Ethel Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005). · Go Syfert
Ethel Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005). Cases Citing This Book View Copy Cite
81 citation events (81 in the last 25 years) across 23 distinct courts.
Strongest positive: Spier v. Coloplast Corp. (tned, 2015-08-17) · Strongest negative: Brown v. DePuy Spine, Inc. (masssuperct, 2007-04-09)
Treatment trajectory · 2005 → 2026 · click a year to view as-of
2005 2015 2026
Top citers, strongest first. 26 distinct citers. How cited ↗
discussed Cited "but see" Brown v. DePuy Spine, Inc.
Mass. Super. Ct. · 2007 · signal: but see · confidence high
But see Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.), cert. den., 126 S.Ct. 420 (2005) (negligence per se claim alleging failure to comply with FDA conditions of approval is a disguised fraud-on-the-FDA claim impliedly preempted under Buckman); Baker v. St.
examined Cited as authority (verbatim quote) Spier v. Coloplast Corp. (2×) also: Cited "see, e.g."
E.D. Tenn. · 2015 · signal: see also · quote attribution · 1 verbatim quote · confidence high
any claim, under state law, then, that defendant failed to warn patients beyond warnings required by the fda ... would constitute state requirements 'different from' or 'in addition to' the requirements of the federal pma application and supplement process.
examined Cited as authority (verbatim quote) Sadler v. Advanced Bionics, Inc. (2×) also: Cited as authority (rule)
W.D. Ky. · 2013 · quote attribution · 1 verbatim quote · confidence high
any claim, under state law, then, that defendant failed to warn patients beyond warnings required by the fda ... would constitute state requirements 'different from' or 'in addition to' the requirements of the federal pma application and supplement process.
examined Cited as authority (rule) Ronald Luckey v. Abbott Laboratories, Inc. (4×) also: Cited "see"
E.D. Ky. · 2026 · confidence medium
Litig., 352 F. App’x 994, 995 (6th Cir. 2009) (applying Garcia’s holding to post PMA approval fraud claims and noting that the dispositive factor is whether the claim requires “proof of fraud committed against the FDA”); Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (barring disguised fraud on the FDA claims under Buckman).
discussed Cited as authority (rule) Arnold v. CooperSurgical, Inc. (2×) also: Cited "see"
S.D. Ohio · 2025 · confidence medium
This type of argument is expressly preempted under federal law because any additional requirements “would constitute state requirements ‘different from’ or ‘in addition to’ the requirements of the federal PMA and supplement process.” Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) (quoting 21 U.S.C. § 360k(a)); see Kemp v. Medtronic, 231 F.3d 216, 236 (6th Cir. 2000) (“[T]o the extent that plaintiffs’ claim is premised on the adequacy of the warnings reviewed and approved by the FDA . . . the claim is . . . preempted.”) Thus, to the extent Ms. Arnold’s failure-…
discussed Cited as authority (rule) Farson v. CooperSurgical, Inc.
N.D. Ohio · 2023 · confidence medium
The Sixth Circuit has held that “[a]ny claim, under state law, . . . that Defendant failed to warn patients beyond warnings required by the FDA . . . would constitute state requirements ‘different from’ or ‘in addition to’ the requirements of the federal PMA application and supplement process.” Cupek v. Medtronic, 405 F.3d 421, 424 (6th Cir. 2005) (citing Kemp v. Medtronic, 231 F.3d 216, 235 (6th Cir. 2000)).
discussed Cited as authority (rule) Arnold v. CooperSurgical, Inc.
S.D. Ohio · 2023 · confidence medium
And in Cupek, a case involving allegedly defective pacemaker leads, the Sixth Circuit observed that it “is the Federal Government, rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (quoting Buckman, 531 U.S. at 349 n.4).
discussed Cited as authority (rule) Sundaramurthy v. Abbott Vascular, Inc.
D. Mass. · 2023 · confidence medium
