MEMORANDUM
TABLE OF CONTENTS
I. Introduction..............................................................518
II. Background..............................................................518
A. Procedural Background................................................518
B. Allegations in the Complaint ...........................................519
III. Jurisdiction and Legal Standard............................................520
A. Jurisdiction..........................................................520
B. Legal Standard.......................................................520
C. Applicable State Law..................................................520
IV. Contentions of the Parties .................................................521
A. Defendants ..........................................................521
B. Plaintiff.............................................................521
V. Federal Regulatory Process: Process to Obtain Approval from the FDA to Market and Sell Prescription Drags.......................................522
VI. Preemption Issues........................................................523
A. Implied Preemption...................................................523
1. Deference to the FDA’s Position that Plaintiffs Claims are Preempted.....................................................525
a. The Government’s Amicus Briefs................................526
b. The Preemption Preamble......................................529
c. Weight Afforded to FDA’s Position..............................530
d. Inconsistency of the FDA’s Position..............................530
e. Retroactivity of the Preamble...................................532
2. Other Evidence Supporting Implied Preemption.......................535
B. Effect of Buckman Co. v. Plaintiffs’ Legal Committee......................538
*518 VII. Issues Arising Under State Law Claims ................................ 538
A. Duty of Care.................................................... 538
1. Defendant GSK: No Duty of Care Owed........................ 538
2. Defendant Apotex: Duty of Care Owed ......................... 543
B. Learned Intermediary Doctrine.................................... 544
C. Reach of Hahn v. Richter......................................... 547
D. Individual Causes of Action ....................................... 548
1. Non-negligence Claims........................................ 548
a. Breach of Implied Warranty (Count II)...................... 548
b. Fraud by Intentional Misrepresentation and Violation of New York Consumer Protection Act (Count III)................. 549
i. Fraud............................................... 549
ii. Violation of New York Consumer Protection Law......... 550
c. Infliction of Emotional Distress (Counts V and VI)............ 552
2. Claims Sounding in Negligence................................. 553
a. Negligence (Count VII) .................................... 554
b. Negligence per se (Count VIII)............................. 554
c. Negligent Misrepresentation (Count IV)..................... 554
d. Strict Liability (Count IX)................................. 555
VIII. Conclusion........................ 555
I. Introduction
Presently before this Court are two Motions to Dismiss, pursuant to F.R. Civ. P. 12(b)(6), filed separately by Defendants Apotex, Inc. and Apotex Corp. (“Apotex”) and Defendant GlaxoSmithKline (“GSK”).
The threshold issue presented by these motions is preemption — whether regulations of a federal agency, promulgated pursuant to a federal statute, and implementing that statute, require the Court to dismiss this pharmaceutical products liability suit based on common law tort principles alleging that inadequate labeling of a prescription drug led to the suicide of Plaintiffs wife.
The answer is “yes” — when Congress passed the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 355(a), the law which gives the Food and Drug Administration (“FDA”) control over the regulation of the prescription drug industry, it vested the FDA with authority to regulate the specifics of drug labeling, making important judgments of what is required for safety of the consuming public, what new drugs may appear in the marketplace, and what warnings their instructions and labels must carry. The analysis that follows will reveal many conflicting court decisions on this topic. Fundamentally, a series of Supreme Court decisions point this Court in the direction of deference, and require dismissal of this case. Accordingly, both Defendants’ motions to dismiss will be granted.
II. Background
A. Procedural Background
Plaintiff Joseph Colacicco (“Plaintiff’) filed his original complaint on October 21, 2005, alleging the suicide death of his wife, Lois, resulted from the Defendant drug manufacturers’ failure to warn of the increased risk of suicidal behavior linked to the anti-depressant Paxil and/or its generic equivalent. On November 22, 2005, Defendant GSK filed its Motion to Dismiss (Doc. No. 5) (“Def. GSK Mem.”). Plaintiff filed a Response (Doc. No. 9) on December 20, 2005, and GSK filed a Reply brief (Doc. No. 11) on December 27, 2005. Defendant Apotex filed a Motion to Dismiss (Doc. No. 10) on December 26, 2005 (“Def. Apotex Mem.”), to which Plaintiff responded on *519 February 7, 2006 (Doc. No. 19). By letter dated March 2, 2006, this Court asked counsel to answer questions that arose from its review of the briefs to date. All parties responded on March 13, 2006.(See Doc. No. 26 by Plaintiff, Doc. No. 27 by Defendant GSK, and Doc. No. 28, by Apo-tex) (“Supp. Mem.”). Oral argument was held on March 17, 2006, at which Plaintiffs counsel withdrew Count I (breach of express warranty). On March 22, 2006, we again asked counsel by letter to answer additional questions that had surfaced, to which counsel responded on March 27, 2006 (See Doc. No. 33 by Apotex, Doc. No. 34 by GSK, and Doc. No. 38 by Plaintiff) (“2nd Supp. Mem.”). Plaintiff filed an Amended Complaint on March 24, 2006 (Doe. No. 32), which asserted in Count III (fraud and violation of consumer protection law against GSK only) what had in the original complaint been plead as two counts against both Defendants-Count III (fraud) and Count X (violation of consumer protection law). 1 Both Defendants GSK and Apotex filed a Response to the Amended Complaint and Supplemental Brief in Support of their Motions to Dismiss, on March 31, 2006 (Doc. Nos. 39 and 40, respectively), and Plaintiff filed a memorandum in opposition to the renewed motions to dismiss on April 6, 2006 (Doc. No. 41). (“3rd Supp. Mem.”). Then, due to the novel preemption issues presented in this case, the Court requested that the FDA file an amicus brief, which it did on May 10, 2006 (Doc. No. 45). See Brief for United States as Amicus Curiae Supporting Defendants, Colacicco v. Apotex, Civ. No. 05-5500, Doc. No. 45 (E.D.Pa. May 10, 2006) (“Colacicco Amicus”). Finally, the parties each submitted a response to the amicus brief on May 17, 2006 (Docs. No. 48, 49, 50) (“4th Supp. Mem.”).
B. Allegations in the Complaint
According to the Complaint, Plaintiffs wife, Lois Ann Colacicco, complained to her oncologist on October 6, 2003 of mild fatigue and depression. She was prescribed Paxil, 2 an anti-depressant drug manufactured by Defendant GSK. Soоn thereafter, she began taking the generic version of the drug, paroxetine hydrochloride, which is a bio-equivalent of Paxil and manufactured by Defendant Apotex. 3 On October 28, 2003, after twenty-two days of ingesting the drug, Lois Colacicco committed suicide in her home.
Paxil is one of a class of drugs known as Selective Serotonin Reuptake Inhibitors (“SSRIs”), which are prescribed for the treatment of depression and anxiety. Plaintiff alleges that despite ample peer-reviewed scientific literature published from the mid-1990s onward linking SSRIs to an increased risk of suicidality, at the time of Plaintiffs decedent’s death the FDA — approved label did not warn of an association between Paxil (manufactured by GSK) and/or its generic equivalent (manufactured by Apotex) and suicidality. 4
*520 Plaintiff filed suit against both Defendants GSK and Apotex, asserting the liability of either or both based on a failure-to-warn theory. Plaintiff contends the warnings, which were disseminated to doctors and the public by GSK, were inadequate to inform adult users of the risk of suicide associated with the drug. He asserts the labeling was prepared solely by Defendant GSK and copied verbatim by Defendant Apotex, which was required as part of the process to obtain approval from the federal FDA to manufacture the generic version of the drug. Alternately, Plaintiff asserts Defendant Apotex manufactured the drug which caused Lois Cola-cicco’s death, and failed to warn adult users of the risk of suicide posed by the drug.
III. Jurisdiction and Legal Standard
A.Jurisdiction
This Court has diversity jurisdiction over this complaint pursuant to 28 U.S.C. § 1332 because the matter in controversy exceeds $75,000 and is between citizens of different states. Plaintiff is a resident of New York. Defendant GSK is a citizen of Pennsylvania. Defendant Apotex is citizen of Florida and Canada.
Venue is appropriate in this district, pursuant to 28 U.S.C. § 1391 because a substantial part of the events or omissions giving rise to Plaintiffs claims occurred in Pennsylvania or were intended to have consequences in Pennsylvania.
B. Legal Standard
When deciding a motion to dismiss pursuant to F.R. Civ. P. 12(b)(6), the court may grant the motion only if, accepting all well-pleaded allegations in the complaint as true, and viewing them in the light most favorable to plaintiff, the plaintiff is not entitled to relief.
Doug Grant, Inc. v. Greate Bay Casino Corp.,
C. Applicable State Law
As a federal court sitting in diversity,
Erie R.R. Co. v. Tompkins,
IV. Contentions of the Parties
A. Defendants
Both Defendants GSK and Apotex contend Plaintiffs entire complaint must be dismissed, because (1) it is impliedly preempted by federal law, (2) Defendants do not owe the Plaintiff a duty of care, (8) the learned intermediary doctrine applies, and (4)
Hahn v. Richter,
Speaking to the threshold issue of preemption, Defendants urge that allowing Plaintiffs case to proceed would thwart the purpose of, and thus actually conflict with, the FDCA, and also that this Court must afford deference to the FDA’s position that its regulations preempt state tort claims. Regarding a duty of care, GSK decrees that as an innovator drug manufacturer, it does not owe a legal duty to a consumer of the generic equivalent of its drug. Apotex asserts that pursuant to the statute governing FDA approval of generic drugs, it was not responsible for the form or content of the paroxetine hydrochloride labeling, and therefore it too did not owe a duty of care to Plaintiff. Third, Defendants urge that the learned intermediary doctrine applies to bar Plaintiffs complaint because adequacy is a question of law and the FDA’s grant of original approval presumptively shows that the warnings were adequate. Finally, Defendants argue that
Hahn,
which held that “where the adequacy of warnings associated with prescription drugs is at issue, ... the manufacturer's negligence is the only recognized basis of liability,” precludes all Plaintiffs claims except those that sound in negligence.
