The world order has been restored.  The clouds have parted, and all today is in perfect resonant harmony.  Ok, we are exaggerating.  A lot.  But we are pleased to report that at least one federal district court has correctly interpreted and applied the PREP Act.  We are sure you are as relieved as we are. 

We reported two weeks ago on a federal district court that got the PREP Act completely wrong.  The law is remarkably straightforward.  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, such as COVID-19.  The Act creates an administrative remedy for allegedly injured individuals, and it grants covered persons immunity from civil liability in connection with countermeasures, like vaccines.  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.”  42 U.S.C. § 247d-6d(d)(1) (emphasis added). 

The misguided case on which we reported two weeks ago ruled that “exclusive” really means “non-exclusive,” and it allowed the plaintiff to pursue a state-law negligence claim based on a COVID vaccine reaction. 

Just days later, a federal court in New Mexico got it exactly right on very similar facts.  In Storment v. Walgreen, Co., No. 1:21-cv-00898, 2022 WL 2966607 (D.N.M. July 27, 2022), the plaintiff alleged that she got dizzy and fell after the defendant pharmacy administered a COVID vaccine.  Id. at *1.  These allegations fell directly within the Act’s preemptive scope, which includes “any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure.”  Id. at *2 (emphasis in original, quoting 42 U.S.C. § 247d-6d(a)(2)(B)). 

It is difficult to imagine how the PREP Act would not apply to the plaintiff’s negligence-based claims, but the plaintiff tried anyway.  She argued that her injury (fainting at the pharmacy) could have occurred with or without a COVID vaccine and thus was not causally related.  Id. at *2.  She could not, however, get around her own allegations that the vaccine was the cause:

Plaintiff appears to argue that because her injuries could have resulted from any vaccination or other medical procedure . . . , the Court should find the PREP Act not applicable.  While it is true that other vaccinations or procedures might also leave customers dizzy, this does not change the fact that Plaintiff’s injuries actually resulted from administration of the COVID-19 vaccine.  The PREP Act therefore applies

Id. at *3.  The court included this additional pithy remark:  “Plaintiff provided no caselaw to support the it-could-have-been-a-different-vaccine argument . . . .”  This judge would make a good blogger.

This order is a true application of the “plain and unambiguous meaning” of a federal statute, and it provides a quintessential example of the PREP Act in action.  The court dismissed the case with prejudice. 

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. 

Now that a childhood COVID-19 vaccine has received FDA approval, the vaccination of school-aged minors is underway.  Just as vaccination requirements for adults have prompted a wave of litigation, we expect the same with respect to COVID-19 vaccination as a prerequisite to attending primary schools.  But with a twist.  Unlike adults who ignore mandatory public health measures, parents are subject to a general common-law duty of care to “control” their minor children.  See Restatement (Second) of Torts §316 (1965) (“A parent is under a duty to exercise reasonable care so to control his minor child as to prevent it from intentionally harming others or from so conducting itself as to create an unreasonable risk of bodily harm to them.”).

Most of the §316 cases we’ve seen (we haven’t looked that hard) involve minor children misusing guns.  E.g., K.H. v. J.R., 826 A.2d 863, 873 (Pa. 2003) (“Although a parent/child relationship by itself is insufficient to render the parents liable for the tortious acts of their children, liability may attach where the negligence of the parents makes the injury possible.”) (misuse of BB gun) (citing, inter alia Restatement Second §316); Robertson v. Wentz, 232 Cal. Rptr. 634, 637-39 (Cal. App. 1986) (§316 firearms case dismissed where parental ability to control not established).

We haven’t seen any vaccination-related court decisions yet, but the scholarly literature discusses situations where one parent might sue another parent over the defendant parent’s sending an unvaccinated kid to school, and allegedly causing the plaintiff parent’s child to become infected.  See Kevin Hooker, “Exemptions to Vaccine Mandates:  The Problem & Possible Remedies,” 14 Hous. J. Health L. & Pol’y 263 (2014); Teri Baxter, “Tort Liability for Parents Who Choose Not to Vaccinate Their Children & Whose Unvaccinated Children Infect Others,” 82 U. Cin. L. Rev. 103 (2013); Dorit Reiss, “Compensating the Victims of Failure to Vaccinate:  What are the Options?” 23 Cornell J. L. & Pub. Pol’y 595 (2013).  The range of possible fact patterns could range from simply knowingly sending an unvaccinated child to school, to sending an unvaccinated child to school when either the child or the parents are known or suspected of having COVID-19, claiming some other bogus form of immunization, to lying about vaccination status to school authorities, all the way up to sending an unvaccinated child to school with forged vaccination papers.  As the links indicate, press reports discussing variants of all of these situations already exist.  Further, where a child is sent to school in violation of a mandatory COVID vaccination requirement, if and when such requirements exist (as they have for decades with respect to vaccination against other diseases), a negligence per se claim might be alleged, in addition to common-law negligence under §316.

However, administration of COVID-19 vaccine (or masking, for that matter) is a classic “covered countermeasure” under the PREP Act, 42 U.S.C. §247d(i)(1).  That led us to wonder whether antivax parents, if sued by other parents for their children infecting the plaintiffs’ children with COVID-19 at school, could claim immunity from suit under the PREP Act.  That would depend on whether parents who chose to withhold a “covered countermeasure” from their own children are “covered persons” under 42 U.S.C. §247d(i)(2).  So, who is a covered person?  The PREP Act provides:

The term “covered person”, when used with respect to the administration or use of a covered countermeasure [such as COVID-19 vaccination or masking], means −

(A) the United States; or

(B) a person or entity that is—

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;

(iii) a program planner of such countermeasure;

(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

Id.

Antivax parents are obviously not the government, or manufacturers, distributors or dispensers of COVID-19 vaccines.  That leaves immunity as a “program planner” on the table.  Parents certainly plan, and are responsible for, the vaccination – or not – of their children.  Indeed, in preparing our Survival of the Vaxxest post we ran across a couple of cases in which failure to vaccinate was a basis for termination of parental rights.  See In re Marsh, 14 A.2d 368, 370 (Pa. Super. 1940); Matter of Christine M., 595 N.Y.S.2d 606, 618 (N.Y. Fam. Ct. Dec. 21, 1992).  So could antivax parents claim PREP Act immunity from suits for damages for their unvaccinated kids infecting their schoolmates?

We turn to the Act’s definition of “program planner”:

The term “program planner” means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b).

42 U.S.C. §247d(i)(6).  The “other person” language of this definition, applicable to a private individual, such as a parent, requires supervision or administration of a “program” that involves “administration, dispensing, distribution, provision, or use” of a “pandemic . . . product” (such as a vaccine or a mask).  That can include someone who “has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance” to such a program.  Id.

That would not seem to include an antivax parent, although without the PREP Act defining “program” we can’t be sure – we’ve seen plenty of ridiculous claims in COVID-19-related litigation already, so an antivax parent might claim to be “establish[ing] requirements” for his or her child’s vaccination, or even to have provided “advice or assistance,” although we doubt that is what the HHS had in mind when it made its PREP Act emergency declaration:

A program planner means a state or local government . . .; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s Declaration.  Under this definition, a private sector employer or community group or other “person” can be a program planner when it carries out the described activities.

85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).  Nor have any of the subsequent amendments to the initial declaration addressed parental actions.

Recent PREP Act caselaw provides another wrinkle.  In COVID-19 cases – mostly involving nursing homes – courts have drawn a distinction between the alleged “failure” of “program administrators” to employ COVID countermeasures and the alleged negligent employment of such countermeasures.  Courts have allowed the first category, claims of nonfeasance, to proceed notwithstanding PREP Act immunity.

