McClelland v. Medtronic, Inc.

• Decision Date: 16 May 2013
• Docket Number: Case No. 6:11–cv–1444–Orl–36TBS.
• Citation: 944 F.Supp.2d 1193
• Parties: Peggy McCLELLAND, Plaintiff, v. MEDTRONIC, INC., Defendant.
• Court: U.S. District Court — Middle District of Florida

944 F.Supp.2d 1193

Peggy McCLELLAND, Plaintiff,

v.MEDTRONIC, INC., Defendant.

Case No. 6:11–cv–1444–Orl–36TBS.

United States District Court,

M.D. Florida,

Orlando Division.

May 16, 2013.

Diana L. Martin, Theodore J. Leopold, Leopold Law, PA, Palm Beach Gardens, FL, for Plaintiff.

Justin Benjamin Aronson, Mary Ellen Pullum, Greenberg Traurig, LLP, Orlando, FL, Lori Gail Cohen, Sara K. Thompson, Greenberg Traurig, LLP, Atlanta, GA, for Defendant.

ORDER

CHARLENE EDWARDS HONEYWELL, District Judge.

This cause comes before the Court on Defendant Medtronic, Inc.'s (“Defendant”) Dispositive Motion to Dismiss Plaintiff Peggy McClelland's (“Plaintiff”) Second Amended Complaint (“Motion to Dismiss”) (Doc. 45). Plaintiff filed a response in opposition to Defendant's Motion to Dismiss (“Response”) (Doc. 46), to which Defendant replied (Doc. 52). For the following reasons, Defendant's Motion to Dismiss will be granted.

I. BACKGROUNDA. Statement of Facts¹

Breanne A. McClelland (the “Decedent”) was a resident of Orange County, Florida until her death on August 11, 2011. Doc. 44, ¶ 1. Plaintiff is the Decedent's mother and the duly appointed personal representative of the Decedent's estate. Id. at ¶ 2. Defendant is a corporation organized under the laws of Minnesota, with its principal place of business in that State. Id. at ¶ 4; Doc. 1, ¶ 12. Defendant “researches, develops, tests, manufactures, markets, promotes, advertises, and sells medical devices.” Doc. 44, ¶ 6. Defendant's largest business segment, Cardiac Rhythm Disease Management, develops products that restore and regulate heart rhythm and improve the heart's pumping function. Id.

In March 2004, Defendant received premarket approval (“PMA”) from the U.S. Food and Drug Administration (“FDA”) for the EnPulse pacemaker Model E1DR21 (the “E1DR21”). Id. at ¶ 8. On or about April 30, 2004, the E1DR21 was surgically implanted in the Decedent. Id. at ¶ 9. Plaintiff alleges that prior to 2009, Defendant became aware that several of its implantable pulse generators, including the E1DR21, were defective in that they could “lock-up and inappropriately trigger ERI/RRT mode in the pacemakers,” leading to “intense cardiac symptoms and fail[ure] to properly regulate cardiac rhythm.” Id. at ¶ 10.

On July 22, 2009, the Decedent consulted with her cardiologist about recurrent heart palpitations. Id. at ¶ 13. On that date, her cardiologist interrogated and reprogrammed the Decedent's E1DR21, in part due to evidence of atrial under-sensing. Id. On August 10, 2009, the Decedent informed her cardiologist's office that she was once again suffering from recurrent heart palpitations. Id. at ¶ 14. The next day, the Decedent visited with her cardiologist, who again interrogated and reprogrammed her E1DR21. Id. at ¶ 15. Upon returning home from the procedure, the Decedent continued experiencing chest pains and heart palpitations. Id. at ¶ 16. Within hours, the Decedent became lethargic and weak and was gasping for air, which prompted Plaintiff to drive her to the hospital. Id. On the way there, the Decedent became unresponsive and died shortly thereafter. Id. On August 12, 2009, one of Defendant's representatives performed an interrogation of the Decedent's E1DR21 and determined that her pacemaker had failed her due to certain deficiencies. Id. at ¶ 17. Approximately eighteen months after the Decedent's death, Defendant issued a recall of many models of its implantable pulse generators, including the E1DR21. Id. at ¶ 18. After this recall, Defendant released a software update to reprogram the defective devices that were recalled. Id.

