PREP Act Immunity in the COVID-19 Era: Recent Decisions Impacting Your Defenses to Coronavirus-Related Claims

17 November 2020 Blog
Authors: Erik K. Swanholt John J. Atallah Jessica N. Walker
Published To: Coronavirus Resource Center:Back to Business Consumer Class Defense Counsel Health Care Law Today Manufacturing Industry Advisor

On March 25, 2020, we reported that the Department of Health and Human Services (HHS) had extended the Public Readiness and Emergency Preparedness (“PREP”) Act to provide immunity to “Covered Persons” providing “Covered Countermeasures” against COVID-19.  As we noted in our April 17 update to the same article, the Office of the General Counsel for HHS issued an omnibus advisory opinion on April 14 that addressed common questions and concerns about the scope of PREP Act immunity.  Critically, the advisory opinion reminded persons and entities seeking PREP Act immunity that they remain responsible for determining both (1) whether they qualify as Covered Persons, and (2) whether their products count as Covered Countermeasures.

The PREP Act was originally signed into law in December 2005.  However, very few courts had interpreted or applied the PREP Act in any appreciable manner prior to the COVID-19 pandemic.  This lack of judicial interpretation left open many questions about how the PREP Act—and, in particular, its grant of immunity to tort liability—would actually be applied in litigation.  Over the last few months, courts across the country have issued decisions that provide insight into the contours of the PREP Act and how it will be applied to cases stemming from the COVID-19 pandemic.

These cases share some common features.  They all involve claims that were initially brought in state court and then removed by defendants on the basis of federal question jurisdiction under the PREP Act.  In each instance, the plaintiffs filed motions to remand their respective cases to state court, and all the remand motions were granted.  The parallel rationales applied by the various courts in these cases together illustrate the limitations of PREP Act immunity as a defense to tort claims related to COVID-19, but they also shed light on potential avenues of defense.

The PREP Act Requires a Causal Connection to the Affirmative Use of Covered Countermeasures, Rather Than an Alleged Failure to Use Such Countermeasures

Estate of Maglioli v. Andover Subacute Rehab Ctr. I, No. 206605 (KM)(ESK), 2020 U.S. Dist. LEXIS 145055, at *1-2 (D.N.J. Aug. 12, 2020).

The first decision, issued by the U.S. District Court for the District of New Jersey, involved claims of negligence, wrongful death, and medical malpractice brought on behalf of residents and patients at the defendants’ nursing care facilities.  Estate of Maglioli v. Andover Subacute Rehab Ctr. I, No. 206605 (KM)(ESK), 2020 U.S. Dist. LEXIS 145055, at *1-2 (D.N.J. Aug. 12, 2020).  The plaintiffs were a group of individuals who had died while in defendants’ care, “allegedly as a result of Defendants’ failure to exercise due care with respect to coronavirus infections.”  Id. at *3.  The defendants removed their case to federal court on the theory that adjudication of their claim of statutory immunity under the PREP Act created a federal question.

In addressing the defendants’ claim of statutory immunity, the court focused on the plaintiffs’ allegations regarding their supposed failure to provide adequate countermeasures to prevent the spread of COVID-19.  The court distinguished such allegations from the notion that the defendants had caused harm through some use or application of countermeasures, stating: “Indeed, Plaintiffs are claiming (inter alia) that the Defendants committed negligence in that, among other things, they failed to take countermeasures, some of them allegedly federally required.”  Id. at 28.  The court also discussed actions alleged in the complaint as other sources of negligence which are not “covered countermeasures” under the PREP Act: social distancing, quarantining, and lockdowns.  Id. at 31.  The court did “not rule that Defendants are, or are not, entitled to a PREP Act defense to this or that claim. … What [it was] deciding is that the PREP Act does not so occupy the field as to squeeze out state-court jurisdiction over what are state-law claims of negligence and require an exclusive federal forum,” and granted the motion to remand on that basis.

