Full opinion text
OPINION STENGEL, District Judge. Table of Contents I. Introduction.292 II. Background.292 III. Judgment on the Pleadings v. Summary Judgment.295 IV. Rule 12(c) Judgment on the Pleadings Standard.296 V. Federal Preemption of State Law Claims t>0 ZD 05 A. Preemption in General. DO ZD 05 B. Express Preemption of Defective Design Claims under the Vaccine Act CO <D 1. Vaccine Act in General — Congress’s Dual Concern. DO ZD ““3 2. The Parties’ Arguments. CO ZD 00 3. Section 22(b) — Against the Backdrop of Product Liability Law and Its Legislative History. CO ZD <D 4. Plaintiffs’ Strict Liability Defective Design Claims against GSK and Wyeth Are Barred. CO o 5. Plaintiffs’ Negligent Defective Design Claims Against GSK and Wyeth Are Barred. 303 C. Failure to Warn Claims Under the Vaccine Act. 1. The Vaccine Act’s Modification of State Law Failure to Warn Claims 2. Parties’ Arguments. 3. Direct Warning Claims. 4. Remaining Failure to Warn Claims. D. Conflict Under the FDCA and FDA Regulations. 1. Recap of Conflict Preemption. 2. Overview of Regulatory Process to Obtain Approval from the FDA of a Biological Product. 00 o -3 3. The FDA’s Preemption Position Regarding Plaintiffs’ Failure to Warn Claims and the Deference to Be Given That Position... 00 o 00 a. FDA’s Position of Preemption Stated in the Preemption Preamble. 00 O CO b. FDA’s Preemption Position as Applied in This Case. O tH CO c. What Deference Should be Given to FDA Position?. CO t-H CO 4. Conclusion.: CO t — ( CO E. Plaintiffs’ Remaining Claims Against Bayer . CO i — ! CO VI. Transfer of Venue Motions.321 VII. Conclusion.324 I.Introduction Eleven-year old Wesley Sykes suffers from neurological injuries which his parents believe were caused by products made by the defendants. When Wesley’s mother was pregnant with Wesley she received an injection of an immune globulin and during Wesley’s first three years of life he received injections of various pediatric vaccines. These medications have two things in common — they were manufactured by a defendant in this action and they contained the preservative thimerosal. Thimerosal is an organic compound which is approximately 50% mercury by weight. Wesley’s parents, the plaintiffs in this case, claim that the thimerosal-con-taining products caused Wesley’s various injuries. They filed this lawsuit against the manufacturers of the vaccines, Smith-Kline Beecham Corporation d/b/a Glaxo-SmithKline (“GSK”) and Wyeth, Inc., f/k/a American Home Products Corporation, and the manufacturer of the immune globulin product, Bayer Pharmaceutical Corporation. The defendants have moved to dismiss the entire state law Complaint based on preemption grounds. The two sources for the preemption of the plaintiffs’ state law claims are: (1) the National Childhood Vaccine Injury Compensation Act of 1986 (“Vaccine Act”), 42 U.S.C. § 300aa-l, et seq., and (2) the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. 301, et seq., and the Food and Drug Administration (“FDA”) regulations promulgated under that statute. In addition, or in the alternative, the defendants have moved to transfer the case to the Eastern District of Virginia. II. Background In 1995, Lisa Sykes was pregnant with her son, Wesley. During her pregnancy, Mrs. Sykes received from her physician a dose of Bayer’s immune globulin blood product, HypRho-D. Mrs. Sykes’s ante-partum shot of HypRho-D contained thim-erosal. Wesley Sykes was born on January 27, 1996. Between February 1996 and September 1998 Wesley received the following vaccines: (1) one dose of Wyeth’s thimerosal-containing Diphteria and Tetanus Toxoids and Acellular Pertussis (“DTaP”) vaccine (marketed under the trade name ACEL-IMUNE®); (2) one dose of Wyeth’s thimerosal-containing Haemophilus influenzae type b (“Hib”) vaccine (marketed under the trade name HibTITER®); (3) three doses of Wyeth’s thimerosal-containing Diphteria and Tetanus Toxoids and Pertussis (“DTP”)-Hib combination vaccine (marketed under the trade name TETRAMUNE®); and (4) three doses of GSK’s thimerosal-containing Hepatitis B vaccine (marketed under the trade name Engerix-B®). According to the Complaint, the ante-partum injection of HypRho-D and the vaccination of Wesley with the defendants’ products resulted in neurological and neuro-developmental injuries to Wesley. In particular, the plaintiffs allege that the mercury contained in the thimerosal preservative in each of the products was toxic and led to Wesley’s injuries. The defendants’ vaccines and Bayer’s immune globulin are “biological products,” as that term is defined in FDA regulations. See 21 C.F.R. § 600.3(h). For all biological products containing a preservative, the FDA must be satisfied that the preservative is safe before the product can be marketed: Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multiple-dose containers shall contain a preservative .... 21 C.F.R. § 610.15 (emphasis added). Thimerosal has been used as a preservative in a number of biological products since the 1930s to prevent the growth of microbial contaminants. In childhood vaccines, thimerosal has been used to “deter[ ] microbial and fungal growth, thereby maintaining safety, purity and potency of vaccines” both during and after the manufacturing process. See Ex. I to GSK’s Mot. to Take Judicial Notice, U.S. Food and Drug Administration Center for Bio-logies Evaluation and Research, Thimero-sal in Vaccines at 2 (updated Nov. 16, 2006), available at http://www.fda.gov/cber/ vaccine/thimerosal.htm. See also Oioens v. Am. Home Prods. Corp., 203 F.Supp.2d 748, 755 (S.D.Tex.2002). The GSK product in question, Engerix-B® vaccine, contained thimerosal as a preservative. It was approved by the FDA for distribution and sale in the United States. The vaccine was distributed with labeling information approved by the FDA. The vaccine’s label disclosed that the vaccine contained “thimerosal (mercury derivative)” as part of the formula, as well as the concentration of the preservative. At all relevant times, the disclosure and description of thimerosal in the label, and the use of thimerosal as an ingredient, could not be changed without FDA approval. See 21 C.F.R. § 601.12 (requiring FDA approval before any changes in the manufacturing methods and labeling of a biological product become effective). All of the Wyeth products administered to Wesley contained thimerosal as a preservative. ACEL-IMUNE®, HibTI-TER®, and TETRAMUNE® were marketed in multi-dose presentations at the time of Wesley’s vaccination, and the FDA mandates that all childhood vaccines “in multi-dose containers shall contain a preservative.” See 21 C.F.R. § 610.15. The FDA approved Wyeth’s vaccines at issue with thimerosal as an ingredient, and Wyeth complied with federal law and regulations regarding the labeling of the vaccines. In the labels submitted and approved by the