Informed Consent Action Network v. Becerra

• Decision Date: 31 March 2022
• Docket Number: 1:21-CV-4134-ALC
• Citation: 595 F.Supp.3d 70
• Parties: INFORMED CONSENT ACTION NETWORK and The Institute of Autism Science, Plaintiffs, v. Xavier BECERRA, in his capacity as the Secretary of the United States Department of Health and Human Services, Defendant.
• Court: U.S. District Court — Southern District of New York

595 F.Supp.3d 70

INFORMED CONSENT ACTION NETWORK and The Institute of Autism Science, Plaintiffs,

v.Xavier BECERRA, in his capacity as the Secretary of the United States Department of Health and Human Services, Defendant.

1:21-CV-4134-ALC

United States District Court, S.D. New York.

Signed March 31, 2022

Elizabeth Ann Brehm, Jessica Wallace, Aaron Siri, Siri & Glimstad LLP, New York, NY, for Plaintiffs.

Dominika Natalia Tarczynska, United States Attorney's Office, New York, NY, for Defendant.

OPINION AND ORDER

ANDREW L. CARTER, JR., United States District Judge:

This is an action brought by two not-for-profit organizations seeking an injunction ordering the Secretary of the United States Department of Health and Human Services, Xavier Becerra, to remove a webpage with the heading "Vaccines Do Not Cause Autism" from the Centers for Disease Control and Prevention website. Before the Court is the HHS Secretary's motion to dismiss the Complaint for lack of subject matter jurisdiction under Rule 12(b)(1) and for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure. For the reasons stated herein, Defendant's motion to dismiss is GRANTED because Plaintiffs lack constitutional standing to bring this suit.

I. FACTUAL BACKGROUND ¹

A. The Parties

Plaintiff Informed Consent Action Network ("ICAN") is a not-for-profit organization with a mission of "improving vaccine safety" through activities such as "investigating and disseminating information underpinning the scientific support for the safety of childhood vaccines in order to address any gaps and strengthen the safety profile of the childhood vaccine schedule." Compl. ¶ 3, 23. Plaintiff Institute for Autism Science ("IAS") is a not-for-profit organization that supports families of children with autism

spectrum disorder ("autism") and "support[s] research to identify the causes of autism in order to better understand how to treat and prevent autism." Compl. ¶¶ 3, 23. Defendant is the Secretary (the "Secretary") of the U.S. Department of Health and Human Services ("HHS"), an Executive Branch agency. Compl. ¶ 24.

B. The National Childhood Vaccine Injury Act of 1986

Under Part 2 of the National Childhood Vaccine Injury Act of 1986 (the "Vaccine Act") ( 42 U.S.C. § 300aa-1, et seq. ), Congress established the National Vaccine Injury Compensation Program, to be administered by the Secretary, "under which compensation may be paid for a vaccine-related injury or death." 42 U.S.C. § 300aa-10(a).² Congress passed the Vaccine Act "[t]o stabilize the vaccine market and facilitate compensation" by "establish[ing] a no-fault compensation program ‘designed to work faster and with greater ease than the civil tort system.’ " Bruesewitz v. Wyeth LLC , 562 U.S. 223, 228, 131 S. Ct. 1068, 1073, 179 L. Ed. 2d 1 (2011) (quoting Shalala v. Whitecotton , 514 U.S. 268, 269, 115 S.Ct. 1477, 131 L.Ed.2d 374 (1995) ). An aggrieved party may file a petition against the Secretary with the United States Court of Federal Claims, which will determine whether the petitioner is entitled to compensation for a vaccine-related injury or death and may seek review of an unfavorable final decision before the United States Court of Appeals for the Federal Circuit. 42 U.S.C. § 300aa-11(a), § 300aa-12(a), § 300aa-12(e) - (f). After judgment is entered by the Court of Federal Claims or the Court of Appeals, "a claimant has two options: to accept the court's judgment and forgo a traditional tort suit for damages, or to reject the judgment and seek tort relief from the vaccine manufacturer." Bruesewitz , 562 U.S. at 228, 131 S.Ct. at 1073, 179 L.Ed.2d 1 (2011) (citing 42 U.S.C. § 300aa-21(a) ).

Pursuant to Subpart C of Part 2 of the Vaccine Act entitled "Assuring a Safer Childhood Vaccination Program in United States," Section 300aa-27 states that the Secretary shall, among other things,

(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on December 22, 1987, and promote the refinement of such vaccines, and

(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.

42 U.S.C. § 300aa-27(a).

Subpart D of Part 2 of the Vaccine Act contains a citizen suit provision, which authorizes "any person [to] commence in a district court of the United States a civil action on such person's own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under [Part 2]" so long as the action is commenced within 60 days after the person "has given written notice of intent to commence such action to the Secretary." 42 U.S.C. § 300aa-31(a) - (b).