In reaching its conclusion that remand to state court was appropriate, the district court also ruminated on what might fall under the PREP Act’s scope, noting: “Here, by contrast, the complaints do not allege that Plaintiffs’ injuries arose from, e.g., Defendants’ administration to them of vaccines or medicines (or for that matter protective gear) – activities that the PREP Act promotes by offering immunity.”  Id. at *27.  Citing the statute, the court emphasized that the PREP Act “covers ‘qualified pandemic or epidemic products’ – products including ‘a drug (as such term is defined in the section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).’” 

Baskin v. Big Blue Healthcare, Case No. 2:20-cv-2267-HLT-JPO, 2020 U.S. Dist. LEXIS 150012 (D. Kan. Aug. 19, 2020).

The second case, out of the U.S. District Court for the District of Kansas, was also a wrongful death action against a care facility “alleging [Defendants] were negligent in failing to protect against COVID-19 infections.”  Baskin v. Big Blue Healthcare, Case No. 2:20-cv-2267-HLT-JPO, 2020 U.S. Dist. LEXIS 150012, at *1 (D. Kan. Aug. 19, 2020).  Defendants removed to federal court, arguing that the doctrine of complete preemption applied to provide federal question subject matter jurisdiction.  Id. at *6. 

In considering this argument, the court summarized the grant of immunity provided by the PREP Act as follows: “[T]he PREP Act creates immunity for all claims of loss causally related to the administration or use of covered countermeasures, which are certain drugs, biological products, or devices.  Exceptions to immunity exist for claims of willful misconduct but suit must be brought in the United States Court for the District of Columbia. …. State laws that differ or conflict regarding the administration or use of covered countermeasures are preempted.”  Id. at *14.

Addressing the allegations in the complaint, the court acknowledged: “nowhere in the complaint do Plaintiffs suggest that the decedent’s death was causally connected to the administration or use of any drug, biological product, or device (i.e., a covered countermeasure[]).  The claim seems to be precisely the opposite: that inaction rather than action caused the death.”  Id. at *14-15.  Because the complaint alleged a failure to use countermeasures, the claims lacked a causal connection to the use of countermeasures, as required under the PREP Act.  Without that causal connection, the PREP Act did not apply and could not “be used to establish federal questions jurisdiction under the doctrine of complete preemption.”  Id. at *21. On that ground, the district court ordered the case remanded to state court.

Notably, the Baskin case is one of 12 related cases against Big Blue Healthcare, all of which were decided together on August 19, 2020, and resulted in the same determination.  See, e.g., Rodina v. Big Blue Healthcare, 2020 U.S. Dist. LEXIS 150021; Lutz v. Big Blue Healthcare, 2020 U.S. Dist. LEXIS 150020.

Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, No. 20cv1198, 2020 U.S. Dist. LEXIS 191885 (W.D. Pa. Oct. 16, 2020)

The U.S. District Court for the Western District of Pennsylvania agreed with the reasoning applied in Maglioli in addressing a similar complaint alleging that the “decedent died because Defendants failed to take preventative measures and failed to utilize covered countermeasures.”  Sherod, 2020 U.S. Dist. LEXIS 191885, at *20 (W.D. Pa. Oct. 16, 2020).  The court found “that because Plaintiff’s Complaint alleges that Brighton failed to provide decedent with any protection/countermeasures, Plaintiff’s claims fall outside the purview of the PREP Act, which purports to provide immunity to facilities like Brighton when a claim is brought against them for the countermeasures the facility actually utilized.”  Id. at *20.

Gunter v. CCRC OPCO-Freedom Square, LLC, No. 8:20-cv-1546-T-36TGW, 2020 U.S. Dist. LEXIS 201622 (M.D. Fl. Oct. 29, 2020)

The U.S. District Court for the Southern District of Florida likewise granted a motion to remand in another case involving the death of a resident at a skilled nursing facility on the grounds that Plaintiff “does not assert any theory of liability that is in any way related to the Defendants’ ‘physical provision’ of any ‘countermeasure’” and thus the PREP Act did not provide a basis for federal question subject matter jurisdiction. Gunter v. CCRC OPCO-Freedom Square, LLC, No. 8:20-cv-1546-T-36TGW, 2020 U.S. Dist. LEXIS 201622, at *15 (M.D. Fl. Oct. 29, 2020).

