Mensing v. Wyeth, Inc.

• Decision Date: 17 June 2008
• Docket Number: Civil No. 07-3919 (DWF/SRN).
• Citation: 562 F.Supp.2d 1056
• Parties: Gladys MENSING, Plaintiff, v. WYETH, INC. (d/b/a Wyeth); Schwarz Pharma, Inc.; Pliva, Inc.; Teva Pharmaceuticals, USA, Inc.; Alpharma, Inc., d/b/a Alpharma Pharmaceuticals; UDL Laboratories, Inc.; Actavis Elizabeth, LLC, and Purepac Pharmaceutical Co.; and the following fictitious party defendants (whether singular or plural, individual or corporate): No. 1, that entity which originally obtained permission from the U.S. Food and Drug Administration to market the drug branded Reglan; No. 2, that entity which obtained permission from the FDA to market the Reglan, metoclopramide and/or metoclopramide HCI ingested by Gladys Mensing; No. 3, that entity which originally manufactured and sold any Reglan which was ultimately ingested by Gladys Mensing: No. 4, that entity which originally manufactured and sold any Reglan, metoclopramide and/or metoclopramide HCI which was ultimately ingested by Gladys Mensing: No. 5, that entity which marketed Reglan or generic metoclopramide and/or metoclopramide HCI, jointly and individually, Defendants.
• Court: U.S. District Court — District of Minnesota

Page 1056

562 F.Supp.2d 1056

Gladys MENSING, Plaintiff, v. WYETH, INC. (d/b/a Wyeth); Schwarz Pharma, Inc.; Pliva, Inc.; Teva Pharmaceuticals, USA, Inc.; Alpharma, Inc., d/b/a Alpharma Pharmaceuticals; UDL Laboratories, Inc.; Actavis Elizabeth, LLC, and Purepac Pharmaceutical Co.; and the following fictitious party defendants (whether singular or plural, individual or corporate): No. 1, that entity which originally obtained permission from the U.S. Food and Drug Administration to market the drug branded Reglan; No. 2, that entity which obtained permission from the FDA to market the Reglan, metoclopramide and/or metoclopramide HCI ingested by Gladys Mensing; No. 3, that entity which originally manufactured and sold any Reglan which was ultimately ingested by Gladys Mensing: No. 4, that entity which originally manufactured and sold any Reglan, metoclopramide and/or metoclopramide HCI which was ultimately ingested by Gladys Mensing: No. 5, that entity which marketed Reglan or generic metoclopramide and/or metoclopramide HCI, jointly and individually, Defendants.

Civil No. 07-3919 (DWF/SRN).

United States District Court, D. Minnesota.

June 17, 2008.

Daniel J. McGlynn, Esq., Minneapolis, M, and Patty F. Trantham, Esq., McGlynn, Glisson & Koch, APLC, Baton Rouge, LA; and Lucia J.W. McLaren, Esq., and Michael K. Johnson, Esq., Goldenberg & Johnson, PLLC, Minneapolis, MN, for Plaintiffs.

Bridget M. Ahmann, Esq., and Erin M. Verneris, Esq., Faegre & Benson LLP; Minneapolis, MN, and Jeffrey R. Pilkington, Esq., and Tom Wagner, Esq., Davis, Graham & Stubbs, LLP, Denver, CO, for Defendant Wyeth, Inc.

Andrew J. Calica, Esq., and Henninger S. Bullock, Esq., Mayer Brown, LLP; New York City, and Erin M. Verneris, Esq., and Bridget M. Ahmann, Esq., Faegre & Benson LLP, Minneapolis, MN, for Defendant Schwartz Pharma, Inc.

Joseph P. Thomas, Esq., Matthew V. Brammer, Esq., Rex A. Littrell, Esq., Cincinnati, OH, and Tiffany Reece Clark, Esq., Ulmer & Berne LLP; and Jan R. McLean, Esq., Sacramento, CA, Tracy J. Van Steenburgh, Esq., and Dana M. Lenahan, Esq., Halleland Lewis Nilan & Johnson PA, Minneapolis, MN, for Defendants PLIVA, Inc.

David L. Hashmall, Esq., Fellhaber Larson Fenlon & Vogt, PA, Minneapolis, MN, for Defendants Teva Pharmaceuticals USA, Inc. and UDL Laboratories, Inc.

Bradley J. Linderman, Esq., and Michael D. Hutchens, Esq., Meagher & Geer, PLLP; Minneapolis, MN, and Richard A. Dean, Esq., Tucker Ellis & West, Cleveland, OH, for Defendants Alpharma Inc., Actavis Elizabeth, LLC, and Purepac Pharmaceutical Co.

MEMORANDUM OPINION AND ORDER

DONOVAN W. FRANK, District Judge.

INTRODUCTION

This matter is before the Court on a Motion to Dismiss brought by Actavis Elizabeth, LLC ("Actavis"); a Motion to Dismiss or for Summary Judgment brought by Pliva, Inc. ("Pliva"); and a Motion for Relief Under Fed.R.Civ.P. 56(f) brought by Plaintiff Gladys Mensing. For the reasons stated below, the Court grants Actavis's and Pliva's motions and denies Plaintiffs motion.¹

BACKGROUND

In her Amended Complaint, Plaintiff alleges that on or about March 23, 2001, her physician prescribed the drug Reglan to her to treat diabetic gastroparesis. (Am. Compl.¶ 27). The active ingredient in Reglan is metoclopramide ("MCP"). MCO, which is available in brand (Reglan) or generic form, is used to treat certain gastrointestinal disorders. Plaintiff alleges that she ingested Reglan/MCP from March 23, 2001, until March 2005, and that her long-term ingestion of Reglan/MCP caused her to develop tardive dyskinesia, a neurological movement disorder. (Id. ¶¶ 27, 32, 34, 37, 38.)

