Although as of yet the data has not been peer reviewed, or subjected to the necessary administrative and scientific scrutiny, there has been considerable recent good news regarding the efficacy of two COVID-19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” products. See 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.