Little greater than a 12 months in the past, in our “Texas Mess” submit, we critiqued what we known as a “weird criticism” just lately filed by the Texas legal professional basic (“TAG”) towards a significant COVID-19 vaccine producer. We described that criticism as a mélange of “varied antivax conspiracy theories regarding COVID-19 vaccines, the FDA, emergency use authorizations, and the media.” On the deserves, we predicted that the entire equipment and kaboodle can be precluded by the PREP Act as a result of: (1) that statute “incorporates probably the most thoroughgoing categorical preemption clauses recognized to the legislation,” and (2) “pandemic countermeasures – particularly vaccines – are on the coronary heart of” the act’s protections.”
And that’s exactly what occurred on the finish of 2024. All the criticism was dismissed for failure to state a declare as a consequence of PREP Act preemption. “Extra particularly, the Courtroom finds that as a matter of legislation below the circumstances of this case, the Defendant is entitled to immunity below the Public Readiness and Emergency Act (‘PREP Act’).” State of Texas v. Pfizer, Inc., C.A. No. 5:23-CV-3l2-C, slip op. at 1 (N.D. Tex. Dec. 30, 2024). Additional, “each the PREP Act and the Meals, Drug, and Beauty Act (“FDCA”) preempt Plaintiffs claims.” Id. at 1-2. Lastly, including insult to damage, the choice held that the TAG failed to use the state’s shopper safety statute appropriately. Id. at 2 (“the alleged statements by Defendant weren’t linked to any ‘commerce or commerce’ or any ‘shopper transaction’”). Due to this fact, the criticism (known as a “petition” in Texas parlance) was “DISMISSED for primarily the explanations argued within the Movement and Reply.” Id. (on-line hyperlinks added).
That’s it. In solely two pages, the complete TAG conspiratorial fantasy bit the mud.
The opinion was sufficiently terse that each Lexis and Westlaw missed it – and we didn’t discover out about it for practically a month.
To study extra in regards to the why, how and wherefore of this dismissal, we adopted the choice’s reference and took a take a look at the defendant’s transient and reply transient in help of the movement to dismiss.
The principal transient bluntly state that TAG “has no authorized proper to insert itself between FDA and the American individuals.” Temporary at 2. Why?
Congress has tasked FDA, not state officers, with deciding whether or not [defendant’s] vaccine is sufficiently protected and efficient, and federal legislation presents a number of insurmountable boundaries to this lawsuit. Not solely does [defendant] have statutory immunity below the PREP Act, however TAG’s claims are preempted twice over.
Id.
Addressing the PREP Act, the principal protection transient identified that even TAG “acknowledged [that], federal legislation supplies [defendant] with broad immunity from claims associated to the COVID-19 vaccine” – in the beginning the PREP Act. Id. at 10. The primary Trump Administration “recognized COVID-19 vaccine manufactures as ‘lined individuals’ and their vaccines as ‘lined countermeasures’” below the statute. Id. TAG’s allegations additionally concerned a PREP Act “declare for loss,” because the act “defines ‘loss’ broadly, stating ‘the time period ‘loss’ means any kind of loss.’” Id. at 11.
Beneath this expansive definition, the statute supplies immunity from claims for “any kind of loss” associated to the administration or use of [defendant’s] vaccine. The claims right here fall squarely inside this broad definition of “loss.” Based on [TAG]’s personal criticism, [defendant’s] alleged “illegal acts or practices” “brought about damage, loss, and harm to [the State], in addition to brought about adversarial results to the lawful conduct of commerce and commerce, thereby immediately or not directly affecting the individuals of this State.” The criticism additional requests damages and restitution, that are solely recoverable when the State or its residents have suffered a “loss.”
Id. (citations omitted). Including up lined individuals and countermeasures, in addition to lined losses, the transient concluded, as to the PREP Act immunity:
The criticism on this case asserts state-law claims for “losses” “attributable to, arising out of, referring to, or ensuing from the administration to and use by” people of [defendant’s] vaccine, a lined countermeasure. Accordingly, the PREP Act immunizes [defendant] towards this lawsuit.
Id. at 12.
Transferring from immunity to preemption, the protection principal transient subsequent argued:
Congress enacted the PREP Act to incentivize non-public firms to help the federal authorities in offering probably lifesaving countermeasures throughout a public well being emergency with out concern of later being sued for actions taken in a time of disaster. In providing immunity to the producers of COVID-19 vaccines, HHS emphasised the intense public well being emergency attributable to the pandemic and the necessity for “a sustained, coordinated proactive response by the [g]overnment so as to include and mitigate the unfold” of the virus. [Defendant] answered the federal authorities’s name. Regardless of this, [TAG] seeks to carry the corporate liable below state legislation for actions “referring to,” amongst different issues, the “design,” “growth,” “medical testing,” and “security and efficacy” of the COVID-19 vaccine. This lawsuit, which is in direct battle with necessary federal prerogatives, is tailor made for dismissal below the PREP Act.
Temporary at 14 (citations omitted).
The protection transient goes on to argue, persuasively, that the TAG criticism can be preempted immediately by the FDCA. Id. at 14-18. However because the court docket’s resolution rests on the PREP Act with out mentioning the FDCA, we’ll skip this side of the protection preemption argument.
Transferring to Texas Misleading Commerce Practices Act (“DTPA”), the protection principal transient factors out a relatively fundamental flaw in TAG’s allegations – the state had nothing to do with the transactions at problem.
