Full opinion text
MEMORANDUM BUCKWALTER, Senior District Judge. Currently pending before the Court is (1) Defendant GlaxoSmithKline’s (“GSK” ’s) Motion for Summary Judgment on the Grounds of Federal Preemption (Docket No. 60), (2) the Response of Plaintiffs Harold L. Garrison, Jr., individually, and Marion Knipe, individually and as ad-ministratrix and administratrix ad prose-quendum of the Estate of Harold Stanley Jake Garrison (Doc. No. 98), (3) Defendant’s Reply Brief (Doc. No. 120), and (4) Plaintiffs Sur-reply Brief (Doc. No. 137). In addition, the Court jointly considers Plaintiffs’ Motion to Strike Evidence Submitted by GSK in Support of Its Motion for Summary Judgment (Federal Preemption) (Doc. No. 107) and Defendant’s Response thereto (Doc. No. 117). This litigation commenced on July 10, 2006, when Plaintiffs sued Defendant for the wrongful death of sixteen-year old Harold Stanley Jake Garrison (“Jake”), who committed suicide after taking Paxil, an antidepressant medication manufactured and sold by GSK. The core of Plaintiffs’ claims alleges that GSK breached its state law duty to warn of the increased risk of suicide in pediatric patients as a result of taking the drug. Defendant now contends that Plaintiffs’ state tort claims are preempted by federal law, i.e. the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. and its implementing regulations, due to a direct and actual conflict between state and federal law. For the following reasons, the Court denies the motion in its entirety. I. BACKGROUND AND UNDISPUTED FACTS A. Jake Garrison’s Suicide In February 2001, deceased Plaintiff Jake Garrison (“Jake”) was referred to dermatologist Booth Durham, M.D., for the treatment of acne. (Pis.’ Ex. 153, Durham Dep. 11:8-17:8, Sep. 5, 2007.) Originally, Dr. Durham treated Jake with Accu-tane. Id. In light of the drug’s labeling, the doctor informed Jake and his mother that the drug could cause suicidal behavior, and required them to sign a consent form. (Id.) The Accutane course of treatment was completed in August or September of 2001. (Id. at 21:13-22:2.) On January 10, 2002, Jake, who was fifteen years old at the time, returned to Dr. Durham as a result of redness and irritation on his face. (Id. at 22:3-23:12.) Dr. Durham prescribed to Jake a fifteen-day supply of Paxil ten milligrams for treatment of his body dysmorphic disorder. (Id. at 23:12-25:21.) The dosage was increased to twenty milligrams after two weeks. (Id. at 25:16-25:21.) At that time, the label for Paxil contained the following statement in the “PRECAUTIONS” section: Suicide: The possibility of a suicide attempt is inherent in depression and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Precautions for Paxil should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. (Plaintiffs’ Statement of Undisputed Facts (“PSUF”) ¶ 23, Ex. 35 at 1610.) The 2002 label also included, in a section entitled “Other events Observed During the Pre-marketing Evaluation of Paxil” (under the sub-heading “Nervous System”), the adverse reaction of “emotional lability,” which was identified as a “frequent event.” (Id. ¶ 24, Ex. 35 at 1614.) Under the section entitled “Pediatric Use,” the label stated, “Safety and effectiveness in the pediatric population have not been established.” (Id. ¶ 25, Ex. 25 at 1611.) Jake refilled a thirty-day prescription for Paxil twenty milligrams, on January 27, 2002, and another thirty-day supply for Paxil twenty milligrams on April 8, 2002. (Pis’ Resp., Objections and Evid. in Response to GSK’s “Statement of Undisputed Facts” in Support of Mot. Summ. J. on Fed. Preemp. (“Plaintiffs’ Objections”) ¶ 1, Exs. 146, 147.) Thereafter, for unknown reasons, Jake stopped taking Paxil. (Id.) On September 11, 2002, Jake refilled another Paxil twenty milligram prescription and took the medication for three days. (Id.) On September 14, 2002, Jake committed suicide by gunshot. (PSUF ¶ 27, Ex. 38.) B. FDA Regulation of New Drugs and Drug Labeling Generally In the FDCA, Congress charged the Food and Drug Administration (“FDA”) with the duty to “promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products” and to “protect the public health by ensuring that ... drugs are safe and effective.” 21 U.S.C. § 393(b)(1), (b)(2)(B) (1997). To satisfy its regulatory mission, the FDA engages in a thorough review of any proposed new drugs prior to their entry in the market. See 21 U.S.C. § 355. Under this procedure, a person or company that wishes to market a new drug must initially file a new drug application (“NDA”) with the FDA. Id. at § 355(b). This NDA requires, among many other things, (a) full reports of investigations which have been made into the safety and effectiveness of the drug; (b) a list of all articles used as components of such drug; (c) a full statement of the composition of such drug; (d) a complete description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (e) samples of such drug and of the articles used as components thereof as the Secretary may require; and (f) specimens of the labeling proposed to be used for such drug. 21 U.S.C. § 355(b)(1); see also 21 C.F.R. § 314.50 (setting forth a complete list of requirements for an NDA). The “labeling” requirement for a drug refers not simply to the label attached to the drug, but rather “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such arti-ele.” 21 U.S.C. § 321(m). By regulation, “[t]he labeling shall contain a summary of the essential scientific information needed for the safe and effective use of the drug.” 21 C.F.R. § 201.56(a). Drug labeling must include specific information under prescribed section headings, including, inter alia, contraindications, warnings and precautions, adverse reactions and use in particular populations, including pediatrics. Id. § 201.56(d)(1). Under the “Warnings” section, “the labeling shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that should be taken if they occur.” 21 C.F.R. § 201.57(e). In addition, Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based on clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location will be specified by the Food and Drug Administration. The frequency of these serious adverse reactions and, if known, the approximate mortality and morbidity rates for patients sustaining the reaction, which are important to safe and effective use of the drug, shall be expressed as provided under the “Adverse Reactions” section of the labeling. Id. Notably, “[t]he labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” Id. The FDA must disapprove an NDA if, among other reasons, it finds that (1) the investigations submitted to the FDA “do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;” (2) “the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions;” (3) the FDA has insufficient information to determine the drug is safe for use under such conditions; (4) “there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof;” or (5) “based on a fair evaluation of all material facts, such labeling is false or misleading in any particular.” 