Defendants also advance several arguments for dismissal with regards to Plaintiffs individual causes of action. First, Defendant Apotex contends that a claim for breach of implied warranty (Count II) is not available in cases involving prescription drugs under Pennsylvania law. Next, Defendant GSK argues that Count III (fraud аnd violation of New York consumer protection statute), which is advanced only against it, fails because: (1) the fraud portion lacks the required particularity under F.R. Civ. P. 9(b), and (2) the consumer protection portion is alleged under the wrong statutory section, does not plead reliance, and is inconsistent with the learned intermediary doctrine. Third, both Defendants assert that Plaintiffs infliction of emotional distress counts (Counts V and VI) fail because the alleged wrongful conduct visited upon his wife did not occur in Plaintiffs presence. Next, Apotex urges Plaintiffs negligence claim (Count VII) must be dismissed because Plaintiff cannot show the existence of a duty and the negligence per se claim (Count VIII) is impliedly preempted. Last, as to the negligent misrepresentation claim (Count IX), Apotex urges that since it made no statements regarding the efficacy and safety of paroxetine hydrochloride to the FDA, Plaintiff cannot show the required element that Apotex knew or should have known that any such representations were false.
B. Plaintiff
Plaintiff argues that preemption is inappropriate for several reasons, including that: (1) the FDCA merely establishes minimum standards and permits manufacturers to unilaterally strengthen warning labels, and (2) deference is unsuitable be *522 cause the FDA’s policy has been inconsistent, and would violate the principle forbidding retroactive application of new rules. Next, Plaintiff urges that pursuant to Pennsylvania’s nuanced duty of care analysis, the Court should find that Defendant GSK owed him a duty of care. As to Apotex, Plaintiff asserts that Apotex, like all product manufacturers, cannot escape the duty it owes to its consumers. Further, Plaintiff contends that the learned intermediary doctrine requires an analysis of the adequacy of the warnings, which is a question of fact that cannot be determined at the 12(b)(6) stage. Finally, regarding Hahn, Plaintiff asserts that a broad reading is improper; Hahn is better understood to have a narrower holding.
As to the individual counts, Plaintiff argues his implied warranty claim is viable, attempting to distinguish the case cited by Apotex. He also cites to numerous specific allegations in his complaint supporting the fraud claim, and argues GSK’s prolific, deceptive, “direet-to-consumer” advertising sufficiently supports his consumer protection claim. Next, Plaintiff contends that as to the infliction of emotion distress counts, it is sufficient that he observed the result of the alleged intentionally outrageоus or negligent conduct. Advancing the same arguments as it did earlier, Plaintiff asserts he has shown a duty of care sufficient to underlie the negligence count, and that preemption is inapplicable to the negligence per se claim. Finally, Plaintiff maintains that at the 12(b)(6) stage, the Court must accept his aver-ments that material submitted to the FDA and the labeling itself was intentionally false and misleading.
V. Federal Regulatory Process: Process to Obtain Approval from the FDA to Market and Sell Prescription Drugs
Analysis of the parties’ arguments requires some understanding of the process for approval to market- and sell generic drugs. The FDCA mandates that drugs are “safe and effective.” 21 U.S.C. § 355(a). Therefore, pharmaceutical manufacturers must obtain regulatory approval for prescription drugs prior to marketing them. Id. For drugs that have not been marketed before, the process for approval requires submission of a new drag application (“NDA”). 21 U.S.C. § 355(a)-®. The NDA.must contain proof of the efficacy and safety of the drug, based on extensive laboratory testing. 21 U.S.C. § 355(b). Further, the FDCA requires refusal of any NDA that includes labeling that “is false or misleading in any particular.” 21 U.S.C. § 355(d) (grounds for refusing new drag application). The obligation against misbranding drags continues thereafter. 21 U.S.C. § 331(a), (b), (k). Under the FDCA, a drug is unlawfully misbranded when its labeling is false or misleading, or does not provide adequate directions for use or adequate warnings against any use dangerous to health. Colacicco Amicus at 4; 21 U.S.C. § 352.
Before 1984, generic drug manufacturers were required to submit their own NDA.
Foster v. American Home Products,
The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Amendments (“HW Amendments”) to the FDCA, Pub.L. *523 No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C. § 355(j), 35 U.S.C. §§ 156, 271, 281), relaxed the procedure for obtaining approval from the FDA to market and sell a generic drug, allowing the generic maker to submit an abbreviated NDA (“ANDA”). Id. 6 The ANDA applicant need only certify that the generic manufacturer will produce a bio-equivalent of the brand name drug and that the labeling and warnings of the generic drug are identical to thаt of the approved innovator drug. 21 U.S.C. § 355(j)(2)(A). ' ■
After approval, a manufacturer may “add or strengthen a contraindication, warning, precaution, or adverse reaction” or “delete false, misleading, or unsupported indications for use or claims for effectiveness.” 21 C.F.R. § 314.70(c)(6)(iii)(A), (D). However, in its amicus brief submitted to the Court in connection with this case, the FDA explained that “a generic drug manufacturer is not permitted to add a warning or caution to the label without prior approval from the FDA.” Colacicco Amicus at 17. This is to assure that any changes to the label would not be “false or misleading,” and thus misbrand the drug.
VI. Preemption Issues
In their briefs and at oral argument, both Defendants contended that Plaintiffs claims are preempted by the federal FDCA, urging that: (1) Plaintiffs claims are impliedly preempted under general preemption principles, and (2) the Supreme Court’s holding in
Buckman Co. v. Plaintiffs’ Legal Committee,
A. Implied Preemption
Pursuant to the Supremacy Clause, any state law conflicting with the exercise of enumerated federal power is preempted. U.S. Const, art. VI, cl. 2. The United States Supreme Court has long recognized that federal preemption of state law can occur in three types of situations: (1) where Congress explicitly preempts state law (“express preemption”), (2) where preemption is implied because Congress has occupied the entire field (“field preemption”), and (3) where preemption is implied because there is. an actual, conflict between federal and state law. (“conflict preemption”).
Schneidewind v. ANR Pipeline Co.,
Defendants concede that express and field preemption are not implicated, Def. Apotex’s Mem. at 9, pursuing only the “conflict” 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.,
*524
Geier
is the most recent in a consistent, long line of cases that articulate the Supreme Court’s principles on imрlied preemption. In that ease, an injured motorist and her parents brought a defective design claim against an automobile manufacturer based on a lack of an automobile airbag in their 1987 Honda Accord.
Geier,
Despite the generality of the definition of conflict preemption, the Supreme Court has urged caution in its application: “[B]e-cause 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,
In contending that Plaintiffs claims are impliedly preempted by federal law, Defendants principally assert that assigning state tort liability would thwart the purpose of — and thus actually conflict with— the Hatch-Waxman Amendments. 7 Further, Defendants argue that under clearly established caselaw, this Court must afford deference to the FDA’s position that its regulations preempt state tort claims for inadequate warnings, which it has articulated in several amicus briefs and in the preamble to new drug labeling regulations issued in 2006. 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) (to be codified at 21 C.F.R. pts. 201, 314, 601) (hereinafter, “Preemption Preamble” to the “Final Rule”) (Def. Apotex Mem. at 9-15; Def. GSK Mem. at 9; Apotex Supp. Mem. at 18-24; GSK Supp. at 10-18; Apotex 2nd Supp. Mem. at 2-10; GSK 2nd Supp. Mem. 1-5).
In its amicus brief to this Court, the FDA goes even further, asserting that because prior to October 2003, the agency had repeatedly determined that there was inadequate evidence of an association between adult use of SSRIs and suicidality, Plaintiffs’ state law failure-to-warn claims are preempted because such a warning statement would actually have been “false and misleading,” and thus contrary to fed *525 eral law. Colacicco Amicus, at 1. We address these arguments in turn.
1. Deference to the FDA’s Position that Plaintiff’s Claims are Preempted
The Defendants and the FDA point to several pieces of evidence which reflect the FDA’s position that Plaintiffs inadequate warning claims are preempted: (1) the May 10, 2006 amicus brief filed in this case representing that the FDA would consider such a warning false and misleading (as well as two prior amicus briefs filed in other cases by the FDA in 2005 and 2002, respectively, indicating the same), (2) the 2006 Preemption Preamble, an official agency statement purporting to establish preemption of conflicting state law claims.
The FDA’s view is critical to this Court’s analysis because Supreme Court precedent dictates that an agency’s interpretation of the statute and regulations it administers is entitled to deference.
Chevron U.S.A, Inc. v. Natural Resources Defense Council, Inc.,
In the context of preemption specifically, the Supreme Court held in 1985 that in the absence of clearly expressed Congressional intent or subsequent developments that reveal a change in that position, the FDA’s position on the preemptive scope of its regulatory authority “is dispositive.”
Hillsborough County v. Automated Med.
