Joseph C. COLACICCO, Plaintiff, v. APOTEX, INC., et al., Defendants, 432 F. Supp. 2d 514

MEMORANDUM BAYLSON, District Judge. 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 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 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). 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, an anti-depressant drug manufactured by Defendant GSK. Soon thereafter, she began taking the generic version of the drug, paroxetine hydrochloride, which is a bio-equivalent of Paxil and manufactured by Defendant Apotex. 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.

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., 232 F.3d 173, 183 (3d Cir.2000).

Accordingly, a federal court may dismiss a complaint for failure to state a claim only if it is clear that no relief could be granted under any set of facts that could be proved consistent with the allegations. Doe v. Delie, 257 F.3d 309, 313 (3d Cir.2001). C. Applicable State Law As a federal court sitting in diversity, Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938), requires that we apply the substantive law of the forum state. Id. at 78-80, 58 S.Ct. 817.

Pursuant to a joint stipulation of all parties, Pennsylvania is the appropriate forum state, and thus the law of Pennsylvania will be applied to Counts I — II, and IV-IX, as well as the fraud portion of Count III of Plaintiffs Complaint. See Exhibit A, Joint Stip. of the Parties at p. 2 ¶ l. Count III also asserts a violation of the New York Consumer Protection law, to which New York law applies. 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, 543 Pa. 558, 673 A.2d 888, 891 (1996), precludes all Plaintiffs claims except those against the seller that sound in negligence. 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. 673 A.2d at 891. 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 and 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 because 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 outrageous 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, 29 F.3d 165 (4th Cir.1994) (applying Maryland law); Tri-Bio Labs., Inc. v. United States, 836 F.2d 135, 138-39 (3d Cir.1987).

Because investigations conducted by the innovator companies were considered trade secrets, generic manufacturers were required to perform their own safety and effectiveness studies. This resulted in additional expenses being passed to consumers, and delay in bringing generic drugs to the market. Id. 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.

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.

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 that 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, 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2000) requires that we find preemption. Further, in response to this Court’s request that the FDA file a brief on the novel preemption issues presented in this case, the government submitted an amicus brief to the Court on May 10, 2006 which also takes the position that Plaintiffs state law claims aré barred by implied preemption. 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., 485 U.S. 293, 299-300, 108 S.Ct. 1145, 99 L.Ed.2d 316 (1988); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1121-22 (3d Cir.1990). 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., 529 U.S. 861, 899, 120 S.Ct. 1913, 146 L.Ed.2d 914 (2000); Pokorny, 902 F.2d at 1120; C.E.R. 1988, Inc. v. Aetna Cas. & Sur. Co., 386 F.3d 263, 268 (3d Cir.2004). Geier is the most recent in a consistent, long line of cases that articulate the Supreme Court’s principles on implied 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, 529 U.S. at 865, 120 S.Ct. 1913.

After concluding that the National Traffic and Motor Vehicle Safety Act of 1966 did not expressly preempt petitioners’ claims, the Court held that the claims nonetheless actually conflicted with the objectives of Federal Motor Vehicle Safety Standard 208 (“Standard 208”) which gave automobile manufacturers a range of choices among different passive restraint devices which were to be gradually introduced over time.

The Court reasoned that plaintiffs claims depended upon the manufacturer having a duty to install an airbag in all 1987 vehicles, which presented an obstacle to the variety and mix of devices that Standard 208 sought. Id. at 881, 120 S.Ct. 1913. Therefore, because the Supremacy Clause “forbids conflicts that make it impossible for private parties to comply with both state and federal law,” the Court concluded that plaintiffs claims were impliedly preempted. Id. at 873, 875, 886, 120 S.Ct. 1913.

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, 386 F.3d at 269-70 (quoting Medtronic Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (case involving express preemption)). Thus, conflict preemption will be found only if the need for it is clear. Pokorny, 902 F.2d at 1122.

In fact, “consideration under the Supremacy Clause starts with the basic assumption that Congress did not intend to displace state law.” Bldg. & Constr. Trades Council of Metro. Dist. v. Assoc. Builders & Contractors of Mass. /R.I., Inc., 507 U.S. 218, 224, 113 S.Ct. 1190, 122 L.Ed.2d 565 (1993). 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.