FDA, Wyeth disclosed the presence and concentration of thimerosal in the vaccines. Bayer’s HypRho-D is a prescription biological product that works by suppressing the immune response of Rh negative pregnant women to Rh positive blood cells from the fetus that enter the mother’s circulation. The FDA requires that every immune globulin contain a preservative and Bayer received approval to use thimerosal during the product licensing process of HypRho-D. See 21 C.F.R. § 640.103(a) (“The final product shall be a 16.5[+/-]1.5 percent solution of globulin containing 0.3 molar glycine and a preservative.”). At all relevant times, the licensing, composition, manufacture, testing, and labeling of Hy-pRho-D, including the use of thimerosal in HypRho-D, was regulated and approved by the FDA. Lisa and Seth Sykes filed a timely petition for compensation on Wesley’s behalf with the National Vaccine Injury Compensation Program (“NVICP”) on October 2, 2000, pursuant to 42 U.S.C. § 300aa-l, et seq. On November 11, 2002, the Sykes filed a notice of withdrawal in the NVICP, and judgment was entered on the withdrawal by the Clerk of the U.S. Court of Federal Claims on January 16, 2003, pursuant to 42 U.S.C. § 300aa-21(b). The Sykes filed an Election to file a civil action on January 24, 2003, pursuant to 42 U.S.C. § 300aa-21(a). On March 14, 2006, the plaintiffs filed their Complaint with this court, individually and as parents of Wesley Sykes. The plaintiffs assert strict products liability and negligence claims against the vaccine manufacturers, GSK and Wyeth, and the HypRho-D manufacturer, Bayer. The strict products liability claim alleges that the vaccines and HypRho-D were defectively designed and safer alternatives existed. The strict liability and negligence claims both allege that the defendants: (1) failed to warn health care professionals of the dangers of thimerosal and the availability of safer alternatives; (2) failed to conduct adequate safety tests to determine whether thimerosal was safe and nontoxic to humans in the doses administered; and (3) failed to comply in all material respects with the relevant FDA requirements. In addition, the Sykes allege Wyeth and GSK intentionally and wrongfully withheld information from the FDA and the U.S. Department of Health and Human Services (“HHS”) regarding the safety and risks of thimerosal, before, during, and after FDA approval of the product license application. By order dated June 19, 2006, discovery was stayed and the defendants were instructed to file motions addressing any federal law preemption issues. GSK filed a motion for summary judgment (Docket No. 39), a motion to take judicial notice of 19 exhibits (Docket No. 40), and a motion to transfer venue (Docket No. 56). Wyeth filed a motion for summary judgment (Docket No. 46) and a motion to transfer venue (Docket No. 57). Bayer filed a motion for judgment on the pleadings (Docket No. 44) and a motion to transfer venue (Docket No. 51). The plaintiffs filed responses to all of the defendants’ motions and counsel presented oral argument on December 18, 2006. III. Judgment on the Pleadings v. Summary Judgment GSK and Wyeth structured their arguments and filings as summary judgment motions. Bayer filed a motion for judgment on the pleadings. All of the defendants attached documents to their motions in support of their arguments. If the court, in its discretion, considers extrinsic evidence presented by the parties on a Federal Rule of Civil Procedure (“FRCP”) 12(c) motion for judgment on the pleadings, the court must treat the motion as a summary judgment motion. See FED. R. CIV. P. 12(c). In this regard, the court must give all parties notice of such a conversion, and provide them with an opportunity to be heard and present further materials in support of their positions on the motion. Id. Such a “conversion” is not required, however, when the court considers documents attached as exhibits to the complaint, documents on which the complaint is based, matters of public record, and materials subject to judicial notice. See Ieradi v. Mylan Labs., Inc., 230 F.3d 594, 600 n. 3 (3d Cir.2000) (“Under Federal Rule of Evidence 201, we may take judicial notice at any stage of the proceeding of a fact not subject to reasonable dispute that is capable of accurate and ready determination by resort to a source whose accuracy cannot be reasonably questioned.”); Pension Benefit Guar. Corp. v. White Consol. Indus, 998 F.2d 1192, 1197 (3d Cir.1993) (holding a court may consider materials outside the complaint without converting motions to dismiss into summary judgment motions where the materials are public records, which includes “letter decisions of government agencies and published reports of administrative bodies”). Since I did not rule that the preemption motions would be treated as motions for summary judgment, and with the plaintiffs not having the benefit of discovery or an opportunity to present any pertinent material outside the pleadings, the defendants’ motions on preemption shall be decided as motions for judgment on the pleadings under FRCP 12(c). I will only consider the exhibits of the defendants that fall into one of these categories: matters of public record and materials subject to judicial notice. I will also rely on the facts that the parties do not contest with respect to the defendants’ products’ FDA approval and label contents. See Docket No. 52, 53, Plaintiffs’ Responses to Defendants’ Statements of Undisputed Facts. It is worth noting, however, that the hundreds of pages of exhibits have little impact on the decision in this case. As the plaintiff points out: “While GSK and Wyeth have attached extensive exhibits with their motions, these do nothing more than establish that the two manufacturers had FDA approval to market their thimerosal-containing vaccines, and that the FDA approved the labels. These matters are not in dispute.” The question for this court is really a matter of law: Given the FDA approvals, are the plaintiffs’ state law tort claims preempted by federal law? IV. Rule 12(C) Judgment on the Pleadings Standard “Motions for judgment on the pleadings brought pursuant to Federal Rule of Civil Procedure 12(c) are reviewed under the same standard as motions to dismiss pursuant to Rule 12(b)(6).” Piskanin v. Hammer, No. 04-1321, 2005 WL 3071760, at *3, 2005 U.S. Dist. LEXIS 28135, at *8 (E.D.Pa. Nov. 14, 2005) (citing Spruill v. Gillis, 372 F.3d 218, 223 n. 2 (3d Cir.2004)). When considering a motion to dismiss under Fed. R. Civ. Proc. 12(b)(6), the court must accept the complaint’s allegations as true and draw all reasonable inferences in the plaintiffs favor. Zimmerman v. HBO Affiliate Group, 834 F.2d 1163, 1164-65 (3d Cir.1987). The court, however, “need not accept as true unsupported conclusions and unwarranted inferences.” Doug Grant, Inc. v. Greate Bay Casino Corp., 232 F.3d 173, 183-84 (3d Cir.2000) (citation and internal quotations omitted). Under Rule 12(b)(6), a defendant may move to dismiss a complaint for “failure to state a claim upon which relief can be granted.” The rule is designed to screen out cases where “a complaint states a claim based upon a wrong for which there is clearly no remedy, or a claim which the plaintiff is without right or power to assert and for which no relief could possibly be granted.” Port Auth. v. Arcadian Corp., 189 F.3d 305, 311-12 (3d Cir.1999). Under Rule 12(b)(6), a complaint should not be dismissed for failure to state a claim “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.” Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). The issue, therefore, is not whether the plaintiff will ultimately prevail, but whether she is entitled to offer evidence to support her claims. Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974); See also Maio v. Aetna, Inc., 221 F.3d 472, 482 (3d Cir.2000). V. Federal Preemption of State Law Claims A. Preemption in General Under the Supremacy Clause of the U.S. Constitution, federal law will override state law in three instances: (1) express preemption, i.e., when Congress expressly preempts state law; (2) field preemption, i.e., when congressional intent to preempt may be inferred from the existence of a pervasive federal regulatory scheme; or (3) conflict preemption, i.e., when state law conflicts with federal law or its purposes and preemption is implied. See English v. General Elec. Co., 496 U.S. 72, 78-79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1120 (3d Cir.1990). 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 Council, 530 U.S. 363, 372-73, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000). Two different preemption issues have been raised in the motions. First, GSK and Wyeth argue that the plaintiffs’ defective design and inadequate warning claims against them are expressly preempted under the Vaccine Act. Second, all three defendants argue that the plaintiffs’ failure to warn claims are conflict preempted due to the FDA’s regulation of them drug labels and the FDA’s position on thimerosal. In addition, Bayer raises additional arguments as to why the balance of the claims against it should be dismissed. I will first address the preemption issue under the Vaccine Act and then discuss the preemp-tory effect of the FDCA and the FDA regulations. Finally, I will turn to Bayer’s remaining arguments and determine their merit. B. Express Preemption of Defective Design Claims under the Vaccine Act 1. Vaccine Act in General — Congress’s Dual Concern Congress recognized that while most children derived a great benefit from childhood vaccination, “a small but significant number have been gravely injured.” Blackmon v. Am. Home Prods. Corp., 328 F.Supp.2d 659, 663-66 (S.D.Tex.2004). These vaccine-related injuries raised two concerns: “(1) the inconsistency, expense, delay, and unpredictability of the tort system in compensating claims of vaccine-injured children; and (2) the instability and uncertainty of the childhood vaccine market inevitably caused by the risks of tort litigation.” Id. In response, Congress passed the Vaccine Act. With it, Congress hoped to prevent manufacturers from leaving vaccine production or significantly increasing their prices, while at the same time compensate victims of vaccine-related injuries quickly. See Schafer v. Am. Cyanamid Co., 20 F.3d 1, 4 (1st Cir.1994) (discussing congressional testimony by vaccine manufacturers regarding insurance and litigation costs). “The Vaccine Act reflects a congressional determination that the disappearance or unavailability of childhood vaccines would cause far greater harm than the inevitable but limited injuries caused by the vaccines themselves. To offset the vicissitudes of the tort system and provide compensation for victims of childhood vaccines, the Vaccine Act established the National Vaccine Program, which provides a unique avenue of recovery for injuries and deaths traceable to vaccinations that works with greater ease and on a faster timetable than the civil tort system.” Blackmon, 328 F.Supp.2d at 663-66 (citing Shalala v. Whitecotton, 514 U.S. 268, 269, 115 S.Ct. 1477, 131 L.Ed.2d 374 (1995)). See also Brice v. Secretary of HHS, 240 F.3d 1367, 1368-69 (Fed.Cir.2001). In effect, the Act “ensures that all children who are injured by vaccines have access to sufficient compensation for their injuries.” H.R.Rep. No. 99-908 at 4 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345. A person alleging a vaccine-related injury can obtain compensation by filing a petition with the Vaccine Court. The petitioner need not prove fault nor causation; he only needs to show that he received the vaccine and then suffered certain - symptoms within a defined period. See 42 U.S.C. §§ 300aa-13, 300aa-14. It is worth noting that an alleged defective design claim would be compensated under this no-fault system. In the event a plaintiff seeking compensation for vaccine-related injuries does not accept the judgment of the Vaccine Court and elects to pursue claims in state or federal court, the Vaccine Act includes certain limitations on state tort claims designed to “free manufacturers from the specter of large, uncertain tort liability, and thereby keep vaccine prices fairly low and keep manufacturers in the market.” Schafer v. Am. Cyanamid Co., 20 F.3d 1, 4 (1st Cir.1994). See also 42 U.S.C. § 300aa-21 (discussing when a petitioner rejects a Vaccine Court’s judgment or withdraw his petition from Vaccine Court). The limitations are stated in 42 U.S.C. § 300aa-22, and convey Congress’s intent to supersede, or preempt, state tort law standards and create legal protections that apply in any civil action brought against a vaccine manufacturer. Therefore, Congress has accomplished preemption with its enactment of the Vaccine Act by its modification of state tort law. See Brice v. Secretary of HHS, 240 F.3d 1367, 1368-69 (Fed.Cir.2001) (recognizing that the Vaccine Act modifies state tort law); Schafer, 20 F.3d at 3 (noting that the Vaccine Act “provide[s] certain federal modification of state tort law”). In sum, a vaccine-injured plaintiff who withdraws from the NVICP is limited by the Vaccine Act in the state law claims he can pursue against a vaccine manufacturer. The pertinent part of the Vaccine Act that modifies state tort law, and is at issue in this case, provides: (a) General. State law shall apply to a civil action brought for damages for a vaccine-related injury or death. (b) Unavoidable adverse side effects; warnings. (1) 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 ... 