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Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. §§300aa-10, et seq.  That litigation, involving DTP and certain other childhood vaccines, nearly destroyed this country’s ability to vaccinate its children against often deadly diseases – much to the delight of antivaxxers everywhere.  After Congress acted in 1986, much to the delight of everyone else, the Act’s alternative compensation system, combined with its strong preemption provisions restricting post-compensation system litigation have largely restored the nation’s childhood vaccine supply to a sound footing.  The Supreme Court did its part in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead.

Now comes DeCostanzo v. GlaxoSmithKline PLC, 2022 WL 17338047 (E.D.N.Y. Nov. 29, 2022), which (if allowed to stand) imperils everything that Congress and the Supreme Court accomplished through the Vaccine Act.  If the antivaxxers win in DeCostanzo, then society as a whole loses, because as the Supreme Court stated in Bruesewitz, “the elimination of communicable diseases through vaccination” is “one of the greatest achievements of public health in the 20th century.”  562 U.S. at 226 (footnote and quotation marks omitted).

DeCostanzo involves what is unquestionably a childhood vaccine – against pertussis (“whooping cough”), the same disease that figured in the original DTP litigation that prompted passage of the Vaccine Act in the first place.  2022 WL 17338047, at *1.  Plaintiff claims that the vaccine really doesn’t work as well as claimed:

The complaint alleges that those who receive [the vaccine] are more likely to transmit whooping cough because although the vaccine reduces symptoms it does not prevent transmission. . . .  As a result . . . plaintiff and millions of others increased their risk of unknowingly transmitting the whooping cough.

Id. (citations to complaint omitted).  Not only that, DeConstanzo is styled as a class action – meaning that everyone receiving the vaccine allegedly suffered this same injury as a result of the claimed “increased” risk of whooping cough transmission to others.

Moreover, the “injury” had to be the risk itself, because there was no economic loss.  “[P]laintiff’s counsel admitted [plaintiff] did not pay for the vaccine, as it was covered by her insurance with no co-pay.”  Id.  The damages alleged in the complaint were “physical and emotional injury” purportedly by “a defective immunity to pertussis” and “receiving a painful injection . . . that they would not have received otherwise.”  Id. at *2 (citation to complaint omitted).  The allegations in the complaint thus fell within the scope of the Vaccine Act, which governs all claims “for damages arising from a vaccine-related injury or death associated with the administration of a vaccine.”  42 U.S.C. §300aa-11(a)(2)(a).  That’s about the only thing that DeCostanzo got right.  “[P]laintiff alleges she suffered a physical injury in the form of defective immunity, among others.  Because [her] claims arise out of a vaccine-related injury, it appears her claims are subject to the [Act’s] exhaustion requirement.”  DeConstanzo, 2022 WL 17338047, at *4 (citing Laughter v. Aventis Pasteur, Inc., 291 F. Supp.2d 406, 411 (M.D.N.C. 2003), and Doe v. Merck & Co., 2019 WL 1298270, at *2 (E.D.N.Y. March 21, 2019), aff’d, 803 F. Appx. 559 (2d Cir. 2020)).

From our perspective the worst part of DeConstanzo is that the plaintiff was allowed to sue even though she never pursued her Vaccine Act claim in good faith.  Here’s what plaintiff did:

[Plaintiff] filed her claim in Vaccine Court, and the following day the Vaccine Court issued an order directing plaintiff to submit medical records and certain other documents.  The plaintiff requested four two-month extensions to submit the documents, all of which were granted.  [After that], the Chief Special Master issued an order stating plaintiff may request to withdraw her petition because the statutory 240-day time period for the special master to issue a decision had expired.  On August 29, 2021, plaintiff timely filed a notice of intent to withdraw, which was granted later that same week.

DeConstanzo, 2022 WL 17338047, at *2 (record citations omitted).

In other words, plaintiff did nothing at all – not submitting a single document or taking any other step to advance the Vaccine Act claim she had filed.  She thus never even filed a “petition” within the meaning of the Act. “A petition for compensation . . . for a vaccine-related injury or death shall contain” a whole bunch of things.  42 U.S.C. §300aa-11(c).  Such as:

  • “[A]n affidavit, and supporting documentation.”
  • Evidence that the claimant “received a vaccine set forth in the Vaccine Injury Table.”
  • Evidence of where the vaccination occurred and that the vaccine “was manufactured by a vaccine manufacturer located in the United States.”
  • Evidence that the claimant “sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table” or “sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table.”
  • Evidence that the claimant “suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine,” “died,” or “suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization.”
  • “[M]aternal 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.”
  • “[I]dentification of any records of the type [previously] described . . . which are unavailable . . . and the reasons for their unavailability.

42 U.S.C. §300aa-11(c)(1-3).  All of this material “shall” be “submit[ted] in accordance with a schedule set by the special master.”  §300aa-11(e).

