Sattelmyer v. Covidien, L.L.C.Sattelmyer v. Covidien, L.L.C.
Rendered on May 5, 2026
On brief: Bey & Associates LLC, and Anita M. Washington, for appellant. Argued: Anita M. Washington.
On brief: Tucker Ellis LLP, and John A. Favret III, for Covidien, LLC.
On brief: Porter Wright Morris & Arthur LLP, C. Darcy Jalandoni, Sara C. Schiavone, and Jhay T. Spottswood-Harrison, for Cardinal Health 200, LLC. Argued: C. Darcy Jalandoni.
Shook Hardy & Bacon LLP, and Bryan T. Pratt, for Covidien, LLC. Argued: Bryan T. Pratt.
APPEAL from the Franklin County Court of Common Pleas
EDELSTEIN, J.
{¶ 1} Plaintiff-appellant, Robyn E. Sattelmyer, appeals from the decision of the Franklin County Court of Common Pleas dismissing her product liability claims against defendants-appellees, Covidien, LLC (“Covidien”), Cardinal Health 200, LLC (“Cardinal
I. FACTS AND PROCEDURAL BACKGROUND
{¶ 2} On December 20, 2022, Ms. Sattelmyer filed a complaint in the Franklin County Court of Common Pleas against Covidien, Cardinal Health, John Doe Corporations 1-5, and OhioHealth Corporation (“OhioHealth”). As pled in the complaint, Ms. Sattelmyer was injured on December 23, 2020 while using an Argyle Infant Heel Warmer during the course and scope of her employment with OhioHealth. The purpose of this product “is to help medical providers provide the right amount of heat to an infant‘s heel for blood sampling.” (Dec. 20, 2022 Compl. at ¶ 12.) It is “activated at the point of care by squeezing the pouch,” which “mixes the substrate inside the pouch causing an exothermic chemical reaction” that “warm[s] the pouch.” (Compl. at ¶ 17, quoting Compl., Ex. 3.) As alleged in the complaint, Ms. Sattelmyer “squeezed the heel warmer to activate it when it exploded all over [her], the patient, and the exam room.” (Compl. at ¶ 20.) The contents of the heel warmer flew into her eyes, causing her to suffer “serious and permanent injuries.” (Compl. at ¶ 22.)
{¶ 3} Count One of the complaint alleged various claims, including manufacturing-defect, design-defect, and nonconformance with manufacturer‘s representations, under the Ohio Product Liability Act (“OPLA”),
{¶ 4} At issue in this case is the sufficiency of the product liability claims as pled in Ms. Sattelmyer‘s complaint.
{¶ 5} On January 24, 2023, Covidien and Cardinal Health (collectively, “appellees”) jointly moved to dismiss Count One of Ms. Sattelmyer‘s complaint pursuant to
{¶ 6} On April 3, 2023, the trial court issued a decision granting appellees’ joint motion and dismissed Ms. Sattelmyer‘s OPLA claims, as alleged in Count One, with prejudice. However, this decision did not resolve Ms. Sattelmyer‘s remaining declaratory judgment claim against OhioHealth and the trial court did not include a
{¶ 7} Ms. Sattelmyer timely appealed from that judgment and now asserts the following two assignments of error for our review:
[I.] THE TRIAL COURT ERRED BY DISMISSING PLAINTIFF‘S CLAIMS AGAINST COVIDIEN, LLC AND THE “JOHN DOE” DEFENDANTS.
[II.] THE TRIAL COURT ERRED BY DISMISSING PLAINTIFF‘S CLAIMS AGAINST CARDINAL HEALTH 200, LLC.
II. ANALYSIS
{¶ 8} In Count 1 of her complaint, Ms. Sattelmyer alleged various product liability claims under the OPLA, including manufacturing defect (
{¶ 9} In her first assignment of error, Ms. Sattelmyer argues the trial court erred in dismissing her OPLA claims against Covidien and John Doe Corporations 1-5 with prejudice. In her second assignment of error, Ms. Sattelmyer contends the trial court erred in dismissing her OPLA claims against Cardinal Health with prejudice. In the interest of efficiency, we address them together.