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. (2) For purposes of paragraph (1), 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. §§ 301 et seq.] and section 351 of the Public Health Service Act [42 U.S.C. § 262] (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 unless the plaintiff shows— (A) that the manufacturer engaged in [fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine or intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval], or (B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions). (c)Direct warnings. 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 ... 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. As the words of the statute indicate, the Vaccine Act provides that “[s]tate law shall apply to a civil action” for “vaccine-related injury,” except in the following instances, when federal law modifies state law: (1) if a plaintiffs vaccine-related injury resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings, then the vaccine manufacturer shall not be liable for damages; (2) if the vaccine manufacturer shows it “complied in all material respects” with the applicable FDA and vaccine statutes and regulation, the FDA-approved warnings are presumed adequate and a plaintiff can rebut that presumption only in one of two ways; and (3) no vaccine manufacturer will be liable “solely due to the manufacturer’s failure to provide direct warnings to the injured party....” 2. The Parties’ Arguments The vaccine defendants argue that the plaintiffs’ design defect claims against them are barred by § 22(b) of the Vaccine Act. The defendants construe this section of the Vaccine Act to impose a total bar on design defect claims arising from vaccine-related injuries so long as the vaccine was produced in accordance with FDA-approved specifications. Under the vaccine defendants’ view, any vaccine-related injury would be deemed “unavoidable” if the vaccine was properly prepared and accompanied by proper warnings. According to GSK and Wyeth, in order to ensure vaccine manufacturers the protection of the Vaccine Act, Congress entrusted the determination of whether a particular vaccine’s design is safe to federal health agencies with the expertise and experience to carry out the mandate, not to juries. The plaintiffs disagree with the defendants’ construction of the Vaccine Act and argue that the Vaccine Act only bars design defect claims if the side effects are determined, on a case-by-case basis, to be “unavoidable.” Plaintiffs claim that their defective design claims are permitted because the injuries suffered by Wesley were not unavoidable. They maintain that the injuries could have been avoided if the defendants had used a mercury-free preservative for multi-dose vials of their vaccines, or if they had simply distributed single-dose vials, which do not require a preservative. Under the plaintiffs’ view, the express language of the statute envisions three types of civil actions: (1) design defect claims where plaintiffs can show that the adverse side effects were avoidable; (2) manufacturing defect claims; and (3) failure to warn claims. Given that both readings of the statute are plausible, and that the plain text of the Vaccine Act does not resolve the proper interpretation, I will look at the legislative history of the Act and any other relevant extrinsic material to decipher Congress’s intent in enacting 42 U.S.C. § 300aa-22(b)(1). See Oklahoma v. New Mexico, 501 U.S. 221, 235 n. 5, 111 S.Ct. 2281, 115 L.Ed.2d 207 (1991) (“[W]e repeatedly have looked to legislative history and other extrinsic material when required to interpret a statute which is ambiguous.”). 3. Section 22(b) — Against the Backdrop of Product Liability Law and Its Legislative History The parties in Blackmon v. Am. Home Prods. Corp., 328 F.Supp.2d 659, 665 (S.D.Tex.2004), staked the same positions as the plaintiffs and vaccine defendants in this case with respect to the application of the Vaccine Act to defective design claims. The court in Blackmon provided a thorough analysis on why interpreting § 22(b) in the context of product liability law, along with the legislative history of the Vaccine Act, defeats a plaintiffs defective design claims: Read against the background of products liability law, the language of § 22(b) shows Congress’s intent to foreclose all design defect claims against vaccine manufacturers. Texas law recognizes three types of product liability claims: (1) defective design, (2) defective manufacture, and (3) inadequate warning or failure to warn. The drafters of § 22(b) were obviously aware of the different heads of products liability, yet the statute identifies only two: manufacturing defect and failure-to-warn claims. The statute singles out these two claims as the variables that determine whether a claimant may sue the manufacturer for a vaccine-related injury. If the alleged defect that caused the claimants injury does not fall into one of these two enumerated categories, the defect is considered “unavoidable,” and the claimant’s tort claim is barred. The origins of § 22(b) reinforce Defendants’ construction of the statute. Congress modeled § 22(b) after comment k in § 402A of the Restatement (Second) of Torts. Using the Pasteur rabies vaccine as an example of “products, which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use,” the Restatement takes the following view of liability: “Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this reason cannot legally be sold except to physicians .... ” Restatement (Second) of Torts § 402A cmt. k (1966). Like § 22(b), comment k distinguishes the three heads of products liability — design defect, manufacturing defect, and warning defect — and rejects the notion of defective design in the context of products with certain known and inherent risks that have nonetheless been accepted as a matter of policy given the benefit provided and the grim consequences that would follow if the product were not available. Under comment k, as long as such a product is “properly prepared, and accompanied by proper directions and warning” — that is, as long as it is free from manufacturing and warning defects — the seller will not be held strictly liable for injuries resulting from risks inherent in the product’s design. The legislative history also supports a construction of § 22(b) that would bar all defective design claims under the conditions outlined in the statute. Two passages in the Report of the Committee on Energy and Commerce suggest that Congress intended the National Vaccine Program’s compensation system to absorb defective design claims. The report states that the Committee looked to comment k “because it intends that the principle in Comment K regarding ‘unavoidably unsafe products ... apply to the vaccines covered in the bill and that such products not be the subject of liability in the tort system.” Report of the Committee on Energy and Commerce, H.R.Rep. No. 99-908 at 26, reprinted in 1986 U.S.C.C.A.N. at 6367. The report also contains