Cole ex rel. Her Eleven-Year-Old Daughter A.C. v. Zucker

LINA COLE, on behalf of herself and her eleven-year-old daughter A.C.;MELISSA GOLPL, on behalf of herself and her fifteen-year-old son P.K.;DENISE RANDELLO, on behalf of herself and her thirteen-year-old daughter A.R.;LISA BOYLE MEYER, on behalf of herselfand her sixteen-year-old daughter K.M.;and TOBY DOELL-CARBONE, on behalf of herselfand her eleven-year-old twins M.C. and J.C., Plaintiffs, v. HOWARD ZUCKER, in his official capacityas the Commissioner of the New York State Department of Health, Defendant.

1:17-CV-251 (FJS/CFH)

UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF NEW YORK

February 28, 2019

APPEARANCES

SIRI & GLIMSTAD LLP

200 Park Avenue, 17th Floor

New York, New York 10166

Attorneys for Plaintiffs

OFFICE OF THE NEW YORK

STATE ATTORNEY GENERAL

The Capitol

Albany, New York 12224

Attorneys for Defendant

OF COUNSEL

AARON SIRI, ESQ.

HELENA O. PEDERSON, AAG

SCULLIN, Senior Judge

MEMORANDUM-DECISION AND ORDER

I. INTRODUCTION

In their complaint, Plaintiffs, all of whom are parents of children between the ages of eleven and sixteen, allege that they commenced this action against Defendant in his official capacity "to challenge the validity of the No Consent or Knowledge Rule[, 10 N.Y.C.R.R. § 23.4,] to the extent it permits health care practitioners in New York State to inject Gardasil or Gardasil-9 manufactured by Merck & Co., Inc., into children without parental consent or knowledge." See Dkt. No. 1, Complaint, at ¶¶ 4, 8.¹ Plaintiffs assert two bases for their action: (1) "the No Consent or Knowledge Rule is invalid because 42 U.S.C. § 300aa-26, part of the National Childhood Vaccine Injury Act, requires that before a child is injected with any vaccine, such as Gardasil or Gardasil-9, the parent or legal guardian of such child must be provided the Vaccine Information Statement created by the Center for Disease Control for the specific vaccine"; and (2) "enforcement of the No Consent Or Knowledge Rule is unconstitutional because it violates the Fourteenth Amendment of the United States Constitution, and enforcement is unlawful for that separate and distinct reason." See id. at ¶¶ 5-6. Thus, Plaintiffs "seek[] a declaration of the invalidity of the No Consent Or Knowledge Rule and a permanent injunction enjoining enforcement of this rule." See id. at ¶ 7.

In their complaint, Plaintiffs assert three causes of action pursuant to 42 U.S.C. § 1983: (1) "deprivation of rights and privileges secured by federal law"; (2) "deprivation of rights and privileges secured by the Constitution [-] Procedural Due Process"; and (3) "deprivation of rights and privileges secured by the Constitution [-] Substantive Due Process." See generally Complaint.

Defendant has moved to dismiss Plaintiffs' complaint pursuant to Rule 12(b)(1) and Rule 12(b)(6) of the Federal Rules of Civil Procedure. See Dkt. No. 8. Plaintiffs oppose this motion. See Dkt. No. 9.

II. BACKGROUND

In May 2016, the New York Department of Health, through Defendant, its Commissioner, promulgated a new regulation that allows health care practitioners to administer HPV vaccines, such as Gardasil or Gardasil-9, to minor children without their parents' consent or knowledge. See Complaint at ¶ 2. That regulation, codified in 10 NYCRR § 23.4, provides as follows:

When a health care provider diagnoses, treats or prescribes for a minor, without the consent or knowledge of a parent or guardian as permitted by section 2305 of the Public Health Law, neither medical nor billing records shall be released or in any manner be made available to the parent or guardian of such minor without the minor patient's permission. In addition to being authorized in accordance with section 2305 of the Public Health Law to diagnose, treat or prescribe for a person under the age of eighteen years without the consent or knowledge of the parent or guardian of such person where the individual is infected with a sexually transmitted disease, or has been exposed to infection with a sexually transmitted disease, health care practitioners may (as authorized by their scope of practice) render medical care related to other sexually transmitted diseases without the consent or knowledge of the parent or guardian.

