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Doe v. Merck & Co., Inc.

UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

SUMMARY ORDER

RULINGS BY SUMMARY ORDER DO NOT HAVE PRECEDENTIAL EFFECT. CITATION TO A SUMMARY ORDER FILED ON OR AFTER JANUARY 1, 2007, IS PERMITTED AND IS GOVERNED

BY FEDERAL RULE OF APPELLATE PROCEDURE 32.1 AND THIS COURT ’ S LOCAL RULE 32.1.1. WHEN CITING A SUMMARY ORDER IN A DOCUMENT FILED WITH THIS COURT, A PARTY MUST CITE EITHER THE FEDERAL APPENDIX OR AN ELECTRONIC DATABASE (WITH THE

NOTATION “SUMMARY O RDER”). A PARTY CITING A SUMMARY ORDER MUST SERVE A COPY

OF IT ON ANY PARTY NOT REPRESENTED BY COUNSEL.

At a stated Term of the United States Court of Appeals for the Second Circuit, held at the Thurgood Marshall United States Courthouse, 40 Foley Squ are, in the City of New York on the

8 th day of May, two thousand twenty

.

Present: JOHN M. WALKER

, JR., ROSEMARY S. POOLER,

GERARD E. LYNCH

, Circuit Judges

.

_____________________________________________________

JANE DOE, individually and as P arent/Guardian of Baby Doe

, BABY DOE, Plaintiff s

- Appell ant s ,

v. 1 9

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MERCK & CO., INC., H EALTH AND HUMAN SERV ICES, ALEX AZAR, i n his official capacity as Secretary of Health and Human Services

, STEPHEN HAHN , M.D. in his official capacity as Acting Commissioner of Food and Drug s ( a division of HHS), UNITED STATES

OF AMERICA

,

Defendant s

-

Appell ees

. 1

_____________________________________________________

Appearing for Appellant s : Patricia Finn

, Nanuet , N.Y.

Appearing for Appellee s : Dino S. Sangiamo ( Adam Possidente, Matthew T. McLaughlin

, Mitchell Y. Mirviss, Davis S. Gray, on the brief ), Venable LLP

, New York, N.Y.

1 The Clerk of Court is directed to amend the caption as above.2 Layaliza Soloveichik

, Assistant United States Attorney ( Varuni

Nelson , Assistant United States Attorney, on the brief ), for Richard P. Donoghue, United States Attorney for the East ern District of

New York , Brooklyn, N.Y.

Appeal from the United States District Court for the Eastern District of New York ( Block

, J

. )

.

ON CONSIDERATION WHEREOF, IT IS HEREBY ORDERED, ADJUDGED,

AND DECREED that the order of said District Court be and it hereby is AFFIRMED

.

Appellant s Jane Doe and Baby Doe (“ Plaintiffs ”) appeal from the March 21, 2019

decision and order of the United States District Court for the Eastern District of New York ( Block

, J .) dismissing their complaint for failure to state a claim upon which relief can be granted

. We assume the parties’ familiarity with the underlying facts, procedural history, and specification of issues for review.

Plaintiffs are a mother and son who allege that the son, Baby Doe, developed autism as a

result of thimerosal

- containing vaccines (“TCVs”), the measles mumps rubella (“MMR”) vaccine, or a combination of the two that he received as an infant. Plaintiffs brought suit against

Merck as the manuf actur er of the MMR vaccine that Baby Doe received in 1999 , as well as the Department of Health and Human Services, the Secretary of Health and Human Services (“Secretary”), the Acting Commissioner of the Food and Drug Administration (“FDA”) , and the

United States (collectively, “ the federal Defendants”).

Plaintiffs’ complaint allege s three c ounts. Count One claim s that all defendants violated

the National Childhood Vaccine Act of 1986 (“Vaccine Act”) , 42 U.S.C. § 300aa

- 1

, et seq

. Count Two allege s that Merck committed fraud and conspired to commit fraud. Count Three seeks declaratory and injunctive relief, primarily in the form of an order directing the Secretary

to instruct the FDA to revoke Merck’s license to manufacture the MMR vaccine

.

We af firm the district court’s decision to dismiss Count One claims against both Merck

and the federal D efendants

. 2 Regarding Merck, Plaintiffs allege that all of their Count One claims arise under the Vaccine Act, but that Act does not establish a private righ t of action against manufacturers, such as Merck. The Vaccine Act sets forth administrative procedures that must be exhausted in order for a petitioner to bring a state law tort claim against a private entity and precludes actions against manufacturers by petitioners who have not administratively

exhausted. See 42 U.S.C. §§ 300aa

- 22(a), 300aa

- 11(a)(2). But neither these provisions nor any other in the Vaccine Act enable petitioners to sue private entities for alleged violations of the

