What if Vaccines Go Wrong?: Liability in COVID-19

A triumph of modern science: multiple Covid-19 vaccines were released within a year since the World Health Organization (WHO) declared the spread of the new, virulent coronavirus a pandemic. These vaccines represent a light at the end of a dreadful tunnel. A tunnel that has plagued loved ones, perforated economies, destabilized governments and overwhelmed healthcare systems. Nevertheless, few processes are entirely without error—there are bound to be [assuredly an extremely small number of] complications from the administration of the vaccines. To seek redress for said edge cases, individuals will undoubtedly turn to the legal system and file lawsuits against a variety of parties: vaccine manufacturers, hospitals, individual doctors, healthcare professionals, and more. The handling of these lawsuits is dictated by a federal law, which in turn is interpreted and further clarified by the federal court system. This post will endeavor to synthesize Covid-19 vaccine liability by dissecting the pertinent federal statutes, court cases, and legal precedents.

What is the PREP Act?: the ‘go-to’ federal law for pandemic vaccine liability

The Public Readiness and Emergency Preparedness Act (PREP Act), passed in 2005, allows the federal government broad rulemaking authority over the parameters of vaccine liability during a national emergency. The act allows the Secretary of Health and Human Services to issue guidance providing immunity from liability “against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’”.

Willful misconduct is further defined within the PREP act as, “An act or a failure to act that is taken intentionally to achieve a wrongful purpose, knowingly without legal or factual justification; and 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.

The standard for review is that of “clear and convincing” evidence: slightly less stringent than “beyond a reasonable doubt” (used in criminal cases), but more stringent than the mere question of “preponderance of evidence”. “Clear and convincing” evidence requires that the issue in question is “highly and substantially more likely to be true than untrue.” In practice, the standards of evidence are relatively straightforward. On one hand, “preponderance of evidence” requires the claim to be at least 51% true, while, on the other hand, “clear and convincing” requires that the evidence be substantially higher than the theoretical level of 50%. In other words, the scale cannot be tightly tipped, it must be heavily leaning towards one resolution. In criminal cases, for example, “beyond a reasonable doubt” means that there is almost no question of the facts and blame within a case.

Intentionally Esoteric?: monetary compensations when vaccines go wrong

Evidently, PREP is a powerful tool for the federal government. Where there is power, there is responsibility. PREP is used at the discretion of the Secretary of Health and Human Services. Former secretary Alex Azar, instituted PREP protections for vaccine companies at the beginning of the pandemic, specifically, March 17, 2020. The enactment of PREP made the Covid-19 vaccine a covered countermeasure, and thus, enacted legal protections for manufacturers. By making the vaccine a covered countermeasure, Secretary Azar also opened the door for vaccine recipients to file claims within the Countermeasures Injury Compensation Program (CICP). The CICP is a fund administered by the Department of Health and Human Services (HHS) that monetarily compensates individuals theoretically harmed by the covered countermeasure, the COVID-19 vaccine, as a last resort.

The Countermeasures Injury Compensation Program (CICP) was created after the vaccine industry went through costly litigation that almost made the industry impossible to operate within. Thus, Congress sought to limit vaccine liability to allow the vaccine industry to flourish. For an individual to receive compensation, the HHS must deem there is “compelling, reliable, valid, medical and scientific evidence demonstrating that the injury for which compensation is sought was caused by the administration or use of a covered countermeasure [the COVID-19 vaccine] and no other more likely cause of the injury is found.” While this standard is, in theory, like the “clear and convincing” evidence standard, determinations are made by HHS in their “sole capacity”, meaning that the process is entirely handled internally, without any third-party judges. The relatively high standard of evidence and the HHS monopoly on handling cases has led to a less than generous number of approved compensation cases. Since the program’s inception in fiscal year 2010, 499 claims have been made to the CICP. Out of these, only a total of 29 were compensated and 10 are currently being processed, leaving 450 cases outright rejected. Overall, the CICP might be seen as a last resort for those who face redressable harm from the administration of the COVID-19 vaccine, as well as any PREP act countermeasure.

Testing the Waters: 3 legal cases that have established limits to the PREP Act

Lawyers have attempted, in three separate cases, to challenge aspects of PREP to test the laws limits on liability. This way, it is possible to establish sufficient jurisprudence (science of law) to demystify the overall protections the statutes (laws) provide. Two of these PREP Act related cases occurred in the New York Supreme Court [In New York, ‘Supreme Court is the name given to lower-tier general trial courts]; as the cases were adjudicated in state court, they do not have any precedential value outside of the state.

Kehler V. Hood: what is a federal precedent for compensation after a vaccination goes wrong?