Labs,
Inc.,
Further, the Court has made clear that such preemptive intent may properly be communicated in
amicus
briefs,
Geier,
The Third Circuit has not rendered an opinion as to the level of deference that should be afforded to the FDA’s position on whether the FDCA impliedly preempts state failure-to-warn claims. However, the Third Circuit considered whether to defer to the FDA’s position on express preemption in the 2004 case
Horn v. Thoratec Corp.,
a. The Government’s Amicus Briefs
In the amicus brief submitted to this Court, the FDA re-affirmed its view that Plaintiffs claims are preempted. Colacic-co Amicus at 1, 13, 15. Explaining this position, the FDA noted that the FDCA prohibits the misbranding of drugs. 21 U.S.C. § 331(a), (b), (k). As explained above, under the FDCA, a drug is unlawfully misbranded when its labeling is false or misleading, or does not provide adequate directions for use or adequate warnings against any use dangerous to health. Colacicco Amicus at 4. Therefore, to the extent that before and up to October 2003, 10 the date of Plaintiffs decedent’s *527 death, the FDA specifically and repeatedly rejected claims that adult use of SSRI’s was associated with increased suicidality because there was no reasonable evidence to support the linkage, the FDA contends that any such warning would have been false or misleading, and contrary to the public interest. For this reason, the FDA asserts that Plaintiff Colacicco’s failure-to-warn claims are preempted by federal law. Id. at 17.
Moreover, the FDA explained that public policy requires that warnings be scientifically substantiated. Dissemination of unsupported warnings, the FDA urged, would deprive patients of efficacious treatment, thereby chilling the drug’s otherwise beneficial use. Id. at 13. The FDA also flatly rejected the often-cited proposition by many courts refusing to apply preemption in prescription drug cases that 21 C.F.R. § 314.70(c) permits drug makers to unilaterally strengthen a warning label without FDA approval. Id. at 6, 17. Instead, it decreed that despite what numerous lower courts 11 around the nation have stated, a “drug manufacturer is not permitted to add a warning or caution to the label without prior approval from the FDA” Id. at 17 (emphasis added).
This position is consistent with the view taken in two prior
amicus
briefs prepared by the FDA in other failure-to-warn cases.
See
Brief for United States as
Amicus Curiae
Supporting Defendant,
Kallas v. Pfizer,, Inc.,
Civ. No. 2:04-cv-0998, 34, 37-38 (D.Utah Sept. 15, 2005) (FDA amicus brief arguing that plaintiffs failure-to-warn claims were preempted because the FDA lacked reasonable evidence of an association between SSRIs aiid suicidality in children in November 2002;, thus, the proposed warning would have misbranded Zoloft, the SSRI at issue)
(“Kallas Amicus
”); Brief for United States as
Amicus Curiae
Supporting Defendant,
Motus v. Pfizer, Inc.,
Civ. Nos. 02-cv-55372, 02-cv-55498, (9th Cir. Sept.10, 2002),
*528 According to the FDA, therefore, it is clear that any insert in October 2003 associating use of paroxetine hydrochloride with suicidality would have constituted misbranding, because it was contrary to the scientific evidence, and thus “false and misleading.” Pursuant to the principles announced in the Supreme Court’s decisions in Chevron, Medtronic, Geier and then-progeny, as well as the Third Circuit’s broad holding in Horn, it is therefore appropriate to afford deference to the FDA’s position based on the Colacicco Amicus alone.
However, in his response to the Colacic-co Amicus, Plaintiff argues that we ought not pay the amicus any deference because (1) the FDA glosses over the importance of 21 C.F.R. § 314.70, which it argues allows manufacturers to strengthen labels without prior FDA approval — and which almost every court that has heretofore rejected preemption has cited, and (2) the FDA has no authority to simply declare that a drug is misbranded, and, at any rate, such opinion is merely hypothetical, as at no time prior to Plaintiffs decedent’s death did either Defendant request a stronger warning. (Pl.’s 4th Supp. Mem. at 3 n. 3, 5, 8-10):
We disagree. As to the Plaintiffs first objection, Plaintiff notes that the plain language of § 314.70 states that the holder of an approved application may make changes in the labeling to “add or strengthen a contraindication, warning, precaution, or adverse reaction,” and may “commence distribution of the drug product involved upon receipt by the agency of a supplement for the change.” 21 C.F.R. § 314.70(c)(6)(iii)(A). He thus contends the provision’s plain language explicitly permits manufacturers to strengthen labels without prior FDA approval. (Pl.’s 4th Supp. Mem. at 3 n. 3). However, 21 C.F.R. § 314.150, cited by the FDA in its amicus brief and by Defendant Apotex, directly supports the FDA’s position that generic drug makers can not unilaterally strengthen their drug. 21 C.F.R. § 314.150 states that the FDA will withdraw approval of a generic maker’s ANDA if the label ceases to be identical to that of the name-brand drug. Interpreting § 314.150, the FDA explained, “[i]f an ANDA applicant believes new safety information should be added to a product’s labeling, it should contact FDA, and FDA will determine whether the labeling for the genеric and listed drugs should be revised. After approval of an ANDA, if an ANDA holder believes that new safety information should be added, it should provide adequate supporting information to FDA, and FDA will determine whether the labeling for the generic and listed drugs should be revised.” 57 Fed.Reg. at 17961. Moreover, despite the plain language of § 314.70, and even if the FDA’s position were not bolstered by 21 C.F.R. § 314.150, this Court believes that principles of deference do not allow us to question the FDA’s interpretation of its own regulations — e.g. that generic drug manufacturers can not make changes without prior approval.
As to the second assertion, Plaintiff argues that the FDA must prosecute an enforcement action to establish a drug is misbranded, citing 21 U.S.C. §§ 331-37, 352. However, these sections merely discuss the requirements of an enforcement or injunctive action if one is brought; no where does the statute declare that the FDA must bring a prosecution to state an
opinion
as to whether a particular drug would have been misbranded if a certain warning had been attached. Further, it is not in dispute that the FDA’s position is a hypothetical. In fact, it is in part
because
neither Defendant requested a stronger warning that the vacuum of information was created that necessitated this Court asking the FDA to render an opinion as to
*529
preemption. Moreover, we note that the Supreme Court has explicitly stated that
amicus
briefs are an appropriate form to express preemptive intent,
Geier,
b. The Preemption Preamble
However, we need not base our conclusion on the amicus briefs alone. In early 2006, the FDA additionally promulgated what we refer to as the “Preemption Preamble,” which states that, “whether it be in the old or new format, [the FDCA] preempts conflicting or contrary state law,” and “conflicting” includes state failure-to-warn claims. 71 Fed.Reg. at 3934, 3936. As in its Colacicco Amicus brief, the FDA in the Preemption Preamble specifically rejected the two main arguments advanced by those courts rejecting preemption: (1) that the FDCA imposes only minimum standards for labeling, and - (2) drug manufacturers have the ability to strengthen warnings without FDA approval. 71 Fed.Reg. at 3934-35; see also Eric G. Lasker, How Will FDA’s New Label Rule Impact Drug Litigation?, 9 No. 10 Andrews Drug Recall Litig. Rep. 9, at 2 (Mar. 13, 2006). As to the “misunderstanding” that FDA labeling requirements represent a minimum safety standard, the FDA Preemption Preamble interprets the FDCA to “establish both a ‘floor’ and a ‘ceiling.’ ” Id. Regarding the argument that manufacturers can modify labels without FDA approval, the FDA urges that “in practice, manufacturers typicаlly consult with FDA before doing so to avoid implementing labeling changes with which the agency ultimately might disagree.” Id. Also, as in the Colacicco Amicus brief, the Preamble asserts that “state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product’s risks, thereby potentially discouraging safe and- effective use of approved products.” Id.
As discussed above, it is abundantly clear that the FDA’s position is entitled to significant deference.
Geier,
*530 c. Weight Afforded to FDA’s Position
First, Plaintiff argues that the Preemption Preamble amounts to mere legal argument that should not affect this court’s inquiry. (Pl.’s Supp. Mem. at 7-11). We disagree. In this case, “the subject matter [of the FDCA] is technical; and the relevant history and background are complex and extensive,” and we find that the FDA is “uniquely qualified to comprehend the likely impact of state requirements.”
Geier,
d. Inconsistency of the FDA’s Position
Second, Plaintiff argues that despite the FDA’s statements that the Preemption Preamble “represents the government’s long standing views” on preemption, 71 Fed.Reg. at 3934, and that its argument in the Colacicco Amicus that its position on “federal preemption of ... failure-to-warn claims [does not] constitute a wholesale change in agency position,” in fact, the FDA has not been сonsistent in its position on preemption. Plaintiff points to two past statements made by the FDA demonstrating that it did not always consider its regulations to have preemptive effect. See 65 Fed.Reg. 81082, 81103 (Dec. 22, 2000) (FDA taking stance in initial proposed version of preamble to what was ultimately enacted as the Final Rule that its regulations are minimum standards, and do not preempt state tort claims); 63 Fed.Reg. 66378, 66384 (Dec. 1,1998) (“[F]ederal preemption could unduly interfere with the goals and objectives of existing State programs ... This final rule is intended to complement these State efforts, not replace or hinder them.”). (Pl.’s Supp. Mem. at 7-11).
In its response to the amicus brief, GSK offered some compelling reasons why the 1998 statement ought not be considered inconsistent with the FDA’s current position. GSK points out that the 1998 declaration related to the FDA’s final regulation on Patient Medication Guides, which is information provided directly to patients, usually by pharmacists. Drug stores and pharmacies, in turn, have traditionally been regulated by the States, not the FDA. See, e.g., 49 Pa.Code § 27.19 (State Board of Pharmacy’s regulation concerning prospective drug review and patient counseling). Thus, to the extent that the FDA commented that federal preemption could unduly interfere with state programs, it appears this concerned state programs regarding what information pharmacists must provide directly to patients. Because the protections afforded by some of these state programs exceeded that required by federal law, the FDA commented that it did not intend to displace these programs. 63 Fed.Reg. at 66384. Accordingly, we concur with GSK that the *531 1998 statement does not undermine the FDA’s current position on preemption, which concerns what information must be provided to physicians about prescription drugs, the regulation of which unquestioningly is exclusively a federal function.
