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.

We were especially interested in making sense of In re Gardasil Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 3138681 (J.P.M.L. Aug. 4, 2022), where the MDL panel recently created an unprecedented multi-district litigation involving a Vaccine Act covered vaccine. After listening to, and thinking about, the Vaccine Act presentations, we can’t be sure, but we don’t think that Vaccine Act claims fit very well into the usual P-side MDL business model. That model, which we’ve seen operate repeatedly, employs outside litigation funding to conduct widespread client solicitation, from which to try to file as many cases as possible, and then do as little work as possible, while the sheer number of claims generates what plaintiffs hope will be irresistible settlement pressure.

Under the Vaccine Act, however, as the MDL panel recognized, all claimants must first “exhaust[] the claim process in the Court of Federal Claims.” 2022 WL 3138681, at *1 n.4. That much we knew before Bexis attended the program. All of the 40 some odd plaintiffs mentioned in the In re Gardasil decision “claim to have exhausted the Vaccine Act claim process.” Id. However, forty people alleging “postural orthostatic tachycardia syndrome” (“POTS”), id. at *1 – characterized by dizziness and occasional fainting when standing up – doesn’t generate much settlement pressure. While those symptoms are doubtless uncomfortable, they’re hardly cancer, implant failure, or some similar life-threatening malady. Plaintiffs have to seek reinforcements.

In that regard, the defendant in Gardasil argued, to no avail, that the usual MDL-related plaintiff-side solicitation “would attract a flood of meritless claims brought solely for the purpose of exhausting the claim process under the Vaccine Act,” which “would overwhelm the already overburdened claim process and would result in an improper evasion of the intended purposes of that process.” Id. at *2. While the MDL panel pooh-poohed these concerns, id., what we learned at the conference indicates that they are serious and real.

The problem lies in the structure of the Vaccine Act. The Act, passed in 1986, provides for “not more than 8 special masters.” 42 U.S.C.A. §300aa-12(c)(1). However, since the compensation program has been operating, the number of covered vaccines (any vaccine that the CDC and its Advisory Committee on Immunization Practices recommend for routine childhood use) has trebled, and “shoulder injury related to vaccine administration” has been added as a compensable condition. See these two blogposts. The shoulder cases (most of which are brought by adults) now make up some 75% of current Vaccine Act claims, according to statistics discussed at the Vaccine Law Conference. Several presenters at the conference – representing both claimants and government defense lawyers – stated that the increased volume of claims is already overwhelming the statutorily limited number of special masters, so that multi-year delays in compensation decisions are commonplace.

Given the current overload of cases, the potential addition of hundreds of new Gardasil claims generated by MDL-style lawyer solicitation would almost certainly crash the entire program for all claimants. POTS claims are not table injuries, thus each claimant must actually prove causation. Few do. Running “postural orthostatic tachycardia syndrome” in the federal claims database in Westlaw produced 137 hits. We looked at the first twenty cases, sorted by “relevance.” Not one received compensation. But the Judicial Panel gave the programmatic argument short shrift, too. 2022 WL 3138681, at *2 (“concerns about the efficient functioning of the Vaccine Court and vaccine hesitancy are properly raised elsewhere”). So much for the supposed “just and efficient conduct” of litigation. 28 U.S.C. §1407(a).

What happens, then?

Under the Vaccine Act, all would-be MDL plaintiffs have to file with the federal claims court. 42 U.S.C. §300aa-11(a)(2)(A). The statute of limitations is three years “after the date of the occurrence of the first symptom.” 42 U.S.C. 300aa-16(a)(2). Since this limitation period runs not from accrual of any claim, but rather when symptoms occur, the Vaccine Act is not subject to any discovery rule:

Congress conveyed its refusal to adopt a discovery rule by implication from the text and structure of the Vaccine Act. The statute of limitations begins to run on a specific statutory date: the date of occurrence of the first symptom or manifestation of onset of the vaccine-related injury recognized as such by the medical profession at large.

Cloer v. Sec’y of HHS, 654 F.3d 1322, 1340 (Fed. Cir. 2011) (en banc). Since MDL-style client solicitation inevitably dredges up many stale claims, the Vaccine Act’s comparatively strict statute of limitations will certainly come into play in Gardasil. E.g., L.A.R. v. Sec’y of HHS, 2019 WL 2285475, at *3 (Fed. Cl. April 12, 2019) (dismissing POTS claim as time barred).

After a claim is filed, the Vaccine Act is intended to function as a congressionally mandated Lone Pine order, requiring all claimants to provide “an affidavit, and supporting documentation” establishing when they received the relevant vaccine, what symptoms they’re claiming, and when those symptoms began. 42 U.S.C. §300aa-11(c)(1). Then each claimant has to produce a slew of documents. First:

(2) except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records (including all physicians’ and nurses’ notes and test results), vaccination records associated with the vaccine allegedly causing the injury, pre- and post-injury physician or clinic records (including all relevant growth charts and test results), all post-injury inpatient and outpatient records (including all provider notes, test results, and medication records), if applicable, a death certificate, and if applicable, autopsy results, and

(3) an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the petitioner and the reasons for their unavailability.

