Opinion
3:23 CV 1409
12-11-2023
SONDRA D. WILLIAMS, Plaintiff, v. BOSTON SCIENTIFIC CORP., Defendant.
MEMORANDUM OPINION AND ORDER
JAMES R. KNEPP II JUDGE
Introduction
Currently pending in this product liability case is Defendant Boston Scientific Corporation's Motion to Dismiss Plaintiff Sondra D. Williams's Amended Complaint. (Doc. 11). The motion is fully briefed and ripe for decision. This Court has jurisdiction pursuant to 28 U.S.C. § 1332. For the following reasons, the Court grants Defendant's motion and dismisses the case in its entirety.
Background
Plaintiff filed her initial complaint in the Lucas County Court of Common Pleas on June 16, 2023. (Doc. 1-2, at 1). Defendant was served on June 23, 2023, and removed the action based on diversity jurisdiction to this Court on July 21, 2023. (Doc. 1, at 1). In response to Defendant's Motion to Dismiss (Doc. 6), Plaintiff sought leave to amend her complaint. (Doc. 8). Upon this Court's grant of that motion, Plaintiff filed an amended complaint on August 28, 2023. (Doc. 10). Defendant then filed the Motion to Dismiss Plaintiff's Amended Complaint currently at issue. (Doc. 11).
In her Amended Complaint, Plaintiff alleges she underwent a bladder surgery on September 29, 2020, during which a pelvic mesh product manufactured by Defendant was used. (Doc. 10, at 1-2). On June 28, 2021, Plaintiff underwent an exploratory surgery for a bowel blockage “which uncovered an internal hernia caused by [the] mesh”. Id. at 1. Plaintiff states the pelvic mesh could not be removed during the exploratory surgery; she alleges the hernia caused by the pelvic mesh has caused her “sustained ongoing pain, suffering, and internal organ damage.” Id. at 2. Plaintiff identifies the pelvic mesh product by “identification numbers[] Upsylon GTINO8714729839217, REFM0068318200, and LOTC003880.” Id.
Standard of Review
On a motion to dismiss under Federal Civil Rule 12(b)(6), the Court tests the complaint's legal sufficiency. The Court construes the complaint in the light most favorable to Plaintiffs, accepts all factual allegations as true, and determines whether the complaint contains “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). Although a complaint need not contain “detailed factual allegations,” it requires more than “labels and conclusions” or “a formulaic recitation of the elements of a cause of action.” Id. at 555. The 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 (2009). “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.
Discussion
Plaintiff brings a design defect claim, a manufacturing defect claim, and a failure-to-warn claim against Defendant related to her injuries allegedly caused by Defendant's pelvic mesh product. (Doc. 10, at 2-3). Defendant moves to dismiss all three claims for failure to state a claim. (Doc. 11, at 1).
Design Defect
The Ohio Products Liability Act (“OPLA”) governs most products liability claims in this state. See, e.g., Tompkin v. American Brands, 219 F.3d 566, 575 (6th Cir. 2000). Under the OPLA, a product is defective in design “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).
Defendant argues that in order to establish a design defect, Plaintiff must establish “(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.” (Doc. 12, at 4) (quoting Tomlin v. Smith & Nephew, Inc., 2020 WL 5230830, at *4 (S.D. Ohio)). But these are the requirements a plaintiff must meet in order to survive summary judgment, not a motion to dismiss. Jones v. Staubli Motor Sports Div. of Staubli American Corp., 897 F.Supp.2d 599, 607 (S.D. Ohio 2012) (citing Hickey v. Otis Elevator Co., 163 Ohio App.3d 765, 769-70 (Ohio Ct. App. 2005)).
Nevertheless, the Court agrees with Defendant that Plaintiff's Amended Complaint provides only conclusory allegations insufficient to survive a motion to dismiss on her design defect claim. The OPLA “requires more, even at the pleading stage,” than a “naked allegation that a product failed, without more”. O.M. Through McConnell v. KLS Martin LP, 560 F.Supp.3d 1084, 1089-90 (N.D. Ohio 2021). Plaintiff states only that Defendant's product caused a hernia and “sustained ongoing pain, suffering, and internal organ damage.” (Doc. 10, at 1-2). The Amended Complaint contains no statements regarding a plausible defect in the mesh. It “tenders naked assertions devoid of further factual enhancement”, which are not sufficient to state a claim. KLS Martin LP, 560 F.Supp.3d at 1089 (quoting Iqbal, 556 U.S. at 678).
Manufacturing Defect
A product is defective in manufacture under the OPLA “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.
At minimum, a plaintiff must provide a “plausible basis to infer the device at issue materially deviated” from specifications or identical units. Parker v. Medtronic Sofamor Danek USA, Inc., 2021 WL 4751185, at *2 (N.D. Ohio); see also Boroff v. Alza Corp., 685 F.Supp.2d 704, 708 (N.D. Ohio 2010); Grubbs v. Smith & Nephew, Inc., 2020 WL 5305542, at *4-5 (S.D. Ohio). As with her design defect claim, Plaintiff states no facts which would explain if or how the mesh was manufactured incorrectly.
Failure to Warn
Under the OPLA, a product is defective for inadequate warning or instruction if “(a) [t]he manufacturer knew or . . . should have known about a risk that is associated with the product and that allegedly caused harm for which the claimant seeks to recover . . . [and] (b) [t]he manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk”. Ohio Rev. Code § 2307.76.
A failure-to-warn claim has three elements: “(1) a duty to warn against reasonably foreseeable risks; (2) a breach of this duty; and (3) an injury that is proximately caused by the breach.” Graham v. Am. Cyanamid Co., 350 F.3d 496, 514 (6th Cir. 2003) (citing Briney v. Sears, Roebuck & Co., 782 F.2d 585, 587 (6th Cir. 1986)). While at the motion to dismiss stage, Plaintiff must only plead facts which would make her allegations plausible, Plaintiff does not allege facts explaining Defendant's duty or how they breached such a duty.
Additionally, the learned intermediary doctrine provides Defendant had a duty to warn only Plaintiff's doctors, not Plaintiff herself or any other third party. Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F.3d 861, 867 (6th Cir. 2006); see also Miller v. Alza Corp., 759 F.Supp.2d 929, 936 (S.D. Ohio 2010) (holding a plaintiff must show an adequate warning would have influenced the physician). Plaintiff's Amended Complaint asserts no facts regarding what warnings were provided regarding Defendant's product or how an adequate warning may have influenced her doctors.
Plaintiff argues Defendant expects her to list in the Complaint “all of the defect details in the product . . . before any discovery is conducted That is not the way litigation works.” (Doc. 14, at 4). But pleading standards “do[] not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Iqbal, 556 U.S. at 678-79.
Conclusion
For the foregoing reasons, good cause appearing, it is
ORDERED that Defendant's Motion to Dismiss (Doc. 11) be, and the same hereby is, GRANTED.