Kellogg v. Wyeth

Decision Date17 December 2008
Docket NumberCase No. 2:07-cv-82.
Citation612 F.Supp.2d 421
PartiesEthel KELLOGG, Plaintiff, v. WYETH, Individually and as Successor-in-Interest to A.H. Robins Company, Inc. and American Home Products Corporation; Schwarz Pharma, Inc.; Actavis, Inc.; Actavis-Elizabeth, L.L.C.; Alpharma, Inc.; Purepac Pharmaceutical Company, Inc.; Teva Pharmaceuticals, USA, Inc.; Bar Pharmaceuticals, Inc.; Pliva, Inc.; and Drug Company Does 1 through 10, inclusive, Defendants.
CourtU.S. District Court — District of Vermont

Jerome F. O'Neill, Esq., O'Neill Kellner & Green, Burlington, VT, Daniel J. McGlynn, Esq., Patty A. Trantham, Esq., McGlynn Glisson, APLC, Baton Rouge, LA, Leslie A. Brueckner, Trial Lawyers for Public Justice, P.C., Louis M. Bograd, Washington, DC, Ralph D. Pittle, Esq., Medical Legal Consultants of Washington, Bellevue, WA, Robert H. Beadel, Law Office of Hector E. Pineiro, Worcester, MA, for Plaintiff.

Robert B. Hemley, Ross A. Feldmann, Gravel and Shea, Stephen J. Soule, Paul Frank & Collins PC, Matthew S. Borick, Downs Rachlin Martin PLLC, John D. Monahan, Jr., Dinse, Knapp & McAndrew, P.C., Thomas P. Simon, McCormick, Fitzpatrick, Kasper & Burchard, P.C., Burlington, VT, Jeffrey R. Pilkington, Esq., Davis Graham & Stubbs LLP, Denver, CO, Andrew J. Calica, Henninger S. Bullock, Mayer Brown LLP, New York, NY, Richard A. Dean, Tucker Ellis & West, Cleveland, OH, U. Gwyn Williams, Goodwin Procter LLP, Boston, MA, Joseph P. Thomas, Matthew V. Brammer, Thomas G. McIntosh, Ulmer & Berne LLP, Cincinnati, OH, Michael J. Marks, Tarrant, Marks & Gillies, Montpelier, VT, for Defendants.

OPINION and ORDER

WILLIAM K. SESSIONS III, Chief Judge.

Plaintiff Ethel Kellogg has sued defendants Wyeth, maker of Reglan, and several generic drug manufacturers of bioequivalent metoclopramide, the active ingredient in Reglan. Kellogg's second amended complaint alleges that the drug company defendants are liable for Kellogg's overexposure to metoclopramide, prescribed for treatment of gastroesophageal reflux disease ("GERD"). The complaint alleges that both Wyeth and the generic manufacturers were aware of the risk of long-term use of the drugs, yet took no steps to discourage the practice.

Several generic drug manufacturers seek dismissal of the complaint against them, arguing that Kellogg's claims are preempted by the Federal Food Drug & Cosmetic Act ("FDCA"), 21 U.S.C. § 301-399a, and its accompanying regulations. Before the Court are Defendant Actavis-Elizabeth, L.L.C.'s ("Actavis") motion to dismiss the complaint under Rule 12(b)(6) (Doc. 29); Defendant Teva Pharmaceuticals USA, Inc.'s ("Teva") motion for judgment on the pleadings (Doc. 64); and Defendants Pliva, Inc. ("Pliva") and Barr Pharmaceuticals, Inc.'s ("Barr") motion to dismiss or for summary judgment (Doc. 67/70).

For the reasons that follow, the motions are denied.

Background

For four years, from 2000 to June 2004, Kellogg took generic metoclopramide as prescribed as treatment for GERD. Prolonged use of metoclopramide, a neuroleptic or antipsychotic drug, can lead to tardive dyskinesia, a neurological disorder, and related extrapyramidal symptoms ("EPS"). EPS is a group of symptoms that may be side effects of antipsychotic medication, and include involuntary movements, tremors, rigidity, restlessness, muscle contractions and the like. According to her complaint, Kellogg's use of metoclopramide caused her to suffer a serious and permanent tardive dyskinesia syndrome, which includes oral dystonic facial grimacing, lip twisting, tongue thrusting, uncontrolled pronation of her feet, gait instability, difficulty swallowing and difficulty controlling her hands and arms.

Kellogg filed her complaint against Wyeth, manufacturer of Reglan, the name brand form of metoclopramide, and several manufacturers of generic metoclopramide. Of the eight counts in her second amended complaint, five are products liability claims brought against all defendants, in which she asserts breach of a duty to exercise reasonable care in product labeling (Count Four); negligence per se in misbranding a prescription drug product (Count Five); strict products liability for failure to provide adequate warnings and instructions for the drug (Count Six); breach of express warranties for failure of the drug to conform to the defendants' representations (Count Seven); and breach of implied warranties since the drug was not fit for its common, ordinary and intended use in long-term therapy for GERD (Count Eight).

