United States Court of Appeals
Fifth Circuit
F I L E D
In the August 16, 2004
United States Court of Appeals Charles R. Fulbruge III
for the Fifth Circuit Clerk
_______________
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
_________________________
Before SMITH, BENAVIDES, and I.
PICKERING, Circuit Judges. A.
Eli Lilly seeks to be treated on like terms as
JERRY E. SMITH, Circuit Judge: the Vaccine Defendants. Because Thimerosal
is not a vaccine, its producers are not vaccine
Plaintiffs Scott and Janice Moss (“the manufacturers as that term is defined in the
Mosses”), the parents of a young child who, Vaccine Act, 42 U.S.C. § 300aa-33(3), so they
they allege, developed autism as a result of re- are not entitled to the protections of the Act’s
ceiving vaccines containing mercury, wish to restriction on the filing of suits.1
pursue state law tort claims for injuries they
suffered as a result of the child’s condition. The Vaccine Act is a remedial program de-
Although their claims are not barred by the signed to provide swift compensation for per-
literal terms of the National Childhood Vac- sons injured by vaccines, while ensuring that
cine Injury Act of 1986 (the “Vaccine Act”), the nation’s supply of vaccines isn’t unduly
42 U.S.C. § 300aa-1 et seq., defendants urge threatened by the costs and risks of tort litiga-
the alternate theories that the statute is broad tion. To that end, victims of a “vaccine-relat-
enough implicitly to preempt any claims it fails ed injury or deat h,” as that term is defined in
directly to address, and that the purpose of the 42 U.S.C. § 300aa-33(5), are barred from
statute requires us to construe its express seeking redress in the courts unless they have
terms broadly and in a way that robs the plain- first filed a claim for recovery in a specialized
tiffs of the right to sue. Vaccine Court.2 See § 300aa-11(a)(2)A).
In the district court, defendants Merck &
Company, Aventis Pasteur Inc., and Wyeth, 1
The Mosses initially pursued claims against
Inc. (the “Vaccine Defendants”), obtained a
Eli Lilly for Amber’s injuries as well as their own,
dismissal on the ground that the Vaccine Act but withdrew all except the claims seeking redress
precludes the Mosses’ pursuit of a tort remedy for injuries incurred in a personal capacity, primar-
for a vaccine-related injury. Cf. FED. R. CIV. ily through loss of consortium with Amber. We
P. 12(b)(1). Defendant Eli Lilly & Company reject the Vaccine Defendants’ contention, prem-
(“Eli Lilly”), the manufacturer of Thimerosal, ised on a strained construction of § 300aa-
the mercury-containing preservative used in 11(a)(2)(B), that the entire suit should be dismissed
several childhood vaccines, obtained a dismiss- because it once contained claims that did not
al on the ground that it too is a vaccine manu- properly belong in federal court. Even assuming
facturer entitled to the protections of the Amber could not pursue her claims against Eli
Vaccine Act. Relying on the text of the statute Lilly in federal court (a proposition we need not
and eschewing the defendants’ invitation to re- decide but is nevertheless strongly in doubt given
write a complex federal regulatory scheme to our conclusion that Eli Lilly is not a vaccine man-
ufacturer), the district court did not abuse its dis-
suit their purposes, we reverse and remand
cretion in allowing the Mosses to amend their
with instruction. 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...)
2
Operating under lower standards of proof, settled that Thimerosal, when used as a preser-
claimants can seek a compensatory award vative, is a component of a vaccine rather than
from the government, acceptance of which an adulterant. Leroy v. Sec’y of Health &
causes them to waive any further tort rights. Human Servs., 2002 U.S. Claims LEXIS 284,
See § 300aa-21(a). The claimant may instead *18-*19 (Fed. Cl. 2002) (citing cases). None-
decline the award and pursue traditional tort theless, its status as a vaccine component no
relief, but with certain restrictions such as an more makes Thimerosal a “vaccine” than does
inability to recover punitive damages. See the inclusion of a piston under the hood of an
§§ 300aa-21(a), 300aa-22. See also Schafer v. automobile make that object an “engine.”
Am. Cyanamid Co., 20 F.3d 1, 3 (1st Cir.
