Class Dismissed

September 17, 2020 - Coronavirus (COVID-19), FDA, Drug & Medical Device, Product Liability
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
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September 16, 2020 - Appellate & Supreme Court, Product Liability
Getting Specific: Supreme Court Once Again Examines Limits of Personal Jurisdiction in Ford Motor Company Cases
By: Grant J. Esposito, Brian R. Matsui and Adam L. Sorensen
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
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May 26, 2020 - 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
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April 30, 2020 - Announcements & Press, Product Liability
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
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April 09, 2020 - Coronavirus (COVID-19), FDA, Product Liability, Pharmaceutical & Medical Devices
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
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March 31, 2020 - Coronavirus (COVID-19), Product Liability, CPSC
CPSC Recall Remedies in the Time of COVID-19
By: Erin M. Bosman, Julie Y. Park and Erin P. Lupfer
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
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March 23, 2020 - Coronavirus (COVID-19), FDA, Product Liability, Pharmaceutical & Medical Devices
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
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January 22, 2020 - Appellate & Supreme Court, Product 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
By: Grant J. Esposito and 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
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July 03, 2019 - FDA, Drug & Medical Device, Product Liability, Pharmaceutical & Medical Devices
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.
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June 20, 2019 - Internet of Things, Product Liability, Consumer Products, CPSC
Change Is in the Air: Buerkle Withdraws Her Nomination to Chair the CPSC
By: Erin M. Bosman, Julie Y. Park and Erin P. Lupfer
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 February 2017, on September 30, and will
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