Anderson et al v. Boston Scientific Corporation et al, No. 1:2012cv00762 - Document 11 (S.D. Ohio 2013)
Court Description: OPINION AND ORDER granting 4 Defendants' Motion to Dismiss. Plaintiffs' complaint is dismissed without prejudice to filing an amended complaint within thirty days of the filing of this order, should Plaintiffs be in a position to cure the defects identified herein. Signed by Judge S Arthur Spiegel on 2/19/2013. (km1)
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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO WESTERN DIVISION : : Plaintiffs, : : : v. : : : BOSTON SCIENTIFIC CORPORATION, : et al., : : Defendants. INGRID ANDERSON, et al., NO. 1:12-CV-00762 OPINION & ORDER This matter is before the Court on Defendants Motion to Dismiss (doc. 4), Plaintiff s response in opposition (doc. 8), and Defendants reply in support thereof (doc. 9). For the following reasons, the Court GRANTS Defendant s motion. I. Background This case is here on diversity of citizenship and arose out of the insertion of a spinal cord stimulator, which was manufactured Plaintiff Ingrid September 7, by Defendant Anderson 2010, and Boston had on Scientific the stimulator September 11, Corporation. implanted 2010 experiencing serious and increasing pain (doc. 2). she on began At the time the device was implanted, Plaintiff was introduced to Defendant Jenny, who told her that she was an employee of Defendant Boston -1- Scientific and that she was to be Plaintiff s liaison between Plaintiff and the doctor doing the insertion (Id.). When Plaintiff began experiencing the pain in her back, she attempted to contact Defendant Jenny six times but did not hear back from Jenny for two days (Id.). When they did speak on September 13, 2010, Jenny informed Plaintiff that she should keep her regularly scheduled appointment with the doctor on September 14, 2010 (Id.). Plaintiff arrived at that appointment in extreme pain, nearly unable to walk (Id.). Upon examining the insertion site, the doctor immediately called an ambulance and sent Plaintiff for emergency surgery for an abscess and infection that had developed in her spinal column (Id.). damage In addition to that infection, Plaintiff also suffered to her bladder, nerve damage, pain, and mental and emotional anguish. Plaintiffs complaint contains three counts: Count One is a negligence claim under Ohio common law, where Plaintiffs allege that Defendant Jenny negligently mishandled information, failed to inform the physician who implanted the stimulator of Plaintiff s condition, and negligently advised simply keep her regularly scheduled appointment. Plaintiff to In Count Two, Plaintiffs allege that Defendant Boston Scientific negligently manufactured, inspected, maintained -2- and/or designed the stimulator in violation of Ohio Revised Code Sections 2307.71 et seq. and/or that Defendant Boston Scientific breached implied warranties of fitness with respect to the stimulator. Count Three is a loss of consortium claim under Ohio common law, where Plaintiffs Chloe and Isabelle Anderson allege that as a result of Defendants negligence and/or defective product, they have suffered a loss of consortium with their mother, Plaintiff Ingrid Anderson (doc. 2). Defendants move to dismiss on the bases that the complaint fails to set forth a plausible cause of action and that Plaintiffs claims are preempted. II. Applicable Standard A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) requires the Court to determine whether a cognizable claim has been pled in the complaint. The basic federal pleading requirement is contained in Fed. R. Civ. P. 8(a), which requires that a pleading "contain . . . a short and plain statement of entitled to relief." the claim showing that the pleader is Westlake v. Lucas, 537 F.2d 857, 858 (6th Cir. 1976); Erickson v. Pardus, 551 U.S. 89 (2007). In its scrutiny of the complaint, the Court must construe all wellpleaded motion. facts liberally Scheuer v. in favor Rhodes, 416 -3- of the U.S. party 232, 236 opposing the (1974). A complaint survives a motion to dismiss if it contain[s] sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. Courie v. Alcoa Wheel & Forged Products, 577 F.3d 625, 629-30 (6th Cir. 2009), quoting Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009), citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007). A motion to dismiss is therefore a vehicle to screen out those cases that are impossible as well as those that are implausible. Courie, 577 F.3d at 629-30, citing Robert G. Bone, Twombly, Pleading Rules, and the Regulation of Court Access, 94 IOWA L. REV. 873, 887-90 (2009). A claim is facially plausible when the plaintiff pleads facts that allow the court to draw the reasonable inference conduct alleged. somewhere between that the defendant is Iqbal, 129 S.Ct. at 1949. probability Twombly, 550 U.S. at 557. and liable for the Plausibility falls possibility. Id., citing As the Supreme Court explained, In keeping with these principles a court considering a motion to dismiss can choose to begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth. While legal conclusions can provide the framework of a complaint, they must be supported by factual allegations. When there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement to relief. Id. at 1950. The admonishment to construe -4- the plaintiff's claim liberally when evaluating a motion to dismiss does not relieve a plaintiff of his obligation to satisfy federal notice pleading requirements and conclusions. allege Wright, more Miller than & Procedure: § 1357 at 596 (1969). bare Cooper, assertions Federal of legal Practice and "In practice, a complaint ¦must contain either direct or inferential allegations respecting all of the material elements [in order] to sustain a recovery under some viable legal theory." Car Carriers, Inc. v. Ford Motor Co., 745 F.2d 1101, 1106 (7th Cir. 1984), quoting In Re: Plywood Antitrust Litigation, 655 F.2d 627, 641 (5th Cir. 1981); Wright, Miller & Cooper, Federal Practice and Procedure, § 1216 at 12123 (1969). Circuit The United States Court of Appeals for the Sixth clarified the threshold set for a Rule 12(b)(6) dismissal: [W]e are not holding the pleader to an impossibly high standard; we recognize the policies behind Rule 8 and the concept of notice pleading. A plaintiff will not be thrown out of court for failing to plead facts in support of every arcane element of his claim. But when a complaint omits facts that, if they existed, would clearly dominate the case, it seems fair to assume that those facts do not exist. Scheid v. Fanny Farmer Candy Shops, Inc., 859 F.2d 434, 437 (6th Cir. 1988). III. Discussion Plaintiffs complaint -5- must be dismissed for the following reasons: Count One fails to set forth sufficient facts from which the Court can plausibly infer liability; Count Three, which is wholly derivative of Count One, necessarily fails as a result; and Count Two fails because the claims contained within are entirely preempted. With respect to Count One, Plaintiffs have failed to set forth factual allegations sufficient to allow the Court to plausibly infer a negligence cause of action. A very generous reading of the complaint does allow for a plausible inference that Defendant Jenny owed a duty to Plaintiff Ingrid Anderson, because Plaintiffs Plaintiff Ingrid representative allege that Anderson and as implanted the device. as Jenny held Defendant Plaintiff s liaison herself Boston to out to Scientific s the doctor who Similarly, the complaint can liberally be read to include facts sufficient to support an inference that Defendant herself Jenny breached available to communicate implanted who duty Plaintiff information doctor that about the when and she when Plaintiff s device. failed she failed condition However, to as to make to the Defendants correctly note, the complaint contains no factual allegations that can support a plausible inference of causation. Plaintiffs simply assert in the complaint that Instead, Plaintiff s injuries were a proximate result of the negligent misconduct of -6- the defendants (doc. 2). and/or Later in the defective spinal the complaint, cord Plaintiffs stimulator assert that Defendant s defective product and/or defendant s [sic] conduct directly and proximately caused or contributed to Plaintiff s injuries (Id.). allegations, These and [w]hile are legal legal conclusions, conclusions can not factual provide the framework for a complaint, they must be supported by factual allegations. Iqbal, 556 U.S. at 679. Plaintiffs seem to contend that their complaint should be allowed to proceed because they can t get to the facts that would support their causes of action without discovery (doc. 8, it is impossible for her Plaintiff to because be there certain has not how yet the [stimulator] injured been discovery ). Unfortunately for Plaintiffs, discovery cannot be used as a fishing expedition to uncover the facts necessary to support the causes of action presented in the complaint, even when the information needed to establish a claim ¦is solely within the purview of the defendant or a third party. Albany 1046, Tractor, 1051 discovery Inc., (6th Cir. process to v. Louisville 2011). obtain Tractor, Plaintiffs facts after Inc., may filing not 650 use suit. New F.3d the Id. Absent factual support from which the Court may plausibly infer negligence, Count One fails to meet the pleading standard set -7- forth by the Supreme Court in Iqbal and Twombly and must therefore be dismissed. With respect to Count Two, the spinal cord stimulator at issue here is subject to the Medical Device Amendments (the MDA ), 21 U.S.C. §360k(a), which amended the Federal Food Drug, and Cosmetic imposing Act. The requirements MDA expressly different preempts from, or from addition in states to federal requirements. 