[T]he complaints do not allege that Plaintiffs’ injuries arose from . . . administration to them of vaccines or medicines (or for that matter protective gear) − activities that the PREP Act promotes by affording immunity. . . .  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.

Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 478 F. Supp.3d 518, 532 (D.N.J. 2020), aff’d on other grounds, ___ F.4th ___, 2021 WL 4890189 (3d Cir. Oct. 20, 2021).  See also Lutz v. Big Blue Healthcare, Inc., 480 F. Supp.3d 1207, 1216-17 (D. Kan. 2020); Gunter v. CCRC OPCO-Freedom Square, LLC, 2020 WL 8461513, at *4 (M.D. Fla. Oct. 29, 2020); Sherod v. Comprehensive Healthcare Management Services, LLC, 2020 WL 6140474, at *7-8 (W.D. Pa. Oct. 16, 2020); Estate of Jones v. St. Jude Operating Co., LLC, 2020 WL 8361924, at *9 (D. Or. Oct. 14, 2020); Martin v. Serrano Post Acute LLC, 2020 WL 5422949, at *2 (C.D. Cal. Sept. 10, 2020).

These situations are essentially the same as allegations that would be asserted against antivax parents whose children allegedly infected a plaintiff’s child with COVID-29 – the defendants didn’t do anything, rather they failed to do something, that being vaccinating (or masking) their children.  Thus it is likely that, in any COVID-19-related litigation against a defendant for failure to vaccinate their children before sending them to school, courts would consider the alleged conduct to be nonfeasance that would escape PREP Act immunity under the above case law.

Finally, there is an express statutory exception to PREP Act immunity for persons who committed “willful misconduct,” which is defined as actions or omissions committed:

(i) intentionally to achieve a wrongful purpose;

(ii) knowingly without legal or factual justification; and

(iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

42 U.S.C. §247d(c)(1)(A).  See Maglioli v. Alliance HC Holdings LLC, ___ F.4th ___, 2021 WL 4890189, at *2 (3d Cir. Oct. 20, 2021) (discussing this exception).  Some of the more aggravated fact patterns we mentioned above – forgery of vaccination documents, affirmatively lying about immunization status, or knowingly sending a COVID-19 positive child to school – might well fit within the PREP Act’s definition of “willful misconduct” and allow litigation to proceed on that basis.

Last week the Third Circuit became the first federal appellate court to decide the question of whether federal courts have jurisdiction over COVID-related tort litigation.  It concluded they did not.  Maglioli v. Alliance HC Holdings LLC, — F.4th –, 2021 WL 4890189 (3d. Cir. Oct. 20, 2021).  A decision directly at odds with the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d and the even broader immunity extended by its many amendments since then.  Our prior discussions of the declaration and amendments can be found here and here.  In reaching its conclusion, the court refused to afford deference to the declarations of the Secretary of the Department of Health and Human Services (“HHS”), refused to find nursing homes were entitled to federal officer jurisdiction, determined the PREP Act did not confer complete immunity, and ruled there was no federal question jurisdiction under Grable & Sons Metal Prod. Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).

The underlying facts are not unique.  Families of residents of two New Jersey nursing homes who died from COVID-19 filed negligence and wrongful death lawsuits against the nursing homes.  The cases were filed in state court but were removed by the defendants asserting all of the above bases for federal jurisdiction.  The appellate decision starts off by acknowledging that the PREP Act’s “scope of immunity is broad.”  The act provides “immunity from all claims arising under federal or state law that relate to the use of a covered countermeasure.”  Id. at *2.  Rather than allowing such claims, the Act establishes a fund to compensate “eligible individuals for covered injuries.”  Id. Essentially, this sets up an administrative remedy as the only recourse for these types of injuries.  There is one exception to the administrative remedy.  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.”  Id.  The intent of the PREP Act is expressly set forth in the Fourth Amendment:

[T]here are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.  Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party’s exclusive remedy is an administrative remedy.

Fourth Amendment, at part XI (emphasis added).  This would seem not only to answer the federal jurisdiction question but also the question of whether the current suit is permissible at all.  If you are alleging serious injury or death as a result of “willful misconduct” you can bring a federal lawsuit.  Otherwise, you may bring a claim for compensation from the fund.  That is it.  No state claim for negligence is contemplated.  But, in deciding the federal jurisdiction question, the Third Circuit essentially inverted the PREP Act finding that by creating a federal cause of action for willful misconduct, Congress left open the door for plaintiffs to pursue negligence claims in state court.

The court’s analysis began with rejecting defendant’s request to give deference to the HHS Secretary’s declaration that they sought to confer federal question jurisdiction over COVID-related tort litigation under a Grable rationale – namely the above quoted language.  The court found that “HHS is not delegated authority under the PREP Act to interpret the scope of federal courts’ jurisdiction.”  Id. at *4.  Since the court found the agency’s interpretation to be beyond its power, it was unwilling to provide it any deference.

That left the court to examine defendants’ three arguments in support of federal jurisdiction.  The first was federal-officer jurisdiction.  To qualify, the claims brought against the defendant must be “based upon the defendant acting under the United States, its agencies, or its officers.”  Id. at *5.  This type of jurisdiction extends to private parties if they were “acting under” federal officers.  The defendant nursing homes argued that they qualified because they are heavily regulated by the federal government.  The court did not find that was sufficient.  Offering a comparison to government contractors, the nursing homes do not “assist or help carry out the duties of a federal superior.”  Id. at *5-6.

Skipping to the third argument, and without regard to the HHS secretary’s declaration, the decision finds no federal question jurisdiction under Grable because the complaints never mentioned the PREP Act, which is merely a defense.  Id. at *12.

But the worst part of the decision is the court’s discussion on complete preemption.  Normally, we address preemption as a defense to state-law claims.  As a defense, it is usually not considered grounds for removal because the defense “does not appear on the face of the well-pleaded complaint.”  Id. at *7. However,

The complete-preemption doctrine provides that a federal question does appear on the face of the complaint when Congress “so completely pre-empt[s] a particular area that any civil complaint raising [the] select group of claims is necessarily federal in character.”

Id. (citations omitted, emphasis in original).  So, if removal is proper where a federal statute “wholly displaces” a state law cause of action, then the current case is removable.  The Third Circuit disagreed in a contradictory two-part discussion.  Part one says everything we say above.  The PREP Act “unambiguously creates an exclusive federal cause of action.”  Id. at *9.  The opinion describes that exclusive federal cause of action as — for injuries caused by covered countermeasures, HHS has “the sole authority” to provide compensation from the designated fund.  Id.  The PREP Act carved out a single exception — where a plaintiff is alleging willful misconduct for serious harm or death, he may bring a federal lawsuit in the District of Columbia after first exhausting all administrative remedies.  Id.  The willful misconduct claim is an exception to the general rule that the only remedy for covered claims is the administrative claim.

But in part two, the court pulls a fast u-turn.  The court posits that the question they need to decide for removal purposes is whether plaintiffs’ state-law claims fall within the scope of the exclusive federal cause of action.  Id.  The court does not find that the nursing homes are not covered individuals or that plaintiffs are not alleging harm from covered countermeasures.  So, the answer should be that plaintiffs’ claims do fall within the exclusive federal cause of action – the administrative remedy.  However, despite its prior definition of the PREP Act’s “exclusive federal cause of action,” just two paragraphs earlier, the court framed the question as whether plaintiffs could bring their negligence cause of action under the PREP Act’s cause of action for willful misconduct.  Id.

