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Open in new tab By Michael R. Mancinelli, JHBL Lead Articles Editor
Buried in the unprecedented disruptions to our economy and way of life created by the worldwide COVID-19 outbreak, the Department of Health and Human Services this week granted liability immunity for activities related to medical countermeasures used against the novel coronavirus.[1]
Given the vast scale and immediacy of this outbreak, the implications of Secretary Alex M. Azar II’s declaration are enormous. In effect, the declaration creates liability immunity for a range of manufacturers and healthcare providers tasked with producing, distributing, and administering COVID-19 countermeasures.
After the dust from this pandemic clears, any negligence cases involving future COVID-19 vaccines, treatments, and certain medical devices, will be barred from state and federal trial courts, with narrow exceptions. By eliminating traditional tort remedies, the only redress for injured parties will be the Countermeasures Injury Compensation Program—a program with restrictive procedures unknown to most attorneys and obscured by a confusing web of federal statutes and regulations.
Legal Authority for Tort Immunity
Such broad power to unilaterally limit tort liability stems from the Public Readiness and Emergency Preparedness Act (“PREP Act”)—a George W. Bush era law enacted in response to bioterrorist threats and concerns about an Avian “Bird” flu pandemic in the early 2000s which never materialized.[2] First passed as an amendment to a defense spending bill in 2005, the PREP ACT was heavily criticized by Senate Democrats at the time, with Massachusetts Senator Edward Moore Kennedy calling for new legislation to remove the liability shield.[3] Nevertheless, the law survived, although the government did not actually implement procedures to administer the compensation program until 2010.[4]
Before declaring a drug, biological product or device a countermeasure, the Secretary of Health and Human Services (“HHS”) must determine “that a disease or other health conditions or threat to health constitutes a public health emergency.”[5]
Notably, in 2009 HHS invoked the PREP Act to declare liability immunity for H1N1 (swine flu) vaccine manufacturers and healthcare providers who administered the vaccine.[6] Later declarations extended liability shields for countermeasures against other highly contagious and deadly pathogens like Ebola, Zika, Anthrax, and Smallpox.[7]
The Countermeasures Injury Compensation Program
Administered by the Health Resources and Services Administration, the CICP compensates individuals (or their estates), who have suffered serious physical injuries or death caused by the use or administration of a covered countermeasure.[8] Following Secretary Azar II’s recent declaration, any person harmed by a COVID-19 countermeasure can seek compensation only through the Countermeasures Injury Compensation Program (CICP). An exception exists, however, for injuries caused by willful misconduct.[9]
A requester for benefits[10] must show the injury occurred during the effective period of a declaration.[11] Requesters must submit a signed Request Form, and copies of medical record release forms showing authorization to release records directly to CICP.[12] Additionally, requesters must arrange for their medical providers to submit directly to the CICP all medical records from one year prior to the date the countermeasure was administered to present.[13] Generally, the deadline to file a request for CICP benefits runs one year from the date that the countermeasure alleged to have caused the injury was administered or received.[14]
Unless HHS later establishes a Covered Countermeasures Injury Table for COVID-19,[15] persons injured by a COVID-19 countermeasure will need to prove causation.[16] The CICP’s causation standard is “proof must be based on compelling, reliable, valid, medical and scientific evidence.”[17] It is not enough to show a temporal association between receipt of the countermeasure and onset of the injury.[18]
For successful CICP requesters there are three forms of benefits available: (1) reimbursement for reasonable and necessary medical services and items to diagnose or treat a covered injury or its health complications; (2) lost wages; and (3) a death benefit for certain survivors.[19] Unsuccessful requesters can motion the Secretary of Health and Human Services to review the determination.[20] No further judicial or administrative review is permitted.[21] “Given this broad statutory prohibition against further review, no determination made under this part (including, but not limited to, eligibility determinations, benefits calculations, payment decisions, and reconsideration decisions) will be subject to any review by Federal or State courts.”[22]
CICP determinations are not published and data concerning the program is difficult to locate. [23] As one state court interpreting the PREP Act in the context of a medical malpractice case noted, “few cases have been published dealing with PREP.”[24] Available data show most requests for benefits filed soon after the CICP first went into operation were related to the 2009 H1N1 pandemic influenza vaccine campaign.[25]
Deciphering this maze of statutes, regulations, and procedures would be extremely difficult for a layperson. Unfortunately, unlike the federal government’s more well-known National Vaccine Injury Compensation Program, CICP requesters are not reimbursed for any attorneys’ fees or costs related to a request for benefits,[26] and requesters for benefits are afforded no adjudicatory hearing to have their traditional day in court, so to speak. Decisions are made on an administrative basis.
For an injured person, or an attorney evaluating the case of a potential client injured by a possible COVID-19 countermeasure, the starting point is to determine: 1) whether there is some nexus between the alleged injury and a covered countermeasure; and 2) whether the person who administered the countermeasure, or their organization, is individually shielded from tort liability.
What are Covered Countermeasures?