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 federal 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., 467 U.S. 837, 844, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984) (holding that it has been “long recognized that considerable weight should be accorded to an executive department’s construction of a statutory scheme it is entrusted to administer”). See also Thomas Jefferson Univ. Hosp. v. Shalala, 512 U.S. 504, 512, 114 S.Ct. 2381, 129 L.Ed.2d 405 (1994);, NVE Inc. v. Dept. of Health & Human Servs., 436 F.3d 182, 186 (3d Cir.2006); C.E.R. 1988, 386 F.3d at 271 n. 11.

However, deference is not absolute; in deciding whether to afford it, courts should review inter alia the consistency with which the agency has applied the particular

interpretation. NLRB v. N.J. Bell Tel. Co., 936 F.2d 144, 147 (3d Cir.1991) (citing West v. Bowen, 879 F.2d 1122, 1134 (3d Cir.1989)). 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., 471 U.S. 707, 714, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985).

Further, the Court has made clear that such preemptive intent may properly be communicated in amicus briefs, Geier, 529 U.S. at 883, 120 S.Ct. 1913, as well as in “regulations,

preambles, interpretive statements and responses to comments.” Hillsborough County, 471 U.S. at 718, 105 S.Ct. 2371. In recent years, each time the Supreme Court has confronted the question of whether the FDCA preempts state law, it has deferred to the FDA’s preemption position. See Geier, 529 U.S. at 883, 120 S.Ct. 1913 (noting that the Court “placets] some weight upon [the federal agency’s

interpretation of the regulation’s] objectives and its conclusion ... that a tort suit ... would stand as an obstacle to the accomplishment and execution of those objectives”); Medtronic, 518 U.S. at 496, 116 S.Ct. 2240 (holding that state law claims involving FDCA

section 510(

k) medical devices, which are subjected to a relatively cursory approval process, were not preempted because the FDA had taken the position that its regulations only preempted claims involving

section 360e(

c) devises, which go through a rigorous pre-market approval process); Buckman, 531 U.S. at 353, 121 S.Ct. 1012 (in which the Court’s holding that the FDCA, as amended by the Medical Devices Amendment (“MDA”), impliedly preempted patients’ state law “fraud-on-the-agency” claims mirrored the position taken by the FDA in its amicus brief submitted to the court). 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., 376 F.3d 163, 171 (3d Cir.2004). Horn held that the plaintiffs state law claims against a heart valve manufacturer were preempted by the express preemption provision of the MDA. Id. at 180. In coming to this conclusion, the court stated that the Supreme Court’s decision in Medtronic required it to afford deference to the FDA’s position that the claims were preempted. Id. at 179.

Moreover, it held that this was the case even though this stance was a change from the FDA’s prior position. Id. (noting “we cannot agree [with Plaintiff] that the FDA’s position is entitled to no deference or ‘near indifference’ simply because it represents a departure from its prior position.”). The court noted that the Supreme Court in Chevron held that a “revised

interpretation by an agency is [still] entitled to deference because an initial agency

interpretation is not instantly carved in stone,” Id. (citing Chevron, 467 U.S. at 863-64, 104 S.Ct. 2778), and that an agency may change its position “so long as it can justify its change with reasoned analysis.” Id. (citing Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983)). Horn held that it was “fully persuaded” that the FDA adequately justified its change in position on preemption. Id. Importantly, while the facts of Horn involved the express preemption provision of the MDA, to which there is no corollary

part in the prescription labeling provisions of the FDCA, the Horn court broadly announced a policy of affording deference to the FDA’s position on preemption, and did not narrow the holding only to cases involving express preemption. 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, the date of Plaintiffs decedent’s 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 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), 2002 WL 32303084, at *16 (amicus brief submitted by FDA contending plaintiffs failure-to-warn case was preempted because, before plaintiffs decedent’s death in 1998, the FDA had considered, and rejected, claims that SSRIs were linked to suicidal behavior in adults, and any warning label would have been “false or misleading” and would therefore have misbranded Zoloft, the SSRI at issue) (“Motus Amicus ”). See also - Lori J. Parker, Proof of Injury Resulting from Antidepressant Medication, 87 Am.Jur. Proof of Facts 3d 119, § 3 (2006).