Mass. Mar. 1, 2022) (holding that where a plaintiff alleges that Abbott breached its implied warranty “that the stent and its component parts were merchantable, safe and fit for ordinary purposes[,]” 3 To the extent that Plaintiff’s motion requests that his negligence claim “proceed to include . . . a theory of ‘negligent recall[,]’” [ECF No. 45 at 2], it is DENIED because the proposed amended complaint does not contain such a claim and, even if it did, “[a]ny claim, under state law, then, that Defendant failed to warn patients beyond warnings required by the FDA, or that Defen…
discussed Cited as authority (rule) Coghill v. Bayer Corporation (2×)
E.D. Ky. · 2020 · confidence medium
Such claims risk implied preemption because an attack on FDA-approved labeling and warning materials undermines the FDA’s prerogatives in medical device regulation.3 Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005). 3 Plaintiff argues Defendants could have changed Essure’s labeling and warning materials without FDA approval using the “Changes Being Effected” process. 21 C.F.R. § 814.39 (d).
discussed Cited as authority (rule) Hafer v. Medtronic, Inc. (2×) also: Cited "see, e.g."
W.D. Tenn. · 2015 · confidence medium
See Sprint, 623 F.3d at 1205 ; Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.2005) (citing Kemp, 231 F.3d at 235 ).
discussed Cited as authority (rule) Stengel v. Medtronic, Inc. (2×)
9th Cir. · 2012 · signal: cf. · confidence medium
Cf. Cupek v. Medtronic, Inc., 405 F.3d 421, 423-24 (6th Cir.2005) (negligence per se claim due to “failure to comply with [FDA] conditions of approval” preempted because it was a “disguised fraud on the FDA claim”).
discussed Cited as authority (rule) Purchase ex rel. Purchase-Weatherly v. Advanced Bionics, LLC
unknown court · 2011 · confidence medium
Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.2005) (citing Buckman, 531 U.S. at 349 , 121 S.Ct. 1012 , and finding allegation that Medtronic was negligent per se for failing to comply with FDA's conditions of approval was "a disguised fraud on the FDA claim,” and, therefore, impliedly preempted). .
cited Cited as authority (rule) Gentry v. HERSHEY CO.
M.D. Tenn. · 2010 · confidence medium
Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005); Bailey v. Johnson, 48 F.3d 965, 967 (6th Cir.1995).
cited Cited as authority (rule) Mattingly v. Medtronic, Inc.
E.D. Mo. · 2007 · confidence medium
Cupek v. Medtronic, Inc. 405 F.3d 421, 424 (6th Cir. 2005).
discussed Cited "see" Franks v. The Cooper Companies. Inc.
D.R.I. · 2024 · signal: see · confidence high
See Cupek v. Medtronic, Inc., 405 F.3d 421 , 444-45 & n.2 (6th Cir. 2005) (dispensing with the question of whether there was a state law duty to warn post-PMA because the court found that the claim was impliedly preempted).
examined Cited "see" Kubicki ex rel. Kubicki v. Medtronic, Inc. (3×) also: Cited "see, e.g."
D.C. Cir. · 2018 · signal: see · confidence high
See Cupek , 405 F.3d at 423 .
examined Cited "see" Kubicki v. Medtronic, Inc. (4×) also: Cited "see, e.g."
D.D.C. · 2018 · signal: see · confidence high
See Cupek, 405 F.3d at 423 .
discussed Cited "see" Aaron v. Medtronic, Inc. (2×) also: Cited "see, e.g."
S.D. Ohio · 2016 · signal: accord · confidence high
Accord Cupek, 405 F.3d at 423-24 (claim that manufacturer failed to comply with the FDA’s "conditions of approval,” which incorporate the FDCA’s reporting requirements, "is a disguised fraud on the FDA claim” preempted by Buckman); see also, e.g., Bryant v. Medtronic, Inc., 623 F.3d 1200, 1205 (8th Cir.2010) (claim that manufacturer was negligent for "not timely fil[ing] adverse-event reports, as required by federal regulations” impliedly preempted as "simply an attempt by private parties to enforce the MDA”); Hafer, 99 F.Supp.3d at 860-61 (claims based upon "failure to file advers…
discussed Cited "see" In Re Sulzer Hip Prosthesis and Knee Prosthesis Liability Litigation
N.D. Ohio · 2006 · signal: see · confidence high
See Cupek, 405 F.3d at 422, 424-25 (concluding that the plaintiff's "`post-sale failure to warn' and post-sale `failure-to-recall' claims" were preempted); Gomez, 442 F.3d at 931 ("Gomez's state-law claims related to [the defendant's] alleged failure to provide information obtained after the FDA approved the [medical device] risk the same interference with the federal regulatory scheme as her other claims and are preempted."). [11] The trial court and the Sixth Circuit Court of Appeals reached essentially the same conclusions again in Cupek . [12] It is also worth noting that Howard states his…