A. Ohio‘s Statutory Scheme for Product Liability Claims
{¶ 10} “Products liability grew out of a public policy judgment that people need more protection from dangerous products than is afforded by the law of warranty.” E. River Steamship Corp. v. Transamerica Delaval, 476 U.S. 858, 866 (1986), citing Seely v. White Motor Co., 63 Cal.2d 9, 15 (1965).
{¶ 11} In 1988, the Ohio General Assembly enacted a statutory scheme for regulating product liability claims, contained in
{¶ 12} The OPLA “abrogate[s] all common law product liability claims or causes of action.”
{¶ 13} OPLA claims can only be brought against a “manufacturer or supplier.”
B. Civil Rule 12(B)(6)
{¶ 14} We review a trial court‘s decision granting a motion to dismiss de novo. State ex rel. Ohio Civ. Serv. Emps. Assn. v. State, 2016-Ohio-478, ¶ 12, citing Perrysburg Twp. v. Rossford, 2004-Ohio-4362, ¶ 5.
{¶ 15} Under
{¶ 16} In determining whether dismissal is appropriate, the trial court “must presume all factual allegations contained in the complaint to be true and must make all reasonable inferences in favor of the plaintiff.” Bullard at ¶ 11. “The trial court may only consider the complaint itself and [certain] written instruments attached thereto by the plaintiff.” McBroom v. Gertmenian, 2018-Ohio-3884, ¶ 12 (10th Dist.), citing Cline v. Mtge. Electronic Registration Sys., Inc., 2013-Ohio-5706, ¶ 9 (10th Dist.); Brisk v. Draf Industries, Inc., 2012-Ohio-1311, ¶ 10 (10th Dist.); and Park v. Acierno, 2005-Ohio-1332, ¶ 29 (7th Dist.). Thus, attachments to the complaint are considered part of the complaint for all purposes.
C. Civil Rule 8
{¶ 17} The basis of the trial court‘s dismissal under
{¶ 18} Ohio is a notice-pleading state. Maternal Grandmother, ADMR v. Hamilton Cty. Dept. of Job & Family Servs., 2021-Ohio-4096, ¶ 10. Pursuant to
{¶ 19} Although a complaint need not state with precision all elements that give rise to a legal basis for recovery, fair notice of the nature of the action must be provided. Bridge v. Park Natl. Bank, 2003-Ohio-6932, ¶ 5 (10th Dist.). To constitute fair notice, the complaint must still allege sufficient underlying facts that relate to and support the alleged claim, and may not simply state legal conclusions. See, e.g., Regulic v. Columbus, 2022-Ohio-1034, ¶ 23 (10th Dist.). The standard simply requires a plaintiff to allege in her complaint a set of facts which, if accepted to be true, would allow the plaintiff to recover. York v. Ohio State Hwy. Patrol, 60 Ohio St.3d 143, 145 (1991). This means that, outside of a few specific circumstances—such as claims involving fraud or mistake, see
{¶ 20} In contrast, the federal pleading standard generally requires that a complaint contain “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face’ ” in order to survive a motion to dismiss for failure to state a claim. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007). “A claim has facial plausibility 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. While the “plausibility standard is not akin to a ‘probability requirement,’ ” it does “ask[] for more than a sheer possibility that a defendant has acted unlawfully.” Id. Thus, under the federal pleading standard, a plausible claim must do more than merely allege entitlement to relief; it must support the grounds for that entitlement with sufficient factual content. See id.
{¶ 21} Notwithstanding the heightened federal pleading standard established in Twombly and Iqbal, the Supreme Court of Ohio “has never adopted that standard.” State ex rel. Ware v. Booth, 2024-Ohio-2102, ¶ 5, fn. 1, citing Maternal Grandmother, ADMR at ¶ 28 (DeWine, J., concurring in judgment only). Indeed, even after Twombly and Iqbal were decided in 2007 and 2009, respectively, the Court has continued to recognize that the heightened federal pleading standard does not apply in Ohio state courts. See, e.g., Ware at ¶ 5, fn. 1; Maternal Grandmother, ADMR at ¶ 25-29 (DeWine, J., concurring in judgment only); State ex rel. Mobley v. Chambers-Smith, 2024-Ohio-1910, ¶ 10, fn. 1 (DeWine, J., concurring). We are bound by these decisions. See, e.g. State v. Bruce, 2022-Ohio-909, ¶ 40 (10th Dist.), quoting State v. Tatom, 2018-Ohio-5143, ¶ 24 (10th Dist.); Zakel v. State, 2022-Ohio-4637, ¶ 7 (8th Dist.).