C. The "Vaccines Do Not Cause Autism" Statement on the Centers for Disease Control and Prevention Website (the "CDC Statement")

The heading "Vaccines Do Not Cause Autism

" (the "CDC Statement") appears as the main heading on the Centers for Disease Control and Prevention ("CDC") website section on "Vaccine Safety" and subsection on "Common Concerns." Compl. ¶ 5.³

?

See Compl. ¶ 5. For the past four decades, federal health authorities have taken the position that "studies establish that vaccines do not cause autism

." Compl. ¶ 4. The Center for Disease Control and Prevention (CDC) asserts this claim—"Vaccines Do Not Cause Autism"—on its website. Compl. ¶ 5. Plaintiffs allege that there are peer-reviewed articles that seem to contest this claim, which indicate that "a majority of parents of children with autism have reported and continue to report one or more vaccines, including DTaP, Hepatitis B, Hib, PCV13, and IPV, as a cause of their child's autism." Compl. ¶ 6.

On October 12, 2017, ICAN sent a demand to the then-serving Secretary of HHS contending that there were no published studies demonstrating that certain vaccines, including for Hepatitis A

and B, Varicella, flu, and other illnesses, do not cause autism. The demand requested that the Secretary "confirm that HHS shall forthwith remove the claim that ‘Vaccines Do Not Cause Autism ’ from the CDC website, or alternatively, please identify the specific studies on which HHS bases its blanket claim that no vaccines cause autism

." Compl. ¶¶ 11, 65. Plaintiffs allege that, even after numerous follow-ups, the Secretary had not identified any studies in support of the CDC Statement.

On June 21, 2019, Plaintiffs made Freedom of Information Act (FOIA) requests for the CDC to provide studies it relied upon for its claim about the vaccine-autism connection with respect to babies. Ultimately, by stipulation entered on March 2, 2020, the CDC identified "a total of 16 studies and 4 reviews," but Plaintiffs allege that "[n]ot one of these studies or reviews supports the claim that vaccines injected into babies – DtaP, Hep B, Hib, PCV13, and IPV – do not cause autism

." Compl. ¶ 14. At least one of the studies provided, prepared by the Institute of Medicine (IOM), found an "association" between DTaP and autism. Compl. ¶ 15. On two more occasions—on or about March 10 and March 27, 2020—Plaintiffs submitted additional FOIA requests for the same information. Both times the CDC responded by pointing them to the previously submitted list of twenty studies. Compl. ¶ 16.

On August 27, 2020, Plaintiffs state that the CDC "finally removed" the "Vaccines Do Not Cause Autism

" claim from its website and, after ICAN "widely publicized" the removal of the statement, the CDC restored the statement to its website. Compl. ¶¶ 18, 84-85. Plaintiffs express concern that the CDC Statement has negative implications for children with autism and children expected to be diagnosed with autism because the causal link between vaccines and autism "should be determined through scientific inquiry." Compl. ¶ 19. They aver that until the CDC removes the statement, "the necessary scientific inquiries will never receive the funding or the attention they deserve." Compl. ¶ 19. Plaintiffs further claim that the refusal of the Secretary to conduct research while asserting on the CDC website that there is no causal link between vaccines and autism for babies is a violation of his statutory duties. Compl. ¶ 20.

The Complaint alleges that the CDC Statement harms Plaintiffs and its members. Compl. ¶¶ 88-107. Plaintiffs request declaratory relief, stating that the HHS Secretary has violated his statutory duties under 42 U.S.C. § 300aa-26 and 42 U.S.C. § 300aa-27 by posting "Vaccines Do Not Cause Autism

" on the CDC website without scientific literature in support of that claim with respect to babies. They also seek an order that the Secretary, and the agencies within his control such as the CDC and the National Institutes of Health (NIH), remove the vaccine-autism claim from their websites until the Secretary can demonstrate to the Court that "the Secretary possesses scientific studies that specifically support that the vaccines given to babies (i.e. , under one year of age) do not cause autism. Compl. ¶ 21.

II. PROCEDURAL HISTORY

Plaintiffs commenced this action on May 7, 2021. ECF No. 1. Defendant filed a motion to dismiss for lack of subject matter jurisdiction under Federal Rule of Civil Procedure 12(b)(1) and for failure to state a claim under 12(b)(6) on August 19, 2021. ECF No. 13. Plaintiffs responded in a joint opposition brief on September 20, 2021. ECF No. 17. On October 12, 2021, Defendant filed a reply. ECF No. 21. The Court deems this motion fully briefed. No oral argument is needed.

III. STANDARD OF REVIEW

A. Rule 12(b)(1)

In reviewing a motion to dismiss under Rule 12(b)(1), a court "must take all facts alleged in the complaint as true and draw all reasonable inferences in...