B. Procedural History

On August 4, 2011, Plaintiff filed a Complaint in the Circuit Court of the Ninth Judicial Circuit in and for Orange County, Florida, asserting state law claims for negligence and strict liability against Defendant. See Doc. 2. Defendant subsequently removed the case to this Court based on diversity jurisdiction under 28 U.S.C. § 1332. See Doc. 1. Thereafter, Plaintiff filed an Amended Complaint against Defendant asserting state law claims for negligence per se and failure to warn. See Doc. 20. Defendant filed a motion to dismiss the Amended Complaint, to which Plaintiff responded. See Docs. 24, 26. On September 27, 2012, this Court entered an Order granting Defendant's motion to dismiss, holding that Plaintiff had failed to state a claim upon which relief could be granted, and that Plaintiff's claims were barred by express and implied preemption. SeeDoc. 43, 2012 WL 5077401. However, the Court granted Plaintiff leave to file a Second Amended Complaint, noting that “a narrow gap exists for a plaintiff's state law claim if it is to avoid express or implied preemption....” Id. at 13.

On October 11, 2012, Plaintiff filed her Second Amended Complaint, asserting a single claim for state law negligence. See Doc. 44, p. 7. Plaintiff alleges that Defendant had a duty to notify the FDA of defects in the E1DR21 which could cause or contribute to death or serious injury, and that Plaintiff breached this duty and violated federal laws and regulations by “failing to promptly and accurately report to the FDA incidents and problems with the EnPulse E1DR21 that occurred after the device received [PMA].” Id. at ¶¶ 28–32. Plaintiff further alleges that if Defendant had complied with its duty to notify the FDA, the E1DR21 would have been recalled prior to the death of the Decedent. Id. at ¶ 34. The instant Motion to Dismiss followed.

II. STANDARD OF REVIEW

To survive a motion to dismiss, a pleading must include a “short and plain statement of the claim showing that the pleader is entitled to relief.” Ashcroft v. Iqbal, 556 U.S. 662, 677–78, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Fed.R.Civ.P. 8(a)(2)). Labels, conclusions and formulaic recitations of the elements of a cause of action are not sufficient. Id. at 678, 129 S.Ct. 1937 (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). Mere naked assertions, too, are not sufficient. Id. A complaint must contain sufficient factual matter, which, if accepted as true, would “state a claim to relief that is plausible on its face.” Id. (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955). “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. The Court, however, is not bound to accept as true a legal conclusion stated as a “factual allegation” in the complaint. Id. Therefore, “only a complaint that states a plausible claim for relief survives a motion to dismiss.” Id. at 679, 129 S.Ct. 1937.

III. DISCUSSIONA. Statutory Framework of the Medical Device Amendments

The regulation of medical devices entering the market is governed by the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq. The FDCA provides that the enforcement of violations “shall be by and in the name of the United States.” 21 U.S.C. § 337(a). In 1976, Congress passed the Medical Device Amendments of 1976 (“MDA”), which amended the FDCA and imposed a regime of detailed federal oversight. See21 U.S.C. § 360c et seq. The new regulatory regime separated medical devices into three classes based on the risks they pose to the public. Id.; Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); United States v. Endotec, Inc., 563 F.3d 1187, 1189–90 (11th Cir.2009). Class I devices are those that present no unreasonable risk of illness or injury and are subject only to “general controls,” such as labeling requirements. Riegel, 552 U.S. at 316, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(A)). Class II devices possess a greater potential for danger and thus warrant “special controls” such as performance standards and postmarket surveillance measures. Id. at 316–17, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(B)). The strictest regulation, Class III, is reserved for devices for which a less stringent classification could not provide reasonable assurance of safety and effectiveness. Id. at 317, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(C)).

1. Premarket Approval

All Class III devices, such as the E1DR21 manufactured by Defendant, must undergo the “rigorous” PMA process administered by the FDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). The PMA process begins with the manufacturer submitting a multi-volume application, detailing a variety of information including the safety and efficacy of the device. Riegel, 552 U.S. at 317–18, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(c)(1)). After the FDA completes its review, PMA is granted only if there is a “reasonable assurance” of the device's “safety and effectiveness.” Id. at 318, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)). The FDA may also condition approval on adherence to performance standards, restrictions upon sale or distribution, or other compliance requirements. Id. at 319, 128 S.Ct. 999 (citing 21 C.F.R. §§ 861.1(b)(3), 814.82).

Even after PMA is granted, manufacturers are forbidden to make changes in design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness, without FDA permission. Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). If a manufacturer wishes to make such a change to a device, it must submit an application for supplemental PMA, which is evaluated under identical criteria as the initial application. Id. (citing 21 U.S.C. § 360e(d)(6)). Moreover, after PMA, manufacturers are subject to reporting requirements. Id. (citing 21 U.S.C. § 360i). These include the obligation to inform the FDA of new clinical investigations or scientific studies, 21 C.F.R. § 814.84(b)(2), and to report incidents where the device may have caused or contributed to death or serious injury, 21 C.F.R. § 803.50(a). Riegel, 552 U.S. at 319, 128 S.Ct. 999.

2. Preemptive Effect of the MDA

Until...