A Texas Mess | Drug & Device Law

A Texas Mess: We are not inclined to mess with Texas.  Heck, a state ornery enough to secede from two different countries to preserve slavery isn’t likely to care, anyway.  So if Texas wants to run its 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).

The Complaint purports to tack these allegations onto broad Texas statutes that generally prohibit “misbranding” in “advertising” as well as “false, misleading, or deceptive acts.”  Id. ¶24 (citing Tex. Health & Safety C. §431.003, and Tex. Bus. & Com. C. §17.46(a)).  The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements.  Complaint ¶¶93-101.  The FDA, however, did not and does not share that belief.  To the contrary, the COVID-19 vaccine in question was fully approved by the FDA as safe and effective on August 23, 2021, and has remained so (or updated versions have) ever since.  The FDA, through its acting commissioner, stated:

[A]s the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

FDA (8/23/21) press release (emphasis original).

The Complaint also cherry-picks other post-FDA approval data that it alleges undercut either the vaccine’s safety or its efficacy.  Complaint ¶¶103-124.  Again, the FDA does not agree.  Indeed, a couple of weeks after the Texas Complaint was filed, the FDA explicitly reaffirmed the safety and efficacy of COVID-19 vaccines, in a correspondence unrelated to the Texas litigation:

We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines.  The agency’s benefit-risk assessment and ongoing safety surveillance demonstrate that the benefits of their use outweigh their risks.

FDA letter, December 14, 2023 (by Peter Marks, director CBER) (emphasis original).

In addition, the Texas Complaint contains various allegations about the manufacturer allegedly “intimidating” or “silencing” a couple of online antivaxxers.  Complaint ¶¶125-138.  We searched the Complaint in vain to find any relationship between that alleged conduct and the State of Texas.  The Complaint nowhere alleges that either the persons allegedly targeted or the persons purportedly targeting their “wild conspiracy theories” have any connection to Texas, which leaves us wondering how the Texas Deceptive Trade Practices Act (“DTPA”) could possibly apply.  Id. ¶138. See Henry Schein, Inc. v. Stromboe, 102 S.W.3d 675, 698 (Tex. 2002); Tracker Marine, L.P. v. Ogle, 108 S.W.3d 349, 358 (Tex. App. 2003); Birdsong v. Toyota Motor Credit Corp., 2002 WL 32830975, at *4 (Tex. Dist. May 15, 2002); Bass v. Hendrix, 931 F. Supp. 523, 529 (S.D. Tex. 1996) (all refusing to apply DTPA extraterritorially).

The reliance allegations in the Complaint are also remarkably conclusory for a statute that requires pleading “with particularity.”  E.g., Sipes v. Petry & Stewart, 812 S.W.2d 428, 431 (Tex. App. 1991); Village Square, Ltd. v. Barton, 660 S.W.2d 556, 559 (Tex. App. 1983).  As to reliance, the allegations of the Complaint don’t even use the term, and speak only of “the public” in general – and nobody in particular.  Complaint ¶¶139-40 (“as a result of”); ¶141 (“directly impacting the public’s decision-making process”); 144 (“resulted in”).  The “result” alleged was that “[a]s of November 10, 2023, Texans have been administered almost 30 million . . . doses” of the defendant’s vaccine.  Id. ¶140.

Finally, the Texas Complaint seeks relief solely under various provisions of the DTPA.  Id. ¶¶153, 156, 160, 164, 167, 170).  It seeks civil penalties in excess of $10 million, miscellaneous costs, and injunctive relief.  Id. ¶172-73.

We don’t intend to say anything further about the Texas Complaint’s factual allegations, even though we don’t believe a word of them.  Much more important than those insinuations is preemption, both under the PREP Act and the FDCA.  The PREP Act contains one of the most thoroughgoing express preemption clauses known to the law, and pandemic “countermeasures” – specifically vaccines – are at the heart of it.

