Byrnes v. Small

142 F.Supp.3d 1262

Lori Byrnes and Matthew Byrnes, Plaintiffs,

v.John Small, Musculoskeletal Institute Chartered, Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc., Defendants.

Case No: 8:14–cv–1726–T–36MAP

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

Signed November 9, 2015

Jeffrey Lee Gordon, Maney & Gordon, PA, Tampa, FL, for Plaintiffs.

Stephen Hamilton Sears, Ashley R. Kellgren, MacFarlane, Ferguson & McMullen, PA, David J. Walz, Edward W. Gerecke, Carlton Fields Jorden Burt, PA, Tampa, FL, Andrew E. Tauber, Mayer Brown, LLP, Washington, DC, Daniel L. Ring, Mayer Brown, LLP, Chicago, IL, Murray S. Levin, Sean P. Fahey, Pepper Hamilton, LLP, Philadelphia, PA, for Defendants.

ORDER

Charlene Edwards Honeywell, United States District Judge

This cause comes before the Court upon the Motion to Dismiss First Amended Complaint filed by Defendants Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, "Medtronic") (Doc. 79). Plaintiffs Lori Byrnes and Matthew Byrnes (collectively, "Plaintiffs") responded in opposition to the Motion (Doc. 84), and Medtronic replied in further support of its Motion (Doc. 87). Medtronic filed two notices of supplemental authority (Docs. 88 and 93), and Plaintiffs also filed a notice of supplemental authority (Doc. 89). The Court, having considered the parties' submissions and being fully advised in the premises, will now GRANT–IN–PART and DENY–IN–PART Medtronic's Motion.

I. BACKGROUND

A. Procedural History

This action arises over the injuries allegedly caused to Lori Byrnes by the bone graft device Infuse, which was implanted in Ms. Byrnes in an off-label manner during a spinal fusion surgery. Plaintiffs' original complaint alleged that Medtronic's actions (and inactions) in promoting the off-label use of Infuse subjected it to liability for fraud, failure to warn, design defect, misrepresentation, negligence, breach of express warranty, and loss of consortium. See Doc. 2. Medtronic moved to dismiss the complaint, and the Court granted the motion. See Byrnes v. Small, 60 F.Supp.3d 1289 (M.D.Fla.2015) ("Byrnes I"). In so doing, the Court held that any cause of action was expressly and impliedly preempted to the extent it was premised on any failure to warn theory, and that the design defect claim was expressly preempted. See id. at 1297–99. The Court also held that to the extent any cause of action was premised on alleged affirmative misrepresentations or warranties made by Medtronic, it was not expressly or impliedly preempted, but that to the extent any claims were not preempted, Plaintiffs had failed to plead them sufficiently.

See id. at 1302.¹ The Court therefore dismissed the Complaint and granted Plaintiffs leave to amend.

Plaintiffs subsequently filed an amended complaint. Doc. 75 ("Am.Compl."). Medtronic now moves to dismiss the First Amended Complaint with prejudice.

B. Statement of Facts²

The allegations describing the Infuse product, Medtronic's off-label promotion of Infuse, and the circumstances of Ms. Byrnes' surgery remain the same as already set forth in detail by this Court in Byrnes I, 60 F.Supp.3d at 1292–94, and are incorporated by reference herein. The First Amended Complaint, however, asserts only four claims—for "Misrepresentation, Fraudulent Misrepresentation and Fraud in the Inducement (First Cause of Action); "Negligence of Misleading Off-label Advertising and Promotion" (Second Cause of Action); "Breach of Express Warranty" (Third Cause of Action); and "Loss of Consortium" (Fourth Cause of Action). The First Amended Complaint also contains additional allegations regarding the express warranties and fraudulent statements made by Medtronic, as will be discussed in detail below.

II. LEGAL STANDARD

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 . (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). Furthermore, mere naked assertions 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 . (citation omitted). The court, however, is not bound to accept as true a legal conclusion stated as a "factual allegation" in the complaint. Id .