the following statement: “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.” Id. The last passage indicates rather clearly the Committee’s intent to relegate design defect claims to the compensation system, provided that the injury-producing vaccine was manufactured and distributed according to applicable federal standards. The Plaintiffs contention that the question whether a side effect was unavoidable must be determined on a case-by-case basis which would permit the jury to decide whether a particular side effect was unavoidable, would provide no protection against design defect claims. A plaintiff could show that an alleged defect was not unavoidable by proving that an alternative design was feasible. Not only is this construction inconsistent with the policy behind the Vaccine Act; it strips the passage of all meaning. If an alleged defect were [sic] truly unavoidable in the broad, literal sense urged by Plaintiffs, a manufacturer could not be subject to liability as a result of that defect. With this meaning, the statute would protect manufacturers from liability only on meritless claims. The Court must presume that Congress intended statutory language to have some effect. Perhaps more importantly, to permit juries in each state to pass judgment on the design of childhood vaccines could interfere with the federal government’s efforts to establish a uniform national standard for childhood vaccines. Congress has established a comprehensive regulatory scheme, administered by the FDA, to control the design and distribution of prescription drugs, including vaccines. See 21 U.S.C. §§ 301-393. Any manufacturer seeking a license to distribute a new vaccine must submit to the FDA a formal Product License Application including information related to the safety, efficacy, labeling, and manufacturing of the specific vaccine. See 42 U.S.C. § 262(a). The FDA licenses each vaccine in accordance with a specific formula and approves specific labeling information. See 21 C.F.R. §§ 601.2, 601.12. After the vaccine is licensed, the manufacturer cannot change the formula or the label without FDA approval. The Vaccine Act delegates questions of vaccine safety to the Secretary of Health and Human Services. Individual challenges to the design of FDA-approved vaccines would undermine. the FDA’s authority to set standards for childhood vaccines. Case-by-case consideration would also expose manufacturers to inconsistent standards, as juries might hold manufacturers liable for design defects in drugs approved by the FDA. The consequences of case-by-case determination of “unavoidability” lend further support to the conclusion that § 22(b) directs the evaluation of vaccine design exclusively to the FDA. Blackmon, 328 F.Supp.2d at 663-66. See also Ferrari v. Am. Home Prods. Corp., No. 02-VS-031404-F, slip op. at 10 (State Ct. of Fulton Cty., Ga. Nov. 30, 2005) (“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 preempts design defect claims.”); Militrano v. Lederle Labs., 3 Misc.3d 523, 769 N.Y.S.2d 839, 843 (N.Y.Sup.Ct.2003), aff'd, 26 A.D.3d 475, 810 N.Y.S.2d 506 (N.Y.App.Div.2006) (“Congress did not intend that national vaccine policy be determined by the vagaries of a jury’s determination on a case-by-case basis.”). See generally Weiner v. Amer. Honda Motor Co., 718 A.2d 305, 307 (Super.Ct.Pa.1998) (listing the three types of defective conditions that may give rise to strict liability in Pennsylvania as manufacturing defect, design defect, and failure to warn defect). L Plaintiffs’ Strict Liability Defective Design Claims against GSK and Wyeth Are Barred I agree with the analysis of the Blackmon court and find that the plaintiffs’ defective design claims against GSK and Wyeth, based on a strict' liability theory, are barred. First, the purpose of the Vaccine Act would not be served if defective design claims could be tried before juries. A case-by-case determination of whether a vaccine was unavoidably unsafe would defeat the protection the Act was intended to provide vaccine manufacturers. The manufacturers would again be subjected to the unpredictability and expense of the tort system and companies would be dissuaded from remaining or entering the vaccine market. Second, the structure of the Vaccine Act read as a whole supports this conclusion. See Pokorny v. Ford Motor Co., 902 F.2d 1116, 1120 (3d Cir.1990) (citing cases that discuss the court’s role in construing statutes and discussing how a court must give effect to a statute as written and as a whole, not to enforce one section at the expense of another). As counsel for the vaccine defendants correctly pointed out at oral argument, the Vaccine Act set up a National Vaccine Program under the supervision of a Director, a task force, and two commissions. See Mot. Hr’g Tr. at 14-15. See also 42 U.S.C. §§ 300aa-1, 2, 5, 19, 27. These entities and individuals were tasked with the role of researching safer vaccines. Congress established this system to handle any safety concerns with childhood vaccines. For example, under a section of the Vaccine Act entitled “Mandate for Safer Childhood Vaccines,” Congress delegated to the HHS Secretary, and not the jury system, the role of “mak[ing] or assuring] improvements in ... the licensing, manufacturing, processing, testing, labeling, warning, ... and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.” 42 U.S.C. § 300aa-27(a)(2). The plaintiffs’ argument would undermine the congressional mandate by replacing the federal agencies’ role with state juries and it would destroy the uniformity Congress intended to establish with the Vaccine Act. Third, as Blackmon demonstrates, the legislative history of § 22(b) clearly supports the conclusion that Congress intended to protect vaccine manufacturers from liability for defective design claims. Congress struck a compromise between the two interests at risk prior to the Vaccine Act — a person injured by the vaccine and the manufacturers of the vaccine. See supra Part V.B.l. The no-fault Vaccine Court established under the Act provides an injured party an avenue for relief and Section 22(b) protects vaccine manufacturers from tort liability for making a product in accordance with FDA specifications. If a vaccine-injured person “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. Finally, product liability law and comment k to the Restatement (Second) of Torts § 402A aid my holding. The Vaccine Act mirrors this established area of tort law for unavoidably unsafe products and limits the strict liability of vaccine manufacturers for vaccine-related injuries to claims that the vaccine deviated from its FDA-approved design or it was not accompanied by proper warnings (and thereby eliminates strict liability defective design claims). Here, the plaintiffs do not claim that the vaccine manufacturers deviated from the FDA-approved design for the vaccines. (The improper warnings claims are discussed below.) Accordingly, the plaintiffs’ strict liability design defect claims against GSK and Wyeth are preempted by the Vaccine Act and I will dismiss them with prejudice. 