Huck v. Wyeth, Inc., No. 12–0596.

• Court: United States State Supreme Court of Iowa
• Writing for the Court: WATERMAN
• Citation: 850 N.W.2d 353
• Parties: Theresa HUCK, Appellant, v. WYETH, INC. d/b/a Wyeth; Schwarz Pharma, Inc.; and Pliva, Inc., Appellees.
• Decision Date: 11 July 2014
• Docket Number: No. 12–0596.

850 N.W.2d 353

Theresa HUCK, Appellant,
v.
WYETH, INC. d/b/a Wyeth; Schwarz Pharma, Inc.; and Pliva, Inc., Appellees.

No. 12–0596.

Supreme Court of Iowa.

July 11, 2014.

[850 N.W.2d 355]

Terrence J. Donahue Jr. of McGlynn Glisson & Mouton, Baton Rouge, Louisiana, and James R. Van Dyke of Eich, Van Dyke, Werden & Steger PC, Carroll, for appellant.

Henninger S. Bullock and Andrew J. Calica of Mayer Brown LLP, New York, New York, and Carl J. Summers of Mayer Brown LLP, Washington, DC, for appellee Schwarz Pharma, Inc.

[850 N.W.2d 356]

Jeffrey F. Peck, Linda E. Maichl, Joseph P. Thomas of Ulmer & Berne LLP, Cincinnati, Ohio, and Gregory M. Lederer of Lederer Weston Craig PLC, Cedar Rapids, for appellee PLIVA, Inc.

Kevin C. Newsom and Lindsey C. Boney IV of Bradley Arant Boult Cummings LLP, Birmingham, Alabama, for appellee Wyeth, Inc.

Richard J. Sapp and Ryan G. Koopmans of Nyemaster, Goode, West, Hansell & O'Brien, P.C., Des Moines, for appellees Wyeth, Inc. and Schwarz Pharma, Inc.

WATERMAN, Justice.

This products liability action against pharmaceutical companies presents several issues involving the interplay between state tort law and federal prescription drug regulation. This case is one of many litigated in state and federal courts nationwide alleging severe side effects from prolonged use of metoclopramide, sold under the brand name Reglan and as a competing generic formulation. The plaintiff in this case used only the generic product. After developing a neurological disorder, she sued the manufacturer of the generic drug as well as the manufacturers of the branded formulation.

The district court dismissed all of plaintiff's claims in several summary judgment rulings. The district court, relying on PLIVA, Inc. v. Mensing, 564 U.S. ––––, ––––, 131 S.Ct. 2567, 2580–81, 180 L.Ed.2d 580, 595 (2011), ruled plaintiff's claims against the generic manufacturer were preempted by federal law that requires conformity with the brand manufacturers' warning labels approved by the Food and Drug Administration (FDA). The district court granted summary judgment for the brand manufacturers based on Mulcahy v. Eli Lilly & Co., which requires proof the defendant manufactured or supplied the product that caused plaintiff's injury. 386 N.W.2d 67, 76 (Iowa 1986). The court of appeals affirmed. We granted plaintiff's application for further review.

For the reasons explained below, we hold plaintiff's state common law tort claims against the generic manufacturer based on inadequate warnings are not preempted to the extent that the generic manufacturer failed to implement a stronger warning approved by the FDA in 2004. We decline, however, to alter long-standing Iowa products liability law to allow recovery against a manufacturer for injuries caused by use of its competitor's product. We thereby join the overwhelming majority of courts, including every federal circuit court of appeals, in holding Reglan brand manufacturers are not liable to plaintiffs who consumed only the competing generic formulation. Accordingly, we vacate the decision of the court of appeals, affirm the district court's summary judgment for the brand manufacturers, reverse in part the summary judgment for the generic manufacturer, and remand for further proceedings against that defendant alone.

I. Background Facts and Proceedings.

We begin with a discussion of federal drug labeling regulation to provide the necessary context for the fighting issues. In 1984, Congress passed the Hatch–Waxman Amendments to the Food, Drug, and Cosmetics Act (FDCA) in order to expand access to affordable generic drugs by reducing barriers to generic market entry. Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98–417, 98 Stat. 1585 (codified in relevant part at 21 U.S.C. § 355 (1988)); see also Mensing, 564 U.S. at ––––, 131 S.Ct. at 2574, 180 L.Ed.2d at 588. Prior federal law compelled virtually all companies to file a new drug application—requiring costly

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clinical trials—to receive FDA approval to market a drug. Mensing, 564 U.S. at ––––, 131 S.Ct. at 2574, 180 L.Ed.2d at 588. Hatch–Waxman eliminated this requirement for a generic drug applicant, instead requiring the applicant to demonstrate its product's chemical and biological equivalence to a previously approved drug—i.e., a brand manufacturer's drug. See id. at ––––, 131 S.Ct. at 2574, 180 L.Ed.2d at 588; see also21 U.S.C. § 355(j)(2)(A) (2006).