There is only one federal court case related to PREP act: Kehler V. Hood. In Kehler, plaintiff Larry Kehler received the vaccine for the H1N1 Influenza Virus, which fell under the guise of the PREP act, as the act was passed in 2005 and the pandemic occurred in 2009. Prior to receiving the vaccination, in October of 2009, Mr. Kehler was diagnosed with transverse myelitis. After receiving the vaccination, Mr. Kelher’s transverse myelitis worsened, and he sought remedy under the belief that the administering doctor, Dr. Diane Hood, should have known that administration of the vaccine would heavily increase the risk of further aggregating Mr. Kehler’s condition. Mr. Kehler further alleged that Dr. Hood failed to consult a specialist in transverse myelitis prior to the administration, as such a specialist would most likely recommend against administration. Ultimately, Kehler filed a lawsuit against the doctor, the hospital (St. Luke’s), and Novartis, the maker of the vaccine; the lawsuit was promptly adjudicated in the federal court for the eastern district of Missouri.

The court dismissed the case against Novartis, stating that the corporation enjoyed projection from liability under the PREP act, as “No injured party here has alleged that Novartis engaged in willful misconduct so as to bring its claim within the statute’s only recognized exception to immunity. As such, the Third-Party Petition against Novartis fails to state a claim upon which relief may be granted.”The court further reasoned that it did not have jurisdiction over the PREP act-related Novartis claim, as “the District Court for the District of Columbia has exclusive jurisdiction over any such claim.”After dismissing the third-party petition against Novartis, the eastern district court of Missouri fell into territory governed by 28 U.S.C. § 1447(c), which states that “the case shall be remanded” “[i]f at any time before final judgment it appears that the district court lacks subject matter jurisdiction.”

Kehler’s attorneys attempted to argue around this point by stating that the PREP act is a federal law, and thus, federal question jurisdiction exists. Nevertheless, citing Gore v. Trans World Airlines, the court found that, “…A federal question must be presented on the face of the properly pleaded complaint to invoke federal court jurisdiction.” Following from Gore, according to the court, federal jurisdiction was annihilated by the PREP act immunity shield, “In the absence of an independent basis for federal jurisdiction, the dismissal of Novartis and all claims against it destroys this Court’s subject matter jurisdiction over the remainder of this case.” Citing Transit Cas. Co. v. Certain Underwriters at Lloyd’s of London, the court stated that “all doubts about federal jurisdiction [must be resolved] in favor of remand”, thus, the case was remanded to the court of St. Louis county, where the remaining parties (Dr. Hood and St Luke’s Hospital) settled out of court.

Therefore, the eastern district of Missouri provided clear guidance to those seeking to sue vaccine manufacturers in federal court: unless there is “willful misconduct,” the chances of success on the merits are slim to none. Furthermore, lawsuits against local doctors and lawyers who provide PREP-related countermeasures are not federal questions and are thus to be adjudicated in state court, where decisions do not serve as federal precedent.

The following cases were tried in New York and thus do not have any precedential value outside of the state.

Parker V. St Lawrence County Public Health Department: does immunity granted by the PREP Act apply to individuals who administer the vaccine?

In Parker, a young girl was vaccinated, at the Lisbon, New York central school, without consent from her mother. The mother then sued, stating that the vaccination constituted negligence in addition to battery against her daughter. While this case does not deal with any harm caused by the vaccine, it touches on the liability of vaccination providers themselves, and the recourse that guardians have over their children. In the initial hearing, defendants (St Lawrence County) moved to dismiss the complaint under the PREP act, on the grounds that the New York State Court did not hold jurisdiction over the inoculation as the action of administration is covered under the PREP act, a federal law. The court first discusses what qualifies as a loss and then addresses the key question of the case: does immunity pursuant to the PREP Act apply to individuals who administer the vaccine?

The statute broadly defines “loss” as “any type of loss, including physical, mental, or emotional injury” or fear thereof (42 U.S.C. § 247d–6d [a][2][A][ii]-[iii] ), and provides that its immunity provision applies to “any claim for loss that has a causal relationship with the administration to an individual of a covered countermeasure [the vaccine],” including, among other things, “administration” (42 U.S.C. § 247d–6d [a] [2][B] [emphasis added]). Thus, the court found that, since the vaccine was administered, the defendant was covered by PREP: “We conclude that plaintiff's state law claims for negligence and battery are preempted by the PREP Act and, inasmuch as the exclusive remedy under the statute is a federal cause of action to be brought in federal court, the complaint must be dismissed for lack of subject matter jurisdiction.”

The court ultimately moved to dismiss the complaint, leaving Parker with no compensation; the Parker case shows the power of PREP act liability—once the needle enters the arm, there is substantially less recourse available through conventional legal means—that is, tort law and the lawsuits through which it is adjudicated. The key part of Parker is the theoretical expansion through the decision of the liability shield to providers of vaccine: most of the vaccine ecosystem, which spans from manufacture to injection, is shielded from liability by the PREP act.