5. Plaintiffs’ Negligent Defective Design Claims Against GSK and Wyeth Are Barred In addition, the plaintiffs’ defective design claims against the vaccine manufacturers based on negligence are preempted for the same reasons as the strict liability claims. The text of the Vaccine Act that limits a manufacturer’s liability is not directed toward any particular cause of action. Section 22(b)(1) states broadly that no manufacturer “shall be liable in a civil action for damages arising from a vaccine-related injury or death.” “A civil action for damages” includes a product liability claim based on strict liability as well as negligence. See Blackmon, 328 F.Supp.2d at 666 (“While comment k is restricted to strict liability claims, § 22(b) is not. Plaintiffs’ negligent design defect claims are therefore barred by the Act.”). Since the plaintiffs’ negligent defective design claims rely on the same factual allegations as the strict liability defective design claims, and the vaccines in question were produced in accordance with FDA-approved specifications, I will dismiss the plaintiffs’ negligent defective design claims against GSK and Wyeth with prejudice. C. Failure to Warn Claims Under the Vaccine Act 1. The Vaccine Act’s Modification of State Law Failure to Warn Claims As previously discussed, the Vaccine Act modified a vaccine-injured plaintiffs ability to pursue a product liability failure to warn claim against a vaccine manufacturer. Section 300aa-22(c) expressly prohibits holding a vaccine manufacturer liable because it failed to directly warn a vaccine recipient or his representative of any potential danger from the vaccine. See 42 U.S.C. § 300aa-22(c). As to claims that a manufacturer failed to adequately warn a health care intermediary, Section 22(b)(2) establishes a legal presumption that vaccine warnings are proper and sufficient if the vaccine manufacturer shows that it complied in all material respects with the FDA regulations applicable to the vaccine at issue. A vaccine-injured plaintiff can overcome this presumption by showing that a manufacturer: (1) engaged in fraud or intentional and wrongful withholding of information during any phase of a proceeding for approval of the vaccine; (2) engaged in intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval; or (3) failed to exercise due care. See 42 U.S.C. § 300aa-22(b)(2). 2. Parties’Arguments The vaccine defendants argue that the plaintiffs’ direct warning claims are expressly preempted by section 22(c). As for the remaining warning claims, the vaccine defendants submitted affidavits and supporting documents to establish its compliance with all relevant FDA regulations and to prove they are entitled to the presumption of adequate warnings. GSK and Wyeth then contend that the plaintiffs cannot come forward with any evidence to defeat the presumption. In particular, they point to the FDA’s official view, after numerous studies, that there is no proof that the use of thimerosal as a preservative in vaccines causes any harm (other than potential local hypersensitivity reactions). See Ex. 1 to GSK’s Mot. to Take Judicial Notice, U.S. Food and Drug Administration Center for Biologies Evaluation and Research, Thimerosal in Vaccines. The plaintiffs counter GSK and Wyeth’s arguments by claiming that the motions for summary judgment on the failure to warn claims are premature since no discovery has occurred. The plaintiffs request that the court grant them the right to conduct discovery before determining whether they can successfully rebut the presumption enumerated in § 22(b)(2). 3. Direct Warning Claims The Vaccine Act clearly bars claims based on a vaccine manufacturer’s failure to provide warnings to an individual who receives its vaccine. See 42 U.S.C. § 300aa-22(c). Therefore, the plaintiffs’ failure to warn claims, insomuch as they are based on the vaccine defendants’ failure to provide direct warnings to the plaintiffs, are dismissed with prejudice. J. Remaining Failure to Warn Claims The plaintiffs aver in their Complaint that the vaccine manufacturers failed to properly warn health care professionals of thimerosal’s danger, failed to comply in all material respects with FDA requirements, and intentionally and wrongfully withheld information from the FDA. GSK and Wyeth attempt to defeat these claims by offering proof via affidavits and supporting documentation of their compliance with all FDA requirements in the licensing and distribution of their vaccines. On a motion for judgment on the pleadings, I cannot consider evidence outside the pleadings without transforming the motion to a motion for summary judgment. And I cannot take judicial notice of the evidence that the vaccine defendants offer to prove that they are entitled to the presumption of section 22(b)(2). Therefore, at this juncture, the question is whether the plaintiffs’ failure to warn claims in the Complaint are preempted due to state tort law being modified under the Vaccine Act. The answer is no. Under the notice pleading requirements of the Federal Rules of Civil Procedure, the plaintiffs have adequately averred facts that the vaccine defendants did not adequately warn medical professionals of the dangers of their product. The Vaccine Act does not preempt failure to warn claims, but rather it creates a presumption if a vaccine manufacturer defendant comes forward with proof of its compliance with federal drug laws and regulations. Whether the vaccine manufacturers in this case have satisfied their burden of production and are entitled to the Act’s presumption of “proper direction and warnings” is a question saved for the summary judgment stage. See Blackmon, 328 F. Supp 2d at 666-67 (“Defendants are not entitled to the presumption until they produce evidence of compliance with the FDA regulations.”). At that point, the plaintiffs will have had the opportunity to conduct discovery and be better equipped to rebut the presumption (if it does attach). Therefore, the plaintiffs have stated failure to warn claims upon which relief can be granted and the Vaccine Act does not prevent the cause of action. I take note of certain allegations of the plaintiffs that fall under their failure" to warn claims. In an attempt to rebut the presumption, the plaintiffs assert in their Complaint that Wyeth and GSK intentionally and wrongfully withheld information from the FDA and the HHS regarding the safety and dangers of thimerosal before, during, and after the FDA approval process of the vaccines at issue. On a motion for judgment on the pleadings, I must accept the plaintiffs’ claims as true. However, the plaintiffs’ allegations of intentionally withholding information sound in fraud and under Federal Rule of Civil Procedure 9(b), fraud must be pled with particularity. See FED. R. CIV. P. 9(b) (“[I]n all averments of fraud ... the circumstances constituting fraud ... shall be stated with particularity.”). The purpose of the heightened pleading standard for fraud claims is “to give[] defendants notice of the claims against them, provide[] an increased measure of protection for their reputations, and reduce[ ] the number of frivolous suits brought solely to extract settlements.” In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1418 (3d Cir.1997). “Boilerplate and conclusory allegations will not suffice. Plaintiffs must accompany then-legal theory with factual allegations that make their theoretically viable claim plausible.” Id. Here, the plaintiffs’ fraud claims are no more than a recitation of the Vaccine Act language. The Sykes do not support their claims of wrongdoing with specific factual allegations, such as what material information was withheld or when it was withheld or who withheld it. Moreover, the defendants’ disclosure to the FDA of their products’ thimerosal ingredient during the licensing process of the vaccines and the FDA’s continued testing and current position on thimero-sal, ie., that there is no causal link between the preservative and neurological injury, lead to the conclusion that permitting the plaintiffs an opportunity to re-plead this claim would be pointless. Accordingly, the plaintiffs’ allegations that the vaccine defendants’ intentionally withheld information from the government are dismissed with prejudice. D. Conflict Preemption Under the FDCA and FDA Regulations Independent of the Vaccine Act preemption, the defendants argue that federal conflict preemption arising out of the FDA’s comprehensive regulation of biological products’ labels bars the plaintiffs’ state law failure to warn claims. The plaintiffs’ response to the defendants contends: (1) FDA preemption does not apply because Congress has not expressed an intent to bar state law claims; (2) the state law tort remedies complement the FDA regulatory program for prescription drugs and biologies; (3) caselaw supports a position against the conflict preemption sought by the defendants; and (4) the FDA’s “Preemption Preamble” is not entitled to any deference. 1. Recap of Conflict Preemption Defendants pursue only “conflict” preemption with their FDA preemption argument. Such a conflict exists where either (1) the state law “stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress” or (2) it is “impossible for a ... party to comply with both state and federal law.” Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 899, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000); Pokorny, 902 F.2d at 1120; C.E.R.1988, Inc. v. Aetna Cas. & Sur. Co., 386 F.3d 263, 268 (3d Cir.2004). In contending that the plaintiffs’ claims are impliedly preempted by federal law, the defendants principally assert that allowing state tort liability in this case would thwart the purpose of the FDA’s comprehensive federal scheme governing the labeling of prescription products. Secondarily, the defendants argue that under the facts of this case compliance with state law could result in misbranded drugs under federal law and conflict preemption was intended to avoid such situations. The Supreme Court has urged caution in the application of conflict preemption: “[Bjecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly preempt state-law causes of action.” C.E.R.1988, 386 F.3d at 269-70 (quoting Medtronic Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)). Thus, conflict preemption will be found only if the need for it is clear. Pokorny, 902 F.2d at 1122. “[Cjonsideration under the Supremacy Clause starts with the basic assumption that Congress did not intend to displace state law.” Bldg. & Constr. Trades Council of Metro. Dist. v. Assoc. Builders & Contractors of Mass./ R.I., Inc., 507 U.S. 218, 224, 113 S.Ct. 1190, 122 L.Ed.2d 565 (1993). 2. Overview of Regulatory Process to Obtain Approval from the FDA of a Biological Product A brief overview of the approval process to market and sell vaccines or immune globulins will be helpful in my analysis of the parties’ arguments. Virtually all aspects of biological products are governed by regulations promulgated by the FDA pursuant to both the FDCA and the Public Health Services Act, 42 U.S.C. §§ 201 et seq. No biological product can be marketed without an FDA-approved license. See 42 U.S.C. § 262(a)(1)(A). Before a product can be approved, the manufacturer must satisfy the FDA that the biologic “is safe, pure, and potent ... [and that] the facility in which [it] is manufactured, processed, packed or held meets standards designed to assure that the biologic continues to be safe, pure, and potent .... ” 42 U.S.C. § 262(a)(2)(C)(I). See 21 C.F.R. § 601.2 (requiring a biologic manufacturer to make a detailed submission to the FDA and demonstrate that its product “meets prescribed requirements of safety, purity, and potency” before a license is issued); id. at § 601.20 (discussing the conditions for issuance of biologic licenses). Any new use or design change of a biologic must be supported with substantial evidence of safety and efficacy and must be reviewed and approved by the FDA. See 21 C.F.R. § 601.12. Any person marketing a biologic product without a FDA license is subject to both civil and criminal penalties. See 42 U.S.C. § 262(d), (f). Biologies are also subject to detailed labeling requirements which dictate virtually every aspect of a biologic’s label. See 21 U.S.C. §§ 331(a), (b), (k), 352; 42 U.S.C. § 262(b); 21 C.F.R. §§ 606.120-.122, 610.60-65; 21 C.F.R. §§ 200, 201. The FDA conducts a detailed review and approval process for the information manufacturers must include in package inserts, which are the primary form of labeling for prescription drugs. See 21 C.F.R. §§ 201.56, 201.57. The FDA also approves any warning that must appear on a drug’s label, which alerts a person of any dangerous use. Id.; 21 U.S.C. §§ 352, 355(b). The FDA allows label warnings detailing when a biologic should not be used (known as “contraindications”) only with respect to “known hazards and not theoretical possibilities” and warnings describing usage risks only if “there is reasonable evidence of an association of a serious hazard.” See 21 C.F.R. §§ 201.56-59. In the case of Bayer’s product, since it was administered to a pregnant woman, its label required word-for-word specific warnings found in the regulations. See 21 C.F.R. § 201.57(f)(6)(c). Finally, once the FDA approves a biologic’s label, it cannot be changed without the FDA’s approval. See 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 fines and other penalties. Each of the defendants’ biologies was at all times fully approved as safe, effective, and not misbranded by the FDA. In addition, Bayer’s product license required the use of thimerosal. See 21 C.F.R. §§ 640.103(a), 610.15, 601.12(a), (b) (requiring a nontoxic preservative for the licensing of an immune globulin). The FDA was aware of the presence of thimerosal in each of the products and the FDA approved the package inserts that disclosed the presence of thimerosal as a “mercury derivative.” The plaintiffs do not dispute these facts. 