Wyskocil v. Medtronic USA, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF OHIO

STEPHANIE WYSKOCIL, Administrator Case No. 1:24-cv-01697-PAB

of the Estate of Robert Wyskocil, Deceased,

Plaintiff, JUDGE PAMELA A. BARKER

-vs-

MEMORANDUM OPINION AND

MEDTRONIC USA, INC., et al., ORDER

Defendants.

Currently pending before this Court is Defendants Medtronic USA, Inc., Medtronic, Inc., and

Medtronic, Inc. dba Covidien’s (collectively “Defendants” or “Medtronic”) Motion to Dismiss filed

on October 10, 2024 (“Defendants’ Motion”). (Doc. No. 7.) On December 19, 2024, Plaintiff filed

her Opposition to Defendants’ Motion (“Plaintiff’s Opposition”). (Doc. No. 9.) On January 2, 2025,

Defendants filed their Reply in support of Defendants’ Motion (“Defendants’ Reply”). (Doc. No.

10.) Accordingly, Defendants’ Motion is ripe for a decision.

For the reasons set forth herein, the Court GRANTS IN PART and DENIES IN PART

Defendants’ Motion.

I. Background

Plaintiff’s Complaint sets forth the following allegations.1

Defendants “are and were at all times pertinent hereto, corporations and/or other business

entities organized or existing under the laws of the State of Minnesota and/or were licensed and/or

1 For purposes of this Opinion, in setting forth the background relevant to Defendants’ Motion to Dismiss, the Court

accepts Plaintiff’s factual allegations as true and construes her Complaint in the light most favorable to her as the non-

moving party. See Gunasekera v. Irwin, 551 F.3d 461, 466 (6th Cir. 2009).

were doing business in the State of Ohio, and/or regularly did or solicited business, or engaged in

other persistent courses of conduct or derived substantial revenue from goods used or consumed or

services rendered in the State of Ohio.” (Doc. No. 1-1 at ¶ 4.) Plaintiff Stephanie Wyskocil is the

duly appointed, qualified and acting Administrator of the Estate of Robert Wyskocil, Deceased

(hereinafter “Decedent”). (Id. at ¶ 1.) Plaintiff brings this action for the exclusive benefit of the next-

of-kin of Decedent. (Id. at ¶ 2.)

On and before September 12, 2020, Decedent was a patient at Western Reserve Hospital

(hereinafter the “Hospital”) and was “being intubated with a Covidien endotracheal tube (ETT),

which tube’s cuff failed [sic] causing an air leak, improper ventilation and oxygen desaturation.” (Id.

at ¶ 3.) Based upon information and belief, Plaintiff alleges that “said ETT was designed,

manufactured and sold by the [Defendants].” (Id.) “During said medical care, two more of

[D]efendants’ ETT’s were employed and failed.” (Id.) “Specifically, ETT No. 3 immediately

experienced a catastrophic failure at the cuff and before a fourth ETT could be employed, [D]ecedent

expired due to oxygen desaturation.” (Id.)

Attached as Exhibit B to Plaintiff’s Complaint is a Discharge Summary dated 09/12/2020

from the Hospital that reads as follows:2

“Early in the morning of 9/12/2020[,] the patient’s endotracheal tube (ETT) cuff failed,

causing an air leak, improper ventilation and oxygen desaturation observable on telemetry.

2 “The law is clear that courts may consider a document which was attached to the complaint in determining whether

dismissal is proper.” DG Gas, LLC v. TA Franchise Systems LLC, 2025 WL 814928, at *5 n.6 (N.D. Ohio Mar. 14, 2025)

(citing Cates v. Crystal Clear Technologies, LLC, 874 F.3d 530, 536 (6th Cir. 2017)); Detrick v. KCS International Inc.,

2025 WL 1133516, at *38 (N.D. Ohio Apr. 17, 2025) (citing Fed. R. Civ. P. 10(c)) (“[A] copy of any written instrument

that is an exhibit to a pleading is part of the pleading for all purposes.”). Because Plaintiff refers to the medical records

in her Complaint and the records are central to her claims, the Court may consider those records. See Bassett v. Nat’l

Collegiate Athletic Ass’n, 528 F.3d 426, 460 (6th Cir. 2008) (“When a court is presented with a Rule 12(b)(6) motion, it

may consider the Complaint and any exhibits attached thereto … so long as they are referred to in the Complaint and are

central to the claims contained therein.”).

2

The decision was made to make an ETT exchange over bougie. The exchange went well and

without incident. Throughout that morning[,] two more patients intubated with COVIDIEN

ETTs experienced cuff failure requiring exchange over bougie. Finally[,] at approximately

0700[,] ETT #2s cuff failed, once again necessitating exchange to resume appropriate

ventilation[.] A replacement ETT (#3) was tested per protocol to ensure all components were

functioning, including the cuff which inflated and deflated properly. A bougie was placed

into ETT #2 to approximately half the length of the bougie[.] ETT #2 was removed over the

bougie, and the replacement (#3) was threaded over the bougie to the previously recorded

depth at the teeth. The cuff was inflated and ventilation was attempted without success: ETT

#3 immediately experienced a catastrophic failure at the cuff.

ETT #4 was tested and prepared, once again ensuring the cuff was functioning. Prior to

attempting an exchange, however, the patient’s oxygen saturation fell to critical levels

requiring emergent bag valve mask ventilation. To achieve an adequate seal, the bougie had

to be forfeited. De novo intubation with ETT #4 was then attempted using a GlideScope to

visualize the airway. Traumatic edema made intubation impossible, however. An attempt at

passing a bougie through the vocal cords was attempted but also unsuccessful. At this point

the patient had gone into cardiac arrest from hypoxia and CPR was initiated. Code blue was

called and ACLS was run for approximately 15 cycles (45 minutes)[.] During this time[,]

surgical and ENT residents at bedside were called upon for an emergency airway.

