This third installment of our series highlights regulators and other stakeholders’ growing focus on e-commerce platforms’ role in protecting consumers from unsafe products, as the percentage of online consumer product sales...more
On March 7, 2024, the U.S. Senate confirmed Doug Dziak as a Commissioner of the Consumer Product Safety Commission (CPSC), filling the final Commissioner seat that has remained vacant since Commissioner Dana Baiocco’s...more
This second installment of our series highlights CPSC’s Office of Compliance Activity and continued aggressive enforcement efforts. Multiple presenters emphasized CPSC’s continued aggressive enforcement. Commenters...more
The Consumer Product Safety Commission (CPSC) was well represented at the International Consumer Product Health and Safety Organization’s annual symposium in Orlando, which took place in February. Agency representatives...more
Courts are increasingly being asked: is AI a product or a service? AI companies currently operate within an undefined products liability space. As companies continue to innovate with AI, courts must grapple with complicated...more
In 2020, Congress passed the National Artificial Intelligence Initiative Act (NAIIA) to strengthen Artificial Intelligence (AI) advances and innovations across multiple sectors by providing investments to National AI Research...more
Cybersecurity is a key risk factor for emerging applications of artificial intelligence to medical devices. Products failing to address security risks may leave themselves vulnerable to cyberattacks. Bad actors target...more
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program....more
California lawmakers are considering a bill that would limit confidentiality in cases involving allegations of defective products or environmental harms by placing restrictions on protective orders and confidentiality terms...more
5/11/2022
/ California ,
Confidentiality Agreements ,
Disclosure ,
Early Dispute Resolution ,
Non-Disclosure Agreement ,
Product Defects ,
Proposed Legislation ,
Protective Orders ,
Right To Know ,
Settlement Agreements ,
Strict Product Liability
More aggressive enforcement actions and increased regulatory activities under the Biden Administration are here. In President Biden’s first weeks, he is making good on his promise to reverse course from the previous...more
The Eastern District of Texas ruled last week that Tyson, a “critical infrastructure” company, properly removed a COVID-19-related case to federal court under the federal officer removal statute, 28 U.S.C. § 1442.[1] In light...more
2/26/2021
/ Compliance ,
Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Federal Court Litigation ,
FEMA ,
Food Safety and Inspection Service (FSIS) ,
Goods or Services ,
Motion to Remand ,
Occupational Exposure ,
Occupational Injury ,
Patriot Act ,
Personal Protective Equipment ,
Tyson Foods ,
Workplace Safety
Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year....more
Welcome to the inaugural edition of Morrison & Foerster’s quarterly newsletter on recent developments in arbitrations, investigations, and commercial and intellectual property litigation that may affect Japanese...more
11/6/2020
/ Arbitration ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Electronic Communications ,
FCPA Corporate Enforcement Policy (CEP) ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
International Chamber of Commerce (ICC) ,
Japan ,
LCIA ,
Remote Hearings ,
SCC ,
Securities and Exchange Commission (SEC)
The Eastern District of Tennessee recently ruled that there is no private right of action under the Consumer Product Safety Act (CPSA) for an alleged violation of a voluntary product safety standard. The ruling narrows the...more
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and...more
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products,...more
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an...more
FDA has been actively working to accelerate access to diagnostic tests for COVID-19 through its extension of Emergency Use Authorizations (EUAs). According to FDA Commissioner Stephen M. Hahn, M.D., “The FDA’s...more
A federal court in Florida has entered a temporary restraining order against the Genesis II Church of Health and Healing (Genesis) and four principals associated with the entity. The order requires defendants to immediately...more
On April 14, the U.S. Department of Health and Human Services (HHS) issued an advisory opinion on the Public Readiness and Emergency Preparedness (PREP) Act to clarify the scope of immunity that accompanies developing and...more
The Consumer Product Safety Commission (CPSC) recognizes that companies everywhere are in the midst of responding to the impact of COVID-19 on business operations, including government stay-at-home orders that could see some...more
As the number of COVID-19 cases in the U.S. grows, the potential shortage of ventilators has become an increasing concern. This week, the U.S. Food and Drug Administration (FDA) took two important steps to keep medical...more
A number of startups announced they would begin selling at-home COVID-19 testing kits this week. These startups included: Carbon Health, a tech-enabled healthcare network that combines virtual and in-person care, Everlywell,...more
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents...more
COVID-19 is, quite literally, putting the medical supply industry to the test. Manufacturers are being pushed to develop novel products like therapies and vaccines to combat the disease as quickly as possible. The Public...more