{¶ 22} The trial court in this case correctly recognized Ohio is a notice-pleading state. (See Apr. 3, 2023 Decision and Entry at 5.) However, on review, we find the trial court applied a heightened pleading standard, akin to the federal Twombly/Iqbal plausibility standard. For the following reasons, we find no basis to hold Ms. Sattelmyer to a heightened pleading standard for her product liability claims asserted under the OPLA. And, under the precedent applicable in Ohio, we find no legal basis to do so.
D. Analysis
{¶ 23} On appeal, Ms. Sattelmyer contends she sufficiently alleged product liability claims against Covidien, Cardinal Health, and John Doe Corporations 1-5—collectively referred to as “Defendant Covidien” throughout Ms. Sattelmyer‘s complaint (see Compl. at ¶ 9)—based on four theories recognized by the OPLA: (1) defective manufacturing under
{¶ 24} At the outset, we note that Ohio case law is limited in application of the notice-pleading standard to OPLA claims.2 Appellees argue for application of a heightened pleading standard to claims brought under the OPLA, pointing to federal case law as persuasive authority. (See Appellees’ Brief at 9, 13, 15-19.) While the decisions of federal courts interpreting a federal rule are persuasive authority for an Ohio state court interpreting a similar Ohio rule, these federal decisions are not binding on this court. See, e.g., Hope Academy, Broadway Campus v. White Hat Mgt., LLC, 2022-Ohio-178, ¶ 32, fn. 6 (10th Dist.); State v. Burnett, 93 Ohio St.3d 419, 422-24 (2001).
{¶ 25} We ultimately find that, under the facts and circumstances of this case, appellees have not provided this court with a compelling reason to depart from the notice-pleading standard applicable to claims brought in Ohio courts. Given the obvious difficulties in obtaining relevant information about the manufacture of a product before a lawsuit is filed and the absence of a strong public policy argument, we see no reason for holding plaintiffs who bring product liability claims under the OPLA to the heightened pleading standard employed by the trial court below. See, e.g., York, 60 Ohio St.3d at 145
{¶ 26} We decline to endorse a review process that permits state trial courts to use these information-access limitations as a bar to justice for OPLA claims at the pleading stage. Indeed, information about a product‘s “design specifications, formula, or [the] performance standards of the manufacturer” would generally be known only by the manufacturer. (Emphasis added.) See
{¶ 27} The fact that a plaintiff does not have access to information relevant—and even necessary—to proving (or disproving) an OPLA claim does not mean, for purposes of surviving a motion to dismiss under
{¶ 28} In this case, Ms. Sattelmyer‘s complaint alleged that on December 23, 2020 (Compl. at ¶ 19), she “squeezed” the Argyle Infant Heel Warmer to “activate it” (Compl. at ¶ 19-20) at work (Compl. at ¶ 10, 32) in connection with patient care (Compl. at ¶ 20) “when
{¶ 29} Ms. Sattelmyer alleged that Covidien “designed, manufactured, and sold the ‘Argyle Infant Heel Warmer’ [she] was attempting to use at a Columbus, Ohio hospital at the time of the incident.” (Compl. at ¶ 10, 26.) In support of that claim, she attached to her complaint photographs depicting the packaging of an Argyle Infant Heel Warmer with Covidien‘s branding. (See Compl. at ¶ 10-11; Compl., Ex. 1.) That packaging showed the FDA Product Code3 for the Argyle Infant Heel Warmer as MH00002T. (Compl., Ex. 1.) Ms. Sattelmyer also attached to her complaint two U.S. Food and Drug Administration (“FDA”) Recall Notices about the heel warmer product at issue in this case, identified as product code MH00002T, that were issued before and after the heel warmer exploded on her in December 2020. (Compl. at ¶ 13-18.)
