in the united states district court for the eastern...
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IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA
LISA SYKES AND SETH SYKES, Individually and as Parents and Natural Guardians of WESLEY ALEXANDER SYKES, a minor child Plaintiffs, vs. GLAXO-SMITHKLINE, Individually and as Successor-In-Interest to SmithKline Beecham Corporation; WYETH, INC., f/k/a AMERICAN HOME PRODUCTS CORPORATION, d/b/a WYETH, INC., WYETH LABORATORIES, WYETH-AYERST, WYETH-AYERST LABORATORIES, WYETH LEDERLE, WYETH LEDERLE VACCINES, and LEDERLE LABORATORIES; and BAYER PHARMACEUTICALS CORPORATION, f/k/a Bayer Corporation, Individually and as Successor-In-Interest to Miles, Inc., Defendants.
§ § § § § § § § § § § § § § § § § § § § § § § § §
CIVIL ACTION NO. 06-1111
DEFENDANT SMITHKLINE BEECHAM CORPORATION D/B/A GLAXOSMITHKLINE’S MOTION FOR SUMMARY JUDGMENT UNDER THE
VACCINE ACT OR ALTERNATIVELY ON GROUNDS OF PREEMPTION AND PRIMARY JURISDICTION
PEPPER HAMILTON LLP Nina M. Gussack (31054) Barry H. Boise (63125) Matthew J. Hamilton (78327) 3000 Two Logan Square 18th & Arch Streets Philadelphia, PA 19103-2799 (215) 981-4053
FULBRIGHT & JAWORSKI L.L.P. Barclay A. Manley 1300 McKinney, Ste. 5100 Houston, Texas 77010 (713) 651-5100 Stephanie A. Smith 600 Congress Avenue, Suite 2400 Austin, Texas 78702-3271 (512) 474-5201
Attorneys for Defendant SmithKline Beecham Corporation d/b/a GlaxoSmithKline
TABLE OF CONTENTS
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INTRODUCTION ......................................................................................................................... 1
FACTUAL BACKGROUND........................................................................................................ 5
A. The Product Labels Plaintiffs Challenge Were Approved by FDA After Rigorous Review .............................................................................. 5
1. SB’s Product License Application for Engerix-B®....................... 6
2. FDA reviewed and prescribed a label for Engerix-B®.................. 7
3. FDA issued a license for Engerix-B® ........................................... 9
B. Congress Has Directed the National Health Agencies to Oversee all Aspects of Vaccine Production and Distribution Through an Elaborate and Comprehensive Regulatory Regime ................................. 10
C. FDA Has Taken an Active Role With Respect to Thimerosal and Thimerosal-Containing Vaccines............................................................. 11
1. A brief history of thimerosal and thimerosal containing vaccines........................................................................................ 11
a. FDA has considered extensive scientific and other data and information regarding thimerosal in vaccines............................................................................ 12
b. The IOM’s independent scientific review of thimerosal containing vaccines rejected a causal link to autism.................................................................... 14
ARGUMENT AND AUTHORITIES.......................................................................................... 16
I. The Vaccine Act Forecloses Plaintiffs’ Claims in This Case .............................. 16
A. The Vaccine Act Preempts Plaintiffs’ Design Defect Claims ................. 16
1. The Vaccine Act sets uniform federal standards for products claims relating to vaccines ............................................ 16
2. Section 22(b) of the Vaccine Act precludes Plaintiffs’ design defect claims..................................................................... 17
a. Congress’ intent was clear ............................................... 19
b. The Vaccine Act’s policy is inconsistent with design defect claims......................................................... 23
c. Plaintiffs’ negligence claims are also barred ................... 24
B. Plaintiffs’ Warnings Claims Likewise Fail.............................................. 25
1. Plaintiffs’ “direct” warnings claims are expressly preempted..................................................................................... 25
TABLE OF CONTENTS (continued)
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2. Plaintiffs’ remaining warnings claims fail because they cannot satisfy the Vaccine Act’s threshold requirements for bringing such claims .................................................................... 26
a. SB is entitled to the presumption that its FDA-approved label is adequate ............................................... 26
b. Plaintiffs have no evidence of facts necessary to overcome the presumption that SB provided “proper directions and warnings”.................................................. 29
II. Plaintiffs’ Pennsylvania Law Failure to Warn Claims Are Preempted Because They Conflict With, and Stand as an Obstacle to, FDA’s Comprehensive Regulation of Prescription Vaccine Labels ............................... 30
A. Conflicts Preemption Applies When the State and Federal Laws Are Fatally in Conflict or the State Law Frustrates the Purpose of the Federal Law........................................................................................ 31
B. Plaintiffs’ Judicial Challenge to SB’s FDA-Approved Labeling “Stands as an Obstacle” to the Accomplishment of the FDA’s Comprehensive Federal Scheme Governing the Labeling of Prescription Products, Including Vaccines .............................................. 33
1. FDA carefully controls the content of labeling for prescription products, including biologics................................... 33
2. FDA-prescribed labeling sets both the “ceiling and the floor” ............................................................................................ 37
3. FDA’s view of the preemptive effect of its labeling decisions is entitled to deference ................................................. 40
a. The new labeling rule sets forth a clear statement from the agency................................................................ 40
b. FDA has consistently restated its position in amicus briefs in pharmaceutical warnings litigation.................... 41
C. The Vaccine Act Does Not “Bar the Ordinary Working of Conflict Preemption Principles” ............................................................................ 42
1. A savings clause does not preclude conflicts preemption ........... 43
2. The Vaccine Act’s saving provision cannot override conflicts preemption based on FDA’s exercise of delegated authority under the FDCA ........................................................... 44
III. The Doctrine of Primary Jurisdiction Provides an Alternative Basis for Deferring to FDA’s Extensive Regulatory Expertise and Experience................. 48
TABLE OF CONTENTS (continued)
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A. Primary Jurisdiction Respects the Role of FDA as the Exclusive Arbiter of Labeling Decisions.................................................................. 48
B. The Findings Necessary to Pursue a Warnings Claim Under the Vaccine Act Should Be Made First and Foremost by FDA..................... 52
1. FDA should determine whether SB has complied with the applicable federal laws and FDA regulations .............................. 53
2. Plaintiffs’ charges that SB withheld material information from FDA should be decided by FDA......................................... 56
CONCLUSION AND PRAYER ................................................................................................. 59
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TO THE HONORABLE UNITED STATES DISTRICT COURT:
Pursuant to Federal Rule of Civil Procedure 56, Defendant SmithKline Beecham
Corporation d/b/a GlaxoSmithKline (“SB”) files this Motion for Summary Judgment Under the
National Childhood Vaccine Injury Compensation Act (42 U.S.C. § 300aa-1, et seq.) (“Vaccine
Act”) or alternatively on grounds of federal preemption and/or primary jurisdiction under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et. seq.) (“FDCA”) and the Public
Health Service Act (42 U.S.C. § 262) (“PHSA”) to show the Court the following:
INTRODUCTION
This is a products liability action brought by Plaintiffs, individually and on behalf of the
minor Plaintiff, Wesley Alexander Sykes, against manufacturers and distributors of childhood
vaccines (and one non-vaccine product) containing the preservative thimerosal and approved by
the U.S. Food and Drug Administration (“FDA”). Plaintiffs allege that thimerosal-containing
products caused Wesley Sykes to experience neurological injuries.1
As prescription biological products, vaccines are subject to a comprehensive statutory
and regulatory system developed under the Vaccine Act, FDCA, and PHSA. Those statutes and
attendant regulations comprehensively govern vaccine design, production, distribution, and
labeling. Plaintiffs’ Pennsylvania law claims threaten to disrupt the federal regulatory scheme
for these prescription biological products.
The clear and overriding purpose of the Vaccine Act is to preserve our nation’s vaccine
supply for our children in order to prevent “deadly, disabling, but preventable infectious
diseases.”2 Through the Act, Congress created the groundbreaking Vaccine Injury
1 See e.g., Plaintiffs’ Complaint and Jury Demand (“Complaint”) ¶¶ 1, 12. 2 H.R. Rep. No. 99-908, at *4 (1986), reprinted in 1986 U.S. Code Congressional and Administrative News (“U.S.C.C.A.N.”) 6344, 6345 (Exhibit A).
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Compensation Program in order to “free[] manufacturers from the specter of large, uncertain tort
liability, and thereby . . . keep[] manufacturers in the market,” while at the same time “ensur[ing]
that all children who are injured by vaccines have access to sufficient compensation for their
injuries.”3 The Vaccine Act thus embodies carefully crafted compromises on many fronts.
For example, Congress has provided a no-fault compensation program for persons
claiming injuries from vaccines administered through the U.S. Court of Federal Claims. Further,
although Congress generally allowed the various states to supply the decisional law in tort cases
for vaccine-related injuries, it engrafted a number of federal standards to insure uniform
protection for vaccine defendants throughout the 50 states. One of these standards precludes a
vaccine company from having to defend a vaccine formula that has been approved by the FDA
against allegations that safer designs were available. This standard applies directly in this case
because Plaintiffs’ theory is that the vaccines administered to Wesley Sykes, prepared according
to their FDA-approved formulas, caused injury because they contained thimerosal. Plaintiffs
challenge the FDA-approved formula itself—not any departure from it. This is precisely the
type of claim that Congress has foreclosed in the Vaccine Act. Rather than permitting juries to
decide whether a particular vaccine could have been made safer, Congress entrusted that role to
the top federal health agencies with the expertise and experience to carry out the mandate to
research and promote the development of safer alternatives.4 All claims that are predicated on a
complaint about a vaccine’s design are preempted by the Vaccine Act, regardless of how they are
3 Id. at 7. 4 See 42 U.S.C. § 300aa-27.
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styled: the Vaccine Act “shows Congress’s intent to foreclose all design defect claims against
vaccine manufacturers.”5
Plaintiffs’ warnings claims are also barred because they cannot meet the limitations that
the Vaccine Act has placed on such claims. As explained below, SB is entitled to the Vaccine
Act’s presumption that its FDA-prescribed warnings were adequate. Plaintiffs thus have the
burden to prove one of the statutory grounds for overcoming the presumption, such as willful and
intentional withholding of material information from the FDA. These exceptions embody
Congress’ intent “that only those significant failures to warn or provide directions that clearly
pertain to vaccine safety and that clearly arise from substantial wrongdoing on the part of the
manufacturer ought to result in liability.”6 Plaintiffs have no evidence that SB duped the FDA or
otherwise engaged in misconduct in obtaining approval for its Engerix-B® vaccine or the
vaccine’s label, and so cannot overcome the statutory threshold for a claim for inadequate
warnings; their warnings claim thus fails as a matter of law.
The Vaccine Act was designed to be a radical and comprehensive departure from the
litigation status quo. There is no question that Congress supplanted the “traditional tort system,”
which posed a threat to the national vaccine supply.7 The plain language of the statute and its
legislative history make clear that summary judgment is appropriate as to Plaintiffs’ design,
warnings, negligence, and testing claims.
5 Blackmon v. Am. Home Prods., Corp., 328 F. Supp. 2d 659, 664 (S.D. Tex. 2004); see also Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 845-46 (N.Y. Sup. Ct. 2003) (“Congress did not intend that national vaccine policy be determined by the vagaries of a jury’s determination on a case-by-case basis.”), aff'd, ___ N.Y.S.2d ___, 2006 WL 489200 (N.Y. App. Div. Feb. 28, 2006). 6 H.R. REP. NO. 99-908, at *26, reprinted in 1986 U.S.C.C.A.N. 6344, 6367. 7 O’Connell v. Shalala, 79 F.3d 170, 173 (1st Cir. 1996).
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Independently, Plaintiffs’ failure to warn claims are preempted under the FDCA and
PHSA. For Plaintiffs to succeed on a failure to warn claim here, they would have to establish
that the warnings contained in SB’s FDA-approved labeling were inadequate notwithstanding the
agency’s careful scrutiny and approval. FDA has thoroughly considered the role of thimerosal in
childhood vaccines and has concluded that the thimerosal contained in these vaccines does not
cause the types of neurological injuries Plaintiffs allege. Thus, the warnings Plaintiffs allege
should have been provided are not scientifically indicated today. Plaintiffs certainly cannot show
that such warnings would have been appropriate—much less required—in 1996, when the Sykes
child was first vaccinated.
FDA has recently and definitively stated its position that failure to warn claims like
Plaintiffs’ are preempted by FDA’s comprehensive “regulation of prescription drug labeling.”8
This statement by the agency—which is “the expert Federal public health agency charged by
Congress with ensuring that drugs are safe and effective”9—is “dispositive on the question of
implicit intent to pre-empt” under the circumstances presented.10 As FDA’s official statement
makes clear, labeling decisions are within its exclusive province; it serves as the final arbiter for
all warnings necessary and appropriate in a prescription label. FDA has concluded that there is a
significant risk to national health when prescription drug warnings “include theoretical hazards
not well-grounded in scientific evidence, [which] can cause meaningful risk information to ‘lose
8 Department of Health and Human Services, Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products (21 C.F.R. parts 201, 314, and 601), 71 Fed. Reg. 3922, 3935-36 (Jan. 24, 2006) (quoting 44 Fed. Reg. 37434 at 37447 (June 26 1979)). 9 Id. at 3934. 10 See Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 714-15 (1985) (stating that agency’s interpretation of preemptive effect is dispositive unless inconsistent with clearly expressed congressional intent or superseded by subsequent events revealing a change in position).
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its significance.’”11 Put another way, “overwarning” has the potential to discourage safe and
effective use of approved products or to encourage inappropriate use and undermine the
objectives of federal pharmaceutical law.12 By law, SB could not have changed its label to
provide the warnings Plaintiffs allege were lacking because there is no evidence that FDA would
have approved such a change. To the contrary—based on FDA’s official position as to
thimerosal in vaccines—that approval would not have been given. Plaintiffs should not be
permitted to bypass the regulatory process by seeking a judicial determination to the contrary.
FDA also has primary jurisdiction over these issues based on its exclusive regulatory
authority over the labeling of these prescription biologics. The findings that Plaintiffs must
obtain to win a failure to warn judgment are clearly within the expertise and experience of the
agency, and uniformity of decision on these issues is required throughout the country. Congress
envisioned and decreed that FDA play this role, FDA has assumed it, and the Court should defer
to the agency’s resolution of these issues. Whether considered in terms of preemption or primary
jurisdiction, Plaintiffs’ claims cannot go forward in this forum because a lay jury’s findings as to
the adequacy of SB’s FDA-approved labeling would be both inappropriate and highly
problematic to the proper administration of FDA’s labeling program for the prescription drug
industry, as Congress has ordained.
FACTUAL BACKGROUND
A. The Product Labels Plaintiffs Challenge Were Approved by FDA After Rigorous Review
The minor Plaintiff in this case, Wesley Sykes, received vaccinations during the first
three years of his life. Complaint ¶ 8. Some of these vaccines are alleged to have contained the
11 71 Fed. Reg. at 3935-36. 12 Id. at 3936.
