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.
We have no inclination to mess with Texas. Heck, a state ornery enough to secede from two different countries in order to preserve slavery isn’t likely to care, anyway. So if Texas wants to run its own power grid, not connect to the rest of us, and freeze in the dark when that system fails, we’re certainly not going to stand in the way. Conversely, when Texas emphatically adopted the learned intermediary rule in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), we hailed it as the best decision of 2012.
But when Texas decides to mess with the rest of us…. Well, that’s different.
So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19. The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic. That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The Texas Complaint also claims that, in various ways, the vaccine manufacturer violated certain mandatory FDCA provisions and FDA regulations (¶22), did not follow voluntary FDA guidance (¶¶25-31), supposedly committed fraud on the FDA by submitting misleading data (¶¶47, 117, 120-21), and mostly that it purportedly misled the public and/or the press (¶¶50, 55-91, 154-55, 157-59, 161-63, 165-66, 168-69).Continue Reading A Texas Mess
Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here. They are: Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).Continue Reading Two New Appellate COVID-Related Developments