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 advisory committee and “concerns . . . whether all public comments were adequately considered and addressed as required by the [Administrative Procedure Act].” Id. In that vein, we had previously concluded that “HHS’s entire discussion” struck us as “pretextual.”
Also of interest was HHS’s description of what would have to happen before COVID vaccine-related injuries could be compensated under the Vaccine Act (“VCIP”), as opposed to the more restrictive PREP Act compensation system (“CICP”) that we mentioned here and here.
COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the VICP. . . . [F]or a new category of vaccines to be covered under the VICP, the following three things must happen: (1) Congress must enact an excise tax on the vaccine, (2) the CDC must recommend it for routine administration to children or pregnant women, and (3) the Secretary must publish a notice of coverage in the Federal Register.
86 Fed. Reg. at 21211-12 (citation and footnote omitted).
Third, we commented in August 2019 that a recently promulgated “formal letter” by the Environmental Protection Agency concerning the pesticide Roundup should, under Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), preempt cancer claims involving that product because “it seems blindingly clear that the EPA has “informed the [regulated entity] that the [agency] would not approve changing the [product’s] label to include that warning.” Quoting Albrecht, 139 S. Ct. at 1678.
While we were right, it appears that we were also wrong – again due to the pervasive administrative law shenanigans of the ancien régime. We simply took the EPA’s action at face value. According to a recent Ninth Circuit decision, we shouldn’t have done that:
Nor does EPA’s 2019 letter, sent after the conclusion of [plaintiff’s] trial to all registrants of products containing glyphosate, carry the force of law. . . . [T]he 2019 letter − stating that EPA believes any pesticide label with a cancer warning due to the presence of glyphosate will be misbranded − did not follow any “formal administrative procedure” that would give the letter the force of law. The 2019 letter was issued without any written notice, gave no hearing or opportunity to respond, and lacked any sort of dispute-resolution process.
Hardeman v. Monsanto Co., ___ F.3d ___, 2021 WL 1940550, at *8 (9th Cir. May 14, 2021).
It appears that Hardeman was bound and determined to affirm that jury verdict no matter what, and since (as our prior post set out at length) there was no way around Albrecht’s implied preemption if the EPA’s letter was taken at face value, Hardeman came up with a rationale that nullified the letter altogether. Is it right? We don’t know the details, but we’ve commented before that the ancien régime often played fast and loose with administrative processes.
Fourth, we posted earlier this year about the Florida Supreme Court’s landmark decision to adopt the federal summary judgment standard. In a recent subsequent ruling, that court decided that the best way to implement that decision was simply to adopt the language of Fed. R. Civ. P. 56 “wholesale” as the rule in Florida (which goes by Fla. R. Civ. P. 1.510). So, effective May 1, 2021, “[t]he amendment we adopt . . . largely replaces the text of existing rule 1.510 with the text of federal rule 56.” In re Amendments To Fla. Rule of Civ. Proc. 1.510, ___ So.3d ___, 2021 WL 1684095, at *2 (Fla. April 29, 2021). Not only does the new rule apply to “pending case,” but parties that had summary judgment denied under the old rule get a do-over under the new rule:
In cases where a summary judgment motion was denied under the pre-amendment rule, the court should give the parties a reasonable opportunity to file a renewed summary judgment motion under the new rule. In cases where a pending summary judgment motion has been briefed but not decided, the court should allow the parties a reasonable opportunity to amend their filings to comply with the new rule. Any pending rehearing of a summary judgment motion decided under the pre-amendment rule should be decided under the pre-amendment rule, subject of course to a party’s ability to file a renewed motion for summary judgment under the new rule.
Id. at *4.
Fifth, in late 2019, we brought our readers the “good news”/“bad news” result in Fitzpatrick v. Wendy’s Old Fashioned Hamburgers of New York, Inc., 96 Mass. App. Ct. 410, 136 N.E.3d 355 (2019). The good news was the court’s denunciation of the “reptile” litigation tactics engaged in by the plaintiff’s in the case. The bad news was the toothlessness of that denunciation in practice, the trial judge’s mistrial was overturned on procedural grounds, and so was the overturning of the reptilian verdict, with instructions to give the plaintiff a do-over.
Well, last week the Massachusetts Supreme Judicial Court reversed and reinstated the trial judge’s mistrial. Most of the opinion was about the knotty procedural question, with the bottom line being that a mistrial motion can’t be held in abeyance to await the verdict, but must be decided immediately. Fitzpatrick v. Wendy’s Old Fashioned Hamburgers of New York, Inc., ___ N.E.3d ___, 2021 WL 2024453, at *4-5. (Mass. May 21, 2021). However, that ruling was made prospective only, id. at *6, and the court threw out the tainted verdict altogether over the plaintiff’s improper Reptile Theory closing argument. “We agree with the judge that certain of the statements made by the plaintiff’s counsel in closing involved an improper appeal to the jurors’ emotions, passions, prejudices, or sympathies.” Id. (citation and quotation marks omitted).
So the Reptile Theory is well on its way to justified extinction in Massachusetts.
Sixth, in our “And Now for Something Completely Different” post last fall, we commented on the unusual analysis used in Gustafson v. Springfield, Inc., 2020 WL 5755493 (Pa. Super. Sept. 28, 2020), to hold the federal Protection of Lawful Commerce in Arms Act – and by implication all federal tort reform legislation – unconstitutional. We called it “at once both paleolithically conservative and pro-plaintiffly radical.” Well we can now call Gustafson “reargument granted, opinion withdrawn.”