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mercury-derived preservative thimerosal. Id. Thimerosal has been used as a preservative in a
number of biological products since the 1930s. U.S. Food and Drug Administration Center for
Biologics Evaluation and Research (“CBER”), Thimerosal in Vaccines at 2 (updated June 22,
2006) (Exhibit 1)13; see also Owens v. Am. Home Prods. Corp., 203 F. Supp. 2d 748, 755 (S.D.
Tex. 2002). It was used as a preservative in certain childhood vaccines to “deter[] microbial and
fungal growth, thereby maintaining the safety, purity and potency of vaccines” both during and
after the manufacturing process. Id.
As explained in more detail below, SB’s Engerix-B® vaccine, which contained
thimerosal as a preservative, was approved by FDA for distribution and sale in the United States.
See, e.g., Declaration of Clare Kahn (Exhibit B) at ¶ 11 & Exhibits B-6 & B-7.14 The vaccine
was distributed with labeling information required and prescribed by FDA, and Plaintiffs do not
allege otherwise. The Engerix-B® label disclosed that the vaccine contained “thimerosal
(mercury derivative)” as part of the formula, as well as the concentration of the preservative. See
Exhibit B, ¶ 8. The disclosure and description of thimerosal in this label could not be changed
without FDA approval. 21 C.F.R. § 601.12 (1989).
1. SB’s Product License Application for Engerix-B®
In order to obtain a license authorizing the sale and distribution of Engerix-B® in the
United States, SB submitted several comprehensive and mandatory applications to FDA. On
November 25, 1987, SB submitted a Product License Application (“PLA”) and Establishment
13 CBER is a division of FDA that regulates biologics, including vaccines. This FDA document can be found at http://www.fda.gov/cber/vaccine/thimerosal.htm. A copy is attached to SB’s Motion to Take Judicial Notice Pursuant to Federal Rule of Evidence 201 (“Motion to Take Judicial Notice”), filed contemporaneously. Subsequent references to sequentially numbered “Exhibits” will be to the attachments to SB’s Motion to Take Judicial Notice. 14 The original of this declaration is attached to this motion. As explained in note 13, supra, the numeric exhibits are attached to SB’s Motion to Take Judicial Notice.
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License Application (“ELA”) to FDA. Exhibit B, ¶¶ 7, 9; see also 21 C.F.R. §§ 601.1, 601.2
(1987). The PLA is an incredibly detailed submission that documents every aspect of the
proposed vaccine, including a full description of the manufacturing methods; data derived from
non-clinical laboratory and clinical studies that demonstrate that the manufactured product met
prescribed requirements of safety, purity, and potency; a description of how the studies were
conducted; samples representative of the product; summaries of lot test results performed on the
representative samples; and specimens of the labels, enclosures, and containers proposed to be
used for the product. E.g., 21 C.F.R. §§ 601.2, 601.3, 610.60-.61 (1987). All of this information
is thoroughly reviewed and considered by FDA in deciding whether to issue a license.
The PLA for Engerix-B® also identified thimerosal as the vaccine preservative,
described the points at which thimerosal was added or used in the manufacturing process,
indicated the target concentration for thimerosal, demonstrated the efficacy of the preservative,
and stated the method and parameters of release testing to ensure a specific amount of thimerosal
in the final product. Exhibit B, ¶ 7.
2. FDA reviewed and prescribed a label for Engerix-B®
As part of its decision to issue the product license, FDA also scrutinized the proposed
labeling15 in a rigorous process. Its formal approval of the final draft labeling came only after it
was satisfied that “a vaccine label’s warnings, use instructions and precautionary information
have been sufficiently revised to include current information regarding the nature and extent of
the dangers posed by such vaccines . . . .” Guidance for Industry: FDA Review of Vaccine
15 “Labeling” includes “all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article, and, therefore, includes any package inserts or information sheets that accompany vaccine products.” See Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information at 1 n.1 (September 2004) (Exhibit 2) (citing 21 U.S.C. § 321(m)).
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Labeling Requirements for Warnings, Use Instructions, and Precautionary Information at 1-3
(September 2004) (“FDA Guidance”) (Exhibit 2).16
In connection with the submission of the PLA for Engerix-B®, SB submitted the specific
proposed wording and content for package inserts (enclosures), containers, and labels for
Engerix-B®. Exhibit B, ¶ 8; see also 21 C.F.R. § 610.2 (1987). As required by FDA
regulations, the Engerix-B® container and package labels included the product name; name,
address, and license number of the manufacturer; lot number; expiration date of the vaccine;
recommended dosage; and a prescribed cautionary statement about prescription biologicals. See
Exhibit B, ¶ 8; see also 21 C.F.R. §§ 610.60-.61 (1987). The package labels as approved by
FDA also stated that the vaccines were “preserved with thimerosal 1:20,000 (mercury
derivative).”17 The proposed package inserts contained the above information, as well as the
following: the preservative used; recommended storage temperature; words of instruction;
recommended dosage and administration; known sensitizing substances; inactive ingredients; the
adjuvant; source of product; identity of each microorganism used in manufacture; and the
minimum potency of the product. Exhibit B, ¶8. The package insert for Engerix-B® also
contained a detailed description of the product and its clinical pharmacology, as well as its
contraindications, warnings, precautions, and adverse reactions. Id. The package inserts were
reviewed by FDA’s scientific and medical experts under a mandate to reject any labeling that
omits any material information relating to safety. 21 U.S.C. §§ 321(n), 331(a), (b), & (k), 352,
16 The FDA Guidance is available at http://www.fda.gov/cber/gdlns/vacclabel.pdf. 17 This language—“1:20,000 thimerosal (mercury derivative) as a preservative”—did not change until SB introduced a preservative-free formula of Engerix-B® after having obtained approval from FDA on or about March 28, 2000. See Exhibit B, ¶ 8 & n.3.
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and 355(d)(7). FDA approved and prescribed the form and content of the Engerix-B® labeling
when it issued SB a license for the product. See Exhibit B-3.
3. FDA issued a license for Engerix-B®
On August 28, 1989, FDA issued Product and Establishment licenses, approving the
distribution of Engerix-B® in the United States. See Exhibits B-6 & B-7 (August 28, 1989,
approval letter from Paul Parkman, M.D., Director, Center for Biologics Evaluation and
Research to Julien Peetermans, SmithKline Biologicals, and Product License, respectively). SB
could not unilaterally make changes in the manufacturing process set forth in the PLA or the
previously approved labeling without FDA’s approval. 21 C.F.R. § 601.12 (1989); see also
Exhibit B, ¶ 11. In fact, the FDA approval letter described above states that “[a]ny changes in
the manufacture, packaging or labeling of the product or the manufacturing facilities will
require the submission of an amendment to either [SB’s] product or establishment license
application for [FDA’s] review and written approval prior to implementation.” Exhibit B-6 at
p. 1 (emphasis added).
Since the time of FDA’s original approval of the Engerix-B® labeling materials, SB has
requested approval for changes in the labeling materials and has made such changes in
accordance with FDA approval. Exhibit B, ¶ 12. SB has not made any changes to its labeling
materials for Engerix-B® that were not approved by FDA. Id. SB distributes Engerix-B® in the
United States together with the labeling materials approved by FDA. Id.
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B. Congress Has Directed the National Health Agencies to Oversee all Aspects of Vaccine Production and Distribution Through an Elaborate and Comprehensive Regulatory Regime
Federal law requires licensing of all biological products through a license application18 to
FDA, as well as FDA approval of the information in vaccine package inserts. 21 C.F.R.
§§ 601.2; 601.12(a) (1989). As noted, FDA conducts a detailed review and approval process for
the information prescription drug manufacturers must include in package inserts, which are the
primary form of labeling for prescription drugs. 21 C.F.R. §§ 201.56, 201.57. And once FDA
approves a label, no changes can be made to that label without FDA’s approval. 21 C.F.R.
§ 601.12. Any unapproved changes to the label may render the product “mis-branded” under
federal law, subjecting the manufacturer to substantial fines and other penalties. 21 U.S.C.
§§ 352, 355(a).
In addition to these regulations requiring FDA approval of prescription drug labeling,
through the Vaccine Act, Congress specifically charged the Secretary of the Department of
Health and Human Services (“HHS”) with an active role in developing safer vaccines and
“mak[ing] or assur[ing] improvements in . . . labeling, warning, [and] use instructions . . . and
research on vaccines, in order to reduce the risk of adverse reactions to vaccines.” 42 U.S.C.
§ 300aa-27(a)(2) (emphasis added). That provision, entitled “Mandate for safer childhood
vaccines,” requires the Secretary to “promote the development of childhood vaccines that result
in fewer and less serious adverse reactions than those vaccines on the market on December 27,
1987, and promote the refinement of such vaccines.” Id. § 300aa-27(a)(1). Section 27 also
provides that the Secretary “shall establish a task force on safer childhood vaccines,” consisting
18 At the time SB submitted its application for a product license, the regulations provided for a “Product License Application.” See part A.1 of the “Factual Background” above. Currently, the regulations require a “Biologics License Application.”
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of “the Director of the National Institutes of Health, the Commissioner of the Food and Drug
Administration, and the Director of the Centers for Disease Control,” which is to consult with the
Advisory Commission on Childhood Vaccines, in order to make recommendations to increase
vaccine safety and efficacy. Id. § 300aa-27(b). Thus, Congress has designated the top
government health agencies—which had been previously and collectively entrusted with national
health policy—to join forces to develop safer alternative vaccines, including ones with better
warnings.
C. FDA Has Taken an Active Role With Respect to Thimerosal and Thimerosal-Containing Vaccines
Consistent with its statutory role, FDA has been actively involved with the review of
safety and efficacy of thimerosal containing vaccines and their labels, like the ones allegedly
administered to Wesley Alexander Sykes. The following sets forth a history of the use of
thimerosal as a preservative, as well as some of the pertinent details of FDA’s role with respect
to these vaccines and its resolution of issues raised by litigants like Plaintiffs throughout the
country.
1. A brief history of thimerosal and thimerosal containing vaccines
Since the early 20th Century, most biologic products (including vaccines) have included
a preservative to prevent the growth of microbial contaminants. As noted, thimerosal was
developed in the late 1920s for this purpose, and has been used extensively in biologicals since
1930. In biologic media, thimerosal breaks down to release ethylmercury. CBER, Thimerosal in
Vaccines at 2 (Exhibit 1).
Thimerosal’s record of safe and effective use was reflected in a February 1976 internal
FDA review on the use of thimerosal in biological products, which concluded in pertinent part:
Most biologics containing thimerosal are given infrequently in half or one milliliter amounts. Since thimerosal contains 49.55% mercury one milliliter of a
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solution containing a one part per 10,000 dilution of thimerosal would have 50 ppm or 25 micrograms of mercury per milliliter. Using doses and schedules recommended by the 1974 American Academy of Pediatric Redbook . . . no dangerous quality of mercury is likely to be received from biologic products in a lifetime.
Gibson, S., Use of thimerosal in biologics production. Memorandum from Assistant Director,
Bureau of Biologics, to Director, Bureau of Biologics, FDA (1976) (Exhibit 3).
In 1997, Congress passed the FDA Modernization Act (“FDAMA”) which, among other
things, required federal agencies to determine the amount of mercury contained in products for
human use. FDA reports that it “has been actively addressing the issue of thimerosal as a
preservative in vaccines” since the passage of FDAMA. CBER, Thimerosal in Vaccines at 6
(Exhibit 1). As part of that effort, FDA “conducted a comprehensive review of the use of
thimerosal in childhood vaccines,” ultimately concluding that there was “no evidence of harm
from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions.”
Id. (citing Ball et al. 2001).
a. FDA has considered extensive scientific and other data and information regarding thimerosal in vaccines
The “controversy over thimerosal in vaccines erupted” in 1999. Immunization Safety
Review Committee, Board on Health Promotion and Disease Prevention, Institutes of Medicine
(“IOM”), Immunization Safety Review: Vaccines and Autism at 5 (National Academies Press
2004) (“IOM Report”) (Exhibit 4).19 In July of 1999, FDA noted that the total ethylmercury
exposure from thimerosal-containing vaccines administered pursuant to the recommended
childhood immunization schedule could potentially exceed the U.S. Environmental Protection
Agency (“EPA”) guidelines for a lifetime’s average daily exposure to methylmercury in fish and
19 The Executive Summary of the IOM Report is attached as Exhibit 4 to SB’s Motion to Take Judicial Notice. The entire report is available at http://www.nap.edu/books/030909237X/html.
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seafood. Concurrently, the American Academy of Pediatrics (“AAP”) issued a notice to its
members stating a preference for thimerosal-free vaccines, but not urging the withdrawal of
thimerosal-containing vaccines from the market. AAP, Notice to Readers: Thimerosal in
vaccines: A joint statement of the American Academy of Pediatrics and the Public Health
Service,20 MMWR 1999; 48(26): 563-65 (Exhibit 5). In fact, the notice expressly approved
administration of thimerosal-containing vaccines if thimerosal-free versions were unavailable,
reflecting the belief that the potential for harm was theoretical only and that the benefits of
administering such vaccines continued to outweigh any potential risks. Id. That notice led both
to further study of thimerosal and to litigation alleging that exposure to thimerosal-containing
vaccines, given in accordance with the recommended childhood vaccination schedule, causes a
“unique” form of mercury poisoning that manifests as autism. E.g., CBER, Thimerosal in
Vaccines at 6 (Exhibit 1).
FDA has considered voluminous safety studies and materials to determine whether
further action need be taken. Id. at 4, 6-7 (summarizing reports of allergic reactions in clinical
literature and noting nonetheless that thimerosal used in vaccines “has a long record of safe and
effective use”). Yet FDA has not changed its view on the safety of thimerosal even with the
benefit of all of the information available to date. Instead, in its Thimerosal in Vaccines article,
updated in June 2006, FDA has concluded that there is “no evidence of harm from the use of
thimerosal as a vaccine preservative, other than local hypersensitivity reactions.” Id. at 6; see id.
at 4 (“[T]himerosal has been the subject of several studies . . . and has a long record of safe and
effective use preventing bacterial and fungal contamination of vaccines, with no ill effects
20 The Public Health Service included FDA, National Institutes of Health (“NIH”), Center for Disease Control and Prevention (“CDC”) and Health Resources and Services Administration (“HRSA”). See U.S. Food and Drug Administration Center for Biologics Evaluation and Research, Thimerosal in Vaccines at 6 (updated June 22, 2006).
