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McNellis v. Pfizer

September 29, 2006


The opinion of the court was delivered by: Simandle, District Judge


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, bring this action contending that Zoloft, an antidepressant drug manufactured by Defendant Pfizer, Inc., ("Pfizer") 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, and that Pfizer is liable for failure to warn under New Jersey Product Liability Act. In 2005, Pfizer filed a motion for summary judgment arguing that Plaintiffs' state law tort claims are preempted by the Federal Food, Drug and Cosmetic Act (the "FDCA") and its implementing regulations. On December 29, 2005, this Court issued an Opinion (the "December 29 Opinion") and Order (the "December 29 Order") denying Pfizer's motion, without prejudice to renewal after a period of factual discovery. Presently before the Court is Pfizer's motion to vacate this Court's summary judgment order or, in the alternative, to certify under 28 U.S.C. § 1292(b) the December 29 Order for immediate interlocutory appeal. For the reasons expressed below, the Court will (1) deny Pfizer's motion to vacate this Court's December 29 Order but (2) will grant Pfizer's motion to certify the December 29 Order (as augmented by today's Order) for interlocutory appeal and, pursuant to 28 U.S.C. § 1292(b), stay the proceedings in this Court pending a determination by the Court of Appeals.


The Court will include only a brief summary of the relevant facts. Theodore DeAngelis ("DeAngelis") 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.

Plaintiff Beth Ann McNellis ("McNellis"), suing individually and as executrix of the estate of her father, DeAngelis,*fn1 claims that (1) Zoloft, a medication prescribed for Mr. DeAngelis, can and does "drive some people to their death" by suicide; (2) Pfizer failed to adequately warn Mr. DeAngelis's physician of risks of suicidality associated with Zoloft that had become apparent prior to his prescribing of Zoloft to Mr. DeAngelis; 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.)

Plaintiffs' claims against Defendant Pfizer include allegations of (1) defective design, N.J.S.A. 2A:58C-2, et seq. (Count I), (2) failure-to-warn (Count II), (3) violations of the New Jersey Consumer Fraud Act, N.J.S.A. 56:8-2, et seq. (Count III), and (4) 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 the FDA had authorized to be given verbatim. Pfizer filed a 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. On December 29, 2005, this Court denied Pfizer's motion. See McNellis v. Pfizer, Inc., 2005 U.S. Dist. LEXIS 37505 (D.N.J. December 29, 2005).

This Court based its December 29, 2005 ruling in part on regulations of the Food and Drug Administration (FDA) at 21 C.F.R. § 314.70(c)(6) which, under certain circumstances, allows a pharmaceutical manufacturer to strengthen warnings while FDA approval is being sought for an enhanced warning. See id. Specifically, the Court held that "[i]f Plaintiffs can prove to the fact finder that Pfizer had, prior to January, 2003, 'reasonable evidence of an association of a serious hazard with a drug,' see 21 C.F.R. § 201.57(e), then the enhanced warning sought by Plaintiffs herein would not be preempted by the FDCA." Id. at *33.

Pfizer now brings this motion (1) to vacate this Court's December 29 Order or, (2) in the alternative, to certify the December 29 Order for interlocutory appeal, and (3) for an order staying discovery pending appeal. Pfizer moves to vacate the order on the basis that new evidence exists that establishes the actual meaning and intent of 21 C.F.R. § 314.70. Pfizer cites as new evidence a document published by the Food and Drug Administration ("FDA" or the "Agency") on January 24, 2006, about a month after this Court's December 29 Opinion, titled "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products" (the "Final Rule"). The Final Rule, according to Pfizer, explicitly explained the agency's purposes, policies, and intent regarding Section 314.70, how the agency precludes any deviation in labeling notwithstanding the language of Section 314.70, and why preemption should apply in cases such as the present case. See 21 Fed. Reg. 3922, 3933-36, 3967-69 (Jan. 24, 2006). The FDA's new reading of its labeling regulations, the text of which is unchanged in relevant part, constitutes the new evidence that Pfizer posits in this motion to vacate.


A. Pfizer's Motion to Vacate

The district court has inherent power to vacate or revise its interlocutory orders before final judgment when justice so requires. See Gallant v. Telebrands Corp., 35 F. Supp. 2d 378, 394 (D.N.J. 1998). An interlocutory order, such as the prior order herein denying summary judgment, may be vacated when there is newly discovered, non-cumulative evidence or in light of relevant changes in the facts or law of a case that would have altered earlier rulings by the Court. See id.; see also Electric Mobility Corp. v. Bourns, 87 F. Supp. 2d 394, 401 (D.N.J. 2000)("Reconsideration may be justified on the basis of an intervening change in law . . . and is not necessarily barred by Local Civ. R. 7.1(g), requiring motions for reconsideration to be filed within ten days of an order.") Such a motion to vacate, however, is not intended as a vehicle to re-litigate issues that have already been decided. See Gallant, 35 F. Supp. 2d at 394. Rather, "[i]n the absence of newly discovered, non-cumulative evidence, the parties should not be permitted to reargue previous rulings made in the case." Id.