When a brand manufacturer first files a new drug application, the FDA must approve the accuracy and adequacy of a drug's label. See21 U.S.C. § 355(a), (b)(1), (d); Wyeth v. Levine, 555 U.S. 555, 566–67, 129 S.Ct. 1187, 1195, 173 L.Ed.2d 51, 61 (2009). After the initial approval of the new drug application, a brand manufacturer may update its label by filing an application with the FDA to “add or strengthen a contraindication, warning, precaution, or adverse reaction” or to “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product,” but it need not wait for FDA approval. 21 C.F.R. § 314.70(c)(6)(iii)(A), (C) (2006); see also Levine, 555 U.S. at 567–68, 129 S.Ct. at 1196, 173 L.Ed.2d at 62. The equivalence of brand-name and generic drugs is the foundation of the generic drug approval process, and accordingly, federal regulations “require that the warning labels of a brand-name drug and its generic copy must always be the same—thus, generic drug manufacturers have an ongoing federal duty of ‘sameness.’ ” Mensing, 564 U.S. at ––––, 131 S.Ct. at 2574–75, 180 L.Ed.2d at 589; see also, e.g.,21 U.S.C. § 355(j)(2)(A)(v), (4)(G); 21 C.F.R. §§ 314.94(a)(8), .127(a)(7); Abbreviated New Drug Application Regulations, 57 Fed.Reg. 17950–01, 17961 (Apr. 28, 1992) (“[T]he [generic drug's] labeling must be the same as the listed drug product's labeling because the listed drug product is the basis for [generic drug] approval.”). The requirement that generic labeling mirrors that of the brand drug ensures generic manufacturers do not mislead consumers by “inaccurately imply[ing] a therapeutic difference between the brand and generic drugs.” Mensing, 564 U.S. at ––––, 131 S.Ct. at 2576, 180 L.Ed.2d at 590. Manufacturers—both brand and generic—are required to propose stronger warning labels to the FDA if they believe such warnings are needed. Id. at ––––, 131 S.Ct. at 2576, 180 L.Ed.2d at 591.

The United States Supreme Court decisions of Levine and Mensing set parameters for when state-law failure-to-warn claims are preempted by federal prescription drug labeling regulations. First, Levine held that federal drug regulations do not preempt state-law failure-to-warn claims against brand manufacturers because federal law allows brand manufacturers to unilaterally strengthen their warnings. 555 U.S. at 573, 129 S.Ct. at 1199, 173 L.Ed.2d at 65 (concluding requiring brand drug manufacturers to comply with a state-law duty to warn would not obstruct the purposes and objectives of federal drug labeling regulation). “The Court did not find it significant that the FDA has authority to reject unilateral labeling changes ... finding it ‘difficult to accept’ that the FDA would not have permitted a change to a stronger warning.” Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 582 (6th Cir.2013) (quoting Levine, 555 U.S. at 570, 129 S.Ct. at 1197, 173 L.Ed.2d at 63). After Levine, some courts reasoned that generic drug manufacturers would then also be subject to state-law failure-to-warn claims. See, e.g., Demahy v. Actavis, Inc., 593 F.3d 428, 430 (5th Cir.2010)( [“Levine ] shadows our conclusion that the federal regulatory regime governing generics is also without preemptive effect.”), rev'd

[850 N.W.2d 358]

sub nom. Mensing, 564 U.S. at ––––, 131 S.Ct. at 2573, 180 L.Ed.2d at 587; Mensing v. Wyeth, Inc., 588 F.3d 603, 607 (8th Cir.2009) (“After [ Levine ], we must view with a questioning mind the generic defendants' argument that Congress silently intended to grant the manufacturers of most prescription drugs blanket immunity from state tort liability when they market inadequately labeled products.”), rev'd sub nom. Mensing, 564 U.S. at ––––, 131 S.Ct. at 2573, 180 L.Ed.2d at 587.

But, the Supreme Court held otherwise in Mensing, a case involving generic manufacturers of metoclopramide. 564 U.S. at ––––, 131 S.Ct. at 2572, 180 L.Ed.2d at 586. The five-justice majority noted the FDA interprets its regulations “to allow changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA's instructions.” Id. at ––––, 131 S.Ct. at 2575, 180 L.Ed.2d at 590 (emphasis added). Otherwise, a generic manufacturer is obligated to copy the brand manufacturer's approved label. See id. at ––––, 131 S.Ct. at 2575, 180 L.Ed.2d at 590. Accordingly, the Court agreed with the FDA's interpretation of its regulations that “changes unilaterally made to strengthen a generic drug's warning label would violate the statutes and regulations requiring a generic drug's label to match its brand-name counterpart's.” Id. at ––––, ––––, 131 S.Ct. at 2575, 2580, 180 L.Ed.2d at 590, 595 (emphasis added) (highlighting that “[b]efore the Manufacturers could satisfy state law, the FDA—a federal agency—had to undertake special effort permitting them to do so”). Due to this conflict, the Court held federal law categorically preempts state-law failure-to-warn claims against generic manufacturers. Id. at ––––, 131 S.Ct. at 2580–81, 180 L.Ed.2d at 595. “The Court distinguished the situation in [ Levine], which it characterized as holding that ‘the possibility of impossibility’ (i.e., possible FDA subsequent denial) was not enough for impossibility preemption from the case at hand, which concerned ‘the possibility of possibility’ (i.e., possible FDA prior approval).” Fulgenzi, 711 F.3d at 583 (quoting Mensing, 564 U.S. at ––––n. 8, 131 S.Ct. at 2581 n. 8, 180 L.Ed.2d at 596 n. 8)....