560 F.Supp.3d 1084
N.D. Ohio2021Background
- Infant plaintiff O.M. (born 2018) received bilateral KLS Martin mandibular distractors on Jan. 8, 2019 to treat micrognathia.
- By Jan. 17, 2019 an x-ray showed the left device broken; surgeons replaced it on Jan. 22, 2019 with another KLS device.
- On Jan. 31, 2019 the right-side KLS device was discovered broken despite being examined and found intact during the Jan. 22 surgery.
- On Feb. 5, 2019 both KLS devices were removed and replaced with a device from a different manufacturer; O.M. underwent multiple surgeries and alleges ongoing injuries and damages.
- Plaintiffs sued under the Ohio Product Liability Act (manufacture, design, warning, failure-to-conform), for breach of implied warranties, negligence, loss of consortium, and sought punitive damages; KLS moved to dismiss under Rule 12(b)(6).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Manufacturing defect (OPLA §2307.74) | Two KLS devices implanted initially failed quickly while a later KLS unit did not, supporting an inference of a manufacturing deviation | Complaint lacks detail showing deviation from other identical units or manufacturing specs | Allowed to proceed: complaint plausibly alleges a manufacturing defect |
| Design defect (OPLA §2307.75) | Product failed while implanted, so design was defective | A bare product failure, without additional facts (recalls, known risk, design flaws), is insufficient under Rule 8 | Dismissed: failure alone does not plead a plausible design-defect claim |
| Inadequate warning/instruction (OPLA §2307.76) | Defendant failed to warn of risks that led to injury | No allegations that KLS knew of the risk or that any warning (or lack thereof) caused the injury | Dismissed for failure to allege facts showing duty/breach/causation |
| Failure to conform to representations (OPLA §2307.77) | Device did not conform to KLS representations about quality/performance | Complaint identifies no specific representations, reliance, or causation | Dismissed: no factual allegations identifying a representation or reliance |
| Implied warranties (UCC / common law) | Warranties of merchantability/fitness arose and were breached | Contract-based warranty needs privity (none pleaded); tort-based implied warranty is preempted by the OPLA | Contract warranty claim dismissed for lack of privity; tort-based implied warranty dismissed as preempted by OPLA |
| Negligence (common law) | KLS negligently manufactured, designed, assembled, distributed the distractors | OPLA abrogates common-law product-liability claims; plaintiff did not plead a services-based negligence claim | Dismissed as preempted: the alleged negligence is a product claim under OPLA |
| Loss of consortium & Punitive damages | Consortium and punitive relief are pleaded derivatives/remedies of substantive claims | Punitive damages are not an independent cause of action | Loss of consortium survives only to the extent underlying claims survive; punitive damages may be sought only if permitted by the surviving substantive claims |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard requires factual plausibility)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (complaint must raise claim above speculative level)
- Darby v. Childvine, Inc., 964 F.3d 440 (6th Cir.) (applying plausibility standard to Rule 12(b)(6))
- Eidson v. Tennessee Dep’t of Children’s Servs., 510 F.3d 631 (6th Cir.) (courts need not accept conclusory legal assertions)
- Center for Bio-Ethical Reform, Inc. v. Napolitano, 648 F.3d 365 (6th Cir.) (distinguishing well-pleaded facts from conclusory allegations)
- In re Porsche Cars N. Am., Inc. Plastic Coolant Tubes Prods. Liab. Litig., 880 F. Supp. 2d 801 (S.D. Ohio) (discussing implied warranty and pleading requirements)
- Miles v. Raymond Corp., 612 F. Supp. 2d 913 (N.D. Ohio) (OPLA preempts common-law implied-warranty claims)