Tag: US
US Executive Order on AI Regulation Signals Litigation Risks Across Jurisdictions
A group of Cooley partners in Business, Communications, and CDP have authored an update on the recent US Executive Order seeking to limit US state AI regulation and establish a national AI policy framework. Multinational companies should monitor cross-border implications, especially in light of other evolving regimes like the EU […]
Webinar: General Product Safety Regulation – Where Are We One Year On?
Monday, 15th December 2025 // 4:00 PM GMT // 5:00 PM CET // 6:00 PM EET It’s been a year since the European Union’s (EU) General Product Safety Regulation (GPSR) started to apply. While some aspects of the regulation have settled into practice, others remain open to interpretation, and the […]
Cooley Litigation Trends Webinar Series – Marketplaces + Ecommerce
Please join Cooley’s litigation team for the next session of our continued legal education (CLE) webinar series, where we explore trends and insights on the disputes landscape in the UK and mainland Europe, and the issues that drive them.
Enrique Capdevila, Andrew Linch, James Maton, Claire Temple
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Regulator Session 2
Regulator Session 2: ‘Global Regulator Update’ ICPHSO’s Global Regulator Update featured senior representatives from the US Consumer Product Safety Commission (CPSC), the UK’s Office for Product Safety and Standards (OPSS), the European Commission and the National Consumer Commission of South Africa. The panel explored the most significant regulatory activities in […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Plenary Session 1
‘Market Surveillance and Product Recalls: Linking Policy to Action in Case of Online Sales’ Plenary session 1 featured speakers from Amazon, TIC Council Americas, UL Solutions and Anushi Amin of Cooley (UK) LLP. The panel examined how the new European Union (EU) General Product Safety Regulation (GPSR) would affect the […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium
Cooley’s international products team will be attending the ICPHSO 2025 Annual Meeting and Training Symposium, “Fostering Bridges Within the Product Safety Community,” in Orlando, Florida, from February 17 – 20, 2025. We will be posting highlights from the plenary panel sessions on our Productwise blog throughout the event.
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.
Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel
EU’s General Product Safety Regulation: An Expanded Concept of Safety
In the second in a series of blogs on the European Union’s new General Product Safety Regulation, the Cooley products team takes a look at the expanded concept of safety under the new rules and why this matters.
Calif. Ruling Heightens Medical Product Maker Liability
On June 20, the California Supreme Court issued its decision in Himes v. Somatics LLC. This 7-0 ruling has vast implications for manufacturers of medical products, namely manufacturers of prescription drugs and medical devices that reach patients through a learned intermediary, as well as for medical providers and the healthcare industry as a whole.
PFAS Regulation: EPA Designates Two PFAS as Hazardous Substances Under CERCLA
On April 19, 2024, the US Environmental Protection Agency (EPA) issued a final rule that designates two PFAS chemicals – PFOA and PFOS – as ‘hazardous substances’ subject to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, also known as Superfund). The rule will take effect under CERCLA, giving the EPA increased authority to investigate and respond to PFAS contamination and seek recovery of costs associated with cleanup efforts. The EPA sees the new rule as a significant step in its regulation of PFAS.