1994) (Breyer, C.J.) (detailing the restrictions Thimerosal is part of the finished product,
on suits). to be sure, but it is not the finished product it-
self, and on its face the statute governs only
The Vaccine Act does not apply to all vac- lawsuits filed against manufacturers of a com-
cine-related lawsuits, however, but only those pleted vaccine shipped under its own label and
brought against a “vaccine administrator or listed in the Vaccine Injury Table. Not sur-
manufacturer.” § 300aa-11(a)(2)(A). The Act prisingly, Thimerosal is not sold as a vaccine,
defines “vaccine manufacturer” as “any corpo- nor is it listed in the statute’s table.
ration, organization, or institution, whether
public or private . . . which manufactures, im- If a plaintiff is able to trace his injury to the
ports, processes, or distributes under its label manufacturer of a chemical that does not, in
any vaccine set forth in the Vaccine Injury and of itself, qualify for protection under the
Table.” § 300aa-33(3). Still, the statute does Vaccine Act, there is nothing in the Act that
not define the term “vaccine,” requiring us to prevents him from going to court and attempt-
ascertain the meaning of that word through ing to prove that his injuries were caused by
ordinary principles of statutory construction. that chemical. The burden of proof at trial
In the absence of a controlling definition, we may be complicated by the difficulty inherent
interpret statutes according to their plain, or- in demonstrating that the injury was proxi-
dinary meaning.3 mately caused by that singular component,
rather than the vaccine itself, but this does not
Under the plain meaning of the Vaccine mean the Vaccine Act prevents plaintiffs from
Act, Eli Lilly is not a vaccine manufacturer, so trying; it only prohibits them from filing the
the Mosses are not barred from suing it. It is Thimerosal-based claim against the manufac-
turer of a vaccine, something Eli Lilly cannot
2
claim to be solely on the basis of its manufac-
(...continued) ture of Thimerosal.
processing claims under the Vaccine Act. See 42
U.S.C.§ 300aa-12. The “Vaccine Court” consists
B.
of a special master under the jurisdiction of the
Eli Lilly argues that our conclusion contra-
Court of Federal Claims.
dicts the Vaccine Court’s analysis in Leroy.
3
Pioneer Inv. Servs. Co. v. Brunswick Assocs. Specifically, it reads Leroy as having decided
Limited P’ship, 507 U.S. 380, 388 (1993); Conn. that victims of Thimerosal-related injuries are
Bank of Commerce v. Republic of Congo, 309 free to pursue claims for relief in the Vaccine
F.3d 240, 260 (5th Cir. 2002).
3
Court, and that today’s decision gives rise to recompense for injuries incurred in a personal
the prospect of double recovery. capacity. Just as the Vaccine Act does not
protect all defendants, it does not apply to all
We disagree. In Leroy, the Vaccine Court tort suits having some connection to the ad-
was presented with a jurisdictional challenge ministration of a vaccine. Rather, the restric-
premised on the notion that Thimerosal is tion on filing tort claims applies only to those
present in vaccines only as an adulterant or who have “sustained a vaccine-related injury
contaminant. Leroy, 2002 U.S. Claims LEXIS or death and who [are] qualified to file a peti-
284, at *10. Because the Vaccine Act does tion for compensation under the Program.”
not apply to injuries caused by those sorts of § 300aa-11(a)(9). In this way, the Vaccine
impurities, see § 300aa-33(5), the classification Act treats “the tort suit procedural bar and
of Thimerosal under one of those headings Vaccine Court compensation as opposite sides
would have left plaintiffs free to sue vaccine of the same coin.” Schafer, 20 F.3d at 5. The
manufacturers in traditional courts so long as program delays the filing of only those tort
they argued that it was the Thimerosal and not claims for which it first provides an alternate
the vaccine that caused their injuries. The source of compensation.
Vaccine Court rejected the challenge, how-
ever, concluding that Thimerosal is a com- To file a petition for compensation, a claim-
ponent of the vaccines in which it is found. Id. ant must be either a person who has sustained
at *27-*29. As a result, the Vaccine Court a vaccine-related injury, orSSif the victim is a
concluded, the Vaccine Act encompasses minor, disabled or deceasedSSthat person’s
claims filed against a manufacturer or admin- legal representative. § 300aa-11(b)(1)(A).
istrator of a vaccine premised on the allegation Any person who fits one of those descriptions
that an injury was caused by a vaccine contain- and “meets the requirements of subsection
ing Thimerosal. Id. at *66. (c)(1) of this section” may file a petition for
compensation. Id.
