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.
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.
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing, and marketing of allegedly unapproved stem cell products derived from birth-related products, such as placentas, amniotic tissues, umbilical cords, and umbilical cord blood.
These products, which include human cells, tissue, and cellar and tissue-based products (also known as HCT products) are intended to treat a variety of orthopedic issues, autism, cardiac issues, dementia and arthritis. HCT products are considered “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Examples of HCT products include “bone, ligament, skin, dura mater, heart valve, cornea, hematopoietic stem/progenitor cells derived from peripheral and cord blood, manipulated autologous chondrocytes, epithelial cells on a synthetic matrix, and semen or other reproductive tissue.”
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.