Casabianca vs. Mount Sinai Med. Ctr., Inc: what if the injection was never administered?

In Casabianca vs. Mount Sinai Med. Ctr., Inc, plaintiff Elizabeth Casabianca sued Mount Sinai because the hospital did not provide the H1N1 vaccine to her husband, Angelo, who later died of H1N1-related complications. The hospital moved to dismiss under the PREP act, stating that the hospital was covered by the PREP act as the vaccine was a covered countermeasure, and thus, was immune from liability. The court did not agree, as judge Alice Schlesinger stated in her opinion, the PREP act “makes clear that the vaccine must be administered to or used by a patient. The amendment broadens the scope of persons covered by the Act, but it still only applies to the actual use of the vaccine in the manner in which it was intended; i.e., for "the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a declaration issued under the Act". Again, the injury must be one "caused by physical provision of a countermeasure to a recipient". In other words, something bad, perhaps not anticipated, has occurred from the administration or use of the vaccine…”

Seeing as Mr. Casabianca never received the vaccine and there was no administration, the PREP act does not apply. Evidently, the timing of coverage of PREP act liability is clear: once the vaccine enters the patients armed, the liability begins. Before then, is a question of medical liability that is for the courts to decide under standard medical tort laws.

It is important to note once more that the above cases (Casabianca and Parker) are state court cases and thus do not serve as federal precedent. Furthermore, there are other cases related to the PREP act, but no others involve vaccines, and instead, involve other possible countermeasures, mainly the usage of nursing homes and personal protective equipment.

Money Talks: CICP vs.VICP

After reviewing the aforementioned cases, it may seem as if the only recourse that an individual harmed by the COVID-19 vaccine is to make their case to the Countermeasures Injury Compensation Program (CICP). As mentioned, the CICP has only approved 29 cases for compensation out of a pool of nearly 500. I will not endeavor to entirely explain the reason for the lack of approvals but will operate under the fact that a large number of the rejections for compensation, as reported by HHS, simply do not meet the scientific criteria for compensation. The determination of harm is made entirely within HHS, and thus, not open to public review. In a time as fraught with mistrust as government as now, the HHS’ belief in continuing the relatively opaque CICP is fraught with erroneous reasoning. Instead, in agreement with Dorit Reiss, a law professor at UC Hastings College of Law, the US HHS should choose the Vaccine Injury Compensation Program (VICP).

The Vaccine Injury Compensation Program (VICP) differs from CICP in that the VICP protocol involves vaccines specifically, not qualified countermeasures to public health emergencies. Created by the National Childhood Vaccine Injury Act of 1986, the program, according to the department of justice, “is designed to encourage vaccination by providing a streamlined system for compensation in rare instances where an injury results from vaccination… More than 6,000 people have been paid more than $3.9 billion (combined) since the Program’s 1988 inception.”The VICP is a no-fault system, meaning that there is no compensation paid on the part of the vaccine companies and rather the program is funded with excise tax revenue from vaccines themselves. Unlike the CICP, where the claim is made through HHS, the claim in question here is made through the United State Court of Federal Claims. The process is then controlled in concert with the courts, HHS, and the department of justice: each federal agency submits a report based on the evidence available, regarding both legal and medical evidence, to a “Special Master” who is appointed by the court. The Special Master then looks at the compiled reports and decides whether to grant compensation. The entire process involves many attorneys and doctors, including specialized attorneys that are members of the Vaccine Injured Petitioners Bar Association, which, according to their website, “is a group of experts in the National Vaccine Injury Compensation Program providing advice and ideas on specific challenges facing vaccine attorneys.” The Special Master that is appointed by the court to review the claims is also an attorney. As the case is heard within the US Court of Federal Claims, the ultimate decision is public record, along with the facts and law of the matter (where not blocked by the Health Insurance Portability and Accountability Act).

