Court Finds No Private Right of Action Under Consumer Product Safety Act for Alleged Violation of Voluntary Standard
- 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.[1] The ruling narrows the claims in a pending lawsuit about hoverboards and... ›
First Decisions Limit PREP Act Immunity in Coronavirus Context
By: Erin M. Bosman and Julie Y. Park
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 medical products. So far, so good: the first court decisions interpreting PREP Act... ›Getting Specific: Supreme Court Once Again Examines Limits of Personal Jurisdiction in Ford Motor Company Cases
By: Brian R. Matsui
Despite their repeated efforts to provide guidance to lower courts, the Justices once again find themselves in a familiar position: attempting to clarify the constitutional limits on courts’ power to exercise personal jurisdiction over defendants. The Supreme Court’s docket has seen a steady stream... ›- - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability, Emergency Use Authorization (EUA)
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps... › MoFo Named #1 Producer of Quality Products-Liability Content
For the second year in a row, Morrison & Foerster has been named the “Top Firm” for Products Liability content by JD Supra’s 2020 Readers’ Choice Awards. The awards recognize just a single firm in each practice area. Erin Bosman , co-chair of the... ›CARES Act of 2020: Guide for Drug and Device Companies
The Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) is an unprecedented $2 trillion economic stimulus package passed to help mitigate the economic and health consequences caused by the COVID-19 pandemic and to strengthen the U.S. health system going forward. The... ›CPSC Recall Remedies in the Time of COVID-19
By: Erin M. Bosman and Julie Y. Park
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 operations temporarily close. Given these “extraordinary circumstances,” the CPSC issued a notice... ›PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis
By: Erin M. Bosman and Julie Y. Park
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 Readiness and Emergency Preparedness (PREP) Act encourages drug and medical... ›Start Your Engines: The U.S. Supreme Court Will Yet Again Review the Constitutional Limits of Personal Jurisdiction in a Pair of Cases Involving Ford Motor Company
By: Brian R. Matsui
Lower courts’ inability or refusal to confine cases to their proper fora compels the Supreme Court to spend precious docket space restating the rules governing personal jurisdiction. The Due Process Clauses of the Fifth and Fourteenth Amendments limit courts’ authority to exercise personal jurisdiction... ›Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR
By: Erin M. Bosman and Julie Y. Park
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 (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) Program.... ›