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 generic 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 preemption. Moreover, we note that the Supreme Court has explicitly stated that amicus briefs are an appropriate form to express preemptive intent, Geier, 529 U.S. at 883, 120 S.Ct. 1913, which, pursuant to Chevron, Medtronic, Geier, we must afford significant deference. 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 typically 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, 529 U.S. at 883, 120 S.Ct. 1913; Chevron, 467 U.S. at 844, 104 S.Ct. 2778; Hillsborough County, 471 U.S. at 714, 105 S.Ct. 2371; Horn, 376 F.3d at 180. However; notwithstanding the unambiguous position taken by the FDA in the Colacicco Amicus and in the Preemption

Preamble, and despite the general rule requiring deference, Plaintiff argues that deference is not appropriate in this case for three reasons: (1) the

preamble is mere legal argument that deserves no weight, (2) the FDA’s policy has been inconsistent, and (3) it would be improper to retroactively apply'the

Preamble. 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, 529 U.S. at 883, 120 S.Ct. 1913, citing Medtronic, 518 U.S. at 496, 116 S.Ct. 2240. Given the overwhelming caselaw on the issue of deference, and specifically the Supreme Court’s holdings in Geier and Hills-borough County that preemptive intent may properly be communicated in amicus briefs,

preambles and interpretive statements, we find Plaintiffs argument lacks merit. Geier, 529 U.S. at 883, 120 S.Ct. 1913; Hillsborough County, 471 U.S. at 718, 105 S.Ct. 2371. Further, it is not the function of this Court, or for a jury empaneled to decide this case, to substitute its judgment for the FDA’s about these medical issues. Congress has given the FDA broad power, the President has appointed its executives, some subject to the advice and consent of the Senate, and it has rendered its judgment on these issues.

The FDA has acted within its authority, and this Court must respect its expert judgment that an October 2003 warning label other than approved by the FDA would have been in direct, actual conflict with federal law. 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 consistent 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 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.

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, 467 U.S. at 863-64, 104 S.Ct. 2778 (holding “[t]he fact that the agency has from time to.time changed its

interpretation ... does not ... lead us to conclude that no deference should be accorded the agency’s

interpretation of the statute. An initial agency

interpretation is not instantly carved in stone.” See. also Horn, 376 F.3d at 179 (“[W]e cannot agree [with Plaintiff] that the FDA’s position .is entitled to no deference ... simply, because it represents a departure from its prior position.”)). “On the contrary, the agency, to engage in informed rulemaking, must consider varying

interpretations and the wisdom of its policy on a continuing basis.” Chevron, 467 U.S. at 863-64, 104 S.Ct. 2778; see also Antonin Scalia, Judicial Deference to Administrative

Interpretations of Law, 1989 Duke L.J. 511, 518 (1989) (Chevron embraces concept that merely because agency

interpretation is “new” or “changing,” it is not somehow suspect). . Moreover, we do find it significant; that after 2000, the FDA has been very consistent. 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, 2004 WL 2191804, *6 (S.D.Tex. Feb.20, 2004) (holding state failure-to-warn claims were preempted, because any warning label linking said drugs to suicide would have been false and misleading).

Accordingly, even though the FDA’s prior position on preemption has not been entirely consistent, this Court finds it proper to give significant weight to the FDA’s unambiguous statement in the Colacicco Amicus brief and in the Preemption

Preamble that Plaintiffs claims are preempted. Hillsbor-ough County, 471 U.S. at 714, 105 S.Ct. 2371; Chevron, 467 U.S. at 844, 104 S.Ct. 2778; Horn, 376 F.3d at 179. See also Needleman v. Pfizer, Inc., 03-CV-3074, 2004 WL 1773697, *2-5 (N.D.Tex. Aug.6, 2004); Dusek, 2004 WL 2191804 at *10. Accordingly, based on deference alone, this Court would deem any state failure-to-warn claim impliedly preempted. e. Retroactivity of the

Preamble Finally, Plaintiff questions whether the Preemption

Preamble, promulgated 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., 2006 WL 560639, *5 (N.J.Super.Mar. 3, 2006); Laisure-Radke v. Par Pharm., Civ. No. 03-3654, 2006 WL 901657, *3 (W.D.Wash. Mar.29, 2006). 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, 963 F.2d 603, 606 (3d Cir. 1992). “Interpretive” rules, on the other hand, seek only to interpret the meaning already in properly issued regulations and are meant “to give guidance to its staff and affected parties as to how the agency intends to administer a statute or regulation.” Id.; Daughters of Miriam Ctr. for the Aged v. Mathews, 590 F.2d 1250, 1258 (3d Cir.1978). Thus, “if the rule in question merely clarifies or explains existing law or regulations, it will be deemed interpretive.” Bailey v. Sullivan, 885 F.2d 52, 62 (3d Cir.1989).