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established other than minor local reactions at the site of injection.”).21 To this day, FDA has
never mandated or even suggested that vaccine companies include warnings on thimerosal-
containing vaccines for potential “neurodevelopmental” or “autistic” disorders, even though
FDA acknowledges that there is at least one vaccine containing the preservative thimerosal—an
inactivated flu vaccine—currently available and recommended for pediatric use. Id. at 7 & Table
1 (“Fluzone (AP)”).22
b. The IOM’s independent scientific review of thimerosal containing vaccines rejected a causal link to autism
During this same time-frame, the NIH and CDC requested that the IOM undertake an
independent scientific review of the very issues raised by this litigation. The IOM’s
Immunization Safety Review Committee (“IOM Safety Committee”) examined the hypothesis
that thimerosal containing vaccines are causally associated with autism, reviewing a wide variety
of studies, epidemiological data, and other information related to vaccines and autism from the
U.S., Denmark, Sweden, and the United Kingdom. In May 2004, after reviewing the available
21 Likewise the European Agency for the Evaluation of Medicinal Products (“EMEA”)—which is the equivalent of the United States FDA—has concluded that recent evidence demonstrates “no association between the vaccination with thiomersal [thimerosal]-containing vaccines and specific neurodevelopmental disorders.” EMEA Public Statement on Thiomersal in Vaccines for Human Use—Recent Evidence Supports Safety of Thiomersal-Containing Vaccines (March 24, 2004), http://www.emea.eu.int/pdfs/human/press/pus/119404en.pdf (Exhibit 6). (Note: In Europe, thimerosal is known as thiomersal). 22 In FDA’s “Thimerosal in Vaccines: Frequently Asked Questions,” FDA indicates its view that thimerosal containing flu vaccines are safe for children:
Q: Is it safe for children to receive an influenza vaccine that contains thimerosal?
A: Yes. There is no convincing evidence of harm caused by the small doses of thimerosal preservative in influenza vaccines, except for minor effects like swelling and redness at the injection site.
Recent research suggests that healthy children under the age of 2 are more likely than older children and as likely as people over the age of 65 to be hospitalized with flu complications. Therefore, vaccination with thimerosal-preservative containing influenza vaccine and thimerosal-reduced influenza vaccine is encouraged when feasible in children, including those that are 6-23 months of age.
http://www.fda.gov/cber/vaccine/thimfaq.htm at 8 (Exhibit 7).
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evidence on both sides of the debate, the IOM Safety Committee concluded that “the evidence
favors rejection of a casual relationship between thimerosal containing vaccines and autism.”
IOM Report at 7, 65 (emphasis in original) (Exhibit 4).23
The IOM Safety Committee’s Report is only one of a series of pronouncements by
independent advisory committees and other institutions concerned with vaccine safety, all of
which have concluded that there is no reliable scientific evidence demonstrating a link between
thimerosal-containing vaccines and autism or autism spectrum disorders.24 FDA is quite familiar
with the IOM Report and these other safety studies, and its views are consistent with their
conclusions. See, e.g., CBER, Thimerosal in Vaccines at 6, 7-8.
23 The IOM Safety Committee explained its established framework for assessing causality as follows. It begins with a position of neutrality as to the hypothesis under review, determining whether the
weight of available clinical and epidemiological evidence determines whether it is possible to shift from that neutral position to a finding for causality (“the evidence favors acceptance of a causal relationship”) or against causality (“the evidence favors rejection of a causal relationship”). The committee does not conclude that the vaccine does not cause the adverse event merely because the evidence is inadequate to support causality. Instead, it maintains a neutral position, concluding that the “evidence is inadequate to accept or reject a causal relationship.”
IOM Report at 2-3 (Exhibit 4). 24 World Health Organization (“WHO”), Statement on Thiomersal, August 2003, available at http://www.who.int/vaccine_safety/topics/thiomersal/statement200308/en/print.html (Exhibit 8); WHO, Position of the Global Advisory Committee on Vaccine Safety regarding concerns raised by recent paper about the safety of thiomersal-containing vaccines, available at http://www.who.int/vaccine_safety/topics/thiomersal/statement/en/print.html (Exhibit 9); EMEA, EMEA Public Statement On Thiomersal In Vaccines For Human Use – Recent Evidence Supports Safety of Thiomersal-Containing Vaccines, March 24, 2004 (Exhibit 6); Committee on Safety of Medicines, Annual Report for 2003, http://www.mca.gov.uk/aboutagency/regframework/csm/csm_ar.pdf (Exhibit 10); CSM, Statement From The Committee On Safety Of Medicines: Further Data Support Safety Of Thiomersal In Vaccines, available at http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/safetymessages/thiomersalstatement_210203.pdf (Exhibit 11); CDC, Thimerosal & Vaccines, available at http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/faqs-thimerosal.htm - 7 (Exhibit 12); AAP, What Parents Should Know About Thimerosal, available at http://www.cispimmunize.org/fam/thimerosal.htm (Exhibit 13); AAP, Study fails to show a connection between thimerosal and autism (2003) available at http://www.cispimmunize.org/pro/doc/Geiersummary.doc) (Exhibit 14).
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ARGUMENT AND AUTHORITIES
I. The Vaccine Act Forecloses Plaintiffs’ Claims in This Case
A. The Vaccine Act Preempts Plaintiffs’ Design Defect Claims
The Complaint alleges that the vaccine companies are strictly liable for Wesley Sykes’
injuries because “the vaccine products . . . were unreasonably and dangerously defective because
they contained dangerous levels of ethyl mercury25 . . . [and] [t]here existed at all times a safer,
practical and feasible alternative to the use of ethyl mercury as a means of preventing the
contamination of defendants’ vaccine[s] . . . .” Complaint ¶¶ 16-17. Plaintiffs also allege the
vaccine companies were negligent because they “[i]ncluded dangerous levels of a known
neurotoxin . . . [and] failed to use safer, feasible and practical alternative packaging designs that
would have completely eliminated the use of mercury-containing ingredients in the shots used by
plaintiff . . . .” Id. ¶ 27(a) & (b). Plaintiffs do not allege that the vaccines administered to the
child contained a manufacturing defect. The crux of Plaintiffs’ case is that the vaccines
administered to Wesley Sykes were supposedly defectively designed because they contained
thimerosal. The Vaccine Act precludes claims—like Plaintiffs’—that an FDA-approved vaccine
was defectively designed.
1. The Vaccine Act sets uniform federal standards for products claims relating to vaccines
Under the Supremacy Clause of the Constitution, state law must yield to acts of Congress
and other forms of federal law, which form “the Supreme Law of the Land.” U.S. CONST.
art. VI. Preemption is but one facet of the Supremacy Clause, and it applies when federal law
essentially displaces a state claim in favor of a federal cause of action or other remedial
25 As noted above, thimerosal breaks down to release ethylmercury. CBER, Thimerosal in Vaccines at 2 (Exhibit 1).
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scheme.26 Even when it does not entirely eradicate a state law claim, the Supremacy Clause can
be used to place limits on, and make other modifications of, state law, such as Congress has done
in the substantive and procedural provisions of the Vaccine Act. See Brice v. Sec’y of Health &
Human Servs., 240 F.3d 1367, 1368 (Fed. Cir. 2001) (recognizing that the Vaccine Act modifies
state tort law); Schafer v. Am. Cyanamid Co., 20 F.3d 1, 3 (1st Cir. 1994) (Vaccine Act
“provide[s] certain federal modifications of state tort law”).
The Vaccine Act provides that “State law shall apply to a civil action” for “vaccine-
related injury,” 42 U.S.C. § 300aa-22(a), except in the following respects, in which case the
federal statute supplies the standards:
• No vaccine manufacturer shall be liable for damages arising from a vaccine-related injury “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” 42 U.S.C. § 300aa-22(b)(1);
• FDA-approved warnings are presumed to be adequate if the vaccine company demonstrates “that it complied in all material respects” with the applicable FDA and vaccine statutes and regulations. Id. § 300aa-22(b)(2).
• No vaccine manufacturer will be liable “solely due to the manufacturer’s failure to provide direct warnings to the injured party . . . .” Id. § 300aa-22(c).
In Section 22, Congress has expressly provided that Pennsylvania law must yield to these
standards. As explained below, application of these standards in this case mandates summary
judgment in favor of SB.
2. Section 22(b) of the Vaccine Act precludes Plaintiffs’ design defect claims
The first of the federal standards at issue in this motion, Section 22(b)(1) of the Vaccine
Act, provides that:
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were
26 See part II.A, infra.
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unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
42 U.S.C. § 300aa-22(b)(1). This provision is not limited to any particular type of tort claim.
Rather, its plain language immunizes vaccine manufacturers from all civil liability with respect
to vaccines that are “properly prepared” and “accompanied by proper directions and warnings.”
Id. In other cases involving indistinguishable allegations about thimerosal containing vaccines,
the courts have concluded that this language preempts personal injury claims premised on state
tort law design defect allegations. See Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d
659, 665 (S.D. Tex. 2004) (Ҥ 22(b) directs the evaluation of vaccine design exclusively to the
FDA.”); Ferrari v. Am. Home Prods. Corp., No. 02-VS-031404-F, slip op. at 10 (State Ct. of
Fulton Cty, Ga. Nov. 30, 2005) (Exhibit C) (“Congress [did not] leave vaccine design standards
open to reexamination under the laws of each state, with the potential for interstate conflict: the
Vaccine Act sets one rule, applicable nationwide, that pre-empts design defect claims.”); cf.
Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 843 (N.Y. Sup. Ct. 2003) (noting that “this section
preempts state law to the extent stated”), aff'd, ___ N.Y.S.2d ___, 2006 WL 489200 (N.Y. App.
Div. Feb. 28, 2006).
In finding preemption, the Blackmon court considered both interpretations of the
unavoidable injury language of Section 22(b) that were posited by the parties. The first view—
and the view adopted by the Court—is that the statutory provision directs an absolute immunity
from liability for design defect claims arising from vaccine-related injuries. Blackmon, 328
F. Supp. 2d at 663. The alternative view, argued by Plaintiffs, is that the Act “only bars design
defect claims if the side effects are determined, on a case-by-case basis, to be ‘unavoidable.’”
Id.; see also Militrano, 769 N.Y.S.2d at 843-44 (recognizing that Section 22(b) might be read to
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mean either that any injury from a properly prepared and warned vaccine is unavoidable, or that
the determination of unavoidability should be made on a case-by-case basis).
In determining that the Vaccine Act imposes a total bar on design claims related to
vaccines, the Blackmon court turned to the Restatement (Second) of Torts and the legislative
history of the Act. Blackmon, 328 F. Supp. 2d at 663-64. The Militrano court also considered
“the legislative history of the Act, the Restatement (Second) of Torts, and the case law that
existed at the time the Act was enacted.” Militrano, 769 N.Y.S.2d at 844. The Ferrari court
likewise observed that the legislative history “confirms Congress's intention” to adopt a
“statutory standard” “immuniz[ing] manufacturers of ‘properly prepared’ products that are
‘accompanied by proper directions and warnings’ from all design defect claims.” Ferrari, slip
op. at 10. As these courts correctly found, “the background of products liability law”
demonstrates that Congress intended Section 22 to provide complete immunity from tort liability
based upon the design of vaccines. Blackmon, 328 F. Supp. 2d at 664; Militrano, 769 N.Y.S.2d
at 844-45; Ferrari, slip op. at 8-10.
a. Congress’ intent was clear
As the Blackmon, Militrano, and Ferrari courts have concluded, a review of the
legislative history compels the conclusion that Congress intended Section 22(b) to immunize
vaccine companies from liability for defective design. The need for this type of protection was
appreciated by Congress when a series of lawsuits against vaccine manufacturers was threatening
to interfere with the nation’s vaccine supply. H.R. Rep. 99-907, 1986 U.S.C.C.A.N. at 6345-48
(1986). Because of the costs of litigation and insurance (and its dwindling availability), it was
becoming prohibitive for manufacturers to supply vaccines. Id. at 6347. Congress recognized
that having a uniform national vaccine regimen was a crucial public good—one that had saved
countless lives—and feared that continued development and production of vaccinations would
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cease if the manufacturers remained unprotected from the high costs of litigation. Id. at 6346-47.
Balanced against its concerns for protecting this very positive benefit to public health was
Congress’ interest in affording individuals with vaccine-related injuries prompt, comprehensive,
and effective compensation. Id.
To effect its plan, Congress established the Vaccine Court to adjudicate claims of
vaccine-related injury and to award compensation to injured individuals. The Vaccine Court
uses substantive and evidentiary standards far more relaxed than would apply in a civil action in
state or federal court. Moss v. Merck & Co., 381 F.3d 501, 503 (5th Cir. 2004). Notably, a
claimant need not prove liability on the part of the vaccine company, and in some cases is
entitled to a presumption of causation. Militrano, 769 N.Y.S.2d at 843. The statutory
compensation process is designed to render generous awards expeditiously. Moss, 381 F.3d at
503; see also Owens, 203 F. Supp. 2d at 752. To protect the supply of childhood vaccines in the
United States, Congress also provided substantial protection to vaccine manufacturers from
costly civil litigation by: (i) barring civil actions arising from vaccine-related injuries unless the
claim was first presented in the Vaccine Court and the remedy available there exhausted; and
(ii) immunizing vaccine manufacturers from liability for alleged vaccine-related injuries caused
by vaccines that were properly prepared and accompanied by proper directions and warnings;
and (iii) providing certain presumptions as to warnings and against punitive damages for
companies who complied with federal laws and regulations. Moss, 381 F.3d at 503; see also
Blackmon, 328 F. Supp. 2d at 663-65.
The no-fault design of the Act, together with Section 22(b) of the Act, reflect a
significant legislative compromise in providing, on the one hand, universal access to
compensation for vaccine-related injuries—whether a particular state’s law would have afforded
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it or not—and on the other hand affording uniform protection to vaccine manufacturers for
vaccine products produced in accordance with FDA-approved specifications. 1986
U.S.C.C.A.N. at 6354, 6366-67. In discussing the Vaccine Act, the Committee on Energy and
Commerce reported:
Given the existence of the compensation system in [the Vaccine Act], the Committee strongly believes that Comment k is appropriate and necessary as the policy for civil actions seeking damages in tort. Vaccine-injured persons will now have an appealing alternative to the tort system. Accordingly, if they cannot demonstrate under applicable law either that a vaccine was improperly prepared or that it was accompanied by improper directions or inadequate warnings [they] should pursue recompense in the compensation system, not the tort system.
1986 U.S.C.C.A.N. at 6367 (emphasis added). This “passage indicates rather clearly the
Committee’s intent to relegate design defect claims into the compensation system, provided that
the injury-producing vaccine was manufactured and distributed according to applicable federal
standards.” Blackmon, 328 F. Supp. 2d at 665. Thus, it is clear that, as a matter of public policy,
Congress intended for such vaccines to be immune from suit in the state tort system.
Moreover, the structure of the Vaccine Act read as a whole supports this result. Congress
certainly did not intend for juries to make case-by-case determinations as to what vaccines are
“unavoidably unsafe,” a result that would not provide manufacturers any insulation from the high
litigation costs that Congress was seeking to forestall. See Blackmon, 328 F. Supp. 2d at 665
(allowing a case-by-case determination of unavoidably unsafe would “strip the [Vaccine Act] of
all meaning” because it “would provide no protection against design defect claims”). Instead,
Congress specifically delegated that important function to the HHS Secretary in the Vaccine Act.
