Wright v. Medtronic, Inc.

• Decision Date: 23 January 2015
• Docket Number: Case No. 1:13–cv–716.
• Citation: 81 F.Supp.3d 600
• Parties: Angie L. WRIGHT, Plaintiff, v. MEDTRONIC, INC., Medtronic Sofamor Danek, USA, Inc., and Medtronic Vertelink, Inc., Defendants.
• Court: U.S. District Court — Western District of Michigan

81 F.Supp.3d 600

Angie L. WRIGHT, Plaintiff

v.MEDTRONIC, INC., Medtronic Sofamor Danek, USA, Inc., and Medtronic Vertelink, Inc., Defendants.

Case No. 1:13–cv–716.

United States District Court, W.D. Michigan, Southern Division.

Signed Jan. 23, 2015.

Curtis Hoke, The Miller Firm LLC, Orange, VA, Nicholas John Spigiel, Kreis Enderle Hudgins & Borsos PC, Kalamazoo, MI, for Plaintiff.

Lisa Marie Baird, Michael Kevin Brown, Reed Smith LLP, Los Angeles, CA, Daniel L. Ring, Mayer Brown LLP, Chicago, IL, Matthew J. Lund, Pepper Hamilton LLP, Southfield, MI, for Defendants.

OPINION

JANET T. NEFF, District Judge.

Pending before the Court in this diversity-products liability action is Defendants' Motion to Dismiss (Dkt 113). Plaintiff filed a response in opposition to Defendants' motion (Dkt 115), and Defendants filed a reply (Dkt 116). Defendants have also since filed numerous supplemental authorities for the Court's consideration (Dkts 123–26, 131–33). Having conducted a Pre–Motion Conference in this matter and having fully considered the parties' written briefs and accompanying exhibits, the Court finds that the relevant facts and arguments are adequately presented in these materials and that oral argument would not aid the decisional process. See W.D. Mich. LCivR 7.2(d). For the reasons that follow, the Court determines that Defendants' motion is properly granted in part and denied in part.

I. BACKGROUND

Defendants, whom Plaintiff sometimes collectively references as “Medtronic,” design, manufacture, construct, assemble, inspect and sell various types of medical drugs and devices, including spinal surgery drugs and devices, and specifically the Infuse Bone Graft

and LT–Cage, collectively known as “Infuse,” which is the medical device at issue in this case (Dkt 95, First Amend. Compl. ¶ 5).¹ Infuse, the trade name for rhBMP–2, a bone morphogenetic protein, is used as an alternative to procuring bone graft material from another part of a patient's body or from a cadaver (id. ¶¶ 79–82).

On July 2, 2002, the Food and Drug Administration (FDA) approved Infuse for use in an Anterior Lumbar Interbody Fusion (ALIF) procedure involving a single-level fusion in the L4–S1 region of the lumbar spine (Dkt 95, First Amend. Compl. ¶¶ 57–58, 84, 88). ALIF is performed by approaching the spine from the front through an incision in the abdomen and is primarily used to treat pain resulting from disc collapse (id. ¶¶ 58, 88). Infuse's FDA-approved label indicates the following:

The InFUSE™ Bone Graft

/LT–CAGE™ Lumbar Tapered Fusion Device consists of two components containing three parts—a tapered metallic spinal fusion cage, a recombinant human bone morphogenetic protein and a carrier/scaffold for the bone morphogenetic protein and resulting bone. The InFUSE™ Bone Graft is inserted into the LT–CAGE™ Lumbar Tapered Fusion Device component to form the complete InFUSE™ Bone Graft /LT–CAGE™ Lumbar Tapered Fusion Device. These components must be used as a system. The InFUSE™ Bone Graft component must not be used without the LT–CAGE™ Lumbar Tapered Fusion Device component.

(Defs.' Ex. 3, Dkt 114–3 at 2) (emphases in original). The label further indicates that the device “is to be implanted via an anterior ... approach,” warning that “[t]he safety and effectiveness of the InFUSE Bone Graft

component ... used in surgical techniques other than anterior ... approaches have not been established” (id. at 4–5). The label expressly cautions that “the potential for ectopic ... or undesirable exuberant bone formation exists” (id. at 6).

Plaintiff indicates that while the product's label remains substantially the same as that approved by the FDA in 2002, the FDA has made minor amendments to the label through post-approval supplements (Dkt 95, First Amended Compl. at 22 n. 1). For example, on July 29, 2004, the FDA approved a supplement expanding the indicated spinal region from L4–S1 to L2–S1 and later granted approval for uses in certain oral maxillofacial surgeries (id. ).

Similarly, Plaintiff represents that while Infuse was initially approved in 2002 for use with the LT–CAGE component, the FDA later approved it for use with an INTER FIX Cage component in 2003 (id. at 34 n. 2).