Generally, under the PREP Act, a covered countermeasure means “a qualified pandemic or epidemic product . . . a security countermeasure . . . or . . . a drug . . . biological product . . . or device . . . authorized for emergency use.”[27] Subsequent legislation, the Pandemic and All-Hazards Preparedness Reauthorization Act, further expanded this definition to encompass select medical products permitted for unapproved use under an Emergency Use Authorization.[28]
Providing a layman’s definition, the CICP website explains “[a] countermeasure is a vaccination, medication, device, or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat.”[29] The COVID-19 declaration itself states:
Covered Countermeasures are 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.[30]
While it is clear from the declaration that COVID-19 vaccines and medications will be covered, the term “device” leaves some room for ambiguity. Considering the number of COVID-19 patients around the world that have required ventilators due to lung damage, it is likely “device” will encompass ventilators. Under the language of the declaration, “device” will also probably encompass defective respirators, surgical gowns, or gloves worn by healthcare providers.
Who are covered persons?
The statutory phrase “covered person” includes the United States itself as well as persons or entities that are manufacturers, distributors or program planners of countermeasures, healthcare providers, or agents of any of the aforementioned categories.[31] As the statute says:
Subject to other provisions of [the PREP Act], 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 use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.[32]
Absent willful misconduct, the COVID-19 declaration should shield from tort liability any healthcare provider tasked with treating a COVID-19 patient. It will also cover anyone who administers a vaccine, as well as any companies engaged in manufacturing COVID-19 biologics or products used to treat the virus.
Is Tort Immunity Warranted?
While COVID-19 countermeasures will save lives, side effects from, or adverse reactions to countermeasures are always possible. On one-hand, healthcare providers and manufacturers should be able to do what needs to be done to contain the COVID-19 outbreak without the concern of future litigation for negligent acts. There are many unknowns associated with this outbreak that would make it difficult to show a breach of due care in a traditional negligence case.
On the other hand, traditional tort remedies are a much fairer remedy for injured parties—in procedure and substance. The CICP process is unfriendly to requesters and traditional tort remedies off an injured party their day in court, so to speak. The CICP could make the process more transparent by publishing its decisions so that the public, and lawyers, can have a better understanding about how the process works and how the program applies the relevant statutes and regulations. Furthermore, with no further appeals beyond internal review, the lack of judicial oversight is disheartening.
Regardless, lawyers must work within the confines of the existing statutory and regulatory scheme. Congress conceived the CICP and liability immunity for precisely what we are dealing with right now—a pandemic virus difficult to contain.
Michael Mancinelli is 3L day student at Suffolk University Law School and the Journal of Health & Biomedical Law’s Lead Article Editor. He is also a co-online editor of JHBL’s website and blog. Michael has clerked at Karsner & Meehan, PC, a personal injury and workers’ comp law firm in Taunton, MA and interned at New Bedford District Court. Before law school, Michael worked for 4.5 years as a paralegal at Conway Homer, PC, a Boston firm that specializes in National Vaccine Injury Compensation Program cases. As an undergraduate, Michael majored in broadcast journalism at Suffolk University and covered high school sports for the Boston Globe as a correspondent. He has volunteer-coached football at his high school south of Boston since 2009. Michael is interested in personal injury litigation, criminal law, municipal law, and public policy. Michael may be reached at mrmancinelli@suffolk.edu.
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHBL or Suffolk University Law School.
[1] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198 (Mar. 17, 2020).
[2] See Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act, 2006, Pub. L.109-148, 119 Stat. 2818 (2005).
[3] See Sheryl Gay Stohlberg, Legal Shield for Vaccine Makers is Inserted into Military Bill, N.Y. Times, A-26 (Dec. 20, 2005); Congressional Record, Senate, 152 CONG REC S4357, Vol. 152, No. 56, KENNEDY AMENDMENT SA 3896.
[4] See Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Interim Final Rule, 75 Fed. Reg. 63,655 (interim final rule Oct. 15, 2010) (to be codified at 42 C.F.R. pt. 110).
[5] 42 U.S.C. § 247d-6d(b) (2018) (outlining the procedure for the Secretary to issue declarations). The statute further provides a list of factors for the Secretary to consider before issuing a declaration:
In deciding whether and under what circumstances to issue a Declaration . . . with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure.
Id.
[6] See Pandemic Influenza Vaccines—Amendment, 74 Fed. Reg. 30,294 (June 25, 2009) (declaring H1N1 vaccine a covered countermeasure).
[7] See Ebola Virus Disease Vaccines—Amendment, 84 Fed. Reg. 764 (notice Jan. 31, 2019) (extending liability immunity through Dec. 31, 2023); Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines, 83 Fed. Reg. 38,701 (notice Aug. 7, 2018) (extending Aug. 1, 2016 declaration until Dec. 31, 2022); Anthrax Medical Countermeasures—Amendment, 80 Fed. Reg. 76,514 (notice Dec. 9, 2015) (extending Oct. 1, 2008 declaration until Dec. 31, 2022); Smallpox Medical Countermeasures—Amendment, 80 Fed. Reg. 76,546 (notice Dec. 9, 2015) (extending Oct. 10, 2008 declaration until Dec. 31, 2022); Pandemic Influenza Medical Countermeasures—Amendment, 80 Fed. Reg. 76,506 (notice Dec. 9, 2015) (extending Oct. 17, 2008 declaration until Dec. 31, 2022).
