Marmol v. St. Jude Med. Ctr.

• Citation: 132 F.Supp.3d 1359
• Decision Date: 24 September 2015
• Docket Number: Case No. 8:15–cv–1276–T–30TGW.
• Parties: Delio MARMOL, Plaintiff, v. ST. JUDE MEDICAL CENTER and Pacesetter, Inc., Defendants.
• Court: U.S. District Court — Middle District of Florida

132 F.Supp.3d 1359

Delio MARMOL, Plaintiff,

v.ST. JUDE MEDICAL CENTER and Pacesetter, Inc., Defendants.

Case No. 8:15–cv–1276–T–30TGW.

United States District Court, M.D. Florida, Tampa Division.

Signed Sept. 24, 2015.

Javier M. Vazquez, The Pendas Law Firm, Tampa, FL, for Plaintiff.

David J. Walz, Edward W. Gerecke, Carlton Fields Jorden Burt, PA, Tampa, FL, for Defendants.

ORDER

JAMES S. MOODY, JR.

, District Judge.

THIS CAUSE comes before the Court upon Defendants' Motion to Dismiss First Amended Complaint (Doc. 10), Plaintiff's response in opposition (Doc. 12), and Defendants' reply (Doc. 15).¹ The Court, having reviewed the motion, response, and reply, and being otherwise fully advised in the premises, concludes that Defendants' motion should be granted because Florida does not recognize private causes of action, like the products liability claims brought by Plaintiff, for violations of the Food and Drug Administration's ("FDA") regulations. Plaintiff also has no remedy under federal law because the Medical Device Amendments Act of 1976 precludes Plaintiff from asserting a private cause of action to enforce violations of the Act. While Plaintiff can petition the FDA to enforce its regulations, in Florida, Plaintiff currently lacks a judicial remedy to compensate him for the injuries he has sustained.

BACKGROUND

Plaintiff commenced this products liability action against Defendants for injuries allegedly caused by defects in a model 1582 Riata lead² that was implanted in Plaintiff on January 5, 2009.³ Defendants developed and manufactured the Riata lead, which is a Class III medical device approved by the FDA's premarket approval ("PMA") process. Plaintiff alleges that he began to sustain electrical shocks from his defibrillator

unrelated to his condition in April 2012 and that he was thereafter informed by his doctor that his Riata lead had been recalled by the FDA due to failures associated with the lead insulation which could cause the leads to become externalized.⁴ Although Plaintiff underwent surgery to have the Riata lead removed and replaced, his surgeon was unable to extract the Riata lead.

Plaintiff alleges that his Riata lead was defective in that it suffered from extrusion of the conductor, compromised lead insulation, increased lead impedance, and electrical abnormalities because Defendants failed to (1) manufacture the internal conductors at sizes consistent with specifications, (2) manufacture the leads with uniform insulation diameters, (3) comply with the approved methods and specifications for curing and sterilization of the leads, (4) process the leads in the appropriate solution consistent with federal specifications, and (5) properly crimp the leads. Plaintiff alleges that each of these manufacturing defects was inconsistent with Defendants' obligations under FDA regulations, the PMA documents, or both. As a result of Defendants' noncompliance with federal specifications, the Riata leads were subject to abrasion of the insulation surrounding the leads' cables or conductors, which can cause the cables to protrude through the insulation and the leads to short producing unnecessary shocks and preventing the lead from properly communicating with the attached implantable cardiac defibrillator

.

Accordingly, Plaintiff asserts claims under Florida law for (1) strict liability manufacturing defect, (2) negligent manufacturing defect, and (3) failure to warn. Defendants move to dismiss Plaintiff's complaint under Federal Rule of Civil Procedure 12(b)(6)

, raising numerous arguments, including that Plaintiff's complaint is inadequately pled and that the Medical Device Amendments of 1976 ("MDA") and Florida law preclude Plaintiff's claims.

STANDARD OF REVIEW

Pursuant to Federal Rule of Civil Procedure 12(b)(6)

, a complaint may be dismissed for failure to state a claim upon which relief can be granted. In considering a motion to dismiss under Rule 12(b)(6), a court must accept the factual allegations of the complaint as true and evaluate all inferences derived from those facts in the light most favorable to the plaintiff. See Erickson v. Pardus, 551 U.S. 89, 94, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007). Conclusory allegations, unwarranted factual deductions, or legal conclusions masquerading as facts, however, are not entitled to the assumption of truth. See Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) ; Davila v. Delta Air Lines, Inc., 326 F.3d 1183, 1185 (11th Cir.2003).