Act. A s we held in Olm sted v. Pruco Life Ins urance Co. of N ew Jersey , 283 F.3d 429, 432 (2d Cir. 2002), where “[n]o provision of [a statute] explicitly provides for a private right of action for violations of [specific provisions of that statute], . . . we must presume that Con gress did not intend one.” That presumption is reinforced here because the provisions in question focus on the “person regulated rather than the individuals protected.” Id. at 432

- 33 (internal quotation marks

2 Although the district court relied on different grounds in dismissing Count One, we are free to affirm on any ground that has support in the record. See Wright v. Giuliani , 230 F.3d 543, 547 (2d Cir. 2000).3 and citation omitted). Moreover, Congress creat ed a citizen

- suit provision to allow claims against the Secretary for failure to perform an act or duty under the Act, 42 U.S.C. § 300aa

- 31, and “Congress’s explicit provision of a private right of action to enforce one section of a statute suggests that o mission of an explicit private right to enforce other sections was intentional.”

Olmsted , 283 F.3d at 433. The district court was therefore correct in dismissing Plaintiffs’ claims against Merck under Count 1.

Although Plaintiffs may sue the Secretary

— an d only the Secretary

— pursuant to 42 U.S.C. § 300aa

- 31, Plaintiffs’ complaint contains no factual allegations articulating which duties were violated or how they were violated. 3 Plaintiffs’ claims against the Secretary for violations

of the Vaccine Act were thus properly dismissed. See Ashcroft v. Iqbal , 556 U.S. 662, 678 (2009) (“ To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. ” (internal quotation marks and citation

omitted ) ).

We likewise affirm the district court’s dismissal of Count Two. “Under New York law, to state a cause of action for fraud, a plaintiff must allege a representation of material fact, the falsity of the representati on, knowledge by the party making the representation that it was false when made, justifiable reliance by the plaintiff and resulting injury.” Lerner v. Fleet Bank, N.A.

, 459 F.3d 273, 291 (2d Cir. 2006) (internal quotation marks and citations omitted). He re, however, there was no reliance. The relevant vaccines were given to Baby Doe in 1999

, yet the earliest allegedly fraudulent act took place in June 2000. Accordingly, Plaintiffs cannot establish that they relied on the purportedly fraudulent conduct. Se e id. (explaining that plaintiff could not demonstrate reliance on a statement in making an investment because the investment predated the statement). And because Plaintiffs’ fraud claim fails, so does their conspiracy

- to

- commit

fraud claim. See Crigger v. Fahnestock & Co., Inc. , 443 F.3d 230, 237 (2d Cir. 2006) (“Under New York law, civil conspiracy to commit fraud, standing alone, is not actionable if the underlying independent tort has not been adequately pleaded.” (internal quotation marks

, ellipses, an d citation omitted) )

.

Finally, we affirm the district court’s dismissal of Count Three. With respect to Plaintiffs’ challenge to the FDA’s licensing of Merck to manufacture the MMR vaccine, the district court’s

invocation of the doctrine of primary juris diction was not erroneous. Reliance on the doctrine of primary jurisdiction is “ appropriate whenever enforcement of the claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an

administr ative body.” Ellis v. Tribu n e Television Co. , 443 F.3d 71, 81 (2d Cir. 2006) (internal quotation marks and citation omitted). Here, the relevant considerations counsel for the conclusion that on this matter the FDA has primary jurisdiction

. T he question of the efficacy and safety of Merck’s vaccines “ involves technical or policy considerations within the agency's particular field of expertise .” See i d. at 82

- 83. In addition , this type of licensing is within the agency’s discretion under 42 U.S.C. § 262. See Ellis , 443 F.3d at 8 3 . Moreover, uniformity would be more appropriately reached through application to one administrative agency rather

3 Although Plaintiffs allege some facts in their briefing on appeal, Plaintiffs failed to allege any

of these facts in their complaint despite having filed three different complaints in this action.

Plaintiffs “should not be able effectiv ely to amend a complaint through any document short of an amended pleading.” Grayson v. Mayview State Hosp. , 293 F.3d 103, 109 n.9 (3d Cir. 2002).4 than the various courts. See i d. a t 82. And lastly, although the FDA provides for “citizen petitions,” 21 C.F.R. § 10.30 , there is no indication that Plaintiffs have filed on e here. For these reasons, we agree with the district court that challenges to Merck’s license should be directed in

the first instance to the FDA.

With respect to Plaintiffs’ challenge to New York’s MMR

- vaccine requirements, it is not apparent to us how any of the federal Defendants could be liable for New York’s decision to require the MMR vaccine, and the State of New York is not a defendant in this suit. Indeed, Plaintiffs style this as a Fourteenth Amendment challenge, but the Fourteenth Amendment “applies to the states but not to the federal government.” See Noel v. Chapman , 508 F.2d 1023, 1026 n.2 (2d Cir. 1975)

. Therefore, the district court correctly dismissed Count Three as well.

We have considered the remainder of Plaintiffs’ arguments and find them to be without merit. Accordingly, the order of the district court hereby is AFFIRMED.

FOR THE COURT: Catherine O’Hagan Wolfe, Clerk