Tracheostomy was attempted approximately 3 times, but was complicated by body habitus.

Ultimately when an emergent airway had been established the patient had lost all cardiac

electrical activity as confirmed by telemetry and cardiac ultrasonography. Patient was

pronounced dead at 0905. Daughter was present in family waiting room at time of death and

was notified immediately. All post-mortem protocol was completed and cross checked by

senior nursing staff.”

(Doc. No. 1-1 at PageID #15.)

According to Plaintiff, “at all times pertinent hereto, [Defendants] were the manufacturers of

the products referenced … above, as that term is defined under OHIO REV. CODE STAT. ANN. §

2307.71(I).” (Compl. at ¶ 10.) Plaintiff alleges that “[a]s a direct and proximate result of the

[D]efendants’ defective products, [Decedent] died on September 12, 2020.” (Compl. at ¶ 5.) Plaintiff

claims various damages “against [D]efendants, jointly and severally, on behalf of the next-of-kin, for

the wrongful death of [Decedent] …” (Compl. at PageID #10.)

In her Complaint, Plaintiff asserts four different violations of Ohio product liability statutes.

Specifically, Plaintiff alleges that “the products as manufactured by [Defendants] were defective in

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manufacture and construction as described in OHIO REV. CODE STAT. ANN. § 2307.74, were

defective in design or formulation as described in OHIO REV. CODE STAT. ANN. § 2307.75, were

defective due to inadequate warnings and instructions as described in OHIO REV. CODE STAT.

ANN. § 2307.76, and were defective because they did not confirm to representations made by their

manufacturers as described in OHIO REV. CODE STAT. ANN. § 2307.77. (Compl. at ¶ 11.)

Plaintiff further alleges that “each of the defective conditions of the products as described above,

pursuant to OHIO REV. CODE STAT. ANN. § 2307.73, was singularly a proximate cause of the

harm for which plaintiff seeks to recover compensatory damages …” (Compl. at ¶ 12.) Finally,

Plaintiff alleges that Defendants “were negligent in the design, manufacture, construction, assembly,

production, modification, rebuilding, installation, testing, marketing, post-marketing, sale, servicing,

and/or maintenance of the products and in failing to provide adequate warnings and instructions.”

(Compl. at ¶ 13.)

II. Procedural History

On September 6, 2022, Plaintiff initially filed suit against Medtronic and various healthcare

Defendants in state court. (Cuyahoga County Court of Common Pleas, Case No. CV-22-968491.)

On March 24, 2023, Defendants filed a motion to dismiss in the state court action. (See Doc. No. 7-

2 at PageID #86.) On August 1, 2023, the state court denied Defendants’ motion to dismiss as to all

claims except for Plaintiff’s claim for failure to warn, which was dismissed. (Id. at PageID #86–87.)

On September 21, 2023, Plaintiff voluntarily dismissed the remaining claims against Medtronic. (See

Cuyahoga County Court of Common Pleas, Case No. CV-22-968491, 9/21/2023 Docket Entry.)

On September 11, 2024, Plaintiff refiled her lawsuit in state court against Defendants by way

of the present Complaint. (See Doc. No. 1-1 at PageID #7.) In her Complaint, Plaintiff asserted four

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product liability claims under Ohio Rev. Code §§ 2307.74, 2307.75, 2307.76, and 2307.77

respectively.3 (See Compl. at ¶ 11.) On October 1, 2024, Defendants removed this action from state

court to federal court. (See Doc. No. 1.) Plaintiff did not file a motion to remand.

On October 10, 2024, Defendants filed their Motion to Dismiss for Failure to State a Claim.

(Doc. No. 7.) On December 19, 2024, Plaintiff filed her Opposition to Defendants’ Motion to

Dismiss. (Doc. No. 9.) On January 2, 2025, Defendants filed their Reply in support of their Motion.

(Doc. No. 10.) Accordingly, Defendants’ Motion is ripe for a decision.

III. Standard of Review4

Defendants move to dismiss Plaintiff’s claims as asserted against them under Rule 12(b)(6)

of the Federal Rules of Civil Procedure. Pursuant to Rule 12(b)(6), the Court accepts Plaintiff’s

factual allegations as true and construes the Complaint in the light most favorable to Plaintiff. See

Gunasekera v. Irwin, 551 F.3d 461, 466 (6th Cir. 2009). To survive a motion to dismiss under this

Rule, “a complaint must contain (1) ‘enough facts to state a claim to relief that is plausible,’ (2) more

than ‘a formulaic recitation of a cause of action’s elements,’ and (3) allegations that suggest a ‘right

to relief above a speculative level.’” Tackett v. M & G Polymers, USA, LLC, 561 F.3d 478, 488 (6th

Cir. 2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555–56 (2007)).

3 As indicated previously, Plaintiff also alleged that Defendants “were negligent in the design, manufacture, construction,

assembly, production, modification, rebuilding, installation, testing, marketing, post-marketing, sale, servicing, and/or

maintenance of the products and in failing to provide adequate warnings and instructions.” (Compl. at ¶ 13.) The Court

does not interpret this sole allegation as Plaintiff intending to assert a separate cause of action for negligence. However,

to the extent that Plaintiff is attempting to assert a separate cause of action for common law negligence, that claim is

dismissed because Plaintiff has failed to plead the necessary elements for asserting such a claim.