{¶ 30} The 2015 FDA Recall Notice, naming Covidien as the manufacturer of the heel warmer (product code MH00002T), cautioned that the product‘s packaging design “may break during activation resulting in spillage of the contents on patients or healthcare workers causing potential skin/eye irritations.” (Compl. at ¶ 13-15; Compl., Ex. 2.) The 2021 FDA Recall Notice, naming Cardinal Health as the manufacturer of the same product (product code MH00002T), indicated that the infant heel warmer was being recalled in order to add a caution statement reminding the user to activate the heel warmer away from the face and the infant based on “reports of pack rupture or leaking during activation.” (Compl. at ¶ 18; Compl., Ex. 3.) This recall notice listed potential harms caused by contact with the liquid inside the heel warmer pouch as “rash, burn[,] and inflammation.” (Compl. at ¶ 18; Compl., Ex. 3.) Consistent with the defect (exploding) and harms referenced in
1. Manufacturing Defect—R.C. 2307.74
{¶ 31} Appellees argue that in order to establish a manufacturing defect claim, Ms. Sattelmyer must prove: (1) a defect in a product the defendant manufactured; (2) that the defect existed when the product left the defendant‘s control; and (3) that the defect proximately caused the plaintiff‘s injuries. (Appellees’ Brief at 17-18, citing Carroll v. Alliant Techsystems, Inc., 2006-Ohio-5521, ¶ 9 (10th Dist.).) But, in actuality, these are the requirements a plaintiff must meet in order to survive summary judgment or prove her claim at trial—not to survive a motion to dismiss under
{¶ 32} In evaluating the sufficiency of Ms. Sattelmyer‘s defective manufacturing claim, the trial court found the complaint failed to include factual allegations “as to how the product deviated from its intended design specifications, formula, or performance standards” and failed to allege the defect “existed when the product left” the manufacturer‘s control under
{¶ 33} These specific facts support Ms. Sattelmyer‘s allegation, under Ohio‘s notice-pleading standard, that the heel warmer deviated from its intended design specifications or
{¶ 34} Of course, this determination does not mean Ms. Sattelmyer will succeed at proving her manufacturing defect claim. Rather, we find she has sufficiently pled her claim under Ohio‘s notice-pleading standard. Again, it bears repeating that information about a product‘s manufacturing process and the condition of a product when it left a manufacturing facility will not often be available to consumers before a product liability lawsuit is commenced. It is sound public policy to permit plaintiffs like Ms. Sattelmyer to engage in discovery where, as was the case here, a consumer is injured by a product while using the product in its intended manner.
2. Design Defect—R.C. 2307.75
{¶ 35} As to Ms. Sattelmyer‘s defective design claim,
{¶ 36} With respect to her design defect claim, appellees argue Ms. Sattelmyer had to prove (1) the existence of a defect in the product at issue, (2) the defect existed at the time the product left the hands of the manufacturer, and (3) the defect was the direct and proximate cause of the plaintiff‘s injury. (Appellees’ Brief at 13-14.) But “these are the requirements a plaintiff must meet in order to survive summary judgment, not a motion to dismiss.” Williams, 2023 U.S. Dist. LEXIS 220371, at *4, citing Jones, 897 F.Supp.2d at 607, citing Hickey, 163 Ohio App.3d at 769-70. See also Nationwide Mut. Ins. Co. v. ICON Health & Fitness, Inc., 2005-Ohio-2638, ¶ 3-5 (10th Dist.) (reviewing evidence relevant to jury‘s verdict on plaintiffs’ design defect claims following trial).
