Shannon Powers v. Merck & Company, Inc. ( 2019 )

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 19a0366n.06
No. 18-4001
UNITED STATES COURT OF APPEALS
FOR THE SIXTH CIRCUIT
FILED
SHANNON POWERS, Parent and Natural ) Jul 17, 2019
Guardian of L.P., a Minor, et al., ) DEBORAH S. HUNT, Clerk
)
Plaintiffs-Appellants, )
) ON APPEAL FROM THE UNITED
v. ) STATES DISTRICT COURT FOR
) THE SOUTHERN DISTRICT OF
MERCK & COMPANY, INC., et al., ) OHIO
)
Defendants-Appellees. ) 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,1 nor 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 vaccine-
related 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.