The COVID-19 pandemic has closed courthouses from coast to coast for all but essential proceedings. Most civil trials and hearings are on hold. Some courts are encouraging, and in some cases ordering, the continuation of discovery — including depositions using video or audio conferencing. Others have extended discovery schedules to await easing of pandemic restrictions. This post examines the different approaches courts are taking and the arguments litigants might make — or respond to — about whether to proceed with remote depositions. In a second post, we’ll discuss practical considerations for lawyers who choose to — or are ordered to — proceed with remote depositions.
Subject: COVID-19
FDA Gives Guidance on Reporting Medical Device Shortages
Last week, FDA released guidance for life sciences manufacturers that produce medical devices and components “critical to public health,” including materials that support or sustain life, or are used in emergency care or surgery. If there is an anticipated (or actual) disruption that may result in a shortage based on increased demand or supply-side interruption, the FDA must be notified no later than seven calendar days from the onset. The requirement to notify the Agency applies to a broad range of devices and equipment, and lasts for the duration of the COVID-19 emergency.
The FDA’s guidance on this topic arises out of the March 27, 2020, CARES Act amendments to the Food, Drug and Cosmetic Act. Those updates, codified at 21 U.S.C. § 356j, mirror similar provisions for prescription drug shortages implemented in December 2016. While the statutory provisions contemplate that a device manufacturer would provide notice to the FDA of an anticipated shortage or interruption at least six months in advance, or “as soon as is practicable,” the recent guidance recognizes that this may not be possible under current market conditions.
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Effectively Navigating PREP Act Case Law – The Products Liability Perspective
Since the federal Public Readiness and Emergency Preparedness Act (the PREP Act) was enacted by Congress in 2005, only a few courts have substantively commented on the Act’s requirements. The PREP Act provides federal immunity against state law tort claims to covered entities that manufacture covered countermeasures used to fight diseases and viruses declared as national emergencies, such as COVID-19.
The pivotal case substantively applying the PREP Act’s immunity defense is Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (N.Y. App. Div. 2012). The Parker court held that because the plaintiffs’ daughter was administered a covered countermeasure to prevent the H1N1 virus, their state law claims for negligence were preempted and barred by the PREP Act’s immunity provisions. To date, no reported decision has permitted traditional state law tort claims against a manufacturer for the alleged use of a covered countermeasure under the PREP Act.
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Preparing for the COVID-19 Immunity Preemption Defense
As manufacturers of vaccines, pharmaceutical medicines, ventilators and respirators engage substantial resources and ramp up production to help fight COVID-19, many have presumably done so under the immunity protections afforded by the federal Public Readiness and Emergency Preparedness Act (the PREP Act codified at 42 USC §247d-6d), and Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). Because of industry-wide uncertainty surrounding PREP Act immunity and the need for immediate and urgent action on the part of manufacturers, the U.S. Department of Health and Human Services (HHS) recently issued a non-binding Advisory Opinion explaining the scope of PREP Act coverage, its immunity provisions in the context of COVID-19 countermeasures, and informal guidance on the preemptive effect of the federal law.
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