Reynolds v. Medtronic, Inc.

JOY REYNOLDS, Plaintiff, v. MEDTRONIC, INC., et al., Defendants.

Case No. 3:20-cv-403

UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF OHIO WESTERN DIVISION AT DAYTON

May 10, 2021

Judge Thomas M. Rose

ENTRY AND ORDER GRANTING, IN PART, AND DENYING, IN PART, DEFENDANTS' MOTION TO DISMISS PLAINTIFF'S FIRST AMENDED COMPLAINT (ECF NO. 13)

This is a products liability case brought by Plaintiff Joy Reynolds ("Reynolds").¹ In her First Amended Complaint (the "Complaint"), Reynolds brings state-law claims under Ohio law against Medtronic based on her use of an allegedly defective Medtronic SynchroMed II pump system. (See ECF No. 12.) In the Motion to Dismiss (ECF No. 13) (the "Motion"), Medtronic argues that Reynolds's claims are expressly preempted by federal law, impliedly preempted, or inadequately pleaded and deficient under Ohio law. (ECF No. 13.) Therefore, Medtronic moves the Court to dismiss the Complaint for failure to state a claim upon which relief may be granted, pursuant to Federal Rule of Civil Procedure 12(b)(6). In response, Reynolds argues that her claims are parallel claims that escape preemption and comply with the pleading standards. (ECF No. 14.) For the reasons discussed below, the Court GRANTS the Motion with respect to Counts 2 and 3 in the Complaint, but DENIES the Motion with respect to Counts 1 and 4.²

I. BACKGROUND

This background section is based on allegations made by Reynolds in the Complaint. According to the Complaint, "Reynolds suffered severe injuries and hospitalizations as a foreseeable, direct, and proximate result of the defects in the Medtronic SynchroMed II Programmable Implantable Infusion Pump System for intrathecal drug delivery, which was implanted in her abdomen." (ECF No. 12 at PageID 271.)

The SynchroMed II Programmable Implantable Infusion Pump System (the "Device") is a Class III medical device. (Id. at PageID 278.) It is a programmable drug infusion system implanted in the body for drug delivery. (Id. at PageID 277.) The Device includes an infusion pump connected to a thin, flexible catheter attached to a patient's intrathecal space (spinal canal), into which the pump delivers medication. (Id.) Each of the Defendants is involved in the Device's design, assembly, manufacture, testing, packaging, labeling, marketing, distribution, sale, and/or promotion. (Id. at PageID 273)

The U.S. Food and Drug Administration ("FDA") approved the Device through the Premarket Approval ("PMA") process on March 14, 1988. (Id. at PageID 278.) Since its initial approval, Medtronic has sought FDA approval of numerous supplements or changes to the Device originally approved. (Id.; see also ECF No. 13 at PageID 534-35 and its Exhibits A, B, and C (indicating approval of various supplements).)

Medtronic (allegedly) knew there was a manufacturing problem with the catheters used in the Device and that there have been such problems for years. (ECF No. 12 at PageID 280.) Internal Medtronic documents dating back nearly a decade (allegedly) establish both that the catheters were always problematic and that Medtronic knew the catheters were problematic. (Id.) Medtronic included summaries of these problems in each of its Product Performance Reports, includingreports from 2012 through 2018. (Id. at PageID 280-84.) The FDA has issued at least 19 recalls concerning SynchroMed II pump models and at least 27 recalls concerning SynchroMed II catheters and catheter-pump connectors during the time the Device has been on the market. (Id. at PageID 299-303.) On September 21, 2017, Medtronic initiated a recall of the Medtronic Ascenda Intrathecal Catheter for the SynchroMed II pump (the "Z-0537-2018 recall"). (Id. at PageID 308.) The FDA posted the Z-0537-2018 recall on February 6, 2018, and the recall was terminated on March 20, 2020. (Id.) The recall was issued because of the possibility that some distributed catheters were at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump. (Id.)

Moreover, in 2006, 2007, 2008, 2009, 2012, and 2013, the FDA conducted numerous inspections of Medtronic's manufacturing and quality-control facilities in Minnesota and Puerto Rico, (allegedly) discovering many significant violations of federal law governing the manufacture and quality control of PMA medical devices, including the Device and associated intrathecal catheters, as recorded in FDA Form 483s and Warning Letters issued to Medtronic. (Id. at PageID 289-98.) This includes that the methods used in, or the facilities or controls used for, their manufacture, packaging, storage, or installation were not in conformance with the Good Manufacturing Practices ("GMPs") issued by the FDA. (Id. at PageID 289-90.) In fact, throughout the Device's history, the FDA has repeatedly notified Medtronic that the Device's manufacturing failed to conform to manufacturing requirements enumerated in federal regulations and statutes. (Id. at PageID 298.) Reynolds alleges that those federal violations caused defects and malfunctions in her Device, resulting in her injuries and damages. (Id.)