On March 11, 2010, Plaintiff, a Michigan resident, had a spinal surgery using Defendants' Infuse device in an off-label manner (Dkt 95, First Amend. Compl. ¶ ¶ 1, 105). “Instead of performing an anterior procedure, Plaintiff's surgeon opted for a posterior procedure with an unapproved cage/spacer product” (id. ¶ 106). Plaintiff alleges that Defendants, through their sales representatives and paid “Key Opinion Leaders,” directly and indirectly promoted, trained and encouraged Plaintiff's surgeon to use the Infuse Bone Graft

in an off-label manner, including using it in posterior procedures and using the rh-BMP2 component of Infuse with an unapproved cage or spacer (id. ¶ 107). Plaintiff alleges that she “never recovered from her surgery and continues to have daily severe disabling back and nerve pain, and has had to have two spinal cord stimulators implanted into her back on two separate occasions” (id. ¶¶ 53, 108).

In her five-count First Amended Complaint filed on November 21, 2013, Plaintiff alleges “Failure to Warn” (Count I); “Design Defect” (Count II); “Negligence” (Count III); “Fraud” (Count IV); and “Breach of Express and Implied Warranties” (Count V) (Dkt 95). In lieu of answering the First Amended Complaint, Defendants filed a Pre–Motion Conference request, proposing to file a motion to dismiss Plaintiff's First Amended Complaint (Dkt 97). Following a Pre–Motion Conference in December 2013, this Court issued a briefing schedule on the proposed motion (Dkt 102). The parties filed their motion papers in March 2014 (Dkts 113–22).

II. MOTION STANDARD

Defendants filed their motion to dismiss under Fed.R.Civ.P. 12(b)(6), arguing, in pertinent part, that Plaintiff's claims are preempted. See Trollinger v. Tyson Foods, Inc., 370 F.3d 602, 608 (6th Cir.2004) (explaining that preemption does not normally concern the subject-matter jurisdiction of a court to hear a claim, but “the merits of the claim itself—namely, whether it is viable and which sovereign's law will govern its resolution”).

Defendants also assert under Rule 12(b)(6) that Plaintiff's claims fail on independent federal and state-law grounds. Under Rule 8(a)(2) of the Federal Rules of Civil Procedure, a complaint must contain a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). A complaint will survive a motion to dismiss if the plaintiff alleges facts that “state a claim to relief that is plausible on its face” and that, if accepted as true, are sufficient to “raise a right to relief above the speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 545, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). The plausibility standard “is not akin to a ‘probability requirement,’ but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are ‘merely consistent with’ a defendant's liability, it ‘stops short of the line between possibility and plausibility....’ ” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955 ).

“In alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.” Fed.R.Civ.P. 9(b). Specifically, the Sixth Circuit Court of Appeals has held that “[i]n complying with Rule 9(b), a plaintiff, at a minimum, must allege the time, place, and content of the alleged misrepresentation on which he or she relied; the fraudulent scheme; the fraudulent intent of the defendants; and the injury resulting from the fraud.” United States ex rel. Bledsoe v. Cmty. Health Sys., Inc., 501 F.3d 493, 504 (6th Cir.2007) (quoting Coffey v. Foamex L.P., 2 F.3d 157, 161–62 (6th Cir.1993) (internal quotation marks omitted)). “Malice, intent, knowledge, and other conditions of a person's mind may be alleged generally.” Fed.R.Civ.P. 9(b).

In deciding a motion to dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6), the court must treat all well-pleaded allegations in the complaint as true and draw all reasonable inferences from those allegations in favor of the nonmoving party. Total Benefits Planning Agency, Inc. v. Anthem Blue Cross & Blue Shield, 552 F.3d 430, 434 (6th Cir.2008). “[W]hen a document is referred to in the pleadings and is integral to the claims, it may be considered without converting a motion to dismiss into one for summary judgment.” Commercial Money Ctr., Inc. v. Ill. Union Ins. Co., 508 F.3d 327, 335–36 (6th Cir.2007). Also, “[a] court may consider public records without converting a Rule 12(b)(6) motion into a Rule 56 motion.” Jones v. City of Cincinnati, 521 F.3d 555, 562 (6th Cir.2008). See, e.g., Chapman v. Abbott Labs., 930 F.Supp.2d 1321, 1323 (M.D.Fla.2013) (taking judicial notice of the FDA-approved label and the statements contained therein because the label “can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned”); In re Epogen & Aranesp Off–Label Mktg. & Sales Practices Litig., 590 F.Supp.2d 1282, 1286 (C.D.Cal.2008) (granting request for judicial notice of drug labels publicly available on FDA website in connection with motion to dismiss).

“[T]he tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.” Iqbal, 556 U.S. at 678, 129 S.Ct. 1937. Further, “the court need not accept as true a legal conclusion couched as a factual allegation, or an unwarranted factual inference.”Handy–Clay v. City of Memphis, Tenn., 695 F.3d 531, 539 (6th Cir.2012) (citation and internal quotation marks omitted). The parties do not dispute for purposes of...