Wax v. Aventis Pasteur Inc.

• Decision Date: 30 October 2002
• Docket Number: No. CV 02-2018(JBW).,CV 02-2018(JBW).
• Parties: Andrew WAX, et al., Plaintiffs, v. AVENTIS PASTEUR INC., f/k/a/Connaught Laboratories, et al., Defendants.
• Court: U.S. District Court — Eastern District of New York

240 F.Supp.2d 191

Andrew WAX, et al., Plaintiffs, v. AVENTIS PASTEUR INC., f/k/a/Connaught Laboratories, et al., Defendants.

No. CV 02-2018(JBW).

United States District Court, E.D. New York.

October 30, 2002.

Parker & Waichman, by Adena Edwards, Jerrold S. Parker, Great Neck, NY, Douglas & London, by Michael London, New York, NY, for Plaintiffs.

Wilson, Elser, Moskowitz, Edelman & Dicker, LLP, by Patrick J. Brennan, Orrick, Herrington & Sutcliffe, LLP, by Daniel James Thomasch, Lauren Jill Elliot, Hughes, Hubbard & Reed, LLP, by Deirdre Joan Sheridan, Theodore V.H. Mayer, Schoeman, Updike & Kaufman, LLP, by Beth Lori Kaufman, Patterson, Belknap, Webb & Tyler, LLPO, by Robert D. Wilson, Jr., Harris Beach, LLP, by Frederick Fern, Judi Abbott Curry, Konrad F. Payne, Landman, Corsi, Ballanine & Ford, P.C., by Daniel S. Moretti, McCarter & English, LLP, by Samuel J. Abate, Jr., Strongin, Rothman & Abrams, LLP, by David Abrams, New York, NY, Venable, Baetjer & Howard, LLP, by Dino S. Sangiamo, Paul F. Strain, Baltimore, MD, Shook, Hardy & Bacon, LLP, by James H. Davis, Mark A. Dover, Kansas City, MO, for Defendants.

AMENDED MEMORANDUM ORDER

WEINSTEIN, Senior 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 a vaccine.

21 C.F.R. § 610.15 provides:

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 it 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 the 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 the claim 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. See e.g., Individual Justice in Mass Tort Litigation, The Effect of Class Actions, Consolidations, and Other Multiparty Devices 123 (1995); A Major Revival in Research on Vaccines, N.Y. Times, Aug. 22, 1990, at D7; Compensation Cutoff, Newsday, Sept. 10, 1990, at 2; John W. Dornberger, Thimerosal-Containing Vaccine Litigation, For the Defense, 12 (Oct. 2002).

There are two issues presented by this motion: (1) the degree of deference this court should give to the position of HHS and 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."

When neither the statute nor 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, 120 S.Ct. 1655. See also Auer v. Robbins, 519 U.S. 452, 461, 117 S.Ct. 905, 137 L.Ed.2d 79 (1997). "The 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, 535 U.S. 106, 122 S.Ct. 1145, 1154-55, 152 L.Ed.2d 188 (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, 120 S.Ct. 1655. 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 Procedure Act, including public notice and comment," are entitled only to "some deference" (internal quotation marks omitted)).

If the views of the Administrator of the Program or the Secretary of HHS constitute statements of general policy, interpretive rules, or a course of precedent developed though informal means—i.e., nonregulatory pronouncements—then a court may give the views some weight, but it is not bound by the agency's interpretation. Christensen, 529 U.S. at 587, 120 S.Ct. 1655. Opinion letters issued by departments responsible for administering Congressional Acts are "entitled to respect" under the Supreme Court's decision in Skidmore, 323 U.S. at 140, 65 S.Ct. 161, but only to the extent that those interpretations have the "power to persuade." Christensen, 529 U.S. at 587, 120 S.Ct. 1655; see also Arabian American Oil Co., 499 U.S. at 256-58, 111 S.Ct. 1227; Skidmore, 323 U.S. at 140, 65 S.Ct. 161 (factors in the level of deference depend on the circumstances as well the degree of agency's care, consistency, formality, relative expertness, and persuasiveness of the agency's position).

While not bound by HHS's interpretation, and possibly that of OSM. the wellreasoned views of the Administrator of the Program "constitute a body of experience and informed judgment to which the courts and litigants may properly resort for guidance ... and ... considerable weight should be accorded to an executive department's construction of a statutory scheme it is entrusted to administer." United States v. Mead, 533 U.S. 218, 227-28, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001) (quotation marks omitted). This is particularly true since the decision of OSM will be based on adjudicated decisions with opposing interested parties submitting evidence and arguments.

In ruling on the persuasiveness of HHS's and OSM's interpretation, a court must keep in mind the circumstances under which the interpretation was made and the overall purpose of the Act. It must also examine the facts and circumstances surrounding the interpretation by the Administrator of the Program in determining what weight and level of deference to accord the relevant statutory interpretation. See Skidmore, 323 U.S. at 140, 65 S.Ct. 161.

Even though unbound, the court defers, for the purposes of this motion, to HHS's interpretation that injuries caused by thimerosal in vaccines are "vaccinerelated" for purposes of the Program. HHS, through "statements of interest" and publications, has expressed the consistent position that injuries caused by thimerosal in vaccines are, "vaccine-related" for purposes of the Program.

In view of the overall purpose of the Program, the court is persuaded that it is appropriate for the present to defer to OSM's experience and expertise on the scientific issues now posed even though resolution of...