 Of course, the answer is no.  Plaintiffs do not allege the defendant nursing homes acted “intentionally” or “without legal or factual justification.”  Id. at *10.  In fact, the PREP Act expressly provides that willful misconduct is something “more stringent than a standard of negligence in any form or recklessness.”  Id. But that is not the issue.

Having focused only on the willful misconduct action, the court views the PREP Act as creating a separate federal cause of action that is different from the state law claims brought by plaintiffs.  In fact, the court goes on to say “Congress could have created a cause of action for negligence or general tort liability.  It did not.”  Id.  But it did.  It created an administrative claim that is solely administered by the HHS.  The purpose of the PREP Act is to funnel all pandemic claims into a federal administrative claim program, except for egregious intentional conduct for which a federal cause of action was provided.  The combination of an administrative compensation fund and a federal claim are historically where courts have found complete preemption because such provisions wholly displace state law.  Instead, here, the Third Circuit determined that because the limited federal cause of action is not complete, state law negligence-based claims remain unaffected — meaning that nobody will ever bother pursuing the much more difficult to prove federally provided claim.

Having ignored the federal compensation scheme, intended to embrace what was not to be litigated, as a basis for complete preemption, the court effectively neutered it.  While the court said it was only deciding the jurisdiction issue, not whether a New Jersey state court would or should find plaintiffs’ claims preempted – the Third Circuit certainly made that defense more difficult with sound bites we are sure plaintiffs will wholeheartedly embrace.

A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of writing about COVID, because we’ve mostly left that to others. When the tongue of history tells the final tale of Covid, we suspect it will be a catalogue of human errors, with occasional hiccups of heroism and ingenuity.

Covid implicates science more than law, but we are lawyers and we know how to stick to our lane. (That is an out and out lie, of course. At the drop of a hat or mask we are happy to bloviate ignorantly and loudly about Covid lockdowns and anti-vaxxers.) Just as with public health measures, legal responses to Covid have had a mixed, perhaps mostly bad, track record in contending with Covid. Depressingly stupid laws have been passed and predictably silly lawsuits have been filed.

But the Public Readiness and Emergency Preparedness (PREP) Act was a singularly sensible response to Covid. We have written about the PREP Act before, but for a quick refresher, recall that the PREP Act provides that “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, related to or resulting from the administration to or the use by an individual of a covered countermeasure if the [Secretary of Health and Human Services has issued a declaration permitting the administration of that covered countermeasure.]”. In a major health emergency, you don’t want hesitancy based on fears of liability. Ah, but how will the PREP Act be enforced in cases where things go wrong and all the sympathy goes to the injured party?

Cannon v. Watermark Retirement Communities, Inc., 2021 U.S. Dist. LEXIS 133613, 2021 WL 3033762 (E.D. Pa. July 19, 2021), is an interesting PREP Act decision from the Eastern District of Pennsylvania. It is also another example of the courts letting plaintiffs chip away at the ostensibly broad preemption that the Act and the HHS directives created.

Instead of suing over a nursing home patient catching COVID, the decedent here had COVID and was treated for it with an “experimental” drug combination, hydroxychloroquine and doxycycline. The estate alleged that the family was concerned about the experimental treatment because it was not FDA approved and had a history of causing heart problems, and that the decedent’s son explicitly declined to consent to the experimental treatment. The estate also contended that the treatment was not permitted to be used either outside of a hospital or on asymptomatic patients. But it was administered here just the same. Following this treatment the decedent allegedly “deteriorated” and died. The estate of the decedent brought a wrongful death and survival action against the senior community for negligence, negligence per se, and reckless and outrageous conduct.

The defendant senior community filed a Rule 12(b)(6) motion to dismiss based on PREP Act immunity. The court denied the motion to dismiss, reasoning that the treatment was not a “covered countermeasure” under the PREP Act because FDA’s emergency authorization was limited to persons who were hospitalized with COVID, and the decedent was never hospitalized. Thus, according to the court, the experimental treatment did not “fall within the clear, explicit, and limited scope of the drug’s FDA emergency use authorization.” That sounds almost like a presumption of non-immunity.

The defendant argued that PREP Act immunity also applies to the “misuse” of a covered countermeasure. The court disagreed because it interpreted “misuse” to be limited to nonuse or omission. What happened in Cannon was an affirmative misuse, not a nonuse or omission. We’re not sure this distinction makes sense either in terms of statutory interpretation or underlying policy, but there it is.

The defendant’s final defense was invocation of the PREP Act’s safe harbor provision, which extends immunity to circumstances in which a covered countermeasure was administered by someone who reasonably could have believed that the countermeasure was being used appropriately. The court held that on a motion to dismiss, where all inferences must be drawn in favor of the plaintiff, the court could not conclude that the defendants reasonably believed it was administering a covered countermeasure because the PREP Act’s definition of the “population” was unambiguous and the decedent fell outside it – she was neither hospitalized nor determined to be eligible for clinical trials.

It will be interesting to see whether the defendant in Cannon can make out facts supporting a reasonable belief that the countermeasures were appropriate. We wouldn’t be surprised if they ultimately do so. But in the meantime, the case goes on, with discovery and all the other expensive machinery of civil litigation. It is possible that the aims of the PREP Act are not being well served.

We’ve already commented about the broad scope of tort immunity conferred by the March, 2020 Notice of Declaration under the Public Readiness & Emergency Preparedness Act (“PREP Act”), 42 U.S.C. §247d-6d.  That original immunity covered all aspects of government-related or sponsored production and use of anti-COVID countermeasures.  It was, as one of our colleagues put it, broad enough to cover a fight in the parking lot while waiting for drive-through COVID testing.

Well, COVID-19-related PREP Act tort immunity just got a whole lot bigger.

Yesterday, the Department of Health & Human Services (“HHS”) released a “Fourth Amendment” to the March Declaration, entitled innocuously enough, “Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 and Republication of the Declaration” (“Fourth Amendment”).  While we also looked for this in yesterday’s Federal Register, we didn’t find it (note:  it is now at 85 Fed. Reg. 79190 (HHS Dec. 9 2020).

In what appears to be HHS’s administrative response to the ongoing congressional deadlock over whether to create COVID-19 related immunity affecting the private sector, this Fourth Amendment undertakes to extend PREP Act immunity to a broad swath of purely private sector activities related to the administration, and in some cases the non-administration, of COVID counter measures.  The HHS summary states, among other things, that PREP Act immunity extends to:

  • “substantial federal legal and policy interests . . . [that require] a more consistent pathway for Covered Persons to manufacture, distribute, administer or use Covered Countermeasures across the nation and the world.”
  • “situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and this Declaration’s liability protections.”
  • “provide liability protections for, among other things, additional private-distribution channels”
  • “an additional category of Qualified Persons . . . [namely] healthcare personnel using telehealth to order or administer Covered Countermeasures for patients in a state other than the state where the healthcare personnel are permitted to practice.”

Fourth Amendment, Summary, at items c, f, g, h.

What does that mean?

As for what we do, litigation, to have a “uniform interpretation,” the Fourth Amendment expressly intends for there to be “an exclusive Federal cause of action”:

[T]here are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a uniform interpretation of the PREP Act.  Under the PREP Act, the sole exception to the immunity from suit and liability of covered persons under the PREP Act is an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct by such covered person. In all other cases, an injured party’s exclusive remedy is an administrative remedy.