3. The FDA’s Preemption Position Regarding Plaintiffs’ Failure to Warn Claims and the Deference to Be Given That Position The defendants argue that the FDA’s position on preemption, as articulated in the preamble to the 2006 drug labeling regulations and several amicus briefs, bars the plaintiffs’ failure to warn claims against them. See Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed.Reg. 3922-97 (Jan. 24, 2006) (effective date June 30, 2006) (“Preemption Preamble”). The defendants contend that this court must afford deference to the FDA’s view that its regulations preempt certain state tort claims for inadequate warnings, including the plaintiffs’. The plaintiffs dispute the defendants’ claim of deference and argue the Preemption Preamble conflicts with the FDA’s earlier position on the preemption of state law. a. FDA’s Position of Preemption Stated in the Preemption Preamble In 2006, the FDA issued its most recent labeling rule. In the preamble to the new rule, the FDA explained the implications of its labeling regulations on product liability claims and “the government’s long standing views on preemption.” See 71 Fed Reg. 3922, 3934. As the FDA summarized at the outset of its discussion on preemption, “FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.” Id. The FDA then addressed certain instances when it believes state laws are preempted, with one situation pertinent to this case: “FDA believes 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. In such cases, including the statement in labeling or advertising would render the drug misbranded under the act (21 U.S.C. § 352(a) and (f)).” Id. at 3935. See also id. at 3936 (“FDA believes that ... the following claims would be preempted by its regulation of prescription drug labeling: ... (3) claims that a drug sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule, including § 201.57(c)(5)” (requiring that contraindications reflect “[known] hazards and not theoretical possibilities”)). In the Preemption Preamble, the FDA addressed why these state law claims interfere with the federal objectives of drug labeling, and are therefore preempted. First, state law inadequate warning claims can result in manufacturers exaggerating the risks of a vaccine or immune globulin to avoid liability, and, as a result, discourage a biologic’s beneficial use. Second, state law warning claims can lead to over-warning, which also has a negative impact on patient safety and public health. “[L]a-beling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to ‘lose its significance.’ ” 71 Fed.Reg. at 3934. A product with too many warnings can result in the significant contraindications and side effects being overshadowed. Third, state law inadequate warning claims undermine the “FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.” Id. Under the state tort systems, lay juries get to second-guess the FDA’s careful assessment of the benefits versus the risks of a specific drug to the general public and drive manufacturers to propose “defensive labeling” to avoid state liability. Therefore, “FDA interprets the act 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.” Id. In addition, the FDA detailed in the Preemption Preamble the role it plays in approving and updating a drug label: FDA is the expert Federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading. Under the act and FDA regulations, the agency makes approval decisions based ... on a comprehensive scientific evaluation of the product’s risks and benefits under, the conditions of use prescribed, recommended, or suggested in the labeling (21 U.S.C. 355(d)).... 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 ensure safe and effective use. 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. Id. In the realm of vaccines, the FDA has issued a guidance paper detailing its continued, active involvement in the review of vaccine labels to ensure their accuracy. See Ex. 2 to GSK’s Mot. to Take Judicial Notice, Guidance for Industry: FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information (September 2004) (“FDA continues to engage in an ongoing, ease-by-case review of all vaccine labeling and routinely requires revision of labeling that is found too inadequate to warn health care providers of the risk associated with the use of a particular vaccine.”). Finally, the FDA rejected the idea that drug manufacturers have “latitude under FDA regulations to revise labeling by adding or strengthening warning statements” without FDA approval. 71 Fed.Reg. at 3934. This belief had been the basis for many courts to overrule preemption claims, but in reality, “the determination of whether labeling revisions are necessary is, in the end, squarely and solely FDA’s under the act.” Id. at 3934. b. FDA’s Preemption Position as Applied in This Case In this case, based on the FDA’s position on preemption in the preamble and its articulation of the objectives of the federal labeling scheme, the plaintiffs’ failure to warn claims against the defendants would be preempted for the following reasons: (1) the defendants’ products’ labels disclosed the use of thimerosal and its mercury content; (2) the FDA considered the use of thimerosal as a preservative in each of the defendants’ products as nontoxic; (3) the FDA has considered and dismissed any risk associated with the use of thimerosal in vaccines or biologies; and (4) Bayer’s product label contained a warning that covered the plaintiffs’ concerns. As a result of its active role in assessing the adequacy of vaccine labels, the FDA issued a statement regarding its 1999 “comprehensive review” of the use of thim-erosal in childhood vaccines: “[There is n]o evidence of harm from the use of thim-erosal as a vaccine preservative, other than local hypersensitivity reactions.” Ex. 1 to GSK’s Mot. to Take Judicial Notice, U.S. Food and Drug Administration Center for Biologies Evaluation and Research, Thim-erosal in Vaccines at 5. Athough this statement by the FDA was issued after Wesley received his vaccines, it is reasonable for this court to conclude that the FDA would have reached the same conclusion in 1996, when less information was available and fewer studies existed discussing a connection between thimerosal and neurological injury. If GSK and Wyeth sought to add a warning to their products regarding thimerosal’s “dange