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 or likeness present significant challenges for regulators.  As deepfakes increasingly become indistinguishable from authentic content, members of Congress, federal regulatory agencies, and third-party stakeholders all have called for action to mitigate the threats deepfakes can pose for elections.  

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. Yet, the statement also drew swift criticism from some stakeholders and observers, who argue that it represents a departure from SBTi’s science-based approach to corporate climate action. 

Following the criticism, on April 11, “the overwhelming majority” of SBTi’s staff, which felt “compelled to issue multiple clarifications” of the Board’s statement, published a remarkable public response.  Thereafter, on April 12, the Board supplemented its April 9 statement to clarify that no changes to the SBTi standards had been finalized. However, the Board’s statement and staff’s response show that interested stakeholders will have opportunities to provide SBTi with critical input regarding the use of EACs in Scope 3 emissions abatement that could have a material effect on any related revisions to the SBTi standards.  

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. Though the regulation was set to take effect in 2020, Macquarie did not discuss the regulation in its public filings.

Earlier this month, lawmakers released a discussion draft of a proposed federal privacy bill, the American Privacy Rights Act of 2024 (the “APRA”).  While the draft aims to introduce a comprehensive federal privacy statute for the U.S., it contains some notable provisions that could potentially affect the development and use of artificial intelligence systems.  These provisions include the following:

With the 2024 election rapidly approaching, the Biden Administration must race to finalize proposed agency actions as early as mid-May to avoid facing possible nullification if the Republican Party controls both chambers of Congress and the White House next year. 

The Congressional Review Act (CRA) allows Congress to overturn rules issued by the Executive Branch by enacting a joint resolution of disapproval that cancels the rule and prohibits the agency from issuing a rule that is “substantially the same.”  One of the CRA’s most unique features—a 60-day “lookback period”—allows the next Congress 60 days to review rules issued near the end of the last Congress.  This means that the Administration must finalize and publish certain rules long before Election Day to avoid being eligible for CRA review in the new year.

Overview of the CRA

The CRA requires federal agencies to submit all final rules to Congress before the rule may take effect.  It provides the House with 60 legislative days and the Senate with 60 session days to introduce a joint resolution of disapproval to overturn the rule.  This 60-day period counts every calendar day, including weekends and holidays, but excludes days that either chamber is out of session for more than three days pursuant to an adjournment resolution.  In the Senate, a joint resolution of disapproval receives only limited debate and may not be filibustered.  Moreover, if it has been more than 20 calendar days since Congress received a final rule and a joint resolution has not been reported out of the appropriate committee, a group of 30 Senators can file a petition to force a floor vote on the petition.   

If a CRA resolution receives a simple majority in both chambers and is signed by the President, or if Congress overrides a presidential veto, the rule cannot go into effect and is treated “as though such rule had never taken effect.”[1]  The agency is also barred from reissuing a rule that is “substantially the same,” unless authorized by future law.[2]    

Election Year Threat: CRA Lookback Period

These procedures pose special challenges for federal agencies in an election year.  If a rule is submitted to Congress within 60 days before adjournment, the CRA’s lookback provision allows the 60-day timeline to introduce a CRA resolution to start over in the next session of Congress.

This procedure ultimately requires the current administration to assess the threat of a CRA resolution against certain rules and determine whether to issue the rule safely before the deadline or risk a potential CRA challenge. 

As previewed in our prior post regarding new California employment laws from the 2023 legislative session, employers must implement a comprehensive workplace violence prevention plan (WVPP) and provide employee training on the WVPP by this coming July 1, 2024.  The WVPP requirement (under new California Labor Code Section 6401.9), augments the existing obligation for California employers to create and maintain an injury and illness prevention plan and is intended to combat incidents of workplace violence, which is the second leading cause of fatal occupational injuries in the United States according to OSHA.  The new compliance requirements are described below, along with steps employers can take to get ready.

On 10 April 2024, the European Parliament adopted its position on the Commission proposal to reform the core EU pharmaceutical legislation (see here and here).  In doing so, the European Parliament has met its ambitious timeline to adopt its position before the upcoming Parliamentary elections and marks a significant step in the legislative process. 

Parliament’s position comes less than a year since the Commission published its proposal, which consists of a new directive replacing Directive 2001/83/EC and a new master regulation replacing Regulation 726/2004, which will also consolidate the orphan and pediatric medicines regulations (see our prior EU Pharma Legislation Review blog series).  Many of Parliament’s amendments to the Commission proposal will be seen as improvements by the innovative industry, but there remain challenges and unresolved questions.

We provide below the top 8 takeaways for industry to consider during the next phase of the legislative process, which is a detailed review by the Council.

The Northern District of Illinois recently denied certification to several proposed classes of purchasers of a seizure drug called Acthar in City of Rockford v. Mallinckrodt ARD, Inc., No. 3:17-cv-50107, 2024 WL 1363544 (Mar. 29, 2024).  Class plaintiffs had alleged that defendant Express Scripts, a drug distributor, conspired with Mallinckrodt, a drug manufacturer, to raise the price of Acthar through an exclusive distribution arrangement.  In denying certification to the damages classes, the court determined that plaintiffs had not met Rule 23(b)(3)’s predominance standard because they lacked a reliable economic model showing that damages were “capable of measurement on a classwide basis,” as required by Comcast Corp. v. Behrend, 569 U.S. 27, 34 (2013).

Another federal district court has dismissed a putative class action complaint asserting that an online retailer’s chat feature violated the users’ privacy under the California Invasion of Privacy Act (“CIPA”), Cal. Penal Code §§ 630 et seqSee Garcia v. Build.com, Inc., Case No. 22-cv-1985-DMS-KSC (S.D. Cal. Mar. 29, 2024), ECF 37.