The plaintiff in DeCostanzo thus never submitted anything that could pass for a “petition” under the Vaccine Act.  Instead, she gamed the system, turning the congressionally required prerequisite to any private litigation against a childhood vaccine manufacturer into a mere waiting period.  That is entirely contrary to congressional intent, which the Supreme Court discussed at length in Bruesewitz:

Successful claimants receive compensation for medical, rehabilitation, counseling, special education, and vocational training expenses; diminished earning capacity; pain and suffering; and $250,000 for vaccine-related deaths.  Attorney’s fees are provided, not only for successful cases, but even for unsuccessful claims. . . .  The quid pro quo for this, designed to stabilize the vaccine market, was the provision of significant tort-liability protections for vaccine manufacturers. The Act requires claimants to seek relief through the compensation program before filing suit.

562 U.S. at 229 (footnotes omitted) (emphasis added).

Therefore, the DeCostanzo plaintiff did not “seek relief through the compensation system” – she intentionally avoided seeking relief, obtaining successive extensions and playing out the statutory 240-day string without ever taking a single affirmative step to pursue the phony “claim” she admitted.

We discussed dismissal of Vaccine Act claims for failure to prosecute in our recent post discussing the Gardasil MDL.  Scheduling rules “do[] not relieve a party from a free, calculated, and deliberate choice” to lose.  M.D. by Dilascio v. Sec’y of HHS, 153 Fed. Cl. 544, 559-60 (Fed. Cl. 2021).  The Federal Circuit, the appellate court for Vaccine Act cases, has held that special masters have “discretion [to] dismiss[ a] petition for failure to prosecute,” Byrd v. Sec’y of HHS, 778 F. Appx. 924, 927 (Fed. Cir. 2019), invoking Vaccine Rule 21(b), allowing a special master to “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.”  Id.

The defendants raised the plaintiff’s sham Vaccine Act claim in DeConstanzo, as a failure to exhaust the compensation system as required by the Act, rightly calling it an “end run.”  2022 WL 17338047, at *4.  But the decision ignored plaintiff’s failure to take even minimal steps to prosecute her claim – because the Vaccine Act special master had done likewise.  2022 WL 17338047, at *5 (“here the Vaccine Court issued a decision granting petitioner’s request to withdraw her petition”).  The reason for the Vaccine Court allowing such withdrawals is pure desperation – as discussed in our earlier Vaccine Act post, that court is simply overwhelmed and will do anything to reduce its docket:

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 . . . has trebled, and “shoulder injury related to vaccine administration” has been added as a compensable condition.  The shoulder cases . . . now make up some 75% of current Vaccine Act claims. . . .  [T]he increased volume of claims is already overwhelming the statutorily limited number of special masters, so that multi-year delays in compensation decisions are commonplace.

(Citations omitted).

DeCostanzo asserted that “the plain language of the statute” did not condition withdrawal on any good faith effort at pursuing the claim that was being withdrawn.  Id. at *4.  That’s rich, given that the same statute’s “plain language” also specified what a “petition” must contain – precisely what the claim here did not.  Contrary to the decision, there was never anything valid in DeCostanzo to withdraw.

Just as plainly Congress did not contemplate withdrawal being used as a ploy to avoid the statutory “quid pro quo” recognized in Bruesewitz.  562 U.S. at 229.  Bruesewitz rejected a pro-litigation interpretation of the Vaccine Act because “the word ‘unavoidable’ would do no work” and the “remainder of [another] provision” would become “superfluous.”  Id. at 232, 236.  What happened in DeCostanzo is far worse.  If the do-nothing-and-withdraw dodge permitted in DeCostanzo is allowed to stand, then the Act’s entire “generous compensation scheme,” id. at 238, no longer does “any work” and becomes superfluous.

[T]he Act’s structural quid pro quo leads to the same conclusion:  The vaccine manufacturers fund from their sales an informal, efficient compensation program for vaccine injuries in exchange they avoid costly tort litigation. . . .  Taxing vaccine manufacturers’ product to fund the compensation program, while leaving [costly tort litigation] virtually unaltered, would hardly coax manufacturers back into the market.

562 U.S. at 239-40 (footnotes omitted).

And there’s more.  In the very first section of the Vaccine Act, Congress sought to prevent lawyers who would rather litigate from deliberately sabotaging their client’s potential claims under the Act.

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).  DeCostanzo is, as we mentioned previously, styled as a class action.  Have the attorneys advised the putative class members of the information required by this section of the Vaccine Act?  Since the decision does not even mention this provision of the Act, we don’t know.

While it may or may not have been realistic for Congress to rely on attorney ethics to prevent intentional impairment of Vaccine Act claims, that it did so is another reason why DeCostanzo’s supposed “plain language” recognition of Vaccine Act claimants’ unfettered ability to withdraw is − in the larger context of what the Act was intended to allow and to prevent − an absurd construction.  Attorneys are not supposed to torpedo their own clients’ claims.  At minimum the extensions that plaintiff received should have worked an estoppel of sorts – likewise extending the 240-day deadline to prevent the kind of bad-faith claim filing that DeCostanzo waved through.

The entire purpose of the Vaccine Act is for its alternative compensation system “[t]o stabilize the vaccine market and facilitate compensation” through “a no-fault compensation program designed to work faster and with greater ease than the civil tort system.”  Bruesewitz, 562 U.S. at 228 (citation and quotation marks omitted).  DeCostanzo cites Bruesewitz only once, for this proposition – but nowhere analyzes the profoundly destructive effect of unlimited creation and withdrawal of phantom claims as a gateway to the litigation-infested environment that had prompted Congress to act in the first place.

