Moss, et al v. Merck and Co, et al

United States Court of Appeals
Fifth Circuit
F I L E D
August 16, 2004
Charles R. Fulbruge III
Clerk
In the
United States Court of Appeals
for the Fifth Circuit
_______________
No. 03-30958
_______________
SCOTT MOSS, INDIVIDUALLY AND ON BEHALF OF AMBER MOSS;
JANICE MOSS,
Plaintiffs-Appellants,
VERSUS
MERCK & COMPANY, ET AL.,
Defendants,
MERCK & COMPANY,
AVENTIS PASTEUR INC.,
INDIVIDUALLY AND AS SUCCESSOR IN INTEREST,
ALSO KNOWN AS CONNAUGHT LABORATORIES INC.,
ALSO KNOWN AS PASTEUR MERIEUX, ALSO KNOWN AS PASTEUR MERIEUX CONNAUGHT;
ELI LILLY & COMPANY, AND WYETH,
Defendants-Appellees,
_________________________
Appeal from the United States District Court
for the Western District of Louisiana
_________________________

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Before SMITH, BENAVIDES, and
PICKERING, Circuit Judges.
JERRY E. SMITH, Circuit Judge:
Plaintiffs Scott and Janice Moss (“the
Mosses”), the parents of a young child who,
they allege, developed autism as a result of re-
ceiving vaccines containing mercury, wish to
pursue state law tort claims for injuries they
suffered as a result of the child’s condition.
Although their claims are not barred by the
literal terms of the National Childhood Vac-
cine Injury Act of 1986 (the “Vaccine Act”),
42 U.S.C. § 300aa-1 et seq., defendants urge
the alternate theories that the statute is broad
enough implicitly to preempt any claims it fails
directly to address, and that the purpose of the
statute requires us to construe its express
terms broadly and in a way that robs the plain-
tiffs of the right to sue.
In the district court, defendants Merck &
Company, Aventis Pasteur Inc., and Wyeth,
Inc. (the “Vaccine Defendants”), obtained a
dismissal on the ground that the Vaccine Act
precludes the Mosses’ pursuit of a tort remedy
for a vaccine-related injury. Cf. FED. R. CIV.
P. 12(b)(1). Defendant Eli Lilly & Company
(“Eli Lilly”), the manufacturer of Thimerosal,
the mercury-containing preservative used in
several childhood vaccines, obtained a dismiss-
al on the ground that it too is a vaccine manu-
facturer entitled to the protections of the
Vaccine Act. Relying on the text of the statute
and eschewing the defendants’ invitation to re-
write a complex federal regulatory scheme to
suit their purposes, we reverse and remand
with instruction.
I.
A.
Eli Lilly seeks to be treated on like terms as
the Vaccine Defendants. Because Thimerosal
is not a vaccine, its producers are not vaccine
manufacturers as that term is defined in the
Vaccine Act, 42 U.S.C. § 300aa-33(3), so they
are not entitled to the protections of the Act’s
restriction on the filing of suits.1
The Vaccine Act is a remedial program de-
signed to provide swift compensation for per-
sons injured by vaccines, while ensuring that
the nation’s supply of vaccines isn’t unduly
threatened by the costs and risks of tort litiga-
tion. To that end, victims of a “vaccine-relat-
ed injury or deat h,” as that term is defined in
42 U.S.C. § 300aa-33(5), are barred from
seeking redress in the courts unless they have
first filed a claim for recovery in a specialized
Vaccine Court.2 See § 300aa-11(a)(2)A).
1 The Mosses initially pursued claims against
Eli Lilly for Amber’s injuries as well as their own,
but withdrew all except the claims seeking redress
for injuries incurred in a personal capacity, primar-
ily through loss of consortium with Amber. We
reject the Vaccine Defendants’ contention, prem-
ised on a strained construction of § 300aa-
11(a)(2)(B), that the entire suit should be dismissed
because it once contained claims that did not
properly belong in federal court. Even assuming
Amber could not pursue her claims against Eli
Lilly in federal court (a proposition we need not
decide but is nevertheless strongly in doubt given
our conclusion that Eli Lilly is not a vaccine man-
ufacturer), the district court did not abuse its dis-
cretion in allowing the Mosses to amend their
pleadings. Cf. Bass v. Parkwood Hosp., 180 F.3d
234, 241 (5th Cir. 1999).
2 We use the term “Vaccine Court” as short-
hand for the adjudicative procedures set up for
(continued...)