Fourth Amendment, at part XI (emphasis added).  Grable, as long-time blog readers know, is a Supreme Court decision finding federal subject matter jurisdiction over ostensibly state-law claims that “necessarily raise[]” “important” federal issues for which a federal forum was needed to “vindicate [federal] administrative action.”  514 U.S. at 314-15.  While Grable expected such situations to be “rare,” id. at 315, that is unlikely to be the case under the HHS Fourth Amendment.

 

Substantively, HHS has created an additional “pathway” for immunity that removes the prior prerequisite under the Declaration’s other Limitations on Distribution requiring that “covered persons” using on-label “Covered Countermeasures” being distributed under FDA auspices to combat COVID-19 have an agreement with the federal government.  The Fourth Amendment creates a “third distribution channel” allowing a Covered Person that manufactures, tests, develops, distributes, administers, or uses the Covered Countermeasure under FDA or NIOSH (for “respiratory devices”) auspices even though “there is no federal agreement or authorization.”  Fourth Amendment, at §VII.  A manufacturer, distributor, program planner, or qualified person that satisfies the other requirements of the PREP Act and prior HHS declarations, is immunized even if there is no federal agreement to cover those activities and those activities are not part of the authorized activity of an Authority Having Jurisdiction.  Id.:

I have determined that liability protections are afforded to Covered Persons only for Recommended Activities involving:

  1. Covered Countermeasures that are related to present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements;
  2. Covered Countermeasures that are related to activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures following a Declaration of Emergency; or
  3. Covered Countermeasures that are:
  4. licensed, approved, cleared, or authorized by the FDA (or that are permitted to be used under an Investigational New Drug Application or an Investigational Device Exemption) under the FD&C Act or PHS Act to treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or
  5. a respiratory protective device approved by NIOSH under 42 CFR part 84, or any successor regulations, that the Secretary determines to be a priority for use during a public health emergency declared under section 319 of the PHS Act to prevent, mitigate, or limit the harm from COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom.

To qualify for this third distribution channel, a Covered Person must manufacture, test, develop, distribute, administer, or use the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization (or pursuant to an Investigational New Drug Application or Investigational Device Exemption), or the NIOSH approval.

Fourth Amendment, Additional Amendments at VII.  Thus PREP Act immunity now extends to entities, such as nursing homes or manufacturing plants, acting in a purely private capacity, as long as they “manufacture, test, develop, distribute, administer, or use” Covered Countermeasures.  This extension of PREP Act immunity to purely private activities, if not entirely mooting the current congressional stalemate, appears to eliminate a large portion of the liability situations Congres has been debating.

The Fourth Amendment also broadens the definition of a PREP Act “Covered Person” to include not only pharmacists administering COVID vaccines, but “any person authorized . . . to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures.”  Fourth Amendment, Additional Amendments at V.  “Authorized” is nowhere limited by any requirement that the Covered Person actually have prescribed, administered, etc. a Covered Countermeasure.  Telemedicine is also now explicitly within the scope of PREP Act immunity.  Id. at V(e).

Also, remember those PREP Act cases we discussed that distinguished between the administration and non-administration of Covered Countermeasures?  The Fourth Amendment also broadens immunity to include non-administration situations where there is a “limited” supply of such countermeasures:

Where there are limited Covered Countermeasures, not administering a Covered Countermeasure to one individual in order to administer it to another individual can constitute “relating to . . . the administration to . . . an individual” under 42 U.S.C. 247d-6d. . . .  Prioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.

Fourth Amendment, Additional Amendments at IX.

Nor is PREP Act immunity limited to COVID-19 itself.  Part VIII of the Additional Amendments provides extends immunity to “other diseases, health conditions, or threats that may have been caused by COVID–19, . . . including the decrease in the rate of childhood immunizations, which will lead to an increase in the rate of infectious diseases.”

The Fourth Declaration also extends the immunity for “an additional 12 months,” until October 1, 2024, and defines causation under the PREP Act’s compensation program (the “Countermeasures Injury Compensation Program” or CICP) to require “compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation.”  Fourth Amendment, Additional Amendments, at XII-XIV.

There are many details in the Fourth Amendment that we have left out or glossed over.  As the footnotes to the Fourth Amendment indicate, there are also advisory opinions and guidances in addition to the original Declaration and, now, four amendments.  We recommend that anyone interested in the matters discussed in this blogpost read the Fourth Amendment for themselves or discuss it with their lawyers.

Although as of yet the data has not been peer reviewed, or subjected to the necessary administrative and scientific scrutiny, there has been considerable recent good news  regarding the efficacy of two COVID-19 vaccines, being developed by Pfizer and Moderna, respectively.

It is now more likely than ever that within a few months the largest mass vaccination effort in decades will occur as governments across America and around the world seek to create herd immunity to COVID-19 by something other than the current do-nothing, non-efforts we see in all too many places.

While we hope and expect that PREP Act Immunity will preclude massive civil litigation over the risks – real or imagined – of these (and hopefully other) COVID-19 vaccines,  we thought it appropriate to at least dust off and examine the body of law that had developed concerning liability for mass vaccinations in years past, without the benefit of modern legislation like the PREP Act.

Probably the most significant of the mass vaccination cases was Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), written by Judge John Minor Wisdom (whose lofty reputation does not rest on his product liability decisions).   Reyes both adopted the learned intermediary rule under Texas law and simultaneously recognized an exception to the rule for situations, as in Reyes, where an ordinarily prescription-only product was dispensed essentially without physician intervention.  Id. at 1270 (vaccine “administered . . . by a registered nurse; there were no doctors present”).

Reyes recognized that vaccines were “unavoidably unsafe” products under Restatement (Second) of Torts §402A, comment k (1965):

[I]t [is] what the Restatement calls an “unavoidably unsafe product,” one which cannot be made “safe” no matter how carefully it is manufactured.  Such products are not necessarily “unreasonably dangerous,” for as this Court has long recognized in wrestling with product liability questions, many goods possess both utility and danger.

498 F.2d at 1273 (citations omitted).  Applying the unavoidably unsafe standard in Reyes (also called, in 1970s parlance “unreasonably dangerous per se”) meant that:

[T]he scales must tip in favor of availability.  The evil to be prevented – [the disease and its symptoms] − is great.  Although the danger that vaccinees may contract polio is qualitatively devastating, it is statistically miniscule.

Id. at 1274.  Rather, the duty created by an unavoidably unsafe product is to provide warnings about its unsafe attributes.  Id. at 1274-75.

This duty to warn was subject to the learned intermediary rule:  “where prescription drugs are concerned, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.”  Id. at 1275 (footnote omitted).  But, although “there is no question that [the] vaccine is licensed for sale only as a prescription drug,” it was not in fact used in that fashion.  Id. at 1276.  Hence the exception:

[W]here no individualized medical judgment intervenes between the manufacturer of a prescription drug and the ultimate consumer, “it is the responsibility of the manufacturer to see that warnings reach the consumer, either by giving warning itself or by obligating the purchaser to give warning.”  Where there is no physician to make an “individualized balancing . . . of the risks” . . . the very justification for the prescription drug exception evaporates.

Id. (quoting Davis v. Wyeth Laboratories, 399 F.2d 121, 131 (9th Cir. 1968)).  Where a prescription medical product manufacturer “knows or has reason to know that it will not be dispensed as such a” prescription product, then “the manufacturer is required to warn the ultimate consumer, or to see that he is warned.”  Id.

