United States District Court, Eastern District of New York
October 30, 2002
ANDREW WAX, ET AL., PLAINTIFFS
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
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, 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.,
non-regulatory 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. 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, but only to the extent that those interpretations have the "power to
persuade". Christensen, 529 U.S. at 587; See also, Arabian American Oil
Co., 499 U.S. at 256-258; Skidmore, 323 U.S. at 140 (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
well-reasoned views of the Administrator of the Program "constitute a
body of experience and informed judgment to which this court 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.
While not bound, the court defers, for the purposes of this motion, to
HHS's interpretation that injuries caused by thimerosal in vaccines are
"vaccine-related" 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
the meaning of the operative terms at issue may determine statutory
meanings and jurisdiction of this court.
Defendants argue that, based on the provisions of the Vaccine Act and
the stipulations of counsel, plaintiff's position with respect to the
statute of limitations will not be worsened by dismissal of their
vaccine-related claims in the instant case. The Vaccine Act provides that
if the present civil action is dismissed and a petition is filed with the
Vaccine Court within one year of the date of dismissal, the date that
this case was filed in this court will be deemed the date that the
Vaccine Court petition was filed. See 42 U.S.C. § 300aa-11
(a)(1)(B). While the Vaccine Court petition is pending in the Vaccine
Court, limitations on actions under state law "shall be stayed . . . ."
See 42 U.S.C. § 300aa-16(c). Consequently, defendant's urge,
plaintiff's position after the dismissal of this action will be the same as
if they had properly followed the mandatory provisions of the Vaccine
Nevertheless, in the exercise of discretion, the court will not dismiss
the case, but will stay it pending application by plaintiffs for relief
pursuant to the Program and a decision by the OSM. The court will await
the Vaccine Court's decision and will defer temporarily to HHS's
interpretation in order to permit the Vaccine Court to make a decision
after holding hearings.
Dismissal might be inappropriate in view of statute of limitation
implications that might be adverse to plaintiffs. The case is important
enough to plaintiffs to warrant this careful course of action.
The court will put off deciding on whether scientific hearings can be
held by this court to determine the meaning of the statute until after
the Vaccine Court has had an opportunity to hold hearings. Cases cited by
defendants which suggest that experts may not be relied upon by a federal
district judge in interpreting statutory language in the main refer to
jury determinations. See Thimerosal Defendant's Supplemental Brief in
Support of Dismissal of Plaintiff's Claims, 5-9 (Oct. 17, 2002). The
court's power to take judicial notice of the meaning of words and to
inform itself by hearings is not limited by jury inhibitions. Cf. F.R. of
Civ. P.44.1 ("The court, in determining foreign law, may consider any
relevant material or source, including testimony . . . .").
The case is stayed to permit plaintiffs to proceed administratively
under the Program. Any party may move for a lifting of the stay or other
relief upon a change of circumstances. The case shall be marked closed
for statistical administrate purposes only.
The parties have jointly moved to clarify the order of October 30,
2002. It stayed
the case pending application by plaintiffs for relief
pursuant to the National Vaccine Injury Compensation Program and a
decision by the Office of Special Masters ("OSM"). A stay is
The court clarifies its order by dismissing the case without
prejudice. The OSM can decide whether it has jurisdiction. Cf. Leroy v.
Sec'y of Dep't of Health & Human Servs., No. 02-392V, 2002 U.S.
Claims LEXIS 284 (Fed. Cl. Oct. 11, 2002).
Effective November 25, 2002, the Homeland Security Act of 2002 amends
section 2133 of the Public Service Health Act, 42 U.S.C. § 300aa-33.
The amendment includes a "Clarification of Definition of Vaccine." The
term now "includes all components and ingredients listed in the vaccine's
product license application and product label," Pub. L. 107-296, 116
Stat. 2135, § 1716 (2002) — which presumably covers the
thimerosal (mercury) component plaintiffs contend was not previously
included. The amendment applies "to all actions or proceedings pending on
or after the date of enactment of this Act, unless a court of competent
jurisdiction has entered judgment (regardless of whether the time for
appeal has expired) in such action or proceeding disposing of the entire
action or proceeding." § 1717.
The court need not consider whether the amendment applies to the
pending proceeding. Its decision of October 30, 2002, as clarified, is
based on the law prior to the effective date of the amendment, November
The case is dismissed without costs or disbursements. For good cause,
judgment will be deemed entered as of October 30, 2002 for purposes of
application of the Homeland Security Act, and as of December 16, 2002 for
purposes of appeal, but a thirty-day extension of time to file a notice of
appeal is granted. See Fed.R.App.Pro. 4(a)(5)(A)(ii). But see
© 1992-2003 VersusLaw Inc.