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Zaccarello v. Medtronic, Inc.

United States District Court, W.D. Missouri, Southwestern Division

August 6, 2014

JIMMY ZACCARELLO, Plaintiff,
v.
MEDTRONIC, INC., et al., Defendants

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[Copyrighted Material Omitted]

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For Jimmy Zaccarello, Plaintiff: Christopher Schnieders, LEAD ATTORNEY, Wagstaff & Cartmell, Kansas City, MO; Jaime E. Moss, LEAD ATTORNEY, PRO HAC VICE, James Paul Sizemore, PRO HAC VICE, Ruth Rizkalla, Sizemore Law Firm, PLC, El Segundo, CA; Lowell Finson, LEAD ATTORNEY, PRO HAC VICE, Phillips Law Firm, El Segundo, CA.

For Medtronic Inc, Medtronic Sofamor Danek USA, Inc., Medtronic Vertelink Inc, Medtronic Sofamor Danek, Inc., Defendants: Andrew E. Tauber, LEAD ATTORNEY, PRO HAC VICE, Mayer Brown LLP, Washington, DC; Michael Kevin Brown, LEAD ATTORNEY, Reed Smith LLP, Los Angeles, CA; Samuel J. Abate , Jr., LEAD ATTORNEY, PRO HAC VICE, Pepper Hamilton, LLP, New York, NY; Steven E. Ward, LEAD ATTORNEY, Turner, Reid, Duncan, Loomer & Patton, Springfield, MO.

For Warsaw Orthopedic, Inc., Defendant: Andrew E. Tauber, LEAD ATTORNEY, PRO HAC VICE, Mayer Brown LLP, Washington, DC; Michael Kevin Brown, LEAD ATTORNEY, Reed Smith LLP, Los Angeles, CA; Steven E. Ward, LEAD ATTORNEY, Turner, Reid, Duncan, Loomer & Patton, Springfield, MO.

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ORDER

BRIAN C. WIMES, UNITED STATES 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. BACKGROUND[1]

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

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should 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. Plaintiff's 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. Plaintiff's 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, Plaintiff's 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 Plaintiff's claims are preempted by the Medical Device Amendments (" MDA" ) to the Federal Food, Drug and Cosmetic Act (" FDCA" ). Defendants alternatively argue that Plaintiff's 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 A. 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 ...


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