Zaccarello v. Medtronic, Inc.

38 F. Supp. 3d 1061, 2014 WL 3866607, 2014 U.S. Dist. LEXIS 108008
CourtDistrict Court, W.D. Missouri
DecidedAugust 6, 2014
DocketCase No. 3:13-CV-01161-BCW
StatusPublished
Cited by7 cases

This text of 38 F. Supp. 3d 1061 (Zaccarello v. Medtronic, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Missouri primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Zaccarello v. Medtronic, Inc., 38 F. Supp. 3d 1061, 2014 WL 3866607, 2014 U.S. Dist. LEXIS 108008 (W.D. Mo. 2014).

Opinion

ORDER

BRIAN C. WIMES, District Judge.

This matter is before the Court on Defendants’ motion to dismiss (Doc. # 87). For the following reasons, the Court grants-in-part and denies-in-part the motion.

I. BACKGROUND1

A. Defendants’ Product.

Defendants design, manufacture, and sell the Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device (“Infuse”). This medical device is used in spinal fusion surgeries and consists of two components: (1) a bone graft substitute (“Infuse Bone Graft”), and (2) a hollow, metal cylinder (“LT-Cage”).

On July 2, 2002, the Food and Drug Administration (“FDA”) approved Infuse through the required premarket approval process. The FDA indicated Infuse [1065]*1065should be used for single-level anterior lumbar interbody fusions placed within the L4-S1 region. The FDA also emphasized that the Infuse Bone Graft must not be used without the LT-Cage. Thus, any operation that uses Infuse in a manner inconsistent with the above constitutes an “off-label” use of the device

B. Plaintiffs Surgery.

On November 10, 2006, Plaintiff underwent a transforaminal lumbar interbody fusion at L4-L5. His physician performed the surgery using Infuse in the following off-label manner: the device was implanted by means of a posterior—not anterior— approach and an LT-Cage was not used. During his surgery, two of Defendants’ sales representatives were present in the operating room. A few months after his surgery, Plaintiff began experiencing severe, chronic, and ongoing pain in his lower back, left, hip, and left leg.

C. Plaintiffs Claims.

Plaintiff filed this personal injury lawsuit because he attributes his pain to Defendants’ promotion of Infuse for “off-label” uses. Plaintiff alleges that Defendants actively promoted the off-label use of Infuse through its sales representatives and consulting physicians despite known adverse side effects. Plaintiff asserts that he would not have undergone the off-label procedure if he or his surgeon had known of the off-label risks

Based on these allegations, Plaintiffs second amended complaint asserts eleven claims: (1) manufacturing defect, (2) design defect, (3) failure to warn, (4) negligence, (5) strict liability (excluding design defect), (6) breach of express warranty, (7) fraudulent misrepresentation and fraud in the inducement, (8) fraud by concealment, (9) misrepresentation, (10) negligence per se, and (11) violations of the Missouri Merchandising Practices Act (“MMPA”).

Defendants move to dismiss all claims under Federal Rule of Civil Procedure 12(b)(6). Defendants primarily argue that Plaintiffs claims are preempted by the Medical Device Amendments (“MDA”) to the Federal Food, Drug and Cosmetic Act (“FDCA”). Defendants alternatively argue that Plaintiffs claims fail on independent grounds under both federal and Missouri law.

II. LEGAL STANDARDS

A. Federal Rule Of Civil Procedure 12(b)(6).

To survive a Rule 12(b)(6) motion to dismiss, the complaint must contain, “sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” 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, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). This standard requires the plaintiff to plead “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id.

B. Federal Rule Of Civil

Procedure 9(b).

Rule 9(b) establishes a heightened pleading standard for complaints alleging fraud. To survive a Rule 9(b) challenge, the complaint must plead “such facts as the time, place, and content of the defendant’s false representations, as well as the details of the defendant’s fraudulent acts, including when the acts occurred, who engaged in them, and what was obtained as a result.” United States ex rel Joshi v. St. Luke’s Hosp., Inc., 441 F.3d 552, 556 (8th Cir.2006) (internal citations omitted).

C.Preemption.

Congress enacted the MDA in 1976 and granted the FDA authority to regulate the [1066]*1066safety and effectiveness of medical devices sold in the United States. 21 U.S.C. §§ 301 et seq. Under the MDA, different types of medical devices receive different levels of scrutiny.

The devices receiving the most scrutiny are those in Class III, which includes Defendants’ Infuse. A Class III device is subject to a rigorous premarket approval process that includes FDA review of the device’s benefits, effectiveness, risks of injury, and proposed labeling. Id. at § 360c(a)(l)(C). After receiving approval, a manufacturer must receive supplemental approval from the FDA before making any changes to the device that affect safety or effectiveness. Id. at § 360e(d)(6)(A)(i).

To preserve the FDA’s regulatory authority over medical devices, the MDA includes an express preemption provision that provides, with a few exceptions not applicable here, that:

[N]o 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).

The Supreme Court discussed this provision in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), and established a two-step analysis for determining whether a state-law claim is expressly preempted. First, the court must determine whether the federal government established requirements applicable to the medical device. Id. at 321-23, 128 S.Ct. 999. Second, the court must determine whether the state-law claim would impose requirements “different from, or in addition to,” the federal requirements. Id. A state-law claim is expressly preempted if the answer to both questions is “yes.”

A state-law claim escapes express preemption if the claim imposes duties that parallel the federal requirements because the second step of the Riegel analysis is not satisfied. But such a claim may nonetheless be impliedly preempted under 21 U.S.C. § 337(a). The Supreme Court discussed implied preemption in Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341

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Cite This Page — Counsel Stack

Bluebook (online)
38 F. Supp. 3d 1061, 2014 WL 3866607, 2014 U.S. Dist. LEXIS 108008, Counsel Stack Legal Research, https://law.counselstack.com/opinion/zaccarello-v-medtronic-inc-mowd-2014.