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Canary v. Medtronic, Inc.

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

April 18, 2017

JANET CANARY, Plaintiff,
MEDTRONIC, INC., Defendant.



         In May of 2013, Plaintiff was implanted with a spinal cord stimulator manufactured by Defendant Medtronic, Inc. Within a few days after this device was activated, Plaintiff allegedly developed a severe allergic reaction and hives over her entire body, and she was admitted to an intensive care unit at a local hospital. It was soon determined that Defendant's device had triggered Plaintiff's allergies to latex and rubber, and the device was removed in June of 2013. Based on this incident, Plaintiff has asserted state-law product liability and fraud claims against Defendant, alleging that Defendant's medical device had manufacturing and design defects, that Defendant failed to provide adequate warnings against the alleged defects in its device, and that Defendant's representatives made misrepresentations to Plaintiff about the safety of Defendant's medical device.

         Through the present motion filed on January 3, 2017, Defendant seeks the dismissal of Plaintiff's first amended complaint under Federal Rule of Civil Procedure 12(b)(6).[1] In support of this motion, Defendant argues that Plaintiff's product liability claims are preempted by federal law, either expressly or by implication, and that Plaintiff also has failed to adequately plead her state-law claims of product liability and fraud.

         On April 12, 2017, the Court heard oral argument on Defendant's motion. For the reasons stated more fully below, the Court GRANTS IN PART AND DENIES IN PART Defendant's motion to dismiss, holding that Plaintiff's product liability claims are expressly preempted but that she may go forward with her claim of fraud.

         I. FACTS

         The facts giving rise to this suit are set forth in Plaintiff's first amended complaint, and Plaintiff's factual allegations are accepted as true for present purposes. Defendant Medtronic, Inc. designs, manufactures, markets, and sells a variety of medical devices, including the PrimeAdvanced spinal cord stimulator at issue in this case. This product is deemed a Class III medical device under federal law, and Defendant therefore had to secure the approval of the federal Food and Drug Administration (“FDA”) before it could market and sell this device. See 21 U.S.C. § 360c(a)(1)(C)(ii).[2]

         In February of 2008, Plaintiff Janet Canary was involved in a motor vehicle accident and sustained serious injuries to her spine. Over the next few years, Plaintiff underwent a number of fusion surgeries to address these injuries. Following these surgeries, Plaintiff's physicians recommended that she consider the implantation of a permanent spinal cord stimulator to address her chronic neck and back pain.

         As Plaintiff decided whether to pursue this course, she met on multiple occasions with her doctors and one of Defendant's representatives, identified in the complaint as “Violet.” The first such meeting was held on June 11, 2012, and Plaintiff alleges that she informed Violet on this occasion that “she had a latex and rubber allergy” and had experienced “allergic reactions to materials used in [her] previous fusion surgeries.” (First Amended Complaint at ¶ 18.) Plaintiff asserts that she also disclosed these allergic reactions in a questionnaire provided to Defendant at this meeting. When Plaintiff asked Defendant's representative, Violet, whether “other patients have had allergic reactions to any of the manufacturing materials and/or components in [Defendant's] spinal cord stimulators, ” Violet responded that no patients had experienced such an allergic reaction, and she assured Plaintiff that “a latex and rubber allergy did not prevent implantation of [Defendant's] spinal cord stimulators.” (Id. at ¶ 21.)

         Based on these representations, Plaintiff agreed to a trial use of Defendant's spinal cord stimulator, and a physician implanted this trial device on October 11, 2012. In contrast to a permanent implant, the majority of the trial device remained outside of Plaintiff's body. Although Plaintiff did not experience any allergic reactions during this trial, she notes that the trial device “was only activated for less than six hours, ” and was “implanted for less than 24 hours because it was accidentally pulled out of her back during the trial.” (Id. at ¶ 23.)

         Plaintiff next met with her physician and Defendant's representative, Violet, on April 24, 2013. Plaintiff again inquired about other patients who might have had allergic reactions to the materials used in Defendant's spinal cord stimulators, and Violet again responded that there had been no such allergic reactions, and that a latex or rubber allergy would not preclude the implantation of Defendant's spinal cord stimulators. (See Id. at ¶ 24.) Accordingly, Plaintiff elected to go forward with the implantation of a permanent spinal cord stimulator, and this procedure was scheduled for May 16, 2013.