The inconsistency in the December 2000 declaration is more problematic. We find it is difficult to reconcile the FDA’s current position with that statement, which was made in the FDA’s initial notice of its intent to revise the prescription drug labeling regulations, which ultimately was enacted as the Final Rule. At that time, the FDA “determined that this proposed rule
does not contain policies that have federalism implications or that preempt State law.”
65 Fed.Reg. at 81103 (emphasis added). Further, despite our specifically asking the FDA to address whether their current position can be reconciled with the December 2000 statement, the
Colacicco Amicus
brief is completely silent on the 2000 statement.
See
Letter to Counsel for the Government Re: Follow-Up Questions for the Amicus Brief,
Colacicco v. Apotex,
Civ No. 05-5500 (Doc. No. 44) (E.D.Pa. May 4, 2006);
Colacicco Amicus
at 20.
14
Nonetheless, although consistency of an administrative agency’s , position is a factor, as
Chevron
made clear, there is no longer any justification for not giving deference to an agency’s interpretation of law merely because it is not the agency’s longstanding position.
Chevron,
Moreover, we do find it significant; that after 2000, the FDA has been very consis
*532
tent.
16
On four occasions — -in the
Colacic-co Amicus,
the
Preemption Preamble,
the
Kallas Amicus,
and the
Motus Amicus
— it set forth detailed analyses of its position that the Supremacy Clause bars state tort liability specifically for failure to include a warning on a drug label that is in conflict with or contrary to the warnings approved by the FDA.
See Colacicco Amicus, Preemption Preamble, Kallas Amicus, Motus Amicus.
Moreover, the 1998 and 2000 statements in the Federal Register referred more generally to the regulations and not to the specific circumstances here — where Plaintiffs proposed warning would have misbranded the drug.
Dusek v. Pfizer, Inc.,
No. Civ.A. H-02-3559,
e. Retroactivity of the Preamble
Finally, Plaintiff questions whether the Preemption Preamble, prоmulgated in 2006, may be retroactively applied to the October 2003 death of the decedent in this case. This appears to be an issue of first impression, as only two courts have had occasion to mention the Final Rule, and neither have specifically considered the question of retroactivity as to the Preemption Preamble in particular.
Abramowitz v. Cephalon, Inc.,
A brief primer on administrative law is necessary to address the parties’ claims because the law governing administrative rule-making, and in turn retroactivity, largely hinges on how the agency’s stance is classified — that is, whether the agency’s position is a substantive rule, an adjudicative rule, an interpretive rule, or a statement of policy under the Administrative Procedure Act (“APA”).
The APA defines a “substantive” or “legislative” rule as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency” 5 U.S.C. § 551(4). These rules have the force and effect of law and must be promulgated in accordance with the proper notice and comment procedures under the APA.
Beazer E., Inc. v. U.S. Envtl. Prot. Agency, Region III,
Similarly excluded from the APA’s notice and comment requirements, and lacking the force of law, are “general statements of policy.”
United States v. Mead Corp.,
The Supreme Court has made clear that substantive rules may not be retroactively applied.
Bowen v. Georgetown Univ. Hosp.,
In
Appalachian States Low-Level Radioactive Waste Commission v. O’Leary,
However, if the Preemption Preamble is a statement of policy, the law on retroac-tivity is less clear, particularly in the Third Circuit. While most circuits adhere to the definition of policy statements as pronouncements to “advise the public
prospectively,” Mada-Luna v. Fitzpatrick,
Thus, having determined that in the Third Circuit, an “interpretive rule” likely may apply retroactively, but a “statement of policy” likely may not, our determination as to which category the Preemption Preamble falls into is important. Certainly to say that the law in this area is less than clear is an understatement.
See Cmty. Nutrition Inst. v. Young,
That said, the FDA’s position that it is merely clarifying its “longstanding views on preemption,” 71 Fed.Reg. at 3934 — e.g., that it is only “only remind[ing the] affected parties of existing duties” — weighs heavily in favor of concluding that the Preemption Preamble is an interpretive rule.
Beazer,
2. Other Evidence Supporting Implied Preemption
As additional evidence of conflict preemption, Apotex argues that tort liability for inadequate warnings would “stand[ ] as an obstacle to the accomplishment and execution of the full purposes and objectives” of the FDCA.
Geier,
In response, Plaintiff argues that while generic makers must rely on the innovator manufacturer’s labeling and research to get initial approval, once the ANDA is approved, the regulations explicitly permit strengthening of product warning labels. 21 C.F.R. § 314.70(e)(6)(iii)(A), (D); 57 Fed.Reg. 17950, 17961. Thus, he argues the FDCA establishes a floor and not a ceiling with regards to labeling standards. He too cites to numerous cases — but also none by the Third Circuit — that have confronted this exact issue and have concluded that state failure-to-warn claims are not preempted by the FDCA and its attendant regulations.
See, e.g., Hurley v. Lederle Labs. Div. of Am. Cyanamid Co.,
Since the Third Circuit has not confronted this issue, any caselaw cited is merely persuasive. That said, these decisions, authored by eminent jurists, are forceful, analytical, and — if the Court believed it was authorized to make the analysis — it might very well agree with them. This Court has concluded not that their analysis itself is wrong, but rather that it is improper for a federal district judge to engage in this analysis in the first place.
First, it is important to note that in contrast to the instant case, those courts had neither (1) a clear amicus brief from the FDA addressing the specific facts of the case before it, and representing its judgment and authority that plaintiffs common law claims are impliedly preempted (Colacicco Amicus), or (2) an express statement of policy, formally published in the Federal Register, taking the position that state law failure-to-warn claims are preempted by the FDCA (Preemption Preamble). These documents are disposi-tive to our determination that Plaintiffs claims are preempted.
Second, this is not a case about individual rights or Constitutional interpretation, in which judges have obligations to protect civil liberties, but is essentially a case about economics — whether a drug company should be at risk for damages because of the death of a woman taking its drugs. When Congress established the elaborate system of legislation for the introduction of new drugs, and authorized a federal agency to implement and police its operation, the resolution of claims arising out of alleged shortcomings in drug instructions and labeling should be as allowed by Congress. Congress has not provided for such claims, and the FDA has taken the position that plaintiffs claims based on state law are inconsistent with its statutory-administrative regimen. Kenneth W. Starr, Judicial Review in the Post-Chevron Era, 3 Yale J. on Reg. 283, 308 (1986) (“intrusions not clearly mandated by Congress or the Constitution into the processes and decisions of [a federal agency]” should be avoided because administrative agencies are not subordinate to the federal courts in the organizational structure established by the Constitution).
It is of course true that this Court or any other trial judge with a case such as this could proceed to trial (where a jury would be required to render a verdict based on the same medical judgments considered by the FDA), and appeals by the losing party would wind their way through the court system. However, because preemption is warranted, the case should be dismissed now; if the Court is wrong, Congress can fix this error quickly, and so can the executive branch, by installing different managers at the FDA. Ultimately, this Court believes it is far more desirable that the important issues presented by this case, indeed tragic in its facts, are better addressed by elected officials, legislative and executive, than by appointed judges, a belief which itself has been echoed by the Supreme Court.
See Chevron,
Also, the FDA in the Colacicco Amicus brief and in the Preemption Preamble— which we have already determined deserves considerable deference — squarely rejected Plaintiffs other arguments. The Preemption Preamble specifically analyzes and dispels the “misunderstanding” cited by numerous lower courts that FDA labeling requirements represent a minimum safety standard, clarifying that the FDCA “establish[es] both a ‘floor’ and a ‘ceiling.’ ” Preemption Preamble, 71 Fed.Reg. at 3934-35.
Third, we find compelling Defendant Apotex’ argument that, pursuant to the relaxed generic approval process mandated by the Hatch-Waxman Amendments, it was
required
to use verbatim the language of Defendant GSK’s warning label during the ANDA application and approval process. Thus, assigning a duty to include a warning different from GSK’s approved label inherently conflicts with the FDCA. Additionally, although many courts have held that once the ANDA is approved, 21 C.F.R. § 314.70 explicitly permits unilateral strengthening of product warning labels, the FDA now says otherwise. In its
ami-cus
brief, the FDA explicitly asserts that “there is no statutory or regulatory provision permitting the manufacturer to make a labeling change to its generic drug without prior FDA approval.”
Colacicco Ami-cus
at 6.
See also
Preemption Preamble, 71 Fed.Reg. at 3934-35. Presumably, this is to insure that the added language is substantiated by scientific data and if not — as would have been the case if Apotex tried to add a label linking paroxetine hydrochloride to suicidality in October 2003 — it would have been deemed “misleading” and, thus, in violation of federal law.
Colacicco Amicus
at 15. Therefore, notwithstanding other lower courts’ holdings that the plain language of § 314.70 seems to permit pharmaceutical manufacturers to add or strengthen warning without prior FDA approval, we interpret
Geier
to require us to respect the FDA’s conclusion that such changes are not allowed, as the FDA is “uniquely qualified” to interpret the regulations which it is entrusted by Congress to administer.
Geier,
Accordingly, we find that state tort law which would hold a generic drug manufacturer liable for failing to modify a label when, pursuant to the Hatch-Waxman *538 Amendments to the FDCA, the ANDA approval process required that the labeling be the same as that approved for the innovator drug, and a when the FDA would have deemed any post-approval enhancements “false or misleading,” would actually conflict with the FDCA. For these reasons, as well as our conclusion that we must afford deference to the FDA’s position that the claims are preempted, we find that Plaintiffs failure-to-warn claims are impliedly preempted. 19
B. Effect of Buckman Co. v. Plaintiffs’ Legal Committee
Finally, Defendants also urge that Buck-man Co. v. Plaintiffs’ Legal Committee requires that this Court find preemption in this case. We disagree.
