Waltenburg v. St. Jude Med., Inc.
| Decision Date | 18 July 2014 |
| Docket Number | Civil Action No. 3:13–CV–01106–TBR. |
| Citation | 33 F.Supp.3d 818 |
| Court | U.S. District Court — Western District of Kentucky |
| Parties | Shawn WALTENBURG, et al., Plaintiffs v. ST. JUDE MEDICAL, INC., et al., Defendants. |
Anthony C. Gadlage, Kelly M. Rowan, Lee E. Sitlinger, Sitlinger, McGlincy, Theiler & Karem, Louisville, KY, for Plaintiffs.
Charles M. Pritchett, Jr., Lori Elizabeth Hammond, Frost Brown Todd LLC, Louisville, KY, for Defendants.
This matter is before the Court upon Defendants St. Jude Medical, Inc., and Pacesetter, Inc.'s Motion to Dismiss. (Docket No. 13.) Plaintiffs Shawn Waltenburg and Jamie Waltenburg have responded, (Docket No. 16), and Defendants have replied, (Docket No. 19). This matter now is ripe for adjudication. For the reasons that follow, Defendants' Motion will be GRANTED IN PART and DENIED IN PART.
Implantable cardioverter defibrillators
(ICDs) are life-saving devices used to detect and treat irregular heart rhythms. An ICD can correct slow heart rates, pace rapid heart rates, and administer electrical impulses to stabilize a heart and allow it to return to an appropriate rhythm. Wires called “leads” are attached to an ICD and then inserted through a major vein and attached directly to the muscle on the inside of the heart, thereby connecting the ICD to the heart. Electrodes that sense the heart's rhythm are built into the leads and are positioned where they can monitor the heartbeat. Lower voltage electrodes can provide pacing therapy to correct irregular heart rhythms. Electrical impulses for defibrillation are provided through higher voltage conducting leads.
Plaintiff Shawn Waltenburg (Mr. Waltenburg) was implanted with a St. Jude “Riata” lead, model number 1580, on September 9, 2004. Plaintiffs claim that shortly after implantation, Mr. Waltenburg began to experience recurring unexplained episodes of defibrillator
discharge in which he received electrical shocks from the defibrillator. Mr. Waltenburg states that he was advised by his physicians in October 2012 that “his Riata lead showed signs of inside-out erosion of the conductors.” (Docket No. 16, at 2.) Mr. Waltenburg says his physicians continue to monitor the lead but have not recommended removal because of the serious risks associated with such a procedure. Plaintiffs allege that Mr. Waltenburg has suffered both physical and emotional injuries, including “inappropriate electrical shocks, medical treatment including diagnostic testing, compromised lead insulation, increased lead impedance, and electrical abnormalities in his Riata lead which have caused him physical pain and discomfort and ha[ve] resulted in medical treatment and hospitalization, as well as severe mental anguish.” (Docket No. 16, at 3.)
Plaintiffs originally filed this action in Jefferson Circuit Court on October 18, 2013. (See Docket No. 1–1, at 4.) Defendants subsequently removed to this Court on November 11, 2013. (Docket No. 1.) Defendants filed their first motion to dismiss on December 16, 2013. (Docket No. 5.) Plaintiffs responded and requested leave to amend their Complaint. (Docket No. 8.) The Court granted Plaintiffs' request and denied Defendants' first motion to dismiss with leave to refile after the filing of Plaintiffs' Amended Complaint. (Docket No. 9.) Plaintiffs thereafter filed their Amended Complaint on February 14, 2014. (Docket No. 10.) In their Amended Complaint, Plaintiffs assert four primary claims: (1) strict liability manufacturing defect; (2) negligent manufacture; (3) negligence per se; and (4) negligent failure to warn. (Docket No. 10, at 28–32.) Plaintiffs also assert a claim for punitive damages, and Jamie Waltenburg asserts a derivative claim for loss of consortium. (Docket No. 10, at 32.) Defendants now renew their Motion to Dismiss, arguing that Plaintiffs have failed to state a plausible claim for relief and that Plaintiffs' claims are preempted by federal law.