Both Actavis and Pliva manufacture MCP, a generic version bioequivalent of Reglan.² Reglan, the reference listed drug for MCP, was approved by the FDA in 1980. In March 1985, the FDA required that Reglan's label be updated to include a warning regarding the risk of developing tardive dyskinesia. Actavis and Pliva revised their insert labeling to comport to approved changes to the Reglan label. There is no dispute that the labels for both Actavis's and Pliva's MCP were at all relevant times the same as Wyeth's Reglan label.

Plaintiff asserts state-law tort claims against both Wyeth and the manufacturers of generic MCP. Although Plaintiff has asserted a variety of claims against Actavis and Pliva, at the core of all of Plaintiffs claims is the basic assertion that Actavis and Pliva failed to adequately warn about the association between long-term ingestion of MCP and movement disorders. For example, Plaintiff alleges that Actavis and Pliva ignored scientific and medical literature establishing a higher risk of developing tardive dyskinesia, failed to request a labeling revision to the FDA, and failed to report safety information directly to the medical community.

Actavis and Pliva move separately to dismiss Plaintiff's claims against them, arguing that Plaintiff's claims are preempted by federal law.

DISCUSSION

I. Motions to Dismiss

A. Standard of Review

In deciding a motion to dismiss, a court assumes all facts in the complaint to be true and construes all reasonable inferences from those facts in the light most favorable to the complainant. Morton v. Becker, 793 F.2d 185, 187 (8th Cir.1986). In doing so, however, a court need not accept as true wholly conclusory allegations, Hanten v. Sch. Dist. of Riverview Gardens, 183 F.3d 799, 805 (8th Cir.1999), or legal conclusions drawn by the pleader from the facts alleged. Westcott v. City of Omaha, 901 F.2d 1486, 1488 (8th Cir. 1990). A court may consider the complaint, matters of public record, orders, materials embraced by the complaint, and exhibits attached to the complaint in deciding a motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Porous Media Corp. v. Pall Corp., 186 F.3d 1077, 1079 (8th Cir.1999).

To survive a motion to dismiss, a complaint must contain "enough facts to state a claim to relief that is plausible on its face." Bell Atl. Corp. v. Twombly, ___ U.S. ___, ___, 127 S.Ct. 1955, 1974, 167 L.Ed.2d 929 (2007). Although a complaint need not contain "detailed factual allegations," it must contain facts with enough specificity "to raise a right to relief above the speculative level." Id. at 1964-65. This standard "calls for enough fact[s] to raise a reasonable expectation that discovery will reveal evidence of [the claim]." Id. at 1965. The Court evaluates a motion brought under Rule 12(c) under the same standard as a motion brought under Rule 12(b)(6). Fed.R.Civ.P. 12(c) and (h)(2).

B. Federal Preemption

A state law that conflicts with a federal law is preempted under the Supremacy Clause of the Constitution, U.S. Const. art. VI, cl. 2. Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 712-13, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985). Congressional intent to preempt state law can either be expressed in statutory language or implied in the structure and purpose of federal law. Id. Implied preemption has two types— field and conflict preemption. Field preemption is inferred where Congress legislates so pervasively in a particular field that no room remains for supplementary state legislation. Id. Even if Congress has not completely displaced state regulation, preemption may occur when state law actually conflicts with federal law. Id. Conflict preemption arises when compliance with both federal and state regulations is a physical impossibility, or when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Id. (citing Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 83 S.Ct. 1210, 10 L.Ed.2d 248 (1963) and Hines v. Davidowitz, 312 U.S. 52, 67, 61 S.Ct. 399, 85 L.Ed. 581 (1941)). State laws can be preempted by both federal statutes and federal regulations. Id. at 713, 105 S.Ct. 2371.

Both Actavis and Pliva assert that Plaintiffs claims are conflict preempted. First, they argue that as generic drug manufacturers, they cannot comply with both federal law that requires their generic drug labels to be the "same as" the Reglan® label and with a state-imposed duty to heighten warning labels. In particular, Actavis and Pliva contend that it would be impossible for it to comply with both the Abbreviated New Drug Application ("ANDA") provisions of the Food, Drug & Cosmetic Act ("FDCA") and the labeling requirements Plaintiff seeks to impose pursuant to state law. In addition, both Actavis and Pliva maintain that Plaintiff's claims are conflict preempted because the state laws pose an obstacle to Congressional objectives in enacting federal law applicable to generic drug manufacturers and vesting exclusive authority to regulate prescription drug labeling with the Food and Drug Administration ("FDA").

In support of their preemption arguments, both Actavis and Pliva point to the Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman Act" or the "Act") (codified at 21 U.S.A. § 355(j)). The Hatch-Waxman Act codified the ANDA procedures being used by the FDA. Actavis and Pliva assert that under the ANDA procedures, a generic manufacturer is required to put exactly the same language on its warning labels as the listed drug.³

1. Regulatory Framework

To determine whether or not Plaintiff's claims are preempted, the Court must first understand the relevant regulatory framework. The FDA is the federal agency charged by Congress in the FDCA with regulating the manufacture, sale, and labeling of new prescription drug products that are marketed for human consumption and, in particular, to ensure the safety and efficacy of new drugs. 21 U.S.C. § 393. In this capacity, the FDA regulates the introduction of all new drugs. 21 U.S.C. § 355(b). Under 21 U.S.C. § 355(a), "[n]o person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with...