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
Public policy favors scientific and medical research. So do we. While the theories of various claims asserted against sponsors of medical research—and the reasons for rejecting them—vary greatly, the underlying incentive to promote good research certainly plays a role in protecting those that sponsor and conduct medical research from virtually unlimited liability for alleged
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
Bexis was a mere college freshman, and a Princeton football manager, on September 28, 1974. In the first game of the season, Rutgers played Princeton at Princeton’s old (and rather decrepit) Palmer Stadium. With about three minutes to go and Rutgers up 6-0, Rutgers fans swarmed the field and tore down both sets of goalposts. When Princeton tied the game up with less than half a minute left, without goalposts we could not kick an extra point. A two point conversion failed, and Rutgers escaped with a tie.
Not quite half a century later, Rutgers scored an actual win. This time Bexis is pleased. In Children’s Health Defense, Inc. v. Rutgers, the State University of New Jersey, ___ F.4th ___, 2024 WL 637353 (3d Cir. Feb. 15, 2024) (“CHD”), the Third Circuit affirmed the right of a publicly supported university to require COVID-19 vaccination as a prerequisite to its students’ in-person attendance. We blogged about this outcome in the district court, and its precedential affirmance is even more significant.Continue Reading Tear Down the Goalposts – Rutgers Wins
As insightful and modest as the Blog can be, we are not infallible. Every once in a while, two posts get written on the same decision, sometimes because we try to make sure a new post goes up every non-holiday weekday of the year. Because of the aforementioned modesty, however, we are hesitant to deprive
Of late, the Fifth Circuit has come in for some criticism over rulings involving science, the FDA, and medicines. But apparently even it has its limits—and Article III standing is one.
In Children’s Health Defense v. FDA, No. 23-50167, 2024 U.S. App. LEXIS 1528, 2024 WL 244938 (5th Cir. 1/23/24), a non-profit and several
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
About two months ago, we marveled at the notion that challenges to facially neutral state and local government vaccine requirements were still percolating through the legal system. We probably should not have been surprised by the persistence of frivolous litigation. After all, our day job entails defending litigations that can last years longer than they
If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us. Public mask usage seems to have increased. We heard how the “tripledemic” of viruses had made hospital beds scarce. We have had colleagues out of commission instead of completing our assignments. The