across the world have grappled with the implications of AI, including how it is and could be regulated using existing and new legal frameworks. For example, since our December 2023 update:

More companies than ever before are launching smart medical devices and industry growth seems endless as new products and technologies are announced daily. However, before companies push products to market, it’s crucial to understand key aspects of device approval, and company and patient protection. In this webinar, our speakers will outline intellectual property strategies, U.S. Food and Drug Administration considerations, and data cybersecurity concerns that are inherent to all smart medical devices. They will explore the legal issues that can significantly decrease the risk profile and potential liabilities throughout a product's lifecycle and create safer, more reliable products for consumers.

47 USC  230 (“Section 230”) was enacted as part of the United States Communications Decency Act (CDA), providing immunity to interactive computer service providers for third-party content. Known as “the 26 words that created the internet,” this statute is responsible for the development of the modern internet as we know it. While Section 230 has allowed online platforms—like major social media platforms and search engines—to flourish, the broad legal protections that Section 230 provides have become controversial. To no success, various members of Congress, the Presidential Administration, and political candidates have called for Section 230 reforms, and for the first time, the way in which we use the internet may change depending how the U.S. Supreme Court rules in a highly-anticipated Section 230 case this term. 

Endless articles rattle on about the brave new world of the metaverse, as if it’s an unprecedented step for commercial and social life. As lawyers, however, we know that there is precedent for everything. This presentation looks at the legal precedent that will likely inform the development of metaverse law. We will look at virtual-world cases involving both common law and federal law. We’ll also look at the pockets where virtual-world caselaw has yet to be developed and consider what types of precedent will fill those gaps. Finally, we’ll discuss what this all means for practitioners who hope to guide their clients in the metaverse.

Attorneys John Fuson, Hilary Johnson, Robbie Jost, and Andrew McElligott will present a webinar for the Orange County Bar Association Health Care Law Section titled, "3D Printing at the Point of Care: Compliance and Liability Concerns" on Thursday, November 10, 2022. This session will provide (1) a primer on how the FDA regulates medical devices, (2) an outline of how FDA plans to regulate 3D printing of devices at the point of care and legal issues raised by this new model as compared to traditional manufacturing, (3) an examination of the state of product liability litigation when it comes to 3D printed devices and the potential product liability risks when healthcare facilities take on the role of traditional manufacturers, and (4) an analysis of different intellectual property scenarios healthcare facilities must be aware of when 3D printing POC devices.

Supply chain disruptions have exacerbated strains and weaknesses in existing trade infrastructure, causing widespread ripple effects throughout the global economy.  From an international trade perspective, companies face real-time pressures to make business decisions that may have complex legal implications going forward.  Our International Trade Team will lead a discussion highlighting current risks companies are encountering, potential legal implications, and strategies to mitigate risks in real-time in this dynamic and changing landscape.

A failure to meet safety compliance and regulatory obligations can undo the herculean efforts to surmount supply chain challenges and get products into the US. Our Products Liability and Regulatory Compliance lawyers will discuss the impacts of current efforts by regulators to police product safety at the ports, the expectations of federal safety regulators at the ports and how to use compliance documentation to speed the process when products have been stopped for inspection. Our discussion will cover activities at CPSC, NHTSA, EPA and FDA. The panel will also discuss the challenge of counterfeit products and parts and how safety can be a lever to stop counterfeits. Given the increased costs of shipping, downstream recovery opportunities may help alleviate some of the monetary pressures and our panel will discuss these opportunities as well as the contract clauses that can allocate risks appropriately when things do go wrong.

In the second installment of Crowell & Moring’s webinar series, our Government Contracts attorneys will discuss the impacts of the current and expected supply chain issues on federal government contractors and their compliance responsibilities. Our panelists will discuss contract clauses that may be at risk as the supply chain delays continue, including requirements for domestic preferences, prohibitions on counterfeit parts, and protecting national security interests.  This panel will also cover the expected Government enforcement of supply chain-related compliance violations, including False Claims Act liability.

For any company marketing a product, managing the risks associated with defective or non-compliant products is a key part of the process, both prior to and during commercialization. In particular, you will first need to determine which regulatory framework applies by mapping out the context in which the product is to be made available. Then, once the product has been placed on the market, you will need to know how to handle the various issues that could arise in relation to safety or regulatory non-compliance. 

Please join Crowell & Moring for an A to Z summary of the Infrastructure Bill on November 18, 2021 from 2 pm to 4 pm when professionals from across the firm will digest and explain the significance of the recently passed Bipartisan Infrastructure Bill (BIB). The Crowell & Moring team will walk through the amount, description, timeline and pathways for funding related to coming infrastructure projects related to (1) roads, bridges and tunnels; (2) power infrastructure and clean energy transmission; (3) electric vehicle (EV) infrastructure; (4) electrification of vehicle fleets; (5) rail; (6) airports; (7) ports and waterways; and (8) environmental remediation and related new regulatory issues. The Crowell & Moring team will also walk through the infrastructure funding mechanisms and explain how federal or state government contracts, and/or public-private partnerships, related to this new $1 trillion in infrastructure investments might take place from late 2021 through 2022. 

Supply chain issues are a top concern for many companies across industries and markets. Please join us for a webinar series that explores these issues and provides insights on the various legal and tactical considerations as companies think about supply chain disruption, impacts, and solutions.

The U.S. Consumer Product Safety Commission (“CPSC”) is in a state of transition. The Democrats will soon have a majority of commissioners. Acting Chairman Bob Adler has announced that he will not seek re-nomination when his current term ends later this year. The Division of Compliance and Field Operations has reorganized, and we have already seen two civil penalty matters announced in 2021, which is two more than the total number of civil penalties announced over the past two years. 

A COVID-19 vaccine may be ready for distribution in the United States by the end of the year. Polls show that a significant percentage of Americans are reluctant to get vaccinated, at least initially, and public health officials are recommending a cautious approach to the issue. U.S. businesses will have to resolve important and potentially controversial questions once vaccines become available, including the issue of whether companies should require vaccinations of their employees and/or customers. News reports also suggest that vaccination may be required by federal and/or state governments, which would be an unprecedented mandate leading to additional compliance questions and potential liability concerns for businesses. 

Cheri Falvey will be moderating a panel of government agency experts in navigating the requirements for distributing personal protective equipment and disinfectants during the pandemic. This session will explain the various regulatory bodies that have some level of oversight on promotional products businesses and identify what they do and how they interact with the industry. The ever-popular PPE category will be used to illustrate the challenges of multiple regulatory jurisdictions.

Beyond the CPSC, many federal agencies play a role in regulating consumer products and health and safety claims surrounding their intended use. In this session, Cheryl Falvey breaks down the regulatory roles and rules at play, and recent enforcement actions taken by Food and Drug Administration, Federal Trade Commission, and U.S. Environmental Protection Agency on products marketed as COVID-19 disinfectants and personal protective equipment among others.

The International Law Institute is hosting an Inter-University Center for Terrorism Studies (ICTS) Ambassadors' Forum titled, "Global COVID-19 and Sports: Threats and Responses." Crowell & Moring attorneys Chalana Damron, Tom Gies, and Kristof Roox will be presenting, along with several distinguished panelists. Together, they will explore the lessons learned and best strategies to counter current and future challenges to sports as a result of COVID-19.