42 U.S.C. § 300aa-27. That provision, entitled “Mandate for safer childhood vaccines,” requires
the Secretary to “promote the development of childhood vaccines that result in fewer and less
serious adverse reactions than those vaccines on the market on December 27, 1987, and promote
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the refinement of vaccines.” Id. § 300aa-27(a)(1). It further directs the Secretary to “make or
assure improvements in . . . the licensing, manufacturing, processing, testing, labeling, warning, .
. . and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.” Id.
§ 300aa-27(a)(2). Section 27 also provides that the Secretary “shall establish a task force on
safer childhood vaccines,” consisting of “the Director of the National Institutes of Health, the
Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease
Control,” which is to consult with the Advisory Commission on Childhood Vaccines, in order to
make recommendations to increase vaccine safety and efficacy. Id. § 300aa-27(b). Thus,
Congress determined that the top government agencies—which had been previously and
collectively entrusted with national health policy—should join forces to develop safer alternative
vaccines. In doing so, Congress left no room for juries throughout the 50 states to second-guess
those determinations.
Indeed, in light of its expressly stated concern for nationally uniform treatment of
vaccines and comprehensive regulation of prescription biologicals, it makes no sense for
Congress to have allowed room for potentially conflicting jury decisions to determine whether a
particular injury was “unavoidable.” Applying the laws of 50 different states, and fact finding on
a case-by-case basis, to determine whether a design-related injury was “unavoidable” would
destroy the consistency and uniformity Congress intended to establish when it passed the
Vaccine Act. See Blackmon, 328 F. Supp. 2d at 665 (allowing case-by-case determinations of
unavoidability is “inconsistent with the policy behind the Vaccine Act [and] strips the passage of
all meaning”); Militrano, 769 N.Y.S.2d at 845 (“Given [Congress’s] clear intent to limit
manufacturer liability, and the forceful statements in the Committee reports. . . Congress did not
intend that national vaccine policy be determined by the vagaries of a jury’s determination on a
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case-by-case basis.”). Thus, under the Vaccine Act, it is not up to a court or jury to determine
whether an alleged side effect is “unavoidable” regardless of vaccine design, or, alternatively
whether a different design may have prevented injury. See Blackmon, 328 F. Supp. 2d at 665;
Militrano, 769 N.Y.S.2d at 845-47. As a matter of law, Section 22(b) precludes claims against
SB based upon alleged defects in its vaccine’s design.
b. The Vaccine Act’s policy is inconsistent with design defect claims
An equally important part of the legislative backdrop of the Vaccine Act is the
comprehensive federal regulation of prescription products, including vaccines. The vaccine
formulas containing thimerosal as a preservative were approved by the FDA.27 The vaccine
companies could not have prepared their vaccines differently from the formulas authorized by
the FDA for each vaccine without violating federal laws, including prohibitions against
mislabeling and misbranding. See 21 U.S.C. § 301, et seq.; 42 U.S.C. § 262; 21 C.F.R. § 600, et
seq.
Consequently, if design defect claims could be used to allow jurors to determine that a
vaccine was not “unavoidably unsafe” (and therefore immune from liability), vaccine companies
could be placed in an irreconcilable conflict between complying with FDA regulations and
satisfying state tort standards. Ferrari, slip op. at 12 (“The FDA's authority to determine the
uniform national design for childhood vaccines would be undermined if . . . [plaintiffs] were
allowed to challenge vaccine designs under Georgia law . . . .”); Blackmon, 328 F. Supp. 2d at
665 (rejecting a proposed construction of Section 22(b) that would require a case-by-case
27 Section 351 of the Public Health Service Act creates a licensing process specifically for biological products, including vaccines. See 42 U.S.C. § 262. Biological products include “any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.” See 21 C.F.R. § 600.3(h).
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determination of whether a side effect was an unavoidable consequence of the vaccine’s FDA-
approved design). Vaccine companies would face the heavy burden of defending against
speculative allegations that safer alternatives were available and the very real possibility that a
jury would find that the manufacturer should have distributed a vaccine that the FDA was
unwilling to license. Such uncertainties and the costs associated with defending against them
would have the potential to drive vaccine manufacturers out of the market, threatening the
nation’s available vaccine supply. Of course, one of the central purposes of the Vaccine Act was
to reduce that very risk. See, e.g., O’Connell v. Shalala, 79 F.3d 170, 172-73 (1st Cir. 1996).
Both the language of the Vaccine Act and its legislative history make clear that Congress
limited the tort liability of vaccine companies to claims that the vaccine deviated from its FDA-
approved design or was not accompanied by proper warnings (although these latter claims are
further limited by federal law, as discussed in more detail below). Design defect claims, like the
ones Plaintiffs urge here, are preempted by the Vaccine Act and should be resolved as a matter of
law.
c. Plaintiffs’ negligence claims are also barred
Plaintiffs’ negligence count (Count II) merely restates the same factual allegations made
in its strict liability count (Count I) and should be summarily adjudicated for the same reasons
that the design defect claims fail. The Vaccine Act does not limit its preemptive effect to strict
liability claims, but rather provides that “[n]o vaccine manufacturer shall be liable in a civil
action for damages arising from a vaccine-related injury” unless certain statutorily prescribed
conditions are met. 42 U.S.. § 300aa-22(c). As a result, the Vaccine Act preempts Plaintiffs’
common law claims for negligence. See, e.g., Blackmon, 328 F. Supp. 2d at 655-56 (holding that
plaintiffs’ negligent design defect claims were barred by the Vaccine Act); Militrano, 769
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N.Y.S.2d at 852-53 (finding that plaintiffs’ negligence and implied warranty claims were barred
by the Act); see also Ferrari, slip op. at 8.
B. Plaintiffs’ Warnings Claims Likewise Fail
Plaintiffs allege that SB’s label was inadequate because it failed to warn of the presence
and neurotoxic risks of the preservative thimerosal and failed to inform Plaintiffs that “there
were safer alternatives to the mercury-containing products that [Wesley Sykes] was exposed to.”
Complaint ¶ 19.28 To the extent these claims are mere recasts of Plaintiffs’ design defects
claims, they fail for the reasons set forth in part I.A. As separate warnings claims, they fail as
well.29
1. Plaintiffs’ “direct” warnings claims are expressly preempted
Plaintiffs claim that the vaccine companies failed to provide vaccine consumers like
themselves with warnings concerning the preservative thimerosal used in vaccines. Their
Complaint alleges that the Vaccine Manufacturers “failed to warn . . . the individuals to whom
their thimerosal-containing shots were administered . . .” of the risk of harm from mercury.
Complaint ¶ 19.
Claims that SB and the other vaccine defendants failed to warn consumers generally and
Plaintiffs in particular about the risks of using thimerosal as a preservative in vaccines are
preempted by Section 22(c) of the Vaccine Act, which mandates that:
28 As noted above, the Engerix-B® label specifically described the amount of the preservative thimerosal contained in the vaccine. See “Factual Background” at part A.2. 29 Plaintiffs also allege that defendants failed “to conduct adequate safety tests to determine whether thimerosal was safe and nontoxic . . . .” Complaint ¶¶ 20, 27(d). This allegation does not support an independent claim for relief, but rather appears to support either Plaintiffs’ design or warnings claims. See Viguers v. Philip Morris USA, Inc., 837 A.2d 534, 541 (Pa. Super. 2003) (Pennsylvania does not recognize “a ‘duty to test’ that would be the basis of such claim”), aff’d, 881 A.2d 1262 (Pa. 2005); see also Oddi v. Ford Motor Co., 234 F.3d 136, 143-44 (3d Cir. 2000) (applying Pennsylvania law); Fane v. Zimmer, 927 F.2d 124, 130 (2d Cir. 1991).
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No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
42 U.S.C. § 300aa-22(c). Because vaccines are distributed and administered exclusively through
physicians and health professionals, Congress recognized this area as one in which the safe and
effective use of the product did not depend on direct warnings to persons receiving vaccines (or
their legal representatives). See H.R. Rep. 99-908, reprinted in 1986 U.S.C.C.A.N. 6344, 6368.
As noted in Blackmon when granting summary judgment on an almost identical warnings claim,
“the Vaccine Act clearly bars claims based on a manufacturer’s failure to provide warnings to
the public or to consumers.” Blackmon, 328 F. Supp. 2d at 666; see also Ferrari, slip op. at 12-
13. To the extent that Plaintiffs claim they should have been warned about the use of thimerosal
as a preservative in vaccines, those claims are expressly preempted by the Vaccine Act.
2. Plaintiffs’ remaining warnings claims fail because they cannot satisfy the Vaccine Act’s threshold requirements for bringing such claims
a. SB is entitled to the presumption that its FDA-approved label is adequate
The Vaccine Act affords vaccine manufacturers a legal presumption that their warnings
are adequate if they “show that [they] complied in all material respects with all requirements
under the Federal Food, Drug, and Cosmetic Act and Section 262 of this title [the PHSA]
(including regulations issued under such provisions) applicable to the vaccine and related to
vaccine-related injury or death for which the civil action was brought.” 42 U.S.C.
§ 300aa-22(b)(2); see also Blackmon, 328 F. Supp. 2d at 667 (manufacturer must show material
-27-
compliance with the FDA regulations related to approval and labeling that are relevant to the
vaccines and injury claims at issue to meet burden of production).30
As the HHS Secretary has explained it, “vaccine manufacturers generally have a
complete defense to liability based on ‘failure to warn’ if they have ‘complied in all material
respects with all requirements under the Food, Drug, and Cosmetic Act and Section 351 of the
Public Health Service Act.’” Statement of Interest Submitted by the U.S. Department of Health
and Human Services, King v. Aventis Pasteur, Inc., CV 01-1305-AS at 14 (D. Ore. Mar. 4, 2002)
(Exhibit 15) (quoting 42 U.S.C. § 300aa-22(b)(2))31; see cf. Hurley v. Lederle Labs., 863 F.2d
1173, 1179 (5th Cir. 1988) (“A state law determination on this issue [of the adequacy of a
vaccine warning] should not be interjected to overrule the decision of the FDA. Such a
procedure would place vaccine manufacturers in a position where they could not comply with
both obligations.”).32
30 The Blackmon court rejected the premise that merely obtaining a license from FDA was sufficient to establish entitlement to the presumption. Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 659, 666 (S.D. Tex. 2004). Although SB disagrees with this conclusion in light of the regulatory regime for vaccines described above—which includes rigorous review and approval of the labeling in connection with issuing a license—it also offers the Declaration of Clare Kahn to detail its regulatory compliance with the applicable laws and regulations, which satisfies its burden of production. 31 The provision of the Vaccine Act quoted by HHS in its Statement of Interest provides in full that:
[A] vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.A. §§ 301, et seq.] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought . . . .”
42 U.S.C. § 300aa-22(b)(2). 32 While the vaccinations in Hurley predated the Vaccine Act’s effective date, the court of appeals nonetheless found implied preemption as to the plaintiff’s warnings claims, remanding for a determination as to whether the defendants had withheld material information from the FDA in connection with the approval process for the vaccines at issue. Hurley v. Lederle Labs., 863 F.2d 1173, 1179 (5th Cir. 1988).
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Considering the extensive FDA review process—see “Factual Background” parts A and
B; see also part II.B.1, below—the FDA’s approval of a vaccine label is sufficient to establish
regulatory compliance for purposes of Section 22(b)(2)’s presumption as to adequate warnings.
See, e.g., Henley v. FDA, 77 F.3d 616, 620 (2d Cir. 1996) (“FDA’s determination of what
labeling best reflects current scientific information regarding the risk and benefits” of a
prescription product “involves a high degree of expert scientific analysis.” (internal quotations
and citation omitted)); Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (FDA’s
“judgments as to what is required to ascertain the safety and efficacy of drugs fall squarely
within the ambit of the FDA’s expertise and merit deference from us.”); see also Brooks v.
Howmedica, Inc., 273 F.3d 785, 788 (8th Cir. 2001) (en banc) (observing that the FDA’s review
process for new drugs is “a rigorous process” that involves review and consideration “by a panel
of FDA experts”). “Approval of a biologics license application or issuance of a biologics license
shall constitute a determination that the establishment(s) and the product meet applicable
requirements to ensure the continued safety, purity, and potency of such products.” 21 C.F.R.
§ 601.2(d).33
SB’s summary judgment proof satisfies its burden of production34 under Section 22(b)(2)
of the Vaccine Act by demonstrating that FDA issued a product license for Engerix-B®. See,
e.g., Exhibit B ¶ 11 & B-7. Further, SB has demonstrated compliance with its statutory and
regulatory obligations with respect to Engerix-B® in all material respects, as detailed in the
33 At the time these vaccines were approved, the process involved a PLA. Since that time, the FDA has provided that biological products be licensed through the submission of a Biologics License Application. 34 Cf. St. Mary’s Honor Ctr. v. Hicks, 509 U.S. 502, 509 (1993) (describing the burden of production in the context of a Title VII discrimination action as “necessarily preced[ing] the credibility-assessment stage” and so neither entails nor requires a credibility assessment to determine whether a party has satisfied its burden).
-29-
Declaration of Clare Kahn (Exhibit B) ¶¶ 6-15. As a result, and as a matter of law, SB is
entitled to the presumption that its Engerix-B® warnings were adequate under Section 22(b)(2).
b. Plaintiffs have no evidence of facts necessary to overcome the presumption that SB provided “proper directions and warnings”
The Vaccine Act’s presumption is rebuttable, but Congress made it clear that the
statutory exceptions to the adequate-warnings presumption raise a high bar: “In establishing this
presumption, the Committee intends to make clear its view that only those significant failures to
warn or provide directions that clearly pertain to vaccine safety and that clearly arise from
substantial wrongdoing on the part of the manufacturer ought to result in liability.” See H.R.
Rep. 99-908, at 26, reprinted in 1986 U.S.C.C.A.N. 6344, 6367 (emphasis added). This part of
the analysis also takes into account “the information available to the manufacturers at the time
that the vaccines were produced and the specific warnings provided to physicians and other
medical intermediaries.” Blackmon, 328 F. Supp. 2d at 667.
Plaintiffs have pled that the vaccine company defendants “intentionally and wrongfully
withheld information from the federal Food and Drug Administration and the U.S. Department
of Health and Human Services regarding the safety, efficacy, risks and dangers of thimerosal
before, during, and after FDA approval of the product license applications for [their] products.”
Complaint ¶ 22; see id. ¶ 27(f).35 This language essentially tracks Section 22(b)(2)(A)’s
standards for overcoming the presumption, which are themselves borrowed directly from the
punitive damages statute, prohibiting punitive damages absent a heightened showing of unlawful
35 As noted, SB understands these allegations to relate to Plaintiffs’ burden to overcome the adequate-warnings presumption of Section 22(b)(2), rather than to constitute independent claims for relief, which would be clearly preempted by the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348 (2001) (concluding that “fraud-on-the-FDA” claims were preempted by federal law).
