Thorn v. Medtronic Sofamor Danek, USA, Inc.

81 F. Supp. 3d 619, 2015 U.S. Dist. LEXIS 7687, 2015 WL 328885
CourtDistrict Court, W.D. Michigan
DecidedJanuary 23, 2015
DocketCase No. 1:13-cv-239
StatusPublished
Cited by20 cases

This text of 81 F. Supp. 3d 619 (Thorn v. Medtronic Sofamor Danek, USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, W.D. Michigan primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp. 3d 619, 2015 U.S. Dist. LEXIS 7687, 2015 WL 328885 (W.D. Mich. 2015).

Opinion

OPINION

JANET T. NEFF, District Judge.

Pending before the Court in this diversity-products liability action is Defendants’ Motion to Dismiss (Dkt. 50). Plaintiff filed a response in opposition to Defendants’ motion (Dkt. 52), and Defendants filed a reply (Dkt. 53). Defendants have also since filed numerous supplemental authori[621]*621ties for the Court’s consideration (Dkts 54-57, 61-62). 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.

I. BACKGROUND

Defendants designed and manufactured the medical device at issue in this case: “Infuse,” a bio-engineered bone filling material containing a bone morphogenetic protein (Dkt. 35, Amend Compl. ¶ 7).1 Infuse is used as an alternative in certain spinal surgeries to graft a patient’s own bone (id.). The purpose of Infuse is to accomplish the same clinical outcomes as grafting a patient’s own bone, without the pain often associated with grafting bone from the hip or other sites (id.).

The Food and Drug Administration (FDA) approved Infuse on July 2, 2002 for use in the lower, lumbar region of the spine to treat degenerative disc disease (Dkt. 35, Amend. Compl. ¶ 10). It was approved by the FDA for anterior-approach lumbar surgery (performed through the abdomen) surgeries at L4 though SI in combination with an “LT-Cage” and a spongy carrier or scaffold (id.). Infuse’s FDA-approved label indicates the following:

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

(Defs.’ Ex. 3, Dkt. 51-3 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, a Michigan resident, had a spinal surgery on March 4, 2010 using Defendants’ Infuse device in an off-label manner, i.e., in a posterior — approach lumbar surgery (performed through the back) (Dkt. 35, Amend. Compl. ¶ 10). Plaintiff claims that “his body produced ectopic and uncontrollable bone growth” because the Infuse “created bone grown outside of the cage in which it was to be confined and into Plaintiffs spinal column with the ultimate result that his spinal cord was compressed and he suffered intractable pain” (id. ¶ 14). Plaintiff alleges that Defendants failed to accurately explain the risks to his surgeon and, in fact, “actively misled him (and ultimately Plaintiff) by their off-label promotion of Infuse, including their financial sponsoring of physicians and articles de[622]*622termined to portray Infuse as safe even for off-label use” (id ¶ 16). Plaintiff underwent a revised interbody fusion in April 2012, which was performed by using a piece of Plaintiffs hip bone as. the grafting material in lieu of Infuse (id ¶ 34). Plaintiff alleges that despite the revision surgery, he continues to suffer from significant pain and disability as a result of his exposure to Infuse (id ¶ 35).

In his three-count Amended Complaint filed on October 25, 2013, Plaintiff alleges “Failure to Warn” (Count I); “Negligence and Gross Negligence” (Count II); and “Breach of Warranty” (Count III) (Dkt. 35). In lieu of answering the Amended Complaint, Defendants filed a Pre-Motion Conference request, proposing to file a motion to dismiss Plaintiffs Amended Complaint (Dkt. 36). Following a Pre-Motion Conference in December 2013, this Court issued a briefing schedule on the proposed motion (Dkt. 41). The parties filed their motion papers in March 2014 (Dkts. 50-53).

II. MOTION STANDARD

Defendants filed their motion to dismiss under Fed.R.Civ.P. 12(b)(6), arguing, in pertinent part, that Plaintiffs 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 Plaintiffs 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 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 non-moving party. Total Benefits Planning Agency, Inc. v. Anthem Blue Cross & Blue Shield, 552 F.3d 430, 434 (6th Cir.2008). “[WJhen 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.”

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81 F. Supp. 3d 619, 2015 U.S. Dist. LEXIS 7687, 2015 WL 328885, Counsel Stack Legal Research, https://law.counselstack.com/opinion/thorn-v-medtronic-sofamor-danek-usa-inc-miwd-2015.