The opinion of the court was delivered by: Honorable Jerome B. Simandle
This products liability case arises from the suicide death of Theodore DeAngelis on January 30, 2003. Plaintiffs, Beth Ann McNellis, on behalf of the estate of Theodore DeAngelis, deceased, and in her own right, contend that Zoloft, an antidepressant drug manufactured by Defendant Pfizer, Inc., which Theodore DeAngelis began taking shortly before he died, was responsible for his suicide. Plaintiffs contend principally that Pfizer's warnings regarding suicide as a possible adverse reaction associated with Zoloft were inadequate. Presently before the Court is the motion for summary judgment of Defendant Pfizer, Inc., in which the issue presented is whether, in the circumstance of the ongoing regulation and scrutiny of Zoloft, the Food and Drug Administration's regulation of prescription drugs under the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq. ("FDCA") and federal regulations preempts Plaintiffs' state law tort claims arising from the alleged failure to give sufficient warning of the possibility of an increased risk of suicide in depressed patients associated with this medication. For the reasons discussed below, this motion will be denied without prejudice to renewal upon completion of a limited period of discovery.
Plaintiff Beth Ann McNellis, suing individually and as executrix of the estate of her father, Theodore DeAngelis (collectively, "Plaintiffs"), claims that (1) Zoloft, a medication prescribed for Mr. DeAngelis, can and does "drive some people to their death" by suicide; (2) Pfizer, Inc. failed to adequately warn Mr. DeAngelis's physician of that purported fact; and (3) the purported failure to warn caused Mr. DeAngelis to ingest Zoloft and become more prone to the suicide which ended his life. (Compl. at ¶¶ 10, 12, 16.)
Theodore DeAngelis ("Decedent") was a sixty-four year old retiree who, in late 2002, began to feel depressed and consulted his family doctor. Mr. DeAngelis was initially prescribed Lexapro, an anti-depressant, but disliked that medication and was prescribed Zoloft instead on January 22, 2003. Six days later, Mr. DeAngelis consulted a psychiatrist, who prescribed a higher dose of Zoloft. Two days later, on January 30, 2003, Mr. DeAngelis was found dead, having taken his own life. Mr. DeAngelis apparently had no prior history of depression or suicidal tendencies, and had not previously taken anti-depressant medications before Lexapro.
Plaintiffs filed suit in Atlantic County Superior Court and the case was removed to this Court on March 4, 2005. Plaintiffs' claims against Defendant Pfizer, Inc. ("Pfizer") include allegations of defective design, N.J.S.A. 2A:58C-2, et seq. (Count I), failure to warn (Count II), violations of the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-2, et seq. (Count III), and breach of express warranty (Count IV). Plaintiffs' primary contention is that Pfizer failed to adequately warn of the risk of suicidality associated with antidepressants such as Zoloft, despite the presence of the warning label which FDA had authorized to be given verbatim. Pfizer filed the instant motion for summary judgment, arguing that Plaintiffs' state law tort claims are preempted by the federal Food, Drug and Cosmetic Act and its implementing regulations. Extensive oral argument was held and shortly thereafter Plaintiffs filed a motion for an extension of time to complete discovery pursuant to Fed. R. Civ. P. 56(f). Supplemental briefing was received from both parties as to the merits and the Rule 56(f) motion to extend discovery, which have been carefully considered.
A. Summary Judgment Standard of Review
Summary judgment is appropriate when the materials of record "show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(c). A dispute is "genuine" if "the evidence is such that a reasonable jury could return a verdict for the non-moving party." See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A fact is "material" only if it might affect the outcome of the suit under the applicable rule of law. Id. Disputes over irrelevant or unnecessary facts will not preclude a grant of summary judgment. Id.
In deciding whether there is a disputed issue of material fact, the court must view the evidence in favor of the non-moving party by extending any reasonable favorable inference to that party; in other words, "[T]he nonmoving party's evidence 'is to be believed, and all justifiable inferences are to be drawn in [that party's] favor.'" Hunt v. Cromartie, 526 U.S. 541, 552 (1999) (quoting Liberty Lobby, 477 U.S. at 255). The threshold inquiry is whether there are "any genuine factual issues that properly can be resolved only by a finder of fact because they may reasonably be resolved in favor of either party." Liberty Lobby, 477 U.S. at 250; Brewer v. Quaker State Oil Refining Corp., 72 F.3d 326, 329-30 (3d Cir. 1995) (citation omitted).