21 U.S.C. § 355(d); 21 C.F.R. § 314.125. Further, the FDA “will approve an application and send the applicant an approval letter if none of the[se] reasons ... for refusing to approve the application applies.” 21 C.F.R. § 314.105(a). The FDA “will approve an application and issue the applicant an approval letter ... on the basis of draft labeling if the only deficiencies in the application concern editorial or similar minor deficiencies in the draft labeling.” Id. § 314.105(b). “Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior to marketing.” Id. A drug may be deemed “misbranded” if its labeling is “false or misleading,” 21 U.S.C. § 352(a), fails to bear “adequate directions for use” or fails to bear “such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users.” 21 U.S.C. § 352(f). Failure to include a scientifically valid warning the FDA believes is necessary, or the inclusion of warning information not based on reliable scientific evidence, causes the labeling of the drug to be deemed “false and misleading,” and renders the drug misbranded. (Def. Mot. Summ J. Fed. Preemp., Ex. A (“Arning Decl.”), ¶ 15 (citing 21 U.S.C. §§ 331(a), 331(b), 331(k), 352(a) and 352(f)).) Again, the labeling must be identical, in every material respect, to the labeling that accompanies the approval letter. 21 C.F.R. § 314.105(b). Distribution of a misbrand-ed drug that fails to comply with the FDA-approved labeling is prohibited and may result in withdrawn approval of the NDA, in rem forfeiture, injunction, and/or criminal prosecution against the responsible person. 21 U.S.C. §§ 332(a), 333, 334(a), 337(a); 21 C.F.R. § 314.150(b). Once a drug is approved, it is included in the FDA’s published list of approved drugs. 21 U.S.C. § 355(j)(7). Even after approval of the NDA, however, the FDA maintains substantial control over a prescription drug’s safety and the content of its labeling. The FDA can move to withdraw approval of a drug on a showing that the drug is unsafe or ineffective. Id. § 355(e). Further, the FDA can withdraw approval if, among other reasons, “on the basis of new information before [the FDA], evaluated together with the evidence before [the FDA] when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the [FDA] specifying the matter complained of.” Id. Drug manufacturers also maintain continuing obligations to report to the FDA adverse drug experiences, 21 C.F.R. § 314.80(c), as well as any “significant new information ... that might affect the safety, effectiveness, or labeling of the drug product.” 21 C.F.R. § 314.81(b)(2)(i). Per the regulations in effect at the time relevant to this litigation, an applicant is required to notify the FDA of any changes to an approved drug, including its labeling, by one of three methods. 21 C.F.R. § 314.70(a)-(d). Subsection (b) governs “changes requiring supplemental submission and approval prior to distribution of the product made using the change (major changes),” including any change in labeling, other than one described in later subsections. Id. at § 314.70(b)(2)(v). Subsection (d) references minor changes that could be submitted with the drug manufacturer’s annual report, but does not allow any changes in labeling. Id. at § 314.70(d). Finally, subsection (c), concerns “moderate changes” that may be made before FDA approval pursuant to a Changes Being Effected (“CBE”) supplement. 21 C.F.R. § 314.70(c)(3), (6); (Arn-ing Decl. ¶ 17.) Changes under this section do not require prior approval, but do require supplemental submission to the FDA for review and final approval. 21 C.F.R. § 314.70(c)(6). Among the alterations that may be unilaterally made by a manufacturer under this section are changes to “add or strengthen a contraindication, warning, precaution or adverse reaction.” 21 C.F.R. § 314.70(c)(6) (iii)(A). Like other warnings, changes to warnings may only be added when there is “reasonable evidence of an association of a serious hazard with a drug; a causal connection need not have been proved.” 21 C.F.R. § 201.57(c). Although “in practice, manufacturers typically consult with FDA prior to adding risk information to labeling,” Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 FR 3922-01, 3934 (Jan. 24, 2006), such prior consultation is not required in the regulations. 21 C.F.R. § 314.70(c)(6)®. If the FDA disapproves of the revised label, it may order the manufacturer to cease distribution of the drug products made with the change. 21 C.F.R. § 314.70(c)(7). C. The Regulatory History of Paxil Paxil is generally classified as a selective serotonin reuptake inhibitor (“SSRI”), currently approved on a prescription basis only for the treatment of depression, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder and premenstrual dysphoric disorder in adult patients. (Arning Decl. ¶ 5.) On November 20, 1989, SmithKline Beecham Pharmaceuticals (“SB”) filed an NDA for paroxetine (Paxil) seeking FDA approval for the treatment of depression in adults. (Id. ¶ 19.) In support of ths application, SB submitted data to the FDA, including toxicology data, animal studies and clinical studies in humans, as well as data on suicides, suicide attempts and suicidal behavior. (Id. ¶ 21.) In 1990, prior to the completion of the FDA’s review, press reports of a possible linkage between increased suicidality and Prozac, another SSRI, began to surface. As a result, in 1990 and 1991, two groups filed “Citizen Petitions,” seeking either the withdrawal of NDA approval for Prozac, which was the only approved S SRI at the time, or alternatively, a warning statement in labeling regarding an increased risk of suicide. (Def. Mot. Summ. J. Fed. Preemp., Ex. B (“Howard Decl”), Exs. 4 and 5.) Dr. Martin Brecher, the lead FDA safety reviewer on the Paxil NDA, contacted SB and requested a report discussing the relationship between Paxil and “violence-ideation and suicide-ideation.” (Arning Decl. ¶ 22, Ex. 1.) The following May, SB submitted a report stating that, “data from prospective clinical trials in depressed patients clearly demonstrates that patients randomized to paroxetine therapy were at no greater risk for suicidal ideation or behavior than patients who were randomized to placebo or other active medication.” (Id. ¶ 23, Ex. 2.) Given this information, Dr. Brecher issued his Safety Review report, which concluded that, “Although the instruments available may not be ideal to capture the elusive clinical events reported by Teicher in 6 patients, there is no signal in this large data base that paroxetine exposes a subset of depressed patients to additional risk for suicide, suicide attempts or suicidal ideation.” (Id. ¶ 24, Ex. 3 at 25.) In September of 1991, the FDA held a Psychopharmacological Drugs