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misconduct. See 42 U.S.C. § 300aa-22(b)(2) (incorporating by reference the first two standards
from § 300aa-23(d)(2)).36 In adopting those standards, Congress used the terms “fraud,”37
“intentional,” and “wrongful” as modifiers of “withholding,” all of which indicate purposeful
and knowing, unlawful behavior, rather than recklessness or negligence. In fact, the third option
of section 23(d)(2)—the punitive damages statute from which these standards are drawn—speaks
to “other criminal or illegal activity relating to the safety and effectiveness of vaccines,” 42
U.S.C. § 300aa-23(d)(2)(C) (emphasis added).
These standards are demonstrably onerous. In light of FDA’s official view, after
thorough study of numerous studies and other scientific sources, that there is no evidence of
harm relating to the use of thimerosal as a preservative in vaccines (other than potential local
hypersensitivity reactions), Plaintiffs will not be able to come forward with any evidence to
create a fact issue, much less establish, that FDA would change its mind. Nor can they show the
kind of unlawful conduct on the part of SB that would be necessary to defeat the adequate
warnings presumption. Accordingly, under Federal Rule of Civil Procedure 56(c) and (e), SB is
entitled to summary judgment on Plaintiffs’ warnings claims holding that its warnings were
adequate as a matter of law.
II. Plaintiffs’ Pennsylvania Law Failure to Warn Claims Are Preempted Because They Conflict With, and Stand as an Obstacle to, FDA’s Comprehensive Regulation of Prescription Vaccine Labels
Independent of the Vaccine Act grounds for summarily adjudicating Plaintiffs’ warnings
claims set forth above in part I.B.2, federal conflict preemption bars Plaintiffs’ attempt to impose
36 Section 22(b)(2)(A) incorporates by reference the first two subparagraphs of the punitive damages provision, section 23(d)(2), which set out the pre-approval and post-marketing fraud or intentional withholding standards discussed above. See 42 U.S.C. §§ 300aa-22(b)(2)(A), 300aa-23(d)(2). 37 Plaintiffs avoid pleading “fraud,” presumably to avoid the heightened pleading requirements of Federal Rule of Civil Procedure 9(b).
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liability under state tort law for any purported failure to provide a warning for thimerosal
containing vaccines that would have violated federal drug labeling provisions.
Plaintiffs allege that SB’s label was inadequate because it failed to warn of “(a) the
presence of ethyl mercury in the products; (b) the neurotoxic properties of the ethyl mercury
contained in the thimer[o]sal; (c) the risks of injury arising from exposure to mercury-based
compounds such as the thimerosal contained in the defendants’ products; or (d) that there were
safer alternatives to the mercury-containing products that he was exposed to.” Complaint ¶ 19.
As explained above, the labeling Plaintiffs challenge was prescribed by FDA, and SB could not
have altered it without FDA approval. Plaintiffs’ claims that a different label should have been
used are preempted.
A. Conflicts Preemption Applies When the State and Federal Laws Are Fatally in Conflict or the State Law Frustrates the Purpose of the Federal Law
Under the Supremacy Clause of the U. S. Constitution, U.S. CONST. art. VI, federal law
will override state law in three instances: (i) Congress expressly preempts state law (express
preemption); (ii) Congressional intent to preempt may be inferred from the existence of a
pervasive federal regulatory scheme (field preemption—implied); or (iii) state law conflicts with
federal law or its purposes (conflicts preemption—implied). English v. General Elec. Co., 496
U.S. 72, 78-79 (1990). “[T]he purpose of Congress is the ultimate touchstone” in every
preemption case. Medtronic, Inc. v. Lohr, 518 U.S. 470, 494 (1996).
At issue in this case is the third type of preemption, conflict preemption. Conflict
preemption occurs either “where it is impossible for a private party to comply with both state and
federal law” (impossibility) or where “under the circumstances of [a] particular case, [the
challenged state law] stands as an obstacle to the accomplishment and execution of the full
purposes and objectives of Congress” (frustration of purpose). Crosby v. Nat’l Foreign Trade
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Council, 530 U.S. 363, 372-73 (2000) (citing Florida Lime & Avocado Growers, Inc. v. Paul,
373 U.S. 132, 142-43 (1963); see also Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 873
(2000) (citing Hines v. Davidowitz, 312 U.S. 52, 66-67 (1941)). Federal regulations “have no
less pre-emptive effect than federal statutes.” Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta,
458 U.S. 141, 153 (1982); see also Sprietsma v. Mercury Marine, 537 U.S. 51, 64-65 (U.S.
2002) (holding that a theory of implied conflicts preemption by agency regulation was “viable,”
even given a conflict between it and the scope of the express saving clause).
Indeed, Congress explicitly intended for state law claims in conflict with FDA’s
determinations to be preempted. In the 1962 Harris-Kefauver Drug Amendments, Pub. L. No.
87-781, (Oct. 10, 1962) (codified as amended in scattered sections of Title 21 of the U.S. Code)
(the “1962 Amendments”),38 Congress provided that state law in “direct and positive conflict”
with those amendments would be preempted. Id. at § 202 (referred to in historical note to 21
U.S.C.A. § 321 (West 1999).39
FDA’s core statutory authority over prescription drug labeling survives today from the
1962 Amendments,40 and therefore § 202 is as good law today as it was the day President
38 The 1962 Amendments, which established the basic principles of FDA’s regulation of prescription drugs, were a result of the tragedy of the drug thalidomide in Europe—a tragedy largely averted in the United States because FDA medical officer, Frances Kelsey, M.D., refused to approve thalidomide in this country. See Philip J. Hilts, PROTECTING AMERICA’S HEALTH: THE FDA, BUSINESS, & ONE HUNDRED YEARS OF REGULATION 152-54 (2003). 39 Section 202 provides as follows:
Nothing in the amendments made by this Act to the Federal Food Drug & Cosmetic Act shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.
21 U.S.C. § 202 (emphasis added). See Bansemer v. Smith Labs, Inc., 1990 WL 132579, at *4 n.2 (E.D. Wis. 1988) (citing § 202). 40 Compare 1962 Amendments, § 102(c) (amending 21 U.S.C. § 355(d) to require FDA to disapprove proposed drug labeling if, “based on a fair evaluation of all material facts, such labeling is false or misleading in any particular”), with current version at 21 U.S.C. § 355(d) (same).
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Kennedy signed it into law. Consequently, there is an unmistakable congressional intent to
preempt state law in conflict with FDA’s prescription drug labeling authority. As explained
below, Plaintiffs’ claim that SB failed to provide adequate warnings as to the presence of
thimerosal in its vaccines and the risks associated with thimerosal is tantamount to a request that
this Court declare SB’s FDA-required label inadequate—one preempted by federal law.
B. Plaintiffs’ Judicial Challenge to SB’s FDA-Approved Labeling “Stands as an Obstacle” to the Accomplishment of the FDA’s Comprehensive Federal Scheme Governing the Labeling of Prescription Products, Including Vaccines
1. FDA carefully controls the content of labeling for prescription products, including biologics
When promulgating its most recent labeling rule, FDA explained its role in approving
prescription product labels and the agency’s official view of the implications of its labeling
decisions. See Department of Health and Human Services, Requirements on Content and
Format of Labeling for Human Prescription Drug and Biological Products (21 C.F.R. parts 201,
314, and 601), 71 Fed. Reg. 3922, 3933-36 (Jan. 24, 2006). The purpose of adopting a new rule
was “to enhance the ability of health care practitioners to access, read, and use prescription drug
labeling.” 71 Fed. Reg. at 3923.
In the preamble to the new rule, FDA addressed the role of preemption in prescription
drug labeling, indicating that it had previously asked the Department of Justice to file amicus
briefs in tort suits throughout the country to express the agency’s official position that FDA
labeling decisions should preempt contrary state law. Id. at 3934. Considering it to be “useful to
set forth in some detail the arguments made in those amicus briefs,” FDA stated that the
preamble discussion “represents the government’s longstanding views on preemption, with a
particular emphasis on how that doctrine applies to State laws that would require labeling that
conflicts with or is contrary to FDA-approved labeling.” Id.
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FDA, in its own words,
makes approval decisions based not on abstract estimation of [a prescription product’s] safety and effectiveness, but rather on a comprehensive scientific evaluation of the product’s risks and benefits under the conditions of use prescribed, recommended or suggested in the labeling. FDA considers not only complex clinical issues related to the use of the product in study populations, but also important and practical public health issues pertaining to the use of the product in day-to-day clinical practice, such as the nature of the disease or condition for which the product will be indicated, and the need for risk management measures to help assure in clinical practice that the product maintains its favorable benefit-risk balance. The centerpiece of risk management for prescription drugs generally is the labeling which reflects thorough FDA review of the pertinent scientific evidence and communicates to health care practitioners the agency’s formal, authoritative conclusions regarding the conditions under which the product can be used safely and effectively. FDA carefully controls the content of labeling for a prescription drug, because such labeling is FDA’s principal tool for educating health care professionals about the risks and benefits of the approved product to help insure safe and effective use.
71 Fed. Reg. at 3934 (citing 21 U.S.C. § 355(d)) (emphasis added). FDA went on to indicate
that, even after labeling is approved, “FDA continuously works to evaluate the latest available
scientific information to monitor the safety of products and to incorporate information into the
product’s labeling when appropriate.” 71 Fed. Reg. at 3934. As a result, FDA concludes that
“State laws conflict with and stand as an obstacle to achievement of the full objectives and
purposes of Federal law when they purport to compel a firm to include in labeling or advertising
a statement that FDA has considered and found scientifically unsubstantiated.” Id. at 3935. The
imposition of additional warnings under state law “can erode and disrupt the careful and truthful
benefits and risks that prescribers need to make appropriate judgments about drug use.” Id.
FDA made clear that “the determination whether labeling revisions are necessary is, in the end,
squarely and solely FDA’s under the act.” Id. at 3934.
The FDA’s preamble discussion dispels any legitimate argument that federal regulations
provide only minimum standards for drug warnings, leaving states free to impose more stringent
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requirements.41 Instead, FDA’s self-described role is to guard against overwarnings on drug
labeling, which pose the serious threat of unduly discouraging use of beneficial drugs and
diluting other, more important warnings. 71 Fed. Reg. at 3935. A warning that “includes
theoretical hazards not well-grounded in scientific evidence can cause meaningful risk
information to ‘lose its significance.’” Id. (quoting 44 Fed. Reg. 37434 at 37447 (June 26
1979)). But that is not the only risk of “overwarning”—“State-law attempts to impose additional
warnings can lead to labeling that does not accurately portray a product’s risks, thereby
potentially discouraging safe and effective use of approved products or encouraging
inappropriate use and undermining the objectives of the act.” Id. Thus, FDA concludes, claims
like Plaintiffs’—seeking to hold a pharmaceutical company liable for “failing to include
contraindications or warnings that are not supported by evidence . . . reflect[ing] [k]nown
hazards and not theoretical possibilities”—should be preempted. 71 Fed. Reg. at 3936.
Further, as explained in both the FDA’s Guidance (Exhibit 2), and the article from
CBER,42 Thimerosal in Vaccines at 6 (Exhibit 1), FDA takes an extremely active role in
decisions related to all aspects of vaccine regulation, including labeling. Even after approval of
the vaccine and labeling, FDA has a directive under the Vaccine Act to thoroughly review “the
warnings, use instructions, and precautionary information distributed with” childhood vaccines
to “determine whether such warnings instructions, and information ‘adequately warn health care
41 FDA’s comments in this regard are in apparent response to opinions holding that FDA requirements set only a minimum standard that States are free to supplement through their own laws. E.g., Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (1st Cir. 1981); Salmon v. Parke-Davis, 520 F.2d 1359 (4th Cir. 1979); Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1018 (S.D. Ill. 2001); Mazur v. Merck & Co., Inc., 742 F. Supp. 239, 246-47 (E.D. Pa. 1990); In re Tetracycline Cases, 747 F. Supp. 543 (W.D. Mo. 1989). FDA cited each of those decisions as examples of “[a]nother misunderstanding of the [FDCA] encouraged by State law actions”—“that FDA labeling requirements represent a minimum safety standard.” 71 Fed. Reg. at 3934-35. FDA responds that far from minimum safety standards, its authority under the FDCA is “to establish both a ‘floor’ and a ‘ceiling’ . . . .” Id. at 3935. 42 See note 13, supra.
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providers of the nature and extent of the dangers posed by such vaccines.’” FDA Guidance at 2
(quoting 42 U.S.C. § 300aa-1 note). In fulfilling that directive, FDA independently surveys
adverse event reporting and other data sources, including epidemiological information and
reports in the medical literature, to identify potential information that could warrant label
revision and communicates the information it deems appropriate to vaccine companies. Id. at 1,
3. And,
[w]hen new information on a vaccine’s safety and efficacy becomes available after licensure, FDA reviews the data and determines whether package inserts and other labeling should be revised to include this new information. FDA notifies manufacturers if their package inserts do not reflect currently available information regarding the warnings, use instructions, and precautionary information. In such a case, FDA also typically recommends that appropriate revision is necessary.
FDA Guidance at 3 (emphasis added). The agency’s “continuing review of warnings and
precautions and use instructions sections of the label helps assure that labels in distribution are
adequate to inform health care providers of the risks of vaccines.” Id. at 6.
FDA has studied the very hypothesis Plaintiffs claim the Vaccine Defendants should have
warned about in their FDA-approved labels and announced publicly that there is “no evidence of
harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity
reactions.” See CBER, Thimerosal in Vaccines, at 6 (Exhibit 1). It is not surprising, in light of
FDA’s conclusion, that FDA has never notified the Vaccine Defendants that it believed their
labeling was inadequate as to the risks of the preservative thimerosal, and the agency has
certainly not issued any directives for changes to the approved vaccine labeling, though
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thimerosal containing vaccines continued to be distributed under the approved labels.43 It is
inconceivable that FDA would have stood by silently had it believed that the warnings had
become inadequate in light of claims, like Plaintiffs’ here, that thimerosal was causing a
“unique” form of mercury poisoning to children.
Plaintiffs should not be permitted to collaterally challenge FDA’s decision by claiming
that the FDA-approved label for Engerix-B®—the only label SB could use—was inadequate.
See, e.g., Colacicco v. Apotex, Inc., ___ F. Supp. 2d ___, 2006 WL 1443357, at *16-17 (E.D. Pa.