[8] 42 C.F.R. § 110.3(z) (2018) (defining serious injury as physical, warranting hospitalization or causing significant loss of function or disability). “Physical biochemical alterations leading to physical changes and serious functional abnormalities at the cellular or tissue level in any bodily function may, in certain circumstances, be considered serious injuries.” Id. Death satisfies the requirement. 42 C.F.R. § 110.3(g) (2018).
[9] See 42 U.S.C. § 247d-6d(d)(1) (2012).
[10] 42 C.F.R. § 110.3(v) (2018) (“Requester means an injured countermeasure recipient, or survivor, or the estate of a deceased injured countermeasure recipient . . .who files a Request Package for Program benefits, or on whose behalf a Request Package is filed, under this part.”).
[11] See 42 U.S.C. § 247d-6d(b) (2018) (describing requirements for effective time period of declaration); 42 C.F.R. § 110.20(a) (2018) (describing general requirements to establish a covered injury).
[12] 42 C.F.R. § 110.51 (2018).
[13] See 42 C.F.R. § 110.50 (2018) (outlining medical records required for CICP to determine whether a covered injury was sustained). Requesters may also submit letters from treating physicians or additional medical documentation or scientific evidence. Id.
[14] See 42 C.F.R. § 110.42 (2018) (setting deadline for filing). “A requester will satisfy the filing deadline as long as the signed Request Form is completed . . . and submitted within the governing filing deadline described in [sec.] 110.42.” 42 C.F.R. § 110.43 (2018). “A Request Package comprises all the forms and documentation that are submitted to enable the Secretary to determine eligibility and calculate benefits.” 42 C.F.R. § 110.41 (2018).
[15] See 42 C.F.R. § 110.20(b) (2018). “A Table lists and explains injuries that, based on compelling, reliable, valid, medical and scientific evidence, are presumed to be caused by a covered countermeasure, and the time periods in which the onset . . . of these injuries must occur after administration or use of the covered countermeasures.” Id. Currently, only pandemic influenza vaccines fall under a Table which creates this presumption. See 42 C.F.R. § 110.110 (2018).
[16] See 42 C.F.R. § 110.20(c) (2018) (outlining causation requirement).
[17] Id.
[18] Id.
[19] See 42 C.F.R. §110.2 (2018) (providing summary of available benefits). “In general, the benefits paid under the Program, are secondary to any obligation of any third-party payer to provide or pay for such benefits.” Id.
[20] See 42 C.F.R. § 110.91 (2018) (“Upon review, the Secretary may affirm, vacate, or modify the determination in any manner the Secretary deems appropriate.”).
[21] See 42 C.F.R. § 110.92 (2018).
[22] See supra, note 4 and accompanying text.
[23] Peter H. Meyers, Article, Fixing the Flaws in the National Vaccine Injury Compensation Program, 63 Admin L. Rev. 785, 833-37 (2011) (discussing the CICP in relevant part). Using the Freedom of Information Act, Meyers obtained information from the Department of Health and Human Services about CICP requests for benefits shortly after the program became active:
HHS indicated that as of July 12, 2010, it had received 230 requests for benefits regarding the H1N1 swine flu vaccine, 3 requests regarding the anthrax vaccine, and 1 request each with respect to the smallpox vaccine, the Japanese encephalitis vaccine, Relenza (zanamivir), and Tamiflu (oseltamivir). (citing Letter from Thomas Flavin, Freedom of Info. Officer, Dep’t of Health & Human Servs., to Peter H. Meyers, Professor, The George Wash. Univ. Law Sch. (July 21, 2010) (on file with Author))
Id. at n. 251.
[24] Casabianca v. Mount Sinai Med. Ctr., Inc., 2014 N.Y. Misc. LEXIS 5998, at *4 (N.Y. Sup. Ct. Dec. 2, 2014) (interpreting statute to determine whether malpractice action for failure to immunize against H1N1 was barred).
[25] Robert Roos, HHS: 386 Injury Claims Filed Over H1N1 Countermeasures, Center for Infectious Disease Research and Policy (Mar. 16, 2011) http://www.cidrap.umn.edu/news-perspective/2011/03/hhs-386-injury-claims-filed-over-h1n1-countermeasures.
[26] See 42 C.F.R. § 110.44(d) (2018) (prohibiting payment for legal or personal representatives).
[27] 42 U.S.C. § 247d-6d(i)(1).
[28] https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/.
[29] Countermeasures Injury Compensation Program, Health Resources & Services Admin., https://www.hrsa.gov/cicp/index.html
[30] Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19, 85 Fed. Reg. 15,198 (Notice of Declaration Mar. 17, 2020).
[31] See 42 U.S.C. § 247d-6d(i)(2) (2012).
[32] See 42 U.S.C. § 247d-6d(i)(1) (2012) (defining countermeasure under the statute).