Further, interpretive rules and statements of policy are exempted from the APA’s notice and comment requirement. Beazer, 963 F.2d at 606. 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., 533 U.S. 218, 121 S.Ct. 2164, 2173-75, 150 L.Ed.2d 292 (2001); Madison v. Res. for Human Dev., Inc., 233 F.3d 175, 179 (3d Cir.2000).

Although the term is not defined in the APA, the Supreme Court has afforded deference to the definition proffered in the Attorney General’s 1947 Manual on the Administrative Procedure Act (“Attorney General’s Manual”), stating it is a pronouncement “issued by an agency to advise the public prospectively of the manner in which the agency proposes to exercise a discretionary power.” Lincoln v. Vigil, 508 U.S. 182, 197, 113 S.Ct. 2024, 124 L.Ed.2d 101 (1993); Attorney General’s Manual 30, n. 3 (1947). The Supreme Court has made clear that substantive rules may not be retroactively applied. Bowen v. Georgetown Univ.

Hosp., 488 U.S. 204, 208, 109 S.Ct. 468, 102 L.Ed.2d 493 (1988). Here, while the rule to which the Preemption

Preamble is attached is the type of rule governed by Georgetown University, the

preamble lacks force of law, and is not a substantive rule. However, it is not initially clear whether the Preemption

Preamble is an “interpretive rule” or a “statement of policy.” In Appalachian States Low-Level Radioactive Waste Commission v. O’Leary, 93 F.3d 103, 113 (3d Cir.1996), the Third Circuit' held that because an interpretive rule merely clarifies what existing rights and obligations had always been, retroactivity concerns are irrelevant. Accord: United States v. Tomasino, 206 F.3d 739 (7th Cir.2000); Cowen v. Bank United of Tex., FSB, 70 F.3d 937, 943 (7th Cir.1995); Pope v. Shalala, 998 F.2d 473, 483 (7th Cir.1993); Ill. by the Ill. Dep’t of Pub. Aid v. Bowen, 786 F.2d 288, 292 (7th Cir.1986). Cf. Beazer, 963 F.2d at 609 (in case involving the retroactive application of the EPA’s

interpretation of certain regulatory language via adjudication, which the Third Circuit held to be proper, stating in dicta that the “[APA] ... expressly prohibits] an agency from retroactively imposing an interpretive rule upon a regulated party”). 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, 813 F.2d 1006, 1014 (9th Cir.1987); Am. Hosp. Ass’n v. Bowen, 834 F.2d 1037, 1046 (D.C.Cir.1987); Burroughs Wellcome Co. v. Schweiker, 649 F.2d 221, 224 (4th Cir. 1981); Am. Bus. Ass’n v.

United States, 627 F.2d 525, 529 (D.C.Cir.1980), the Eleventh Circuit has explicitly held that a statement of policy that clarifies existing law may be applied retroactively. Jean v. Nelson, 711 F.2d 1455, 1479 (11th Cir. 1983). While the Third Circuit has not addressed this issue, we conclude that it would follow the definition in the Attorney General’s Manual, which has been afforded deference by the Supreme Court and which states that policy statements only apply prospectively, as well as the strong weight of authority that favors the view that policy statements may not be applied retroactively.

Lincoln, 508 U.S. at 197, 113 S.Ct. 2024; Attorney General’s Manual 30, n. 3. 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, 818 F.2d 943, 946 (D.C.Cir.1987) (quoting authorities describing the distinction between legislative rules and general policy statements as “tenuous,” “blurred,” “baffling,” and “enshrouded in considerable smog”). See also Am. Bus. Ass’n, 627 F.2d at 529 (distinction between categories of agency pronouncements is actually “enshrouded in considerable smog----”); Noel v. Chapman, 508 F.2d 1023, 1030 (2d Cir.1975).

In fact, we can not actually envision a reason for the outcome regarding retroac-tivity to differ based on whether a particular communication is a policy statement or an interpretive rule, as both are agency

interpretations of regulatory schemes. Thus, to the extent we must make this choice based on the confused caselaw in this area, it seems to put form before substance. 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, 963 F.2d at 606. This is because, while not dispositive, the promulgating’s agency’s view “that a new statement is a clarification of existing law ... is generally given much weight.” Heimmer-mann v. First Union Mortgage Corp., 305 F.3d 1257, 1260 (11th Cir.2002). Accordingly, we find that the Preemption

Preamble merely clarifies existing law and has no prohibited retroactive effect. However, we also conclude that the issue of retroac-tivity is not dispositive, because the Preemption

Preamble is only one of several pieces of evidence which reflect the FDA’s position that Plaintiffs claims are preempted. Thus, even if the

Preamble is not retroactive, we would still come to the same conclusion affording deference based on the FDA’s opinion as expressed in its current and prior amicus briefs. 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, 529 U.S. at 899, 120 S.Ct. 1913.