May 25, 2006); Henley v. FDA, 77 F.3d 616, 621 (2d Cir. 1996) (“The FDA possesses the
requisite know-how to conduct such [scientific] analyses, by sifting through the scientific
evidence to determine the most accurate and up-to-date information regarding a particular drug,
and how those data affect human usage.”); see also Bernhardt v. Pfizer, Inc., No. 00 Civ. 4042,
2000 WL 1738645, at *2-3 (S.D.N.Y. 2000) (deferring to the primary jurisdiction of FDA the
decision whether to issue emergency notice pertaining to hypertension product, Cardura, finding
that “[t]he FDA, not this Court, has the relevant expertise”).44
2. FDA-prescribed labeling sets both the “ceiling and the floor”
Plaintiffs may argue that courts around the country have held that the FDA approval
process sets a minimum safety standard, or “floor” as to the adequacy of a label that state law
can augment.45 This is simply not so according to FDA itself. FDA has made clear that its role
in prescribing labels involves a number of carefully calibrated scientific and policy concerns:
43 SB could not have itself sought such a warning because it believes that such a warning is not scientifically indicated. 21 C.F.R. § 201.57(c)(5) (requiring that contraindications reflect “[k]nown hazards and not theoretical possibilities”); see also id. § 201.57(c)(6) (requiring drug manufacturer to seek FDA approval for a labeling change to add a new warning when it has “reasonable evidence of a casual association with a drug . . .”). 44 See also part III, infra. 45 See note 41, supra.
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“In fact, FDA interprets the [FDCA] to establish both a ‘floor’ and a ‘ceiling,’ such that
additional disclosures of risk information can expose a manufacturer to liability under the act if
the additional statement is unsubstantiated or otherwise false or misleading.” 71 Fed. Reg. at
3935; see also Colacicco, 2006 WL 1443357, at *17 (“We agree with FDA’s position that
ensuring that warnings be scientifically substantiated is an important policy.”) Dowhal v.
SmithKline Beecham Consumer Health Care, 32 Cal.4th 910, 919 (2004) (“Once an application
has been approved, any change in the labeling requires a supplement to the application and
approval by the FDA, either before or after the change”).
Plaintiffs throughout the country have asserted that prescription products are safer with
more warnings. FDA has made clear that this assumption is not valid. See 71 Fed. Reg. at 3935
(“Overwarning, just like underwarning, can similarly have a negative effect on patient safety and
public health.”). Sound policy reasons underlie FDA’s approach to avoiding misbranding and
“overwarning”:
In formulating the label for a product to be marketed – as distinguished from a decision whether or not to permit the product to be marketed – the FDA must take into account the effect of proposed labels on the consumer. Whether a label is potentially misleading or incomprehensible is essentially a judgment of how the consumer will respond to the language of the label. As we have noted, a truthful warning of an uncertain or remote danger may mislead the consumer into misjudging the dangers stemming from use of the product, and consequently making a medically unwise decision. The authority of the FDA, we conclude, extends to barring warnings that are misleading in this fashion.
Dowhal, 32 Cal.4th at 934 (holding that California’s Proposition 65, to the extent it may be read
to require specific warnings of cancer or reproductive toxicity on federally-regulated, non-
prescription smoking cessation products, conflicts with federal law and is therefore preempted).
The California Supreme Court thus appreciated and gave effect to FDA’s need to balance the
competing interests necessary to provide effective drug warnings, reasoning that “the FDA
warning serves a “nuanced” goal — to inform pregnant women of the risks of NRT [nicotine
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replacement therapy], but in a way that will not lead some women, overly concerned about those
risks, to continue smoking. This creates a conflict with the state’s more single-minded goal of
informing the consumer of the risks.” 32 Cal.4th at 935.
Similarly “nuanced” goals are inherent in FDA’s oversight of prescription product
labeling nationally. See 71 Fed. Reg. at 3935 (FDA’s concern about tort suits encouraging “lay
judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the
general public—the central role of FDA—sometimes on behalf of a single individual or group of
individuals”). Moreover, the Vaccine Act tasks the HHS Secretary, in conjunction with FDA
and other top health agencies, with an active role in developing safer vaccines and appropriate
warnings. 42 U.S.C. § 27. Thus, in the context of vaccines, FDA plays an especially important
role in prescribing warnings that should not be compromised by individual states’ requirements.
The FDA-mandated vaccine labels are not a “minimum standard,” but rather a delicate balance
between the need to inform health care providers of all likely risks without causing undue alarm
or diluting warnings of real risks by inclusion of other risks that are merely theoretical or not
fully substantiated. Cf. Colacicco, 2006 WL 1443357, at *17 (“Dissemination of unsupported
warnings risks diluting those that are scientifically supported, and/or discouraging safe and
effective use of a particular drug. This could deprive patients of efficacious treatment, thereby
chilling the drug’s otherwise beneficial treatment.”). Unmerited warnings carry a serious
potential to frighten parents into not vaccinating their children. Not vaccinating children could
potentially imperil the nation’s health, thus presenting a substantial obstacle to the fulfillment of
Congress’ goals in insuring the widespread and appropriate use of vaccines.
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3. FDA’s view of the preemptive effect of its labeling decisions is entitled to deference
While preemption is a legal doctrine grounded in the Supremacy Clause to be decided by
the judiciary, the agency’s view of the preemptive effect of its own actions is entitled to
considerable weight. Where Congress has “delegated to [the agency] authority to implement the
statute; the subject matter is technical; and the relevant history and background are complex and
extensive[,] [t]he agency is likely to have a thorough understanding of its own regulation and its
objectives and is ‘uniquely qualified’ to comprehend the likely impact of state requirements.”
Geier, 529 U.S. at 883 (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 496, 506 (1996)); see also
Sprietsma, 537 U.S. at 67-68.
a. The new labeling rule sets forth a clear statement from the agency
In promulgating its most recent labeling rule, FDA has indicated in no uncertain terms
that it considers warnings claims like Plaintiffs’ to be preempted by FDA’s labeling decisions.
See part II.B.1. The effective date of the new rule is June 30, 2006, 71 Fed. Reg. at 3928, but the
preamble comments about preemption reflect “the government’s longstanding views on
preemption.” Id. at 3934. In this regard, the official statements in the preamble to the new rule
are interpretive and thus can be given deference immediately:
[T]he FDA's position that it is merely clarifying its “longstanding views on preemption,” 71 Fed. Reg. at 3934—e.g., that it is only “only remind[ing the] affected parties of existing duties”—weighs heavily in favor of concluding that the Preemption Preamble is an interpretive rule. . . . Accordingly, we find that the Preemption Preamble merely clarifies existing law and has no prohibited retroactive effect.
Colacicco, 2006 WL 1443357, at *15 (stating that the preamble is but one piece of evidence
supporting a finding of preemption (citing Beazer E., Inc. v. U.S. EPA Region III, 963 F.2d 603,
606 (3d Cir. 1992)). A similar result should obtain in this case.
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b. FDA has consistently restated its position in amicus briefs in pharmaceutical warnings litigation
As noted above, FDA has also submitted amicus briefs in several labeling cases around
the country, and it has consistently asserted in these briefs that its labeling decisions should
preempt conflicting state law requirements. Copies of some of these amicus briefs are submitted
as exhibits to SB’s concurrently filed Motion to Take Judicial Notice as Exhibits 16, 17, & 18.
Notably, FDA’s official position as stated in an amicus brief is entitled to deference, especially
on the issue of conflict preemption. Sprietsma, 537 U.S. at 67-68; see also Geier, 529 U.S. at
883.
In the recent Colacicco decision from this Court, it reviewed and credited other FDA
amicus briefs in similar cases, all in accord with the position that any addition to the FDA-
approved warning associating the product at issue with suicidality—as the plaintiffs effectively
sought through their failure to warn claim in that case—“was contrary to the scientific evidence
and thus false and misleading.” Colacicco, 2006 WL 1443357, at *9.46 Although the Vaccine
Defendants are not aware of any FDA proceeding that has been initiated to require a warning like
the one Plaintiffs propose, FDA has extensively reviewed the role of thimerosal in vaccines and
has concluded that there is “no evidence of harm from the use of thimerosal as a vaccine
preservative, other than local hypersensitivity reactions.” CBER, Thimerosal in Vaccines at 6.
In light of this conclusion—which, as noted, is consistent with the independent advisory
46 The Colacicco court observed that FDA’s amicus brief in that case was filed in part to counter decisions from “numerous lower courts around the nation” that had refused to apply preemption, instead holding that “21 C.F.R. § 314.70(c) permits drug makers to unilaterally strengthen a warning label without FDA approval.” Colacicco v. Apotex, Inc., ___ F. Supp. 2d ___, 2006 WL 1443357, at *9 (E.D. Pa. May 25, 2006) (citing McNellis v. Pfizer, Inc., Civ. No. 05-1286, 14 (D.N.J. Dec. 29, 2005); Witczak v. Pfizer, 377 F. Supp. 2d 726, 729 (D. Minn. 2005); Zikis v. Pfizer, Inc., Civ. No. 04-8104, 6 (N.D. Ill. May 9, 2005); Cartwright v. Pfizer, 369 F. Supp. 2d 876, 882 (E.D. Tex. 2005)). Both FDA and the Colacicco court concluded that these courts’ interpretation of the regulatory scheme was in error. Id. (reciting and deferring to FDA’s position that additional warnings or cautions must be approved by FDA).
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committees and institutions that have concluded that there is no reliable scientific evidence
demonstrating a causal link between thimerosal-containing vaccines and the neurological injuries
Plaintiffs allege47—FDA has not directed thimerosal-related changes to the labels for thimerosal
containing vaccines, considering them to be adequate under its expert and thoroughly considered
analysis. In the preamble to the new rule, FDA stated that preemption should occur both when
FDA has previously concluded that a particular warning was not scientifically indicated and
when FDA concludes that a contraindication or warning is “not supported by evidence that meets
the standards set forth in this rule, including § 201.57(c)(5) (requiring that contraindications
reflect ‘[k]nown hazards and not theoretical possibilities’) and (c)(7),” 71 Fed. Reg. at 3936.
(§ 201.57(c)(7) prescribes inclusion of adverse events “for which there is some basis to believe
there is a causal relationship between the drug and the occurrence of the adverse event.” 21
C.F.R. § 201.57(c)(7).)
Consequently, as the FDA’s preamble to its new labeling rule and amicus briefs make
clear, a decision by a Pennsylvania court requiring Plaintiffs’ proposed warning would be in
direct conflict to FDA’s considered opinion that it is not scientifically indicated.
C. The Vaccine Act Does Not “Bar the Ordinary Working of Conflict Preemption Principles”
Some courts have considered the Vaccine Act to prohibit a finding that products claims
are impliedly preempted under the FDCA or PHSA. See, e.g., Hurley, 863 F.2d at 1178
(“Finally, we believe that any case for preemption is doomed by the National Childhood Vaccine
Injury . . . Act”); Mazur v. Merck & Co., Inc., 742 F. Supp. 239, 246-47 (E.D. Pa. 1990); Abbot
v. American Cyanamid Co., 844 F.2d 1108, 1113-1114 (4th Cir. 1988); Morris v. Parke, Davis &
Co., 667 F. Supp. 1332, 1340 (C.D. Cal. 1987). Their analysis appears to hinge on the structure
47 See note 24, supra.
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of Section 22 of the Vaccine Act, which provides that “State law shall apply to a civil action” for
“vaccine-related injury,” except in the following respects, in which case the federal statute
supplies the standards.” 42 U.S.C. § 300aa-22(a) (emphasis added).48 In light of recent
teachings of the United States Supreme Court, this reasoning is certainly wrong.
1. A savings clause does not preclude conflicts preemption
In Geier, the U.S. Supreme Court was confronted with a similar statutory scheme in the
National Traffic and Motor Vehicle Safety Act of 1966 (“Motor Vehicle Safety Act”), which,
like the Vaccine Act, contained an express preemption and a “saving” clause49 reserving non-
preempted claims to the laws of the several states. 529 U.S. at 867-68. Finding the express
preemption clause not to cover the claims at issue, the Court was squarely presented with the role
of conflicts preemption in an analogous setting to this one.
In Geier, the family of a woman injured in an auto accident sued the car’s manufacturer,
Honda Motor Co. (“Honda”), claiming that Honda’s product was defectively designed because
Honda failed to install airbags, which would have prevented her injuries. Id. at 865. The district
court dismissed the lawsuit, finding these claims to be preempted by a federal safety standard
announced by the Department of Transportation (“DOT”) under the authority of the Motor
Vehicle Safety Act regarding passive safety restraints, including airbags. Id. The Supreme
Court held that “this kind of ‘no airbag’ lawsuit conflicts with the objectives of the [safety
standard], a standard authorized by the Act, and is therefore preempted by the Act.” Id. at 866.
48 See part I.A.1, supra.
49 “That provision, a saving clause, says that compliance with a federal safety standard does not exempt any person from any liability under common law.” Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 868 (2000)
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The Geier Court recognized that the saving clause would operate to preserve the
plaintiffs’ claim that airbags were required under state law because it was not expressly
preempted. Id. at 868. Nonetheless, the Court held that “the saving clause (like the express pre-
emption provision) does not bar the ordinary working of conflict preemption principles.” Id. at
869 (emphasis in original). The Court concluded that “[n]othing in the saving clause suggests an
intent to save state-law tort actions that conflict with federal regulations.” Id. Its reasoning is
instructive here:
Why, in any event, would Congress not have wanted ordinary pre-emption principles to apply where an actual conflict with a federal objective is at stake? Some such principle is needed. In its absence, state law could impose legal duties that would conflict directly with federal regulatory mandates, say, by premising liability upon the presence of the very windshield retention requirements that federal law requires. Insofar as petitioners’ argument would permit common-law actions that “actually conflict” with federal regulations, it would take from those who would enforce a federal law the very ability to achieve the law’s congressionally mandated objectives that the Constitution, through the operation of ordinary pre-emption principles, seeks to protect. To the extent that such an interpretation of the saving provision reads into a particular federal law toleration of a conflict that those principles would otherwise forbid, it permits that law to defeat its own objectives . . . .
Geier, 529 U.S. at 872 (emphasis added) (citing, inter alia, Am. Tel. & Tel. Co. v. Central Office
Tel., Inc., 524 U.S. 214, 228 (1998)). Thus, the Vaccine Act’s express preemption and savings
clauses, 42 U.S.C. § 300aa-22(a) – (c), cannot be interpreted to trump the ordinary operation of
conflicts preemption as announced by FDA.
2. The Vaccine Act’s saving provision cannot override conflicts preemption based on FDA’s exercise of delegated authority under the FDCA
Although, as noted above, the FDCA, PHSA, and Vaccine Act are part of an integrated
and comprehensive federal regulatory scheme orchestrated by FDA, it does not follow that the
Vaccine Act’s saving clause takes precedence over the FDCA or PHSA in terms of conflicts
preemption. The FDCA is a separate statute that empowers and directs FDA to oversee all
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labeling for prescription products, and it is the labeling scheme administered under the FDCA,
rather than the Vaccine Act, that FDA believes preempts state law. See part II.B.1, supra.