Advisory Committee (“PDAC”) meeting to consider further whether there was an association between SSRIs and suicide. (Howard Decl., Ex. 6.) The study was based primarily on information received on Prozac, with no information given on Paxil. (PSUF ¶ 155, Ex. 135.) The FDA did not dismiss the possibility of a connection and suggested that further study on this issue was encouraged. (Pis. Exs. 135 at 126, 137.) Nonetheless, the unanimous conclusion that resulted from the PDAC was that no credible evidence existed to conclude that “antidepressant drugs cause the emergence and/or intensification of suicidality and/or other violent behaviors.” (Howard Decl, Ex. 6 at 294.) As a result, the FDA denied the pending citizen petitions in 1991 and 1992 respectively, concluding that “[t]here is no reasonable evidence of an association between the use of Prozac and suicidality.” (Id. Ex. 7 at 15.) The FDA asked the PDAC to independently evaluate the data on Paxil. (Arning Decl. ¶ 25.) On October 5, 1992, the PDAC held its panel meeting and FDA officials presented their analysis of the Paxil NDA, including clinical trial data on safety and efficacy. (Id. ¶¶ 25-27.) Dr. Thomas Laughren, an FDA official, reported that “there was no suggestion here of emergence of suicidality with paroxe-tine.” (Id. ¶ 26, Ex. 4 at 29-30.) Ultimately, the PDAC deemed Paxil safe and effective for use in the treatment of adult depression and voted unanimously in favor of approval. (Id. ¶ 27, Ex. 4 at 153-54.) The FDA issued an approval letter for Paxil on December 29, 1992, but made clear that the approval was conditioned on the use of the FDA-approved prescribing information accompanying the letter. (Id. ¶ 28, Ex. 5 at 1.) The original FDA-approved labeling did not include any warning or other statement regarding an increased risk of suicide or suicidality from Paxil. (Id. ¶ 28, Exs. 5 and 6.) Indeed, the only references to “suicide” or “suicide attempt” appeared in the description of “a major depressive episode” and a precaution that suicide is “an inherent risk in depressed patients.” (Id. ¶ 28, Ex. 5 at 4-5.) In the approval letter, however, the FDA stated, “[pjlease consider conducting post-approval studies with [Paxil] in depressed children and adolescents. Depression is common in these populations and it is likely that [Paxil] will be used in children and adolescents, despite the absence of any relevant data. Consequently, we feel it would be useful for you to obtain data pertinent to the safety and efficacy of [Paxil] in these groups.” (Id. ¶ 28, Ex. 5 at 2.) Another citizen petition was filed with the FDA in 1997, seeking to require a warning in the prescribing information for Prozac that “people who are considered at risk for suicide and who begin to take [Prozac] should be carefully observed and should consider taking a sedative as well.” (Howard Deck, Ex. 9.) The FDA rejected this petition, on June 25, 1997, finding that no labeling revisions were warranted. (Id. Ex. 10.) From the date of the original approval in 1992 to the present, the FDA has reviewed and approved at least twelve supplemental NDAs for new therapeutic indications for Paxil. (Id. ¶ 37.) On each occasion, the FDA conducted a review of the cumulative safety and efficacy data and proposed labeling; and each approval was conditioned on the verbatim use of the FDA-approved prescribing information and warnings. (Arning Decl. ¶ 35-39, and Exs. 18, 19, 20.) When required, SB and/or GSK submitted to the FDA an Integrated Safety Summary (“ISS”) summarizing available information about the safety of the drug product, including adverse events. (Id. ¶ 39.) Likewise, on various other occasions between July 1995 and February 2003, in response to FDA requests or on its own, SB and/or GSK submitted data regarding Paxil and its relation to the risk of suicide. (Id. ¶¶ 30-34.) None of the reviews resulted in the FDA requiring GSK to change the Paxil label to reflect a causal connection between Paxil and suicide. (Id. ¶¶ 35-37.) D. GSK’s Efforts to Obtain Approval for Pediatric Use of Paxil and Resulting Label Changes On April 11, 2002, GSK filed a Supplemental New Drug Application to the FDA “proposing the use of Paxil to treat children and adolescents with major depressive disorder and obsessive compulsive disorder.” (PSUF ¶ 26, Exs. 36, 37.) In connection with its application, GSK submitted Study 329 and Study 377, both of which had been completed in 1998, and Study 701, which was completed in January of 2001. (Id.) On October 7, 2002, Dr. Andrew Mosholder, the FDA reviewer of the pediatric Supplemental NDA for Paxil completed his review. In the section of his report regarding efficacy, he stated: For Study 377: “This trial did not provide any evidence that paroxetine is active in the treatment of adolescent MDD [major depressive disorder].” For Study 701: “This trial did not provide any evidence that paroxetine is effective in the treatment of pediatric MDD.” For Study 329: “[T]his trial should be considered a failed trial, in that neither active treatment group showed superiority over placebo by a statistically significant margin.” (Id. ¶ 28, Ex. 39.) In his report regarding safety, Dr. Mosholder stated: The most prominent adverse reactions not seen in corresponding adult trials appear to involve behavioral effects; these events were coded with terms such as hostility and emotional lability. As previously noted, the sponsor’s method of coding these events was potentially confusing, and thus additional information will be helpful for the purpose of definitively assessing the potential behavioral toxicity for paroxetine in pediatric patients.... Further assessment of the safety profile will have to await the sponsor’s reply to requests for additional information. (Id. ¶ 29, Ex. 39 at 6.) Accordingly, on October 21, 2002, the FDA issued a letter to GSK regarding its pediatric Supplemental NDA requesting additional information and clarification including “an expanded version of [a table of adverse events coded under the terms hostility, emotional lability or agitation], including all psychiatric and behavioral adverse events, and also those that occurred among placebo patients” and GSK’s “rationale for coding suicide attempts and other forms of self-injurious behavior under the ... term ‘emotional lability.’ ” (Id. ¶ 30, Ex. 40.) On May 21, 2003, seven months after the FDA’s request for clarification as to GSK’s study results, GSK submitted a briefing document to the UK’s equivalent of the FDA, the Medicines and Healthcare Products Regulatory Agency (“MHRA”). This document summarized the clinical trial data on Paxil for the treatment of adolescents with depression, obsessive compulsive disorder and social anxiety disorder, in preparation for a meeting at which GSK was seeking approval for this population and for these indications. (Id. ¶ 35, Ex. 43.) On May 30, 2003, the MHRA issued a “Rapid Alert,” which stated that Paxil would be contraindicated for the treatment of adolescent depression since the clinical trial data did not show efficacy and that the trial results “demonstrate a significant safety issue in relation to suicidal behavior.” (Id. ¶ 30, Ex. 46.) Dr. Thomas Laughren, team leader of the FDA’s Psychiatric Drug Products in the Division of Neuropharmacological Drug Products, contacted GSK on May 23, 2003, indicating that he had received a telephone call from the MHRA “regarding GSK’s analysis of suicide events associated with the use of Paxil in pediatric patients.” (Id. ¶ 36.) He asked GSK for the same information provided to the MHRA, which GSK indicated was already “in transit.” (Id.) Upon receipt of GSK’s supplemental submission in partial response to the FDA’s October 10, 2002 letter, the FDA drafted a “Request for Consultation” memo, dated June 5, 2003, which noted that GSK’s re-analyzed data, clarifying what events were included under the term “emotional lability,” suggested an excess risk of suicidality in patients taking Paxil compared to those taking placebo. (Id. ¶ 44, Ex. 48.) At that time, GSK had not proposed labeling changes. (Id. ¶ 42, Ex. 47.) On June 10, 2003, the British Department of Health issued a press release announcing: “Paxil must not be used for the treatment of children,” due to “an increase in the rate of self-harm and potentially suicidal behavior in this group when Paxil is used for depressive illness.” (Id. ¶45, Ex. 49.) On June 19, 2003, the FDA issued a Talk Paper reporting that it was “reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 treated with the drug Paxil for major depressive disorder.” (Arning Deck ¶ 42, Ex. 23.) The advisory stated, “[although the FDA had not completed its evaluation of the new safety data, FDA is recommending that Paxil not be used in children and adolescents for the treatment of MDD, and Paxil is currently not approved for use in children and adolescents.” (Id.) In June and July 2003, GSK issued “Dear Healthcare Professional” letters in the United Kingdom and Canada, respectively, informing physicians that Paxil should not be used for the treatment of depression in the children and adolescents under the age of 18. (PSUF ¶ 46, Ex. 50; ¶51, Ex. 54.) On July 22, 2003, the FDA requested adverse event data from the manufacturers of all of the “modern drugs” used to treat major depressive disorder, in order to further assess suicidality in pediatric patients enrolled in clinical studies. (Id. ¶ 53, Ex. 55.) The FDA then issued a Public Health Advisory and corresponding Talk Paper, on October 27, 2003, stating that the “data do not clearly establish an association between the use of these drugs and increased suicidal thoughts or actions by pediatric patients,” but it was “not possible at this point to rule out an increased risk of [increased suicidal thoughts or actions] for any of these drugs, including Paxil.” (Id. ¶ 56, Ex. 58.) Thereafter, in February of 2004, the FDA advisory committee convened to “address recent concerns about reports of suicidal ideas and behavior developing in some children and adolescents during treatment of depression with an SSRI or similar newer antidepressants.” (Id. ¶ 59, Ex. 61 at 12-13.) Ultimately, the advisory committee recommended that the FDA issue an immediate warning concerning the potential risk of suicidality in pediatric patients and agreed that the data should be analyzed further. (Id. ¶ 61, Ex. 62.) On March 22, 2004, the FDA issued a Public Health Advisory cautioning about the need to closely monitor adults and children being treated with antidepressants to determine whether there is a worsening of depression. (Arning Decl. ¶ 49, Ex. 30.) It also noted that, after initial reports and studies with Paxil, and subsequent reports on studies of other drugs, there appeared to be “an increased risk of suicidal thoughts and actions in the children given antidepressants.” (Id.) In May of 2004, GSK sent a “Dear Healthcare Professional” letter to doctors in the United States alerting them to the FDA’s Public Health Advisory. (PSUF ¶ 62, Ex. 64.) The advisory committee met again in September 2004, and concluded that the data, in the aggregate, reflected an increased risk of suicidality in pediatric patients and recommended that the FDA consider new class labeling changes. (Id. ¶¶ 66-67, Ex. 69.) A new Public Health Advisory and letter issued from the FDA on October 15, 2004, directing manufacturers to add a “black box” warning and expanded warning statements to the labeling of all antidepressant medications describing the increased risk of suicidality in children and adolescents being treated with antidepressants, and to include information about the results of pediatric studies. (Id. ¶ 72, Ex. 74; Arning Deck ¶ 55, Ex. 34.) On November 12, 2004, GSK filed labeling supplements to the Paxil and Paxil CR NDA’s to include the labeling changes requested by the FDA in the October 15, 2004 letter. (Arning Decl. ¶ 56.) On January 26, 2005, the FDA notified GSK that it decided to “modify the new PI [package insert] slightly so that the language in the ‘Warnings Section’ of the PI more precisely mirrors the language set forth in the black box warning.” (PSUF ¶ 74, Ex. 76.) The FDA approved the labeling supplements for Paxil and other antidepressants, on January 26, 2005, to require the following “black box” warning: Suicidality in Children and Adolescents Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of [insert established name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or other unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Insert established name] is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. (Arning Deck ¶ 59, Ex. 76.) II. SUMMARY JUDGMENT STANDARD OF REVIEW Summary judgment is proper “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Feb. R. Civ.P. 56(c). A factual dispute is “material” only if it might affect the outcome of the case. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). For an issue to be “genuine,” a reasonable fact-finder must be able to return a verdict in favor of the non-moving party. Id. On summary judgment, it is not the court’s role to weigh the disputed evidence and decide which is more probative, or to make credibility determinations. Boyle v. County of Allegheny, Pennsylvania, 139 F.3d 386, 393 (3d Cir.1998) (citing Petruzzi’s IGA Supermarkets, Inc. v. Darling-Delaware Co. Inc., 998 F.2d 1224, 1230 (3d Cir.1993)). Rather, the court must consider the evidence, and all reasonable inferences which may be drawn from it, in the light most favorable to the non-moving party. Matsushita Elec. Indus. Co. v. Ze nith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (citing United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962)); Tigg Corp. v. Dow Coming Corp., 822 F.2d 358, 361 (3d Cir.1987). If a conflict arises between the evidence presented by both sides, the court must accept as true the allegations of the non-moving party, and “all justifiable inferences are to be drawn in his favor.” Anderson, 477 U.S. at 255, 106 S.Ct. 2505. Although the moving party bears the initial burden of showing an absence of a genuine issue of material fact, it need not “support its motion with affidavits or other similar materials negating the opponent’s claim.” Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986). It can meet its burden by “pointing out ... that there is an absence of evidence to support the nonmoving party’s claims.” Id. at 325, 106 S.Ct. 2548. Once the movant has carried its initial burden, the opposing party “must do more than simply show that there is some metaphysical doubt as to material facts.” Matsushita Elec., 475 U.S. at 586, 106 S.Ct. 1348. “There must ... be sufficient evidence for a jury to return a verdict in favor of the non-moving party; if the evidence is merely colorable or not significantly probative, summary judgment should be granted.” Armbruster v. Unisys Corp., 32 F.3d 768, 777 (3d Cir.1994), abrogated on other grounds, Showalter v. Univ. of Pittsburgh Med. Ctr., 190 F.3d 231 (3d Cir.1999). III. DISCUSSION A. Preemption Generally The issue presently before the Court is whether Plaintiffs’ state law claims alleging that Defendant improperly failed to warn Plaintiffs of the risk of increased suicidality in pediatric users of Paxil are preempted by federal law. The doctrine of preemption finds its origins in the Supremacy Clause of the United States Constitution, which provides that the “Constitution, and the laws of the United States which shall be made in Pursuance thereof ... shall be the supreme Law of the Land.” U.S. Const. art. VI, cl. 2. In Gibbons v. Ogden, the United States Supreme Court interpreted the Supremacy Clause to invalidate any state laws that “interfere with, or are contrary to” the federal law. 22 U.S. (9 Wheat) 1, 211, 6 L.Ed. 23 (1824). Preemption occurs in three primary situations: (1) “express” preemption, when Congress explicitly states its intent to preempt state law; (2) “field” preemption, when Congress’ intent to preempt state law in particular area is inferred from either the comprehensive scheme of federal regulation in that area or the dominant federal interest in that area; and (3) “conflict” preemption, when “state law is nullified to the extent that it actually conflicts with federal law,” even though Congress has not displaced all state law in that area. Colacicco v. Apotex, Inc., 521 F.3d 253, 261 (3d Cir.2008) (quoting Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985)). Conflict preemption occurs “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.’ ” Sykes v. GlaxoSmithKline, 484 F.Supp.2d 289, 307 (E.D.Pa.2007) (quoting Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 899, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000)). The wealth of cases discussing preemption in the case of pharmaceutical failure to warn claims concur — and the parties in this case do not dispute — that the issue here is one of conflict preemption. Colacicco, 521 F.3d at 262; Mason v. Smithkline Beecham Corp., 546 F.Supp.2d 618, 621 (S.D.Ind.2008); Dobbs v. Wyeth Pharms., 530 F.Supp.2d 1275, 1278 (W.D.Okla.2008). Accordingly, the Court limits its discussion to that subject area. Plaintiffs and Defendant dispute the applicability of what is commonly known as the presumption against preemption. Because states are themselves independent sovereigns, the United States Supreme Court has recognized a general presumption that Congress does not intend to preempt state law causes of action. Bldg. and Constr. Trades Council of Metro. Dist. v. Assoc. Builders and Contractors of Mass./RI, Inc., 507 U.S. 218, 224, 113 S.Ct. 1190, 1194, 122 L.Ed.2d 565 (1993). In Medtronic, Inc. v. Lohr, the Supreme Court stated that “[i]n all preemption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” 518 U.S. 470, 485, 116 S.Ct. 2240, 2250, 135 L.Ed.2d 700 (1996) (citations, internal quotation marks and alterations omitted); see also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125 S.Ct. 1788, 1801, 161 L.Ed.2d 687 (2005) (recognizing a “basic presumption against pre-emption” due to long history of tort litigation against manufacturers of poisonous substances.) Notably, however, the application of such a presumption is not proper in all circumstances, particularly where uniquely federal interests are at issue. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 347-48, 121 S.Ct. 1012, 1017, 148 L.Ed.2d 854 (2001) (finding no presumption against preemption where interests at stake were uniquely federal in nature and were not traditionally regulated by states); Pennsylvania Employees Ben. Trust Fund v. Zeneca, 499 F.3d 239, 251 (3d Cir.2007) (finding preemption of state law fraud claims in context of prescription drug advertising). Two recent Third Circuit cases have attempted to further define the contours of this presumption. In Colacicco v. Apotex, the Third Circuit explicitly discussed the application of the presumption against preemption in a state law failure to warn case against two pharmaceutical manufacturers. 521 F.3d 253, 265 (3d Cir.2008). The Court rejected the defendants’ arguments that a presumption was completely inapplicable in such cases. Id. at 265 n. 11. It recognized, however, that the presumption was more appropriate in a case of field preemption, “where Congress’ mere presence in a given field indiscriminately nullifies all state law in the field, than in the context of conflict preemption, which excludes state law only to the extent that it requires individuals to act contrary to conflicting federal obligations.” Id. Ultimately, the Third Circuit suggested that the implied conflict preemption inquiry, which analyzes preemption in the absence of any explicit Congressional intent, effectively supplants the presumption. Id. at 265 (internal citations and quotations omitted). In its most recent discussion of this issue, however, the Third Circuit qualified its statements in Colacicco and noted that it does not “lightly infer” preemption where “state compensatory regimes have traditionally played an important role.” Fellner v. Tri-Union Seafoods, L.L.C., 539 F.3d 237, 248 (3d Cir.2008). The court noted that, “it is hard to imagine a field more squarely within the realm of traditional state regulation than a state tort-like action seeking damages for an alleged failure to warn consumers of dangers arising from the use of a product.” Id. Such state tort law is often complementary to federal regulatory regimes and “preemption may leave individuals with no private remedy, where traditionally there has been one.” Id. Accordingly, it distinguished Colacicco and emphasized that it would continue to