First, Apotex contends that to impute liability for failing to change the label when, as part of the approval process under the ANDA, it was required, to use verbatim the language of Defendant GSK’s warning label, inherently conflicts with the FDCA. Further, Apotex urges that imposing a duty to develop or strengthen warning labels would essentially constitute a return to the drug approval scheme in place before the H-W Amendments, thus conflicting with the Act’s statutory purpose to relax the generic approval process.

Finally, Apotex points to numerous cases outside the Third Circuit, which has not addressed the issue, holding that the FDCA preempts state tort claims for injuries resulting from ingestion of a prescription drug. See, e.g., Needleman, 2004 WL 1773697 at *2-5 (involving the anti-depressant Zoloft); Dusek, 2004 WL 2191804 at *2-10 (involving Zoloft); Ehlis v.

Shire Richwood, Inc., 233 F.Supp.2d 1189, 1198 (D.N.D.2002) (involving Adderall, a drug used for treatment of ADHD in children); Abramowitz, 2006 WL 560639, at *5 (involving pain-management drug Actiq); see also C.E.R.1988, 386 F.3d at 270; Pokorny, 902 F.2d at 1123; Kanter v. Warner-Lambert Co., 99 Cal.App.4th 780, 794, 122 Cal.Rptr.2d 72 (2002); Cellucci v. Gen. Motors Corp., 550 Pa. 407, 706 A.2d 806, 811 (1998); Guice v. Charles Schwab & Co., 89 N.Y.2d 31, 651 N.Y.S.2d 352, 674 N.E.2d 282, 289 (1996) (cases finding preemption but not involving the FDCA). (Def. Apotex’s Mem. at 8-14; Def. Apo-tex’s Supp.

Mem. at 18-24; Def. Apotex’s 2nd Supp. Mem. at 2-8). 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., 863 F.2d 1173 (5th Cir.1988) (noting “the great majority of United States district courts which have addressed this issue have ruled against preemption” and Citing seventeen previous decisions to that effect); Laisure-Radke, 2006 WL 901657 at *3 (involving the anti-depressant Prozac); McNellis, Civ.

No. 05-1286, 14 (involving the antidepressant Zoloft); Witczak, 377 F.Supp.2d at 729 (involving Zoloft); Zikis, Civ. No. 04-8104, 8 (involving Zoloft); Cartwright, 369 F.Supp.2d at 887 (involving Zoloft); In re Paxil Litig., [docket # ], 2002 WL 31375497, *1 (C.D.Cal,2002) (involving the anti-depressant Paxil). See also Osburn v. Anchor Labs., Inc., 825 F.2d 908, 912-13 (5th Cir.1987) (involving FDA regulations for veterinary drugs, which are very similar, if not virtually identical to the regulations regarding drugs for humans); Caraker v. Sandoz Pharm.

Corp., 172 F.Supp.2d 1018, 1032-36 (S.D.Ill.2001) (manufacturer’s common law duty under Illinois law to warn individuals of postpartum lactation-control drug’s dangers was not preempted by federal law). (Pi’s Response to GSK at 17-18; Pi’s Response to Apotex at 6-12 Pi’s Supp. Mem. at 12). 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, 467 U.S. 837, 104 S.Ct. 2778; Cass R. Sunstein, Law and Administration After Chevron, 90 Colum. L.Rev.2071, 2088-90 (1990) (“Chevron is best understood and defended as a frank recognition that sometimes

interpretation is not simply a matter of uncovering legislative will, but also involves extratextual considerations of various kinds, including judgments about how a statute is best or most sensibly implemented. Chevron reflects a salutary understanding that these judgments of policy and principle should be made by administrators rather than judges.”); Laurence H. Silberman, Chevron: The Intersection of Law and Policy, 58 Geo. Wash.