The PREP Act goes into effect upon a federal declaration of public health emergency.  42 U.S.C. §§247d(a), 247d-6d(a)(1).  The Texas Complaint admits that happened, Complaint ¶35, and our prior post here covered it in detail.   Under the Act a “qualified countermeasure” includes any “biological product” (what vaccines are) used “to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease).”  42 U.S.C. §247d-6d(a)(2)(A)(i).  The PREP Act also contains strong “liability protections” for “covered countermeasures” and “covered persons,” which are defined terms:

(1) Covered countermeasure

The term “covered countermeasure” means–

(A) a qualified pandemic or epidemic product (as defined in paragraph (7));. . . . [or]

(C) a . . . biological product . . . that is authorized for emergency use in accordance with [pertinent portions of the FDCA.]

42 U.S.C. §247d-6d(i)(1).  The term “biological product” includes vaccines.  42 U.S.C. §262(i)(1).(2) Covered person

The term “covered person”, when used with respect to the administration or use of a covered countermeasure, means −. . .

(B) a person or entity that is −

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;. . . or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

42 U.S.C. §247d-6d(i)(2). Obviously, a vaccine manufacturer is a “covered person.”

For “covered persons” and “covered countermeasures” the Act provides extensive preemption:

(8) Preemption of State law

During the effective period of a declaration . . ., or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the Federal Food, Drug, and Cosmetic Act.

42 U.S.C. §247d-6d(b)(8).

Given the PREP Act’s express preemption provisions, the Texas AG’s suit seems certain to be preempted in its entirety.  Texas, the last time we looked, is a state.  Strike one.  The suit alleges events (the purported misrepresentations) that entirely occurred during the “effective period” (which is continuing) of the emergency declaration.  Strike two.  The suit “relates to” – at least – “the . . . development, clinical testing or investigation, . . . distribution, sale, . . . purchase, marketing, promotion, . . . use, [or] any other aspect of safety or efficacy” of a “covered countermeasure” – the defendant “manufacturer[’s]” COVID-19 vaccines.  Strike three. See M.T. as next friend of M.K. v. Walmart Stores, Inc., 528 P.3d 1067, 1075-76 (Kan. App. 2023) (finding defendant’s vaccine to be a covered countermeasure; preempting all claims), review denied (Kan. Aug. 25, 2023); Goins v. Saint Elizabeth Medical Center, 640 F. Supp.3d 745, 753 (E.D. Ky. 2022) (same result as to other COVID-19 vaccine).

The Texas Complaint is certainly “different from, or is in conflict with” the “requirements” imposed upon the defendant vaccine manufacturer under the COVID-19 emergency declaration, since what the Complaint labels as “deceptive” under state law involves information that the FDA determined – and as late as last month, reaffirmed – was sufficient to support both an emergency use authorization and full agency approval.

Since the PREP Act is expressly preemptive, Texas cannot take refuge in  any presumption against preemption, as we most recently discussed here.

[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016).

A federal statute expressly preempts a state law when Congress adopts express language defining the existence and scope of preemption.  And when the statute contains an express preemption clause, the court does not indulge “any presumption against preemption but instead focus[es] on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.”

Young Conservatives of Texas Foundation v. Smatresk, 73 F.4th 304, 311 (5th Cir. 2023) (quoting PR v. Franklin).

“[T]here is clear congressional intent that the prescribed remedies be exclusive.”  Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580, 587 (5th Cir. 2022).  “To encourage voluntary participation in the distribution of these countermeasures, the Secretary of [HHS] invoked the [PREP Act], to provide legal immunity for the individuals and organizations who provided these countermeasures to the public.”  Leonard v. Alabama State Board of Pharmacy, 61 F.4th 902, 905 (11th Cir. 2023).  The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005:

To encourage the expeditious development and deployment of medical countermeasures during a public health emergency . . . [by] authoriz[ing] the [HHS] Secretary to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. . . .  In the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.

