Readers of this blog know that we love preemption in all its forms, including preemption based in the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. §247d-6d.
During the COVID-19 pandemic, a needlessly politicized public health emergency, the PREP Act provided important liability protections to health care providers, vaccine manufacturers, and others working hard
Covid-19 is not over. Per doctor advice (namely, that geezers whose primary form of exercise consists of removing Meursault corks should do their best to avoid Covid) we recently received yet another Covid-19 jab. We’re not up to double digits yet, but cannot be far from it. For those of you who would gleefully castigate
Little more than a year ago, in our “Texas Mess” post, we critiqued what we called a “bizarre complaint” recently filed by the Texas attorney general (“TAG”) against a major COVID-19 vaccine manufacturer. We described that complaint as a mélange of “various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency
From our very first post back in early 2020 on preclusive power of the PREP Act, 42 U.S.C. §247d-6d, we were impressed by the scope of its combined preemption and immunity language. There, we quoted the language from the HHS secretary’s emergency declaration:
[A] covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.
Quoting 85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).Continue Reading Deconstructing the PREP Act
The Vermont Supreme Court correctly applied the PREP Act last week to dismiss state-law claims arising from a COVID vaccine. See Politella v. Windham Southeast School Dist., No 23-AP-237, 2024 WL 3545717 (Vt. July 26, 2024) (to be published in A.3d). This was an easy case, and the PREP Act (aka the “Public Readiness
The PREP Act is having a moment. Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies. The declaration of COVID-19 as an “emergency” has thus thrust the PREP Act into the limelight. Heck, when you’re a federal
We’ve discussed decisions applying preemption under the Public Readiness & Emergency Preparedness Act (hereafter “PREP Act”), 42 U.S.C. §247d-6d, on several occasions since the COVID-19 pandemic began. At this point, some four years after the COVID-19 pandemic declaration, we believe that sufficient PREP Act preemption precedent has accumulated, and that the caselaw is sufficiently
Much like the placement of a comma, differences in capitalization can affect meaning quite a bit. Take PrEP and PREP. The former refers to the use of certain antiviral medications for pre-exposure prophylaxis to HIV, which has been hailed as a paradigm shift in treating HIV. We recall that FDA was so impressed with
We are medical device and pharmaceutical lawyers, so preemption is our thing. It may not make for scintillating cocktail conversation, but we find the intersection between Constitutional law (the Supremacy Clause and the federal/state balance of power) and public policy issues (health and safety, and regulation versus litigation as the best way to promote
Law school exams are usually exercises in issue spotting. Buried within the fact scenarios are various legal issues. The student earns points by identifying those issues and discussing how they should be resolved. Sequence also matters. It makes sense to walk through threshold issues, such as jurisdiction, first.
Goins v. Saint Elizabeth Medical Center, Inc.