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Operating under lower standards of proof,
claimants can seek a compensatory award
from the government, acceptance of which
causes them to waive any further tort rights.
See § 300aa-21(a). The claimant may instead
decline the award and pursue traditional tort
relief, but with certain restrictions such as an
inability to recover punitive damages. See
§§ 300aa-21(a), 300aa-22. See also Schafer v.
Am. Cyanamid Co., 20 F.3d 1, 3 (1st Cir.
1994) (Breyer, C.J.) (detailing the restrictions
on suits).
The Vaccine Act does not apply to all vac-
cine-related lawsuits, however, but only those
brought against a “vaccine administrator or
manufacturer.” § 300aa-11(a)(2)(A). The Act
defines “vaccine manufacturer” as “any corpo-
ration, organization, or institution, whether
public or private . . . which manufactures, im-
ports, processes, or distributes under its label
any vaccine set forth in the Vaccine Injury
Table.” § 300aa-33(3). Still, the statute does
not define the term “vaccine,” requiring us to
ascertain the meaning of that word through
ordinary principles of statutory construction.
In the absence of a controlling definition, we
interpret statutes according to their plain, or-
dinary meaning.3
Under the plain meaning of the Vaccine
Act, Eli Lilly is not a vaccine manufacturer, so
the Mosses are not barred from suing it. It is
settled that Thimerosal, when used as a preser-
vative, is a component of a vaccine rather than
an adulterant. Leroy v. Sec’y of Health &
Human Servs., 2002 U.S. Claims LEXIS 284,
*18-*19 (Fed. Cl. 2002) (citing cases). None-
theless, its status as a vaccine component no
more makes Thimerosal a “vaccine” than does
the inclusion of a piston under the hood of an
automobile make that object an “engine.”
Thimerosal is part of the finished product,
to be sure, but it is not the finished product it-
self, and on its face the statute governs only
lawsuits filed against manufacturers of a com-
pleted vaccine shipped under its own label and
listed in the Vaccine Injury Table. Not sur-
prisingly, Thimerosal is not sold as a vaccine,
nor is it listed in the statute’s table.
If a plaintiff is able to trace his injury to the
manufacturer of a chemical that does not, in
and of itself, qualify for protection under the
Vaccine Act, there is nothing in the Act that
prevents him from going to court and attempt-
ing to prove that his injuries were caused by
that chemical. The burden of proof at trial
may be complicated by the difficulty inherent
in demonstrating that the injury was proxi-
mately caused by that singular component,
rather than the vaccine itself, but this does not
mean the Vaccine Act prevents plaintiffs from
trying; it only prohibits them from filing the
Thimerosal-based claim against the manufac-
turer of a vaccine, something Eli Lilly cannot
claim to be solely on the basis of its manufac-
ture of Thimerosal.
B.
Eli Lilly argues that our conclusion contra-
dicts the Vaccine Court’s analysis in Leroy.
Specifically, it reads Leroy as having decided
that victims of Thimerosal-related injuries are
free to pursue claims for relief in the Vaccine
2(...continued)
processing claims under the Vaccine Act. See 42
U.S.C.§ 300aa-12. The “Vaccine Court” consists
of a special master under the jurisdiction of the
Court of Federal Claims.
3 Pioneer Inv. Servs. Co. v. Brunswick Assocs.
Limited P’ship, 507 U.S. 380, 388 (1993); Conn.
Bank of Commerce v. Republic of Congo, 309
F.3d 240, 260 (5th Cir. 2002).

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Court, and that today’s decision gives rise to
the prospect of double recovery.
We disagree. In Leroy, the Vaccine Court
was presented with a jurisdictional challenge
premised on the notion that Thimerosal is
present in vaccines only as an adulterant or
contaminant. Leroy, 2002 U.S. Claims LEXIS
284, at *10. Because the Vaccine Act does
not apply to injuries caused by those sorts of
impurities, see § 300aa-33(5), the classification
of Thimerosal under one of those headings
would have left plaintiffs free to sue vaccine
manufacturers in traditional courts so long as
they argued that it was the Thimerosal and not
the vaccine that caused their injuries. The
Vaccine Court rejected the challenge, how-
ever, concluding that Thimerosal is a com-
ponent of the vaccines in which it is found. Id.
at *27-*29. As a result, the Vaccine Court
concluded, the Vaccine Act encompasses
claims filed against a manufacturer or admin-
istrator of a vaccine premised on the allegation
that an injury was caused by a vaccine contain-
ing Thimerosal. Id. at *66.
Leroy, therefore, stands for nothing more
than the unremarkable proposition that a Thi-
merosal-related injury, occurring as a result of
the administration of a vaccine, is a vaccine-
related injury within the meaning of the Vac-
cine Act. That does not end our inquiry, how-
ever, because a claim is barred under the stat-
ute only if it alleges a vaccine-related injury
and is filed against a vaccine manufacturer.
§ 300aa-11(a)(2)(A). It is this latter require-
ment that Eli Lilly fails to meet, and, as a re-
sult, the Vaccine Act affords it no cover from
the Mosses’ claims.
II.
The Mosses’ suit against the Vaccine De-
fendants relies on Louisiana tort law and seeks
recompense for injuries incurred in a personal
capacity. Just as the Vaccine Act does not
protect all defendants, it does not apply to all
tort suits having some connection to the ad-
ministration of a vaccine. Rather, the restric-
tion on filing tort claims applies only to those
who have “sustained a vaccine-related injury
or death and who [are] qualified to file a peti-
tion for compensation under the Program.”
§ 300aa-11(a)(9). In this way, the Vaccine
Act treats “the tort suit procedural bar and
Vaccine Court compensation as opposite sides
of the same coin.” Schafer, 20 F.3d at 5. The
program delays the filing of only those tort
claims for which it first provides an alternate
source of compensation.
To file a petition for compensation, a claim-
ant must be either a person who has sustained
a vaccine-related injury, orSSif the victim is a
minor, disabled or deceasedSSthat person’s
legal representative. § 300aa-11(b)(1)(A).
Any person who fits one of those descriptions
and “meets the requirements of subsection
(c)(1) of this section” may file a petition for
compensation. Id.
Of singular importance is the requirement in
§ 300aa-11(c)(1)(A) that the claimant be able
to state in an affidavit that he “received a
vaccine set forth in the Vaccine Injury Table
or, if such person did not receive such a vac-
cine, contracted polio, directly or indirectly,
from another person who received an oral pol-
io vaccine.” Because Scott and Janice Moss
neither received a vaccine nor contracted polio
from someone who did, they are unable to sat-
isfy the requirements of subsection (c)(1). As
a result, they are ineligible to file a petition, see
§ 300aa-11(b)(1)(a), and the Vaccine Act’s
restriction on the filing of tort suits does not