apply the traditional presumption absent Supreme Court guidance to the contrary. Id. Based on the Third Circuit’s varying pronouncements, this Court now finds that although the outcome of this case turns ultimately on the existence or non-existence of an actual conflict between state and federal law, the .general presumption against preemption remains viable. Guided by these principles, the Court turns to the specific claims at issue. B. Preemption of Plaintiffs’ New Jersey State Law Failure to Warn Claim Defendant’s preemption claim argues that a direct conflict exists between Plaintiffs’ failure to warn claims under New Jersey state law and the FDCA. New Jersey law provides that a manufacturer must warn of all known adverse effects of a drug as soon as reasonably feasible upon actual or constructive knowledge of the danger. Feldman v. Lederle Labs., 97 N.J. 429, 479 A.2d 374, 388-89 (1984). Defendant asserts that had it included, in Paxil’s labeling, the warnings on the increased risk of pediatric suicide proposed by Plaintiffs under New Jersey tort law, the drug would have been deemed mis-branded within the meaning of 21 C.F.R. §§ 352(a), 352(f)(1). In turn, Defendant claims that it would have been held liable under federal law. Id. at §§ 332-34. Because it could have not remained in compliance with both state and federal law as it stood prior to September 2002 — when Jake Garrison committed suicide — Defendant avers that an actual and direct conflict exists, thus triggering the preemption of New Jersey law. Defendant’s argument, however, offers an overly-simplistic description of the allegedly conflicting federal law. Notwithstanding the FDA’s approval of Paxil’s labeling in December of 1992 and GSK’s obligation to use that labeling, drug manufacturers, at the time relevant to this litigation, maintained a continuing obligation to revise a label “to include a warning as soon as there [was] a reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” 21 C.F.R. § 201.57(e). These regulations “contemplate that information may arise before and after application approval that, in the mind of the manufacturer, calls into question the current safety of the drug with respect to any or all indications and calls for a strengthened warning.” Caraker v. Sandoz Pharms. Corp., 172 F.Supp.2d 1018, 1033-34 (S.D.Ill.2001). As noted above, such changes to a drug’s labeling to “add or strengthen a contraindication, warning, precaution or adverse reaction,” may be made by a CBE supplement, which is at the manufacturer’s own initiative and prior to FDA approval. 21 C.F.R. § 314.70 (c) (6) (iii). Although such changes must be submitted to the FDA for review and final approval, the FDA’s subsequent disapproval does not result in a retroactive “misbranding” of the label or subject the manufacturer to legal sanctions. Tucker v. SmithKline Beecham Corp., Civ. A. No. 04-1748, 2008 WL 2788505, at *3 (S.D.Ind. July 18, 2008); see also 21 C.F.R. § 314.70 (“[I]f the agency disapproves of the supplemental application, it may order the manufacturer to cease distribution of the drug product(s) made with the manufacturing change.”). In short, such provisions hold that a drug manufacturer, upon having “reasonable evidence of an association of a serious hazard with a drug,” which has not been considered and rejected by the FDA, may unilaterally add that warning to a drug’s labeling and then submit to the change to the FDA for approval without facing any risk of noncompliance with federal law. By the same token, however, a drug manufacturer cannot, without violation of federal law, change the labeling of a drug to include the warning of a potential association between a hazard and the drug in the face of an express FDA rejection of that warning or absent “reasonable evidence” of such an association. See O’Neal v. Smithkline Beecham Corp., 551 F.Supp.2d 993, 1003 (E.D.Cal.2008); Mason v. Smithkline Beecham Corp., 546 F.Supp.2d 618, 626 (C.D.Ill.2008). Thus, the resolution of the preemption issue in this case turns on two questions. First, the Court must determine whether the FDA has clearly and publicly stated its position, prior to the prescription and suicide at issue in this case, as to either the substance of the proposed warning regarding increased risk of suicidality in pediatric users of Paxil or the intent to preempt corresponding state tort suits. Second, if the Court finds that the FDA, in fact, took no position on the propriety of a pediatric suicidality warning prior to September of 2002, we must inquire if there was, at that time, reasonable evidence of an association between Paxil and pediatric suicidality, such that GSK could have amended the label without risking non-compliance with federal law. The Court addresses each question in turn. 1. Express FDA Preemption of a Pediatric Suicidality Warning Defendant first argues that Plaintiffs’ state law claims conflict directly with the FDA-mandated labeling and warnings for Paxil. More specifically, it contends that during the relevant period prior to Jake Garrison’s suicide, the FDA expressly considered the propriety of the proposed sui-cidality warning, yet repeatedly declined to require the inclusion of such a warning on Paxil labeling. The FDA’s refusal to act on such warnings, according to Defendant, operates as an unequivocal effort to preempt state failure to warn actions. In support of this argument, Defendant relies heavily on two sources: (1) the recent Third Circuit opinion in Colacicco v. Apo-tex, Inc. and (2) the FDA’s 2006 Preamble to its revised regulations. a. The Colacicco Opinion The bulk of Defendant’s argument, both in its initial brief and its reply, asserts that the Third Circuit’s recent opinion in Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir.2008) controls this case and clearly requires a finding of preemption. As the Third Circuit is the lone appellate case to explicitly discuss these issues with regard to Paxil, and as its holdings are binding upon this Court, its reasoning merits extensive discussion here. In Colacicco, the plaintiffs were the surviving relatives of two adults who had committed suicide, one of whom took the antidepressant Paxil and one of whom took the antidepressant Zoloft. Id. at 256-57. The United States District Court for the Eastern District of Pennsylvania considered the Paxil case and found that the plaintiffs’ failure to warn claim was preempted by federal law. Id. at 256. The United States District Court for the District of New Jersey, on the other hand, denied the defendant’s motion for summary judgment on the grounds of preemption. Id. at 257. The Third Circuit consolidated the two eases to consider the issue of whether the plaintiffs could “maintain their state-law tort actions against the manufacturers of two such drugs on the theory that the drugs’ labeling failed to warn of their association