Ronald Luckey v. Abbott Laboratories, Inc.

District Court, E.D. Kentucky·Decided March 26, 2026·No. 5:25-cv-00389·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY CENTRAL DIVISION (at Lexington)

RONALD LUCKEY, ) ) Plaintiff, ) Civil Action No. 5: 25-389-DCR ) V. ) ) ABBOTT LABORATORIES, INC., ) MEMORANDUM OPINION ) AND ORDER Defendant. )

*** *** *** *** Defendant Abbott Laboratories Inc. (“Abbott”) has moved to dismiss Plaintiff Ronald Luckey’s Amended Complaint for failure to state a claim under Rule 12(b)(6) of the Federal Rules of Civil Procedure. [Record No. 19] After reviewing the parties’ arguments, the undersigned is satisfied that Luckey’s state claims against Abbott are preempted. Thus, he fails to state a claim upon which relief may be granted. I. Luckey had a Trifecta Tissue Heart Valve with Glide Technology (“Trifecta GT”) implanted during a surgical procedure in 2018. [Record No. 16 at ¶ 18] The Trifecta GT device was “originally developed, licensed, manufactured, marketed and sold” by St. Jude Medical, Inc. Id. at ¶ 5. The United States Food and Drug Administration (“FDA”) granted the Trifecta GT’s pre-market approval (“PMA”) in 2016 pursuant to 21 CFR 814. Id. at ¶ 6. Abbott, a “multinational medical device and health care company,” acquired St. Jude Medical, Inc. in 2017. Id. at ¶ 6. It is alleged that, as early as 2016, the “publicly available data indicated that well over 100 Abbott Trifecta valves had demonstrated aortic regurgitation.” [Record No. 16 at ¶ 9] That number continued to climb with 100 additional valves each year exhibiting that same

issue. See id. at ¶¶ 10–15. But despite this “publicly available data,” Abbott “consistently warranted, advertised and marketed” that the Trifecta GT valve “would last fifteen to twenty years.” Id. at ¶ 16. In February 2023, the FDA released a letter to healthcare providers that informed them that “[i]nformation from published literature suggests a higher cumulative incidence of early (five years or less) [structural valve deterioration (“SVD”)] for Trifecta valves compared to other commercially available surgical bioprosthetic valves.” [Record No. 16 at ¶ 19] Abbott

sent letters to Trifecta valve customers the same day informing them that “a recent literature review of the Trifecta valve indicates a higher early and midterm cumulative incidence of SVD relative to comparator bovine pericardial valves.” Id. at ¶ 20. Abbott initiated a voluntary withdrawal of the “Trifecta family of valves” five months later. Id. at ¶ 21. In 2024, Luckey “began experiencing fatigue and shortness of breath.” He then reported those concerns to his cardiologist. [Record No. 16 at ¶ 22] Luckey’s preliminary

echocardiogram indicated that his “Trifecta valve potentially had thickening and calcification of the aortic valve leaflets, aortic stenosis and aortic regurgitation.” Id. at ¶ 24. Trans- esophageal echocardiogram imaging confirmed aortic valve regurgitation and aortic valve stenosis, resulting from “prosthetic thickening/calcification.” Id. at ¶ 25. Cardiology physicians at the Cleveland Clinic concluded that Luckey’s Trifecta valve likely had early SVD and scheduled surgery for September 2024 to remove and replace the valve. See id. at ¶¶ 26, 28. The post-surgical pathology report indicated the valve had tears, “severe calcification and severe pannus formation,” as well as “severe calcification and severe fibrosis on the leaflets” with one being immobile. [Record No. 16 at ¶ 29] These failures paralleled those

that were the impetus for Abbott’s withdrawal of the Trifecta GT from the market. Id. at ¶ 30. Luckey initially filed his Complaint on September 16, 2025, in Fayette Circuit Court. [Record No. 1-1] However, Abbott removed the case to this Court pursuant to its diversity jurisdiction. [Record No. 1] Luckey tendered an Amended Complaint by agreement on January 6, 2026. [Record Nos. 12 and 16] Luckey brings claims under Kentucky law for strict liability (Count I), negligence (Count II), breach of express and implied warranties (Count III), and failure to warn (Count

IV). [Record No. 16] He seeks damages against Abbott relating to his surgery, hospitalization, outpatient care, lost wages and future earning capacity, and pain and suffering. Id. at ¶ 31. Abbott moves to dismiss the Amended Complaint, requesting a hearing on the motion and arguing that Luckey’s claims are preempted by federal law. [Record No. 19] Alternatively, it contends that those claims are insufficiently pled and outside the applicable statute of limitations. [Record No. 19-1 at 9]

Luckey agrees that a hearing is necessary but insists that his Amended Complaint is adequately pled. [Record No. 25] This matter is fully briefed and ready for the Court’s resolution. The Court, however, concludes that a hearing is not necessary to resolve the pending motion. II. When evaluating a motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, the Court must determine whether the complaint alleges “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). The plausibility standard is met “when the plaintiff pleads factual content that allows the court to

draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id. (quoting Twombly, 550 U.S. at 556). While a complaint need not contain detailed factual allegations, a plaintiff must provide more than mere labels and conclusions, and “a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. And while plaintiffs are not required to plead facts showing that the defendant is likely to be responsible for the harm alleged, they must demonstrate “more than a sheer possibility that a defendant has acted unlawfully.” Iqbal,

556 U.S. at 678. Next, when reviewing a motion under Rule 12(b)(6), the court must “accept all of plaintiff’s factual allegations as true and determine whether any set of facts consistent with the allegations would entitle the plaintiff to relief.” G.M. Eng’rs & Assoc., Inc. v. West Bloomfield Twp., 922 F.2d 328, 330 (6th Cir. 1990). A court may consider exhibits attached to the defendant’s motion to dismiss if they are referenced in the complaint and central to the claims

therein. Bassett v. Nat’l Collegiate Athletic Assoc., 528 F.3d 426, 430 (6th Cir. 2008). Finally, whether federal preemption thwarts the plaintiff’s state law claims is a question of law that may be decided on motion to dismiss. See GTE Mobilnet of Ohio v. Johnson, 111 F.3d 469, 475 (6th Cir. 1997); McDaniel v. Upsher-Smith Lab’ys, Inc., 893 F.3d 941, 944 (6th Cir. 2018). Regulatory Background and Preemption Congress enacted the Medical Device Amendments (“MDA”) to the Federal Food, Drug, and Cosmetic Act (“FDCA”) in 1976 to govern medical devices intended for human

Free access — add to your briefcase to read the full text and ask questions with AI

Ronald Luckey v. Abbott Laboratories, Inc., (E.D. Ky. 2026).

Ronald Luckey v. Abbott Laboratories, Inc. (Ronald Luckey v. Abbott Laboratories, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Related

§ 360c
21 U.S.C. § 360c
§ 360e
21 U.S.C. § 360e
§ 360k
21 U.S.C. § 360k
§ 337
21 U.S.C. § 337