On April 22, 2024, the European Federation of Pharmaceutical Industries and Associations (“EFPIA”) issued a statement on the application of the AI Act in the medicinal product lifecycle. The EFPIA statement highlights that AI applications are likely to play an increasing role in the development and manufacture of medicines.  As drug development is already governed by a longstanding and detailed EU regulatory framework, EFPIA stresses that care should be taken to ensure that any rules on the use of AI are fit-for-purpose, adequately tailored, risk-based, and do not duplicate existing rules ..read more

Senate Commerce Committee Chair Maria Cantwell (D-WA) and Senators Todd Young (R-IN), John Hickenlooper (D-CO), and Marsha Blackburn (R-TN) recently introduced the Future of AI Innovation Act, a legislative package that addresses key bipartisan priorities to promote AI safety, standardization, and access.  The bill would also advance U.S. leadership in AI by facilitating R&D and creating testbeds for AI systems. First, the bill would codify the AI Safety Institute at the National Institute of Standards and Technology (NIST), a body established last year by the Commerce Department to d ..read more

A court in the Southern District of New York recently dismissed a lawsuit alleging that an “All Natural” representation on the front label of defendant’s beverage products was false and misleading because the products contained synthetic citric acid and used vegetable and fruit juice concentrates for color.  Valencia v. Snapple Beverage Corp., 2024 WL 1158476 (S.D.N.Y. Mar. 18, 2024). Plaintiff alleged that the “All Natural” representation on the label was misleading because it used citric acid, “an industrially produced, synthetic ingredient.”  The court held that this generalized a ..read more

On April 16, 2024, the IRS issued fact sheet FS-2024-13 providing answers to frequently asked questions  about the tax treatment of work-life referral services provided to employees under an employer’s work-life referral program. The FAQs clarify that, under certain circumstances, the value received from work-life referral services provided to employees through a work-life referral program can be excluded from federal income and employment taxes as a “de minimis fringe” benefit. A work-life referral program is an employer-funded fringe benefit that provides referral services to eligible e ..read more

Environmental, social, and corporate governance (ESG) initiatives have become increasingly important in today’s business setting.  Increased awareness and heightened scrutiny of ESG-related issues, combined with third-party litigation funding, has led to a surge in ESG-related litigation and enforcement actions as consumers, regulators, and investors seek to hold companies accountable for claims about their environmental and social impact.   This post explores the emerging trends shaping the landscape of ESG litigation, which are increasingly centralized in courts in the District of ..read more

In six months’ time, on 17 October 2024, Member State laws that transpose the EU’s revised Network and Information Systems Directive (“NIS2”) will start to apply.  As described in more detail in our earlier blog post (here), NIS2 significantly expands the categories of organizations that fall within scope of EU cybersecurity legislation. This new, cross-sector law imposes additional and more granular security and incident reporting rules, enhanced governance requirements that apply to organizations’ “management bodies,” and creates a stricter enforcement regime. Organizations that are pre ..read more

In recent months, the European Court of Justice (“CJEU”) issued five judgments providing some clarity on the scope of individuals’ rights to claim compensation for “material and non-material damage” under Article 82 of the GDPR. These rulings will inform companies’ exposure to compensation claims, particularly in the context of the EU’s Collective Redress Directive, but open questions remain about the quantum of compensation courts will offer in these cases and we expect both the CJEU and national courts to deliver additional case-law clarifying this topic in the coming year (for more informat ..read more

A New Orleans magician recently made headlines for using artificial intelligence (AI) to  emulate President Biden’s voice without his consent in a misleading robocall to New Hampshire voters. This was not a magic trick, but rather a demonstration of the risks AI-generated “deepfakes” pose to election integrity.  As rapidly evolving AI capabilities collide with the ongoing 2024 elections, federal and state policymakers increasingly are taking steps to protect the public from the threat of deceptive AI-generated political content. Media generated by AI to imitate an individual’s voice ..read more

On April 9, the Board of Trustees of the Science Based Targets initiative (SBTi), a climate action organization that has validated corporate decarbonization targets for more than 4,200 companies to-date, issued a statement announcing that environmental attribute certificates (EACs), including carbon credits generated by voluntary carbon projects, may be used to abate Scope 3 greenhouse gas (GHG) emissions. It is possible to view the Board’s statement, unprecedented for SBTi, as recognition of the practical challenges associated with achieving Scope 3 emissions abatement without utilizing EACs ..read more

In a short, unanimous opinion on April 12, 2024, the Supreme Court shut the door on “pure omission” claims under Rule 10b–5 and made clear that the Rule is limited to claims based on false or misleading statements. The case, Macquarie Infrastructure Corp. v. Moab Partners, L.P., concerns alleged omissions in Defendant Macquarie’s SEC filings related to its subsidiary’s operation of bulk liquid storage terminals.  In 2016, the United Nations’ International Maritime Organization issued a regulation limiting this subsidiary’s ability to store high-sulfur fuel oil, its single largest product ..read more