Reynolds has an extensive pain history and a past medical history of Degenerative Disc Disease, among other ailments. (Id. at PageID 274.) On or about September 6, 2018, afterconsultation regarding her chronic pain, Reynolds had a Device implanted in her body to deliver pain medication. (Id.) This took place during the time of the Z-0537-2018 recall. (Id. at PageID 308.) In addition to the Device's failure to reduce her pain, Reynolds experienced new pain at the site of the Device in the weeks afterward. (Id. at PageID 274.) On or about September 29, 2018, physicians told Reynolds that MRIs showed the implanted catheter was wrapped around a bulging disc in her back. (Id. at PageID 275.) On October 29, 2018, while continuing to suffer from severe pain, Reynolds's physicians determined that the implanted Device "was free and able to rotate/twist, and that every time the Device was twisting it would cause a kink in the catheter." (Id. at PageID 276.) A physician recommended that she have the Device "revised." (Id.)

On or about January 15, 2019, a doctor removed Reynolds's Device from her body. (Id.) The doctor noted in an operative report that there was severe twisting of the catheter throughout the flank, possibly being the reason for its kinking off. (Id.) The doctor also noted that it was difficult to ascertain whether the actual catheter had sheared off from the Device insertion site or from the Device itself right at the connector. (Id.) Additionally, it was found that the sutures from the previous anchoring of the Device were loose and the pump was free in the pocket. (Id.) Reynolds experienced a significant reduction in her pain levels after the Device was removed. (Id. at PageID 277.)

Reynolds alleges that, due to its defects and malfunctions, her Device failed to deliver the prescribed medications as programmed, resulting in underdosing and withdrawal from opiate and benzos medications, as well as severe pain and the inability to properly manage her pain. (Id.) More specifically, she experienced a lack of therapeutic effect because the medication from the pump was not delivered into her intrathecal spine space due to the catheter kinking or shearing off from the Device insertion site or from the Device itself at the connector. (Id. at PageID 308-09.)This caused her to incur additional medical bills and suffer pain, lasting injury, mental anxiety, and depression. (Id. at PageID 277.)

The Complaint brings four claims against Medtronic, all under Ohio law: (1) Strict Liability Manufacturing Defect (Ohio Rev. Code § 2307.74); (2) Strict Liability Inadequate Warning or Instruction (Ohio Rev. Code § 2307.76); (3) Breach of Implied Warranty of Merchantability (Ohio Rev. Code §§ 1302.27 & 1302.28); and (4) Punitive Damages (Ohio Rev. Code § 2315.21(C)(1)). The Complaint alleges that this Court has diversity subject-matter jurisdiction over the action pursuant to 28 U.S.C. § 1332(a). (ECF No. 12 at PageID 274.)

On February 18, 2021, Medtronic filed the Motion, seeking dismissal of the Complaint. (ECF No. 13.) On March 3, 2021, Reynolds filed her Response to the Motion (ECF No. 14) (the "Response"). And, on March 17, 2021, Medtronic filed a Reply memorandum in support of the Motion (ECF No. 15) (the "Reply"). The Motion is fully briefed and ripe for review and decision.

II. STANDARD OF REVIEW

Federal Rule of Civil Procedure 8(a)(2) requires that a complaint contain a "short and plain statement of the claim showing that the pleader is entitled to relief." While this rule "does not require 'detailed factual allegations' ... it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." 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, 555, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007)).

A motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6) tests the sufficiency of the complaint. Fed. R. Civ. P. 12(b)(6) (providing for motions to assert a "failure to state a claim upon which relief can be granted"). "To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face." Iqbal, 556 U.S. at 678. A claim is facially plausible when it includes "factual contentthat allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Id. This standard is not the same as a probability standard, but "asks for more than a sheer possibility that a defendant has acted unlawfully." Id. "Where a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief." Id. (internal quotation marks omitted). Thus, if a plaintiff has "not nudged [its] claims across...