All Claims Means ALL: The PREP Act Provides Immunity in COVID-19 Vaccination Case

ABSTRACT: The Kansas Court of Appeals recently issued a decision in M.T. v. Walmart Stores, Inc., addressing the applicability of the PREP Act immunity for claims surrounding a failure to secure parental consent prior to administering a COVID-19 vaccine to a minor.  In doing so, the Court touched on issues surrounding the language of the Act involving who is covered, what is covered, and preemption.

In M.T. and M.T., as next friend of her minor daughter, M.K. v. Walmart Stores, Inc. and Mark Schukar, a consolidated appeal from the District Court of Johnson County, Kansas, the Kansas Court of Appeals affirmed in part and reversed in part the District Court’s decision. Specifically, the Court of Appeals found that the District Court erred in not dismissing all of the Plaintiff Mother’s claims that she brought against Defendants Walmart and Schukar due to the immunity provided by the Public Readiness and Emergency Preparedness (PREP) Act. 

Plaintiff Mother’s claims arose after Defendant Schukar, a pharmacist at Walmart, administered a Pfizer COVID-19 vaccine to the Plaintiff Mother’s minor child, M.K., without her parental consent, despite having the minor’s 21-year-old brother-in-law present. The Plaintiff Mother alleged that her minor child was told that she could receive the vaccine without parental consent because she was 15 years old. However, Kansas law actually requires parent consent for medical treatment if the minor is under the age of 16. See K.S.A. § 38-123b. The Plaintiff sought damages for alleged, but unspecified physical injuries to her daughter and for her own emotional injuries, asserting claims against defendants Walmart and Schukar for invasion of the right of privacy (and interfering with parental control), battery, negligence, consumer protection violations, and punitive damages.

The District Court originally dismissed most of her claims because they were barred by the PREP Act. See 42 U.S.C. § 247d-6d(a), (d). Both parties appealed – the Plaintiff Mother arguing that none of her claims should have been dismissed, while the Defendants argued that all of her claims should have been dismissed. The appeals were consolidated into the appeal at issue here.

Background on The PREP Act

The PREP Act, enacted on December 30, 2005, as Public Law 109-148, Division C, § 2, amended the Public Health Service (PHS) Act. Ultimately, the amendments to the PHS Act concerning liability immunity and a compensation program were codified within 42 U.S.C. § 247d-6d. The PREP Act essentially provides liability immunity to “covered persons” (individuals or entities) for any claim for loss that has a causal relationship with the administration of a “covered countermeasure,” except for claims involving “willful misconduct.” Id. A covered countermeasure includes, among other things, a qualified pandemic or epidemic product and a drug, biological product, or device that is authorized for emergency use (which includes vaccines). See Id.; 42 USC § 262(i)(l).

The immunity provided applies 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 ….”, which includes “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.” See 42 U.S.C.§ 247d-6d(a)(1), (2)(B) (emphasis added). There is also a preemption provision within the statute, preventing any State of political subdivision of State from establishing, enforcing, or continuing in effect as to a covered countermeasure any provision of law or legal requirement that conflicts with the requirements of the statute and essentially relates to any matter included in a requirement applicable to a covered countermeasure under the statute or under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]. See 42 U.S.C.§ 247d-6d(b)(8).

Former Secretary Alex M. Azar II, issued a Declaration concerning medical countermeasures against COVID-19 that would be covered under the PREP Act and, subsequently, various amendments have been made to clarify and/or otherwise add categories of qualified countermeasures, qualified persons, and/or categories of disease, health conditions or threats. One such covered countermeasure for which liability immunity is in effect is as to “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19.”

