McConnell v. KLS Martin LPMcConnell v. KLS Martin LP
Case Information
*1 UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION
O.M., A MINOR AND THROUGH ) Case No. 1:21-cv-121 HIS PARENTS, ALEC AND )
JESSICA McCONNELL, et al. , ) Judge J. Philip Calabrese
)
Plaintiffs, ) Magistrate Judge Thomas M. Parker )
v. )
)
KLS MARTIN LP, et al. , )
)
Defendants. )
)
OPINION AND ORDER
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. ( , ¶ 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 *3 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.” ( , ¶ 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
*4
440, 444 (6th Cir. 2020) (citing
Binno v. American Bar Ass’n
,
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
,
Therefore, the Court must distinguish between “well-pled factual allegations,”
which must be treated as true, and “naked assertions,” which need not.
See Iqbal
,
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), *6 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. ( , ¶ 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 *7 other authorities on which Defendant relies. (ECF No. 17, PageID #115.) Unlike this case, Tomlin did not allege that the device broke while implanted. If Plaintiffs had filed suit based only on the allegation that Ms. McConnell observed that something was not right with O.M., then Tomlin would support an argument for dismissal. However, the first amended complaint states a plausible manufacturing-defect claim under Section 2307.74 of the Ohio Revised Code.
I.B. Design Defect
The Ohio Product Liability Act defines a product as 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 . . . .” Ohio Rev. Code § 2307.75(A). 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.”
Tomlin v. Smith & Nephew, Inc.
, No. 3:19-cv-354,
In addition to the facts pleaded in the first amended complaint and already discussed, Plaintiffs allege that the “subject mandibular distractors [were] defective in design and/or formulation pursuant to the provisions of O.R.C. Section 2307.75 and as otherwise provided by law.” (ECF No. 16, ¶ 18, PageID #98.) Plaintiff’s allegations of a design defect do little more than recite the elements of the cause of action under *8 Section 2307.74. But “a formulaic recitation of the elements of a cause of action will not do.” Iqbal , 556 U.S. at 678 (quoting Twombly , 550 U.S. at 570). “Nor does a complaint suffice if it tenders naked assertions devoid of further factual enhancement.” Id. (cleaned up). As pleaded, therefore, the first amended complaint raises the question whether a product failure, without more, alleges a plausible product defect. As a matter of law, it does not. Plaintiffs point to no authority suggesting otherwise.
Another case from this District supports this conclusion. In
Redinger v. Stryker
Corp.
, No. 5:10 CV 104,
Shortly after
Redinger
, the Southern District of Ohio denied a motion to
dismiss where the complaint alleged only that the device failed while implanted.
See
Foust v. Stryker Corp.
, No. 2:10-cv-00005,
Plaintiffs object that they cannot plead more than they did without access to
information “not readily available publicly [that] will have to be obtained through
discovery.” (ECF No. 20, PageID #156;
see also id.
, PageID #157.) But Rule 8 “does
not unlock the doors of discovery for a plaintiff armed with nothing more than
conclusions.”
Iqbal
,
I.C. Inadequate Warning or Instruction
The Ohio Product Liability Act provides that 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. Ohio Rev. Code § 2307.76(A) & (B).
Under the statute, a claim for inadequate warning or instruction 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.”
Mitchell v. Michael Weinig,
Inc.
, No. 2:17-cv-905, 2020 WL 5798043, at *10 (S.D. Ohio Sep. 28, 2020) (quoting
Monroe v. Novartis Pharms. Corp.
, 29 F. Supp. 3d 1115, 1125 (S.D. Ohio 2014)
(quoting
Graham v. American Cyanamid Co.
,
Plaintiffs allege that the “subject mandibular distractors [were] defective due to inadequate warning or instruction” and that the “failure to furnish proper warning and instruction directly and proximately caused” the alleged injuries and damages. (ECF No. 16, ¶¶ 19 & 21, PageID #98.) Beyond this allegation, and the facts previously discussed, Plaintiffs fail to allege facts that state a claim. Even assuming the foreseeability of the risk of the device breaking after implantation, the first amended complaint contains no allegation that Defendant knew of that risk. Nor does it contain any information about whether Defendant warned of the risk or that the absence of a warning caused the alleged injuries.
The authorities on which Plaintiffs rely are unavailing. (ECF No. 20, PageID
#158.) In
Tomlin
, the court declined to dismiss the plaintiff’s failure to warn claim.
I.D. Failure to Conform to Representations
Under the Act, a “product is defective if it did not conform, when it left the
control of its manufacturer, to a representation made by that manufacturer.” Ohio
*11
Rev. Code § 2307.77. “A plaintiff seeking to recover under § 2307.77 must prove: (1)
that the manufacturer made a representation as to a material fact concerning the
character or quality of the manufacturer’s product; (2) that the product did not
conform to that representation; (3) that the plaintiff justifiably relied on that
representation; and (4) that the plaintiff’s reliance on the representation was the
direct and proximate cause of the plaintiff’s injuries.”
Tomlin
,
II. Breach of Implied Warranty
Plaintiffs allege that Defendant breached the implied warranties of
merchantability and fitness for a particular purpose as their second cause of action.