Leroy, therefore, stands for nothing more
than the unremarkable proposition that a Thi- Of singular importance is the requirement in
merosal-related injury, occurring as a result of § 300aa-11(c)(1)(A) that the claimant be able
the administration of a vaccine, is a vaccine- to state in an affidavit that he “received a
related injury within the meaning of the Vac- vaccine set forth in the Vaccine Injury Table
cine Act. That does not end our inquiry, how- or, if such person did not receive such a vac-
ever, because a claim is barred under the stat- cine, contracted polio, directly or indirectly,
ute only if it alleges a vaccine-related injury from another person who received an oral pol-
and is filed against a vaccine manufacturer. io vaccine.” Because Scott and Janice Moss
§ 300aa-11(a)(2)(A). It is this latter require- neither received a vaccine nor contracted polio
ment that Eli Lilly fails to meet, and, as a re- from someone who did, they are unable to sat-
sult, the Vaccine Act affords it no cover from isfy the requirements of subsection (c)(1). As
the Mosses’ claims. a result, they are ineligible to file a petition, see
§ 300aa-11(b)(1)(a), and the Vaccine Act’s
II. restriction on the filing of tort suits does not
The Mosses’ suit against the Vaccine De-
fendants relies on Louisiana tort law and seeks
4
apply to them, see § 300aa-11(a)(9).4 As an alternate strain of their defense, the
Vaccine Defendants contend that the district
That much is plain on the face of the stat- court properly dismissed the Mosses’ claims
ute, but the lack of statutory ambiguity does because they are implicitly preempted by the
not stop the Vaccine Defendants from arguing Vaccine Act. We reject this argument, too, for
that a literal application of the regulatory we will not lightly infer that Congress has im-
scheme “will thwart the intent and purpose of plicitly preempted state claims using an instru-
the Act, and interfere with its operation.” Be- ment that explicitly preempts other claims, see,
cause the Vaccine Act was motivated by a de- e.g., Freightliner Corp. v. Myrick, 514 U.S.
sire to unburden vaccine manufacturers from 280, 288 (1995), and the Vaccine Defendants
the costs and risks of tort litigation, the argu- offer no persuasive reason to make that infer-
ment goes, the Act should be construed as ential leap in this case. Accord Schafer, 20
barring those claims as well. F.3d at 6-7.
We disagree. If it is indeed the case that Congress could not have been much more
loss-of-consortium claims frustrate this com- plain in its desire not to preempt tort claims
plex federal regime, Congress can enact a filed by persons who are ineligible to recover
change. For all we know, this possibility was in the Vaccine Court.6 We therefore agree
considered, and a conscious decision was with the First Circuit thatSSassuming arguen-
made not to regulate consortium claims. Ei- do that state tort law permits claims for loss of
ther way, it is not for this court to decide what consortium (and about which we express no
Congress should have done, but only to apply opinion)SSthere is nothing in the Vaccine Act
a statute that on its face has nothing to say that implicitly or explicitly prevents this suit
about consortium claims. Because the Vac- from going forward. Schafer, 20 F.3d at 2.
cine Act neither provides a mechanism for
their recovery on a loss of consortium suit, nor III.
openly bars their right to pursue remedies af- For the foregoing reasons, the judgment is
forded by state tort law, the Mosses may REVERSED and the Mosses’ claims reinstat-
pursue their claims.5 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-
5
ber’s legal representatives, and only to seek redress (...continued)
of her injuries. See § 300aa-11(b)(1)(A); Head v. Congress took no action to amend the statute in the
Sec’y of Health & Human Servs., 26 Cl. Ct. 546, intervening decade, it is not unreasonable to con-
547 n.1 (1992). clude that the consequences of today’s holding are
not so extreme as the Vaccine Defendants would
5
It is also far from obvious that this result will have us believe.
wreak the apocalyptic results foretold by the Vac-
6
cine Defendants. The same observation was made Cf. § 300aa-11(a)(9) (“This subsection ap-
in Schafer, with a concurrence openly calling on plies only to a person who has sustained a vac-
Congress to revisit the issue. Schafer, 20 F.3d at 7 cine-related injury or death and who is qualified to
(Stahl, J., concurring). In light of the fact that file a petition for compensation under the Pro-
(continued...) gram.”).
5
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.
6