Not quite two months ago, the Dept. of HHS published a notice of proposed rulemaking that would make a significant change in the National Vaccine Injury Compensation program.  See 85 Fed. Reg. 43,791 (HHS July 20, 2020).  If this becomes a final rule, it could affect the prevalence of civil litigation involving vaccines.

HHS seeks to undo an Obama-era change that added two conditions to the table of compensable vaccine-related injuries:

On January 19, 2017, the Department issued a final rule amending the Table (Final Rule) that, among other things, added SIRVA [Shoulder Injury Related to Vaccine Administration] and vasovagal syncope [injection-triggered fainting] to the Table. . . .  The Final Rule followed a 2012 Institute of Medicine (IOM) report, . . . the work of nine HHS workgroups that reviewed the IOM findings; and consideration of the Advisory Commission on Childhood Vaccines (ACCV) recommendations.

The Department now proposes to remove SIRVA and vasovagal syncope from the Table. . . .

85 Fed. Reg. at 43,795 (citations and footnotes omitted).

Interestingly, the notice indicates that, to the extent they were consulted at all, the IOM, the HHS workgroups or the AACV oppose HHS’ reversal.  See Id. at 43802-03 (proposal “do[es] not meet the tenets of the . . . Guiding Principles” because it is not “made to the benefit of petitioners”).  We find the HHS proposal concerning because it explicitly seeks to create more tort litigation, supposedly as an attempt to “incentivize” proper vaccine administration.  Having lived through the DTP wars that brought about the Vaccine Act in the first place, we don’t think that vaccination and litigation – any litigation – are a good match.

The HHS proposal distinguishes SIRVA and, to a lesser extent, vasovagal syncope from the other vaccine-related injuries in the table because they relate to “administration” of vaccines by health-care providers, as opposed to the inherent risks of the vaccines themselves.  “SIRVA is, of course, not a vaccine, and it is not an injury caused by a vaccine antigen, but by administration of the vaccine by the health care provider.”  Id. at 43,796.

There is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself. . . . [S]houlder lesions are more likely to be the consequence of a poor injection technique . . . rather than antigens or adjuvants contained in the vaccines.

85 Fed. Reg. at 43,795 (citations and footnotes omitted).  The proposal devotes less attention to vasovagal syncope, but asserts the same general conclusion.  “[V]asovagal syncope results from the act of injection, rather than the vaccine or its components.”  Id. at 43,796.

HHS is thus now taking the position that SIRVA occurs primarily because health care providers are “negligent” in how they inject vaccines – we kid you not.  “The scientific literature indicates that SIRVA likely results from poor vaccination technique, rather than the vaccine or its components alone.”  Id. at 43,795.

First, the Department has concluded that the Vaccine Act should be read as not applying to cover injuries, like SIRVA and vasovagal syncope, which involve negligence by the vaccine administrator.

85 Fed. Reg. at 43,796 (emphasis added).  “[N]egligent administration . . . can encompass anything from negligent needle placement to ‘the doctor’s negligent dropping of an infant patient.’”  Id. (quoting Amendola v. Secretary, Dept. of HHS, 989 F.2d 1180, 1186-87 (Fed. Cir. 1993)).  “[T]hat Congress asked the Secretary to ‘make or assure improvements’ in the ‘administration’ of vaccines . . . does not imply that the compensation program covers negligent administration.”  Id. (citation omitted).  So HHS now wants people to sue doctors and other health care providers instead.

However, what actually drove the Vaccine Act was a desire to decrease the transaction costs of compensation for vaccine-related injuries generally, because fear of injury was leading to resistance to vaccination:

[T]here were many complaints that obtaining compensation for legitimate vaccine-inflicted injuries was too costly and difficult.  A significant number of parents were already declining vaccination for their children, and concerns about compensation threatened to depress vaccination rates even further.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 227 (2011) (footnotes omitted).  These concerns would not seem to be limited to the subset of vaccine-related injuries acknowledged in the HHS proposal, but would exist regardless of who was responsible for the injury.