1. The Preamble to the Final Rule is New Evidence

In its submissions and at oral argument, Pfizer argues that there have been two significant developments since the December 29 Order which constitute new evidence and that this new evidence should cause the Court to reconsider its denial of Pfizer's earlier motion for summary judgment. The most significant development, Pfizer argues, is the issuance of the Final Rule on January of 2006. The preamble to the Final Rule (the "Preamble"), according to Pfizer, constitutes new, compelling evidence requiring vacation of this Court's December 29 Order because it confirms the position the FDA had taken in amicus briefs in other cases that Pfizer had earlier submitted for consideration by this Court.*fn2 The second development is the recent decision of Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006), in which the court (1) gave deference to the FDA's interpretation (outlined in the Preamble) of its own regulations, and (2) held that the regulations to the FDCA preempt state failure-to-warn tort claims.

Plaintiffs counter-argue that Pfizer's motion to vacate rests on a faulty premise --- that the Preamble to the FDA's newly issued Final Rule constitutes new evidence. According to Plaintiffs, the Preamble simply repeats the same position that was already argued to and rejected by this Court. Plaintiffs point out numerous examples of where both Pfizer and the Court have explained that the issue before the Court on Pfizer's motion for summary judgment was whether the FDCA and the FDA's regulations conflict with New Jersey's failure-to-warn law and whether the state law cause of action is preempted. Now, according to Plaintiffs, Pfizer seeks the "unusual" relief of a motion to vacate because the FDA's position on the preemptive effect of its regulations --- which is identical to the FDA's position as articulated in the Motus and Kallas amicus briefs --is now articulated in "an advisory preamble" to the Final Rule. (Pl.'s Opp. Br. at 5.) Plaintiffs continue, contending that the format for this advisory opinion is meaningless because the Preamble and the Motus and Kallas amicus briefs carry the same weight -- they are both advisory positions from the FDA, see 21 C.F.R. § 10.80, and, thus, there is no new evidence before the Court. See Gallant, 35 F. Supp. 2d at 378.

This Court disagrees with Plaintiffs and finds that the Preamble to the Final Rule is new evidence that should be considered in a motion to vacate. The Preamble is an official agency statement purporting to establish preemption of conflicting state law claims. At minimum, the Final Rule is an advisory opinion representing the formal position of the FDA. As an advisory opinion, it "represents the formal position of FDA on a matter and except [under unusual situations involving an immediate or significant danger to health], obligates the agency to follow it until it is amended or revoked." 21 C.F.R. § 10.85(e). The Preamble is also distinguishable from an amicus brief. Amicus briefs, by their nature, are drafted in the context of specific ongoing litigation. The Motus and Kallas briefs, for example, represent the FDA's position on an issue that is tailored to those particular cases. In contrast, in the Preamble, the Agency (1) put forth its general position on the preemptive effect of its regulations (rather than a position tailored to a particular case) and (2) is obligated to follow it until amended or revoked. See 21 C.F.R. § 10.85(e).

2. Although the Issuance of the Preamble is "New Evidence," it does not Warrant Vacation of this Court's December 29 Order

a. Pfizer's Argument

Next Pfizer argues that the issuance of the Final Rule articulating the FDA's interpretation of its regulations (specifically, that the regulations preempt state tort law) requires this Court to vacate its December 29 Order. According to Pfizer, because the Preamble represents an administrative agency interpreting its own regulations, the FDA's interpretation of regulations related to the FDCA are entitled to substantial deference. See Auer v. Robbins, 519 U.S. 452 (1997)(courts must give an administrative agency's interpretation of its own regulations substantial deference). Specifically, Pfizer argues that, in the Preamble, the FDA reaffirms that "under existing preemption principles, FDA approval of labeling...preempts conflicting or contrary State law." 71 Fed. Reg. at 3934. The Preamble to the Final Rule also addresses the factual situation where the FDA has specifically considered and rejected the warning a plaintiff advocates, and explains why such an action by a plaintiff would, if allowed to proceed, impair the Agency's safety purposes and policies. Id. Specifically, the Preamble states:

FDA believes that State laws conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal law when they purport to compel a firm to include in labeling or advertising a statement that FDA has considered and found scientifically unsubstantiated.

Id. at 3935. Pfizer argues that this statement explains why two positions that served as the basis for this Court's December 29 Order misinterpret the agency's regulations. First, the FDA states that its labeling regulations are not "minimum standards" (as the Court's Opinion holds) but "establish both a 'floor' and 'ceiling.'" Id. Second, the FDA states that Section 314.70 ---the FDA regulation that explicitly permits drug manufacturers to unilaterally strengthen warning labels at any time without regulatory pre-approval --- negates the preemptive effect of labeling requirements and "conflicts with the agency's own interpretations" of its own regulations. Id. Rather, the FDA explains that Section 314.70 does not preclude preemption because the FDA remains the final arbiter of the form and content of all labeling regardless of whether the manufacturer may temporarily alter a medication's label.

Next Pfizer argues that the Final Rule also addresses why preemption precludes a plaintiff from arguing to a jury or court that a manufacturer withheld information from the FDA. The Preamble to the Final Rule states that the FDA precludes:

[C]laims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which has been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn (unless FDA has made a finding that the sponsor withheld material information ...

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