with an increased risk of suicidality” or whether the “actions taken by the [FDA] pursuant to its authority under the [FDCA] and the corresponding regulatory scheme preempt the plaintiffs’ state-law failure to warn claims.” Id. at 256. After discussing basic preemption law and the presumption against preemption, the Third Circuit noted that the FDA “has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without scientific basis and would therefore be false and misleading.” Id. at 269 (footnote omitted). To reach this conclusion, the court provided a lengthy history of both Zoloft and Paxil, particularly with respect to the FDA’s consideration of whether antidepressants caused or intensified suicidal thoughts in adults. Id. at 269-270. In doing so, it noted that the FDA had repeatedly approved of the Paxil labeling in effect at the time of the plaintiffs’ death and had also approved it for multiple new indications. Id. at 270. Additionally, the court cited to (1) the FDA’s June 19, 2003 public statement to address reports associating the pediatric use of Paxil with suicidality, in which it stated: “[t]here is no evidence that Paxil is associated with an increased risk of suicidal thinking in adults,” and (2) its October 2003 Public Health Advisory that was limited to increased suicidality in pediatric users of antidepressants, with no mention of a similar warning for adults. Id. at 270-71. Athough the court noted that the FDA had not formally rejected such a proposed warning or CBE supplement, id. at 272, it declined to find that, in order to rise to the level of a conflict, the FDA’s rejection of a warning must be “imbued with the formality proposed by the plaintiffs.” Id. at 272. Rather, it held that “[t]he FDA clearly and publicly stated its position prior to the prescriptions and deaths at issue here.” Id. at 271. The court concluded that: Because the standard for adding a warning to drug labeling is the existence of ‘reasonable evidence of an association of a serious hazard with a drug,’ 21 C.F.R. § 201.57(e), and the FDCA authorizes the FDA to prohibit false or misleading labeling, a state-law obligation to include a warning asserting the existence of an association between SSRIs and suicidality directly conflicts with the FDA’s oft-repeated conclusion that the evidence did not support such an association. Therefore, under the circumstances of this case, the plaintiffs’ failure-to-warn claims are preempted by the FDA’s actions taken in accordance with its statutory authority. Id. at 271. Contrary to Defendant’s arguments, the Court does not deem this case dispositive of the one currently before us. As a primary matter, the Third Circuit explicitly limited is holding “to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.” Id. at 271-72. In light of the FDA’s public rejection of an adult suicidality warning, it did not need to decide “whether preemption would be appropriate under different facts — such as where the FDA had not rejected the substance of the warning sought or where the FDA only stated its position after a lawsuit had been initiated or under the broader theories of preemption argued by the parties.” Id. at 271. Further, the court did not opine on “whether the FDA’s mere approval of drug labeling is sufficient to preempt state-law claims alleging that the labeling failed to warn of a given danger,” or “whether FDA approval of drug labeling constitutes minimum standards in the absence of the FDA’s express rejection of a specific warning.” Id. at 271; see also Fellner v. Tri-Union Seafoods, 539 F.3d 237, 244-45 (3d Cir.2008) (confirming that Colacicco finding of preemption was premised on the fact that although the regulations allowed a manufacturer to unilaterally amend warnings with subsequent FDA approval, the FDA “in a number of different agency proceedings had previously considered the scientific evidence relied upon by plaintiffs and had exercised its prerogative under the regulations to reject suicidality warnings based on that evidence.”). Given such limitations, this case is clearly exempted from the Colacicco holding. The Third Circuit focused solely on whether a claim for failure issue a warning regarding adult suicidality was preempted. At no point did the court mention any studies that were done with respect to pediatric use of Paxil. Indeed, as agreed by the parties in this case, Paxil has never been approved for pediatric use and, therefore, the FDA never reviewed any safety and efficacy data regarding pediatric use prior to approval of the drug. Moreover, the Third Circuit did not cite to any pre-September 2002 FDA document, public announcement or health advisory regarding the FDA’s position on pediatric suicidality associated with Paxil. Finally, the court noted that, at the same time the FDA publicly dismissed any link between SSRIs and adult suicidality, it expressly warned of a risk of increased suicidality in pediatric users of antidepressants. Cola-cicco, 521 F.3d at 271. Quite unlike the concerns regarding adult suicidality, the FDA had not “clearly and publicly stated its position” dismissing any risk of pediatric suicidality prior to the prescriptions at issue. As the Third Circuit left open the question of whether such evidence existed with respect to pediatric use of Paxil, we decline to deem Colacicco controlling of the outcome of this litigation. b. The 2006 Preamble Alternatively, Defendant argues that the FDA has clearly stated its position generally with respect to preemption of state failure-to-warn lawsuits, such as the one brought here, in the 2006 Preamble to the amended regulations. In this Preamble, the FDA remarked that such lawsuits have “directly threatened the agency’s ability to regulate manufacturer dissemination of risk information for prescription drugs.” Requirements on Content and Format of Labeling for Human Prescription Drugs and Biological Products, 71 Fed.Reg. 3922-01, 3934 (Jan. 24, 2006) (effective date June 30, 2006) (“2006 Preamble”). It went on to explain that its position was “long standing,” and that its labeling requirements are not simply minimum standards, but rather “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. at 3934-35. Because the FDA felt that state failure-to-warn lawsuits could “erode and disrupt the careful and truthful representations of the benefits and risks that prescribes need to make appropriate judgments about drug use,” it indicated its belief that various state law failure to warn claims are preempted. Id. at 3935-36. Defendant now contends that this Court must afford deference to the FDA’s view that its regulations preempt certain state tort claims for inadequate warnings, including those similar to the ones brought by Plaintiffs in this case. The FDA’s pronouncement, while due consideration, is likewise not conclusive of preemption. It is well-established that “in the absence