4 The Court agrees with Defendants’ assertion that the state court’s denial of Defendants’ previous motion to dismiss is

not relevant here because the state court evaluated the motion under Ohio R. Civ. P. 8—a more lenient standard than the

heightened federal pleading standard set forth in Twombly. See Tuleta v. Med. Mut. Of Ohio, 6 N.E.3d 106, 113–15 (8th

Dist. 2014).

5

The measure of a Rule 12(b)(6) challenge—whether a complaint raises a right to relief above

the speculative level—“does not ‘require heightened fact pleading of specifics, but only enough facts

to state a claim to relief that is plausible on its face.’” Bassett v. Nat’l Collegiate Athletic Ass’n, 528

F.3d 426, 430 (6th Cir. 2008) (quoting Twombly, 550 U.S. at 555–56). “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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

Deciding whether a complaint states a claim for relief that is plausible is a “context-specific task that

requires the reviewing court to draw on its judicial experience and common sense.” Id. at 679.

Consequently, examination of a complaint for a plausible claim for relief is undertaken in

conjunction with the “well-established principle that Federal Rule of Civil Procedure 8(a)(2) requires

only a short and plain statement of the claim showing that the pleader is entitled to relief. Specific

facts are not necessary; the statement need only give the defendant fair notice of what the … claim is

and the grounds upon which it rests.” Gunasekera, 551 F.3d at 466 (quoting Erickson v. Pardus, 551

U.S. 89, 93 (2007)) (internal quotation marks omitted). Nonetheless, while “Rule 8 marks a notable

and generous departure from the hyper-technical, code-pleading regime of a prior era, … it does not

unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Iqbal, 556

U.S. at 679.

IV. Analysis

Plaintiff asserts four claims under the Ohio Product Liability Act (“OPLA”) as follows: (1)

Products Defective in Manufacture or Construction (O.R.C. § 2307.74); (2) Products Defective in

Design or Formulation (O.R.C. §2307.75); (3) Products Defective Due to Inadequate Warning or

Instruction (O.R.C. § 2307.76); and (4) Products Defective Due to Nonconformance with

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Manufacturers’ Representations (O.R.C. § 2307.77). Defendants challenge each of these claims on

the premise that they fail to meet the pleading requirements of Federal Rule of Civil Procedure 8.

Finally, Plaintiff alternatively seeks leave to conduct discovery to supplement her claim if this Court

finds her allegations insufficient as pled. The Court will evaluate each claim below.

A. O.R.C. § 2307.74: Manufacturing Defect

The Court first begins with Plaintiff’s manufacturing defect claim under § 2307.74.

In Defendants’ Motion, Medtronic asserts that Plaintiff must establish that the device

“deviated in a material way from the design specifications, formula, or performance standards of the

manufacturer, or from otherwise identical units manufactured to the same design specifications,

formula, or performance standards,” and that the “defective aspect of the product was a proximate

cause of the injury and that the defendant manufactured the actual product in question.” (Doc. No.

7-1 at PageID #79.) Medtronic contends that “Plaintiff does not even pay lip service to these

requirements in her Complaint” and instead simply alleges that “multiple ETTs ‘failed’ and that the

products were defective.” (Id.) Thus, Medtronic maintains that there are no “allegations setting forth

the legal requirements of a manufacturing defect claim, much less how the ETTs supposedly failed

to conform to specifications.” (Id. (emphasis in original).) Finally, Medtronic asserts that Plaintiff

is not entitled to an inference of deviation from any specification because all three ETTs experienced

the same failure—as opposed to situations where only some products failed but others did not,

implying that the former deviated from the product specifications established by the latter. (Id. at

PageID #79–80.)

In her Opposition, Plaintiff asserts that she has sufficiently pled a claim under § 2307.74.

(Doc. No. 9.) Specifically, Plaintiff points to her allegations that: (i) Decedent was a patient intubated

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with Defendants’ “Covidien” endotracheal tube; (ii) the “medical record of the procedure references

clearly that the tube failed, allowing an air leak”; and (iii) “[f]urther attempts to intubate decedent

with one or more Covidien tubes were unsuccessful as the tubes failed resulting in decedent’s

demise.” (Id. at PageID #91.) Plaintiff indicates that her counsel previously attempted to secure

product information from the Hospital but “received no cooperation and no product information”

from the Hospital, which “thwarted/opposed discovery in the State case.” (Id. at PageID #92.)

Nonetheless, Plaintiff contends that the records attached to her Complaint are “crystal clear that the

only device that failed was manufactured by Medtronic” and that the “product that failed was

manufactured by [Defendants] and no one else.” (Id. at PageID #93.) Although “at this time,

[P]laintiff does not know why the device(s) failed,” Plaintiff asserts that such failure(s) “clearly …

resulted in [D]ecedent’s demise,” and thus, “Plaintiff should be permitted to conduct discovery to

determine why [D]efendants’ product failed.” (Id.)

In Defendants’ Reply, Medtronic contends that Plaintiff “cites no authority addressing similar

allegations that would support her conclusion” that she has sufficiently pled her claims. (Doc. No.

10 at PageID #102–03.) Moreover, Medtronic asserts that Plaintiff “failed to address any of the case

law cited in Medtronic’s opening brief establishing that such barebones allegations are insufficient

under Twombly/Iqbal to infer a cause of action as to product defect under Ohio law.” (Id. at PageID

#103.) Medtronic thus reiterates that Plaintiff’s claims should be dismissed. (Id.)

