Geier v. Am. Honda Motor Co.

16 Analyses of this case by attorneys

  1. SG’s Latest Brief On Implied FDCA Preemption Under Buckman

    Reed Smith LLPJames BeckJune 5, 2015

    Id. Cf.Geier v. American Honda Motor Co., 529 U.S. 861, 881-82 (2000) (deliberate, policy-driven decision to not require certain action can constitute preemptive agency action). In a situation where a product was never even brought before an agency, Spreitsma’s no-preemption rationale would seem to apply even more strongly.

  2. Implied Preemption and Monograph Drugs

    Reed Smith LLPJames BeckDecember 12, 2016

    . . . To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail . . . .Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 352 (2001). See also: Spreitsma v. Mercury Marine, 537 U.S. 51, 65, 123 S.Ct. 518, 154 L.Ed.2d 466 (2002); Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000); Freightliner v. Myrick, 514 U.S. 280, 288-289 (1995). The combination found in §379r of preemption and savings clauses do not “create some kind of ‘special burden’” that would “specially disfavor pre-emption.”

  3. Toxic Tort and Environmental Litigation: What Does a Reformed TSCA Mean for Private Rights of Action Under State Law? (9/16)

    Bond, Schoeneck & King, PLLCThomas SmithSeptember 14, 2016

    [11] See 15 U.S.C. § 2617(g)(1)(B). [12] E.g., Sprietsma v. Mercury Marine, 537 U.S. 51, 63 (2002); Geier v. Am. Honda Motor Co., 529 U.S. 861, 868 (2000). [13] See 537 U.S. at 54.

  4. Wyeth v. Levine’s ‘Clear Evidence' Language: Clearly Misunderstood

    Foley Hoag LLPDavid GeigerFebruary 3, 2016

    )[18] See, e.g., 324 Liquor Corp. v Duffy, 479 U.S. 335, 351 (1987) (Supreme Court “customarily accepts the factual findings of state courts in the absence of exceptional circumstances”); Cal. Retail Liquor Dealers Ass’n v. Midcal Aluminum, 445 U.S. 97, 111-112 (“we customarily accept the factual findings of state courts in the absence of ‘exceptional circumstances’”); cf. Fed. R. Civ. P. 52(b) (findings of fact may not be set aside unless “clearly erroneous.”)[19] Geier v. Am. Honda Motor Co., 529 U.S. 861, 885 (2000) (emphasis added). Notably, however, the court did not rely on, or even quote, this language at any point in its decision in Wyeth, instead premising its holding on the Vermont courts’ factual findings and the lack of clear evidence to reverse them.

  5. Preemption and OTC Drugs

    Reed SmithSeptember 27, 2023

    tions contained in this part and each of the conditions contained in any applicable monograph. Any product which fails to conform to each of the conditions contained in this part and in an applicable monograph is liable to regulatory action.21 C.F.R. §330.1 (emphasis added). In fact, 21 U.S.C. §337(a) also tells us that the United States the sole authority to police alleged violations of the FDCA. It provides:[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.If that weren’t enough, Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), recognized that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 337(a). So, even setting aside 21 U.S.C. §379r for a moment, “it is false so it also is ‘misbranded’” claims can be impliedly preempted even if they are not expressly preempted. See Buckman, 531 U.S. at 352 (citing Geier v. American Honda Motor Co., 529 U.S. 861 (2000)).The second is that OTC monographs impose federal requirements—including labeling requirements—on the drugs they cover, and manufacturers are not free to unilaterally change them. As a result, implied preemption derived from PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) is worth consideration as well. For a fuller explanation of that, the blog also has you covered.Finally, getting back to express preemption, the whole, very general “false under state law is the same as misbranded under federal law” notion just doesn’t hold water. As noted, the FDA’s determination that an OTC drug “is not misbranded” per 21 C.F.R. §330.1 if it complies with monograph labeling is a determination that the label is not false or misleading. Challenging OTC monograph-compliant label statements as false under state law quite simply is an attempt to impose a state law requirement “that is different from or in addition to, or that is otherwise not i

  6. In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

    Reed Smith LLPJames BeckSeptember 24, 2015

    Buckman holds that, notwithstanding the absence of express preemption applicable to §510(k) medical devices under Lohr, implied preemption nonetheless bars tort claims that conflict with the FDA regulatory scheme. That the device in question wasn’t covered by express preemption in no way limits the applicability of implied preemption: To the extent [plaintiff] posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail [because] ... neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles.Id. at 352 (quoting Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000)). Thus, Lohr was no obstacle to implied preemption of a “fraud on the FDA” claim against the manufacturer of a §510(k) device.

  7. POM v Coca-Cola: The FDA, the Lanham Act and Regulation through Litigation

    Strasburger & Price, LLPMichael A. WalshJune 13, 2014

    Id. at 14. The Court reconciled the apparent inconsistency with its ruling in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), barring a claim where the federal agency allowed for various options for compliance, stating:Here, by contrast, the FDA has not made a policy judgment that is inconsistent with POM’s Lanham Act suit. This is not a case where a law suit is undermining an agency judgment, and in any event the FDA does not have authority to enforce the Lanham Act.

  8. Zogenix Prevails in Initial Challenge to Massachusetts Emergency Order Banning ZOHYDRO ER

    Hyman, Phelps & McNamara, P.C.Kurt R. KarstApril 16, 2014

    If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health. SeeGeier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000). The Commonwealth’s emergency order thus stands in the way of “the accomplishment and execution of” an important federal objective.

  9. Rear-View Liability: NHTSA Issues New Rule Requiring Rear Visibility Technology

    Schiff Hardin LLPShawna BootheApril 8, 2014

    The lawsuits were based on an alternative design theory that airbags were a safer technology installed in other vehicles and should have been installed on the vehicle that was the subject of the lawsuit.But in 2000, the United States Supreme Court held that In Geier v. Am. Honda Motor Co., Inc., defective design lawsuits over the phase-in of airbags were preempted by the NHTSA regulation. See Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861. The Court applied ordinary preemption principles and reasoned that NHTSA expressed a clear purpose for the phase-in of airbags in the regulation that would ‘actually conflict’ with tort actions against vehicle manufacturers in compliance with the phase-in.

  10. Williamson v. Mazda: Impact on FMVSS Preemption

    Rumberger Kirk & CaldwellMay 4, 2011

    At issue in Williamson was whether FMVSS 208, which provides manufacturers with a choice of installing lap and shoulder belts or only lap belts in rear inner seats, preempted a state lawsuit alleging that a Mazda mini van was defective for not having lap and shoulder belts.The Court used the analysis it created in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), in which it held that another portion of FMVSS 208 providing manufacturers with a choice of whether utilize passive restraint systems other than airbags pre-empted any state tort suit based upon the manufacturer’s decision not to use air bags.However, the Court came to the opposite conclusion with regard to the FMVSS provision at issue in Williamson.The Court identified the subsidiary questions it created in Geier to address the preemption question: (1) whether the statute’s express pre-emption provision pre-empts the state tort suit; (2) whether the statute’s saving clause forecloses operation of ordinary pre-emption principles (i.e. federal statutes pre-empt state laws that actually conflict with the federal law); and (3) whether the state tort action, in fact, conflicts with the federal regulation.