Opinion ID: 2756494
Heading Depth: 2
Heading Rank: 3

Heading: Design Defect and Breach of Implied Warranty

Text: Brinkley next challenges the dismissal of her non-warning design defect and breach of implied warranty claims.6 Pliva maintains Brinkley’s claims are preempted 6 Brinkley proposes we should reverse the dismissal of these claims and remand “for initial consideration by the district court, as in Bell and Fullington.” We find remand unnecessary in this case. The Supreme Court’s analysis in Bartlett established -8- under Mensing and Bartlett, in which the Supreme Court held “that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under [Mensing].” Bartlett, 570 U.S. at ___, 133 S. Ct. at 2470. In Bartlett, the Supreme Court concluded federal law preempted a New Hampshire design defect claim against a generic drug manufacturer because the FDCA and its supporting regulations prohibited the manufacturer from altering the design of the allegedly defective drug or changing its labeling. See id. at ___, ___, 133 S. Ct. at 2470-71, 2475 (citing 21 U.S.C. § 355(j)(2)(A)(ii)-(v), (8)(B), and 21 C.F.R. § 320.1(c)). Noting “New Hampshire imposes design-defect liability only where ‘the design of the product created a defective condition unreasonably dangerous to the user,’” as determined by weighing “‘the magnitude of the danger’” against “‘the utility of the product,’” the Supreme Court determined a generic drug manufacturer could only avoid liability under state law “either by changing a drug’s design or by changing its labeling,” which federal law prohibits. Id. at ___, 133 S. Ct. at 2474, 2476 (quoting Vautour v. Body Masters Sports Indus., Inc., 784 A.2d 1178, 1181-82 (N.H. 2001), and discussing Restatement (Second) of Torts (Restatement) § 402A (1963 and 1964) (strict product liability)). The Supreme Court concluded the New Hampshire design defect claim was “‘without effect’” because it was impossible for the generic manufacturer to comply with both its state law duty to change the drug’s design or labeling and its federal law duty to keep the drug and its labeling the same “as the brand-name drug on which it is based.” Id. at ___, 133 S. Ct. at 2475-77 (quoting Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). The Supreme Court also rejected the proposition that the a clear framework for examining Brinkley’s remaining claims, and, unlike Fullington, the parties have had an opportunity to brief and argue these issues after Bartlett, leaving us without reservations about evaluating Brinkley’s claims under Missouri law. See Bartlett, 570 U.S. at ___, 133 S. Ct. at 2473-78. -9- manufacturer “could escape the impossibility” “by simply leaving the market.” Id. at ___, 133 S. Ct. at 2477-78. Thus under Mensing and Bartlett, federal law preempts any state law claim requiring a generic manufacturer to redesign its drug, change its labeling, or leave the market to avoid liability under state law. Since Bartlett, there is a growing consensus in the federal circuit courts that the preemption analysis in Mensing and Bartlett proves fatal to state law claims like Brinkley’s. See, e.g., Johnson, 758 F.3d at 61213; Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 679-80 (5th Cir. 2014); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig. (No. II), 751 F.3d 150, 164 (3d Cir. 2014); Drager v. PLIVA USA, Inc., 741 F.3d 470, 476-79 (4th Cir. 2014); Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 396-97 (6th Cir. 2013); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1288-89 (10th Cir. 2013). Analyzing Brinkley’s design defect and implied warranty claims under this framework, we conclude the FDCA and its supporting regulations preempt her claims because Pliva could only avoid liability under Missouri law by redesigning its product, changing its labeling, or leaving the market for metoclopramide.
