Blankenship v. Medtronic, Inc.

Decision Date25 March 2014
Docket NumberCase No. 4:13–CV–1087 CEJ.
Citation6 F.Supp.3d 979
CourtU.S. District Court — Eastern District of Missouri
PartiesLaura BLANKENSHIP, Plaintiff, v. MEDTRONIC, INC., et al., Defendants.


Christopher J. Quinn, John J. Driscoll, Driscoll Firm, P.C., St. Louis, MO, J. Paul Sizemore, Ruth Rizkalla, The Sizemore Law Firm PLC, El Segundo, CA, for Plaintiff.

Martin J. Buckley, Buckley And Buckley, L.L.C., St. Louis, MO, Andrew E. Tauber, Mayer Brown LLP, Washington, DC, Michael K. Brown, Elizabeth Graham Minerd, Lisa M. Baird, Mildred Y. Segura, Nabil A. Bisharat, Michael K. Brown, Reed Smith LLP, Los Angeles, CA, for Defendants.


CAROL E. JACKSON, District Judge.

This matter is before the Court on the motion to dismiss the second amended complaint for failure to state a claim filed by defendants Medtronic, Inc., Medtronic Sofamor Danek USA, Inc., Medtronic Vertelink, Inc., Medtronic Sofamor Danek, Inc., and Warsaw Orthopedic, Inc. (collectively, Medtronic) pursuant to Fed.R.Civ.P. 12(b)(6). The defendants also move for a hearing and oral argument. Plaintiff has responded and the issues are fully briefed.

I. Background

Medtronic is in the business of designing, manufacturing, and selling medical devices, including the InFUSE™ Bone Graft/ LT–CAGE™ Lumbar Tapered Fusion device (Infuse). The bone graft component is inserted into the fusion cage component to form the complete device. On July 2, 2002, Infuse was approved by the Food and Drug Administration (FDA) through the required pre-market approval process and was “indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (ddd) at one level from L4–S1 ... to be implanted via an anterior open or an anterior laparoscopic approach.” 1 [Doc. 57–1, 57–2]. On December 1, 2003, the FDA approved the Infuse bone graft to be used with an INTERFIX Cage for identical surgical applications as the LT–Cage. [Doc. # 57–4].

On September 19, 2007, plaintiff underwent a cervical diskectomy and fusion at C4–5, C5–6 and C6–7, with instrumentation and placement of the Infuse bone graft at each level. The cage used in plaintiff's surgery was neither an LT–Cage nor an INTERFIX Cage. Plaintiff claims that shortly after her surgery she experienced severe, chronic, and ongoing numbness and pain in her head, throat, neck, shoulders, and arms. Plaintiff alleges that she is permanently and totally disabled from the pain and numbness and is unable to maintain employment.

Plaintiff attributes her injuries to Medtronic's improper promotion of the Infuse device for “off-label uses.” 2 Plaintiff alleges that despite the FDA's specific description of the use for which the device was indicated, Medtronic created “a marketing plan that explicitly included the improper overpromotion of off-label uses, by artificially lowering the price of the surgery and instructing their sales forces to visit physicians and other health care providers and mislead them into the false belief that Infuse Bone Graft was safe for all spinal surgeries, and safe for use with non-FDA metal cage devices.” [Doc. 24, at 20]. Plaintiff asserts that she would not have consented to the cervical surgery if she had been aware of the off-label risks.

In the second amended complaint, plaintiff asserts the following claims: (1) manufacturing defect; (2) failure to warn; (3) design defect; (4) negligence; (5) strict liability; (6) fraud; (7) negligence per se; (8) intentional misrepresentation; and (9) violations of California's unfair competition law. Medtronic has moved to dismiss all claims on the basis that they are expressly and impliedly preempted by the Medical Device Amendments of 1976, 21 U.S.C. §§ 360k(a), 337(a).

