HHS Guidance Broadens PREP Act Immunity, Tightens Focus on Public/Private Cooperation
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- 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 deploying countermeasures to COVID-19. The PREP Act grants tort... ›
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... ›- - TCPA
More Autodialer Confusion: Second Circuit Decision Deepens Circuit Split
By: Adam J. Hunt and Michael G. Ahern
On April 7, 2020, the Second Circuit Court of Appeals vacated a district court’s decision granting summary judgment to a defendant in a TCPA class action and deepened a split among federal courts by holding that the systems the defendant used to send text... › 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... ›FDA Inspires Modifications and Quick Authorizations for Ventilators
By: Erin M. Bosman and Julie Y. Park
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 facilities equipped with life-saving ventilators. Ventilator Modification Enforcement... ›Ninth Circuit Provides Guidance on Pre-certification Discovery
By: Claudia M. Vetesi
Earlier this year, the Ninth Circuit held that plaintiffs cannot avail themselves of liberal discovery rules in order to locate class representatives. The court found that Rule 26(b)(1) of the Federal Rules of Civil Procedure, which governs the discovery process, does not authorize discovery... ›FDA Warns Against At-Home COVID-19 Testing Kits
By: Erin M. Bosman and Julie Y. Park
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, a company that offers food sensitivity and various other home health tests, and... ›Text Messaging in a Time of COVID-19: FCC Guidance on “Emergency Messages” and Restrictions on Telemarketing in New York
By: Tiffany Cheung and Adam J. Hunt
With nearly half of the United States population being either urged or ordered to stay at home and avoid all non-essential travel in light of the COVID-19 crisis, modern forms of communication such as telephone calls, video chat, and, of course, text messaging, are... ›Steering Ahead: NHTSA Looks to Modernize Rules for Automated Driving Systems
By: Claudia M. Vetesi
Last week, the U.S. Department of Transportation (“DOT”) steered into a new direction that may accelerate the development of self-driving technologies. The DOT’s National Highway Traffic Safety Administration (“NHTSA”), in an effort to modernize Federal Motor Vehicle Safety Standards (“FMVSS”), issued a notice of... ›FDA Calls “All Hands on Deck” to Keep Hand Sanitizer Stocked
By: Erin M. Bosman and Julie Y. Park
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 communicating its policy on the manufacture of certain alcohol-based... ›