discussed Cited "see" Howard v. Sulzer Orthopedics, Inc.
N.D. Ohio · 2006 · signal: see · confidence high
See Cupek, 405 F.3d at 422, 424-25 (concluding that the plaintiffs " 'post-sale failure to warn' and post-sale ‘failure-to-recall’ claims” were preempted); Gomez, 442 F.3d at 931 ("Gomez’s state-law claims related to [the defendant’s] alleged failure to provide information obtained after the FDA approved the [medical device] risk the same interference with the federal regulatory scheme as her other claims and are preempted.”). .
discussed Cited "see" McMullen, Jack v. Medtronic Inc
7th Cir. · 2005 · signal: accord · confidence high
Accord Cupek v. Medtronic, Inc., 405 F.3d 421, 424-25 (6th Cir. 2005) (holding that common-law post-sale duty to warn claim was preempted by requirements imposed through the PMA process).
cited Cited "see" Jack McMullen and Barbara McMullen v. Medtronic, Inc.
7th Cir. · 2005 · signal: accord · confidence high
Accord Cupek v. Medtronic, Inc., 405 F.3d 421, 424-25 (6th Cir.2005) (holding that common-law post-sale duty to warn claim was preempted by requirements imposed through the PMA process).
discussed Cited "see, e.g." Green v. Bayer Corporation
E.D. Ark. · 2021 · signal: see also · confidence low
Litig., 623 F.3d at 1205 (holding “[w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is pre-empted.”; see also Cupek v. Medtronic, 405 F.3d 421 (6th Cir. 2005) (holding that any state law claim alleging failure to warn patients beyond warnings required by the FDA constitutes different or additional requirements under the pre-market approval (“PMA”) process and thus not parallel); Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000) (“to the extent that plainti…
discussed Cited "see, e.g." Hill v. Bayer Corporation
E.D. Mich. · 2020 · signal: see also · confidence low
Litig., 623 F.3d 1200, 1205 (8th Cir. 2010); see also Cupek v. Medtronics, 405 F.3d 421 (6th Cir. 2005) (holding that any state law claim alleging failure to warn patients beyond warnings required by the FDA constitutes different or additional requirements under the pre-market approval (“PMA”) process and thus not parallel); Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000) (“to the extent that plaintiff’s claim is premised on the adequacy of the warnings reviewed and approved by the FDA, . . . the claim is . . . preempted”).
discussed Cited "see, e.g." In Re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation
D. Minnesota · 2009 · signal: see, e.g. · confidence medium
See, e.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.2005). 16 *1160 Furthermore, Medtronic correctly notes that the FDA regulations cited by Plaintiffs permit a device manufacturer to give certain warnings, but Plaintiffs’ failure-to-warn theory necessarily requires a showing that Medtronic was required to give those warnings.
discussed Cited "see, e.g." Hughes v. Cook
W.D. Tenn. · 2006 · signal: see also · confidence medium
The Sixth Circuit, focusing on § 360k(a), “translated Lohr’s emphasis on the FDA regulations” into a three-part MDA preemption test: “(1) [has] the FDA ... established specific counterpart regulations or other specific federal requirements; that are (2) [specific ] to a particular device; and thus (3) make state regulations different from, or in addition to, the specific FDA requirements?” Id. at 224 (emphasis added); see also Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.2005) (affirming Kemp’s three-part test for MDA preemption).
Retrieving the full opinion text from the archive…
Ethel CUPEK, Et Al., Plaintiffs-Appellants,
v.
MEDTRONIC, INC., Defendant-Appellee
04-3201.
Court of Appeals for the Sixth Circuit.
Apr 21, 2005.
405 F.3d 421
ARGUED: Joseph M. Callow, Jr., Keat-ing, Muething & Klekamp, Cincinnati, Ohio, for Appellants. Thomas M. Parker, Parker, Leiby, Hanna & Rasnick, Akron, Ohio, for Appellee. ON BRIEF: Joseph M. Callow, Jr., Louis Francis Gilligan, Gregory M. Utter, Jason M. Cohen, Keat-ing, Muething & Klekamp, Cincinnati, Ohio, for Appellants.
Kennedy, Moore, Sutton.
Cited by 37 opinions  |  Published