L.Rev. 821, 823 (1990) (“Chevron’s importance is its recognition that ... agencies ... maintain a comparative institutional advantage over the judiciary in interpreting ambiguous legislation that the agencies are charged with applying.”); Richard J. Pierce, Jr., The Role of Constitutional and Political Theory in Administrative Law, 64 Tex. L.Rev. 469, 506 (1985) (noting the Chevron Court “recognized that policy choices should be made by the most politically accountable branch of government, and that the judiciary is the least politically accountable branch”).

Further, although the facts of Chevron may have involved ambiguous terms in a statute, its principles have been consistently carried into the far reaches of administrative law, and governs this case as well. Geier, 529 U.S. at 883, 120 S.Ct. 1913; Chevron, 467 U.S. at 844, 104 S.Ct. 2778; Hillsborough County, 471 U.S. at 714, 105 S.Ct. 2371; Horn, 376 F.3d at 180. See generally, Scalia, Judicial Deference, supra. 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, 529 U.S. at 883, 120 S.Ct. 1913. Finally, we agree with the FDA’s position that ensuring that warnings be scientifically substantiated is an important public policy.

Dissemination of unsupported warnings risks diluting those that are scientifically supported, and/or discouraging safe and effective use of a particular drug. This could deprive patients of efficacious treatment, thereby chilling the drug’s otherwise beneficial use. Colacicco Amicus at 13.

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 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. 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, 531 U.S. at 353, 121 S.Ct. 1012.

Defendants argued in their briefs and at oral argument that this case stands for the proposition that the FDCA preempts the negligence per se claim at minimum, and possibly all Plaintiffs state tort law claims asserting inadequate warning. (Def. GSK’s Mem. at 9; Apotex’s Mem. at 25; Def. GSK’s Supp. Mem. at 18-19; Apotex’ Supp. Mem. at 24-25). 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, 531 U.S. at 347, 121 S.Ct. 1012.

Here, there is no “fraud on the FDA” alleged and there is no comparative authority permitting the FDA to police non-compliance with the warning label regulations by virtue of not affirmatively providing stronger warnings. Further, as evidence of the fact that Buckman does not usurp all state tort claims, we note that numerous post -Buckman federal cases have rejected the preemption argument for claims based on inadequate warning labels on prescription drugs. See, e.g., Laisure-Radke, 2006 WL 901657 at *3; McNellis, Civ. No. 05-1286, at 14; Witc-zak, 377 F.Supp.2d at 729; Zikis, Civ.

No. 04-8104, at 8; Cartwright, 369 F.Supp.2d at 887; In re Paxil, 2002 WL 31375497, at *1; Caraker, 172 F.Supp.2d at 1032-36. Simply stated, Buckman is irrelevant to the preemption issues presented in this case. 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 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, 29 F.3d 165 (4th Cir.1994) (applying Maryland law), a case in which the Fourth Circuit held that a innovator drug manufacturer does not owe a legal duty to a consumer of a generic drug. (Def. GSK’s Mem. at 3-6; Def. GSK’s Reply at 4-5; Def. GSK’s Supp. Mem. at 2-3, 7). 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, 562 Pa. 547, 756 A.2d 1166, 1169 (2000), which lays out five distinct factors, including public policy, that must be considered in determining whether a duty of care exists, this Court must allow a jury to find that Defendant GSK owed a duty of care. (Pi’s Response to GSK at 4-12; PL’s Supp. Mem. at 2-3, 6-7).

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 upon the actor; and (5) the overall public interest in the proposed solution. Althaus, 756 A.2d at 1169.

However, while Althaus and its progeny lay out the general rubric for determining duty, the Pennsylvania courts have not specifically faced the question of whether a name brand drug manufacturer owes a legal duty to generic brand consumers. Thus, absent clear precedent, this Court must decide how it believes the Pennsylvania Supreme Court would decide the issue. 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, 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, 29 F.3d at 167. Wyeth moved for

summary judgment on all counts, asserting, like GSK, that it could not be held liable under any theory because it did not manufacture or produce the drug taken by the deceased infant. Id. After the district court granted the motion for Wyeth on all counts, the case proceeded on appeal to the Fourth Circuit. Id. at 168. 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 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 generic 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, 2003 WL 203067 (N.D.Tex. Jan.28, 2003) (under Texas law); DaCosta v. Novartis AG, 01-cv-800, 2002 WL 31957424 (D.Or.