III. DISCUSSION

A. Fraud (First Cause of Action)

To state a claim for fraud, a plaintiff must allege: "(1) a false statement concerning a material fact; (2) the representor's knowledge that the representation is false; (3) an intention that the representation induce another to act on it; and (4) consequent injury by the party acting in reliance on the representation." Butler v. Yusem, 44 So.3d 102, 105 (Fla.2010) (quotation marks, citation, and emphasis omitted). "[A] party must state with particularity the circumstances constituting fraud ...." Fed.R.Civ.P. 9(b). The purpose of this requirement is to alert the defendant to the "precise misconduct with which [it][is] charged" and to protect the defendant "against spurious charges of immoral and fraudulent behavior." Brooks v. Blue Cross and Blue Shield of Florida, Inc., 116 F.3d 1364, 1370–71 (11th Cir.1997) (quotation marks and citations omitted). This requirement is satisfied if the complaint sets forth "(1) precisely what statements were made in what documents or oral representations ..., and (2) the time and place of each such statement and the person responsible for making ... same, and (3) the content of such statements and the manner in which they misled the plaintiff, and (4) what the defendants obtained as a consequence of the fraud." Ziemba v. Cascade Int'l, Inc., 256 F.3d 1194, 1202 (11th Cir.2001) (quotation marks and citation omitted). Nevertheless, the particularity requirement must not be applied to abrogate the concept of notice pleading, and "alternative means are also available to satisfy the rule." Durham v. Business Management Associates, 847 F.2d 1505, 1511–12 (11th Cir.1988) ; see also Friedlander v. Nims, 755 F.2d 810, 813 n. 3 (11th Cir.1985) ("a court considering a motion to dismiss for failure to plead fraud with particularity should always be careful to harmonize the directives of rule 9(b) with the broader policy of notice pleading").

In Byrnes I, the Court dismissed Plaintiffs' fraud claim without prejudice because "Plaintiffs [had] failed to plead fraud with the requisite particularity.... Indeed, Plaintiffs only allege[d] in a vague and conclusory manner that Medtronic ‘fraudulently concealed and misrepresented’ the dangers of the off-label use of Infuse, Compl. ¶¶ 265–67, but fail[ed] to identify with particularity any misrepresentations and/or concealments that were actually relied upon by Dr. Small, [the doctor who performed the surgery at issue on Ms. Byrnes,] or how those misrepresentations and/or concealments proximately caused Ms. Byrnes' injuries." 60 F.Supp.3d at 1298.

In the First Amended Complaint, Plaintiffs now allege that Medtronic made the following false statements to Dr. Small:

• In September 2000, through its agents Drs. SD Boden, TA Zdeblick, HS Sandu, and SE Heim, that the bone graft substitute in Infuse, recombinant human bone morphogenetic protein type 2 ("BMP") "is and was safe to use in an off-label manner and applied at multiple disc levels, and from a posterior approach, and would not otherwise cause ectopic bone growth," Am. Compl. ¶ 267(a);

• In 2002, through its agents Drs. SD Boden, J Kang, HS Sandu, and JG Heller, that clinical pilot trials demonstrated that BMP "is and was safe to use in posterolateral lumbar spine fusion applied at multiple disc levels, and would not otherwise cause ectopic bone growth," id. ¶ 267(b);

• In 2002, through its agents JK Burkus, MF Gornet, CA Dickman, and TA Zdeblick, that using BMP with tapered interbody cages was safe when "applied at multiple disc levels, and would not otherwise cause ectopic bone growth," id. ¶ 267(c);

• In 2002, through its agents JK Burkus, EE Transfeldt, and SH Kitchel, that clinical and radiographic outcomes using BMP with tapered interbody cages at multiple disc levels "demonstrated no significant findings and did not otherwise cause ectopic bone growth," id. ¶ 267(d);• In 2003, through its agents DS Baskin, P Ryan, and V Sonntag, that " ‘[a] prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein–2 with the CONERSTONE–SR allograft ring and the ATLANTIS anterior cervical plate’ demonstrated no significant findings and did not otherwise cause ectopic bone growth," id. ¶ 267(e);

• In 2003, through its agents JK Burkus, SE Heim, MF Gornet, and TA Zdeblick, that " ‘[a]n integrated analysis of clinical trials using the LT–CAGE lumbar tapered fusion device demonstrated no significant findings and did not otherwise cause ectopic bone growth,’ " and that BMP was "superior to the autograft bone," id. ¶ 267(f);

• In 2003, through its agent Dr. J Kenneth Burkust, that a radiographic assessment of interbody fusion using BMP demonstrated its efficacy for fusion and that it "would not otherwise cause any increased risk of ectopic bone growth or any complication," id. ¶ 267(n);

• In 2004, through its agents RW Haid, CL Branch, JT Alexander, and JK Burkus, that " ‘[p]osterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages' was safe to use in an off-lable manner and applied at multiple disc levels, and from a posterior approach, and

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