Under the OPLA, a “product is defective in manufacture or construction if, when it left the

control of its manufacturer, it deviated in a material way from the design specifications, formula, or

performance standards of the manufacturer, or from otherwise identical units manufactured to the

same design specifications, formula, or performance standards.” See O.R.C. § 2307.74. For

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manufacturing defect claims, “[a]t a minimum, courts have required allegations that the defendant

manufactured the product, that the product was used by the plaintiff, that the product failed while

being used by the plaintiff, and that the portion of the product that failed could be identified and is so

identified in the complaint.” Barreca v. AngioDynamics, Inc., 2015 WL 5085260, at *3 (N.D. Ohio

Aug. 27, 2015); Grubbs v. Smith & Nephew, Inc., 2020 WL 5305542, at *4 (S.D. Ohio Sept. 4, 2020);

see also Fed. Ins. Co. v. Nanoscience Instruments, Inc., 2023 WL 2932282, at *2 (S.D. Ohio April

13, 2023). “At minimum, a plaintiff must provide a ‘plausible basis to infer the device at issue

materially deviated’ from specifications or identical units.” Williams v. Boston Scientific Corp., 2023

WL 9596983, at *2 (N.D. Ohio Dec. 11, 2023) (citing Parker v. Medtronic Sofamor Danek USA,

Inc., 2021 WL 4751185, at *2 (N.D. Ohio Oct. 12, 2021)).

The Court finds that Plaintiff has sufficiently pled these elements at this stage. First, Plaintiff

alleges that Defendants manufactured the ETT.5 Second, Plaintiff alleges that the ETT was used in

Decedent’s treatment and failed during such use.6 Third, Plaintiff alleges that the portion of the

product that failed could be identified and is so identified. Specifically, Plaintiff pleads that the ETT

experienced a failure at the “cuff”7—a specific part of the ETT.

5 See Compl. at ¶ 3 (“Based upon information and belief, said ETT was designed, manufactured and sold by the Medtronic

defendants.”).

6 See id. (“[Decedent] was a patient at Western Reserve Hospital on and before September 12, 2020, and was being

intubated with a Covidien endotracheal tube (ETT), which tube’s cuff failed causing an air leak, improper ventilation and

oxygen desaturation … Specifically, ETT No. 3 immediately experienced a catastrophic failure at the cuff …”).

7 See id. (“Specifically, ETT No. 3 immediately experienced a catastrophic failure at the cuff …”) (emphasis added); see

also Doc. No. 1-1 at PageID #15 (“The cuff was inflated and ventilation was attempted without success. ETT #3

immediately experienced a catastrophic failure at the cuff.”).

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These collective allegations provide a “plausible basis to infer the device at issue” materially

deviated from “design specifications, formula, or performance standards of the manufacturer, or from

otherwise identical units manufactured to the same design specifications, formula, or performance

standards.” Williams, 2023 WL 9596983, at *2; § 2307.74. Contrary to Defendants’ assertions,

Plaintiff does more than “merely allege[] that multiple ETTs ‘failed’ and that the products were

defective …” (Doc. No. 7-1 at PageID #79.) Rather, Plaintiff specifically identifies the cuff as the

source of the ETT’s failure and describes such failure as “immediate[]” and “catastrophic.” (Compl.

at ¶ 3.) Such allegations create a plausible basis to infer that the ETT materially deviated from the

performance standards of Defendants or from otherwise identical units manufactured.8 See, e.g.,

Barreca, 2015 WL 5085260, at *1–3 (finding allegation that “catheter had detached” from Mediport

product with frayed ends sufficient to plead claim under § 2307.74 because the portion of the

Mediport product that failed “could be identified and is so identified in the complaint”).

Defendants’ cited authority is distinguishable. First, Defendants assert that the court in Perry

v. Ethicon, Inc., 2022 WL 912214 (S.D. Ohio Mar. 29, 2022), dismissed a manufacturing defect claim

related to a medical device “far more detailed than those alleged in Plaintiff’s Complaint.” (Doc. No.

7-1 at PageID #79.) In Perry, the plaintiff brought a manufacturing defect claim regarding a TVT-S

device. 2022 WL 912214 at *11. There, however, the plaintiff alleged “that ‘[m]ost TVT-S pelvic

mesh products are comprised’ of the same ‘biologically incompatible’ polypropylene mesh.” Id.

8 Indeed, any assertion to the contrary would imply that “immediate[]” and “catastrophic” cuff failure is a performance

standard set by Defendants for all their ETTs—in other words, that ETT #3 did not deviate from any performance

standards for identical units because all units are designed to experience “immediate[]” and “catastrophic” cuff failure.

To the extent that Defendants advance such a theory, the Court rejects it at this stage and instead finds a “‘plausible basis

to infer the device at issue materially deviated’ from specifications or identical units.” Williams, 2023 WL 9596983, at

*2.

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(emphasis added). In other words, the plaintiff expressly acknowledged that the allegedly deficient

“pelvic mesh” at issue was used in most of the TVT-S products that were manufactured—the exact

opposite of an allegation that one unit of a product deviated from the manufacturing specifications of

otherwise identical units. Id. For this exact reason, the court dismissed the manufacturing defect

claim. Id. at *12. Here, by contrast, Plaintiff specifically alleges that the particular ETTs used in

Decedent’s treatment suffered “immediate[]” and “catastrophic” failure specifically at the cuffs.

(Compl. at ¶ 3.)