Even Where Affirmative Use of Covered Countermeasures Is Implicated by the Claim, Courts Require a Causal Connection

In the context of a labor and employment dispute, the U.S. District Court for the Central District of California recently granted a motion to remand wage violation claims brought by hospital employees against their employer, which had started requiring some “hourly employees to arrive at least 15 minutes prior to the start of their shift so that they could undergo medical screenings before being allowed into their worksites,” without compensating the employees for this additional time.  Haro v. Kaiser Found. Hosps., CV 20-6006-GW-JCx, 2020 U.S. Dist. LEXIS 162522, at *1 (C.D. Cal. Sept. 3, 2020).  The defendant removed the case, asserting federal question jurisdiction under both the PREP Act and the Labor Management Relations Act. 

As in the cases above, the plaintiff filed a motion to remand, which the district court granted after determining that PREP Act immunity did not apply because “Haro’s minimum wage claim is not causally connected to any of Kaiser’s covered countermeasures.”  Id. at *6.  While the hospital argued “its medical screeners use various personal protective equipment, such as masks and face shields, and therefore its screening process is a use of a covered countermeasure,” the court found the “minimum wage claim is not causally connected to the screening procedures themselves, but rather the requirement that employees show up 15 minutes before their shifts start,” noting that the hospital could have conducted the medical screenings while the employees were on the clock, thus avoiding the minimum-wage claim entirely.  Id. at *7.

PREP Act Immunity May Still Apply, Even if It Does Not Completely Preempt All State Law Claims

These recent decisions have also emphasized other procedural approaches, outside the context of remand proceedings, where the PREP Act may still apply to provide immunity.  For example, the Maglioli court declined to rule on whether “Defendants are, or are not, entitled to a PREP Act defense to this or that claim,” leaving it to “the state courts to decide on remand.”  Maglioli, 2020 U.S. Dist. LEXIS 145055, at *31 (D.N.J. Aug. 12, 2020). 

In addressing a similar wrongful death case against a nursing home, the U.S. District Court for the Central District of California likewise stated: “If Defendants believe that some or all of Plaintiffs’ state law claims are barred by the PREP Act, the appropriate response is to file a demurrer in state court.  If the state court dismisses the state law claims, Plaintiffs could then decide if they wish to file claims under the PREP Act in the District of the District of Columbia, the court with exclusive jurisdiction over such claims.”  Martin v. Serrano Post Acute LLC, CV 20-5937 DSF (SKx), 2020 U.S. Dist. LEXIS 165874, at *5 (C.D. Cal. Sept. 10, 2020).

Key Takeaways for You and Your Business

In this first wave of decisions, federal courts have rejected defendants’ attempts to use the PREP Act as a basis for removal under federal question jurisdiction.  Specifically, they have rejected the argument that the PREP Act completely preempts common law tort claims where the allegations lack a causal connection to the use of Covered Countermeasures.  A claim based on the failure to use Covered Countermeasures will thus likely be found to lack the required causal connection.

Accordingly, we expect that courts across the country will continue to find that certain recommendations for preventing or limiting the spread of the coronavirus, such as social distancing, quarantining, or lockdowns, fall outside of the PREP Act’s definition of Covered Countermeasures. 

The courts in the recent cases have clarified that the PREP Act applies to the use of “any drug, biological product, or device.”  Thus, the manufacturers, suppliers, distributors, and end-users of such products (i.e., vaccines, medicines, and personal protective equipment) would likely be more successful in arguing complete preemption and immunity under the PREP Act.  The courts have emphasized, however, the need for a case-by-case approach to analyzing the PREP Act’s scope and application.

Companies in all sectors continue to be impacted by COVID-19. Foley is here to help you effectively address the short- and long-term impacts on your business interests, operations, and objectives. Foley provides insights and strategies across multiple industries and disciplines to deliver timely perspectives on the wide range of legal and business challenges that companies face conducting business while dealing with the impact of the coronavirus. Click here to stay up to date and ahead of the curve with our key publications addressing today’s challenges and tomorrow’s opportunities. To receive this content directly in your inbox, click here and submit the form.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services