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apply to them, see § 300aa-11(a)(9).4
That much is plain on the face of the stat-
ute, but the lack of statutory ambiguity does
not stop the Vaccine Defendants from arguing
that a literal application of the regulatory
scheme “will thwart the intent and purpose of
the Act, and interfere with its operation.” Be-
cause the Vaccine Act was motivated by a de-
sire to unburden vaccine manufacturers from
the costs and risks of tort litigation, the argu-
ment goes, the Act should be construed as
barring those claims as well.
We disagree. If it is indeed the case that
loss-of-consortium claims frustrate this com-
plex federal regime, Congress can enact a
change. For all we know, this possibility was
considered, and a conscious decision was
made not to regulate consortium claims. Ei-
ther way, it is not for this court to decide what
Congress should have done, but only to apply
a statute that on its face has nothing to say
about consortium claims. Because the Vac-
cine Act neither provides a mechanism for
their recovery on a loss of consortium suit, nor
openly bars their right to pursue remedies af-
forded by state tort law, the Mosses may
pursue their claims.5
As an alternate strain of their defense, the
Vaccine Defendants contend that the district
court properly dismissed the Mosses’ claims
because they are implicitly preempted by the
Vaccine Act. We reject this argument, too, for
we will not lightly infer that Congress has im-
plicitly preempted state claims using an instru-
ment that explicitly preempts other claims, see,
e.g., Freightliner Corp. v. Myrick, 514 U.S.
280, 288 (1995), and the Vaccine Defendants
offer no persuasive reason to make that infer-
ential leap in this case. Accord Schafer, 20
F.3d at 6-7.
Congress could not have been much more
plain in its desire not to preempt tort claims
filed by persons who are ineligible to recover
in the Vaccine Court.6 We therefore agree
with the First Circuit thatSSassuming arguen-
do that state tort law permits claims for loss of
consortium (and about which we express no
opinion)SSthere is nothing in the Vaccine Act
that implicitly or explicitly prevents this suit
from going forward. Schafer, 20 F.3d at 2.
III.
For the foregoing reasons, the judgment is
REVERSED and the Mosses’ claims reinstat-
ed. At oral argument, the Mosses represented
that they would be satisfied with an order stay-
ing their suit until the Vaccine Court renders a
4 The Mosses are eligible to file a claim with the
Vaccine Court, but only in their capacity as Am-
ber’s legal representatives, and only to seek redress
of her injuries. See § 300aa-11(b)(1)(A); Head v.
Sec’y of Health & Human Servs., 26 Cl. Ct. 546,
547 n.1 (1992).
5 It is also far from obvious that this result will
wreak the apocalyptic results foretold by the Vac-
cine Defendants. The same observation was made
in Schafer, with a concurrence openly calling on
Congress to revisit the issue. Schafer, 20 F.3d at 7
(Stahl, J., concurring). In light of the fact that
(continued...)
5(...continued)
Congress took no action to amend the statute in the
intervening decade, it is not unreasonable to con-
clude that the consequences of today’s holding are
not so extreme as the Vaccine Defendants would
have us believe.
6 Cf. § 300aa-11(a)(9) (“This subsection ap-
plies only to a person who has sustained a vac-
cine-related injury or death and who is qualified to
file a petition for compensation under the Pro-
gram.”).

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decision on the award, if any, to Amber. The
case is therefore REMANDED with instruc-
tion to stay the proceeding pending a result in
the Vaccine Court, and for any further pro-
ceedings that are not inconsistent with this
opinion.

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