The Question(s) and Answer(s) on Appeal

The District Court found that the Plaintiff Mother’s claims for battery, claims for losses or damages, and claims regarding deception as to the efficacy of the vaccine and its approval status were causally related to the covered countermeasure - e.g., providing the Pfizer COVID-19 vaccine - and dismissed those claims. However, the District Court would not dismiss the remaining claims concerning Plaintiff Mother’s allegations surrounding failure to obtain parental consent. Specifically, in refusing to dismiss those claims, the District Court focused on parenting being a “fundamental constitutional right and issues of consent and the age of majority are traditionally state law issues”; thus, the Act couldn’t interfere with or preempt those rights where the Act did not expressly intend to do so.  

There were two questions certified for appeal:

(1) "Is the [PREP Act] and its immunity provision completely preemptive of all state law causes of action, regardless of the theory, so long as there is any connection or involvement whatsoever with a covered countermeasure?"; and

(2) "Does the [PREP Act] give covered persons absolute immunity to violate Kansas parental consent or age of medical consent for minors law?"

However, because it believed the questions certified by the District Court went beyond the actual controversy, the Court of Appeals limited its review to the question:

“Whether a claim based on the administration of a covered countermeasure without parental consent is causally related to the administration of a covered countermeasure.” 

It ultimately answered that question in the affirmative – in that because the PREP Act applies to any claim for loss that has a causal relationship with the administration to an individual of a covered countermeasure, all of Plaintiff Mother’s claims should be dismissed – even those claims that were based on a failure to obtain parental consent. 

In other words, the Court of Appeals agreed with the Defendants that the language of the PREP Act was unambiguous: all claims means all claims, not "all claims except for those based on a violation of a fundamental right."

To get there, the Court of Appeals first established that the injection of Pfizer COVID-19 vaccine was a covered countermeasure, as recognized by the Secretary and FDA declaring the vaccine “as a vaccination contemplated under” the PREP Act, which the Court was permitted to take judicial notice of, and based on the allegations in the Petition. Defendants were also “covered persons” for purposes of the PREP Act.

The Court of Appeals also rejected the argument that application of the PREP Act was improper at the motion to dismiss phase because nothing in her Petition permitted ascertainment as to whether Walmart obtained the vaccine through one of the two means of distribution specific by the Secretary of Health and Human Services – either by agreement with the federal government or in response to the COVID-19 pandemic. In so rejecting, the Court of Appeals recognized that there is no evidence that the vaccine was sold commercially before the pandemic, unlike, for example, a case involving hand sanitizer.

The Plaintiff Mother further argued that the application of the PREP Act was improper because her Petition focused on claims of inaction, which fall outside the scope of the PREP Act’s available immunity, and/or that the PREP Act does not cover failure to act and that obtaining parental consent is not a covered countermeasure. The Court of Appeals was not so persuaded – specifically pointing out that such “claims of inaction” are, for example, claims for a failure to administer or use a covered countermeasure, not for the improper administration of the covered countermeasure. In this case, there was, in fact, a successful administration of the covered countermeasure – the vaccine – by covered persons, even if it was arguably improper due to the minor’s age and lack of parental consent.  As such, the exception the Plaintiff Mother was arguing for did not apply.  

The Court further recognized that the Plaintiff Mother’s preemption argument – that her negligence claim was outside the scope of the PREP Act because willful misconduct claims have been found to not displace state law claims for negligence and recklessness – was misplaced. The Court found that even if the PREP Act does not completely preempt state-law intentional tort claims, the same “does not establish that its immunity protections do not apply to intentional tort claims causally related to the administration of a covered countermeasure.” 

Ultimately, the Court held that the PREP Act applied to all of the Plaintiff Mother’s claims – even those based on the failure to secure parental consent and found that the District Court erred in denying Defendants’ motions to dismiss, in part, due to failing to dismiss all the claims. It reversed and remanded the cases so that the Plaintiff Mother’s claims would all be dismissed.

This decision should shine some light on and provide hope for Defendants in the future seeking to challenge Petitions on the basis of the PREP Act’s applicability and provide further support for dismissal of all claims causally related to the administration of a covered countermeasure by covered persons.