McKenney v. Purepac Pharmaceutical Co. (167 Cal. App. 4th 72, 2008)

Opinion

ARDAIZ, P. J.

Appellant Carlyne McKenney brought this civil action against respondent Purepac Pharmaceutical Company (Purepac) and other defendants. Appellant alleges that she was injured as a result of using the prescription drug metoclopramide manufactured by Purepac. The superior court sustained Purepac’s demurrer to McKenney’s fourth amended complaint and entered judgment in favor of Purepac. The pleading alleges that metoclopramide is the active ingredient of the brand name drug Reglan, and that Purepac “distributed the generic drug metoclopramide.” It alleges that there were “false and/or misleading statements contained in” Purepac’s labeling of the drug, and that the labeling “substantially understated and downplayed the risks of tardive dyskinesia,” a condition McKenney contracted as a result of her treatment with metoclopramide. The superior court concluded: “All of Plaintiff’s causes against Purepac are pre-empted by federal law. . . . Defendant Purepac is not the original manufacturer of Reglan. It is a generic manufacturer of metoclopramide and, as such, must obtain approval by the FDA before issuing any label [on] metoclopramide which deviates from the labeling previously approved by the FDA.”

Appellant contends that the court erred in sustaining the demurrer to her fourth amended complaint. As we shall explain, we agree with appellant. We hold that the federal requirement that a generic drug have the same labeling as a reference listed drug does not necessarily result in federal preemption of a state tort action against the generic manufacturer for failure to adequately warn of the dangers of the drug. We will reverse the judgment.

STANDARD OF REVIEW

“The party against whom a complaint or cross-complaint has been filed may object, by demurrer or answér . . . , to the pleading on any one or more of the following grounds: [][]... [][] (e) The pleading does not state facts sufficient to constitute a cause of action.” (Code Civ. Proc., § 430.10.) “The familiar terms ‘general demurrer’ and ‘special demurrer’ do not appear in the statutes. The name ‘general demurrer’ is, however, universally applied to a demurrer raising the fundamental ground: ‘The pleading does not state facts sufficient to constitute a cause of action.’ (C.C.P. 430.10(e).)” (5 Witkin, Cal. Procedure (4th ed. 1997) Pleading, § 904(3), pp. 365-366; see also Weil & Brown, Cal. Practice Guide: Civil Procedure Before Trial (The Rutter Group 2008) § 7:37 (rev. # 1, 2007).) “The absence of any allegation essential to a cause of action renders it vulnerable to a general demurrer. A ruling on a general demurrer is thus a method of deciding the merits of the cause of action on assumed facts without a trial.” (Linder v. Thrifty Oil Co. (2000) 23 Cal.4th 429, 437, fn. 4 [97 Cal.Rptr.2d 179, 2 P.3d 27].) “Neither trial nor appellate courts should be distracted from the main issue, or rather, the only issue involved in a demurrer hearing, namely, whether the complaint, as it stands, unconnected with extraneous matters, states a cause of action.” (Griffith v. Department of Public Works (1956) 141 Cal.App.2d 376, 381 [296 P.2d 838].)

