Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca6-18-04001/USCOURTS-ca6-18-04001-0/pdf.json

Parties Involved:
Merck & Company, Inc.
Appellee
Merck, Sharp & Dohme Corporation
Appellee
Shannon Powers
Appellant
William Powers
Appellant

Document Text:

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION

File Name: 19a0366n.06

No. 18-4001

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

SHANNON POWERS, Parent and Natural 

Guardian of L.P., a Minor, et al.,

Plaintiffs-Appellants,

v.

MERCK & COMPANY, INC., et al.,

Defendants-Appellees.

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ON APPEAL FROM THE UNITED 

STATES DISTRICT COURT FOR 

THE SOUTHERN DISTRICT OF 

OHIO

OPINION

Before: SILER, COOK, and NALBANDIAN, Circuit Judges.

PER CURIAM. Shannon Powers and William Powers, as parents and guardians of their 

minor daughter L.P., appeal the district court’s order dismissing their complaint. The parties have 

waived oral argument, and this panel unanimously agrees that oral argument is not needed. See 

Fed. R. App. P. 34(a).

In their complaint against Merck & Company, Inc., and Merck, Sharp & Dohme 

Corporation (collectively, Merck), the Powerses alleged that L.P. began experiencing adverse 

symptoms after receiving Gardasil—an HPV (human papillomavirus) vaccine manufactured by 

Merck—which they claimed came from a lot contaminated with viral HPV DNA. Merck asked 

the district court to dismiss the complaint, arguing that the Powerses failed to state a claim because 

they had not exhausted their administrative remedies as required by the National Childhood 

Vaccine Injury Compensation Act (Vaccine Act), and their complaint did not show that they were 

exempt from that requirement. The district court granted that motion and dismissed the complaint.

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We review de novo whether a complaint fails to state a claim. In re NM Holdings Co., 622 

F.3d 613, 618 (6th Cir. 2010). To survive dismissal, a complaint must “contain sufficient factual 

matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 

556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). 

A complaint must therefore allege facts that make it reasonable to infer that the defendant is liable 

for the claimed misconduct, as opposed to making unsupported legal conclusions or offering 

speculation in support of a claim. See id. at 679. 

The Vaccine Act requires an individual seeking to recover for a “vaccine-related injury or 

death”—which is defined, in part, as “an illness, injury, condition, or death associated with one or 

more of the vaccines set forth in the Vaccine Injury Table”—to exhaust his administrative remedies 

via a petition filed with the U.S. Court of Federal Claims before turning to a state or federal court. 

42 U.S.C. §§ 300aa-11(a), 300aa-33(5). But if the injury is associated with “an adulterant or 

contaminant intentionally added to such a vaccine,” it is not a vaccine-related injury and, as a 

result, the Vaccine Act’s exhaustion requirement does not apply. 42 U.S.C. § 300aa-33(5). Here, 

it is not disputed that the Powerses did not exhaust their administrative remedies,1nor is it disputed 

that they needed to allege that L.P. did not suffer from a vaccine-related injury, which would 

exempt them from the administrative process. 

A vaccine-related injury is “an illness, injury, condition, or death associated with one or 

more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include 

an illness, injury, condition, or death associated with an adulterant or contaminant intentionally 

added to such a vaccine.” 42 U.S.C. § 300aa-33(5). The issue here is whether viral HPV DNA 

constitutes an “adulterant” or “contaminant” under § 330aa-33(5). If so, the claim here is not a 

vaccine-related injury and can proceed outside the Court of Federal Claims.

 

1 The U.S. Court of Federal Claims dismissed the Powerses’ petition as untimely, and the Powerses 

did not appeal that decision. See Powers v. Sec’y of Health & Human Servs., No. 14-1195V, 2016 

WL 1730189 (Fed. Cl. Apr. 8, 2016). 

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The Vaccine Act does not define “adulterant” or “contaminant,” so we look to the plain 

meaning of those terms for an answer. See Conn. Nat’l Bank v. Germain, 503 U.S. 249, 253-54 

(1992). A contaminant is a substance that “render[s] impure by contact or mixture”—something 

that “corrupt[s], defile[s], pollute[s], taint[s], [or] infect[s].” Oxford English Dictionary (2d ed 

1989). Similarly, an adulterant is a substance that “make[s] impure,” or “corrupts” or “debase[s].” 

Id. Both words share the core feature of including an ingredient that does not belong. See Owens 

ex rel. Schafer v. Am. Homes Prods. Corp., 203 F. Supp. 2d 748, 754–55 (S.D. Tex. 2002) 

(alteration in original) (quoting The American Heritage Dictionary 58 (2d ed. 1992); Webster’s 

9th New Collegiate Dictionary 283 (9th ed. 1991)). That’s why the Federal Circuit has explained 

that this exclusion only captures claims based on “a foreign substance [that was] purposefully 

introduced into the vaccine itself.” Amendola v. Sec’y, Dep’t of Health & Human Servs., 989 F.2d 

1180, 1186 (Fed. Cir. 1993) (emphasis added). Thus, something that a manufacturer adds 

intentionally as an ingredient cannot be an “adulterant” or a “contaminant” as understood in the 

statute. See, e.g., Bordenkircher v. Am. Home Prods., No. 5:03-cv-443, 2004 WL 6066904, at *2 

(M.D. Fla. Mar. 25, 2004) (explaining that thimerosal was neither an adulterant nor a contaminant 

because “it is purposefully used as an ingredient in the approved formulation of a vaccine” (quoting 

Owens, 203 F. Supp. 2d at 755)).

The Powerses alleged that Gardasil from a lot intentionally contaminated with viral HPV 

DNA caused L.P.’s injuries. But crucially, they contend that Merck “intentionally” added viral 

HPV DNA “to their formula.” Complaint, ¶ 8. So according to the Complaint, viral HPV DNA is 

neither an adulterant nor a contaminant and is, instead, a component of Gardasil. As a result, the 

Powerses failed to allege that L.P. received a contaminated vaccine and did not suffer a vaccinerelated injury.

Nor are we persuaded by the argument that the Complaint makes out a claim for relief 

simply because it alleges words like “contaminant” and “intentional.” See Reply Br. at 5–6. 

Conclusory allegations are never sufficient to overcome a motion under Rule 12(b)(6). See Iqbal,

556 U.S. at 678–79. The Powerses must allege facts that—if true—would establish that viral HPV 

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DNA amounts to a contaminant or adulterant under the Vaccine Act. Simply labeling it as a 

contaminant and claiming that Merck intentionally added it to the formula is not enough. 

Nevertheless, the Powerses maintain that they should have been given the chance to engage 

in discovery prior to a ruling on Merck’s motion to dismiss. But they were not entitled to discovery 

prior to dismissal because a party “may not use the discovery process to obtain [the facts necessary 

to state a claim] after filing suit.” New Albany Tractor, Inc. v. Louisville Tractor, Inc., 650 F.3d 

1046, 1051 (6th Cir. 2011). 

Accordingly, we AFFIRM the district court’s order dismissing the Powerses’ complaint.

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