Defendants’ reliance on Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538 (N.D. Ohio

July 30, 2012), is misplaced. In Tolliver, the plaintiff was prescribed a prescription drug Plavix. Id.

at *1. Some time later, the Food and Drug Administration issued a warning that Plavix could be less

effective in certain people who could not metabolize the drug. Id. The plaintiff, however, alleged no

allegations or facts showing that Plavix deviated from any design specifications or performance

standards. Id. at *3. Nor did the complaint allege that the plaintiff was in the class of people for

whom Plavix was less effective or that such lessened ineffectiveness resulted from a design deviation.

Id. In fact, the plaintiff’s complaint “contain[ed] no factual allegations at all to support a causal

relationship between [the plaintiff’s] taking of Plavix and his medical problems.” Id. The only

relevant allegation was a conclusory allegation that the defendants breached their duty to

“manufacture Plavix in a safe a[nd] suitable manner for its intended purpose.” Id. The present case

is distinguishable. Plaintiff points to a specific defect (the “cuff”) of particular ETTs used during

Decedent’s treatment. (See Compl. at ¶ 3; Doc. No. 1-1 at PageID #15.) Such “failure” was

“immediate[]” and “catastrophic,” implying that the ETTs at issue malfunctioned in a manner

inconsistent with the performance standards for otherwise identical ETTs. (Id.) This is unlike the

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plaintiff in Tolliver, who alleged no facts to support a plausible inference that the Plavix he took

deviated from any other units of Plavix manufactured by the defendants. See Tolliver, 2012 WL

3074538, at *3.

Defendants’ reliance on O.M. Through McConnell v. KLS Martin LP, 560 F. Supp.3d 1084

(N.D. Ohio 2021), also is misplaced. In O.M., the plaintiff brought a manufacturing defect claim as

to a medical device called a mandibular distractor. Id. at 1086. The plaintiff had two devices

surgically implanted in his lower right and left jaw, and both devices failed within a short timeframe.

Id. at 1086–87. A third mandibular distractor that was inserted in place of the broken device was not

alleged to have failed. Id. at 1087. The court found that because the “third device inserted later did

not fail and remained implanted longer than it took the first device to fail, the two devices originally

inserted might plausibly have ‘deviated in a material way … from otherwise identical units

manufactured to the same design specifications, formula, or performance standards.” Id. at 1088

(internal quotation marks omitted).

In O.M. the court expressly held that requiring a plaintiff to “explain how the subject devices

deviated from Defendant’s other mandibular distractors … seeks to hold [the plaintiffs] to a higher

standard than the one Rule 8 imposes.” Id. at 1088 (emphasis added). At this stage, Plaintiff merely

needs to provide a “‘plausible basis to infer the device at issue materially deviated’ from

specifications or identical units.” Williams, 2023 WL 9596983, at *2. As explained above, Plaintiff

has met this burden. Further, the plaintiff in O.M. did not plead any specific allegations as to the

product failure other than noticing that “something was not right” with the devices and that “x-rays

revealed the devices broke”—hence the court’s heavy reliance on inferences. 560 F. Supp.3d at 1088.

Yet in the instant matter, the “portion of the product that failed could be identified and is so identified

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in the complaint”—the ETT’s “cuff.” Barreca, 2015 WL 5085260, at *3. Finally, nothing in O.M.

suggests that Plaintiff’s claim must fail simply because all the devices failed9 as opposed to some

failing and some succeeding. Just the opposite. The court in O.M. permitted an inference that the

two devices that failed were—based on their failures—“manufactured at approximately the same

time.” O.M., 560 F. Supp.3d at 1088. In similar fashion, it is entirely plausible for the failing ETT

devices here to have also been “manufactured at approximately the same time” and thus all have

suffered the same material deviations from the performance standards of the Defendants or otherwise

identical units—namely, “immediate[]” and “catastrophic failure at the cuff.” Id.; (Compl. at ¶ 3).

Accordingly, for all the reasons stated above, the Court finds that dismissal of Plaintiff’s

manufacturing defect claim under § 2307.74 is not warranted.

B. O.R.C. § 2307.75: Design Defect

The Court next turns to Plaintiff’s design defect claim under § 2307.75.

9 In any event, contrary to Defendants’ assertions, it is not entirely clear that Plaintiff would not be entitled to the exact

same inference as in O.M. because the ETTs may have deviated with respect to their specific failures. Indeed, Exhibit B

attached to Plaintiff’s Complaint reveals that Decedent was first admitted to the Hospital on September 9, 2020. (Doc.

No. 1-1 at PageID #15.) Specifically, Decedent was taken to the emergency department (“ED”) via Emergency Medical

Services (“EMS”), during which “squad found pulse ox to be 70%.” (Id.) Then, “[i]n ED, he was put on a NRB with

100% O2, but continued to decline resulting in emergency intubation.” (Id. (emphasis added).) After that emergency

intubation, there is no mention of ETT failure until “[e]arly in the morning of 9/12/2020 [when] the patient’s endotracheal

tube (ETT) cuff failed” for the first time. (Id.) This failure prompted two further ETT replacements that morning, ETT

#2 and ETT #3, each of which also failed. (See id.) It is presumed that all three ETT’s referenced in these medical records

are the same ETT’s manufactured by Medtronic, given that Plaintiff’s Complaint also references exactly three ETT’s that

were employed, and explicitly alleges that the initial ETT “was designed, manufactured and sold by the Medtronic

defendants,” and that “two more of defendants’ ETT’s were employed and failed.” (Doc. No. 1-1 at PageID #9.) A

liberal construction of this information—as required by Rule 8—suggests that Decedent was initially intubated with an

ETT on September 9, 2020, and that no ETT failure occurred until September 12, 2024, three days later. Further, while

the first ETT used for the initial intubation on September 9, 2020, appears to have been functional for three days, “ETT

#3 immediately experienced a catastrophic failure at the cuff” upon being implemented. (Doc. No. 1-1 at PageID #15.)