[T]he federal authorities was the only U.S. purchaser of the vaccine throughout 2020 and 2021 − when [defendant] allegedly overstated the vaccine’s advantages − and till very just lately the federal authorities made the vaccine obtainable, freed from cost, to all individuals residing in the US.
Id. at 19 (quotation omitted). Thus, the allegations didn’t concern any “commerce or commerce” topic to state regulation. The feds purchased the vaccine, and gave it away free to the general public. On one finish, Texas can’t regulate the federal authorities, and on the opposite, the DTPA is “involved with ‘enterprise,’ not gratuitous transactions.” Id. at 20 (quotation omitted). “Commerce,” as utilized in a misleading practices statute, “means ‘[t]he enterprise of shopping for and promoting or bartering items or providers.’” Id. at 21 (quotation omitted).
[R]ead as an built-in entire, . . . the DTPA applies to personal enterprise transactions, not charitable endeavors or large-scale authorities applications to advance the general public well being. . . . [Defendant] Pfizer didn’t make [any] statements in reference to the sale of the vaccine. As beforehand mentioned, the statements in query, which Pfizer allegedly made in 2020 . . ., passed off lengthy after [defendant] contracted to supply a whole bunch of hundreds of thousands of doses to the federal authorities; the vaccine was not on the market to particular person Texans. As a result of [defendant’s] so-called “misrepresentations” on this case have been disseminated to most of the people − which obtained the vaccine at no cost − and never the federal officers who really licensed and bought the product, the alleged misstatements didn’t happen “within the conduct of any commerce or commerce” and the criticism fails to state a DTPA declare.
Id. at 22 (citations omitted).
The protection reply transient, additionally talked about within the opinion, principally reiterated these similar factors. TAG, the defendant argued, “argues for a narrower studying,” however solely by “cherry decide[ing] phrases from the statute whereas ignoring the entire statutory language.” That flaw “permeated” TAG’s papers, “which misleadingly cite[d] not simply the language of the PREP Act, but in addition the DTPA and the related case legislation.” Reply br. at 2-3. TAG “violate[d bedrock] canons of development at each flip.” Id. at 3. First, the PREP Act’s protections are hardly restricted to “private damage.”
Beneath the PREP Act, “the time period ‘loss’ means any kind of loss.” This broad language just isn’t restricted to private accidents. In truth, the statute supplies “any kind of loss” additionally contains, however just isn’t essentially restricted to, “lack of or harm to property, together with enterprise interruption loss.” Learn as an built-in entire, the PREP Act’s immunity provision extends far past “bodily or psychological loss.”
Id. at 4 (citations omitted).
Subsequent, TAG argued that the DTPA didn’t require the state to show a loss – however that ignored TAG’s personal criticism, which repeatedly alleged varied losses. Id. The PREP Act additional “prohibits claims far past these stemming ‘from the administration of’ a lined countermeasure.” Id. The PREP Act’s “broad grant of immunity” reached any allegations that “come up out of” or “relate to” administration of the COVID-19 vaccine, and the “very first web page” of TAG’s criticism alleged that the purported “deceptive” claims brought about “a whole bunch of hundreds of thousands of People” to obtain the defendant’s vaccine. Id. at 5 (citations and citation marks omitted). The reply identified that “Courts have rejected as ‘nonsensical’ the argument that shopper safety claims lack a ample nexus to the ‘administration’ of a lined countermeasure.” Id. (quotation omitted).
Additional, whereas states had no energy to implement vaccine-related claims, the PREP Act included an “express carve-out for federal enforcement actions.” Id. at 6 (quotation omitted). TAG’s “absurd” argument {that a} producer “may declare with impunity that the vaccine cures most cancers, completely misse[d] the purpose.” Id. Most cancers was not a throughout the “the class or classes of ailments” throughout the authorities’s PREP Act declarations. Id. (citations and citation marks omitted).
TAG’s arguments towards PREP Act preemption have been equally unavailing:
[TAG]’s claims are in direct battle with [the statute]. The criticism’s complete premise is that [defendant’s] statements in regards to the vaccine misled people, thus “hurt[ing] Texas and its residents.” Even [TAG] agrees that such claims, if introduced by people, can be barred. . . . [TAG] asserts, nonetheless, that the state might carry the identical declare “on behalf of the general public curiosity of its residents” performing as “parens patriae.” This can’t be right; the preemption clause can be meaningless if states may carry the very claims the statute bars people from bringing. At a minimal, [TAG]’s interpretation would learn the phrase “implement” out of the preemption clause completely. That’s one thing courts mustn’t ever do.
Id. at 7 (citations omitted). Nor did the inane “mirror” federal necessities argument matter. The PREP Act, versus the FDCA, can’t be misinterpret on this vogue, as a result of the PREP Act doesn’t depend on the FDCA in any respect. Id.
Nor, because the protection reply identified repeatedly, did TAG supply any precedent supporting its place that federal distribution of free vaccines someway got here throughout the purview of the DTPA. Id. at 8-10. Aside from nitpicking the precedent cited within the defendant’s transient, TAG “d[id] not meaningfully handle the DTPA’s statutory textual content.” Id. at 9. Positive, the state didn’t itself should be a “shopper,” but it surely needed to be suing over “shopper” transactions, which free federal distribution was not. Id. “[T]he Texas Legislature was involved with ‘enterprise,’ not gratuitous transactions.” Id. at 10 (quotation and citation marks omitted).
We perceive that TAG is taking an enchantment. We don’t suppose that even the Fifth Circuit will discover that enchantment very interesting.