In
Buckman,
the Supreme Court held that the FDCA, as amended by the Medical Device Amendments, impliedly preempted the plaintiff patients’ state law “fraud-on-the-agency” claims against a manufacturer’s regulatory consultant, based on statements allegedly made to the FDA in the course of seeking pre-market approval for orthopedic bone screws.
Buckman,
The Court agrees with Plaintiff that
Buckman
is distinguishable. In
Buck-man,
the manufacturer of certain orthopedic bone devices hired a consulting company to help the manufacturer “navigat[e] the federal regulatory process.” Plaintiffs brought suit not against the manufacturer, but instead alleging the defendant consultant company had defrauded the FDA in obtaining approval for the orthopedic screws. Thus, when the Supreme Court held that the claims were impliedly preempted by the FDCA, it limited this holding to the rationale that
policing fraud upon the FDA
is decidedly a federal function.
Buckman,
VII. Issues Arising Under State Law Claims
A. Duty of Care
1. Defendant GSK: No Duty of Care Owed
However, we do not rest our dismissal of GSK on preemption alone. Because we hold that a name brand drug manufacturer does not owe a legal duty to *539 consumers of a generic equivalent of its drug, at least for Defendant GSK, the lack of a duty of care provides a second basis for dismissing all claims against it.
Defendant GSK contends that under Pennsylvania law, “the most essential characteristic of any product liability action ... is that the defendant manufactured or sold the product in question” and because GSK did neither, it had no direct relationship with Plaintiff or his decedent. Thus, GSK argues it owed no duty of care and therefore cannot be liable under any theory. In support of this contention, GSK cites
Foster v. American Home Products,
Plaintiff responds that Defendant GSK’s reliance on
Foster,
based on Maryland law, is inapposite. First, he notes that “direct to consumer” (“DTC”) advertising has dramatically expanded since
Foster
was decided, from $242 million in 1994 to approximately $2.38 billion in 2001, which has increased consumers’ reliance on name-brand advertising, even if they actually take the generic. Second, in contrast to Maryland, in which foreseeability is the principal determinant of duty, Plaintiff contends Pennsylvania employs a more nuanced duty analysis. Specifically, Plaintiff avers that under the Pennsylvania Supreme Court’s analysis in
Althaus v. Cohen,
In
Althaus,
the Pennsylvania Supreme Court held that the determination of whether a duty exists in a particular case is rooted in public policy and involves the weighing of numerous factors, which include: (1) the relationship between the parties; (2) the social utility of the actor’s conduct; (3) the nature of the risk imposed and foreseeability of the harm incurred; (4) the consequences of imposing a duty upоn the actor; and (5) the overall public interest in the proposed solution.
Althaus,
Having reviewed the caselaw nationwide, it appears that
Foster,
decided by the Fourth Circuit and applying Maryland law, is the single case which has confronted this issue most directly and in most detail. In Foster,
20
the parents of an infant who died after ingesting a generic drug, sued Wyeth, the manufacturer of the brand-name version of the prescription.
Foster,
Specifically before the Fourth Circuit was the question whether the manufacturer of a brand-name prescription drug could be held liable on a negligent misrepresentation theory for an injury caused by a generic equivalent drug manufactured by another company. Id. The court answered “no,” reasoning that there is no recognized cause of action based on negligent misrepresentation against one manufacturer for injuries stemming from use of another manufacturer’s product. Id. Quite simply, the circuit court found that all products liability actions require proof that the defendant made the product to which the alleged injuries are attributable. M 22 Further, the Foster court held that although the generic drug approval process requires generic manufacturers to initially use the same labeling as the previously approved innovator drug, this does not absolve them of liability for the representations made on their own drugs. Id. at 170-71. Moreover, the Foster court noted that it would be unfair to use an innovator drug manufacturer’s statements regarding its drug as the basis for liability for injuries caused by another manufacturer’s drug: while the generic manufacturer reaps the financial benefits of the name brand manufacture’s research and “rid[es] on the coattails of its advertising,” the innovator drug manufacturer has no control whatsoever over the manufacturing or labeling of the genеric substitute. Id. at 171. Finally, citing a complete lack of precedent, the Foster court concluded that a foreseeability analysis similarly did not lead to the imputation of a duty of care on the innovator drug manufacturer, because to do so would “stretch the concept of foreseeability too far.” Id. In sum, it found that “Wyeth is under no duty of care to the plaintiffs.” Id.
Notably, the
Foster
decision has encountered widespread acceptance; a review of caselaw reveals that every state and federal district court which has confronted the issue of innovator drug-manufacturer liability has either adopted the
Foster
reasoning or cited
Foster
with approval.
See Tarver v. Wyeth, Inc.,
Civil Action No. 3-04-2036, slip. op. (W.D.La. Apr. 28, 2005) (applying Louisiana law);
Block v. Wyeth, Inc.,
02-cv-1077,
While this Court is of course not bound by
Foster
and its progeny, we — like our sister courts across the nation — find it persuasive and adopt its holding. First, although Maryland law differs slightly from Pennsylvania’s as to ascertaining a duty of care and as to the elements of certain product liability theories (e.g., strict liability), it is the same with respect to an essential and elementary characteristic of product liability law: both states require that the defendant manufacture or sell the product in question.
See, e.g. Hahn,
To the extent that Pennsylvania law on the existence of duty requires the additional consideration of public policy, this does not advance Plaintiffs claims against GSK. Contrary to Plaintiffs assertion thаt this Court is free to divine its own interpretation of public policy, in fact, Pennsylvania courts generally ascertain public policy “by reference to the laws and legal precedents and not from general considerations of supposed public interest.”
Prudential Prop. & Cas. Ins. Co. v. Colbert,
*543 Like in Foster, Plaintiff in this case invites this Court to drastically expand the boundaries of Pennsylvania tort law without precedent or policy to support his position. 25 We believe the Supreme Court of Pennsylvania would not accept this invitation, and accordingly, we decline to do so as well. Thus, this Court holds that under Pennsylvania law, there is no duty of care owed by a brand-name prescription drug manufacturer to a plaintiff allegedly injured by a generic equivalent drug manufactured by another company. Thus, even if this Court’s conclusion regarding preemption were found to be improper, the claims against Defendant GSK must still be dismissed. 26
2. Defendant Apotex: Duty of Care Owed
Defendant Apotex asserts that it was not responsible for the form or substance of the labeling connected with paroxetine hydrochloride, and therefore it too did not owe a duty of care to Plaintiff that would give rise to liability against it. For the reasons that follow, this contention must be rejected.
In making this argument, Apotex focuses on the H-W Amendments, which allow a generic maker to rely on the innovator’s testing and require it to use identical labeling as the innovator in order to obtain FDA approval. Thus, Apotex argues that, “like a pharmacist who assembles the components of a drug prescribed by a physician,” its only duty with respect to labeling was to attach a label which was the same as that approved for Paxil, which it did. As for a more generalized duty, Apotex cites to foreseeability and public policy, two critical factors in the Althaus duty analysis. It urges: (1) the H-W Amendments made it unforeseeable that it could be held liable for inadequacies in labels it did not create, and (2) the H-W Amendments are a clear policy expression by Congress to avoid imposing a duty on generic manufacturers. Further, distinguishing Foster, Apotex takes the position that because the generic manufacturer was no longer a party to the suit when the case was decided, the Fourth Circuit’s holding that the generic manufаcturer owes a duty of care to consumers who ingest its drug is mere dicta. (Def. Apotex’s Mem. at 5-9; Def. Apotex’s Supp. Mem. at 7-18, 25-29).
*544 Plaintiff counters that quite simply, Apo-tex, like all product .manufacturers, cannot escape the duty it owes to all its consumers. This is because it has a very direct relationship with them: it makes and labels the drug they take. (PL’s Resp. at 4-6).
In deciding whether Apotex owed Plaintiff a duty of care, we address the
Althaus
factors in turn. As a threshold matter, Apotex challenges the first
Althaus
factor, the relationship between the parties. Citing
Makripodis v. Merrell-Dow Pharmaceuticals Inc.,
Moreover, we find the Foster court’s discussion of generic manufacturer liability — specifically foreseeability and public policy — compelling. While it is true that the ANDA process requires generic manufacturers to use the same labeling as the previously approved innovator drug, we cannot agree that this absolves them of liability for the representations made on their own drugs. That basic tort concepts always hold a manufacturer liable for its products makes liability based on inadequate labeling foreseeable to Apotex. Nor can we agree that the H-W Amendments are a clear policy expression by Congress to avoid imposing a duty on generic manufacturers or made it unforeseeable that Apotex could be held liable for inadequacies in its own labels. If that was Congress’ intent, it or the FDA would have said so. Moreover, Plaintiffs argument that this portion of Foster is dicta is irrelevant, as we have already acknowledged that Foster has no controlling effect on this court. Whether dicta or not, we look to this part of Foster for its reasoning, and because this reasoning is well-articulated and persuasive, this Court adopts it.
Finally, the last two
Althaus
factors— the social utility of the actor’s conduct, and the consequences of imposing a duty upon the actor — do not weigh against finding a duty owed by Apotex. While one could argue that there is social utility in making less-expensive, generic substitutes available to the public, this Court is mindful of the fact that Apotex is still a business, manufacturing drugs like paroxetine hydrochloride not for some altruistic reason, but to realize a profit. Apotex reaps the financial rewards of selling paroxetine hydrochloride, and it cannot hide from liability by crying regulatory foul. Also, the economic consequences of imposing a duty upon Apotex are marginal, given that a duty of care is imposed on all product manufacturers.