In United States v. Locke, 529 U.S. 89, 106 (2000), the Supreme Court was confronted
with an argument that a saving clause in a later statute should be read to apply also to an earlier
statute, and thus “alter the pre-emptive effect of the [statute] or regulations promulgated
thereunder.” Locke, 529 U.S. at 104-106. The saving clause, entitled “Preservation of State
authorities,” used the language “Nothing in this act” in disclaiming federal pre-emption. Id. The
Court noted the inconsistency of the language “Nothing in this act” with applying the saving
clause to other acts, but did not rest solely on this textual basis. Id. The Court examined many
other factors, including the statutory framework as a whole and the goals of the statute, as an aid
to an ultimate inquiry aimed at discovering Congressional intent with respect to whether the
saving clause should operate to deprive regulations issued pursuant to a prior statute of pre-
emptive effect, and ultimately determined that it should not. Id. In finding the saving clause to
be inapplicable as to the earlier statute, the Court noted that it is “quite unlikely that Congress
would use a means so indirect as the savings clauses . . . to upset the settled division of authority
. . . . We decline to give broad effect to saving clauses where doing so would upset the careful
regulatory scheme established by federal law.” Id. at 106.50
The Geier Court observed that Congress would certainly have the authority to enact a
savings clause that could transcend the legislation in which it was adopted and preserve state
claims in an entire area of law, but it had not done so in that case. 529 U.S. at 872. Likewise,
Locke understands that such authority is available, albeit rarely used. One such example is in the
50 The Locke decision predates Geier and thus should not be taken to imply that the saving clause would have any prohibitionary effect on implied conflicts preemption of the statute in which it appears under current law.
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insurance arena, which Congress has historically deferred to the fifty states. The following
provision demonstrates that, when Congress wishes to tie its hands with respect to state law for
all intents and purposes, it knows precisely how to do so with express language:
1012. Regulation by State law; Federal law relating specifically to insurance; applicability of certain Federal laws after June 30, 1948 (a) State regulation. The business of insurance, and every person engaged therein, shall be subject to the laws of the several States which relate to the regulation or taxation of such business.
(b) Federal regulation. No Act of Congress shall be construed to invalidate, impair, or supersede any law enacted by any State for the purpose of regulating the business of insurance, or which imposes a fee or tax upon such business, unless such Act specifically relates to the business of insurance: Provided, That after June 30, 1948, the Act of July 2, 1890, as amended, known as the Sherman Act [15 USCS §§ 1 et seq.], and the Act of October 15, 1914, as amended, known as the Clayton Act, and the Act of September 26, 1914, known as the Federal Trade Commission Act, as amended [15 USCS §§ 41 et seq.], shall be applicable to the business of insurance to the extent that such business is not regulated by State law.
15 U.S.C. § 1012 (emphasis added). The Vaccine Act’s direction that “State law shall apply to a
civil action” for “vaccine-related injury,” except as modified in the Vaccine Act, does not even
approximate this language in terms of indicating an intent to preserve state law as against the
preemptive effect of any other law.
Further, Locke teaches that the Vaccine Act’s savings clause should be read in full
context of Congress’ intent and design. 529 U.S. at 104-106; see also Int'l Paper Co. v.
Ouellette, 479 U.S. 481, 493-494 (1987) (“Given that the Act itself does not speak directly to the
issue, the Court must be guided by the goals and policies of the Act in determining whether it in
fact pre-empts an action based on the law of an affected State . . . After examining the [Act] as a
whole, its purposes and its history . . . we do not believe Congress intended to undermine [its
legislation] through a general saving clause.”). The full context of the Vaccine Act compels the
conclusion that Congress would not have intended its “savings” clause to prevent conflicts
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preemption for labeling decisions under the FDCA—especially when considering that vaccine
companies must comply with the labeling regulations under that regime. As noted above, the
Vaccine Act was passed as a radical and comprehensive piece of legislation aimed at protecting
the nation’s vaccine supply. Congress, fearing that the loss of a single vaccine manufacturer
would cripple the nation’s vaccine supply, acted swiftly and comprehensively to establish a new
regulatory regime for vaccines. It passed the Vaccine Act in 1986, recognizing that
“[v]accination of children against deadly, disabling, but preventable infectious diseases has been
one of the most spectacularly effective public health initiatives this country has ever
undertaken.” H.R. Rep. NO. 99-908 at 4, reprinted in 1986 U.S.C.C.A.N. 6344, 6345-46. In
passing the Act, Congress balanced the need to provide claimants with a just and efficient
remedy while also safeguarding the nation’s supply of vaccines by protecting vaccine
manufacturers from excessive litigation costs. Id. In this regard, Congress realized that the cost
of vaccine-related litigation had significantly reduced the number of manufacturers willing to sell
childhood vaccines. Id. at 4, 607, reprinted in 1986 U.S.C.C.A.N. at 6347-48; see also Schafer
v. Am. Cyanamid Co., 20 F.3d 1, 4 (1st Cir. 1994). Consequently, Congress sought to preserve
the market by providing vaccine companies substantive and procedural protections beyond what
a manufacturer of other prescription products could expect. E.g., H.R. Rep. 99-908, 1986
U.S.C.C.A.N. at 6344.51 Considering this background, it is inconceivable that Congress would
have intended that vaccine companies would be subject to state tort law when other
pharmaceutical products were exempted by conflicts preemption.
51 At the time the Vaccine Act was adopted, the “great majority” of courts to have addressed the issue had ruled against a finding of implied preemption in pharmaceutical products cases. See, e.g., Hurley, 863 F.2d at 1176-77 & n.2 (collecting cases).
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As a result, to conclude that the language of the saving clause in the Vaccine Act
abrogates the supremacy of all other federal statutes in cases of conflict with state law “place[s]
more weight on the saving clauses than those provisions can bear, either from a textual
standpoint or from a consideration of the whole federal regulatory scheme of which [the statute]
is but a part.” Locke, 529 U§. at 105. It is “quite unlikely that Congress would use a means so
indirect as the savings clauses. . . to upset the settled division of authority.” Id. at 106. Like
Locke, this Court should “decline to give broad effect to saving clauses where doing so would
upset the careful regulatory scheme established by federal law.” Id. at 106.
III. The Doctrine of Primary Jurisdiction Provides an Alternative Basis for Deferring to FDA’s Extensive Regulatory Expertise and Experience
In the alternative, and in the event the Court decides that Plaintiffs’ failure to warn claims
are not barred by the Vaccine Act (part I.B.2) and are not preempted (part II), it should consider
the appropriate deference to accord FDA’s decisions on the matters entrusted to it. The doctrine
of primary jurisdiction is designed to permit the Court to consider and give effect to FDA’s role
as the nation’s expert on matters of prescription labeling in general and thimerosal containing
vaccines in particular. Thus, if the Court were to determine that Plaintiffs’ warnings claims are
not preempted or otherwise unsubstantiated, it should consider the principles of primary
jurisdiction and refer the matters to FDA for findings.
A. Primary Jurisdiction Respects the Role of FDA as the Exclusive Arbiter of Labeling Decisions
The Supreme Court has defined the doctrine of primary jurisdiction as a “principle, now
firmly established, that in cases raising issues of fact not within the conventional experience of
judges or cases requiring the exercise of administrative discretion, agencies created by Congress
for regulating the subject matter should not be passed over.” Far East Conference v. United
States, 342 U.S. 570, 574 (1952). Uniformity and consistency in the regulation of business
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entrusted to a particular agency are secured, and the limited functions of review by the judiciary
are more rationally exercised, by preliminary resort for ascertaining and interpreting the
circumstances underlying legal issues to agencies that are better equipped than courts by
specialization, by insight gained through experience, and by more flexible procedures. Id.
The doctrine was created by the Supreme Court in Texas & Pac. Ry. v. Abilene Cotton
Oil Co., 204 U.S. 426 (1907), and it has been developed by courts in order to avoid conflict
between a court and an administrative agency arising from either the court’s lack of expertise
with the subject matter of the agency’s regulation or from contradictory rulings by the agency
and the court. MCI Communications Corp., v. American Tel. & Tel. Co., 496 F.2d 214, 220 (3d
Cir. 1974). Under the doctrine, a court should refer a matter to an administrative agency for
resolution, even if the matter is otherwise properly before the court, if it appears that the matter
involves technical or policy considerations which are beyond the court’s ordinary competence
and within the agency’s particular field of expertise. Id. Referral of the issue to the
administrative agency52 does not deprive the court of jurisdiction; it has discretion either to retain
jurisdiction or, if the parties would not be unfairly disadvantaged, to dismiss the case without
prejudice. Reiter v. Cooper, 507 U.S. 258, 268-69 (1993) (citing Carnation Co. v. Pacific
Westbound Conference, 383 U.S. 213, 222-223 (1966); Mitchell Coal & Coke Co. v.
Pennsylvania R. Co., 230 U.S. 247 (1913); Jaffe, Primary Jurisdiction, 77 HARV. L. REV. 1037,
1055 (1964)).
52 As explained in Reiter v. Cooper, 507 U.S. 267, 268 n.3 (1993), “referral” is an inexact term. It is sometimes loosely described as a process whereby a court refers an issue to an agency, but the Supreme Court notes that most statutes contain no mechanism through which a court can on its own authority demand or request a determination from the agency; that is left to the adversary system, and the court merely stays its proceeding while the plaintiff files an administrative complaint. Further action by the district court should be stayed so as to give the plaintiff a reasonable opportunity to apply to the agency for a ruling. Id.
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Primary jurisdiction is not simply a polite gesture of deference to the agency seeking an
advisory opinion. Once a court determines that a claim contains some issue within the special
competence of an administrative agency, the doctrine of primary jurisdiction counsels the court
to refer the matter to the administrative agency. Phone-Tel Communications, Inc. v. AT&T
Corp., 100 F. Supp. 2d 313, 321 (E.D. Pa. 2000) (quoting Reiter, 507 U.S. at 268). The agency’s
determination is then binding upon the court and the parties (subject, of course, to appellate
review through normal channels) and is not subject to collateral attack in the pending court
proceeding. MCI Tel. Corp. v. Teleconcepts, Inc., 71 F.3d 1086, 1103 (3d Cir. 1995) (citing
Elkin v. Bell Tel. Co., 420 A.2d 371, 376 (Pa. 1980) (footnotes omitted)).
No fixed formula exists for applying the doctrine of primary jurisdiction. United States v.
Western Pac. R. Co., 352 U.S. 59, 64 (1956). The U.S. Supreme Court has emphasized,
however, that the doctrine comes into play when the reasons for the existence of the doctrine are
present and when the purposes it serves will be aided by its application in the particular
litigation. Id. In determining whether the doctrine applies, courts have consistently looked to the
twin purposes articulated by the Supreme Court in Western Pacific: (1) the desirable uniformity
that results when a specialized agency decides certain types of questions committed to its
particular expertise; and (2) the expert and specialized knowledge of the agency involved. Id.;
AT&T Communications, Inc. v. Consolidated Rail Corp., 285 F. Supp. 2d 649, 661 (E.D. Pa.
2003) (citing Chabner v. United of Omaha Life Ins. Co., 225 F.3d 1042, 1051 (9th Cir. 2000);
Pejepscot Indus. Park, Inc. v. Maine Centr. R. Co., 215 F.3d 195, 205 (1st Cir. 2000); United
States v. Any and All Radio Station Transmission Equip., 204 F.3d 658, 664 (6th Cir. 2000);
Williams Pipe Line Co., v. Empire Gas Corp., 76 F.3d 1491, 1496 (10th Cir. 1996). The
principal justification for the doctrine is the need for an orderly and sensible coordination of the
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work of agencies and courts. Cheyney State College Faculty v. Hufstedler, 703 F.2d 732, 736
(3d Cir. 1983).
Some courts have delineated factors to determine whether primary jurisdiction should
apply in a particular case, such as: (i) whether the question at issue is within the conventional
experience of judges or whether it involves technical or policy considerations within the
agency’s particular field of expertise; (ii) whether the question at issue is particularly within the
agency’s discretion; (iii) whether there exists a substantial danger of inconsistent rulings; and
(iv) whether a prior application to the agency has been made. Bernhardt, 2000 WL 1738645,
*253; see also AT&T Corp. v. PAB, Inc., 935 F. Supp. 584, 589-90 (E.D. Pa. 1996) (citing
National Comm. Ass’n v. American Tel & Tel., 46 F.3d 220, 222 (2d Cir. 1995)).
The court in Bernhardt analyzed these four factors in connection with claims regarding
the antihypertensive drug Cardura and determined that FDA had primary jurisdiction over the
plaintiffs’ warning claims. Bernhardt, 2000 WL 1738645 at *1. In that case, the plaintiffs
sought an order requiring Cardura manufacturer Pfizer to send a notice to Cardura users and their
physicians regarding a recent study about the drug. Pfizer and the United States argued that
FDA had primary jurisdiction to determine whether the study findings warranted the issuance of
notices to Cardura users and their physicians.54 Id. The court found that FDA had the relevant
expertise to address plaintiffs’ claims and had the authority from Congress to do so. Id. at *2-3.
Further, the court expressed concern that if it issued an order regarding Cardura warnings, there
would be the potential for inconsistent directions concerning a serious medical ailment and how
53 FDA cited to Bernhardt in its preamble as an example of a decision using primary jurisdiction to avoid a conflict with FDA’s labeling decisions. See 71 Fed. Reg. at 3934. 54 Pfizer and the United States also claimed that the plaintiffs’ claims were preempted. Because the court found that FDA had primary jurisdiction, it did not discuss the preemption argument. Bernhardt v. Pfizer, Inc., 2000 WL 1738645 at *1.
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it is best treated. Id. at *3. Finally, the Court found that plaintiffs’ failure to make a prior
application to FDA for the issuance of the notices was not dispositive and that no substantial
delay would result from the application of the primary jurisdiction doctrine in that case.
Accordingly, the Bernhardt court stayed that part of the plaintiffs’ case until FDA made a
determination on the issue. Id. As explained below, each of the factors considered by the federal
courts counsels in favor of referring to FDA the threshold requirements for Plaintiffs’ warnings
claims under the Vaccine Act.
B. The Findings Necessary to Pursue a Warnings Claim Under the Vaccine Act Should Be Made First and Foremost by FDA
Independent of conflicts preemption under the FDCA and attendant regulations, the
Vaccine Act expressly limits state warnings claims, and certain statutory showings must be met
before a warnings claim can be asserted under Pennsylvania or any other state’s law. See, e.g.,
42 U.S.C. § 300aa-22(b). Section 22(b)(2) of the Vaccine Act establishes a legal presumption
that FDA-approved warnings are proper and sufficient if the manufacturer shows that it
complied, in all material respects, with the federal laws and FDA regulations related to approval
and labeling that are applicable to the vaccines at issue and to the alleged vaccine-related injury.
