Mensing v. Wyeth, Inc., 08-3850.

Citation588 F.3d 603
Decision Date27 November 2009
Docket NumberNo. 08-3850.,08-3850.
PartiesGladys MENSING, Plaintiff-Appellant, v. WYETH, INC., doing business as Wyeth; Pliva, Inc.; Teva Pharmaceuticals, USA, Inc.; Alpharma, Inc., doing business as Alpharma Pharmaceuticals; UDL Laboratories, Inc.; Actavis Elizabeth, LLC; Schwarz Pharma, Inc.; Purepac Pharmaceutical Company, 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-Appellees.
CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)

Louis M. Bograd, argued, Washington, DC, (Claire P. Prestel Washington, DC, Daniel J. McGlynn, Baton Rouge, LA, Michael K. Johnson, Lucia J.W. McLaren, Wilbur W. Fluegel, Minneapolis, MN, on the brief) for appellant.

Henninger S. Bullock, argued, New York, NY, (Scott Chesin, Andrew Calica, New York, NY, Bridget Maria Ahmann, Erin Marie Verneris, Minneapolis, MN, on the brief) for appellee, Schwarz Pharma, Inc.

Joseph Paul Thomas, argued, Cincinnati, OH, (Linda E. Maichl, Cincinnati, OH, David L. Hashmall, Minneapolis, MN, on the brief) for appellee, Pliva, Inc.

Before WOLLMAN, MURPHY, and BYE, Circuit Judges.

MURPHY, Circuit Judge.

Gladys Mensing brought this failure to warn and misrepresentation case against a number of manufacturers of Reglan and its generic form, alleging that the medication she had taken caused her to develop tardive dyskinesia, a severe neurological movement disorder. The manufacturers moved for summary judgment and dismissal. The district court dismissed her claims against the generic defendants on the basis of federal preemption and against the name brand manufacturers on the basis that she had not taken their products. Mensing appeals, and we affirm the judgment in favor of the name brand manufacturers but reverse as to the generic manufacturers.

I.

In March 2001 Gladys Mensing's doctor prescribed Reglan to treat her diabetic gastroparesis, and her pharmacist filled her prescription with its generic bioequivalent, metoclopramide. Minn.Stat. § 151.21. After four years of ingesting metoclopramide, Mensing developed tardive dyskinesia. Mensing sued the manufacturers and/or distributors of generic metoclopramide (generic defendants). Mensing's complaint includes a variety of claims, but she has not challenged the district court's characterization that "at the core" they all assert failure to warn. Mensing v. Wyeth, Inc., 562 F.Supp.2d 1056, 1058 (D.Minn.2008). Mensing argues that despite mounting evidence that long term metoclopramide use carries a risk of tardive dyskinesia far greater than indicated on the label, no metoclopramide manufacturer took steps to change the label warnings. According to her allegations, metoclopramide manufacturers in fact promoted the drug for long term use. Although she never ingested the name brand drug, Mensing also sued the manufacturers of Reglan (name brand defendants) for fraud and negligent misrepresentation on the theory that her doctor relied on Reglan's label when assessing the risks and proper use of metoclopramide.

All defendants filed motions to dismiss or for summary judgment. The district court granted the motions to dismiss by generic defendants Actavis Elizabeth and Pliva and motions for summary judgment by generic defendants Teva, Wyeth, and UDL Laboratories on the ground of federal preemption. The court concluded that Mensing's failure to warn claims created an impermissible conflict with federal law because they would require generic manufacturers to deviate from the name brand drug label; they were therefore preempted. The court also granted summary judgment to name brand defendants Schwarz and Wyeth,1 holding that they owed Mensing no duty of care under Minnesota law because she never ingested their product.

Grants of motions to dismiss and for summary judgment are subject to de novo review. We affirm a dismissal if, taking all the plaintiff's allegations as true, they "state a claim to relief that is plausible on its face." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). On review of summary judgment, we "view the evidence in the light most favorable to the nonmoving party" and affirm only when "there are no genuine issues of material fact[.]" Takele v. Mayo Clinic, 576 F.3d 834, 838 (8th Cir.2009) (quotations omitted).

II.

We first address the generic defendants' argument that federal law preempts state failure to warn claims against them. Since a purely legal issue of statutory interpretation is raised, the generic defendants' motions for summary judgment and dismissal will be considered together.

