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).

M.T. – PREP Act preemption

Of the two, we see the slightly earlier M.T. case as the more important – because it concerns preemption, a subject near and dear to our defense-oriented hearts.  M.T. is the first appellate court to consider PREP Act preemption substantively, as opposed to as a “complete preemption” basis for federal subject matter litigation.  Given the broad reach of the PREP Act’s express preemption clause, it doesn’t surprise us that the court held that all of the plaintiff’s claims, even those that struck us as “creative,” are preempted.

The PREP Act’s express preemption clause provides:

Subject to the other provisions of this section, a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued with respect to such countermeasure.

42 U.S.C.A. §247d-6d(a)(1).  All of the relevant terms in this clause:  “loss,” “covered person,” “countermeasure,”  are defined elsewhere in this section.  Also of relevance is a provision concerning the “scope” of the Act’s preemption:

The immunity under paragraph (1) applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.

Id. §247d-6d(b).  See, M.T., 2023 WL 3135662, at *3-5 (detailed PREP Act discussion).

As M.T. recognized, this preemption clause is “broadly worded.”  Id. at *13; see id. at *1, 4 (also describing PREP Act express preemption as “broad”).  Suffice it to say that it covers the administration of COVID vaccines – the heart of this nation’s response to the COVID-19 pandemic.

The plaintiff appears to be a rabid antivaxxer – so rabid that she apparently alienated her own children on this issue.  The relevant facts were quite concisely stated:

In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent.  She came with her 21-year-old brother-in-law.  [Plaintiff] claimed [the defendant] . . . pharmacist . . . “injected [daughter] with a substance labeled a Pfizer covid vaccine . . . according to [the] vaccination record.

M.T., 2023 WL 3135662, at *1 (quoting complaint).  Plaintiff’s stilted description of the COVID vaccine as a “substance labeled” as a vaccine further indicates what the defendant was up against.

The plaintiff asserted the following claims, either against the pharmacy, the unfortunate pharmacist, or both:  (1) invasion of privacy, by “intruding” on her “private relationship” with her daughter; (2) violation of “parental right of control”; (3) battery; (4) negligent “failure to secure consent, to warn, or to “inform of acceptable alternative treatments”; (5) vicarious negligence; (6) “failure to train employees and institute proper policies”; (7) “deceptive” consumer practices about consent and the “experimental nature of the vaccine”; and (8) punitive damages.  Id. at *2.

Every last one of these claims was preempted, given that the vaccine was a PREP Act “covered countermeasure” and the defendants were “covered persons” when they administered the COVID vaccine.  Plaintiff seemed to expect this, and repeatedly relied on the intentional vagueness of her own pleadings in an attempt to stave off dismissal.  E.g., M.T., 2023 WL 3135662, at *5 (plaintiff “contends her petition does not allege enough facts from which the district court could determine the PREP Act applies”).  M.T. did not allow plaintiff to take advantage of her own pleading deficiencies to avoid preemption by “disput[ing] whether the Pfizer COVID-19 vaccine was actually a vaccine.”  Id.  Her antivax “claims about the efficacy of the vaccine [were] beside the point” because “[a]pplication of the PREP Act does not turn on the effectiveness of the countermeasure.”  Id.

As to the existence of a “countermeasure,” M.K. took judicial notice of “declarations issued by the Secretary and FDA declaring [that this] vaccine [w]as a vaccination contemplated under the PREP Act.”  Id. at *6.  Likewise, the defendants were PREP Act “covered persons” as a matter of law.

[A] “covered person” in relevant part [i]s a person or entity that is a distributor of a covered countermeasure, a qualified person who administered a covered countermeasure, or an employee or agent of a distributor or qualified person.  The term “distributor” . . . includ[es] retail pharmacies.  The term “qualified person,” in turn, . . . include[s] licensed health care professionals or other individuals who are authorized to prescribe, administer, or dispense a covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed.

Id. at *8 (PREP Act citations omitted).

Preemption did the rest.  Given plaintiff’s antivax claims that her daughter “was deceived into engaging in ‘a medical experiment,’” there were no claims that relied on the defendants’ purported total “inaction.”  Id.  Plaintiff sued because her daughter obtained the vaccine without her consent – thus, by definition, her claims involved “the administration or use of covered countermeasures.”  Id. at *9.  The various nursing home decisions (see our discussions here, here, and here) were thus inapplicable, because all of those cases alleged failure to use any countermeasures at all.  Id. at *9-10.  Given the scope of the PREP Act’s express preemption, where, as in M.K., a covered measure was administered preemption reached all claims, even those involving allegations of “omissions.”

Negligence claims − including those of action and those of omission − are covered by the PREP Act when they are causally related to the administration or use of a covered countermeasure.  The Act did not apply to the plaintiffs’ claims in the cases cited by [plaintiff] because those claims were not causally related to the administration or use of covered countermeasures − they were causally related to the failure to administer or use covered countermeasures.

Id. at *10.  That included all of plaintiff’s informational claims.  The M.T. court called it like it saw it:

[Plaintiff’s] claims for withholding or misrepresenting information are properly characterized as claims for the alleged improper administration of a covered countermeasure.  That is, they relate to how that covered countermeasure was administered and are thus covered under the Act.