42 U.S.C. § 300aa-22(b)(2). Once a vaccine company establishes its entitlement to the adequate-
warning presumption, it is incumbent upon Plaintiffs to prove one of the statutory grounds for
overcoming the presumption, such as willful and intentional withholding of material information
from FDA. Id.; see also part I.B.2.b, supra. These exceptions embody Congress’ intent “that
only those significant failures to warn or provide directions that clearly pertain to vaccine safety
and that clearly arise from substantial wrongdoing on the part of the manufacturer ought to result
in liability.” H.R. REP. NO. 99-908, at 26, reprinted in 1986 U.S.C.C.A.N. 6344, 6367 (Exhibit
A). As Congress has explicitly decreed in the Vaccine Act, collateral challenges to the FDA’s
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decisions on vaccine warnings should not be allowed unless there is proof that the regulatory
approval process has been infected with serious wrongdoing on the part of the regulated entity.
As explained, the Court should consider the primary jurisdiction of FDA to make the requisite
findings under the Vaccine Act.55
1. FDA should determine whether SB has complied with the applicable federal laws and FDA regulations
FDA should consider whether SB has complied, in all material respects, with the federal
laws and FDA regulations related to approval and labeling that are applicable to the vaccines at
issue and to the alleged vaccine-related injury, as is necessary to entitle the Vaccine Defendants
to the statutory presumption that their warnings are adequate under 42 U.S.C. § 300aa-22(b)(2).
FDA has certified that its approval of a product license application (“PLA”) “constitute[s] a
determination that the . . . product meet applicable requirements to ensure the continued safety,
purity, and potency of such products.” 21 C.F.R. § 601.2(d). As noted, labeling is an integral
part of the license application. See 21 C.F.R. § 610.2. Having applied for and received licenses
for their vaccine products, the Vaccine Defendants are thus entitled to the Vaccine Act’s
presumptions that their FDA-prescribed warnings were adequate. See part I.B.2.a, supra. If
there were any doubt in the Court’s mind, it should refer the matter to FDA under the doctrine of
primary jurisdiction.
The core principles of primary jurisdiction—agency expertise and the need for
nationwide uniformity—fully support resorting to FDA to make this highly specialized
regulatory determination. See MCI, 71 F.3d at 1104 (citing Elkin, 491 Pa. 123, 134 (discussing
complexity, expertise, and the need for uniformity and consistency as the considerations to
55 As explained above at part I.B.2, Section 22 of the Vaccine Act presents independent grounds for summarily adjudicating these claims under that statutory framework.
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weigh in determining whether jurisdiction should rest in the agency or in the court)).56
Consistent with its directives under the FDCA and PHSA, FDA designed the regulatory system
that must be reviewed for compliance. FDA, rather than a lay jury, should wade through the
maze of its regulatory requirements governing vaccines. Further, Section 22(b)(2) requires that
the regulatory requirements necessary to establish the Vaccine Act’s presumption be “applicable
to the vaccine and related to vaccine-related injury . . . for which the civil action was brought
. . . .” 42 U.S.C. § 300aa-22(b)(2) (emphasis added). FDA is in a far better position than a civil
jury to determine which of the myriad regulatory requirements it has created are “applicable to
the vaccine and related to vaccine-related injury” that Plaintiffs have alleged. Id. And its
decision on the matter is vital to insure consistency of application of these requirements. A
dozen different juries would likely have a dozen different views as to what is necessary to show
compliance with this complicated regulatory regime.
The Bernhardt factors also support the application of primary jurisdiction here. The first
Bernhardt factor—analyzing whether the issue is within the conventional experience of judges or
whether it involves technical or policy considerations within the agency’s particular expertise—
clearly favors referral to FDA. Any decision as to whether the Vaccine Defendants “complied in
all material respects” with the applicable FDA and vaccine statutes and regulations, 42 U.S.C.
§ 300aa-22(b)(2), involves a substantial understanding of the complex regulatory process
governing prescription biological products. See part II.B.1, above. Such issues are particularly
within FDA’s expertise. See Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 654 (1973)
56 FDA’s preamble to the new labeling rule confirms that the twin principles undergirding the doctrine of primary jurisdiction are served by deferring to the agency’s judgment on these complicated issues relating to prescription product labeling. As detailed above, FDA is “the expert Federal public health agency charged by Congress with ensuring that drugs are safe and effective,” 71 Fed. Reg. at 3934, and considers matters regarding labeling to be necessarily within its exclusive province in order to maintain nationwide uniformity and safety standards. See part II.B, supra.
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(noting that agency expertise is superior to courts’ by virtue of its “specialization, insight gained
through experience, and by more flexible procedures”); cf. Henley, 77 F.3d at 621 (“The FDA
possesses the requisite know-how to conduct [an analysis of conflicting studies] by sifting
through the scientific evidence to determine the most accurate and up-to-date information
regarding a particular drug”); Public Citizen Health Research Group v. Commission. Food &
Drug Admin., 740 F.3d 21, 29 (D.C. Cir. 1984) (Whether a drug “is sufficiently dangerous to
require a warning label is a factual question demanding the medical expertise the FDA possess
and [courts] lack.”); Premo Pharm. Lab., Inc. v. United States, 629 F.2d 795, 803 (2d Cir. 1980)
(Whether a drug is safe and effective “is to be determined by the FDA which, as distinguished
from a court, possesses superior expertise, usually of a complex scientific nature, for resolving
the issue.).
The second Bernhardt consideration likewise favors referral of this question. As noted,
Congress has established a comprehensive regulatory scheme, administered by FDA, to control
the design and distribution of prescription drugs, including vaccines. Blackmon v. American
Home Products Corp., 328 F. Supp. 2d 659, 665 (S.D. Tex. 2004) (citing 21 U.S.C. §§ 301-393
and Grundberg v. Upjohn Co., 813 P.2d 89, 99 (Utah 1991) (discussing in detail the pre-approval
screening and post-market surveillance undertaken by FDA)). The regulatory scheme
established by Congress contemplates that the complex scientific and public health issues
involved in drug labeling should be resolved by the agency created for that purpose. See
Cottrell, Ltd. v. Biotrol Int’l, Inc., 191 F.3d 1248, 1255 (10th Cir. 1999) (“[C]laims that require
direct interpretation and application of the FDCA are not properly recognized because such
matters are more appropriately addressed by the FDA, especially in light of Congress’s intention
to repose in that body the task of enforcing the FDCA.” (quoting Braintree Labs, Inc. v. Nephro-
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Tech., Inc., No. 96-2459-JWL, 1997 WL 94237, at *6 (D. Kan. Feb. 26, 1997)); American Home
Prods. Corp. v. Johnson & Johnson, 672 F. Supp. 135, 145 (S.D.N.Y. 1987) (public interest
presumed to be adequately represented by FDA, whose control over drug labeling is “pervasive
and complete”).
Third, there is great risk of inconsistent rulings if a jury were permitted to decide whether
the Vaccine Defendants satisfied the material aspects of the regulatory process. FDA, rather than
a lay jury, should determine whether FDA’s regulatory requirements were satisfied. See Fulton
Cogeneration Assocs. v. Niagara Mohawk Power Corp., 84 F.3d 91, 97 (2d Cir. 1996) (“The aim
of the [primary jurisdiction] doctrine . . . is to ensure that courts and agencies with concurrent
jurisdiction over a matter do not work at cross-purposes.”).
The fourth factor—whether a prior application has been made to the agency—adds
nothing to the balance of whether primary jurisdiction should rest with the FDA. The fact that
Plaintiffs have not made an application to FDA for its determination on the issue is at most
neutral to the analysis because there is an available administrative route to obtain such
findings—Plaintiffs can request FDA to make the requisite findings pursuant to the “citizen
petition” provision of 21 C.F.R. § 10.30 (2006); see also Bernhardt, 2000 WL 1738645, at *3.
They have not and cannot allege that FDA has refused to consider their request. That they have
not yet made such a request is no impediment to this Court’s authority to refer to the agency.
2. Plaintiffs’ charges that SB withheld material information from FDA should be decided by FDA
FDA should also address Plaintiffs’ allegations that the Vaccine Defendants intentionally and
wrongfully withheld information regarding the safety, efficacy, risks and dangers of thimerosal
before, during, and after FDA approval of the product license applications, or otherwise failed to
exercise due care. Complaint ¶¶ 22 and 27(f). Plaintiffs make these allegations in an effort to
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overcome the statutory presumption of adequate warnings allowed under 42 U.S.C. § 300aa-
22(b)(2). See part I.B.2.b, supra. If the Court does not determine, as a matter of law, that
Plaintiffs lack evidence to support their allegations in this regard as requested above, FDA
should decide whether the allegations can be proven.
In Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348 (2001), the U.S.
Supreme Court considered FDA’s extensive role in policing “fraud-on-the-FDA” in concluding
that such claims were preempted by federal law. It explained that the federal statutory scheme
amply empowers FDA to punish and deter fraud against the Administration, and this authority is
used by the Administration to achieve a somewhat delicate balance of statutory objectives. The
balance sought by the Administration can be skewed by allowing fraud-on-the-FDA claims
under state tort law.
Although Buckman was a preemption case, the same factors that influenced the Court’s
decision that the state law fraud-on-the FDA claims were impliedly preempted are quite relevant
to a primary jurisdiction analysis. The Buckman Court discussed in detail the FDA’s regulatory
authority to police fraud as follows:
Accompanying these disclosure requirements are various provisions aimed at detecting, deterring, and punishing false statements made during this and related approval processes. The FDA is empowered to investigate suspected fraud, see U.S.C. § 372; 21 CFR § 5.35 (2000),57 and citizens may report wrongdoing and petition the agency to take action, § 10.30. In addition to the general criminal proscription on making false statements to the Federal Government, 18 U.S.C. §1001 (1994 ed., Supp. V), the FDA may respond to fraud by seeking injunctive relief, 21 U.S.C. § 332, and civil penalties, 21 U.S.C. §333(f)(1)(A); seizing the device, §334(a)(2)(D); and pursuing criminal prosecutions, §333(a). The FDA thus has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.
57 Section 5.35 (2000) regarding FDA's empowerment to investigate suspected fraud, was amended in 2004, and the information is available on the FDA website. See FDA Staff Manual Guides, Volume II - Delegations of Authority, SMG 1410.32, available at http://www.fda.gov/smg/1410_32.html (Exhibit 19).
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Id. at 349. These same powers are implicated by Section 22(b) of the Vaccine Act.
Further, state law fraud-on-the-FDA claims inevitably conflict with FDA’s responsibility
to police fraud consistently with the Administration’s judgment and objectives. The Court in
Buckman found, as a practical matter, complying with FDA’s detailed regulatory regime in the
shadow of 50 States’ tort regimes “will dramatically increase the burdens facing potential
applicants—burdens not contemplated by Congress in enacting the [relevant statutes].” Id. at
350. In addition, the Buckman Court found that fraud-on-the FDA claims would also cause
applicants to fear that their disclosures to FDA, although deemed appropriate by the
Administration, will later by judged insufficient in state court. Applicants would then have an
incentive to submit a deluge of information that the Administration neither wants nor needs,
resulting in additional burdens on FDA’s evaluation of an application. Id. at 351. Consequently,
the Supreme Court concluded that FDA, rather than the court system, should determine whether
a party withheld or concealed material information before, during, and after the product license
application. Id.
The policy considerations animating the Buckman decision should apply with equal force
to this Court’s consideration of FDA’s primary jurisdiction to make such findings. FDA alone
should determine whether the Vaccine Defendants engaged in fraud or intentional withholding of
information during the regulatory process, and FDA is in an exclusive position to determine
whether its labeling decisions would have been different had it been aware of the yet-to-be
identified “facts” Plaintiffs claim were unlawfully concealed. Accordingly, whether the Court
uses the legal construct of preemption or the discretionary doctrine of primary jurisdiction, it
should insure that proper deference is accorded FDA.
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CONCLUSION AND PRAYER
For these reasons, Defendant SmithKline Beecham Corporation d/b/a GlaxoSmithKline
requests that the Court:
(i) grant SB summary judgment on Plaintiffs’ claims predicated upon allegations that its
FDA-approved product design was defective or that safer alternative products were available;
(ii) grant SB summary judgment on Plaintiffs’ direct warnings claims,
(iii) grant SB summary judgment on Plaintiffs’ remaining warnings claims, or
alternatively, hold as a matter of law that SB has established its entitlement to a presumption that
its FDA-approved warnings were adequate as a matter of law;
(iv) alternatively,
(a) dismiss Plaintiffs’ claims for failure to warn as preempted under the
FDCA and PHSA, or in the alternative;
(b) hold that the findings discussed above are within the primary jurisdiction
of FDA and stay proceedings in this case unless and until such time as Plaintiffs
obtain affirmative findings from FDA under Section 22(b)(2) of the Vaccine Act
as would be necessary to bring a claim for inadequate warnings; and
(v) grant SB such other and further relief to which it is entitled.
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Dated: July 14, 2006 Respectfully submitted,
/s/ Matthew J. Hamilton Nina M. Gussack (31054) Barry H. Boise (63125) Matthew J. Hamilton (78327) PEPPER HAMILTON LLP 3000 Two Logan Square 18th & Arch Streets Philadelphia, PA 19103-2799 (215) 981-4053 Barclay A. Manley FULBRIGHT & JAWORSKI L.L.P. 1300 McKinney, Ste. 5100 Houston, Texas 77010 (713) 651-5100 OF COUNSEL: Stephanie A. Smith FULBRIGHT & JAWORSKI L.L.P. 600 Congress Avenue, Suite 2400 Austin, Texas 78702-3271 (512) 474-5201 ATTORNEYS FOR DEFENDANT SMITHKLINE BEECHAM CORPORATION D/B/A GLAXOSMITHKLINE
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CERTIFICATE OF SERVICE
I hereby certify that on July 14, 2006, I caused a true and correct copy of the foregoing to
be served upon the following by United States Mail, First Class postage prepaid:
Clifford J. Shoemaker 9711 Meadow Lark Road Vienna, VA 22182-1951 Dianne M. Nast Roda & Nast PC 801 Estelle Drive Lancaster, PA 17601 John H. Kim The Kim Law Firm Two Shell Plaza Suite 2500 777 Walker St. Houston, TX 77002 Lawrence R. Cohan Anapol Schwartz Weiss Cohan Feldman & Smalley 1710 Spruce Street Philadelphia, PA 19103 Michael L. Williams Williams, Love, O'leary, Craine & Powers, P.C. 9755 SW Barnes Road, Suite 450 Portland, OR 97225-6681 Daniel J. Thomasch Lauren Elliot Orrick Herrington & Sutcliffe LLP 666 Fifth Ave New York, NY 10103 Reetu Dandora Reed Smith LLP 2500 One Liberty Place 1650 Market St. Philadelphia, PA 19103
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Douglas J. Gunn Watkins & Eager PLLC 400 East Capitol St., Suite 300 Jackson, MS 39201 Fred M. Haston, III Bradley, Arant, Rose & White 2001 Park Place Tower, Suite 1400 Birmingham, AL 35203-2736 William F. Goodman, III Watkins & Eager PLLC 400 East Capitol St. ,Suite 300 Jackson, MS 39201 Rachel Castillo Rosser Eckert Seamans Cherin & Mellott LLC 1515 Market St., 9th Fl Philadelphia, PA 19102 /s/ Matthew J. Hamilton