See, e.g., Hahn,
B. Learned Intermediary Doctrine
A third ground cited by Defendants for dismissing the entire complaint, which we
*545
reject at this stage of the litigation, is the “learned intermediary” doctrine (“LID”), under which a drug manufacture’s liability is based on its warning labels targeted at doctors, not consumer-patients. (Def. Apotex’s Mem. at 16; Def. GSK’s Supp. Mem. at 22-26; Def. Apotex’s Supp. Mem. at 37-40). Plaintiff counters that the LID does not apply because: (1) he has plead that Defendants failed to provide adequate warnings to among others, decedent’s treating and/or prescribing physician, Compl. at ¶ 86, and (2) the doctrine requires an analysis of the adequacy of the warnings, a question of fact which cannot be determined at this early stage. Further, citing
Perez v. Wyeth Labs.,
Under Pennsylvania’s LID, a prescription drug manufacturer meets its duty to warn by providing an adequate warning to a “learned intermediary” (usually a physician) as opposed to the public or individual patient-eonsumérs.
Mazur v. Merck & Co.,
Nonetheless, we conclude the LID does not bar any of Plaintiffs claims at *546 this stage of the litigation. 27 While we agree with Defendants that pursuant to the LID, warning labels are targeted at doctors, not consumer-patients, in fact, Plaintiff properly plead that Defendants failed to provide adequate warnings to his decedent’s treating and/or prescribing physician. Compl. at ¶ 86.
Further, the doctrine only applies if the facts support the conclusion that a drug manufacturer
adequately
warns doctors of a drug’s dangers; it does hot shield drug manufacturers from liability if the warnings they provided to physicians would not permit the physicians to adequately advise their patients.
See, e.g., Amore v. G.D. Searle & Co.,
C. Reach of Hahn v. Richter
Finally, Defendants argue that in addition to barring Plaintiffs strict liability claim, the broad holding announced by the Pennsylvania Supreme Court in
Hahn v. Richter,
In
Hahn,
in barring a strict liability claim against a manufacturer of a prescription drug, the Pennsylvania Supreme Court broadly held that “where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability.”
Hahn,
While Plaintiff admitted on the record at oral argument that all his claims were based on Defendant’s failure-to-warn, Plaintiff nonetheless argues that, in fact,
*548
Hahn
does not control because that court presumed the products were marketed with
proper warnings,
whereas here Plaintiff
challenges
the adequacy of the warnings. (Pi’s Response to GSK at 18-19; Pi’s Supp. Mem. at 3-5). We find this contention to be without merit. First, the court’s broad statement that negligence is the only recognized basis of liability any time “where the adequacy of warnings associated with prescription drugs
is at issue
” unambiguously demonstrates the holding applies to all failure-to-warn claims, which inherently call into question the adequacy of prescription drug warnings. Second, the
Hahn
court did not just carelessly pronounce a broad holding. Instead, it relied on a well-developed line of cases, including
Mazur, Incollingo,
and
Baldino,
to come to its conclusion. Also, and importantly, the court took great pains to explain
why
failure to exercise reasonable care is the only cause of action that should be permitted for claims which are based on failure-to-warn. Quoting comment k of the Restatement (Second) of Torts § 402A, the court reasoned that prescription drugs “supply the public with ... apparently useful and desirable produces],” which protect against serious and even deadly diseases.
Hahn,
We therefore hold that Hahn requires us to dismiss Count IX (strict liability), as well as all of Plaintiffs remaining claims except the four that sound in negligence: negligent misrepresentation (Count IV), negligent infliction of emotional distress (Count VI), negligence (Count VII), and negligence per se (Count VIII). Accordingly, Count II (breach of implied warranty), Count III (fraud by intentional misrepresentation and violation of New York consumer protection law), Count V (intentional infliction of emotional distress), and Count IX (strict products liability) must be dismissed. 31
D. Individual Causes of Action
Assuming arguendo that Plaintiffs claims were not barred by preemption, lacking duty of care, and/or the reach of Hahn, or this Court’s holding as to any or all of those issues were found to be erroneous, Defendants would have to respond to the following arguments pertaining to Plaintiffs individual causes of action. We therefore address each seriatim.
1. Non-negligence Claims
a. Breach of Implied Warranty (Count II)
First, citing the Pennsylvania Superior Court’s decision in
Makripodis v. Merrell-Dow Pharmaceuticals Inc.,
In dismissing a claim for the implied warranty of merchantability against a retаil pharmacist, the
Makripodis
court broadly stated that “the very nature of prescription drugs ... precludes claims
*549
for breach of the implied warranty of merchantability.”
Makripodis,
We concur with Defendants that Makri-podis bars Plaintiffs implied warranty claim. As a court sitting in diversity, we must apply state law. Here, the Superior Court unambiguously held that persons or entities providing prescription drugs can not be held liable for the breach of implied warranty. Further, we find Plaintiffs contention that Makripodis does not apply because the case involved a claim against a pharmacy instead of a drug manufacturer to be without merit. The Makripodis court based its decision not on who the defendant was, but rather on the inherently dangerous “nature of prescription drugs.” Id. It is precisely because of the risks posed that such drugs may be obtained only upon the prescription of a licensed physician and that imposition of a warranty of fitness for ordinary purposes is inappropriate. Accordingly, this Court must preclude Plaintiffs claim for breach of the implied warranty of merchantability. Even if Plaintiffs complaint was not otherwise barred, Count II would still be dismissed.
b. Fraud by Intentional Misrepresentation and Violation of New York Consumer Protection Act (Count HI)
In his Amended Complaint, Plaintiff consolidated the two prior Counts III and X (asserted against both Defendants) into a single new Count III, which sets forth both fraud and violation of New York consumer protection law claims against Defendant GSK only. GSK asserts that both must be dismissed. For the reasons that follow, we disagree that the fraud portion should be dismissed, but agree as to the New York Consumer Protection portion of the count.
i. Fraud
The elements of fraud by intentional misrepresentation under Pennsylvania law are: (1) a representation; (2) which is material to the transaction at hand; (3) made falsely, with knowledge of its falsity or recklessness as to whether it is true or false; (4) with the intent of misleading another into relying on it; (5) justifiable reliance on the misrepresentation; and, (6) the resulting injury was proximately caused by the reliance.
Murray,
Defendant GSK argues that Plaintiffs fraud claim lacks the required particularity under F.R. Civ. P. 9(b). Specifically, Defendant GSK asserts the fraud claim must be dismissed because Plaintiff has failed to allege that decedent’s prescribing physician relied on any particular statement or information provided by GSK. (Def. GSK’s 3rd Supp. Mem. at 2-^4).
In contrast to the original Complaint, Plaintiffs Amended Complaint includes *550 numerous specific allegations that all information available about Paxil or its generic equivalent was disseminated by GSK, and that this information was justifiably relied upon by the decedent and her physician. This specificity can be found in the following paragraphs of the Amended Complaint:
28. During [a conversation the physician had with Mrs. Colacicco about the risks of taking paroxetine], Lois was advised that there were no “obvious interactions” between paroxetine and Lo-razepam “identified in Micromedex,” which is a healthcare research engine that provides drug summaries for physicians.
32. Any and all knowledge that Lois Colaciceo’s physicians possessed concerning Paxil came from the following sources, which either contained or were the direct result of GSK’s manipulated data, material misrepresentations and omissions, and inadequate warnings concerning Paxil: [the 2003 Physicians Desk Reference, the Micromedex, GSK’s sales representatives, GSK’s website, and GSK’s advertisements].
35. When Lois Colacicco’s ... physicians decided to prescribe Paxil ... they based their decisions solely upon the aforesaid manipulated data, false promotion and incomplete warnings.
36.... There was no information available at that time about the drug that Lois Colacicco was taking other than what had been promulgated and disseminated by GSK.
37. Lois Colacicco ... and her ... physicians justifiably relied upon all of the information that had been promulgated and disseminated by GSK....
Amended Compl. at ¶ 28, 32, 35-37 (italics added). Thus, based on the allegations alone, had the claims against GSK not been dismissed earlier for preemption and lack of a duty of care, and had we not found that Hahn precluded Plaintiffs non-negligence claims, the fraud portion of Count III would survive.
ii. Violation of New York Consumer Protection Law
Plaintiff also аlleges in Count III that “by engaging in deceptive acts and practices and false advertising,” Defendant GSK violated section 349 of the New York Consumer Protection Law. Amd. Compl. at ¶ 40; N.Y. Gen. Bus. Law § 349.
A prima facie case for recovery under section 349 of the statute for “deceptive acts or practices” requires a showing that defendant is engaging in an act or practice that is deceptive or misleading in a material way and that plaintiff has been injured by reason thereof.
Oswego Laborers’ Local 214 Pension Fund v. Marine Midland Bank,
Although not pleaded by Plaintiff, to assert a cause of action for false advertising under section 350, a plaintiff must demonstrate that the advertisement: (1) had an impact on consumers at large; (2) was deceptive or misleading in a material way; and (3) resulted in injury.
Andre Strishak & Assocs., P.C. v. Hewlett Packard Co.,
First, Defendant GSK contends that insofar as Plaintiff alleges that GSK engaged in false advertising, that portion of Plaintiffs claim should be dismissed because: (1) false advertising claims fall under N.Y. Gen. Bus. Law § 350, and (2) Plaintiff has not plead under section 350 or alleged the required reliance on any specific advertisement. Second, while not entirely clear, GSK appears to argue that the New York Consumer Protection Law is inherently inconsistent with the learned intermediary doctrine. Finally, citing
Gray v. Seaboard Securities, Inc.,
Plaintiff counters that he sufficiently plead actual reliance on GSK’s materials, and that Defendant’s contеntion that its conduct was not aimed at consumer-patients, or that recovery under state consumer protection laws is somehow barred by the learned intermediary doctrine, is belied by the very nature of “direct-to-consumer” advertising. Further, Plaintiff attempts to distinguish Gray, noting that court sought to avoid allowing additional protections beyond those afforded under the federal Securities Exchange Act, while the FDCA offers no such protection. (Pi’s Response to Apotex at 19-20; Pi’s 3rd Supp. Mem. at 4-5).