II. Legal Standard
A. Motion to Dismiss

The purpose of a motion to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure is to test the legal sufficiency of the complaint. The factual allegations of a complaint are assumed true and construed in favor of the plaintiff, “even if it strikes a savvy judge that actual proof of those facts is improbable.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 556, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (citing Swierkiewicz v. Sorema N.A., 534 U.S. 506, 508 n. 1, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002)); Neitzke v. Williams, 490 U.S. 319, 327, 109 S.Ct. 1827, 104 L.Ed.2d 338 (1989) (Rule 12(b)(6) does not countenance ... dismissals based on a judge's disbelief of a complaint's factual allegations”); Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974) (a well-pleaded complaint may proceed even if it appears “that a recovery is very remote and unlikely”). The issue is not whether the plaintiff will ultimately prevail, but whether the plaintiff is entitled to present evidence in support of his claim. Id. A viable complaint must include “enough facts to state a claim to relief that is plausible on its face.” Bell Atlantic Corp., 550 U.S. at 570, 127 S.Ct. 1955; see also id. at 563, 127 S.Ct. 1955 (“no set of facts” language in Conley v. Gibson, 355 U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957), “has earned its retirement.”). “Factual allegations must be enough to raise a right to relief above the speculative level.” Id. at 555, 127 S.Ct. 1955.

B. Fraud

Fed.R.Civ.P. 9(b) establishes a heightened pleading standard for complaints alleging fraud. The Eighth Circuit has described Rule 9(b)'s particularity requirement:

Rule 9(b)'s particularity requirement demands a higher degree of notice than that required for other claims, and is intended to enable the defendant to respond specifically and quickly to the potentially damaging allegations. To satisfy the particularity requirement of Rule 9(b), the complaint must plead such facts as the time, place, and content of 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. Put another way, the complaint must identify the “who, what, where, when and how” of the alleged fraud.

United States ex rel. Joshi v. St. Luke's Hosp., Inc., 441 F.3d 552, 556 (8th Cir.2006) (internal citations omitted). A plaintiff must state an underlying basis for its assertions sufficient to provide an indicia of reliability. Id. at 557 (citation omitted). While a plaintiff need not allege specific details of every alleged fraud, the plaintiff must provide some representative examples of the alleged misconduct. Id.

C. Express and Implied Preemption

In the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FDCA), Congress authorized the FDA to regulate the safety and effectiveness of medical devices. See21 U.S.C. § 301 et seq. The devices receiving the most federal oversight are those in Class III,3 which includes the Infuse device at issue here. A Class III device is subject to a rigorous pre-market approval process, which includes FDA review of the device's benefits, effectiveness, risks of injury, and proposed labeling. § 360c(a)(1)(c). If a manufacturer wishes to make any changes in design specifications, manufacturing processes, labeling, or other feature that would affect the device's safety or effectiveness after receiving the pre-market approval, it must submit a supplemental application for additional FDA approval. § 360e(d)(6).

“To preserve federal regulatory authority over medical devices and thereby enable the FDA to balance various statutory objectives,” the MDA contains an express preemption provision, which prevents states from imposing requirements on medical devices that are “different from, or in addition to” those imposed by the FDCA. See Gavin v. Medtronic, Inc., 2013 WL 3791612, *3 (E.D.La. July 19, 2013); § 360k(a). The Supreme Court has established a two-step inquiry for determining whether state law claims are expressly preempted. Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). First, the court must determine whether the federal government established requirements applicable to the medical device. If yes, then the court must determine whether the state claims would impose requirements different from, or in addition to, the federal requirements. Id. at 321–23, 128 S.Ct. 999. The Eighth Circuit has explained that [w]here a federal requirement permits a course of conduct and the state makes it obligatory, the state's requirement is in addition to the federal requirement and thus is preempted.” In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1205 (8th Cir.2010).

However, the MDA does not prevent a state from providing a damages remedy for a violation of state law that parallels a federal requirement under the MDA. Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir.2013) ([T]he MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty[.]). “In order for a state requirement to be parallel to a federal requirement ... 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.” McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir.2005). Additionally, [t]o properly allege parallel claims, the complaint must set forth facts pointing to specific [federal] requirements that have been violated.” Wolicki–Gables v. Arrow Int'l, Inc., 634 F.3d 1296, 1301 (11th Cir.2011); Otis–Wisher v. Fletcher Allen Health Care, Inc., 951 F.Supp.2d 592, 598 (D.Vt.2013) ([A] plaintiff must do more than simply incant the magic words ‘Medtronic violated FDA regulations' in order to avoid preemption.”).

While it is established that parallel claims are not preempted under the MDA, “it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.” Buckman Co. v. Plaintiffs' Legal...

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