{¶ 37} In her complaint, Ms. Sattelmyer alleged “the package design and/or selection [of the heel warmer] was the defect that caused the package rupture that led to injuries of users and others, including Plaintiff in this incident.” (Compl. at ¶ 24.) Furthermore, her allegation that the heel warmer packaging broke when activated in its intended manner (i.e., squeezing on the packaging) tenders more than a mere “ ‘naked allegation that a product failed, without more.’ ” Compare Williams at *4, quoting O.M. Through McConnell v. KLS Martin LP, 560 F.Supp.3d 1084, 1089-90 (N.D.Ohio 2021). It is true that Ms. Sattelmyer‘s complaint does not specifically allege that the non-exhaustive list of risk factors in
{¶ 38} As notice pleading is not an onerous requirement, the trial court was obligated at this stage to draw all reasonable inferences in Ms. Sattelmyer‘s favor. On review, we find the complaint alleged sufficient facts from which we can reasonably infer—as we must—that the risks associated with a heel warmer used in the care of infants known, by at least 2015, to explode and spray harmful chemical liquid onto medical staff and infant children when used in its intended manner exceeds the benefits associated with the product
{¶ 39} Having determined that Ms. Sattelmyer‘s complaint provided appellees with the requisite notice to marshal their defense to this claim, we reject appellees’ argument and find Ms. Sattelmyer‘s complaint pled sufficient facts satisfying the statutory elements of a defective-design claim under the OPLA to survive the motion to dismiss.
3. Nonconformance with Representations—R.C. 2307.77
{¶ 40} To succeed on a failure to conform claim under
{¶ 41} On review, we agree with the trial court‘s finding that Ms. Sattelmyer did not identify in her complaint any express representation(s) made by appellees about the heel warmer in her complaint. She merely alleged the product “did not conform to representations made about the product when it left the control of Defendant Covidien.”
{¶ 42} Because Ms. Sattelmyer did not attribute any express representation to Covidien, Cardinal Health, or John Doe Corporations 1-5 in her complaint—much less allege any specific representation of a material fact was expressly made by Covidien, Cardinal Health, or John Doe Corporations 1-5 concerning the character, quality, or safety of a product—her nonconformance claim was inadequately pled. As such, we find no error in the trial court‘s decision to dismiss the OPLA claim alleged under
4. Inadequate Warning or Instructions—R.C. 2307.76
{¶ 43} As to the inadequate-warning claim, we note that Ms. Sattelmyer did not argue in her memorandum opposing dismissal that her complaint alleged an OPLA claim based on inadequate warning or instruction. But, on appeal, she cites to language in her complaint alleging “[t]he Argyle Infant Heel Warmer . . . failed to have proper warnings, which made it unsafe and dangerous to use” as support for her contention that she also alleged a claim for inadequate warning under
{¶ 44} “Unless the danger posed by a product is generally known and recognized by a consumer, Ohio imposes on manufacturers two related duties to warn: a duty to warn of dangers known to the manufacturer at the time of sale of the product and a duty to warn of dangers that were not obvious at the time of sale but became known to the manufacturer after the product was sold to a consumer.” Linert v. Foutz, 2016-Ohio-8445, ¶ 26. These duties are codified in
{¶ 45} However, contrary to Ms. Sattelmyer‘s contention otherwise, she did not specifically allege any facts in her complaint to reasonably suggest that any actions by Covidien, Cardinal Health, or John Doe Corporations 1-5 resulted in an inadequate warning or instruction about the heel warmer. (See Compl. at ¶ 26-30.) Although Ms. Sattelmyer attached photographs depicting the packaging of the Argyle Infant Heel Warmer to her complaint (Compl., Ex. 1), the text on the packaging is mostly illegible. The complaint also lacked any factual statement about what, if any, warning or instructions had been issued about the product at the time of the incident or, for that matter, any allegation claiming Ms. Sattelmyer had no knowledge about the risk the heel warmer could explode when squeezed on December 23, 2020. Simply put, Ms. Sattelmyer did not allege facts explaining appellees’ duty to warn or how she believes they breached such duty.