Id.  Thus, plaintiff’s arguments were “nonsensical.”  Id.

Plaintiff’s “misplaced” arguments concerning the scope of preemption met the same fate.  She confused preemption with the jurisdictional concept of “complete preemption.”  Id. at *11.  Her “claims all flow from the allegation that a COVID-19 vaccine was administered” and were “based on the supposed harms associated with such vaccines.”  Id.  All preemption (as opposed to complete preemption) required, under the PREP Act’s express preemption clause, were that the claims be “causally related to the administration of a covered countermeasure.”  Id.  They were, and that was the end of them.

Nor did the PREP Act contain any preemption exception for purported “intentional torts.”  Id.  Once again, plaintiff had erroneously attempted to use complete preemption cases in an ordinary preemption case.  Id.

Plaintiff’s claims alleging failure to obtain parental consent fared no better.  Without the administration of a “covered countermeasure” – the COVID-19 vaccine – those claims would not exist.  Id. at *14-15.  That was enough to satisfy the statute’s “but for” causation test.  “[A]ny claim causally related to the administration by a covered person of a covered countermeasure is covered by the Act, even claims based on the failure to obtain consent.”  Id. at *15.  Plaintiff’s attempt to create an implied carve-out for parents’ “fundamental” constitutional right “to decide their children’s care,” failed given “the plain text of the Act.”  Id. at *16.  Congress made “a policy decision . . . that potential tort liability arising from errors in administering a vaccine program “must give way to the need to promptly and efficiently respond to a pandemic.”  Id. (citations and quotation marks omitted).

[W]e find the PREP Act applies to [plaintiff’s] claims based on the failure to secure parental consent.  The text of the Act is unambiguous:  The Act applies to all claims causally related to the administration by a covered person of a covered countermeasure.

Id.

Finally, plaintiff in M.T. ginned up a variety of case-specific procedural claims that don’t interest us.  Suffice it to say, those arguments were also meritless.  Id. at *12-14.

Gahl – No right to demand ivermectin

Gahl, our second appellate COVID-related case, affirmed Gahl v. Aurora Health Care, Inc., 977 N.W.2d 756 (Wis. App. 2022), the intermediate appellate decision that we discussed here.  The initial, and now overturned, trial court injunction in this case was one of those early surprise attacks on the medical standard of care that led us to write our opus on the law applicable to demands for mandatory off-label use – our intent being to help counsel for healthcare providers faced with bizarre claims involving critically ill persons in short-fused litigation.

Gahl, however, did not cite any of the cases we discussed.  Indeed, the Wisconsin Supreme Court, while reaching the only logical result – that the mandatory ivermectin injunction was erroneous – strove to avoid the merits altogether.  Rather, Gahl reversed due to the absence of any legal justification for the injunction, while never discussing the reasons that no such justifications existed.  Gahl “emphasize[d]” both “the limited nature of our review” and “that this case is not about the efficacy of Ivermectin as a treatment for COVID-19.”  Id. at *11.

Reversal was based on the lack of any articulated legal basis for the unprecedented injunction mandating that the defendants facilitate the off-label use of a prescription drug.  Id. at *12.

[W]e do not know on what basis the circuit court issued the injunction.  The circuit court cited no law in either its written order or its oral ruling, as [plaintiff] conceded at oral argument before this court.  This in itself constitutes an erroneous exercise of discretion.

Id. (footnotes omitted).  A court acting without “a rational and explainable basis” by definition abuses its discretion.  Id.

A court’s ipse dixit in an injunctive proceeding is no more valid than a purported expert’s say-so in a Rule 702 proceeding:

The circuit court’s written order granting [plaintiff] relief does not cite any statute, case, or other source of law as a foundation allowing for its issuance.  Although the circuit court later clarified its intent in oral comments, those oral comments likewise did not identify any law on which the order was premised. Absent any citation to law establishing a legal basis for the order, we cannot determine that the circuit court employed the reasoning process our precedent demands.

Id. at *14.

That was it.  Gahl did not investigate why the utter paucity of supportive precedent for mandatory medical treatment injunctions existed, even though it received at least three amicus curiae briefs – including one from the American Medical Association – that presumably discussed the sort of issues that we addressed in our blogpost.  Id. at *2.  Indeed, Gahl did not even cite the precedent from other states that overwhelmingly concludes that similar ivermectin-related injunctions are unsupportable.  See Shoemaker v. UPMC Pinnacle Hospitals, 283 A.3d 885, 896-97 (Pa. Super. 2022); Pisano v. Mayo Clinic, 333 So.3d 782, 790 (Fla. App. 2022); Abbinanti v. Presence Center & Suburban Hospitals Network, 191 N.E.3d. 1265, 1271-72 (Ill. App. 2021); Texas Health Huguley, Inc. v. Jones, 637 S.W.3d 202, 207 (Tex. App. 2021); Frey v. Health-Michigan, 2021 WL 5871744, at *4-5 (Mich. App. Dec. 10, 2021); DeMarco v. Christiana Care Health Services, Inc., 263 A.3d 423, 426 (Del. Ch. 2021); Salier v. Walmart, Inc., ___ F. Supp.3d ___, 2022 WL 3579752, at *4 (D. Minn. Aug. 19, 2022).

So Gahl reached the right result – but it was somewhat galling that it avoided every issue of substance.