Background
Terry Reitz was admitted to Regional West Medical Center’s emergency department on November 26, 2020, diagnosed with COVID-19, and placed on a ventilator for respiratory support. While intubated, he developed sacral pressure injuries. He filed suit on September 23, 2022, but died on February 4, 2023. His wife, Vivian Reitz, was appointed personal representative and filed an amended complaint alleging four causes of action: res ipsa loquitor, informed consent, negligent training and supervision, and medical malpractice. Vivian claimed that Regional West Physicians Clinic and Regional West Medical Center failed to meet the standard of care by inadequately training and monitoring nursing staff to prevent pressure injuries in ventilator-dependent patients.
Appellees moved for summary judgment, asserting immunity under the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. §§ 247d-6d, 247d-6e, which shields covered persons from liability for losses arising from covered countermeasures. The district court granted the motion, finding that the ventilator constituted a covered countermeasure and that Terry’s pressure injuries arose out of, related to, and resulted from its administration. The court dismissed all claims with prejudice.
The Court’s Holding
The Nebraska Court of Appeals affirmed the district court’s grant of summary judgment. The court held that Vivian’s state law tort claims are preempted by the PREP Act. The court concluded that appellees were “covered persons” under the PREP Act—licensed healthcare entities authorized to administer medical devices—and that the ventilator constitutes a “covered countermeasure” as an instrument designed to treat disease.
The court applied the statutory language of the PREP Act, which provides immunity when three elements are satisfied: (1) a covered person administered (2) a covered countermeasure that (3) caused or gave rise to loss. The court found that all three elements were met. The ventilator’s use in treating COVID-19 could not be separated from the development of pressure injuries, and Vivian failed to produce evidence that the injuries did not arise out of, relate to, or result from the ventilator’s administration. The court rejected any distinction between “direct causation” and the broader statutory language of “caused by, arising out of, relating to, or resulting from,” holding that the plain language encompasses the full causal nexus.
Key Takeaways
- The PREP Act provides broad immunity to healthcare entities administering covered countermeasures used in treating pandemics or epidemics, preempting state negligence and medical malpractice claims.
- A ventilator used in COVID-19 treatment qualifies as a “covered countermeasure,” even when the injury (pressure sores) is an indirect or secondary consequence of its use.
- At summary judgment, once the defendant establishes the causal nexus between the countermeasure and the injury, the plaintiff bears the burden of producing evidence to refute that connection; failure to do so results in judgment as a matter of law.
- The PREP Act’s statutory language—”caused by, arising out of, relating to, or resulting from”—is interpreted broadly to encompass injuries beyond direct causation.
- The PREP Act channels remedies away from state courts and into the federal Countermeasure Injury Compensation Program, the exclusive remedy for non-willful-misconduct claims.
Why It Matters
This decision reinforces expansive federal preemption of state medical malpractice claims arising from COVID-19 treatment. It establishes that healthcare providers have near-complete immunity from negligence liability when treating pandemic patients with federal countermeasures, even for injuries that are collateral consequences of treatment (such as hospital-acquired pressure injuries resulting from prolonged immobilization). This significantly limits injured patients’ access to state courts and damages and redirects claims to a federal compensation program with potentially lower recovery thresholds.
The court’s broad interpretation of the causal nexus requirement—treating pressure sores in a ventilator-dependent patient as sufficiently “related to” the use of a ventilator—establishes a high bar for plaintiffs to escape PREP Act preemption. Healthcare providers treating pandemic patients face minimal exposure to state negligence liability, which may reduce incentives to implement additional safeguards against preventable harms that are causally connected to the use of medical countermeasures. For practitioners, this underscores the need to explore federal compensation remedies rather than state litigation when COVID-19 or other covered countermeasures are involved.