O.M. Through McConnell v. KLS Martin LP

560 F.Supp.3d 1084

O.M., a Minor and THROUGH his Parents, Alec and Jessica MCCONNELL, et al., Plaintiffs,

v.KLS MARTIN LP, et al., Defendants.

Case No. 1:21-cv-121

United States District Court, N.D. Ohio, Eastern Division.

Signed September 17, 2021

Paul W. Flowers, Stephan C. Kremer, W. Craig Bashein, Bashein & Bashein, Cleveland, OH, for Plaintiffs.

Russell W. Porritt, II, Andrew J. Stough, Ward, Anderson, Porritt, Bryant, Lord & Zachary, Toledo, OH, for Defendant KLS Martin LP.

OPINION AND ORDER

J. Philip Calabrese, United States District Judge

Defendant KLS Martin LP designed and manufactures a mandibular distractor device used to treat micrognathia, also known as mandibular hypoplasia, a condition in which the jaw is underdeveloped with potential consequences for eating and speech during childhood development. Shortly after his birth, O.M. underwent surgery and had mandibular distractors inserted. They allegedly failed, necessitating explanation, multiple surgeries, and follow-up treatments and resulting in injuries and damages. Defendant moves to dismiss the first amended complaint. For the reasons the follow, the Court GRANTS IN PART AND DENIES IN PART Defendant's motion.

STATEMENT OF FACTS

On this motion to dismiss, the Court takes the following allegations in the first amended complaint as true and construes them in Plaintiffs’ favor.

On January 8, 2019, when he was about two months old, O.M. had surgically implanted in his lower right and left jaw a mandibular distractor, a medical device used to treat micrognathia, also called mandibular hypoplasia. (ECF No. 16, ¶¶ 6–8, PageID #96.) KLS designed and manufactured each device. (Id. , ¶ 8.) Less than two weeks later, by January 17, 2019, Jessica McConnell, O.M.’s mother, noticed something wrong with O.M., and an x-ray revealed that the device on the left side of his jaw was broken, while the device on the right remained intact. (Id. , ¶¶ 9–10, PageID #97.) O.M. underwent a second surgery on January 22, 2019 to replace the broken device with another one, which KLS also designed and manufactured. (Id. , ¶ 10.) During this surgery, the mandibular distractor on the right "was examined and found to be intact." (Id. )

About a week after the second surgery, on January 31, 2019, O.M.’s mother again noticed something was not right, and an x-ray revealed that the right-side device was now broken. (Id. , ¶ 11.) In other words, the mandibular distractor in O.M.’s right jaw failed just over three weeks after its insertion, two weeks after x-ray confirmation that it remained intact, and nine days after examination during surgery confirmed it had not failed. In a third surgery, on February 5, 2019, both KLS devices were removed and replaced with a mandibular distractor a different manufacturer made. (Id. , ¶ 12.) Plaintiffs do not allege that the third KLS mandibular distractor, the one inserted in the surgery on January 22, 2019 in place of the broken device in O.M.’s left jaw, failed. By February 5, 2019, that replacement device (the one that had not failed) had been in place since January 22, 2019—a period of two weeks, several days longer than it took the first device to fail.

As a result of these events, O.M. has suffered "physical injury, disability, medical expenses, pain and suffering, subsequent multiple surgeries, mental anguish and distress, loss of enjoyment of life and is now more vulnerable to the increased likelihood of future complications." (Id. , ¶ 14.)

STATEMENT OF THE CASE

Based on these allegations, Plaintiffs assert four causes of action: (1) statutory products liability; (2) breach of the implied warranties of merchantability and fitness for a particular purpose; (3) negligence; and (4) loss of consortium. Plaintiffs’ products liability claim alleges that the mandibular distractors were defectively manufactured (id. , ¶ 17, PageID #98); defectively designed (id. , ¶ 18); defective due to an inadequate warning or instruction (id. , ¶ 19); and failed to conform to Defendant's representations about the product (id. , ¶ 20). Plaintiffs also seek punitive damages. (ECF No. 16, ¶¶ 41–45, PageID #101.) Defendant moves to dismiss under Rule 12(b)(6).