of a clear congressional command as to pre-emption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect.” Medtronic v. Lohr, 518 U.S. 470, 505, 116 S.Ct. 2240, 2260, 135 L.Ed.2d 700 (1996) (Breyer, J., concurring in part) (citing Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 721, 105 S.Ct. 2371, 2379, 85 L.Ed.2d 714 (1985)). The Supreme Court has noted that “a specific intention of agency intent to pre-empt, made after notice-and-comment and rulemaking,” is not necessary to find conflict preemption. Geier v. Am. Honda Motor Co., 529 U.S. 861, 885, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000). The degree of deference to be attributed to an agency’s informal position on preemption, however, depends on the extent of the agency’s care, the consistency of the agency’s position over time, the coherence of the agency’s views, relative expertise to the technicality of the subject matter and the complexity of the background and relevant history. Colacicco, 521 F.3d at 274 (citing Geier, 529 U.S. at 883, 120 S.Ct. 1913). Moreover, the Geier case did “not suggest that courts abdicate their duty to examine whether federal and state law actually conflict” or indicate that exclusive reliance must be placed on an agency’s views. Fellner, 539 F.3d 237, 249-50 (citing Geier). The Third Circuit has touched on, without conclusively deciding, the weight to be given to the 2006 Preamble at issue in this case. Id. Citing to the Supreme Court’s pronouncements, the court stated that, notwithstanding the informality of the statement and the absence of notice-and-comment rulemaking, the statement was still entitled to be considered. Id. at 274-75. Such a position, however, was only “subject to a level of deference approximating that set forth in Skidmore v. Swift & Co., 323 U.S. 134, 65 S.Ct. 161, 89 L.Ed. 124 (1944),” to the extent such an interpretation has the “power to persuade.” Id. Ultimately, the court did not deem the 2006 Preamble dispositive of the issue before it. Rather, it held that “[i]n light of the circumstances in this case, ... the FDA’s rejection of the warning plaintiffs proffer preempts a state-law action premising liability on a drug manufacturer’s failure to include such a warning in the drug labeling notwithstanding that the agency’s view was not subject to notice- and-comment rulemaking.” Id. at 275 (emphasis added). Giving the 2006 Preamble due consideration to the extent it has the power to persuade, this Court rejects Defendant’s contention that the labeling provisions of the FDCA preempt the precise suit at issue. Several factors guide our consideration. First, the Court notes that the prior interpretations of the FDCA are inconsistent with the current view set forth in 2006 Preamble, thus reflecting a virtual “180-reversal” from its earlier position. Tucker v. SmithKline Beecham Corp., Civ. A. No. 04-1748, 2008 WL 2788505, at *5 (S.D.Ill. July 18, 2008) (quoting David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims, 96 GEO. L.J. 461, 474 n. 59 (2008)). In 1994, the FDA remarked on “the sophistication and complexity of private tort litigation in the United States and [stated that] the proposed preemption action is not intended to frustrate or impede tort litigation in this area. Indeed [the] FDA recognizes that product liability plays an important role in consumer protection.” Protecting the Identities of Reporters of Adverse Events and Patients; Preemption of Disclosure Rules, 59 Fed.Reg. 3944, 3948 (Jan. 27, 1994). Thereafter, in 1998, the FDA expressly stated that, “[The] FDA’s regulations establish the minimal standards necessary, but were not intended to preclude the states from imposing additional labeling requirements. States may authorize additional labeling, but they cannot reduce, alter, or eliminate FDA-required labeling.” Prescription Drug Product Labeling: Medication Guide Requirements, 63 Fed.Reg. 66378, 66384 (Dec. 1, 1998). Finally, in a 2000 Proposal of the same amendments at issue in this case, the FDA explicitly stated that it “ha[d] determined that this proposed rule does not contain policies that have federalism implications or that preempt State law.” Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologies; Requirements for Prescription Drug Product Labels, 65 Fed.Reg. 81082-01, 81103 (Dec. 22, 2000). Numerous courts, even those that have ultimately given deference to the FDA’s position in the 2006 Preamble, have similarly recognized this inherent contradiction between the FDA’s interpretations prior to 2006 and the interpretation set forth in the 2006 Preamble. See, e.g., In re Zyprexa Prods. Liab. Litig., 489 F.Supp.2d 230, 273-74 (E.D.N.Y.2007); Colacicco v. Apotex, 432 F.Supp.2d 514, 531 (E.D.Pa.2006); Dobbs v. Wyeth Pharms., 530 F.Supp.2d 1275, 1288 (W.D.Okla.2008); Sykes, 484 F.Supp.2d at 315. Such an inconsistency, under the factors set forth in Geier, weighs against giving the 2006 Preamble significant deference. Second, “while the FDA has a great deal of expertise in regulating the pharmaceutical industry, this expertise does not extend to what is ultimately a question of federal law and congressional policy.” Tucker, 2008 WL 2788505, at *6. The 2006 Preamble is, by regulation, an advisory opinion, binding only on the agency and changeable at any time without notice and comment. See 21 C.F.R. § 10.85(d)(1), (e), (g). “[F]ederal law capable of preempting is [not] created every time someone acting on behalf of an agency makes a statement or takes an action within the agency’s jurisdiction.” Fellner, 539 F.3d 237, 245-46. Congress itself has yet to provide a statement on the issue of preemption with respect to prescription drugs. “[T]his silence is telling” since Congress included express preemption provisions in amendments to the FDCA regarding state-law tort claims in certain contexts, such as for medical devices. In re Zyprexa, 489 F.Supp.2d 230, 276 (E.D.N.Y.2007). If Congress had intended for all FDCA claims to be preempted, logic suggests that it would have made a similar statement with respect to prescription drugs. Id. Thus, to the extent the Preamble conflicts with Congress’s statements or this Court’s own legal findings on preemption, it is not entitled to deference. Finally, and perhaps most importantly, even assuming arguendo that the FDA’s statements are entitled to full deference, the 2006 Preamble does not clearly effect a preemption of this precise case. The FDA identifies six types of state law claims that it believes would be preempted by the FDA regulation of drug labeling, two of which are possibly applicable here: (1) a state law claim “that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by the FDA at the time plaintiff claims the sponsor had an obligation to warn,” and (2) state law claims “that a 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 the rule.” 71 Fed.Reg. at 3936. With r