A.

All prescription drugs require approval by the Food and Drug Administration (FDA) before they may be marketed. Manufacturers of new drugs submit a new drug application (NDA) to the FDA. 21 U.S.C. § 355(a)-(b). An NDA must include information about the drug's safety and efficiency gleaned from clinical trials. Id. at §§ 355(b), (d). It must also propose a label reflecting appropriate use, warnings precautions, and adverse reactions. 21 C.F.R. § 201.56.

Recognizing a need to bring more affordable generic drugs to market as quickly as possible after the patents of name brand drugs expire, Congress passed the Drug Price Competition and Patent Term Restoration Act in 1984. This statute amended the Food, Drug, and Cosmetic Act (FDCA) and is therefore referred to as the Hatch-Waxman Amendments to the FDCA. The Hatch-Waxman Amendments provided an abbreviated new drug application (ANDA) procedure for generic manufacturers. 21 U.S.C. § 355(j). Generic manufacturers do not need to repeat the clinical trials conducted by name brand manufacturers. ANDA's are approved based on the initial safety profile of the name brand drug, as well as any postmarketing surveillance. See Bartlett v. Mutual Pharmaceutical Co., Inc., ___ F.Supp.2d ___, ___-___, No. 08-cv-358-JL, 2009 WL 3126305, at *2-*6 (D.N.H. Sept. 30, 2009) (detailing requirements and history of ANDA procedure). As a result, ANDA applicants must show the FDA that their drug is essentially the same as the name brand drug and that their proposed label is in relevant part identical to the name brand drug label. 21 C.F.R. § 314.94(a)(8).

Drug labels are subject to change. New risks may become apparent only after the drug has been used more widely and for longer periods. When a manufacturer has "reasonable evidence of an association of a serious hazard with a drug[,]" the drug's label must be revised; "a causal relationship need not have been proved." 21 C.F.R. § 201.57(e) (redesignated as 21 C.F.R. § 201.80(e) in 2006, after the conduct at issue here). Manufacturers cannot distribute a "misbranded" drug, 21 U.S.C. §§ 331(a)-(b), including a drug whose "labeling is false or misleading in any particular." Id. at § 352(a). The FDA has several enforcement mechanisms to ensure that drugs with misleading labels are taken off the market. See, e.g., id. at § 333, 355(e).

There are several procedures in 21 C.F.R. § 314.70 by which a manufacturer may supplement its application and propose changes to the drug or its label. "Major changes" require the FDA's prior approval through a prior approval supplement. 21 C.F.R. § 314.70(b). Manufacturers may implement "moderate changes," including changing a label to strengthen a warning based on newly acquired information, through a Changes Being Effected (CBE) supplement. 21 C.F.R. § 314.70(c)(6)(iii)(A)-(D). Manufacturers may implement CBE changes before the FDA formally approves them.

The FDA approved Reglan in 1980. Manufacturers began seeking approval for generic versions of metoclopramide five years later. The generic metoclopramide labels have always been in relevant part the same as the Reglan label. The label warnings about tardive dyskinesia, and other similar but less severe extrapyramidal symptoms, did not change from 1985 through the time Mensing stopped ingesting the drug in 2005. Mensing alleges that despite mounting evidence that long term metoclopramide users were at a much greater risk of movement disorders than indicated by the drug's label, no manufacturer took any step to enhance the warnings.2 Moreover, Mensing asserts that defendants promoted metoclopramide for long term use even though the FDA had approved the drug only for use up to 12 weeks.

Acting on its own initiative pursuant to the Food and Drug Administration Amendments Act of 2007, Pub.L. No. 110-85, 121 Stat. 823 (FDAAA), the FDA ordered manufacturers of Reglan and generic metoclopramide on February 26, 2009 to add a boxed warning to their labels about the increased risks of tardive dyskinesia from long term metoclopramide usage.

B.

In considering a preemption defense we must be attuned to Congressional intent and the presumption against preemption. Wyeth v. Levine, ___ U.S. ___, 129 S.Ct. 1187, 1194-95, 173 L.Ed.2d 51 (2009) (quotation omitted) (courts must assume "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."). In Wyeth, the Supreme Court ruled that failure to warn claims against name brand manufacturers are not preempted by the FDCA. The Court noted the historic coexistence of state tort remedies and federal regulation of...

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