21 U.S.C. § 360k(a)(1)-(2). In 2008, the Supreme Court determined that once a medical device receives premarket approval from the Food and Drug Administration (the FDA ), the MDA's preemption clause bars common law claims challenging the safety and effectiveness of that medical device. Riegel v. Medtronic, Inc., 552 U.S. 312, 321-24 (2008). Using a two-step analysis, the court determined that the FDA's premarket approval process imposes federal requirements as understood by the MDA. Id. at 322. the plaintiffs' requirements state Pursuant the claims different approval requirements. whether Next, the court determined that allowing to spinal to from, or proceed in would addition impose state to premarket first determine Id. at 324. Riegel, cord the Court stimulator is must subject to federal requirements and, if so, whether Plaintiffs state-law claims impose requirements that are different from or in addition to -8- the federal requirements. The first inquiry is easily answered: the spinal cord stimulator is subject to federal requirements because it Riegel, received 552 premarket U.S. at approval 322-3 easily answered. the ( Premarket requirements under the MDA ¦. ). as from FDA. See approval ¦imposes The second question is just Plaintiffs state-law claims assert negligent manufacture, inspection, maintenance and design, as well as breach However, of Plaintiffs implied did warranties not of allege fitness a (doc. single 2). specific manufacturing or design defect in the stimulator or provide any factual basis from which the Court could plausibly infer that Defendant Boston Scientific violated inspection or maintenance standards. FDA manufacturing, The MDA preempts Count Two because Plaintiffs would have to show that the stimulator should have been manufactured, designed, inspected and/or maintained in a manner different from that approved by the FDA. See, e.g., Kemp v. Medtronic, Inc., 231 F.3d 216, 220 (6th Cir. 2000) ( To permit a jury manufacture different [an than to find Medtronic approved what the medical FDA negligent device] approved] for with would be failing [a to to component impose a requirement different from and in addition to those established by the FDA. ). Plaintiffs argue in response -9- to Defendants motion that their product liability claim should not be dismissed because it is a parallel claim and because Congress did not intend to foreclose all recourse to plaintiffs. Unfortunately for Plaintiffs, they are wrong on both points. First, their claim is not a parallel claim. State claims that are premised on a violation of FDA regulations are not preempted by the MDA because such state duties would be parallel requirements rather than additional to them. at 330. to federal Riegel, 552 U.S. Plaintiffs have not, however, alleged a parallel claim because there is nothing in the complaint that even approximates an allegation, let alone anything providing factual support for that allegation, that the spinal cord stimulator deviated from FDA requirements.1 Defendant Boston Instead, Scientific Plaintiffs either claims breached assert duties owed that to Plaintiff Ingrid Anderson or did not comply with Ohio s product 1 In their response, Plaintiffs cite Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) for the proposition that they need not specify the precise defect or regulatory requirement that was violated (doc. 8). That case cites a Sixth Circuit case where the court reversed a grant of summary judgment on a medical device on the basis that the plaintiff s negligence per se claim for violations of the Good Manufacturing Practices, which were incorporated into the premarket approval process of the device at issue, was not preempted. Howard v. Sulzer Orthopedics, Inc., 382 Fed.Appx. 436 (6th Cir. 2010). Neither case can save Plaintiffs complaint here because, unlike those two cases, Plaintiffs simply do not allege or provide any factual support for an allegation of violations of federal law. Plaintiffs complaint is expressly premised on violations of state law. As such, neither Bausch nor Howard is availing. -10- liability law, and those claims are entirely dependent on state law. In essence, the complaint alleges that Defendant Boston Scientific violated state law notwithstanding with the FDA premarket approval process. its compliance This is not a parallel claim. Second, as the Supreme Court discussed in Riegel, Congress did indeed foreclose the very avenue Plaintiffs seek to take. This point was raised by the dissent in Riegel and dispensed with by the majority: The dissent would narrow the pre-emptive scope of the term requirement on the grounds that it is difficult to believe that Congress would, without comment, remove all means of judicial recourse for consumers injured by FDA-approved devices ¦. But, as we have explained, this is exactly what a pre-emption clause for medical devices does by its terms. The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification ¦.It is not our job to speculate upon congressional motives. If we were to do so, however, the only indication available the text of the statute suggests that the solicitude for those injured by FDAapproved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations. Riegel, 552 U.S. at 326 (internal citations omitted). Plaintiffs policy argument cannot stand in the face of the Supreme Court s decision in Riegel. IV. Conclusion Because Plaintiffs complaint -11- fails to set forth sufficient factual allegations from which the Court can infer a plausible claim for liability cause of relief action as and because pled is Plaintiffs preempted, product Defendants motion is GRANTED and Plaintiffs complaint is dismissed without prejudice to filing an amended complaint within thirty days of the filing of this order, should Plaintiffs be in a position to cure the defects identified herein. SO ORDERED. Dated: February 19, 2013 s/S. Arthur Spiegel________________ S. Arthur Spiegel United States Senior District Judge -12-
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