Under this alternative interpretation of Plaintiff’s Complaint, the initial ETT remained in use “longer than it took” ETT

#3 to fail—namely, three days without failure while ETT #3 failed immediately—thereby entitling Plaintiff to the

inference that ETT #3 “might plausibly have deviated in a material way … from otherwise identical units manufactured

to the same design specifications, formula, or performance standards.” O.M., 560 F. Supp.3d at 1088. Accordingly, in

addition to the reasons discussed above, dismissal of Plaintiff’s claim is premature at this stage when viewing her

Complaint in the light most favorable to her as the non-moving party. See Gunasekera, 551 F.3d at 466.

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In Defendants’ Motion, Medtronic asserts similar arguments to the manufacturing defect

claim discussed above. (Doc. No. 7-1 at PageID #80.) Specifically, Medtronic contends that while

Plaintiff “concludes that there was a design defect in the ETT and that Medtronic was negligent in

designing the product, these are not facts that adequately support a design defect claim.” (Id.)

Medtronic asserts that Plaintiff does not “recite the elements of a cause if action for design defect, or

speak to the design of the ETT, its risks, or its benefits.” (Id.) Finally, Medtronic again points to

O.M. as having dismissed a “similarly deficient design defect claim.” (Id.)

In her Opposition, Plaintiff reiterates the same arguments as initially described above in

relation to her manufacturing defect claim. (Doc. No. 9 at PageID #91–94.) In Defendants’ Reply,

Medtronic reiterates that Plaintiff fails to address the case law cited in Defendants’ Motion

“establishing that such barebones allegations are insufficient under Twombly/Iqbal to infer a cause of

action as to product defect under Ohio law.” (Doc. No. 10 at PageID #102–03.)

Under the OPLA, a product is “defective in design or formulation if, at the time it left the

control of its manufacturer, the foreseeable risks associated with its design or formulation …

exceeded the benefits associated with that design or formulation.” See O.R.C. § 2307.75(A). Some

courts have found that to plead a design defect claim, the complaint must allege: “(1) the existence

of a defect in the product at issue, (2) that 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.”10

Parker, 2021 WL 4751185 at *3; O.M., 560 F. Supp.3d at 1089; see also Fox v. Kia America, Inc.,

726 F. Supp.3d 765, 776 (N.D. Ohio 2024).

10 At least one court in this district has determined that these elements “are the requirements a plaintiff must meet in order

to survive summary judgment, not a motion to dismiss.” Williams v. Boston Scientific Corp., 2023 WL 9596983, at *2

(N.D. Ohio Dec. 11, 2023).

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“As with manufacturing defect claims, design defect claims require that the complaint contain

factual allegations as to which portions of the product failed.” Grubbs, 2020 WL 5305542, at *5;

Fed. Ins. Co., 2023 WL 2932282, at *3; see also Darwish v. Ethicon, Inc., 2020 WL 7129582, at *5

(N.D. Ohio Dec. 4, 2020) (citing cases). “Such facts elevate allegations beyond ‘threadbare recitals

or formulaic recitations of the elements of a claim.” Grubbs, 2020 WL 5305542, at *5; see also

Marcum v. DePuy Orthopedics, Inc., 2013 WL 1867010, at *5 (S.D. Ohio May 2, 2013).

Just as with manufacturing defect claims, district courts have permitted design defect claims

to survive dismissal where the complaint makes “allegations that the defendant manufactured the

product; that the product was used by the plaintiff; that the product failed while being used by the

plaintiff; and, that the portion of the product that failed could be identified and is so identified in the

complaint.” Oblak v. Integra Lifesciences Corp., 2017 WL 1831098, at *2 (N.D. Ohio May 4, 2017)

(citing cases); Johnson v. Wal-Mart Stores East Inc., 2018 WL 1083269, at *4 (N.D. Ohio Feb. 28,

2018); Thompson v. DePuy Orthopaedics, Inc., 2014 WL 2874268, at *5 (S.D. Ohio June 24, 2014).

Notably, a “plaintiff is not required to set forth specific facts addressing the multi-factor balancing

test set forth in Ohio Rev. Code § 2307.75 to survive a motion to dismiss.” Thompson, 2014 WL

2874268, at *5; Darwish, 2020 WL 7129582, at *6 (finding that complaint did not need to “balance

all of the risk/benefit factors contained in O.R.C. § 2307.75(B) and (C)”).

In Oblak, the plaintiff brought manufacturing and design defect claims under the OPLA

regarding certain medical hardware. 2017 WL 1831098, at *2–3. The plaintiff alleged that the

medical hardware was manufactured and/or designed by one or more of the remaining named

defendants, and that it failed after it was implanted during his reconstructive ankle surgery. Id. at *3.

Further, the plaintiff alleged generally that one or more of the pieces of medical hardware, each of

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which was expressly identified in the complaint, failed due to medical fatigue fracture. Id. The court

concluded that this was sufficient to allege a design defect because the complaint alleged “that the

defendant manufactured the product,” “that the product was used by the plaintiff,” “that the product

failed while being used by the plaintiff,” and “that the portion of the product that failed could be

identified and is so identified in the complaint.” Id. at *2. Notably, the court opined that “discovery

will serve to clarify the exact nature and cause of the hardware failure, as well as which of the four

remaining [d]efendants in this case … designed the specific piece or pieces of hardware that are

alleged to have failed.” Id. at *3.

