Topic Archives: Product Liability

How FDA is Monitoring the COVID-19 Product Market

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, including drugs, test kits, and PPE sold online with unproven claims. It is working with online marketplaces, domain name registrars, payment processors, and ...›

FDA Signals Flexibility with COVID-19 Tests

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 to accelerate the availability of testing, as we have previously reported. Notably, in its Policy ...›

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 Act includes many provisions addressing specific needs that have come to ...›

CPSC Recall Remedies in the Time of COVID-19

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 that companies may not be in a position to carry out ...›

PREP Act Declaration Emboldens Drug and Device Industry to Innovate in the Face of a Growing Crisis

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 device companies to increase production of existing products currently in short ...›

January 22, 2020Product Liability

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

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 over defendants. Personal jurisdiction comes in two varieties: general and specific. ...›

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

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. In conjunction with the end of the program, FDA also published ...›

Ninth Circuit’s En Banc Hyundai Decision: Less Strict Standard For Settlement Classes

On June 7, 2019, an en banc Ninth Circuit panel affirmed certification of a nationwide settlement class and held, 8-3, that class certification criteria are applied less strictly in a settlement context.[1]  Hyundai II preserves the ability to certify nationwide settlement classes while maintaining more demanding requirements for litigation classes.  As noted in our earlier ...›