To the extent that Plaintiff has accused GSK of “engaging in false advertising,” while we find that Plaintiff sufficiently plead actual reliance, we agree that this allegation necessarily must fall under N.Y. Gen. Bus. Law section 350. 32 Plaintiff improperly plead his entire Count alleging violation of the New York Consumer Protection Law under section 349. Thus, the portion of Plaintiffs Count III alleging false advertising under New York’s Consumer Protection Law must be dismissed. However, even if he had alleged a violation of section 349, it would still be sufficient.
*552
As to Defendant’s other objections, we agree that the learned intermediary doctrine also precludes Plaintiffs claim under the consumer protection statute. While the New York courts have yet to confront this specific issue, we believe our holding is entirely consistent with both the statute and the doctrine. This is because the consumer protection statute forbids deceptive acts or practices likely to mislead a reasonable
consumer,
specifically requiring proof that the defendant’s acts are directed at consumers,
Goshen,
In sum, even if we did not conclude Hahn barred Plaintiffs non-negligence claims, and that all claims against GSK were dismissed for want of a duty and preemption, the consumer protection portion of Count III would still be dismissed.
c. Infliction of Emotional Distress (Counts V and VI)
Both Defendants next argue that Plaintiff has no right to recover for infliction of emotional distress under either a negligent 34 or intentional theory, because both torts require evidence of immediate proximity to the conduct such that it and its consequences are sensorally observed. (Def. GSK’s Mem. at 8-9; Def. Apotex’s Mem. at 20-23). The Court agrees.
The tort of intentional infliction of emotional distress (“IIED”) is defined as: “extreme and outrageous conduct [that] intentionally or recklessly causes severe emotional distress to another.”
Hoy v. Angelone,
Here, it is undisputed that Plaintiff came upon his wife’s body after she had committed suicide. Whatever act or omission was allegedly undertaken by Defendants did not occur in Plaintiffs presence, which is required to establish the tort of infliction of emotion distress under either theory when it involves conduct directed at a third party. Plaintiff argues, however, that the reasoning articulated by Pennsylvania courts in requiring presence is that, in the absence of knowledge of the injury beforehand, the third party has no buffer against the full impact of observing the scene. Thus, he asserts that so long as the third party contemporaneously observes the result of the alleged intentionally outrageous or negligent conduct and has no warning of the incident before coming on the scene, the party sufficiently states a claim for infliction of emotional distress. Since he had no pre-warning of and thus no buffer against the full impact of observing the deceased Mrs. Colacicco after her suicide, Plaintiff therefore asserts both his IIED and NIED claims should survive this motion to dismiss. (Pi’s Response to GSK at 14-17; Pi’s Response to Apotex at 16-17).
Plaintiff misconstrues the caselaw, which clearly requires presence for both IIED and NIED. Both
Mazzagatti v. Evering-ham,
2. Claims Sounding in Negligence
Finally, we consider the individual causes of actions that sound in negligence. As discussed
supra
in Part VII.A.2, we hold that Apotex owed a duty of care to Plaintiff and Plaintiffs decedent, sufficient to give rise to liability against it. Therefore, while barred by preemption, Plaintiffs negligence-based claims against Apo-tex are unaffected by our conclusions: (1) as to the lack of a duty of care owed to GSK, and (2) as to both Defendants regarding
Hahn,
which explicitly allows a plaintiff to pursue inadequate warning
*554
claims under a theory of negligence.
Hahn,
a. Negligence (Count VII)
Under Pennsylvania law, the elements of negligence are: (1) a duty recognized by law, requiring the actor to conform to a certain standard of conduct for protection of others against unreasonable risks; (2) failure to conform to the standard required; (3) a causal connection between the conduct and resulting injury; and (4) actual loss or damage resulting to interests of another.
Griggs v. BIC Corp.,
There is no dispute that Plaintiff has adequately plead the second, third and fourth elements. However, Plaintiff cannot plead negligence without the existence of a duty, which Apotex urges is lacking in this case. (Def. GSK’s Mem. at 6-8; Def. Apotex’s Mem. at 23-24). However, as we previously held that Apotex owed a duty of care to Plaintiff and Plaintiffs decedent, if preemption did not bar Plaintiffs entire complaint, his negligence claim against Apotex would be adequate to survive this motion to dismiss.
b. Negligence per se (Count VIII)
Defendants also contend that the negligence
per se
claim is impliedly preempted, evidenced by the fact that there is no private right of action under the FDCA. (Def. GSK’s Mem. at 9; Def. Apotex’s Mem. at 25).
See In re Orthopedic Bone Screw Prods. Liability Litig.,
The doctrine of negligence per se liability does not create an independent basis of tort liability but rather establishes, by reference to a statutory scheme, a standard of care appropriate to the underlying tort. Thus, if a plaintiff can show violation of a specific statute, this satisfies his or her burden of establishing duty and breach. Here, Plaintiffs negligence per se claim is premised on the alleged violation of the FDCA.
As discussed supra in Part VI, we hold all Plaintiffs claims, including that for negligence per se, are in fact barred by preemption.
c.Negligent Misrepresentation (Count IV)
Finally, Apotex urges that since it made no statements regarding efficacy and safety to the FDA, Plaintiff cannot show the required element of negligent misrepresentation that Apotex knew or should have known that certain representations were false. (Def. Apotex’s Mem. at 19-20).
The elements of negligent misrepresentation are as follows: (1) a misrepresentation of a material fact; (2) made under circumstances in which the party ought to have known its falsity; (3) with an intent to induce another to act on it, and; (4) which results in injury to a party acting in justifiable reliance on the misrepresentation.
Bortz,
Accepting as true Plaintiffs averments that material submitted to the FDA and the labeling itself was intentionally false and misleading to the FDA, the general public, the decedent’s physician, and decedent herself, and that decedent and her physician relied on this information, Compl. at 86-91, this claim must survive. *555 Also, it seems to this Court that even if Apotex did not make misrepresentations or material omissions to the FDA when it sought initial approval, Plaintiffs pleadings support the supposition that Apotex was also aware of an increased risk of suicide after approval and did not seek to strengthen its label. Compl. at 87-89. Accordingly, if Plaintiffs complaint were not otherwise dismissed, the Court would decline to dismiss the negligent misrepresentation claim.
d. Strict Liability (Count IX)
As discussed above, Defendants urge that
Hahn
holds that a manufacturer of drugs is not strictly hable for injury in connection with the use of prescription drugs. (Def. GSK’s Mem. at 9-10; Def. GSK’s Reply at 9). We need not re-visit Plaintiffs argument that
Hahn
does not apply at length; it suffices to say that as discussed
supra
in Part VII.C, we hold that
Hahn
clearly bars strict product liability claims against drug manufacturers, as well as any other failure-to-warn claim that does not sound in negligence.
Hahn,
VIII. Conclusion
For the foregoing reasons, Defendants’ Motions to Dismiss (Doc. Nos. 5 and 10) will be granted. An appropriate Order follows.
ORDER
AND NOW, this 26th day of May 2006, based on the foregoing memorandum and upon consideration of the pleadings and briefs, it is hereby ORDERED that:
1. Defendants’ Motions to Dismiss (Nos. 5 and 10) will be GRANTED WITH PREJUDICE.
2. The Clerk shall close this case.
Notes
. As Plaintiff's counsel withdrew Count I (breach of express warranty) on the record at the March 17, 2006 oral argument, the Court understands the Amended Complaint to omit that count as well.
. The medical records do not indicate whether Lois' physician prescribed Paxil or its generic version; however, it is undisputed that she actually took the generic version.
. The FDA approved Apotex's application to produce the generic form of Paxil on June 30, 2003.
. The FDA recently retreated from its longstanding position that no linkage existed associating suicidality in adults with SSR.I antidepressants, including Paxil. On June 30, 2005, the FDA issued a public health advisory warning of the potential for antidepressant medications to cause suicidal thoughts and behavior in adults. FDA Public Health Advi- *520 soiy, Suicidality in Adults Being Treated with Antidepressant Medications, June 30, 2005, available at http://www.fda.gov/cder/drug/ad-visory/SSRI200507.htm. The FDA is currently engaged in a comprehensive scientific review of existing studies to determine whether there is an increased risk of suicidal behavior in adults treated with antidepressant drugs. Co-lacicco Amicus at 11. On May 11, 2006, citing the results of a clinical study of nearly 15,000 patients treated with both Paxil and placebos, GlaxoSmithKline warned doctors via a letter that Paxil may raise teen suicide risk. See Associated Press, FDA Warns of Suicide Risk for Paxil, May 12, 2006, available at http ://hosted. ap. org/dynamic/stories/P/PAX-IL_SUICIDE_RISK? SITE=COBOU & SECTION=HOME & TEMPLATE=DEFAULT.
. Given that Plaintiff’s decedent’s prescription was prescribed and filled in New York, and she ingested it there, this Court asked counsel by letter dated March 2, 2006 to identify any possible conflict of law issues. The stipulation, which arose as a response to this letter, states that with regard to Counts I through IX, “the law of New York and the law of Pennsylvania are not in conflict, and thus, the laws оf Pennsylvania should be applied there *521 to.” Exhibit A, Joint Stip. of the Parties at p. 2.
