We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption.  See Maglioli v. Alliance HC Holdings LLC, 16 F. 4th 393 (3d Cir. 2021).  The other shoe dropped the other day when a district court ruled that the PREP Act allowed a state-law negligence claim arising from administration of a COVID vaccine, even though the Act clearly mandates that the exclusive cause of action is a willful misconduct claim under federal law.  See Roeder v. Ann Terry, No. 5:22-cv-01796, 2022 U.S. Dist. LEXIS 127474 (E. D. Pa. July 19, 2022). 

This is the exact scenario that the PREP Act was enacted to address.  So how did this happen? 

As we have explained here, Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies.  Thus, when the Secretary of the Department of Health and Human Services declares a public health emergency (such as COVID-19), the Act provides that a “covered person” shall be immune from liability under state and federal law with respect to all claims relating to “covered countermeasures” (such as vaccines). 

To repeat what we wrote here, rather than allowing such claims, the Act establishes a fund to compensate “eligible individuals for covered injuries” through an administrative remedy.  There is only one exception:  The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.”  Roeder, at *7-*8 (quoting 42 U.S.C. § 247d-6d(d)(1)).  The Act also expressly preempts contrary state law, so long as the Secretary’s emergency declaration is in place.  See 42 U.S.C. § 247d-6d(b)(8) (preempting any state requirement “with respect to a covered countermeasure” that is “different from, or is in conflict with, any requirement” under the Act). 

Because the Secretary has declared COVID-19 to be a public emergency multiple times, the Act’s operation should not be complicated:  A person who claims injury arising from a COVID vaccine can apply for compensation through an administrative claim, or he or she can file a lawsuit alleging willful misconduct under federal law. 

The plaintiff in Roeder did neither.  After her spouse sadly passed away following a COVID vaccine, the plaintiff filed a lawsuit in state court alleging negligence.  Roeder, at *1-*2.  Because the PREP Act preempts state-law claims and provides an exclusive remedy under federal law, the defendants removed the case to federal court.  Id. at *2. 

This is where the Third Circuit’s precedent did its damage.  Following Maglioli, the district court applied a two-step process to determine whether the plaintiff’s state-law claims were preempted and thus removable to federal court.  “First, the Court asks whether the statute creates an exclusive federal cause of action.  If the Court concludes that the statute does create an exclusive federal cause of action, then the Court asks whether any of the Plaintiff’s claims fall within the scope of that cause of action.  If both steps are satisfied, then the claims are completely preempted and removable to federal court.”  Roeder, at *4-*5. 

The district court easily found that “the PREP Act clearly evidences congressional intent to create an exclusive cause of action.”  Id. at *5-*6.  The district court then inquired whether the plaintiff claims fell within the scope of the exclusive federal cause of action, i.e., whether the plaintiff alleged willful misconduct.  Id. at *7-*9.  It is difficult to understand the basis for this second inquiry.  An exclusive cause of action means exactly that—it is the only civil claim allowed, with all others being preempted.  It therefore makes no difference whether the plaintiff’s allegations are within the scope of the federal claim.  If she had any claim at all, it was under federal law, which is sufficient to support federal question jurisdiction.  Whether she sufficiently pleaded the claim is another question, but it is one that the federal courts had jurisdiction to address. 

The district court ruled that the plaintiff’s state-law negligence claim fell “outside the scope” of the exclusive federal remedy and thus was not preempted.  By remanding on this basis, the district court (and Third Circuit before it) created a paradox.  They interpreted an act of Congress to create an exclusive claim that is not exclusive.  Bexis would say that the courts have turned the PREP Act on its head, but we can’t help but think of the 1970’s Crystal Gayle song, Don’t It Make My Brown Eyes Blue. 

The PREP Act said “exclusive” (brown), but the district court made it “non-exclusive” (blue).  Go figure.  If anything, Roeder is even more head scratching then the Third Circuit’s opinion in Maglioli.  The Maglioli case involved a nursing home that allegedly failed to take sufficient measures to protect its residents against COVID.  That is to say, the plaintiff alleged nonfeasance.  In Roeder, the plaintiff’s claims arose directly from the affirmative deployment of a quintessential public health emergency countermeasure—a COVID vaccine.  The case is squarely within the PREP Act’s protective crosshairs. 

The impact of this re-colorization of the PREP Act could be very real.  Given the option of alleging a negligence claim under state law, and thus sidestepping the PREP Act altogether, no one will pursue the more exacting willful misconduct claim that the PREP Act expressly allows.  This threatens to reduce greatly the PREP Act’s protection, which Congress enacted for the stated purpose of ensuring access to effective countermeasures during public health emergencies.  Of course, the case is not over.  The Pennsylvania state courts will address the merits, and hopefully they will apply the protection that Congress enacted.