ANALYSIS

At the outset, the parties dispute the standard for considering a motion to dismiss. (ECF No. 20, PageID #149–50; ECF No. 21, PageID #176–77.) In the Court's view, the standard under Rule 12(b)(6) is fairly well settled. At the motion to dismiss stage in any civil action, a complaint must "state[ ] a claim for relief that is plausible, when measured against the elements" of a claim. Darby v. Childvine, Inc. , 964 F.3d 440, 444 (6th Cir. 2020) (citing Binno v. American Bar Ass'n , 826 F.3d 338, 345–46 (6th Cir. 2016) ). A complaint must "contain 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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). A claim is plausible "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. at 678, 129 S.Ct. 1937 (citing Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ). To survive a motion to dismiss, a complaint must "raise a right to relief above the speculative level" into the "realm of plausible liability." Twombly , 550 U.S. at 555, 127 S.Ct. 1955.

When analyzing a complaint under this standard, the Court construes factual allegations in the light most favorable to the plaintiffs, accepts them as true, and draws all reasonable inferences in the plaintiffs’ favor. Wilburn v. United States , 616 F. App'x 848, 852 (6th Cir. 2015). But a pleading must offer more than mere "labels and conclusions," because "a formulaic recitation of the elements of a cause of action will not do." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). Nor is a court required to accept "[c]onclusory allegations or legal conclusions masquerading as factual allegations[.]" Eidson v. Tennessee Dep't of Child.’s Servs. , 510 F.3d 631, 634 (6th Cir. 2007).

Therefore, the Court must distinguish between "well-pled factual allegations," which must be treated as true, and "naked assertions," which need not. See Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 ("Nor does a complaint suffice if it tenders naked assertions devoid of further factual enhancement.") (cleaned up); see also, e.g. , Center for Bio-Ethical Reform, Inc. v. Napolitano , 648 F.3d 365, 375 (6th Cir. 2011) (determining that, because some of the plaintiff's factual allegations were "not well-pleaded[,]" "their conclusory nature ‘disentitles them to the presumption of truth’ "). Rule 8 "does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions." Iqbal , 556 U.S. at 678–79, 129 S.Ct. 1937.

Under this familiar standard, the Court considers whether the first amended complaint states claims on which relief may be granted.

I. Ohio Product Liability Act (First Cause of Action)

Plaintiffs bring claims under Ohio's Product Liability Act for manufacturing defect ( Ohio Rev. Code § 2307.74 ), design defect (id. § 2307.75 ), inadequate warning or instruction (id. § 2307.76 ), and failure to conform to representations (id. § 2307.77 ).

I.A. Manufacturing Defect

Under the Ohio Product Liability act, 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." Ohio Rev. Code § 2307.74.

Plaintiffs allege that the "subject mandibular distractors were defectively manufactured within the meaning of O.R.C. Section 2307.74 and as otherwise provided by law." (ECF No. 16, ¶ 17, PageID #98.) Otherwise, the first amended complaint pleads only that Ms. McConnell noticed that "something was not right" with the devices a few weeks after they were implanted (id. , ¶¶ 16, 11, PageID #97), x-rays revealed the devices broke (id. ), and O.M. had to endure two additional surgeries to replace the broken devices (id. , ¶¶ 10, 12). Further, Plaintiffs allege that the product was unreasonably dangerous and caused O.M.’s injuries. (Id. , ¶ 13.)

Defendant argues that these allegations fail under Rule 8 because they do not explain how the subject devices deviated from Defendant's other mandibular distractors. (ECF No. 17, PageID #114–15.) But this argument seeks to hold Plaintiffs to a higher standard than the one Rule 8 imposes. At the pleading stage, the facts alleged support an inference that the two KLS mandibular distractors originally implanted in O.M.’s jaw on January 8, 2019 might have been defectively manufactured. Both devices implanted during that procedure failed, but a third KLS device inserted later did not. In the current procedural posture, Plaintiffs enjoy an inference that the first two devices were manufactured at approximately the same time. Because a 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." Ohio Rev. Code § 2307.74.

Defendant relies on Tomlin v. Smith & Nephew, Inc. , No. 3:19-CV-354, 2020 WL 5230830, at *5 (S.D. Ohio Sept. 2, 2020). There, the court dismissed a manufacturing defect claim where the plaintiff merely alleged that he experienced pain and discomfort after implantation of a knee and required revision surgery. Accordingly, the Tomlin Court dismissed the claim as too conclusory. So too did the other authorities on which Defendant relies. (ECF No. 17, PageID #115.) Unli...