. The purpose of the H-W Amendments is "to balance the interests of the generic drug manufacturers, who sought to avoid unnecessary testing, against the research investments of the innovator manufacturers, at the same time mindful of the public need for safe commercial drugs.”
Tri-Bio Labs.,
. See supra Part V for an in depth discussion of the Hatch-Waxman Amendments.
. For a history of how the Supreme Court has responded to the FDA’s position on preemption, see Eric G. Lasker, How Will FDA’s New Label Rule Impact Drug Litigation?, 9 No. 10 Andrews Drug Recall Litig. Rep. 9, at 2 (Mar. 13, 2006).
. See Brief for United States as
Amicus Curiae, Buckman Co. v. Plaintiffs' Legal Comm.,
Civ. No. 98-1768,
. The brief, accompanied by a lengthy appendix, outlines how on no less than six occasions between July 1991 and October 2003, the FDA rejected proposals seeking changes in drug labeling regarding suicide for SSRIs. In briefs responding to the
Colacicco Amicus,
Defendants argued that the Court may consider this information without converting the 12(b)(6) into a motion for summary judgment. (Def. Apotex 4th Supp. Mem at 3-8; Def. GSK 4th Supp. Mem at 5-8). Although the information about the FDA rejecting proposals seeking changes in drug labeling is evidence outside the record, a court may properly take judicial notice of public records and consider them in a 12(b)(6) motion.
Pension Benefit Guaranty Corp. v. White Consol. Indus. Inc.,
.
See, e.g., McNellis v. Pfizer, Inc.,
Civ. No. 05-1286, 14 (D.N.J. Dec. 29, 2005);
Witczak v. Pfizer,
. Notably, while the FDA filed
amicus
briefs in both cases, neither
Kallas
nor
Motus
resulted in a judicial decision as to preemption. The
Kallas
case settled before the District of Utah rendered a decision.
Kallas v. Pfizer, Inc.,
Civ. No. 2:04-cv-0998 (D.Utah Oct. 24, 2005) (order granting stipulated motion to dismiss pursuant to settlement). In
Motus,
while the Ninth Circuit rendered a decision affirming summary judgment in favor of defendant, it did so based on lack of causation, declining to reach the issue of preemption.
Motus v. Pfizer, Inc.,
. Plaintiff also argues
Sprietsma v. Mercury Marine,
. In their brief responding to the Colacicco Amicus, Defendant GSK tries to argue that the 2000 statement is not inconsistent, because it was made pursuant to Exec. Order No. 13132, 64 Fed.Reg. 43255 (Aug. 4, 1999), which itself does not mention tort liability. Order 13132, GSK asserts, merely requires agencies to state whether its policies have “federalism implications,” defined as federal actions that "have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.” 65 Fed.Reg. at 81103. GSK therefore contends that because the definition does not mention private tort suits, it was proper for the FDA to find there were no "federalism implications” of its proposed rule. GSK’s argument misses the mark. Certainly to the extent that the FDCA labeling regulations preempt state tort law, this would have "federalism implications,” in that a policy stating that federal law completely trumps state failure-to-warn claims axiomatically has a "substantial [effect] ... on the relationship between the national government and the States.”
. As discussed supra, we recognize that Horn dealt with express preemption under the Medical Device Amendments ("MDA”) to the FDCA, which unlike the prescription drug labeling portions of the FDCA, contained an express preemption provision. However, as the Third Circuit’s holdings were broadly stated, we do not believe this affects the amount of deference a district court must afford the FDA's position on preemption.
. Further, we find it irrelevant whether the FDA's change in position since 2000 has been because of medical judgments, change in governance, or something else.
. Equally clear is the retroactivity .of pronouncements announced by adjudication, where an administrative agency issues a regulation through аn adversary proceeding, based on the facts and the parties before it. Unlike the case of substantive rule-making, the outcome in adjudication is often — and permissibly — applied retroactively to the parties in the case at hand, so long as this will not result in "manifest injustice."
Bowen,
. Plaintiff argues that even if the court decides it may be retroactively applied, the Preemption Preamble — published on January 24, 2006 and connected to a substantive rule due to take effect June 30, 2006 — cannot be applied because the rule is not yet in effect. (Pi's 2nd Supp. Mem. at 6-7). Defendants assert that the Preemption Preamble, unlike the substantive rule amendments to which is it attached, is an advisory opinion that cannot be understood to go "into effect.” (Def. GSK’s 2nd Supp. Mem. at 3; Def. Apotex’s 2nd Supp. Mem. at 10-11). Neither party provided citations, and this Court’s review of caselaw in and outside of the Third Circuit did not uncover anything on point. However, using principles of administrative law as our guide, we note that neither a policy statement nor an interpretive rule has the force of law. Similarly, under the FDA’s own regulations, a preamble to a rule is an "advisory opinion,” that is "not ... a legal requirement." 21 C.F.R. § 10.85(j) (emphasis added). Because by all accounts the preamble lacks the force and effect of law, we agree with Defendants that an effective date analysis would accordingly be irrelevant. The Preamble should be given deference as of the date it was published, January 26, 2006.
. While Count XI (survival action), Count XII (wrongful death) and Count XIII (punitive damages) were not the subject of the current motions to dismiss, we now conclude, sua sponte, that preemption necessarily bars those claims as well.
. For a detailed discussion of Foster, see Jean A. Brodie, Note, Foster v. American Home Products Corp.: Tort Liability for Injuries Caused by Someone Else’s Product?, 12 T.M. Cooley L.Rev. 431, 468 (1995).
. The parents had also filed suit against the generic manufacturer, but had initially mistakenly named the wrong company. In their subsequent suit against the proper manufacturer of the generic, the plaintiffs agreed to a dismissal with prejudice for reasons not stated in the record.
Foster,
. Notably, the district court had considered the negligent misrepresentation claim to be distinct from the negligence, strict liability and breaсh of warranty claims. While it disposed of the latter three because Wyeth was not the manufacturer, the district court refused to do so for the negligent misrepresentation claim. It only granted summary judgment based on plaintiffs' failure to prove reliance on a Wyeth representation, a necessary element of the common law tort of misrepresentation. On appeal, the Fourth Circuit found this distinction to be erroneous, clearly holding that all product liability actions require that the defendant have manufactured the product in question. Id. at 168.
. This concept is well-settled under Pennsylvania law.
See, e.g., Soldo v. Sandoz Pharm. Corp.,
. In contrast, we reject Plaintiff's contention that Pennsylvania's policy of holding pharmaceutical
manufacturers
to a high degree of care supports imputing a duty of care to GSK.
Incollingo,
. In
Bilt-Rite Contractors, Inc. v. Architectural Studio,
. Again, while Counts XI-XIII were not the subject of Defendants’ motions to dismiss, the lack of a duty of care owed by GSK bars those claims as well.
. In Part VII.D.l.b.ii inf'a, we hold that the LID bars Plaintiff’s claim under the New York consumer protection statute. However, we make that decision for reasons entirely different from those discussed here, because of the nature of a consumer protection statute requires it.
. We consider the exhibits to Plaintiff's amended complaint which demonstrate that there was no warning as to an association between the drug and suicidality in October 2003. Specifically, plaintiff attached the “Prescribing Information” available in July 2003 for Paxil/paroxetine hydrochloride (Amd. Compl., Exhibit A), as well as the 2003 description of paroxetine hydrochloride available through Micromedex (Amd. Compl., Exhibit C). While the general rule is that a court may not consider evidence outside the pleadings for a 12(b)(6) motion without converting it to a summary judgment motion, the Third Circuit has held that a court may properly consider a concededly authentic document upon which the complaint is basеd.
Pension Benefit Guar. Corp.,
.We note that generally, whether a particular warning is “■adequate” is a question of fact to be resolved by a jury.
See Dougherty v. Hooker,
. If we reached the merits of the LID issue, any direct-to-consumer C'DTC”) advertising exception would likely not apply. This is because, in the eight years since
Perez,
the New Jersey Supreme Court case making an exception to the LID for direct-to-consumer advertising, was decided, no state has joined New Jersey.
In re Norplant Contraceptive Prods. Liab. Litig.,
. Hahn would also bar Plaintiff's original Count I (breach of express warranty), which Plaintiff voluntarily withdrew at oral argument. However, as Plaintiff's Amended Complaint does not reflect this, we want to clarify that even had Plaintiff not dropped it, the breach of express warranty claim (Count I) would not survive anyway.
. GSK acknowledges that some caselaw suggests that a false advertising claim can be brought under either section 349 or section 350 (but provided no citations to this effect). However, it argued that even if there are any, this interpretation is erroneous as this would render section 350 totally superfluous. Plaintiff did not address this contention at all. This court reviewed the caselaw and found that while some New York courts have permitted advertising claims to be brought under section 349, they have only done so when the complaint alleges that the advertising itself is was a "deceptive practice,” such that the claim may fit under section 349.
See, e.g. B.S.L. One Owners Corp. v. Key Intern. Mfg., Inc.,
. We note that the LID is applied with equal force in New York, where it is referred to as the "informed intermediary” doctrine, as in Pennsylvania.
Lindsay v. Ortho Pharm. Corp.,
. Although the negligent infliction of emotional distress claim obviously sounds in negligence (the remainder of which such claims are discussed in Part VII.D.2, infra), we choose to discuss it with the intentional infliction of emotional distress claim for ease of reference.
. We also note the independent tort of IIED has never expressly been approved by the Pennsylvania Supreme Court.
Taylor,
. Even Plaintiff concedes that, on its face, Hahn appears to preclude his strict liability claim. (Pi’s Supp. Mem. at 4).