The opinion of the court was delivered by: Jack B. Weinstein, Unites States District Judge
The central question is whether thimerosal is "a part of" a children's
"vaccine" for purposes of the National Vaccine Injury Compensation
Program (Program). See 42 U.S.C. § 300aa — 10 et seq. (2000).
Plaintiffs allegedly suffer from autism caused by thimerosal.
Defendants have moved to dismiss.
The relevant statute, 42 U.S.C. § 300aa-33 (5), reads:
the term "vaccine related injury or death" means 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
and 21 C.F.R. § 610.15, which reads:
(a) Any preservative used shall be sufficiently
nontoxic so that the amount present in the recommended
dose of the product will not be toxic to the
recipient, and in the combination used shall not
denature the specific substances in the product to
result in a decrease below the minimum acceptable
potency within the
dating period when stored at
Depending upon the characterization of thimerosal, the Office of
Special Masters (OSM) administering the Program arguably has original
jurisdiction to pass upon plaintiffs' claims. If thimerosal were
characterized as "constituent material" to a vaccine, the OSM would have
jurisdiction. 21 C.F.R. § 610.15; 42 U.S.C. § 300aa-11
(a)(2)(A). If thimerosal were characterized as an "adulterant or
contaminant", this court might have jurisdiction. 42 U.S.C. § 300aa-33
By Autism General Order #1, the OSM has taken steps to adjudicate
related autism claims allegedly caused by a vaccine containing, or
consisting in part of, thimerosal. The Secretary of Health and Human
Services (HHS) has, in effect, opined that thimerosal is not an
adulterant or contaminant. See "Statement of Interest" in King v. Aventis
Pasteur, Inc., CV 01-1305-AS (D. Ore. June 7, 2002) ("[T]he Secretary has
determined that the preservative thimerosal is not an adulterant or
contaminant within the meaning of the Vaccine Act"). See also, United
States Department of Health and Human Services, Health Resources and
Services Administration, "Commonly Asked Questions About the National
Vaccine Injury Compensation Program," available at
http://www.hrsa.gov/osp/vicp/qanda.htm#17 (August 2002) ("Because
Thimerosal is not an adulterant to or contaminant of vaccines,
individuals who have claims relating to thimerosal in vaccines . . . must
first file claims with the [Vaccine Court] before pursuing any other
civil litigation."). The OSM apparently supports this position, at least
preliminarily, through Autism General Order #1, asserting jurisdiction
under the Program over claims concerning thimerosal-containing vaccines
and establishing a schedule for determining whether such vaccines cause
autism and related conditions. In re: Claims For Vaccine Injuries
Resulting in Autism Spectrum Disorder of a Similar Neurodevelopmental
Disorder (Ct. Fed. Cl. July 3, 2002) ("Autism General Order No. 1").
The Program was designed by Congress to permit production of children's
vaccines without court proceedings and threats of tort judgments that
threatened to deter production of vaccines essential to the health of the
nation's children. Individual Justice in Mass. Tort Litigation, The
Effect of Class Actions, Consolidations, and Other Multiparty Devices 123
(1995); See A Major Revival in Research on Vaccines, N.Y. Times, Aug.
22, 1990, at D7; Compensation Cutoff, Newsday, Sept. 10, 1990, at 2.
There are two issues presented by this motion: (1) the degree of
deference this court should give to the position of the HHS and by OSM,
tentatively, that thimerosal as found in vaccines is not an adulterant or
contaminant within the meaning of the statute; and (2) whether this court
is authorized to hold evidentiary hearings to make an independent
determination of the statutory meaning of "adulterant" and "contaminant"
in the context of this case.
When neither the statute nor interpretive regulations provide an
unambiguous authoritative definition or interpretation of words like
adulterant and contaminant, a court applies a Christensen level of
deference to the agency's interpretation. Christensen v. Harris County,
529 U.S. 576, 588, 120 S.Ct. 1655, 146 L.Ed.2d 621 (2000). In
Christensen, the Supreme Court held that an agency's construction of its
own, ambiguous regulation is entitled to deference. Id. at 588. See
also, Auer v. Robbins, 519 U.S. 452, 461, 117 S.Ct. 905, 137 L.Ed.2d 79
(1997). "[T]he level of deference
afforded [the agency's judgment] `will
depend upon the thoroughness evident in its consideration, the validity
of its reasoning, its consistency with earlier and later pronouncements,
and all those factors which give it power to persuade, if lacking power
to control'." Edelman v. Lynchburg College, 122 S.Ct. 1145, 152 L.Ed.2d
188 (March 19, 2002), quoting Skidmore v. Swift & Co., 323 U.S. 134,
140, 65 S.Ct. 161, 89 L.Ed. 124 (1944); Cf. EEOC v. Arabian American Oil
Co., 499 U.S. 244, 256-258, 111 S.Ct. 1227, 113 L.Ed.2d 274 (1991)
(interpretive guidelines do not receive more deferent Chevron analysis).
In Christensen, the court noted that non-regulatory pronouncements from
administrative agencies arrived at without formal adjudicative or notice
and comment periods do not warrant a stringent level of deference. 529
U.S. at 587. See also, e.g., Reno v. Koray, 515 U.S. 50, 61, 115 S.Ct.
2021, 132 L.Ed.2d 46 (1995) (internal agency guidelines, which are not
"subject to the rigors of the Administrative Procedur[e] Act, ...