Another significant aspect of the Vaccine Act that DeCostanzo does not discuss is preemption.  Bruesewitz stands for the proposition that all design defect claims involving covered vaccines, such as the vaccine in DeCostanzo, are preempted.  “[W]e hold that the [Vaccine Act] pre-empts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects.”  562 U.S. at 243.  Given the class-action status of the claim, the injury and the purported “defect” causing the alleged inadequate “immunity” have to be uniform.  That means that plaintiffs are, as a factual matter, pursuing a design defect theory – however they might have styled their claims.

The only claim that can escape preemption under the Vaccine Act is a manufacturing defect claim, which is (under the laws of New York and everywhere else) inherently unique to a particular unit of the product.  E.g., Denny v. Ford Motor Co., 662 N.E.2d 730, 736 (N.Y. 1995) (“in strict products liability cases involving manufacturing defects, the harm arises from the product’s failure to perform in the intended manner due to some flaw in the fabrication process”); Voss v. Black & Decker Manufacturing Co., 450 N.E.2d 204, 207 (N.Y. 1983) (a manufacturing defect involves “a mistake in the manufacturing process”); McCarthy v. Olin Corp., 119 F.3d 148, 154 (2d Cir. 1997) (“a manufacturing defect . . . results when a mistake in manufacturing renders a product that is ordinarily safe dangerous”) (applying New York law).

Similarly, the alleged claims asserting consumer protection statutes, N.Y. G.B.L. §§349-50, and common-law fraud claims, 2022 WL 17338047, at *7, are all dependent on the defendant’s labeling of the vaccine (under the FDCA, labeling includes advertising), and the Vaccine Act is explicit that “a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the [FDCA].”  42 U.S.C. §300aa-22(b)(1).  Nothing in DeCostanzo suggests that the defendant’s vaccine lacked whatever warnings the FDA had approved, and the likelihood that the FDA would give these antivaxxers the time of day on any violation claim is minimal.

Also, to the extent the plaintiff in DeCostanzo alleges injury by virtue of misstatements in advertisements to the general public, 2022 WL 17338047, at *1, that claim should also be facially barred by the Vaccine Act:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine . . . , solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.

42 U.S.C. §300aa-22(c). The statute’s learned intermediary provision contains no direct-to-consumer exception.

Finally, it is by no means settled that the New York consumer protection statutes, N.Y. G.B.L. §§349-50, even permit recovery of alleged personal injury damages as plaintiff alleged.  The only statement to that effect in DeCostanzo – “proof that ‘a material deceptive act or practice caused actual, although not necessarily pecuniary, harm’ is required,” 2022 WL 17338047, at *6 (emphasis original) – is ascribed to two New York Court of Appeals cases.  Id. (citing Small v. Lorillard Tobacco Co., 720 N.E.2d 892 (N.Y. 1999), and Oswego Laborers’ Local 214 Pension Fund v. Marine Midland Bank, N.A., 647 N.E.2d 741 (N.Y. 1995)). Neither of those decisions involved personal injury damages.  Indeed, the plaintiffs in Small sought precisely the opposite.  “[T]hey chose expressly to confine the relief sought solely to monetary recoupment of the purchase price.”  720 N.E.2d at 898.  The plaintiffs in Oswego Laborers weren’t even individuals, but rather pension funds.  647 N.E.2d at 743.  They could not possibly have made a claim for any sort of personal injury.

Conversely, at least two decisions reject recovery of personal injury under these New York statutes.  Wurtzburger v. Kentucky Fried Chicken, 2017 WL 6416296, at *4 (S.D.N.Y. Dec. 13, 2017) (“Plaintiff merely alleges personal injuries, acid reflux, and nothing more.  Such allegations are insufficient and fall short of the injury sought to be addressed by the statutes.”); Goldych v. Eli Lilly & Co., 2006 WL 2038436, at *8 (N.D.N.Y. July 19, 2006) (“damages available to [plaintiff] under Sections 349 and 350 are limited” and do not include innovator liability-based suicide claim).  The only other case cited in DeCostanzo, Boateng v. Bayerische Motoren Werke Aktiengesellschaft, 2022 WL 4357555, at *27 (E.D.N.Y. Sept. 20, 2022), was decided solely on causation/reliance grounds and did not even discuss “cognizable injury,” as DeCostanzo asserted.  2022 WL 17338047, at *7.

Just as vaccination was one of the greatest public health accomplishments of the previous century, the Vaccine Act was one of Congress’ most effective limits on the destructive use of mass tort litigation.  Thus, DeCostanzo is particularly disturbing.  To allow plaintiffs to leapfrog the statute’s alternative compensation system merely by filing empty, non-adjudicable “claims” that utterly fail statutory requirements, and then sitting on their hands for 240 days, makes a mockery of what Congress sought to achieve, and resurrects pre-Act litigation threats to the nation’s vaccine supply.