(ECF No. 16, ¶¶ 23–31, PageID #99.) An implied warranty claim may be brought on
a tort-based theory or a contract-based theory.
In re Porsche Cars N. Am., Inc. Plastic
Coolant Tubes Prods. Liab. Litig.
, 880 F. Supp. 2d 801, 865 (S.D. Ohio 2012);
Caterpillar Fin. Servs. Corp. v. Harold Tatman & Son’s, Enters.
,
II.A. Implied Warranty in Contract
The first amended complaint does not explicitly state whether Plaintiffs bring
a theory of implied warranty in contract, tort, or both. Plaintiffs, however, invoke the
Uniform Commercial Code as adopted in Ohio and allege that Defendant supplied
implied warranties of merchantability and fitness for a particular purpose under
Sections 1302.27 and 1302.28 of the Ohio Revised Code. (ECF No. 16, ¶¶ 26–27,
PageID #99.) Reference to the warranty of merchantability, at least, sounds in
contract.
Mooradian v. FCA US, LLC
, No. 1:17-cv-1132, 2017 U.S. Dist. LEXIS
178558, at *14 (N.D. Ohio Oct. 27, 2017) (citing
In re Porsche
,
Further, Plaintiffs insist in their brief that they are pursuing a claim in tort. ( See ECF No. 20, PageID #163 (“Plaintiff is not seeking any ‘remedy’ available through the UCC as the right to damages for personal injuries arises from the common law of torts.”); id. , PageID #164 (“It must also be stressed that the First Amended Complaint includes general allegations that enforceable express and implied warranties existed which are not based upon the UCC of any state.”).) To the *13 extent there is any doubt Plaintiffs seek to pursue an implied warranty claim in tort only, they concede that “Defendant KLS has justified only a partial dismissal of the theories of recovery that are predicated upon breaches of the warranties implied by R.C. § 1302.27 and 1302.28.” ( , PageID #164.) Based on Plaintiffs’ representations, the Court dismisses the implied warranty claim to the extent it is based in contract.
II.B. Implied Warranty in Tort
“Plaintiffs bringing implied warranty in tort claims must allege that (1) a
defect existed in a defendant’s product that made it unfit for its ordinary, intended
use; (2) the defect existed at the time the product left the defendant’s possession; and
(3) the defect was the proximate cause of the plaintiff’s injuries.”
In re Porsche Cars
,
III. Negligence
Plaintiffs bring a claim for common-law negligence as their third cause of
action. (ECF No. 16, ¶¶ 32–36, PageID #100.) The elements of a negligence claim
under Ohio law are “(1) the existence of a legal duty, (2) the defendant’s breach of
that duty, and (3) injury that is the proximate cause of the defendant’s breach.”
Beckemeyer v. Gelco Corp.
,
The Ohio Products Liability Act “abrogate[s] all common law product liability claims or causes of action.” Ohio Rev. Code § 2307.71(B). Under the Act, a product liability claim includes any claim based on the design or production of a product, the warning or instruction associated with a product, or the failure of a product to conform to a representation or warranty. § 2307.71(A)(13). Accordingly, courts routinely dismiss “non-statutory product-liability claims brought under Ohio law.” McManus v. Smith & Nephew, Inc. , No. 3:19-cv-066, 2020 WL 127702, at *2 (S.D. Ohio Jan. 10, 2020) (collecting cases).
Plaintiffs attempt to avoid preemption by arguing that their negligence claim could be based upon Defendant providing “substandard services instead of defective products.” (ECF No. 20, PageID #167.) Effectively, their argument asks the Court to allow them to proceed on a claim Plaintiffs did not plead. The amended complaint alleges Defendant owed a duty of care to avoid foreseeable harm to Plaintiffs and “negligently manufactured, designed, assembled, distributed, and/or furnished the *15 mandibular distractors,” causing Plaintiffs’ damages. ( , ¶¶ 33–35.) There is no indication in the amended complaint that Plaintiffs seek to bring a negligence action based on substandard services rather than a defective product. Accordingly, the Ohio Products Liability Act abrogates the negligence claim Plaintiffs pleaded.
IV. Loss of Consortium
Plaintiffs’ fourth cause of action is for loss of consortium. (ECF No. 16, ¶¶ 37–40.) As a derivative cause of action, this claim survives to the same extent as Plaintiffs’ substantive claims.
V. Punitive Damages
Plaintiffs seek punitive damages pursuant to Section 2307.80 of the Ohio Product Liability Act. (ECF No. 16, ¶¶ 41–45, PageID #101.) Defendant argues only that the request, styled as the fifth cause of action, should be dismissed because Plaintiffs have not stated a claim for relief under the Act. (ECF No. 17, PageID #128.) A claim for punitive damages is not an independent cause of action, but a remedy. John W. Harry v. Kent Elastomer Prods. , No. 5:20CV1248, ___ F. Supp. 3d ___, 2021 WL 2885877, at *5 n.12 (N.D. Ohio May 6, 2021) (citations omitted). Plaintiffs may pursue this remedy to the extent the law permits.
CONCLUSION
For the foregoing reasons, the Court GRANTS IN PART AND DENIES IN PART Defendant’s motion (ECF No. 17).
SO ORDERED.
Dated: September 17, 2021
J. Philip Calabrese United States District Judge Northern District of Ohio