§300aa-11(c)(2). Second:

The petitioner shall submit in accordance with a schedule set by the special master . . . assessments, evaluations, and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be paid.

§300aa-11(e). Of course, the special masters handling Vaccine Act actually have to enforce these obligations, rather than just wave incomplete filings through, for this aspect of the statute to operate as Congress intended.

If enforced, instead of just trying to rid the Vaccine Court of phony claimants as fast as possible, these statutory requirements should adversely affect the MDL business model of filing many cases, letting them all sit, and opposing any form of Lone Pine order (until after a settlement). The MDL model of both plaintiffs and their counsel doing as close to nothing as they can get away after filing with will be hard to apply in Gardasil. Can would-be MDL plaintiffs take a dive and lose their own cases? Maybe. But such deliberate noncompliance may well amount to “abandonment” of their claims and thus a passive failure to comply with the Vaccine Act’s exhaustion requirements.

There may not be much law, but the applicable rules “do[] not relieve a party from a free, calculated, and deliberate choice” to lose. M.D. by Dilascio v. Sec’y of HHS, 2021 WL 1625084 (Fed. Cl. April 9, 2021). So plaintiffs attempting to tank their own Vaccine Act petitions may well end up losing any chances at recoveries under either the Vaccine Act or the common law.

[T]he chief special master did not abuse her discretion in dismissing [claimant’s] petition for failure to prosecute. Vaccine Rule 21(b) provides that a special master “may dismiss a petition or any claim therein for failure of the petitioner to prosecute or comply with these rules or any order of the special master.”

Byrd v. Sec’y of HHS, 778 F. Appx. 924, 927 (Fed. Cir. 2019) (citations omitted). We would not be surprised if the defendant in the MDL challenged MDL-style do-nothing behavior with Vaccine Act claims as an exhaustion failure, vitiating such claimants’ ability to pursue subsequent tort litigation. Every issue gets litigated to the nth degree in MDLs, so we expect the issue of whether a no-nothing claimant has actually “exhausted” the Vaccine Act’s remedies to be an issue in the Gardasil MDL. We think a claimant’s lack of good-faith effort to pursue his or her own claim as the statute requires should be non-exhaustion that bars any civil suit.

The Vaccine Act’s informational requirements mean that Gardasil plaintiffs, unlike other MDL plaintiffs, may well to have to do some real work on their cases early in the proceedings. If not, a lot of cases will end up being tossed by the Vaccine Act special masters before they ever get to point where they could be withdrawn due to the delay that their sheer numbers would create.

And there’s more. The Vaccine Act foresaw that some lawyers might want to tank their statutory claims to pursue possibly more remunerative litigation elsewhere.

The MDL lay-low-till-settlement business model involves little if any post-solicitation contact between the attorneys representing the plaintiffs and their ostensible clients. That’s not how the Vaccine Act works. In the Act’s very first provision, Congress provided:

It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that compensation may be available under the program for such injury or death.

42 U.S.C. §300aa-10(b). Thus, unlike the usual MDL plaintiffs, these claimants must be informed that the program potentially provides its own payout, under better terms than civil litigation.

Assuming that MDL counsel convince their clients to roll the dice, how long before their mass client solicitation provides reinforcements? The Vaccine Act provides that a claimant may withdraw the petition after 240 days, if the special master has not yet issued a decision on the claim. 42 U.S.C. §300aa-12(d)(3)(A)(ii). That would allow the former Vaccine Act claimant to join the MDL, since the claimant can then make that election. 42 U.S.C. §300aa-21(a). But things have to happen to run that period. Most importantly, if Gardasil claimants drag their feet and fail to comply with the usual orders by which such claims are adjudicated, the special masters may “suspend” their claims for up to an another 150 days. 42 U.S.C. §300aa-12(d)(3)(C). So if Gardasil claimants are as recalcitrant as the defendant in the MDL proceeding argued they might be, then they can be kept in a Vaccine Act proceeding for well over a year – before any decision need be made on their failure to prosecute their actions. The Byrd petition, for instance, was pending for more than 500 days before being dismissed.

Thus, the Gardasil MDL might have unintended consequences. (1) If MDL solicitation succeeds in generating enough POTS claim – all of which are non-table injuries – it might crash the system and finally force Congress to increase the number of Vaccine Act special masters. (2) If such solicitation generates numerous claims barred by the Vaccine Act’s statute of limitations, then those claims shouldn’t be viable in the MDL, because the statute’s tolling effect on state statutes of limitations in other litigation is dependent on the filing of a timely Vaccine Act claim. Blackmon v. American Home Products Corp., 328 F. Supp. 2d 647, 653 (S.D. Tex. 2004). (3) If plaintiffs attempt to tank their own claims by not making the statute’s required filings, that abandonment of their Vaccine Act claims may not count as the statutory exhaustion of remedies required before they can bring an MDL claim. (4) By the time that any significant number of new, solicited claims reach the MDL, the MDL court may have already sorted out the Vaccine Act’s extensive preemption of any remaining state-law claims.

We’ll see what happens.