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
The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more
3/19/2020
/ Coronavirus/COVID-19 ,
Deceptively Misdescriptive ,
Enforcement Actions ,
False Advertising ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
FTC Act ,
Unfair or Deceptive Trade Practices ,
Warning Letters
This week, President Trump announced that he intends to nominate Nancy Beck as Chair and Commissioner of the Consumer Product Safety Commission (CPSC). The five-person CPSC has been short a member since the end of September...more
The U.S. Consumer Product Safety Commission (CPSC) recently elected Commissioner Robert Adler to serve as vice-chair of the CPSC. Commissioner Adler, a Democrat who has served on the CPSC since 2009, is a surprising choice...more
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.” This report describes updates to FDA’s Medical Device Reporting...more
This week, Acting Chairman Ann Marie Buerkle withdrew her nomination to serve as Chairman of the U.S. Consumer Product Safety Commission (CPSC). She will wrap up her tenure as Acting Chairman, a position she has held since...more
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third...more
6/6/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Consumer products companies are familiar with the reporting requirement under Section 15(b) of the Consumer Products Safety Act (the Act), but when does that obligation kick in for statute of limitations purposes? The...more
At a recent product safety conference, Ann Marie Buerkle, Acting Chair of the U.S. Consumer Product Safety Commission (CPSC), announced CPSC’s priorities for 2019. These include technology—both for consumers and within the...more