Pliva, Inc. v. Mensing

564 U.S. 604

131 S.Ct. 2567

180 L.Ed.2d 580

PLIVA, INC., et al., Petitioners,

v.Gladys MENSING.

Actavis Elizabeth, LLC, Petitioner,

v.Gladys Mensing.

Actavis, Inc., Petitioner,

v.Julie Demahy.

Nos. 09–993

09–1039

09–1501.

Supreme Court of the United States

Argued March 30, 2011.

Decided June 23, 2011.

Jay P. Lefkowitz, New York, NY, for Petitioners.

Louis M. Bograd, Washington, DC, for Respondents.

Edwin S. Kneedler, for United States as amicus curiae, by special leave of the Court, supporting the Respondents.

Alexandra W. Miller, Jane M. Ricci, Zuckerman Spaeder LLP, Washington, DC, for Petitioner Actavis Inc.

Irene C. Keyse-Walker, Richard A. Dean, Tucker Ellis & West LLP, Cleveland, OH, for Petitioners Actavis Elizabeth LLC and Actavis Inc.Joseph P. Thomas, Linda E. Maichl, Ulmer & Berne LLP, Cincinnati, OH, Jay P. Lefkowitz, P.C., Michael D. Shumsky, Philippa Scarlett, Kirkland & Ellis LLP, New York, NY, Richard A. Oetheimer, Goodwin Procter LLP, Boston, MA, Jonathan I. Price, Goodwin Procter LLP, New York, NY, William F. Sheehan, Goodwin Procter LLP, Washington, DC, for Petitioners Pliva, Inc., Teva Pharms. USA, Inc., and UDL Labs, Inc.

Michael K. Johnson, Lucia J. W. McLaren, Goldenberg & Johnson, P.L.L.C., Minneapolis, MN, Daniel J. McGlynn, McGlynn, Glisson & Mouton, Baton Rouge, LA, Claire Prestel, Washington, DC, for Respondent Gladys Mensing.

Louis M. Bograd, Washington, DC, for Respondents Gladys Mensing & Julie Demahy.

Richard A. Tonry, II, Raymond Brinson, Brian L. Glorioso, Kristine K. Sims, Tonry, Brinson & Glorioso, L.L.C., Slidell, LA, for Respondent Julie Demahy.

Justice THOMAS delivered the opinion of the Court, except as to Part III–B–2.^*

These consolidated lawsuits involve state tort-law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for generic metoclopramide. The question presented is whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. We hold that they do.

I

Metoclopramide is a drug designed to speed the movement of food through the digestive system. The Food and Drug Administration (FDA) first approved metoclopramide tablets, under the brand name Reglan, in 1980. Five years later, generic manufacturers also began producing metoclopramide. The drug is commonly used to treat digestive tract problems such as diabetic gastroparesis and gastroesophageal reflux disorder.

Evidence has accumulated that long-term metoclopramide use can cause tardive dyskinesia, a severe neurological disorder. Studies have shown that up to 29% of patients who take metoclopramide for several years develop this condition. McNeil v. Wyeth, 462 F.3d 364, 370, n. 5 (C.A.5 2006) ; see also Shaffer, Butterfield, Pamer, & Mackey, Tardive Dyskinesia Risks and Metoclopramide Use Before and After U.S. Market Withdrawal of Cisapride, 44 J. Am. Pharmacists Assn. 661, 663 (2004) (noting 87 cases of metoclopramide-related tardive dyskinesia reported to the FDA's adverse event reporting system by mid–2003).

Accordingly, warning labels for the drug have been strengthened and clarified several times. In 1985, the label was modified to warn that "tardive dyskinesia... may develop in patients treated with metoclopramide," and the drug's package insert added that "[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended." Physician's Desk Reference 1635–1636 (41st ed.1987); see also Brief for Petitioner PLIVA et al. 21–22 (hereinafter PLIVA Brief). In 2004, the brand-name Reglan manufacturer requested, and the FDA approved, a label change to add that "[t]herapy should not exceed 12 weeks in duration."

Brief for United States as Amicus Curiae 8 (hereinafter U.S. Brief). And in 2009, the FDA ordered a black box warning—its strongest—which states: "Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible .... Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases." See Physician's Desk Reference 2902 (65th ed.2011).

Gladys Mensing and Julie Demahy, the plaintiffs in these consolidated cases, were prescribed Reglan in 2001 and 2002, respectively. Both received generic metoclopramide from their pharmacists. After taking the drug as prescribed for several years, both women developed tardive dyskinesia.