10 N.Y.C.R.R. § 23.4.

Under § 2305 of New York Public Health Law, "[a] licensed physician . . . may diagnose, treat or prescribe for a person under the age of twenty-one years without the consent or knowledge of the parents or guardian of said person, where such person is infected with a sexually transmitted disease, or has been exposed to infection with a sexually transmitted disease." N.Y. Pub. Health Law § 2305(2). Section 23.4 broadens the scope of § 2305 by permitting health care practitioners to "render medical care related to other sexually transmitted diseases [("STD"s)]" to minors even if they have not been infected with or exposed to an STD infection. Therefore, pursuant to § 23.4, health care practitioners may provide medical treatment related to STD prevention, such as administering a vaccine to protect against an STD such as the Human Papilloma Virus ("HPV"), tominors without the consent or knowledge of their parents.

The Department of Health enacted § 23.4, in part, to guard against HPV, a commonly transmitted STD. Currently, the only available vaccination against HPV is Gardasil or Gardasil-9 (collectively "the HPV vaccine"), which protects against certain strains of the virus, including those that have been linked to cancer. See Complaint at ¶¶ 1-2, 17-18. The HPV vaccine may not protect against the virus if a patient has already been sexually active and, therefore, potentially exposed to the virus. See id. at ¶ 21. Thus, the manufacturers of the HPV vaccine recommend that health care practitioners administer it before a patient is sexually active, i.e., to patients between the ages of 11 and 12 years old, although children as young as 9 years old and older patients who have not yet contracted the virus may also receive the vaccine. See id.

The HPV vaccine is a covered vaccine within the meaning of the National Childhood Vaccine Injury Act ("NCVIA"), and therefore health care practitioners must provide a child's legal representative with certain written materials prior to injecting the child with that vaccine. See 42 U.S.C. § 300aa-26. Specifically, under § 300aa-26(d) of the NCVIA, entitled, "Health care provider duties,"

each health care provider who administers a vaccine set forth in the Vaccine Injury Table [("VIT")] shall provide to the legal representative of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a), supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine.

42 U.S.C. § 300aa-26(d).

Pursuant to subsection (a) of § 300aa-26, the Secretary of Health and Human Services ("HHS") "shall develop and disseminate vaccine information materials for distribution by health careproviders to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table." 42 U.S.C. § 300aa-26(a). To that end, the Secretary of HHS has developed a "Vaccine Information Statement" ("VIS") for each VIT-covered vaccine, including the HPV vaccine. See Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) Vaccine, 81 Fed. Reg. 232299-01 (Apr. 20, 2016); see https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv.html (last visited January 25, 2019). Thus, pursuant to § 300aa-26, health care practitioners must provide parents with an "HPV vaccine VIS" prior to administering the HPV vaccine to their children.

Plaintiffs allege that § 23.4 interferes with their constitutional right under the Fourteenth Amendment to participate in and make medical decisions on behalf of their children because, they claim, the statute prevents health care practitioners from informing parents of their children's decision to receive the HPV vaccine unless their children consent. See Plaintiffs' Memorandum of Law at 15; 10 N.Y.C.R.R. § 23.4. Plaintiffs also assert that § 23.4 prohibits health care practitioners from releasing pertinent medical information, such as the HPV vaccine VIS, to parents without the minor patient's permission, which also deprives them of their constitutional rights.

In addition, Plaintiffs contend that § 23.4 directly conflicts with federal law, in particular the VIS Rule under the NCVIA, which requires health care practitioners to provide parents with an NCVIA-covered vaccine's VIS, including the HPV vaccine, prior to inoculating their children and, by doing so, "deprives parents . . . of vital knowledge about the vaccine that [the VIS Rule] requires the parent to receive" before health care practitioners administer the vaccine, such as (1) the adverse side effects of the vaccine and (2) if their child has previously received the vaccine. See Plaintiffs' Memorandum of Law at 22, 24.

III. DISCUSSION

A. Standard of review

At the commencement of a case, federal courts are "'duty bound' . . . to address the issue of subject matter jurisdiction . . . .'" Brickey v. Superintendent, Franklin Corr. Facility, Civ. No. 9:10-CV-085, 2011 WL 868148, *3 (N.D.N.Y. Feb. 17, 2011) (quoting Filetech S.A. v. France Telecom S.A., 157 F.3d 922, 929 (2d Cir. 1988)). "A case is properly dismissed for lack of subject matter jurisdiction under Rule 12(b)(1) when the district court lacks the statutory or constitutional power to adjudicate it." Makarova v. United States, 201 F.3d 110, 113 (2d Cir. 2000) (citing Fed. R. Civ. P. 12(b)(1)).

In assessing a motion to dismiss under Rule 12(b)(1), courts must "accept as true all material factual allegations in the complaint" but should not draw "argumentative inferences favorable to the party asserting jurisdiction . . . ." Atl. Mut. Ins. Co. v. Balfour MacLaine Int'l Ltd., 968 F.2d 196, 198 ...