The Federal Rules of Civil Procedure require that pleadings, including complaints, contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). A complaint may be attacked for failure “to state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). When considering a Rule 12(b)(6) motion to dismiss, the court will presume that all the factual allegations in the complaint are true and will draw all reasonable inferences in favor of the nonmoving party. Total Benefits Planning Agency v. Anthem Blue Cross & Blue Shield, 552 F.3d 430, 434 (6th Cir.2008) (citing Great Lakes Steel v. Deggendorf, 716 F.2d 1101, 1105 (6th Cir.1983) ).
Even though a “complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citations omitted). Instead, the plaintiff's “[f]actual allegations must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” Id. (citations omitted). That is, a complaint must contain enough facts “to state a claim to relief that is plausible on its face.” Id. at 570, 127 S.Ct. 1955. A claim becomes plausible “when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955 ). If, from the well-pleaded facts, the court cannot “infer more than the mere possibility of misconduct, the complaint has alleged—but it has not ‘show[n]’—‘that the pleader is entitled to relief.’ ” Id. at 679, 129 S.Ct. 1937 (alteration in original) (quoting Fed.R.Civ.P. 8(a)(2) ). “[O]nly a complaint that states a plausible claim for relief survives a motion to dismiss.” Id.
When resolving a motion to dismiss pursuant to Rule 12(b)(6), the Court may consider the complaint and any exhibits attached thereto, public records, items appearing in the record of the case, and exhibits attached to the defendant's motion to dismiss provided such are referenced in the complaint and central to the claims therein. Bassett v. Nat'l Collegiate Athletic Assoc., 528 F.3d 426, 430 (6th Cir.2008) ; see also Stringfield v. Graham, 212 Fed.Appx. 530, 535 (6th Cir.2007) ().
Defendants argue that the Plaintiffs' Amended Complaint should be dismissed because their principal claims in Counts I through IV are preempted by federal law and, even if such claims are not preempted, Plaintiffs have failed to sufficiently state their claims under the requirements of Twombly and Iqbal. The Court will begin by discussing the relevant statutory and regulatory background before turning to the issue of preemption and the Plaintiffs' particular claims.
In 1976, Congress enacted the Medical Device Amendments (MDA), 21 U.S.C. § 360c et seq., to the Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. The MDA established various levels of oversight for medical devices depending on the degree of risk posed. Class I, which is subject to the lowest level of oversight and requires only “general controls,” includes such devices as elastic bandages
and examination gloves. See § 360c(a)(1)(A). At the other end of the spectrum are Class III devices, which receive the highest level of federal oversight and require “premarket approval.” See § 360c(a)(1)(C). A device is classified under Class III where the device “is purported or represented to be for a use in supporting or sustaining human life ... or presents a potential risk of illness or injury” and it cannot be established that a less stringent classification “would provide reasonable assurance of its safety and effectiveness.” § 360c(a)(1)(C)(i)–(ii). It is undisputed that the Riata lead at issue here is a Class III device.
As noted above, Class III devices must undergo premarket approval prior to marketing and sale. See id. Premarket approval, or “PMA,” has been described by the Supreme Court as a “rigorous” process. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). A manufacturer must submit what is typically a multivolume application that includes, among other things, full reports of all studies and investigations of the device's safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device's “components, ingredients, and properties and of the principle or principles of operation”; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device”; samples or device components required by the Food and Drug Administration (FDA); a specimen of the proposed labeling; and any other relevant information. 21 U.S.C. § 360e(c)(1)(A)–(H). After completing its review, the FDA may grant or deny premarket approval, and may condition approval on adherence to performance standards, restrictions on sale and distribution, and/or compliance with other requirements.See 21 C.F.R. §§ 814.82, 861.1(b)(3). The FDA also is free to impose device-specific restrictions by regulation. See 21 U.S.C. 360j(e)(1). The FDA spends an average of 1,200 hours reviewing each application, Lohr, 518 U.S. at 477, 116 S.Ct. 2240, and will grant premarket approval only if it finds...
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