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WAX v. AVENTIS PASTEUR INC.

October 30, 2002

ANDREW WAX, ET AL., PLAINTIFFS
V.
AVENTIS PASTEUR INC., F/K/A/ CONNAUGHT LABORATORIES, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Jack B. Weinstein, Unites States District Judge

AMENDED MEMORANDUM ORDER

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 a vaccine.

and 21 C.F.R. § 610.15, which reads:

Constituent Materials:

(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 recommended temperature.

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 (5).

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, ...


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