Reyes held that the evidence established this exception, whether plaintiff’s inoculation occurred during an actual  “mass” vaccination, or as part of an “ongoing program” did not matter as long as the product was “dispensed without the sort of individualized medical balancing” that doctors perform when they prescribe drugs.  Id. at 1277.  Further, the facts established the defendant’s at least constructive knowledge that what happened was likely:

[Defendant] had ample reason to foresee the way in which its vaccine would be distributed.  A drug manufacturer is held to the skill of an expert in his field, and is presumed to possess an expert’s knowledge [and] . . . familiarity with practices . . . common in the drug industry as to distribution and administration of pharmaceutical products.

Id.  It was “well known” that most polio vaccinations were “dispense[d] . . . to all comers in an ‘assembly line’ fashion” with “neither time nor personnel to make an ‘individualized medical judgment’ of the vaccinee’s needs or susceptibilities.”  Id. (quoting Davis and law review articles – even back in the 1970s law reviews were advocating liability at the expense of public health).  Further, the duty to warn imposed in Reyes was two-fold – either “warn foreseeable users [itself], or see that the [vaccination program sponsor] warned them.”  Id. at 1278-79.

In Davis, the case most heavily relied upon in Reyes, the defendant, through its regional sales representative, had been much more involved in the vaccination process than in later cases:

[O]ne of appellee’s salesmen, was assigned to handle the sales and assist in setting up the clinics. . . . [H]he managed the campaign for the [local] Medical Society.  He furnished books to those in charge of clinics, setting forth schedules and procedures to be followed and details of the physical manner in which the clinics were to be set up and also showing sample promotional letters and advertising matter. He arranged for delivery of the vaccine. . . .  He arranged for the printing of forms and immunization cards and posters urging ‘KO Polio’. . . .  He organized meetings and conferred with those in charge of the separate clinics as to the procedures to be followed.

399 F.2d at 125.  One might say that no good deed goes unpunished.

That was because, supposedly, “[n]o effort was made by [the representative] or the medical society to inform the [person who administered the vaccine] of the existence of risk.  The latter did not read the package insert, nor did appellant.”  Id.  Without even mentioning Erie, Davis adopted strict liability as the law of Montana.  Id. at 127.

[W]e conclude that strict liability does attach to sale of the drug to appellant and that the jury should have been so instructed, either by such an instruction as that requested by appellant or otherwise.  Our conclusion in this respect is based upon our determination that a duty to warn existed.

Id. at 126.  Even if the risk is “less than one out a million,” if it is both known, and serious, “the warning must be given.”  Id. at 129-30.  Davis was influenced by the underlying disease not being active in the area:

[W]here the end sought is prevention of disease (and the likelihood of contracting the disease from natural sources is a relevant factor) the situation is a different one from that in which the disease has already struck and the end sought is relief or cure.  Risks are far more readily taken in the latter case.

Id. at 130.  That, at least, is an argument nobody will be making about COVID-19 (even in Montana).

Since the defendant in Davis “knew that warnings were not reaching the consumer” from its participation in the mass vaccination program, a direct duty to warn was imposed.  Id. at 131.  Davis waved off cost and practicality issues as insignificant:

This duty does not impose an unreasonable burden on the manufacturer. . . .  [While] the vaccine came in bottles never seen by the consumer[,] . . . other means of communication such as advertisements, posters, releases to be read and signed by recipients of the vaccine, or oral warnings were clearly available and could easily have been undertaken or prescribed by appellee.

Id.

A third, somewhat more recent, decision further examined situations where vaccination occurred, allegedly in the absence of individualized medical evaluation.  Mazur v. Merck & Co., 964 F.2d 1348 (3d Cir. 1992), involved a mandatory school-based vaccination program undertaken in response to an epidemic whereby school nurses performed the inoculations.  Id. at 1351-52.  Individualized medical supervision was allegedly minimal:

[The school nurse] also examined the “overall appearance” of students as they passed by her, and, sometimes, asked them how they felt.  On average it took students three to four minutes to pass through the line and be vaccinated.  No physician was present during the inoculation, nor was any representative from either [the defendant] or the CDC.

Id. at 1351.

The “CDC” referred to the United States Centers for Disease Control.  Before the defendant would sell its vaccine for this mass vaccination program, the manufacturer insisted on CDC supervision of that program.  The CDC agreed to the following contractual provision:

The [CDC] represents and agrees that it will (1) take all appropriate steps to assure that all vaccine supplied to various locations within the 50 states, . . . pursuant to the terms of this contract, shall be administered to each patient on the basis of an individualized medical judgment by a physician, or (2) take all appropriate steps to provide to such a patient (or to the patient’s parent or guardian) meaningful warnings relating to the risks and benefits of vaccination, in form and language understandable to such patient, parent or guardian.

Id. (footnote omitted).

Reaffirming that vaccines are “unavoidably unsafe” products under comment k, Mazur held that negligence standards therefore applied.  Id. at 1353-5454.  Mazur then turned to the learned intermediary rule and the “mass immunization exception.”  Was the school nurse – the sole person administering the vaccine – a “learned intermediary”?  Mazur said no:

[N]urses generally are not capable of providing the degree of individualized medical judgment rendered by physicians, and are not authorized independently to prescribe drugs. . . .  As such, we do not believe the [learned intermediary] rule . . . or its rationale extends to nurses.

Id. at 1357 (citations, quotation marks, and footnotes omitted).  Nor did the facts convince the Mazur court that, in this instance, the nurse actually acted as a learned intermediary.  Id. at 1358-59 (“she was never trained in weighing the risks and benefits of vaccination in a given instance”).  Following Reyes and Davis, Mazur concluded that Pennsylvania would adopt the mass immunization exception and that it applied to these facts.  Id. at 1361-64.  Thus, the defendant could not prevail under the learned intermediary rule.

Ultimately, however, the defendant won.  Mazur held that the defendant “acted reasonably” when it “contracted with the CDC and relied upon its guarantee that the . . . vaccine would be administered by a physician or after a meaningful warning had been provided.”  Id. at 1364.  Because negligence standards applied, strict liability pronouncements that warning duties were “nondelegable” were “inapposite.  Id.  Under negligence principles (Restatement §388), “a manufacturer may meet its duty to warn by entrusting the communication of warnings to third persons.”  Id. at 1365.  Thus:

[A] vaccine manufacturer may satisfy its duty to warn in the mass immunization context by obligating the CDC to warn users directly if it informs that agency of the facts which make its vaccine dangerous and reasonably relies on it to communicate such information to users in lay terms. The manufacturer’s responsibility is continuous, and it must therefore apprise the CDC of any risks it later discovers or, in the exercise of reasonable care, should have discovered.

Id. (citation and footnote omitted).

Further, the warning statement drafted by the CDC was adequate as a matter of law.  Disposing of a variety of the usual plaintiff-side warning nitpicking, Mazur concluded “we believe [defendant] adequately informed the CDC of the facts which make its . . . vaccine dangerous.”  Id. at 1367.  Furthermore, it was reasonable for a vaccine manufacturer to rely upon a government agency like the CDC to distribute warning information to vaccine recipients.

Given the resources and funding available to the CDC, as well as its expertise in immunology and public vaccination, we believe [defendant’s] decision to rely on the CDC to warn users directly was reasonable. . . .  The CDC is an agency of the Public Health Service of the United States Department of Health and Human Services.  It is empowered to conduct studies, evaluations, tests, and emergency programs in order to prevent the spread of disease and to improve public welfare.  With respect to vaccines, it plays a vital role in research, development, testing, and distribution. It publishes the Morbidity and Mortality Weekly Report, among other reports, studies, and journals, to educate public health and medical professionals about the risks and benefits of immunization.