“On appeal from a judgment dismissing an action after sustaining a demurrer without leave to amend, the standard of review is well settled. We give the complaint a reasonable interpretation, reading it as a whole and its parts in their context. [Citation.] Further, we treat the demurrer as admitting all material facts properly pleaded, but do not assume the truth of contentions, deductions or conclusions of law. [Citations.] When a demurrer is sustained, we determine whether the complaint states facts sufficient to constitute a cause of action. [Citation.] And when it is sustained without leave to amend, we decide whether there is a reasonable possibility that the defect can be cured by amendment: if it can be, the trial court has abused its discretion and we reverse. [Citation.]” (City of Dinuba v. County of Tulare (2007) 41 Cal.4th 859, 865 [62 Cal.Rptr.3d 614, 161 P.3d 1168]; accord, Reynolds v. Bement (2005) 36 Cal.4th 1075, 1083 [32 Cal.Rptr.3d 483, 116 P.3d 1162]; Zelig v. County of Los Angeles (2002) 27 Cal.4th 1112, 1126 [119 Cal.Rptr.2d 709, 45 P.3d 1171]; Aubry v. Tri-City Hospital Dist. (1992) 2 Cal.4th 962, 966-967 [9 Cal.Rptr.2d 92, 831 P.2d 317]; Blank v. Kirwan (1985) 39 Cal.3d 311, 318 [216 Cal.Rptr. 718, 703 P.2d 58].) Our review of the sufficiency of the complaint is de novo. (McCall v. PacifiCare of Cal., Inc. (2001) 25 Cal.4th 412, 415 [106 Cal.Rptr.2d 271, 21 P.3d 1189]; Zelig v. County of Los Angeles, supra, 27 Cal.4th at p. 1126.) “We also consider matters that may be judicially noticed.” (Reynolds v. Bement, supra, 36 Cal.4th at p. 1083; see Zelig v. County of Los Angeles, supra, 27 Cal.4th at p. 1126; Serrano v. Priest (1971) 5 Cal.3d 584, 591 [96 Cal.Rptr. 601, 487 P.2d 1241].) The burden of demonstrating a reasonable possibility that the defect can be cured by amendment “is squarely on the plaintiff.” (Blank v. Kirwan, supra, 39 Cal.3d at p. 318; see Zelig v. County of Los Angeles, supra, 27 Cal.4th at p. 1126.)

Because a reviewing court will “assume the truth of all well-pleaded factual allegations of the complaint” (Kearney v. Salomon Smith Barney, Inc. (2006) 39 Cal.4th 95, 101 [45 Cal.Rptr.3d 730, 137 P.3d 914]), “the question of plaintiff’s ability to prove these allegations, or the possible difficulty in making such proof does not concern the reviewing court [citations] . . . .” (Alcorn v. Anbro Engineering, Inc. (1970) 2 Cal.3d 493, 496 [86 Cal.Rptr. 88, 468 P.2d 216].). “It is not the ordinary function of a demurrer to test the truth of the plaintiff’s allegations or the accuracy with which he describes the defendant’s conduct. A demurrer tests only the legal sufficiency of the pleading. [Citation.]” (Committee on Children’s Television, Inc. v. General Foods Corp. (1983) 35 Cal.3d 197, 213 [197 Cal.Rptr. 783, 673 P.2d 660].) Thus “[w]hether the plaintiff will be able, to prove the pleaded facts is irrelevant to ruling upon the demurrer.” (Stevens v. Superior Court (1986) 180 Cal.App.3d 605, 609-610 [225 Cal.Rptr. 624].)

Particularly pertinent to the appeal presently before us is the principle that “[w]hen a complaint affirmatively alleges facts amounting to an affirmative defense, it is subject to a demurrer.” (Halvorsen v. Aramark Uniform Services, Inc. (1998) 65 Cal.App.4th 1383, 1391 [77 Cal.Rptr.2d 383].) “A general demurrer will lie where the complaint ‘has included allegations that clearly disclose some defense or bar to recovery.’ [Citation.] Thus, a demurrer based on an affirmative defense will be sustained only where the face of the complaint discloses that the action is necessarily barred by the defense. [Citation.]” (Casterson v. Superior Court (2002) 101 Cal.App.4th 177, 183 [123 Cal.Rptr.2d 637]; accord, Cryolife, Inc. v. Superior Court (2003) 110 Cal.App.4th 1145, 1152 [2 Cal.Rptr.3d 396]; Holiday Matinee, Inc. v. Rambus, Inc. (2004) 118 Cal.App.4th 1413, 1421 [13 Cal.Rptr.3d 766].) Purepac contends that the causes of action alleged in McKenney’s fourth amended complaint are barred by the defense of federal preemption. Thus the issue before us is whether the allegations of that pleading, in conjunction with other matters that may be judicially noticed (see Holiday Matinee, Inc. v. Rambus, Inc., supra, 118 Cal.App.4th at p. 1421), demonstrate that all possible recovery by McKenney is barred by the defense of federal preemption. The parties agree, however, that all of McKenney’s causes of action are based upon the alleged inadequacy of the metoclopramide labeling in warning of the dangers of using the drug.

