McKenney v. Purepac Pharmaceutical Co.

Opinion

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

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

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

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

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.]

Purepac’s successful argument in the superior court, and its argument once again to this court, goes like this. The United States Food and Drug Administration (FDA) “shall—[][] (1) promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner” and “with respect to such products, protect the public health by ensuring that— . . . human and veterinary drugs are safe and effective.” ( 21 U.S.C. § 393 (b)(1), (2)(B).) Pursuant to this congressional directive, the FDA has adopted regulations overseeing the labeling of drugs. (See, e.g., 21 C.F.R. §§ 201.56 , 201.80, 314.70 (2008).) Because Purepac was not free to deviate from the FDA-approved labeling for metoclopramide, any civil liability to McKenney under state law for failure to adequately warn of the dangers of taking the drug are preempted as impermissibly conflicting with the FDA’s authority over drug labeling. To put it a bit simpler, Purepac contends that its metoclopramide labeling was FDA approved, that it could not have utilized any labeling that was not FDA approved, and that therefore it cannot be held liable under state law for failing to use whatever different labeling McKenney may contend Purepac should have used. Purepac argues that being held liable under state law for not utilizing unapproved labeling would “ ‘stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress ....’” (Hillsborough, supra, 471 U.S. at p. 713.)

We see no contention from Purepac that all state civil liability for injury caused by mislabeled drugs is preempted—such as, for example, injury caused by a manufacturer mislabeling a drug and failing to utilize an FDA-approved label for that drug. The FDA itself has said: “FDA recognizes that FDA’s regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted [citations].” (71 Fed.Reg. 3922, 3936 (Jan. 24, 2006) [an FDA document referred to by the parties as the “Final Rules Preamble” or the “Preemption Preamble”].) In considering the preemptive effect of another federal statute involving medical devices,

Purepac persuaded the superior court that Purepac’s status as a generic manufacturer of metoclopramide required preemption of McKenney’s action because Purepac was required, as a generic manufacturer, to use the same labeling used on the originally approved drug, Reglan. Generic drugs obtain FDA approval under a process known as an abbreviated new drug application (ANDA). (See Colacicco v. Apotex Inc. (2008) 521 F.3d 253 , 260.) The FDA has stated that “an ANDA must have labeling that is the same as the reference listed drug . . . .” (57 Fed.Reg. 17950, 17961 (Apr. 28, 1992).) The FDA also, however, must approve the labeling of the original or “reference” drug. (Colacicco v. Apotex Inc., supra, 521 F.3d at pp. 257-260.) The FDA has stated that its mechanism for compelling labeling revisions “applies to both ANDA and NDA drug products” and that “[a]fter 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. 17950, 17961 (Apr. 28, 1992).) We therefore see no reason to distinguish between original or “listed” drugs and their generic equivalents for federal preemption purposes. Nor do we see any indication that the FDA itself has ever taken the position that its labeling requirements for generics would invoke federal preemption principles so as to exempt manufacturers of generic drugs from tort liability.

The Carlin Case

In Brown v. Superior Court (1988) 44 Cal.3d 1049 [ 245 Cal.Rptr. 412 , 751 P.2d 470 ], the California Supreme Court held that a drug manufacturer could not be held strictly liable for failing to warn of risks inherent in a drug even though the manufacturer neither knew, nor could have known by the application of scientific knowledge available at the time of distribution, that the drug could produce the undesirable side effects suffered by the plaintiff. (Id. at p. 1065.) In Anderson v. Owens-Corning Fiberglas Corp. (1991) 53 Cal.3d 987 [ 281 Cal.Rptr. 528 , 810 P.2d 549 ], the court held that “knowledge or knowability is a component of strict liability for failure to warn” (id. at p. 1000), and that evidence of the “state of the art may be relevant to the question of knowability and, for that reason, should be admissible in that

Application of the Law to Appellant’s Allegations

What has changed since Carlin that might cause us to conclude that federal preemption principles would exempt a generic manufacturer of prescription drugs from strict products liability simply because the generic

In the case presently before us, Purepac has not called our attention to anything in the allegations of McKenney’s fourth amended complaint that would demonstrate the necessary applicability of a preemption defense to those allegations. To state this a bit differently, nothing in the McKenney’s fourth amended complaint alleges that Purepac should have given warnings about the use of metoclopramide that the FDA expressly precluded Purepac from giving. The superior court therefore erred in sustaining the demurrer.

Nor has Purepac cited to us any appellate court decision holding that a generic manufacturer of a prescription drug can never be held strictly liable in tort for failure to warn when the generic manufacturer utilizes FDA-approved labeling. In Colacicco v. Apotex Inc. supra, 521 F.3d 253 , the court did find federal preemption, but expressly stated that “[o]ur holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires.” (Id. at pp. 271-272.) In that case the FDA submitted an amicus curiae brief, and even the FDA itself did not take the position that federal preemption always insulates a generic manufacturer utilizing FDA-approved labeling from tort liability for failure to warn. “The FDA explains in the amicus brief that ‘the basis for federal preemption is not the [labeling] guidelines themselves . . . , but rather FDA’s repeated determinations prior to October 2003 that there was insufficient scientific evidence of an association between adult use of SSRI and suicide or suicidality to permit a warning on the labeling for those drugs . . . .’ ” (Colacicco, supra, 521 F.3d at p. 274.) The proper application of federal preemption principles to failure-to-wam claims is presently before the United States Supreme Court in Levine v. Wyeth (2006) 2006 VT 107 [ 944 A.2d 179 ], certiorari granted sub nom. Wyeth v. Levine (2008) _ U.S. _ [ 169 L.Ed.2d 845 , 128 S.Ct. 1118 ]. In Levine v. Wyeth, the Supreme Court of Vermont noted the “general mle that FDA approval of a drag’s label does not preempt state failure-to-wam claims” (944 A.2d at p. 186) and followed that general rale. A dissenting opinion argued that on the facts of that particular case the plaintiff’s claim was preempted. “It is inaccurate ... to characterize the requirements imposed by the jury verdict in this case as merely requiring a ‘stronger warning.’ Rather, what plaintiff sought was an elimination of a use of Phenergan that had been approved by the FDA.” (944 A.2d at p. 198 (dis. opn. of Reiber, C. J.).) Nothing in even the dissenting opinion, however, suggests or supports the expansive reach of federal preemption advocated here by Purepac.

The judgment is reversed. Costs on appeal are awarded to appellant McKenney.

Levy, J., and Dawson, J., concurred.

A petition for a rehearing was denied October 23, 2008, and respondent’s petition for review by the Supreme Court was denied January 14, 2009, S168109. George, C. J., and Baxter, J., did not participate therein.