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By: Bethany J. Hills, Julie Y. Park, and Hilary R. Hoffman
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined, pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, that there is a significant potential for a public health emergency related to the novel …›
By: Erin M. Bosman, Julie Y. Park, and Alexander A. Najarian
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 liability …›
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 …›
By: David J. Fioccola, 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 …›
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 …›
By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, Hilary R. Hoffman, and Alexander A. Najarian
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 Policy
On …›
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 …›
By: Erin M. Bosman, Julie Y. Park, and Bethany J. Hills
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 …›
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 …›
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 …›