Id. at 1368 (quoting trial court opinion in part).  In light of the CDC’s expertise, the manufacturer had no duty to do more, such as “hire[] an independent contractor to review the CDC’s conduct.”  Id. at 1360.  Thus, as a matter of law, the vaccine manufacturer escaped liability in Mazur.

Taken together, Mazur, Reyes, and Davis illustrate the key issues that drive common-law liability analysis mass immunization cases.  Most jurisdictions to have addressed the issue, whether as part of a decision or in dictum, have recognized the so-called “mass immunization” exception.  Restatement (Third) of Torts, Products Liability §6(d)(2) (1998) (learned intermediary rule exception for “when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.”).  See also Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 950 (Ariz. 2016); Allison v. Merck & Co., 878 P.2d 948, 958 n.16 (Nev. 1994) (plurality opinion); Shanks v. Upjohn Co., 835 P.2d 1189, 1195 n.7, 1200 n.17 (Alaska 1992) (dictum); Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 692 (Miss. 1988); DiBartolo v. Abbott Laboratories, 914 F. Supp. 2d 601, 614 (S.D.N.Y. 2012) (dictum); Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 422-23 (D. Alaska 1987) (dictum).

First, vaccines critical enough to be distributed to the general populace are considered “unavoidably unsafe” productsSee also Petty v. United States, 740 F.2d 1428, 1441 (8th Cir. 1984) (applying Iowa law); Unthank v. United States, 732 F.2d 1517, 1523 (10th Cir. 1984) (applying Utah law); Givens v. Lederle, 556 F.2d 1341, 1344-45 (5th Cir. 1977) (applying Florida law); contra Allison, 878 P.2d at 955.  This proposition has since been written into law by the federal Vaccine Act, as discussed here.  Unavoidably unsafe status precludes design defect liability and focus the litigation on warning issues.

Second, the vaccine must be distributed without an individualized medical examination.  The lack of any physician-patient relationship is what defeats the application of the learned intermediary rule and gives rise to the duty to provide a warning directly to the person being vaccinated.  In vaccine cases where a physician-patient relationship exists, the mass vaccination exception should be inapplicable.  Petty, 740 F.2d at 1440; Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (applying Virginia law); Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1346 (E.D.N.Y. 1992).

However, even the presence of a doctor might not be enough for a court determined to impose liability.  Brazzell v. United States, 788 F.2d 1352, (8th Cir. 1986) (applying Iowa law), invoked the mass vaccination exception, claiming that the government’s efforts to encourage vaccine use had steam-rolled the plaintiff’s doctor:

In the instant case appellee did have the help of her doctor.  The doctor testified, however, that he knew nothing more about the vaccine than what the manufacturer and government had told him.  We hold that the doctor’s intervention is not enough to dispel the manufacturer’s duty to warn the ultimate consumer in view of the swine flu program’s exigent circumstances. The program was designed by the government to be at an emergency pitch and it gave physicians little chance to investigate the vaccine they were administering. The only possible sources of information on the vaccine were the manufacturer and the government who had developed and tested it.  The manufacturer, therefore, properly is charged with the duty to warn doctors and consumers of the risks involved. . . .  We have little trouble in viewing doctors in the program, rather than learned intermediaries, as distributors of a defective product.  As stated above, the emergency nature of the program forced this role on them.

Id. at 1358.  Cf. Givens, 556 F.2d at 1345 (despite plaintiff visiting a doctor, “the vaccine was administered here in a manner more like that at a small county health clinic”); Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006, 1013 (N.Y. Sup. 1985) (mass vaccination exception could apply to vaccine administered by corporate doctor to corporate employee pursuant to corporate policy).

The takeaway here is that plaintiffs can be expected to use the mass immunization exception to demand direct warnings in almost any situation short of a full, one-on-one office visit, and maybe even then.

Third, the defendant must be responsible for the claimed failure to warn, notwithstanding any precautions it took.  If the defendant involves itself in the distribution of the vaccine, then it is likely to have a direct warning duty imposed.  However, the defendant can, contractually or otherwise, arrange for a third party – including a governmental entity – to be responsible for preparing and providing end user warnings.  Indeed, the FDA itself has largely taken over the business of approving patient vaccine handouts, such as this one.

However, at least before the FDA got involved, delegating matters to a government agency may not have been enough to avoid tort liability.  Unlike Mazur, Petty found the duty to warn effectively non-delegable:

We recognize that the government has attempted to statutorily assume the duty to warn the vaccinees, however, we do not find that this delegation thereby relieves the manufacturer from liability for any resulting inadequacy of the warning.  The duty to warn is imposed on the manufacturer and in a mass immunization context. . . .  Delegation of the duty does not, in itself, relieve the manufacturer of its obligation, nor should it insulate the manufacturer from liability for deficiencies in the manner in which the chosen intermediary effectuates the manufacturer’s duty.

740 F.2d at 1440.  Another court even challenged the government’s status as a non-biased messenger:

Given the CDC’s admitted biases against discouraging the use of vaccines, a jury could conclude that [defendant] knew or had reason to know that the CDC was not going to provide the truth about [defendant’s] product and did not, in fact, give proper warning

Allison, 878 P.2d at, 958 n.17 (quotation marks omitted).

These cases were all decided before preemption became a well-established defense in product liability cases, and to us demonstrate why preemption is a necessary defense.  Private plaintiffs have no business using state law to second-guess the actions of the FDA and the CDC in the midst of a pandemic.

*          *          *          *

From review of this largely historical collection of precedent, the overwhelming takeaway is that the need for PREP Act and Vaccine Act common-law tort immunity is self-evident.  If the common-law trend evident in these mass vaccination decisions had continued unabated over the intervening decades, there would likely be no vaccines today.  Both the scope of the “mass vaccination” exception to the learned intermediary rule, and the defense of reliance on third-party – usually federal government – to provide warning were under constant pro-plaintiff pressure in the courts, until Congressional intervention largely shut down vaccine-related litigation.

We believe that, by knowing what is out there, putative defendants in any COVID-19 vaccination litigation will be better equipped to argue for both the existence of federal preemption and accompanying tort immunity, and to articulate the sound social policies that support it, in the context of the upcoming effort to vaccinate the public against COVID-19.

Finally, as to this last point, ensuring that the FDA utilizes sound scientific criteria – and only scientific criteria – in making COVID-19 vaccines available to the public will be far more essential to the success of such programs than any amount of litigation.  Vaccination programs will only succeed if the public is convinced that these vaccines have been rigorously evaluated for safety and effectiveness, and we don’t need lawyers trashing science in order to make a buck.

Back in March, we discussed the Administration’s declaration of tort immunity under the “PREP Act” (42 U.S.C. §§247d-6a, et seq.) for “countermeasures” combating the COVID-19 epidemic.  Today, we’re discussing the first cast that we know of to construe this declaration.

That case is Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020), and it arises in the context of the removal of a couple of nursing home negligence actions to federal court.

The defendants, a nursing home operator and certain of its employees, offered two bases for federal jurisdiction:  (1) complete preemption under the aforementioned PREP Act, and (2) federal officer jurisdiction under 28 U.S.C. §1442(a)(1), a topic we recently addressed hereMagioli, 2020 WL 4671091, at *2.  We are mostly interested in the first ground, which involves a lot of so-far legally uncharted territory.