OPINION

KENNEDY, Circuit Judge.

Plaintiffs appeal the district court’s denial of leave to amend their complaint in this product liability action and the grant of summary judgment to Defendant Med-tronic, Inc. based on this court’s earlier decision in Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir.2000), dismissing similar claims. We affirm the district court.

BACKGROUND

Plaintiffs collectively sued Defendant alleging defects in Defendant’s pacemaker leads implanted in them or their spouses. Their cases were consolidated with Kemp v. Medtronic, Inc., No. C-1-97-103, 1999 (N.D. Ohio June 27, 1997) for the purposes of discovery. After all cases were consolidated in the Southern District of Ohio and after the district court denied Plaintiffs class certification, consolidation for trial, and permissive joinder, the parties agreed to administratively close all claims save Kemp. That case was fully litigated and appealed. Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir.2000) (denying the bulk of Plaintiffs’ claims due to federal preemption), rehearing and rehearing en banc denied, No. 99-3720, 2001 WL 91119 (6th Cir. Jan.26, 2001) (unpublished), and cert. denied, 534 U.S. 818, 122 S.Ct. 48, 151 L.Ed.2d 19 (2001).

After resolution of the Kemp case, Plaintiffs filed a motion to reinstate their actions and file an amended complaint to present new causes of action that federal law does not preempt, and to raise arguments that are distinguishable from the arguments made in Kemp. Defendant did not oppose reopening the case and moved the court to grant it summary judgment pursuant to a motion it had earlier filed at the conclusion of the Kemp appeal.

Plaintiffs’ proposed amended complaint comprised eight counts. Counts I and II alleged post-sale “failure to warn” and post-sale “failure to recall” claims against Defendant based on “information learned after FDA review of the Model 4004/4004M PMA Supplement Applications.” [1] Count III alleged that Defendant failed “to [cjomply with [fjederal [r]equire-[*423] ments [consistent with [s]tate [requirements.” (“Medtronic failed to comply with applicable CFR regulations in its Model 4004/4004M PMA Supplement applications.”). Count IV alleged Defendant’s “Negligence Per Se” in its “failure to comply with the [Food and Drug Administrations’s (FDA) ] conditions of approval.” Counts V through VIII reasserted claims originally plead by Plaintiffs in their original complaint with greater factual specificity.

The district court disposed of Plaintiffs’ motion to amend in three separate opinions and then granted summary judgment to Defendant in a final opinion. In the first opinion, issued on December 10, 2001, the district court found that counts V through VIII were directly precluded by Kemp. It also found that count IV was preempted because it was, in essence, a disguised fraud on the FDA claim. The district court found that federal law preempts such claims (citing Kemp and Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341, 348, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001)). The district court additionally found that counts I and II were preempted by federal law because they would impose state requirements “different from” or “in addition to” federal requirements, thus making them futile claims. The court did, however, find that federal law did not preclude Plaintiffs’ proposed count III. It granted Plaintiffs ten days to file an amended complaint alleging that sole claim.

Plaintiffs failed to file the required amended complaint within the allotted time and, instead, on January 14, 2002, requested that the court reconsider its decision. Before the court ruled on that motion, the parties requested a stay to allow them to engage in settlement discussions. The court granted the stay. After lifting the stay, on November 11, 2002, the district court denied Plaintiffs’ request to reconsider its earlier decision. On December 13, 2002, Plaintiffs then requested leave to amend their complaint to allege the claim the court had previously allowed.

In its third opinion, filed on September 10, 2003, the district court denied Plaintiffs leave to amend their complaint, as previously allowed, holding that justice did not require granting Plaintiffs leave at that time, because of the opportunities given them to amend their complaint in a more timely fashion. The district court also expressed concern that Defendant would be unduly prejudiced were it to grant Plaintiffs leave to amend in view of how much time had elapsed since Plaintiffs filed their original complaint. The district court also directed Plaintiffs to show cause why it should not grant Defendant’s motion for summary judgment. Finally, on January 13, 2004, after Plaintiffs filed a response to the show cause order, the district court granted summary judgment to Defendant on the remaining claims. This appeal followed.

