The COVID-19 crisis has impacted virtually all aspects of our daily lives. At Bowman and Brooke, we have taken a deep dive into the unique challenges and potential product liability issues and FDA regulatory implications for companies that make – or will make for the first time – medical products needed to respond to and combat the spread of COVID-19.
Our legal update focuses on several key facets of federal legislation specifically employed to address our country’s emergency response, and the intersection with the FDA and state laws.
In particular, we have considered the Public Readiness and Emergency Preparedness Act (“PREP Act”) and legal immunity from claims; the Public Health Service Act (“PHSA”) as amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (“PAHPRA”) which permits the FDA to issue Emergency Use Authorizations (“EUA”); the role of the FDA and the concept of Federal Preemption; informal guidance documents issued by FDA; liability protection under the Defense Protection Act (“DPA”), and the Coronavirus Treatment Acceleration Program (“CTAP”) announced by the FDA on March 31, 2020.
Please click here to be taken to our full report "Medical Products to Combat the COVID-19 Crisis: Products Liability Issues."
From Bowman and Brooke to all of yours, we wish you health and safety.