Our readers have probably already figured out the substance of the allegations in Maglioli – defendants allegedly negligent in not preventing death/injury caused by COVID-19 at the facility in question.  Plaintiffs, who filed in state court and wished to remain there, “d[id] not in so many words set forth a federal-law cause of action.”  Id.  Defendants, however, alleged that the sweeping immunity conferred by the March, 2020 PREP Act declaration created federal jurisdiction by completely preempting the plaintiffs’ state-law negligence claims:

Defendants removed the actions on the basis that the PREP Act “provides liability protections for pandemic and epidemic products and security countermeasures,” including “respiratory protective devices.”  Defendants state that they are “covered persons” under the PREP Act and that such “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’ during a health emergency.”

Id. (citing 42 U.S.C. § 247d–6d(a)(1)).  Maglioli recognized that the HHS declarations we blogged about before set the scope of immunity and “expand[ed]” the definition of “covered countermeasure” to include:

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, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.

2020 WL 4671091, at *4 (quoting 85 Fed. Reg. 15,198, 15,202 (HHS March 17, 2020)).  “[F]urther expan[sion]” followed to:

Create[] a new category of covered countermeasures eligible for liability immunity under the PREP Act, namely, respiratory protective devices approved by . . . NIOSH . . . that the Secretary determines to be a priority for use during a public health emergency

Id.  See 42 U.S.C. §247d-6d(i)(1)(D) (“a respiratory protective device that is approved by the National Institute for Occupational Safety and Health”).

Maglioli also recognized the PREP Act’s express preemption clause:

During the effective period of a declaration . . . or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that −

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other provision of this chapter, or under the [FDCA].

2020 WL 4671091, at *7 (quoting 42 U.S.C. §247d-6d(b)(8)) (emphasis added).

Maglioli discerned two limits to PREP Act preemption.  First, it held that preempted conduct “is bound to the ‘physical provision of the countermeasures to recipients,” or “relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.’”  Id. at *6 (quoting HHS “supplemental information”).  Second, Maglioli erroneously equated the express preemption with “conflict preemption,” id., which is an implied preemption concept (albeit included in PREP Act’s express preemption language), and asserted that the PREP Act’s preemption clause “does not by itself mandate a federal forum or completely preempt all claims arising out of the adequacy, or not, of the medical care afforded by these defendants when infected with the COVID-19 virus.”  Id. at *7.  At best that second assertion is incomplete.

Here’s what’s wrong with Maglioli.  First, while the PREP Act’s preemption clause did not “mandate a federal forum,” the decision inexplicably failed to discuss 42 U.S.C. §247d-6e(a), which definitely does just that.  This section of the PREP Act expressly establishes an alternative federal compensation program where, as with COVID-19, a PREP Act declaration has issued:

Upon the issuance by the Secretary of a declaration . . . there is hereby established in the Treasury an emergency fund designated as the “Covered Countermeasure Process Fund” for purposes of providing timely, uniform, and adequate compensation to eligible individuals for covered injuries directly caused by the administration or use of a covered countermeasure pursuant to such declaration.

Id.  This is important for “complete preemption” purposes, since the availability of an alternative forum is usually required for this form of jurisdiction to exist.  See Aetna Health Inc. v. Davila, 542 U.S. 200, 208-09 (2004) (because ERISA contains an “integrated enforcement mechanism,” it has “extraordinary pre-emptive power” and “converts state causes of action into federal ones for purposes of determining the propriety of removal”); Beneficial National Bank v. Anderson, 539 U.S. 1, 10-11 (2003) (statute “providing an exclusive federal cause of action” contains “the requisite pre-emptive force to provide removal jurisdiction”); Goepel v. National Postal Mail Handlers Union, 36 F.3d 306, 311 (3d Cir. 1994) (“we have held that the complete preemption doctrine applies only if the statute relied upon by the defendant as preemptive contains civil enforcement provisions within the scope of which the plaintiff’s state claim falls”).

Second, Maglioli is mistaken when it reads the express preemption clause (quoted above) as “at most” “restrict[ing] any state from passing a law that conflicts with the federal government’s requirements for . . . of covered countermeasures.”  2020 WL 4671091, at *9.  That’s just wrong.  The battle over what “requirement” means in an express preemption clause ended years ago.  “Requirement” also includes state tort law:

In interpreting two other statutes we have likewise held that a provision pre-empting state “requirements” pre-empted common-law duties. . . .  Congress is entitled to know what meaning this Court will assign to terms regularly used in its enactments.  Absent other indication, reference to a State’s “requirements” includes its common-law duties.

Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008) (citations omitted).  That ship has definitively sailed.

Other aspects of Maglioli fall in murkier areas.  The plaintiffs in Maglioli argued that “Defendants d[id] not fall within the scope of the PREP Act,” because their claims were “not directed against Defendants’ role in the manufacturing, distribution, administration, or use of a covered countermeasure.”  2020 WL 4671091, at *8 (citation omitted).  The court agreed, tying the scope of preemption to the defendant having actually used a PREP Act “countermeasure”:

Nothing in the language of the Act suggests that it was intended to more broadly displace state-law causes of action for, e.g., malpractice or substandard care − even if proper care possibly would have entailed administration of such countermeasures.

Id.

So Maglioli drew the jurisdictional line between cases where a PREP Act countermeasure was actually used – which by implication would be completely preempted and subject to removal to federal court – but would allow a state-court plaintiff to base a negligence claim on a defendant’s failure to employ such a countermeasure.  “[T]he PREP Act . . . is designed to protect those who employ countermeasures, not those who decline to employ them.”  Id. at *9.  “[A]cts such as social distancing, quarantining, lockdowns, and [the like] . . . are not covered ‘countermeasures’ under the PREP Act at all.”  Id. at *10 (citation and quotation marks omitted).  Cf. §247d-6e(a) (compensation program covers “injuries directly caused by the administration or use of a covered countermeasure”).  We don’t know whether this is the right line or not (“we’re more used to “different from or in addition to” preemption language, under which such claims would be preempted), but as Maglioli appears to be the first decision called upon to draw that line, it is significant.

Maglioli also rejects an “unstated premise” – which may mean a “straw man” − that the PREP Act creates “field preemption.”  2020 WL 4671091, at *8.  Field preemption is very rare, and since the express preemption clause doesn’t flatly state that “all is preempted,” its existence implies that something must be left that is outside of its scope.  So we question whether the defendants were ever actually arguing field preemption.  In any event, Maglioli rejected complete preemption by field preemption as a basis for subject matter jurisdiction:

[T]he PREP Act . . . does not “occupy the field” of negligence or malpractice claims, even if that negligence or malpractice happens to relate to the COVID-19 illness.  Its effect is confined, for example, to the administration of certain countermeasures, and requires case by case analysis.  In short, I think the PREP Act limits the range of what the plaintiff can sue for − whether in state or federal court − but does not rule out all such claims.  Plaintiffs, in pursuing their claims in state court, may find that their claims are confined by those limitations.  I believe, however, that the Act still leaves room for ordinary claims of negligent or substandard care.

Id. at *9.  A broader reading would, as Maglioli observed, id. at *11, effectively federalize all COVID-19-related litigation of this sort (nursing home negligence).