The Court finds the present case to be analogous to Oblak. As discussed at-length above in

relation to the manufacturing defect claim, Plaintiff alleges that Defendants manufactured the ETTs

and that the ETTs were used in Decedent’s treatment. (Compl. at ¶ 3; Doc. No. 1-1 at PageID #15.)

Plaintiff further alleges the ETTs failed during such use. (Id.) Finally, and crucially, Plaintiff does

not merely allege that the ETTs failed, but rather identifies the specific portion of the ETTs that

failed—namely, that ETT #3 “immediately experienced a catastrophic failure at the cuff.” (Id.

(emphasis added).) Just as in Oblak, these allegations are sufficient to withstand dismissal at this

early stage. 2017 WL 1831098, at *3; see also Clark v. Wright Medical Technology, Inc., 2011 WL

2689381, at *2 (S.D. Ohio July 11, 2011) (“Plaintiffs have pled a plausible cause of action that

satisfies Twombley [sic] and Iqbal because Plaintiffs alleged that the product broke either because it

was defectively manufactured or defectively designed and have plead with specificity what portion

of the product failed and when it failed.”).

Defendants reference O.M. once more for the assertion that Plaintiff’s Complaint is deficient.

(Doc. No. 7-1 at PageID #80–81.) Again, however, the Court finds that the allegations in O.M. are

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distinguishable from the present case. Specifically, the complaint in O.M. solely alleged the

following: (1) that the plaintiff “noticed that ‘something was not right’ with the devices a few weeks

after they were implanted”; (2) that “x-rays revealed the devices broke”; and (3) the devices “were

defective in design and/or formulation pursuant to the provisions of O.R.C. Section 2307.75.” 560

F. Supp.3d at 1088–89. Such allegations included no information identifying which specific portion

of the devices failed. By contrast, the present Complaint specifically identifies the cuff of the ETTs

as the point of failure. Accordingly, the Court finds O.M. to be distinguishable.

“[D]iscovery will serve to clarify the exact nature and cause of the … failure.” Oblak, 2017

WL 1831098, at *3. At this preliminary stage, however, the Court finds that Plaintiff has met her

burden in plausibly alleging a design defect sufficient to withstand dismissal.

C. O.R.C. § 2307.77: Failure to Conform to Representations

The Court next turns to Plaintiff’s failure to conform to representations claim under § 2307.77.

In Defendants’ Motion, Medtronic contends that Plaintiff does not state a viable failure to

conform claim in her Complaint. (Doc. No. 7-1 at PageID #81.) Specifically, Medtronic asserts that

a claim under § 2307.77 requires a product not conforming to a “representation made by [the]

manufacturer,” and maintains that “Plaintiff does not allege a single representation made by

[Defendants].” Id. Thus, Medtronic submits that Plaintiff fails to meet Rule 8 pleading requirements.

Id.

In Plaintiff’s Opposition, Plaintiff simply reiterates that her Complaint sufficiently alleges her

claims. (Doc. No. 9.) Plaintiff does not specifically address her failure to conform claim under §

2307.77. (Id.) In Defendants’ Reply, Medtronic reiterates that Plaintiff fails to address the case law

cited in Defendants’ Motion “establishing that such barebones allegations are insufficient under

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Twombly/Iqbal to infer a cause of action as to product defect under Ohio law.” (Doc. No. 10 at

PageID #102–03.)

Under the OPLA, a “product is defective if it did not conform, when it left the control of its

manufacturer, to a representation made by that manufacturer.” See O.R.C. § 2307.77. The OPLA

defines a “representation” as “an express representation of a material fact concerning the character,

quality or safety of a product.” O.R.C. § 2307.71(A)(14). To succeed on a failure to conform claim,

a plaintiff must show that: “(1) the manufacturer made a representation as to a material fact relating

to the character or quality of the product; (2) the product did not conform to that representation; (3)

the plaintiffs justifiably relied on that representation; and (4) the plaintiffs’ reliance on the

representation was the direct and proximate cause of the plaintiffs’ injuries.” Tolliver, 2012 WL

3074538, at *5; see also O.M., 560 F. Supp.3d at 1090–91; Tomlin v. Smith & Nephew, Inc., 2020

WL 5230830, at *2–3 (S.D. Ohio Sept. 2, 2020).

Here, Plaintiff fails to even allege a single representation made by Defendants. Her Complaint

“identifies no representation to which the device did not conform.” O.M., 560 F. Supp.3d at 1091.

Nor does Plaintiff make any attempt in her Opposition to address this claim. Rather, the only

allegation relevant to this claim in Plaintiff’s Complaint is the conclusory allegation that the ETTs

“were defective because they did not conform to representations made by their manufacturers as

described in OHIO REV. CODE STAT. ANN. § 2307.77.” (Compl. at ¶ 11.) Such an allegation

fails to state a claim under the Rule 8 standard. See O.M., 560 F. Supp.3d at 1091.

Accordingly, the Court hereby dismisses Plaintiff’s claim under § 2307.77.

D. O.R.C. § 2307.76: Inadequate Warning or Instruction

Next, the Court turns to Plaintiff’s inadequate warning or instruction claim under § 2307.76.

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In Defendants’ Motion, Medtronic first asserts that Plaintiff’s claim under § 2307.76 is barred

under the doctrine of claim preclusion because the state court already dismissed the claim. (Doc. No.