The moving party always bears the initial burden of showing that no genuine issue of material fact exists, regardless of which party ultimately would have the burden of persuasion at trial. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Country Floors v. Partnership of Gepner and Ford, 930 F.2d 1056, 1061-63 (3d Cir. 1991)(reviewing district court's grant of summary judgment in a trademark action); Lucent Info. Manage. v. Lucent Tech., 986 F. Supp. 253, 257 (D.N.J. 1997)(granting summary judgment in favor of telecommunications provider in trademark action), aff'd, 186 F.3d 311 (3d Cir. 1999); Jalil v. Avdel Corp., 873 F.2d 701, 706 (3d Cir. 1989), cert. denied, 493 U.S. 1023 (1990). However, where the nonmoving party bears the burden of persuasion at trial, as plaintiff does in the present case, "the burden on the moving party may be discharged by 'showing' --- that is, pointing out to the district court -- that there is an absence of evidence to support the nonmoving party's case." Celotex Corp., 477 U.S. at 325.
The non-moving party "may not rest upon the mere allegations or denials of" its pleading in order to show the existence of a genuine issue. Fed. R. Civ. P. 56(e). Plaintiff must do more than rely only "upon bare assertions, conclusory allegations or suspicions." Gans v. Mundy, 762 F.2d 338, 341 (3d Cir. 1985), cert. denied, 474 U.S. 1010 (1985) (citation omitted); see Liberty Lobby, 477 U.S. at 249-50. Thus, if the plaintiff's evidence is a mere scintilla or is "not significantly probative," the court may grant summary judgment. Liberty Lobby, 477 U.S. at 249-50; Country Floors, 930 F.2d at 1061-62.
The Supremacy Clause, Article VI, Clause 2, of the United States Constitution preempts any state law that conflicts with the exercise of federal power. Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 152-53 (1982). Federal law will override state law under the Supremacy Clause when (1) Congress expressly preempts state law; (2) Congressional intent to preempt may be inferred from the existence of a pervasive federal regulatory scheme; or (3) state law conflicts with federal law or its purposes. English v. General Elec. Co., 496 U.S. 72, 78-79 (1990). Defendant Pfizer argues that the third and final form of preemption, namely conflict preemption, is implicated here, and that the complaint must be dismissed.
"[I]f a state common-law claim directly conflicted with a federal regulation . . ., or if it were impossible to comply with any such regulation without incurring liability under state common law, [conflict] pre-emption would occur." Sprietsma v. Mercury Marine, 537 U.S. 51, 65 (2002). Conflict preemption occurs either "where it is impossible for a private party to comply with both state and federal law" or where "under the circumstances of [a] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-73 (2000) (citing Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963), and Hines v. Davidowitz, 312 U.S. 52, 66-67 (1941)). Federal regulations "have no less pre-emptive effect than federal statutes." de la Cuesta, 458 U.S. at 153. The imposition of damages under state law is a form of state action subject to preemption. Geier v. American Honda Motor Co., 529 U.S. 861, 881 (2000). Where, as in the present circumstance, federal law does not directly preempt claims for inadequate warnings upon prescription drugs, the Supreme Court has cautioned that "a court should not find pre-emption too readily in the absence of clear evidence of a conflict." Id. at 885. The Supreme Court has instructed that there is a presumption against conflict preemption, and that the court should presume "that the historic police power of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." New York Conference of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655 (1995)(internal quotations omitted).
C. Plaintiffs' Failure to Warn Claim (Count II)
Defendant maintains that Plaintiffs' common law failure to warn claim is preempted by federal law because the Food and Drug Administration would consider any label suggesting that Zoloft "can and does cause suicide" "false and misleading," and therefore in direct contravention of the Food, Drug and Cosmetic Act.
1. FDA Prescription Drug Approval Process
By operation of federal law, the Food and Drug Administration ("FDA") occupies the field in determining the content of labeling on prescription pharmaceuticals such as Zoloft, as now discussed. The FDA's primary purpose is to protect consumers from dangerous prescription drugs and other products. United States v. Dotterweich, 320 U.S. 277 (1943). The FDA is charged with ensuring that "human and veterinary drugs are safe and effective" and approving prescription medicines as such before they are sold in the United States. 21 U.S.C. § 393(b)(2)(B); § 355(d).
In order to obtain FDA approval for a prescription drug, the drug's manufacturer must file a New Drug Application ("NDA") with the FDA. 21 U.S.C. §§ 355(a), (b), (d). The FDCA requires the FDA to approve an application to market a prescription drug unless, inter alia, (a) the application does not include adequate tests to show whether the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (b) the results of clinical testing show that the drug is unsafe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (c) there is insufficient information to determine whether the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (d) there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; or (e) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular. 21 U.S.C. §§ 355(c), (d).
FDA regulations mandate the general format and content of all sections of labels for all prescription drugs as well as the risk information each section must contain. 21 C.F.R. §§ 201.56, 201.57. The FDA sets out the product-specific labeling requirements in an "approvable" letter the FDA sends to the manufacturer. Id. at § 314.110(a) ("FDA will send the applicant an approval letter if the application . . . substantially meets the requirements of this part and the agency believes that it can approve the application . . . if . . . specific conditions (for example, certain changes in labeling) are agreed to by the applicant. The approvable letter will describe . . . the conditions the applicant is asked to meet."). Final approval of the NDA is "conditioned upon ...