Mar.1, 2002) (applying Oregon law); Christian v. 3M, 126 F.Supp.2d 951, 958 (D.Md.2001) (applying Maryland law); Miller v. Bristol-Myers Squibb Co., 121 F.Supp.2d 831, 836 (D.Md. 2000) (applying Maryland law); Sharp v. Leichus, 2004-CA-0643, 2006 WL 515532 (Fla.Cir.Ct. Feb.17, 2006); Kelly v. Wyeth, MICV 2003-03314-B, 2005 WL 4056740, slip. op. (Super.Ct.Mass. May 6, 2005); Sheeks v. Am. Home Prods. Corp., No. 02CV337, slip. op. (Dist.Ct.Colo. Oct. 15, 2004); Sloan v. Wyeth, Inc., No. MRS-L-1183-04, slip. op (Super.Ct.N.J. Oct. 13, 2004); Beutella v. A.H.

Robins, Civil No. 980502372, 2001 WL 35669202, slip. op. (Utah Dist.Ct. Nov. 7, 2001). 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, 673 A.2d at 891 (product liability claim can only be brought against “a manufacturer” of the drug in question); Mellon v. Barre-Nat’l Drug Co., 431 Pa.Super. 175, 636 A.2d 187, 191-92 (1993) (“In general, a defendant must be identified as the manufacturer, distributor, or seller of the offending product before the injuries suffered by the plaintiff may be found to be proximately caused by some negligent act or omission of the defendant.”). Furthermore, even though foreseeability is the principal determinant of duty in Maryland, Foster indirectly touches on most, if not al, of the Althaus factors.

Specifically, we agree that to impose a duty in this case “would be to stretch the concept of foreseeability too far,” as GSK cannot reasonably expect that consumers will rely on information they provide when actually ingesting another company’s drug. Foster, 29 F.3d at 171. Also, we agree that unfair consequences would result if we were to impose a duty upon GSK, when it obtained no benefit from the sale of Apotex’s generic equivalent and had no control over the manufacturing or labeling of paroxetine hydrochloride, yet it bore the expense of developing Paxil from which Apotex materially benefits. Id. at 170.

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 that 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, 572 Pa. 82, 813 A.2d 747, 752 (2002); Shick v. Shirey, 552 Pa. 590, 716 A.2d 1231, 1237 (1998). As Defendant GSK correctly argues, Pennsylvania courts have recognized the societal importance of new and effective prescription drugs, Gile v. Optical Radiation Corp., 22 F.3d 540, 546 (3d Cir. 1994).

To encourage this process, the courts have also recognized the need not to unduly burden the pharmaceutical industry with unfettered liability. Hahn, 673 A.2d at 890-91 (holding, on policy grounds, that a strict liability claim should not lie against drug manufacturer); Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206, 220 (1971) (holding pharmaceutical manufacturers to a high degree of responsibility) (emphasis added). In addition to evincing policy, this also suggests the “social utility” and “consequences of imposing a duty” prongs in Althaus weigh against finding a duty owed by GSK.

Additionally, the courts and legislature of the Commonwealth have evinced a policy of deference to any well-defined public policy embodied by federal law. See State Farm Mut. Auto. Ins. Co. v. Foster, 585 Pa. 529, 889 A.2d 78, 80-81 (2005) (“the legislative concern for the increasing cost of automobile insurance is the public policy to be advanced by statutory

interpretation of the MVFRL”); In re Estate of Wagner, 584 Pa. 49, 880 A.2d 620, 626 (2005) (holding that the statute creating “child death reviews” to be conducted by the Department of Public Welfare clearly expressed public policy to identify remedial possibilities and better safeguard children, which purpose could not be accomplished if agencies feared making discoverable admissions that could lead to liability, dictated outcome that audits could not be available to plaintiffs as discovery); see also Acands, Inc. v. Travelers Cas. & Sur.

Co., 435 F.3d 252, 258 (3d Cir.2006) (“courts may refuse to enforce arbitration awards that violate well-defined public policy as embodied by federal law.”). More specifically, like the federal courts discussed above, the Pennsylvania courts and legislature have shown deference to the FDCA. They have viewed the FDCA as indicia of a federal policy that in the area of prescription drugs, the FDA is uniquely qualified to decide whether state law stands as an obstacle to the objectives of Congress. See White v.

Weiner, 386 Pa.Super. 111, 562 A.2d 378, 383 (1989) (stating that “our legislature unequivocally has expressed a policy of deference to the federal scheme in the area of drug labeling ... and we can ascertain no reason not to extend that policy to civil cases raising misbranding claims”); see also Horn, 376 F.3d at 1

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