{¶ 46} For these reasons, we find Ms. Sattelmyer failed to clearly articulate facts that would provide appellees with the requisite notice to marshal their defense to an inadequate-warning claim. Thus, even if the trial court erred in failing to address this claim, we nonetheless find that dismissal of the inadequate-warning theory of Ms. Sattelmyer‘s product liability claim was warranted under
5. Dismissal of Claims Against Cardinal Health and John Doe Corporations 1-5
{¶ 47} The trial court dismissed all of Ms. Sattelmyer‘s OPLA claims against Cardinal Health and John Doe Corporations 1-5 on the grounds that the factual allegations relevant to these parties in her complaint lacked the detail necessary for the court to discern a viable cause of action against them under any legal theory. Although not discussed in Ms. Sattelmyer‘s appellate briefing, on review, we find that paragraph nine of her complaint, while perhaps inartful, indicated that Covidien, Cardinal Health, and the John Doe Corporations 1-5 would be collectively referred to as “Defendant Covidien” throughout her complaint. (Compl. at ¶ 9.) Having already determined that Ms. Sattelmyer‘s complaint
E. Disposition
{¶ 48} For these reasons, we find the trial court erred in granting appellees’ joint motion to dismiss under
{¶ 49} Based on the foregoing, we sustain in part, and overrule in part, Ms. Sattelmyer‘s first assignment of error and overrule her second assignment of error. We decline to grant Ms. Sattelmyer‘s request for leave to amend the complaint, as she did not seek leave to amend her complaint in the trial court. It is axiomatic that an appellate court will not address, in the first instance, an argument that falls outside the scope of an appellant‘s assignment of error or has not been properly preserved for appellate review. See, e.g., Zawahiri v. Alwattar, 2008-Ohio-3473, ¶ 10-11 (10th Dist.). By not seeking leave to amend her complaint in the trial court, Ms. Sattelmyer has waived any argument supporting such relief from this court.
III. CONCLUSION
{¶ 50} Having sustained Ms. Sattelmyer‘s first assignment of error in part, and overruled her second assignment of error, we reverse in part, the judgment of the Franklin County Court of Common Pleas and remand this matter for further proceedings in accordance with law and consistent with this decision.
Judgment affirmed in part and reversed in part; cause remanded.
MENTEL, J., concurs.
BEATTY BLUNT, J., concurring in part and dissenting in part.
{¶ 51} I do not believe the trial court committed reversible error when it granted the joint motion of appellees to dismiss filed pursuant to
{¶ 52} The majority‘s conclusion that appellant‘s complaint states claims under the OPLA for manufacturing defect (
{¶ 53} As the majority acknowledges, there is a dearth of Ohio law discussing the application of the notice-pleading standard to claims filed under the OPLA. Nonetheless, Ohio case law is clear that Ohio “incorporated” the notice-pleading standard from the Federal Rules of Civil Procedure as its own. York v. Ohio State Hwy. Patrol, 60 Ohio St.3d 143, 144 (1991). Furthermore, “[b]ecause the Ohio Rules of Civil Procedure are modeled after the Federal Rules of Civil Procedure, federal law interpreting the federal rule is appropriate and persuasive authority in interpreting a similar Ohio rule.” Felix v. Ganley Chevrolet, Inc., 145 Ohio St.3d 329, 333 (2015), citing Stammco, L.L.C. v. United Tel. Co. of Ohio, 2013-Ohio-3019, ¶ 18, citing Myers v. Toledo, 2006-Ohio-4353, ¶ 18, and Marks v. C.P. Chem. Co., Inc., 31 Ohio St.3d 200, 201 (1987). Thus, it is entirely appropriate for this court to look to and rely upon federal cases applying the federal rules of procedure pertaining to notice pleading and motions to dismiss in the context of claims brought under the OPLA.
{¶ 54} Therefore, I would apply the analysis applicable to product liability actions brought under the OPLA as prescribed by the authority set forth in the relevant federal case
{¶ 55} In the case before us, a review of appellant‘s complaint shows that appellant failed to set forth any facts in support of her claims for manufacturing defect (
{¶ 56} Thus, appellant‘s claims under the OPLA are not sufficient to withstand the joint motion of appellees’ to dismiss filed pursuant to
{¶ 57} Notwithstanding the foregoing, I concur in the majority‘s finding that appellant‘s complaint failed to sufficiently allege product liability claims based on theories of inadequate warning (
{¶ 58} Accordingly, I respectfully concur in part, dissent in part, and dissent from the final judgment to reverse in part the judgment of the trial court and remand the matter for further proceedings.
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