“The PREP Act and COVID-19, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures 1, 1 (Cong. Res. Serv. April 13, 2022) (available here).  See, e.g., Cannon v. Watermark Retirement Communities, Inc., 45 F.4th 137, 139 (D.C. Cir. 2022) (quoting this publication).  “The purpose of the PREP Act, as supplemented by the amended PREP Act declaration, was to encourage covered providers to implement covered countermeasures as quickly and broadly as reasonably possible without fear of liability.”  Mills v. Hartford Healthcare Corp., 298 A.3d 605, 630 (Conn. 2023) (citation omitted).  “Under this plain, clear, and unambiguous language, the PREP Act was designed to prevent lawsuits that would arise from the physical provision of covered countermeasures to the end-user,” Pugh v. Okuley’s Pharmacy & Home Medical, ___ N.E.3d ___, 2023 WL 5862281, at *3 (Ohio App. Sept. 11, 2023), which the Complaint here alleges happened nearly 30 million times in Texas.  “The PREP Act, as amended, is an emergency response to the pandemic.  Its evident purpose is to embolden caregivers, permitting them to administer certain encouraged forms of care (listed COVID-19 ‘countermeasures’) with the assurance that they will not face liability for having done so.”  Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 478 F. Supp.3d 518, 529 (D.N.J. 2020), aff’d, 16 F.4th 393 (3d Cir. 2021).  The sweeping liability sought by the Texas Complaint is precisely what the PREP Act was intended to preclude.

Beyond preemption, there’s also PREP Act “immunity” – conferred by the same section of the statute.  We’re not 100% sure that, like a belt and suspenders, immunity matters given the square applicability of the Act’s preemption clause, but here’s how the “immunity” provision works.  It applies to “any type of loss,” which “includes” – but presumably is not limited to – “physical, mental, or emotional injury, illness, disability, or condition” and “loss of or damage to property, including business interruption loss.”  The “scope” of this immunity “applies to any claim for loss that has a causal relationship with the . . . development, clinical testing or investigation, . . . distribution, . . . purchase, marketing, promotion, sale, purchase, . . . or use” of an immune covered countermeasure.  42 U.S.C. §247d-6d(a)(2).

“[A]dministration of the covered countermeasure” is defined broadly to include both the “physical provision of the countermeasures to recipients” and “activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients . . . [and] management and operation of countermeasure programs.”

Mills, 298 A.3d at 571 (quoting COVID-19 emergency declaration,  85 Fed. Reg. 15191, 15200 (HHS March 17, 2020)).

The Texas Complaint’s allegations appear also to be within the scope of PREP Act immunity, but the sort of administrative penalties being sought may not fit within the statute’s definition of loss, although its examples of “loss” are expressly not exclusive.  Cf. Leonard, 61 F.4th at 914-15 (proceedings of medical disciplinary board did not involve “loss”).

In any event, the PREP Act’s immunity provisions primarily involve “complete preemption” – a form of federal subject matter jurisdiction – rather than the usual sort of express preemption we discuss here.  See, e.g., Mitchell, 28 F.4th at 587-88 (discussing complete preemption); Hudak v. Elmcroft of Sagamore Hills, 566 F. Supp.3d 771, 785 (N.D. Ohio 2021) (“it is critical to distinguish between complete preemption and ordinary preemption”), aff’d, 58 F.4th 845 (6th Cir. 2023). However, to the extent the Texas Complaint alleges willful misconduct (or the DTPA requires such conduct), it may well be completely preempted under the PREP Act.  See Manyweather v. Woodlawn Manor, Inc., 40 F.4th 237, 243 (5th Cir. 2022) (“Willful-misconduct claims may proceed only in the federal district court for the District of Columbia.”); Maglioli v. Alliance HC Holdings LLC, 16 F.4th 393, 411-12 (3d Cir. 2021) (no PREP Act federal jurisdiction over actions that do not “allege or imply that the [defendants] acted ‘intentionally to achieve a wrongful purpose’”) (quoting 42 U.S.C. §247d-6d(c)(1)(A)(i)).

Finally, while PREP Act preemption is the focus of today’s post, to the extent that the Texas Complaint can be read to allege – and we think it can – either:  (1) direct fraud on the FDA or (2) that the FDA’s approvals (both emergency and/or final) of the defendant’s vaccine should not have been granted, Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations.  For more on Buckman-based preemption of challenges to FDA product determinations, see our posts here and here.