LEGAL FRAMEWORK

A. The Medical Device Amendments of 1976

Currently, medical devices are regulated by the Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301

–399f. States were once provided discretion to supervise new medical devices. See Stokes v. I–Flow Corp., No. 6:12–cv–991–Orl–36DAB, 2013 WL 1715427, at *2 (M.D.Fla. Apr. 8, 2013). In 1976, however, Congress enacted the MDA, 21 U.S.C. § 360c, which amended the FDCA and "swept back some state obligations and imposed a regime of detailed federal oversight" for medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).

Under the MDA, medical devices are divided into three classes based on the level of risk they pose to the public. See id.

at 316, 128 S.Ct. 999 ; 21 U.S.C. § 360c(a). The degree of federal oversight depends on the class in which a given device falls. See Riegel, 552 U.S. at 316–17, 128 S.Ct. 999. The strictest regulations are imposed upon devices categorized as Class III, which include devices that support or sustain human life or present a potential unreasonable risk of illness or injury, such as replacement heart valves, implanted cerebella stimulators, and pacemaker pulse generators. Id. at 317, 128 S.Ct. 999 (citing 21 U.S.C. § 360c(a)(1)(C) ).

All Class III devices undergo the FDA's "rigorous" PMA process. Id. (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)

). The FDA grants PMA only if there is a "reasonable assurance" of the device's "safety and effectiveness." 21 U.S.C. § 360e(d)(1)(A). After the FDA grants PMA, manufacturers may not change design specifications, manufacturing processes, labeling, or any other attribute that would affect safety or effectiveness without the FDA's permission. Riegel, 552 U.S. at 319, 128 S.Ct. 999 (citing 21 U.S.C. § 360e(d)(6)(A)(i) ). If a manufacturer wishes to make a change to the device's design specifications, manufacturing process, labeling, or other attribute, it must submit an application for supplemental PMA, which undergoes the same rigorous evaluation as the initial PMA. 21 U.S.C. § 360e(d)(6) ; 21 C.F.R. § 814.39(c).

Following PMA, manufacturers must also comply with the FDA's current good manufacturing practices ("CGMPs") and quality system regulation ("QSR") which govern "the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use." 21 C.F.R. § 820.1(a)(1)

. The FDA also mandates certain reporting requirements after PMA, including alerting the FDA of new clinical investigations or scientific studies and reporting incidents where the device may have caused or contributed to death or serious injury. 21 C.F.R. §§ 814.84(b)(2), 803.50(a).

B. Preemptive Effect of the MDA

The MDA contains an express preemption provision for medical devices, which provides:

[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

21 U.S.C. § 360k(a)

. Thus, " ‘[t]he MDA expressly pre-empts only state requirements different from, or in addition to, any requirement applicable ... to the device under federal law.’ " Wolicki–Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1300 (11th Cir.2011) (quoting Riegel, 552 U.S. at 321, 128 S.Ct. 999 ).

In Riegel v. Medtronic, Inc., the Supreme Court examined whether the MDA preempted state-law claims regarding an allegedly defective medical device. In doing so, the Supreme Court set forth a two-part test to determine whether the state-law claim was preempted. Namely, the Court held that preemption under § 360k(a)

applies if (1) the federal government established requirements applicable to the medical device in question, and (2) the state-law claims concerning the device are based on requirements that are "different from, or in addition to" the federal requirements and relate to the safety and effectiveness of the device. Riegel, 552 U.S. at 321–22, 128 S.Ct. 999. The first prong is automatically satisfied if the FDA authorizes commercial distribution of a Class III medical device following the PMA process. Id. at 322–23, 128 S.Ct. 999

.

The Supreme Court clarified that preemption under § 360k(a)

is not absolute and "does not prevent a State from providing a damages remedy for claims premised on a violation of the FDA regulations ... [because] the state duties in such a case ‘parallel,’ rather than add to, federal requirements." Id. at 330, 128 S.Ct. 999. In Wolicki–Gables v. Arrow International, Inc., the Eleventh circuit explained:

"In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under § 360k(a)

, the plaintiff must show that the requirements are "genuinely equivalent." State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law."

634 F.3d at 1300

(quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005) ).

Additionally, the parallel claim must arise from an actual state-law requirement and cannot exist "solely by virtue of the FDCA ... requirements." Buckman...