The public nature of these cases provides us with a clear look as to how the VICP operates. Firstly, the cases elucidate what the VICP covers: “To gain an award, a petitioner must make a number of factual demonstrations, including showing that an individual received a vaccination covered by the statute; received it in the United States; suffered a serious, long-standing injury; and has received no previous award or settlement on account of the injury. Finally – and the key question in most cases under the Program – the petitioner must also establish a causal link between the vaccination and the injury.” Essentially, the petitioner must show that the vaccine was “at least a “substantial factor” in causing or aggravating the condition, and was a “but for” cause.” In other words, “but for” the vaccine, there would be no injury to petitioner—however, and this is a BIG however, this is only for injuries that appear on the vaccine injury table—a list of possible injuries related to vaccines written by the US department of Health and Human services. If the injury is not on the table, then there is a different standard of review as offered by Althen v. HHS. In Althen, the court of federal claims found that the correct standard was the preponderance of evidence standard; as aforementioned, and as the Althen case makes clear, “Under that standard, the petitioner must show that it is “more probable than not” that the vaccination initially caused or aggravated the injury”. While this standard is possibly slightly lower than the “direct causal link” for the table injury cases, it is still one that is difficult to meet for many petitioners, as the evidence for the non-table injury must clearly show a link [that is likely to be verifiable] between the vaccine and injury. It is therefore necessary to explore the standards by which the evidentiary determinations are made by the court-appointed Special Master. The Special Master follows a set of rules outlined by the Althen decision, in weighing evidence, he or she is looking for “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury;” and the logical sequence must be supported by “reputable medical or scientific explanation, i.e., evidence in the form of scientific studies or expert medical testimony.” Furthermore, the Althen court noted that, “a petitioner need not necessarily supply evidence from medical literature supporting petitioner’s causation contention, so long as the petitioner supplies the medical opinion of an expert.” The admissibility of both written and testimony evidence is especially of interest, because the admissibility of expert witness testimony creates a new set of problems: there is a possibility where there is no clear medical literature on COVID-related vaccine complications, but an individual scientist states that she/he has proof that the COVID-19 vaccine directly caused a petitioners harm. The question of the standards by which expert testimony is reviewed is answered by the Daubert trilogy, which outlines the rules for expert testimony in federal courts; according to the case law presented in Terran v. HHS, 195 F.3d 1302, 1316 (Fed. Cir. 1999), the Special Master should use Daubert as a framework for analysis but is not obligated (eph. added) to use the framework. Daubert, which is short for Daubert v. Merrell Dow Pharmaceuticals, Inc., was a case that outlined Federal Rule 702, which states that the judge, or in this case, the Special Master, has gatekeeping ability over what is admitted evidence in court. Under Federal Rule 702, Federal Judges or Special Masters have the ability to decide what evidence is presented under the following guidelines,

“A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) The expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) The testimony is based on sufficient facts or data;

(c) The testimony is the product of reliable principles and methods; and

(d) The expert has reliably applied the principles and methods to the facts of the case.”

The above rule does theoretically leave the door open to nonsense testimony, as one could argue all of the aforementioned in the case of, say, the earth being flat. Therefore, the court in Daubert provides a scientific test that Special Masters can follow, as per Terran:

(a) Whether the theory or technique employed by the expert is generally accepted in the scientific community;

(b) Whether it has been subjected to peer review and publication;

(c) Whether it can be and has been tested;

(d) Whether the known or potential rate of error is acceptable;

(e) Whether the research was conducted independent of the particular litigation or dependent on an intention to provide the proposed testimony.”

It is the Special Master’s exclusive discretion to note if the above standards are fulfilled, with help from HHS and DOJ attorneys and experts. If the above criteria cannot be met, the Special Master can choose to deem the evidence inadmissible. Defense attorneys can submit a motion in limine to compel Special Masters to deem expert witness evidence inadmissible if they believe that expert’s testimony will violate the five-pronged test of scientific validity. It is, nevertheless, once more the exclusive responsibility of the Special Master to determine the validity of the expert under Rule 702; however, the recourse of an appeal or a motion to block adoption of the Special Master’s report is, of course, still available. It is also important to note that an adjudicator need not read Daubert as a checklist. When writing the opinion, the justices explicitly stated: “Many factors will bear on the inquiry, and we do not presume to set out a definitive checklist or test.” Therefore, Daubert’s quasi-tests remain the standard by which vaccine-related evidence is evaluated during VICP hearings.

The COVID-19 Verdict: a suggestion to avoid liability concerns

Overall, clear rules, publicly available decisions, and a history of effective and fair case adjudication make the VICP the pre-eminent receiver of the “gold standard” label. When compared to the CICP, the VICP is clearly better suited to serve the American public regarding the factors of fairness, ease of use, and accountability. In the liability framework provided by the PREP act and subsequent case law, individuals have few places to turn for compensation in the case of COVID-19 vaccines. The government might therefore benefit from 1) replacing the CICP with the VICP and 2) adding the COVID-19 vaccines to the vaccine injury table. This would streamline any further compensation questions and provide a straightforward, public, no-fault compensation program. With a robust no-fault compensation program that provides fair and open adjudication to citizens, vaccine companies can continue to produce miracle mRNA vaccines without liability concerns. A robust compensation program would also allow citizens to be rest-assured that the government can, and will compensate individuals from a revenue-neutral pot so long as the citizen can prove, in a court of law, that he/she/they were directly harmed by the COVID-19 vaccine.

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