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Hornbeck v. Medtronic, Inc.

United States District Court, N.D. Illinois, Eastern Division

June 2, 2014



VIRGINIA M. KENDALL, District Judge.

Defendants Medtronic, Inc. and Medtronic Sofamor Danek, USA, Inc. move to dismiss the claims asserted against them by the Plaintiffs. The Plaintiffs filed an eleven-count complaint against the Medtronic Defendants and a third defendant, Dr. Travis Richardson. The Plaintiffs' claims stem from Plaintiff Donna Hornbeck's August 8, 2011, spinal surgery during which Dr. Richardson implanted a product designed and manufactured by the Medtronic Defendants. The product is a Class III medical device regulated by the Food and Drug Administration. The Medtronic Defendants claim that federal law expressly and impliedly preempts the Plaintiffs' claims. The Medtronic Defendants further claim that the medical community's knowledge of the risks associated with the Medtronic Defendants' product preclude the Plaintiffs' failure-to-warn claims, the Medtronic Defendants' warranty disclaimers preclude the Plaintiffs' warranty claims, and that the Plaintiffs have not pled fraud with particularity. For the reasons stated herein, this Court denies the Medtronic Defendants' motion.


This Court takes the following well-pleaded allegations from the Complaint and treats them as true for purposes of this motion.

The FDA approved the Medtronic Defendants' premarket approval application for the InFUSEreg; Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device on July 2, 2002. (Dkt. No. 1 at ¶ 27.) Together, these two components include a tapered metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the bone morphogenetic protein and resulting bone. ( Id. at ¶ 28.) The use approved by the FDA requires these two components, the InFUSEreg; Bone Graft and the LT-CAGE™ Lumbar Tapered Fusion Device, to be used together. ( Id. at ¶ 29.) The InFUSEreg; Bone Graft component helps form bone to stabilize the diseased region of the spine permanently and the LT-CAGE™ Lumbar Tapered Fusion Device spaces and stabilizes that region of the spine while the bone forms. ( Id. at ¶ 30.)

The FDA approved the InFUSEreg; Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device for an Anterior Lumbar Interbody Fusion procedure involving a single-level fusion in the L4-S1 region of the lumbar spine. ( Id. at ¶ 35.) This procedure, which treats pain resulting from degenerative disc disease, requires an incision in the abdomen. ( Id. ) The FDA did not approve the InFUSEreg; Bone Graft component for use in spinal fusion surgeries without the LT-CAGETM Lumbar Tapered Fusion Device or in posterior lumbar fusion procedures. ( Id. at ¶ 36.)

Even though the use approved by the FDA requires specific components used together in a specific procedure, sales representatives for the Medtronic Defendants promoted the InFUSEreg; Bone Graft component for other uses. ( Id. at ¶ 132.) In addition, the Medtronic Defendants used royalty and consulting agreements with opinion leaders in the field to influence other surgeons to use the InFUSEreg; Bone Graft component in a manner not approved by the FDA. ( Id. at ¶ 133.) These efforts were part of the Medtronic Defendants' plan to expand the use of the InFUSEreg; Bone Graft component beyond that approved by the FDA. ( Id. at ¶ 136.) These efforts included misrepresentations and intentional omissions of risks involved when using the InFUSEreg; Bone Graft component in a manner not approved by the FDA. ( Id. at ¶ 177.)

While promoting the InFUSEreg; Bone Graft component, the Medtronic Defendants did not report adverse events to the FDA. ( Id. at ¶¶ 216-219.) And despite evidence of foreseeable risks such as bone overgrowth and radiculitis, the Medtronic Defendants downplayed or did not warn surgeons of those risks. ( See, e.g., id. at ¶¶ 220-221.) Further, the Medtronic Defendants deceived the medical community by manipulating the medical literature regarding InFUSEreg; Bone Graft component to misrepresent the product's safety and efficacy. ( Id. at ¶ 222.) The Plaintiffs claim that these acts violated federal statutes and regulations. ( Id. at ¶ 129.)

On August 8, 2011, Dr. Richardson implanted the InFUSEreg; Bone Graft component in Donna Hornbeck using a Transforaminal Lumbar Interbody Fusion procedure. ( Id. at ¶ 332.) This procedure involved a posterior approach, did not involve the LT-CAGE™ Lumbar Tapered Fusion Device, and affected more than one level in the lumbar spine. ( Id. ) Plaintiff Donna Hornbeck subsequently experienced pain in the left side of her back that radiated down her left leg as well as numbness and tingling in her left leg. ( Id. ) Subsequent surgical procedures were necessary to address these issues. ( Id. at ¶ 336.)

The Plaintiffs filed their Complaint on October 31, 2013. Donna Hornbeck alleges the following against the Medtronic Defendants: (1) fraudulent misrepresentation and fraud in the inducement (Count I); (2) strict products liability - failure to warn (Count II); (3) strict products liability - design defect (Count III); (4) strict products liability - misrepresentation (Count IV); (5) product liability - negligence (Count V); (6) breach of express warranty (Count VI); and (7) breach of implied warranties of merchantability and fitness (Count VII). Plaintiff John Hornbeck alleges loss of consortium against all of the Defendants.


Federal law protects Class III medical device manufacturers who subject their devices to the premarket approval process from civil liability so long as the manufacturers comply with federal law. Bausch v. Stryker Corp., 630 F.3d 546, 550 (7th Cir. 2010). The Food, Drug, and Cosmetic Act ("FDCA") provides federal oversight of medical devices. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315-16 (2008) (discussing Medical Device Amendments of 1976, 21 U.S.C. § 360c et seq. ). Through the premarket approval process, the Food and Drug Administration evaluates the safety and effectiveness of a proposed medical device, determines whether a manufacturer may market that device, and decides whether to impose any restrictions on that device. See id. at 318 (discussing premarket approval process).

The FDCA expressly preempts any state or local requirement with respect to a medical device that is "different from, or in addition to" the requirements applicable under the FDCA and that "relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device" under the FDCA. 21 U.S.C. § 360k; see also Riegel, 552 U.S. at 516 (discussing 21 U.S.C. § 360k). This preemption provision, however, does not impliedly preempt all state-law claims based on the FDCA. Bausch, 630 F.3d at 557. Rather, well-recognized state-law claims grounded in a state's historic police powers may proceed so long as a violation of the FDCA caused the harm to the plaintiff. Id. at 557-58 (reversing dismissal of state-law claims for negligence and strict liability based on manufacture of Class III medical device in violation of federal law).

There are no special pleading requirements for product liability claims involving Class III medical devices. Bausch, 630 F.3d at 558. Generally, a plaintiff need only allege sufficient facts to state a claim for relief that is plausible on its face. Id. (citing Ashcroft v. Iqbal, 556 U.S. 662 (2009)). A fraud claim, however, requires a plaintiff to state with particularity the circumstances constituting fraud. Fed.R.Civ.P. 9(b); AnchorBank, FSB v. Hofer, 649 F.3d 610, 615 (7th Cir. 2011) ("This ordinarily requires describing the who, what, when, ...

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