Earlier this month, the Judicial Conference’s Advisory Committee on Civil Rules unanimously approved a proposed new rule to the Federal Rules of Civil Procedure to address case management of multidistrict litigation (“MDL”).  The rule is the first addition to the Federal Rules focused on MDLs, and it reflects an attempt to suggest a nationwide approach to MDL case management that tracks approaches to case management that MDL judges have often followed in practice while leaving MDL judges discretion to depart from the suggested procedures depending on the needs of a particular case. The ap ..read more

In March, the Shanghai Market Supervision Bureau and the Shanghai Medical Products Administrative Bureau jointly issued the “Shanghai Cosmetic Industry Advertising Compliance Guidelines” (“Guidelines”).  The Guidelines are based on the national Advertisement Law (as amended 2021) and Cosmetic Labeling Administration Provisions issued by the National Medical Products Administration in 2021.  The Guidelines offer practical guidance and direction in this area. For example, the Guidelines provide that cosmetic manufacturers and distributors should integrate advertisement compliance into ..read more

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series. The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months. 1:  ..read more

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted. This article focuses on the implications for “wellness applications” and medical devices; for an overview of the EHDS generally, see our first post in this series. The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months. 1: Wellness Applications and ..read more

On April 15, the U.S. Supreme Court declined a request by Visa and Mastercard to review a D.C. Circuit decision that appeared to add to a circuit split about how lower courts are to determine whether common issues predominate under Federal Rule of Civil Procedure 23(b)(3).  The case, Visa Inc. v. Nat’l ATM Council, Inc., Case No. 23-814, was part of a long-running dispute between the card companies and ATM operators about ATM fees.  In July, the D.C. Circuit upheld the certification of three different Plaintiff classes over the card companies’ argument that the district court had fai ..read more

On April 17, 2024, the EPA released a final rule designating two perfluorinated chemicals—Perfluorooctanoic Acid (PFOA) and Perfluorooctanesulfonic Acid (PFOS)—as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).  EPA also released enforcement guidance explaining how it intends to apply the new listing with respect to certain types of potentially responsible parties. The rule will go into effect 60 days after publication in the Federal Register, and is the first time the agency has designated any hazardous substances under CERCL ..read more

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