Essentially the generic drug manufacturers assert that because federal law requires them to label their product with exactly the same label as the one approved by the Food and Drug Administration ("FDA") for the name brand manufacturer, federal law preempts any state court tort claim based on failure-to-warn.

I. Regulatory Framework

The FDA is the federal agency charged with "protect[ing] the public health by ensuring that human ... drugs are safe and effective." 21 U.S.C. § 393(b)(2)(B). To that end, the FDA regulates the introduction into interstate commerce of all new drugs. Id. § 355. In 1938, the FDCA established a system of premarket approval for drugs. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 612, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973); see Pub.L. No. 717, 52 Stat. 1040 (1938). Under the 1938 Act, a new drug could not be marketed unless it was shown to be safe for its intended use. See Weinberger, 412 U.S. at 612-13, 93 S.Ct. 2469. The Drug Amendments of 1962 amended the FDCA to require that new drugs be both safe and effective for their intended use. See id.; Pub.L. No. 87-781, sec. 102(a)(1), 76 Stat. 780, 781 (1962).

In order to market a new drug one must file a New Drug Application ("NDA") with the FDA, which must include full reports of investigations into the drug's safety and effectiveness; a list of the drug's components; a full statement of the drug's composition; a description of the manufacturing methods, processing and packing; and "specimens of the labeling proposed to be used for such drug," among other things. 21 U.S.C. § 355(b)(1). The FDA must refuse to approve the NDA if it finds, among other things, that the reports of testing show that the drug is unsafe, fail to show that the drug is safe or are inadequate to show that the drug is safe; that the manufacturing methods are inadequate; that it has insufficient information to determine whether the drug is safe; that there is a lack of substantial evidence that the drug will have its intended effect; or "based on a fair evaluation of all material facts, [the] labeling is false or misleading in any particular." Id. § 355(d). It must withdraw approval of a new drug if it finds that the drug is unsafe, or there is a lack of substantial evidence that the drug is effective. Id. § 355(e).

At the times relevant to this litigation,1 the FDA required prescription drug labeling to "contain a summary of the essential scientific information needed for the safe and effective use of the drug," 21 C.F.R. § 201.56(a) (2004), as well as to include sections describing contraindications, warnings, precautions and adverse reactions. Id. § 201.57(d)-(g) (2004). A manufacturer was required to revise the labeling to include a warning "as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Id. § 201.57(e) (2004).

The FDA also prescribed the procedure by which the labeling for a drug approved under an NDA could be changed to address new information about risks from the use of the drug. See 21 C.F.R. § 314.70(b)(3) (2004). Under § 314.70(c)(2)(i), a change in labeling "[t]o add or strengthen a contraindication, warning, precaution or adverse reaction" could be made before FDA approval by submitting a supplement to the FDA at the time the labeling is changed. Id., § 314.70(c)(2)(i) (2004); see also Proposed Rule, New Drug and Antibiotic Regulations, 47 Fed. Reg. 46,622, 46,623, 46,635 (Oct. 19, 1982) (agency preclearance not required to effect changes to correct concerns about newly discovered risks from the use of the drug). Such a supplemental submission is known as a "Changes Being Effected," or "CBE" supplement.

The FDA maintains a public list of drugs which have been approved for safety and effectiveness under 21 U.S.C. § 355(c). See 21 U.S.C. § 355(j)(7). Drugs on this list are known as "listed drugs." See id., § 355(j)(2)(A)(i). Once a listed drug loses patent protection, a company may seek permission from the FDA to market a generic version of the drug.

The Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Amendments") amended the FDCA to authorize an abbreviated new drug application ("ANDA") process for generic drugs that are bioequivalent to approved new drugs. See Pub.L. No. 98-417, sec. 101, 98 Stat. 1585 (codified at 21 U.S.C. § 355(j)). The legislation's purpose "was to increase competition in the drug industry by facilitating the approval of generic copies of drugs." Mead Johnson Pharm. Group v. Bowen, 838 F.2d 1332, 1333 (D.C.Cir.1988). The Hatch-Waxman Amendments essentially adopted the FDA's procedure at the time for approving generic drugs. See Final Rule, Abbreviated New Drug Application Regulations, 57 Fed. Reg. 17,950, 17,951 (Apr. 28, 1992).

An ANDA must include "information to show that the new drug is bioequivalent to the listed drug," 21 U.S.C. § 355(j)(2)(A)(iv), and "information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug," with limited exceptions. Id., § 355(j)(2)(A)(v). The ANDA applicant is not required to conduct its own safety and effectiveness testing, but is permitted to rely upon the safety and effectiveness evidence presented in the NDA for the listed drug. See Smith-Kline Beecham Consumer Healthcare, L.P. v. Watson Pharms., Inc., 211 F.3d 21, 26 (2d Cir.2000); Mead Johnson, 838...

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