As indicated above, the defendants in Maglioli asserted a second jurisdictional basis for removal −  that they were “acting under” the supervision of the United States, the litigation “related to” their actions “under color” of that federal authority, and they stated a “colorable federal defense.”  2020 WL 4671091, at *3.  This second basis is less novel than the heretofore uninterpreted PREP Act.  We do point out, however, that Maglioli’s restrictive view of federal officer removal is distinctly at odds with the recent Fifth Circuit decision in Latiolais v. Huntington Ingalls, Inc., 951 F.3d 286 (5th Cir. 2020) (en banc), discussed here, which pointed out that the Supreme Court “has consistently urged courts to avoid ‘a narrow, grudging interpretation of §1442(a)(1).’”  Id. at 290 (quoting Willingham v. Morgan, 395 U.S. 402, 407 (1969)).  In particular, Maglioli’s construction of this form of jurisdiction as requiring acts “performed pursuant to an officer’s direct orders or comprehensive and detailed regulations,” 2020 WL 4671091, at *13, is based entirely on cases that predate the 2011 congressional amendment broadening the statute that convinced the en banc Fifth Circuit to abandon more restrictive precedent in Latiolais.

*     *     *     *

Note:  since this post was originally drafted, we have become aware of a second case (rather, set of cases) dealing with the same issue.  Seee.g.Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074, at *6 (D. Kan. Aug. 19, 2020) (reaching similar “conclusion that the PREP Act applies to action, not inaction”) (one of eleven legally identical decisions).

Bexis recently returned from speaking at the 2022 National Vaccine Law Conference.  As a veteran of both the DTP and thimerosal vaccine litigations, he was generally interested in vaccine-related product liability issues, so he stayed for the entire conference.  He was most interested in learning more about the compensation systems provided by the National Childhood Vaccine Injury Act and the PREP Act.  The Vaccine Act, 42 U.S.C. §300aa-10 et seq., seemed most relevant, since the layers of preemption imposed by the PREP Act make product liability litigation over use of PREP Act “covered countermeasures” (which include vaccines) extremely unlikely.

Continue Reading Thoughts on a Vaccine Act MDL

We just bought tickets for ourselves and a dear visiting colleague to see Barry Manilow in concert next month.   We love everything about Barry – his songwriting (we orchestrated many a youthful breakup with “Even Now” played over and over again), his chutzpah (just shy of his 79th birthday, he premiered a new musical, to raves, at the National Yiddish Theatre Folksbiene) and his unabashed and unapologetic joie de vivre and showmanship.  The first time we saw Barry in concert, we were young, in love, and spending the summer at the Jersey Shore.  The first live strains transport us back to those breezy days when we thought we could wish anything into reality simply by believing it enough.

We know better now, of course.  As does the plaintiff in today’s case, which turns on whether a plaintiff can satisfy Twiqbal by pleading facts “on information and belief.”  In Warren v. ResMed Corp., 2022 U.S. Dist. LEXIS 114447 (S.D.N.Y. June 28, 2022), the plaintiff alleged that her husband/decedent died because of a malfunction of the defendant’s ventilator.  (The decedent suffered from a degenerative neurological condition that affected his ability to breathe.)   The complaint alleged that the plaintiff found her husband unresponsive and observed “a gap or opening between the face mask” of the ventilator and the decedent’s face, and that “the gap impaired the functioning of the ventilator in a manner which should have caused an alarm to sound but did not.”  Warren, 2022 U.S. Dist. LEXIS 114447 at *3.  She filed suit in New York state court, and the defendants removed the case to the Southern District of New York.  She asserted all of the usual product liability claims sounding in strict liability, negligence, and breach of warranty, and the defendants moved to dismiss the failure-to-warn and breach of express warranty claims.

In her failure-to-warn claim, the plaintiff alleged that, “[u]pon information and belief,” the decedent’s doctor was provided with a User Guide that one of the defendants prepared and that, she alleged, contained inadequate warnings.   Similarly, in the breach of express warranty claim, the plaintiff alleged, “upon information and belief,” that the doctor and the decedent had “received, read, and reviewed” the defendants’ User Guide and Patient/Caregiver Instruction warranting “that the ventilator was fit, was reasonably safe, capable, and was of merchantable quality.”  Id. at *4-5.  In their motion to dismiss, the defendants argued that the plaintiff’s warnings and warranty claims failed because “the facts alleged ‘upon information and belief . . . [were] not peculiarly in the possession and control of the defendant,” and the complaint did not “contain a statement of facts upon which the beliefs [were] founded.”  Id. at *8 (internal punctuation and citation omitted).  The defendants contended that, “absent such a factual basis, the relevant allegations [were] purely speculative and [could not] provide a basis for” the claims.  Id.  

And the court agreed.  With respect to the failure-to-warn claim, the court held that the complaint “fail[ed] to state a claim because it [did] not plausibly allege that [the doctor] received inadequate warning from the Defendants.”  Id. at *9.  The court continued, “Although the [complaint] is replete with allegations concerning the substance of the allegedly “inadequate” warnings, it does not identify a single fact that supports the Plaintiffs’ ‘belief’ that [the doctor] received the documents in question.” Id. at *9-10.   “As a result,” the court concluded, “the allegation that [the doctor] received the relevant warnings from the Defendants is wholly conclusory.  Because the Plaintiff does not adequately allege that [the doctor] received the relevant warnings, the [complaint] fails to state a claim for failure to warn.”  Id.   This is akin to the “failure to read” argument we regularly make in our prescription drug and device cases:  if the doctor never read the warnings, the allegedly-inadequate warning could not have been a proximate cause of the plaintiff’s injuries.  (You can find our 50-state failure-to-read survey here.)

Similar deficiencies doomed the breach-of-express-warranty claim.  The defendants argued that the plaintiff’s “upon information and belief” pleading failed to adequately plead “the existence of a material statement amounting to a warranty” and “reliance on the warranty.”  The plaintiff countered that it would be “counterintuitive to assume” that the doctor did not receive and rely on the defendants’ express warranty, and that dismissal would be premature because discovery would elucidate the relevant facts.

The court emphasized that the complaint was “bereft . . . of any facts that would permit the inference” that the doctor or the plaintiff read and relied on the defendants’ express warranties and that the deficient pleading was not cured by the plaintiff’s conclusory assertion that it would be “counterintuitive” to assume that she was incorrect in her “information and belief.”  The court concluded, “Because the Plaintiff’s allegation that [the doctor] received and relied upon the documents in question” was not “accompanied by a statement of the facts on which the belief [was] based,” the express warranty claim failed as a matter of law.  Id. at *13-14 (internal punctuation and citations omitted).

Finally, the court rejected the plaintiff’s argument that she should be permitted discovery to develop the facts of her claim, stating that “a plaintiff who has failed adequately to state a claim is not entitled to discovery”; rather, “discovery is authorized solely for parties to develop the facts in a lawsuit in which a plaintiff has stated a legally cognizable claim, not in order to permit a plaintiff to find out whether he has such a claim.”  Id. at *14 (internal punctuation and citations omitted).

The plaintiff sought leave to amend the complaint to plead additional facts to support her claims.  The court explained that, under Second Circuit precedent, amendment was “not warranted . . . absent some indication as to what a plaintiff might add to its complaint in order to make it viable,” and this plaintiff “had not identified what new information she would include” if permitted to amend.  Id. at *15 (internal punctuation and citations omitted).  Nevertheless, the court permitted the plaintiff to move for leave to amend, with the motion to include a memorandum of law explaining how the amended complaint would survive a comparable motion to dismiss.

This last is a nice touch, and one we’ve not seen before.  We like this decision, obviously – we favor anything that forces plaintiffs to marshal facts to back up their claims before they file their lawsuits.  We’ll let you know if we hear anything further on this.  In the meantime, fire up some classic Manilow music, and stay safe out there.