We also looked at the case HHS cited, and Amendola does not stand for exclusion of alleged negligent administration from Vaccine Act compensation.  If anything, it stands for the opposite proposition:

[Plaintiffs] conclude that the Act does not cover mere negligence, either by the manufacturer or the administrator.  However this is too broad a reading. . . .  There is no reference to merely negligent contamination, or to an occasion of negligence in deciding, for example, whether to administer an otherwise satisfactory vaccine. . . .  We see no basis for drawing a bright line that excludes erroneous judgment calls by the administrator. . . .

989 F.2d at 1186.

HHS also asserts that the Vaccine Act’s operative term, “vaccine-related injury or death,” 42 U.S.C. §300aa-11(a)(1), should not be interpreted as requiring something more than “but for,” causation, but should be construed as incorporating, sub silentio, the notion of administrator negligence as a superseding cause.  However, the Vaccine Act itself limits compensation by excluding only injuries “due to factors unrelated to the administration of the vaccine.”  42 U.S.C. §300aa-13(a)(1)(B).  And that’s defined, too:

(2) For purposes of paragraph (1), the term “factors unrelated to the administration of the vaccine”−

(A) does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and

(B) may . . . include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner’s illness, disability, injury, condition, or death.

Id. §300aa-13(a)(2).  Nowhere are “causes,” “factors,” “injuries,” or “conditions” associated with the physical administration of a vaccine statutorily excluded from compensation.  HHS’ superseding cause-based proposal also seems at odds with the nature of the Congressionally intended “no-fault compensation program” itself, in which “[n]o showing of causation is necessary.”  Bruesewitz, 562 U.S. at 228.  The proposal’s attempt to account for this language seems rather forced:

To be sure, the Vaccine Act does in certain places refer to “administration of” or the “administrator” of the vaccine.  But we think that those usages were not meant to suggest the Program covers negligence in the administration of the vaccine, but served other purposes.  At most, these usages render the statute ambiguous with respect to needle injuries.

85 Fed. Reg. at 43,797.  We don’t think so − the statute actually defined the term “factors unrelated to the administration of the vaccine” : − and expressly limited the exclusion to pre-existing conditions.

Thus, to “incentivize” health care providers to administer vaccines more safely, HHS is thus proposing that they should get sued more often.  “Congress wanted to preserve a state tort remedy for certain avoidable injuries, such as those caused by negligent vaccine administration.”  85 Fed. Reg. at 43,797.  “[A]warding no-fault compensation . . . to those with SIRVA and vasovagal syncope claims lessens the incentive to take appropriate precautions.”  Id. at 43,798.  HHS prefers that the public sue negligent vaccine administrators than having to seek contribution itself:

[The Vaccine Act’s] subrogation provision does not properly incentivize the vaccine administrator, since it is unlikely that the Federal government would assert many claims against administrators, given the burden and expense compared to the relatively small potential recovery for the Federal government. Individuals would have a greater incentive to assert such claims if the administrator were negligent.

Id. at 43,801 (emphasis added).  So we are not exaggerating here.  An express purpose of the HHS proposal is to encourage litigation against health care professionals who administer vaccines, and thus to impose “the burden and expense” of litigation on others.

Digging a little deeper, we believe that is possible, even probable, that HHS’ entire discussion of incentives and negligent administration is pretextual.  Another aspect of HHS’ “review” is “the Department’s experience since SIRVA and vasovagal syncope were added.  85 Fed. Reg. at 43,795.  The driving force behind this proposal appears to be to save money, since SIRVA claims in particular now make up more than half of the Vaccine Act docket.  Id. at 43,798.

From FY 2016 through FY 2019, approximately $119,154,985 has been paid out of the Vaccine Injury Compensation Trust Fund (Trust Fund) to compensate SIRVA petitioners, who are overwhelmingly adults. The sheer prevalence of shoulder injuries in the country’s adult population and the low burden of proof placed on petitioners have made it attractive to file SIRVA petitions, even when such claims are dubious.  Petitioners in such cases often prevail because of the low burden of proof and because it is not necessary to prove causation.