THE FOURTH AMENDED COMPLAINT DOES NOT DISCLOSE THAT THIS ACTION IS NECESSARILY BARRED BY THE DEFENSE OF FEDERAL PREEMPTION

Article VI, clause 2 of the Constitution of the United States provides: “This Constitution, and the laws of the United States which shall be made in pursuance thereof; and all treatises made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” This clause “invalidates state laws that ‘interfere with, or are contrary to,’ federal law.” (Hillsborough County v. Automated Medical Labs. (1985) 471 U.S. 707, 712 [85 L.Ed.2d 714, 105 S.Ct. 2371] (Hillsborough), quoting from Gibbons v. Ogden (1824) 22 U.S. 1, 211 [6 L.Ed. 23].)

Federal Preemption Principles

The United States Supreme Court has described at least three different ways in which federal law may supersede or “preempt” state law. “First, when acting within constitutional limits, Congress is empowered to preempt state law by so stating in express terms.” (Hillsborough, supra, 471 U.S. at p. 713.) This is commonly called “express preemption.” Second: “In the absence of express pre-emptive language, Congress’ intent to preempt all state law in a particular area may be inferred where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress ‘left no room’ for supplementary state regulation. [Citation.] Preemption of a whole field also will be inferred where the field is one in which ‘the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.’ [Citations.]” (Id. at p. 713.) This is commonly called “field preemption.” Third: “Even where Congress has not completely displaced state regulation in a specific area, state law is nullified to the extent that it actually conflicts with federal law. Such a conflict arises when ‘compliance with both federal and state regulations is a physical impossibility,’ [citation], or when state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress . . .’ [citation].” (Hillsborough, supra, 471 U.S. at p. 713.) This is commonly called “conflict preemption,” although we note that on this appeal Purepac refers to the second clause of this description of conflict preemption as “obstacle preemption.” Because field preemption and conflict preemption are not express, they are sometimes referred to as forms of “implied” or “implicit” preemption. (See Geier v. American Honda Motor Co. (2000) 529 U.S. 861, 884 [146 L.Ed.2d 914, 120 S.Ct. 1913], and Hillsborough, supra, 471 U.S. at p. 716.) California state courts have repeatedly recognized and applied these same basic principles. (See, e.g., Dowhal v. SmithKline Beecham Consumer Healthcare (2004) 32 Cal.4th 910, 923-924 [12 Cal.Rptr.3d 262, 88 P.3d 1]; Bronco Wine Co. v. Jolly (2004) 33 Cal.4th 943, 955 [17 Cal.Rptr.3d 180, 95 P.3d 422]; Viva! Internat. Voice for Animals v. Adidas Promotional Retail Operations, Inc. (2007) 41 Cal.4th 929, 935-936 [63 Cal.Rptr.3d 50, 162 P.3d 569]; and People v. Edward D. Jones & Co. (2007) 154 Cal.App.4th 627, 637 [65 Cal.Rptr.3d 130].)

There is a “presumption that state or local regulation of matters related to health and safety is not invalidated under the Supremacy Clause.” (Hillsborough, supra, 471 U.S. at p. 715.) “ ‘Where ... the field that Congress is said to have pre-empted has been traditionally occupied by the States “we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” ’ [Citations.]” (Hillsborough, supra, 471 U.S. at p. 715.) California courts have similarly recognized that “[c]ourts are reluctant to infer preemption, and it is the burden of the party claiming Congress intended to preempt state law to prove it.” (Elsworth v. Beech Aircraft Corp. (1984) 37 Cal.3d 540, 548 [208 Cal.Rptr. 874, 691 P.2d 630]; see Olszewski v. Scripps Health (2003) 30 Cal.4th 798, 815 [135 Cal.Rptr.2d 1, 69 P.3d 927]; Viva! Internal Voice for Animals v. Adidas Promotional Retail Operations, Inc., supra, 41 Cal.4th at p. 936.)

“Federal regulations have no less pre-emptive effect than federal statutes. Where Congress has directed an administrator to exercise his discretion, his judgments are subject to judicial review only to determine whether he has exceeded his statutory authority or acted arbitrarily. [Citation.] When the administrator promulgates regulations intended to pre-empt state law, the court’s inquiry is similarly limited: [