.On appeal, Plaintiffs allege three errors. First, Plaintiffs claim that the district court erred in denying them leave to amend their complaint to allege that Defendant was negligent per-se in failing to comply with the FDA’s conditions of approval (count IV of the proposed amended complaint). Second, Plaintiffs allege that the district court erred in denying them leave to amend their complaint to assert Defendant’s post-sale failure to warn and post-sale failure to recall claims (counts I and II of the amended complaint). Finally, Plaintiffs request that this court revisit its holdings in Kemp (and consequently reverse the district court’s denial of leave to amend for counts V through VIII). Plaintiffs did not appeal the district court’s denial of leave to amend count III of the proposed amended complaint.

[*424] ANALYSIS

We review de novo the district court’s determination that granting Plaintiffs leave to amend would be futile. See Ziegler v. IBP Hog Market, 249 F.3d 509, 518 (6th Cir.2001). We do not find error in the district court’s decision. Granting leave to amend on count IV would be futile because that count is a disguised fraud on the FDA claim. The Supreme Court and this court held that federal law preempted such claims. See Buckman, 531 U.S. at 347-48, 121 S.Ct. 1012 (explaining that the usual presumption against preemption does not apply where the field of law is inherently federal and stating that “the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law”); id. at 349 n. 4, 121 S.Ct. 1012 (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: ‘[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.’ ”) (quoting 21 U.S.C. § 337(a)); Kemp, 231 F.3d at 236.

Federal law also preempts proposed amended counts I and II because those counts would impose state requirements “different from” or “in addition to” the federal requirement. See 21 U.S.C. § 360k(a) (“no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement — (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.”). As recognized in Kemp, the FDA requires continuous updates as part of the pre-market approval (PMA) application and supplement process. Kemp, 231 F.3d at 221-22. These updating requirements specifically address warnings and recalls associated with medical devices. See 21 U.S.C. § 360h(a) (giving the Secretary of Health and Human Services the authority to issue or withhold warnings concerning medical devices based on the Secretary’s assessment of the risks); id. § 360(e)(1) (giving the Secretary authority to order manufacturers to cease distributing devices upon a finding they could cause “serious, adverse health consequences or death”); id. § 360h(e)(2)(a) (giving the Secretary authority to issue recall orders); 21 C.F.R. § 803.50 (requiring device manufacturers to report adverse medical device events to the FDA); id. § 810.10 (giving the FDA discretion to determine if a recall is necessary and to decide to delay public notification to avert health risks). Any claim, under state law, then, that Defendant failed to warn patients beyond warnings required by the FDA, or that Defendant failed to recall a product without first going through the PMA supplement process would constitute state requirements “different from” or “in addition to” the requirements of the federal PMA application and supplement process. See 21 U.S.C. 360k(a); see also Kemp, 231 F.3d at 235. Such requirements would, therefore, not “parallel federal safety requirements .... ” Buckman, 531 U.S. at 353, 121 S.Ct. 1012. [2] Plaintiffs’ proposed amended claims themselves undermine[*425] their preemption arguments, because those claims assert that Defendant has duties “independent of any obligations ... to comply with applicable federal regulations.” Such independent duties are, at the very least, “in addition to” federal requirements, and may very well be “different from” federal requirements. Thus, federal law preempts proposed amended counts I and II because those counts would require Defendant to comply with state requirements “different from” or at least “in addition to” federal requirements. Plaintiffs’ request to amend was futile.

Finally, Plaintiffs ask us to revisit our holding in Kemp. We may not do so. “A panel of this Court cannot overrule the decision of another panel. The prior decision remains controlling authority unless an inconsistent decision of the United States Supreme Court requires modification of the decision or this Court sitting en banc overrules the prior decision.” Salmi v. Secretary of Health and Human Services, 774 F.2d 685, 689 (6th Cir.1985). Plaintiffs cite no authority that would allow us to revisit this court’s earlier holding. We hold, therefore, that the district court did not err in denying Plaintiffs leave to amend, because the proposed amendments are futile as described by the district court, this court in Kemp, and the Supreme Court in Buckman.

CONCLUSION

For the foregoing reasons, we AFFIRM the decision of the district court.

1

. Paragraphs 41 and 48 of these two counts read: "These duties are independent of any obligation a manufacturer may have to comply with applicable federal regulations.”

2

. There appears to be significant disagreement between the parties over whether Minnesota or Ohio law applies to this dispute. That question is irrelevant to our disposition of these issues. Federal law would preempt Plaintiffs’ claims regardless of whether Minnesota or Ohio law applied.