This post is to update our readers about subsequent developments in matters covered in some of our prior blogposts.
First, slightly over a year ago we praised Gayle v. Pfizer, Inc., 452 F. Supp.3d 78 (S.D.N.Y. 2020), a prescription drug preemption decision holding, among other things, that a plaintiff could not claim “newly acquired information” simply by dumping a disorganized mass of hundreds of adverse event reports on the judge, and claiming that the burden shifted to the defendant to “analyze” them. Id. at 88. In the interim, the plaintiff in Gayle appealed, and recently the Second Circuit affirmed. Gayle v. Pfizer, Inc., ___ F. Appx. ___, 2021 WL 1904338 (2d Cir. May 12, 2021). Ordinarily, such an affirmance would merit its own post, but the Second Circuit’s memorandum affirmance is only three short paragraphs. The second paragraph is what counts:
For substantially the reasons stated by the District Court in its April 7, 2020 opinion and order, we conclude that the Plaintiffs-Appellants’ state-law failure-to-warn claims are preempted by federal law to the extent that they arose after February 2012, and that they are untimely to the extent that they arose before April 2016. Also for substantially the reasons stated by the District Court, we conclude that leave to amend the complaint is futile.
Id. at *1. Thus, the opinion we liked before now has the added luster of the Second Circuit’s imprimatur.
Second, last September, we expressed our puzzlement at the ancien régime’s proposal to remove from Vaccine Act compensation something called “SIRVA” (Shoulder Injury Related to Vaccine Administration). See 85 Fed. Reg. 43,791 (HHS July 20, 2020). We’ve had quite a few shoulder jabs in our day, but had never heard of this. The oddest part of the proposal was its advocacy of civil tort negligence litigation against persons who administer vaccines as preferable to the Vaccine Act’s compensation system. At the time, this aspect of the proposal struck us as weird and counterproductive.
[W]e are not exaggerating here. An express purpose of the HHS proposal is to encourage litigation against health care professionals who administer vaccines, and thus to impose “the burden and expense” of litigation on others.
Well, the new administration apparently agrees with us. A little over a month ago, it formally withdrew that proposal. See 86 Fed. Reg. 21209 (HHS April 22, 2021). The idea of exposing persons administering vaccines to greater tort liability struck the new administration as counterproductive, just as we had concluded:
As a policy matter, HHS is rescinding the [previous] Final Rule because it is concerned that it would have a negative impact on vaccine administrators, which would be at odds with the Federal Government’s efforts to increase confidence in vaccinations in the United States, particularly in light of efforts to respond to the Coronavirus Disease 2019 (COVID-19) pandemic. . . . Given this unprecedented vaccination effort and the concern that the [previous] Final Rule’s revisions to the Table could negatively impact the COVID-19 vaccination campaign, as well as other campaigns such as annual influenza vaccination efforts, and the January 21, 2021 Final Rule’s associated procedural issues, HHS is rescinding that rule.
86 Fed. Reg. at 21211. HHS also cited the sort of administrative law shennanigans that were all too common under the now-departed ancien régime, “agree[ing] that there were irregularities in how HHS consulted with” the vaccine...
