Publications
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HHS Secretary’s Fourth Amendment to PREP Act Declaration Clarifies Its Intent for Federal Jurisdiction and Broad Application to COVID-19-Related Claims
Fourth Amendment to PREP Act Declaration Issued
December 4, 2020
The fourth amendment to HHS Secretary Azar’s PREP Act Declaration assertively addresses current disputes involving federal jurisdiction for courts hearing disputes about the Act’s application to claims for injury, and further suggests an intention for a broad application of the Act. -
What If Your Automaker-Manufactured Ventilator Is a Lemon?
What If Your Automaker-Manufactured Ventilator Is a Lemon?
May 6, 2020
Ventilators are being manufactured pursuant to U.S. Food and Drug Administration emergency use authorizations by companies that don’t normally make such devices, and the FDA has effectively waived most federal regulations relative to the manufacture of these devices in response to the current health emergency. The Public Readiness and Emergency Preparedness (PREP) Act typically would provide immunity for liability arising from the use of these devices in response to the health emergency, but only for a limited period of time. What happens when the PREP Act authorization expires in October 2024 and one of these ventilators allegedly injures a patient, and what can these companies do to protect themselves from liability claims? -
Liability Immunity Relating to Implementation of Countermeasures to COVID-19
Liability Immunity for Drug and Medical Device Manufacturers, Distributors and Users
March 19, 2020
The focus of an HHS Declaration is to permit the special use of drugs and other medical products during the COVID-19 pandemic that either have not yet been approved or cleared by the FDA or that may be used off-label without the risk of liability in the event of an injury or other claimed loss. In the event of injury, relief can be found via the Countermeasures Injury Compensation Program (CICP). -
Can a Negotiating Class Yield a Covered Settlement in the Opioid Litigation?
"Coverage," a magazine of the ABA section of insurance litigation
December 9, 2019
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Rules for Medical Marijuana Facilities in Missouri and a Look at the Application Process
Cannabis Business Executive
June 3, 2019
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Pre-trip inspections: Are you doing enough?
International Law Office, legal update service for major companies and law firms worldwide
February 20, 2019