In separate suits, Mensing and Demahy sued the generic drug manufacturers that produced the metoclopramide they took (Manufacturers). Each alleged, as relevant here, that long-term metoclopramide use caused her tardive dyskinesia and that the Manufacturers were liable under state tort law (specifically, that of Minnesota and Louisiana) for failing to provide adequate warning labels. They claimed that "despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than that indicated on the label," none of the Manufacturers had changed their labels to adequately warn of that danger. Mensing v. Wyeth, Inc., 588 F.3d 603, 605 (C.A.8 2009) ; see also Demahy v. Actavis, Inc., 593 F.3d 428, 430 (C.A.5 2010).

In both suits, the Manufacturers urged that federal law pre-empted the state tort claims. According to the Manufacturers, federal statutes and FDA regulations required them to use the same safety and efficacy labeling as their brand-name counterparts. This means, they argued, that it was impossible to simultaneously comply with both federal law and any state tort-law duty that required them to use a different label.

The Courts of Appeals for the Fifth and Eighth Circuits rejected the Manufacturers' arguments and held that Mensing and Demahy's claims were not pre-empted. See 588 F.3d, at 614, 593 F.3d, at 449. We granted certiorari, 562 U.S. ––––, 131 S.Ct. 817, 178 L.Ed.2d 550 (2010), consolidated the cases, and now reverse each.

II

Pre-emption analysis requires us to compare federal and state law. We therefore begin by identifying the state tort duties and federal labeling requirements applicable to the Manufacturers.

A

It is undisputed that Minnesota and Louisiana tort law require a drug manufacturer that is or should be aware of its product's danger to label that product in a way that renders it reasonably safe. Under Minnesota law, which applies to Mensing's lawsuit, "where the manufacturer ... of a product has actual or constructive knowledge of danger to users, the ... manufacturer has a duty to give warning of such dangers." Frey v. Montgomery Ward & Co., 258 N.W.2d 782, 788 (Minn.1977). Similarly, under Louisiana law applicable to Demahy's lawsuit, "a manufacturer's duty to warn includes a duty to provide adequate instructions for safe use of a product." Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 269–270 (C.A.5 2002) ; see also La.Rev.Stat. Ann. § 9:2800.57 (West 2009). In both States, a duty to warn falls specifically on the manufacturer. See Marks v. OHMEDA, Inc., 2003–1446, pp. 8–9 (La.App.3/31/04), 871 So.2d 1148, 1155; Gray v. Badger Min. Corp., 676 N.W.2d 268, 274 (Minn.2004).

Mensing and Demahy have pleaded that the Manufacturers knew or should have known of the high risk of tardive dyskinesia inherent in the long-term use of their product. They have also pleaded that the Manufacturers knew or should have known that their labels did not adequately warn of that risk. App. 437–438, 67–69, 94–96. The parties do not dispute that, if these allegations are true, state law required the Manufacturers to use a different, safer label.

B

Federal law imposes far more complex drug labeling requirements. We begin with what is not in dispute. Under the 1962 Drug Amendments to the Federal Food, Drug, and Cosmetic Act, 76 Stat. 780, 21 U.S.C. § 301 et seq., a manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate.¹ See, e.g., 21 U.S.C. §§ 355(b)(1), (d) ; Wyeth v. Levine, 555 U.S. 555, 567, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Meeting those requirements involves costly and lengthy clinical testing. §§ 355(b)(1)(A), (d) ; see also D. Beers, Generic and Innovator Drugs: A Guide to FDA Approval Requirements § 2.02[A] (7th ed.2008).

Originally, the same rules applied to all drugs. In 1984, however, Congress passed the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, commonly called the Hatch–Waxman Amendments. Under this law, "generic drugs" can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.² 21 U.S.C. § 355(j)(2)(A). This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug. A generic drug application must also "show that the [safety and efficacy] labeling proposed ... is the same as the labeling approved for the [brand-name] drug." § 355(j)(2)(A)(v) ; see also § 355(j)(4)(G) ; Beers §§ 3.01, 3.03[A].

As a result, brand-name and generic drug manufacturers have different federal drug labeling duties. A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. See, e.g., 21 U.S.C. §§ 355(b)(1), (d) ; Wyeth, supra, at 570–571, 129 S.Ct. 1187. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's. See, e.g., § 355(j)(2)(A)(v) ; § 355(j)(4)(G) ; 21 CFR §§ 314.94(a)(8), 314.127(a)(7).

The parties do not disagree. What is in dispute is whether, and to what extent, generic manufacturers may change their labels after initial FDA approval. Mensing and Demahy contend that federal law provided several avenues through which the Manufacturers could have altered their metoclopramide labels in time to prevent the injuries here. The FDA, however, tells us that it interprets its regulations to require that the warning labels of a brand-name drug and its...