         On the date of this procedure, Plaintiff met once more with her physician and Defendant's representative, Violet. After Violet once again confirmed that no patients had reported allergic reactions to the materials used in Defendant's spinal cord stimulators and that latex and rubber allergies were no barrier to the use of this device, Plaintiff went ahead with the permanent implantation of Defendant's PrimeAdvanced spinal cord stimulator.

         On May 22, 2013, Plaintiff's physician activated the device that had been implanted a few days earlier. Within five hours, Plaintiff developed pruritus at the site of the device's lead and battery placement, and “[o]ver the next four days, she . . . developed hives over her entire body.” (Id. at ¶ 28.) This allergic reaction got progressively worse over the next few days, to the point that Plaintiff was admitted to the intensive care unit at a local hospital from May 28 to May 31, 2013. Upon her discharge from the hospital, Plaintiff was diagnosed with “contact dermatitis secondary to spinal cord stimulator with resulting urticaria and pruritus.” (Id. at ¶ 34.)

         While Plaintiff was in the midst of this severe allergic reaction, she called Defendant's representative, Violet, on May 26, 2013 and informed her of the various conditions from which she was suffering following the activation of Defendant's device, including “a fever, vomiting, difficulty breathing, swelling of her hands and face, ” and an outbreak of hives over her entire body. (Id. at ¶ 29.) In response, Violet “only then informed [Plaintiff] that other . . . patients had indeed [experienced] allergic reactions to manufacturing materials and/or components of [Defendant's] spinal cord stimulator, which included being covered in hives.” (Id.) More specifically, Plaintiff alleges that Defendant's device “contained latex and/or rubber manufacturing materials and/or components, ” and that Defendant's representative, Violet, was aware prior to the date of Plaintiff's procedure that other patients had suffered allergic reactions to these substances in Defendant's device. (Id. at ¶¶ 30-31.)

         On June 13, 2013, Plaintiff underwent another procedure to remove Defendant's device, and her physician subsequently informed her that another such device could not be implanted due to her latex and rubber allergies. Since her allergic reaction to Defendant's device, Plaintiff continues to suffer from a variety of symptoms, including dermographism and hypersensitivity to products containing certain plastics, rubber, and latex. In this suit, Plaintiff now seeks to recover for these injuries under three state-law theories of product liability - manufacturing defect, design defect, and failure to warn - and she also asserts a state-law claim of fraud arising from Defendant's alleged misrepresentations that its spinal cord stimulator was safe for use by patients with known latex and rubber allergies.


         Through its present motion, Defendant seeks the dismissal under Fed.R.Civ.P. 12(b)(6) of each of the claims asserted in Plaintiff's first amended complaint. When determining whether Plaintiff's claims are subject to dismissal under Rule 12(b)(6) for failure to state a claim, the Court must construe the complaint in a light most favorable to Plaintiff and accept all well-pleaded factual allegations as true. League of United Latin American Citizens v. Bredesen, 500 F.3d 523, 527 (6th Cir. 2007). However, “the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 1949 (2009).

         Moreover, “[w]hile a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 1964-65 (2007) (internal quotation marks, alteration, and citations omitted). Rather, to withstand a motion to dismiss, the complaint's factual allegations, accepted as true, “must be enough to raise a right to relief above the speculative level, ” and to “state a claim to relief that is plausible on its face.” Twombly, 550 U.S. at 555, 570, 127 S.Ct. at 1965, 1974. “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.” Iqbal, 556 U.S. at 678, 129 S.Ct. at 1949.

         The Supreme Court has emphasized that this plausibility standard “is not akin to a ‘probability requirement, ' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678, 129 S.Ct. at 1949. “[W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged - but it has not shown - that the pleader is entitled to relief.” Iqbal, 556 U.S. at 679, 129 S.Ct. at 1950 (internal quotation marks, alteration, and citation omitted). If a plaintiff does "not nudge[] [her] claims across the line from conceivable to plausible, [her] complaint must be dismissed." Twombly, 550 U.S. at 570, 127 S.Ct. at 1974.

         III. ANALYSIS

         A. Plaintiff's Product Liability Claims Are Expressly Preempted by Federal Law.

         1. The Law Governing Defendant's Preemption Challenge

         As the principal argument advanced in its motion, Defendant contends that Plaintiff's state-law product liability claims are preempted by federal law, either expressly or by implication. Before turning to the specific claims of preemption raised by Defendant in this ...

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