Id.  HHS claims that “excessive awards . . . in SIRVA cases threaten the integrity of the [compensation program].”  Id.

But if the Vaccine Act’s statutory compensation program doesn’t pay, who will?  Maybe nobody.  HHS also seems to anticipate that returning SIRVA and vasovagal syncope cases to the tort system would increase transaction costs and thereby make it too expensive for moderately injured people to seek any compensation from anyone.  HHS undertook a study and determined that SIRVA claims have a “median award” of $22,530 in the tort system.  Id.  HHS also “conducted a search in the WestLaw legal database for cases in state court that contained both the terms ‘SIRVA’ and ‘vaccine,’ and found only 20 hits.”  Id. at 43804.  So the preferred course seems to be that nobody recover anything from anyone.

While that might be OK, from our DTP (and thimerosal) experience, we don’t like to see anyone – including health care providers (who are the customers of our clients) – deliberately being left open to suit over injuries allegedly inflicted on people getting vaccinated.  That only encourages lawyers on the other side of the “v.” to attack everyone involved in the vaccination process.  If health care providers are sued, some number of them will inevitably file third-party actions against vaccine manufacturers as alternative causes (which the HHS proposal doesn’t consider at all), leading to what could well be unpreempted civil litigation over vaccines.  See 85 Fed. Reg. at 437,97 (relying on cases holding that “negligent administration” of vaccines is not preempted by the Vaccine Act).

Thus, we think it is preferable that these claims remain under the auspices of the Vaccine Act, as we think the plain language of the statute demonstrates that Congress so intended.  If there are proof problems specific to claims arising from “vaccine administration” as opposed to inherent characteristics of a vaccine, a targeted approach directed at ensuring that alternative causes are ruled out could be undertaken consistently with the statute’s requirements.

The availability of compensation is one less disincentive to vaccination, and with so many hopes currently resting on the rapid development and roll-out of a safe and effective COVID-19 vaccine, we need to be removing disincentives to vaccination, not increasing them.

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Finally, after we’d put together the above post, we learned of yet another vaccine-related development.  On August 20, 2020 HHS published a notice in the federal register, extending PREP Act immunity to certain pharmacy personnel (“certain State-licensed pharmacists to order and administer, and pharmacy interns”) who administer childhood vaccines by changing the definition of “covered persons.”  This expansion of immunity encompasses all childhood vaccines – including those already covered by the Vaccine Act − not just any as-yet unreleased vaccines against COVID-19.  As to Vaccine Act compensation, this declaration states:

Nothing in this Declaration shall be construed to affect the National Vaccine Injury Compensation Program, including an injured party’s ability to obtain compensation under that program.  Covered countermeasures that are subject to the National Vaccine Injury Compensation Program . . . are covered under this Declaration for the purposes of liability immunity and injury compensation only to the extent that injury compensation is not provided under that Program.  All other terms and conditions of the Declaration apply to such covered countermeasures.

Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, at 12th page (unnumbered) (emphasis added).

Given the sweeping scope of PREP Act immunity (see our prior post), the combined effect of these two actions appears to create a bizarre disparity – if childhood vaccines are administered by less trained pharmacists and pharmacy interns, those persons are immune from all injury claims (subject only to the PREP Act’s largely undefined immunity program under 42 U.S.C. §247d-6e(a)).  But if the same vaccines are administered by other health care providers, those providers remain subject to negligence liability under the Vaccine Act for SIRVA and vasovagal syncope, as described above.  To us this disparity, disadvantaging doctors and nurses (covered only by the Vaccine Act) as compared to pharmacists (covered only by the PREP Act), makes no sense.  We question whether HHS’ right hand knows what HHS’ left hand is doing.

This latest development also raises a broader question as to which we admit we do not know the answer:  As to any eventual COVID-19 vaccine, will compensation for (almost certainly inevitable) vaccine-related injuries be governed by the Vaccine Act’s compensation system – which 85 Fed. Reg. 43,791 treats as primarily concerned with “childhood” vaccines – or will such compensation be provided under the heretofore largely undefined standards of the PREP Act’s compensation system?