Missouri, like New Hampshire, imposes design defect liability if the plaintiff establishes “the product, as designed, is unreasonably dangerous and therefore ‘defective’, and that the demonstrated defect caused [her] injuries.” Nesselrode v. Exec. Beechcraft, Inc., 707 S.W.2d 371, 375-76 (Mo. 1986) (en banc) (noting Missouri has adopted Restatement § 402A). Yet “Missouri courts have consistently refused to impose any ‘judicial definition [of unreasonably dangerous] whether derived from consumer expectations, risk-utility, or otherwise.’” Sappington v. Skyjack, Inc., 512 F.3d 440, 446 (8th Cir. 2008) (alteration in original) (quoting Rodriguez v. Suzuki Motor Corp., 996 S.W.2d 47, 65 (Mo. 1999) (en banc)). -10- Instead, in Missouri, “the concept of unreasonable danger . . . is presented to the jury as an ultimate issue without further definition.” Nesselrode, 707 S.W.2d at 378. “The jury gives this concept content by applying their collective intelligence and experience to the broad evidentiary spectrum of facts and circumstances presented by the parties.” Id. “The parties are ‘entitled to assist the jury in defining the term unreasonably dangerous by presenting evidence that the utility of a design outweighs its risks, or that consumer expectations were violated, or any other theory of unreasonable dangerousness supported by the evidence.’” Sappington, 512 F.3d at 446 (quoting Thompson v. Brown & Williamson Tobacco Corp., 207 S.W.3d 76, 90 (Mo. Ct. App. 2006)). Despite the considerable overlap between Missouri and New Hampshire design defect law, Brinkley argues Missouri’s “open-ended” approach to determining whether a product is defective distinguishes her claims from the one preempted in Bartlett. Brinkley places too much weight on Missouri’s approach to determining unreasonable danger. See Drager, 741 F.3d at 478 (concluding any difference between the risk-utility and consumer expectation approaches to evaluating “the unreasonableness of the danger of a product” was “immaterial”); Strayhorn, 737 F.3d at 396-97 (finding implied warranty and design defect claims preempted even though Tennessee had not resolved what “test applies to design-defect claims involving prescription drugs”). As the Sixth Circuit noted in Drager, the Supreme Court “did not determine that the New Hampshire law was preempted because it applied the risk-utility approach. Instead, it concluded that there was no action that the defendant could take under that approach to increase the safety of its product without violating the restrictions of the FDCA.” Drager, 741 F.3d at 478. The Sixth Circuit had “no trouble concluding that the same [wa]s true under either the risk-utility or the consumer-expectations approach.” Id. (“Regardless of the way in which Maryland assesses the unreasonableness of a product’s risks, if PLIVA’s metoclopramide is unreasonably -11- unsafe, there is no apparent action that PLIVA can take in compliance with FDCA restrictions to avoid strict liability.”). Brinkley has not proposed any action Pliva could take that would compel a different result under Missouri law. “Short of exiting the market—which Bartlett rejects—[Brinkley has] failed to identify anything [Pliva] can do [under Missouri’s approach] to reconcile [its] conflicting duties under state and federal law.” In re Fosamax, 751 F.3d at 165. Because Brinkley fails to explain how Pliva could avoid liability under Missouri law for the alleged design defects without changing its product, changing its labeling, or leaving the market, Brinkley’s design defect claims—whether sounding in strict liability or negligence—“are preempted by impossibility.” Drager, 741 F.3d at 476-78; accord In re Fosamax, 751 F.3d at 165.
Brinkley’s non-warning breach of implied warranty claims “fare no better.” Strayhorn, 737 F.3d at 395. In her amended complaint, Brinkley alleges Pliva’s “metoclopramide was not of merchantable quality or fit and safe for its intended use because it was unreasonably dangerous” and Brinkley and her healthcare providers relied on Pliva’s implied warranties to the contrary—to her detriment. The Mensing and Bartlett rationale applies with full force to such claims. See, e.g., Drager, 741 F.3d at 478-79; Schrock, 727 F.3d at 1288-89. At root, Brinkley’s implied warranty claims are an attack on Pliva’s product design or labeling. See Schrock, 727 F.3d at 1288 (“Under Bartlett, a claim that a generic drug manufacturer’s product is unfit for its intended use or unreasonably dangerous is one that would impose a duty to alter the composition of that drug.”). Such claims rush headlong into Pliva’s unyielding duty of sameness under federal law. See Bartlett, 570 U.S. at ___, ___, 133 S. Ct. at 2471, 2475; Drager, 741 F.3d at 478-79 (“[T]o the extent that implied warranties of merchantability or fitness for a particular purpose can arise in this context [i.e. prescription drugs,] . . . they are -12- preempted by the requirements of the FDCA.”); Schrock, 727 F.3d at 1289; cf. Johnson, 758 F.3d at 613 (“Any modified or supplemental warranties by Generic Defendants would have run afoul of the ‘duty of sameness’ identified in Mensing.”). Federal law preempts Brinkley’s implied warranty claims.