7-1 at PageID #81–82.) Medtronic then contends that even if this Court were to independently decide

the issue, Plaintiff does not state a viable claim because Plaintiff makes no attempt to allege a “duty

to warn against reasonably foreseeable risks, breach of that duty, and an injury proximately caused

by said breach.” (Id. at PageID #82.)

In Plaintiff’s Opposition, Plaintiff simply reiterates that her Complaint sufficiently alleges her

claims. (Doc. No. 9.) Plaintiff does not specifically address the merits of her claim under § 2307.76.

(Id.) Notably, however, Plaintiff acknowledges that this claim was dismissed by the state court on

August 1, 2023. (Id. at PageID #94.) In Defendants’ Reply, Medtronic reiterates that Plaintiff fails

to address the case law cited in Defendants’ Motion “establishing that such barebones allegations are

insufficient under Twombly/Iqbal to infer a cause of action as to product defect under Ohio law.”

(Doc. No. 10 at PageID #102–03.)

Under the OPLA, a “product can be defective due to an inadequate warning or instruction

either at the time of marketing, when it left the control of its manufacturer, or at post-marketing.” See

O.R.C. § 2307.76(A)–(B); O.M., 560 F. Supp.3d at 1090. A claim for inadequate warning or

instruction under § 2307.76 has three elements: “(1) a duty to warn against reasonably foreseeable

risks; (2) breach of this duty; and (3) an injury that is proximately caused by the breach.” O.M., 560

F. Supp.3d at 1090 (citing cases).

The Court finds that dismissal of Plaintiff’s claim under § 2307.76 is warranted. First,

Plaintiff’s claim is independently barred on the basis that it has already been dismissed by the state

court, as acknowledged by Plaintiff. (Doc. No. 9 at PageID #94.) Second, notwithstanding the prior

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dismissal, Plaintiff fails to set forth any allegations that Defendants had a duty to warn against

reasonably foreseeable risks, or that Defendants breached this duty by failing to warn of some

reasonably foreseeable risk. See O.M., 560 F. Supp.3d at 1090. Once again, Plaintiff simply reiterates

a conclusory statement that “the products as manufactured by [D]efendants … were defective due to

inadequate warnings and instructions as described in OHIO REV. CODE STAT. ANN. § 2307.76.”

(Compl. at ¶ 11.) This sole allegation again fails Rule 8 pleading requirements.

Accordingly, the Court hereby dismisses Plaintiff’s claim under § 2307.76.

E. Plaintiff’s Request for Discovery

Finally, the Court turns to Plaintiff’s request for leave of court to conduct discovery.

In her Opposition, Plaintiff “seeks leave of court to conduct discovery to plead with greater

specificity, should the Court order that same is necessary.” (Doc. No. 9 at PageID #93.) Plaintiff

indicates that prior to filing the initial suit in state court, she requested extensive product information

from the Hospital and asked for the intubation devices to be preserved, to which she “received no

cooperation and no product information.” (Id. at PageID #92.) Plaintiff further notes that Defendants

are aware of Plaintiff’s dilemma because “counsel for [P]laintiff and counsel for [Defendants] had a

lengthy telephone conversation,” followed by Plaintiff’s counsel “immediately thereafter

forward[ing] to counsel for Medtronic all medical records in [P]laintiff’s possession that made

reference to the product or products in question.” (Id.) Based on these occurrences, Plaintiff requests

discovery to “enable her to determine the cause of the reported intubation devices failures” and “to

plead with greater specificity.” (Id. at PageID #92–93.)

In Defendants’ Reply, Medtronic contends that binding Sixth Circuit precedent that “Twombly

and Iqbal do not permit a plaintiff to proceed past the pleading stage and take discovery in order to

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cure a defect in a complaint.” (Doc. No. 10 at PageID #103.) Accordingly, Medtronic asserts that

Plaintiff should not be permitted leave to conduct discovery. (Id. at PageID #104.)

It is well-settled that “[t]he Supreme Court’s decisions in Twombly and Iqbal do not permit a

plaintiff to proceed past the pleading stage and take discovery in order to cure a defect in a complaint.”

Patterson v. Novartis Pharmaceuticals Corp., 451 Fed. App’x 495, 498 (6th Cir. 2011); see also

Shepard and Associates, Inc. v. Lokring Technology, LLC, 2022 WL 2398392, at n.4 (N.D. Ohio July

1, 2022) (“A plaintiff is not entitled to conduct discovery and gather facts necessary to cure defects

in a pleading.”). Indeed, district courts addressing OPLA claims have rejected this exact argument

that a plaintiff “cannot plead more than they did without access to information ‘not readily available

publicly [that] will have to be obtained through discovery,’” finding that Rule 8 “does not unlock the

doors of discovery for a plaintiff armed with nothing more than conclusions.” O.M., 560 F. Supp.3d

at 1090. Thus, Plaintiff is not entitled to discovery to cure the defects in her now-dismissed claims.

Accordingly, Plaintiff’s request for leave of court to conduct discovery is denied.

V. Conclusion

For the reasons set forth above, the Court GRANTS IN PART and DENIES IN PART

Defendants’ Motion to Dismiss. The Court GRANTS Defendants’ Motion as to Plaintiff’s claims

under § 2307.76 and § 2307.77. The Court DENIES Defendants’ Motion as to Plaintiff’s claims

under § 2307.74 and § 2307.75.

IT IS SO ORDERED.

s/Pamela A. Barker

PAMELA A. BARKER

Date: April 24, 2025 U. S. DISTRICT JUDGE

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