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Fisk v. Medtronic, Inc

United States District Court, N.D. Indiana, South Bend Division

September 25, 2017

TAMI FISK, Plaintiff,
MEDTRONIC, INC., Defendant.



         This is a product liability action over a medical device. Plaintiff Tami Fisk had a device known as the SynchroMed II implanted to deliver pain medication directly to her spine, where she experienced chronic pain. The device consisted of a pump implanted in her abdomen, and a catheter that connected to the pump and ran to the spine, where it delivered the medication. After the device stopped working properly, she had the pump removed in 2013, but the catheter remained implanted. She later began experiencing rubbing and poking sensations in her abdomen, and the catheter eventually pierced through her skin. She thus had to undergo a further surgery to remove the catheter, which had developed infections at both ends. Ms. Fisk filed this suit against Medtronic, Inc., which manufactured the device, alleging a variety of theories under state law. Medtronic moved to dismiss, arguing that the claims are barred in part by the statute of limitations, and that the remaining claims either fail to state a valid claim under state law or are preempted by federal law, or both. For the following reasons, the Court grants the motion in part, and denies it in part.


         Plaintiff Tami Fisk suffers from chronic back pain associated with spinal fusions and back surgeries. To treat that pain, she underwent surgery in 2000 to have a SynchroMed II device implanted in her abdomen to administer pain medication into the intrathecal space of her spine (her spinal canal). The device includes two components: a pump and a catheter. The pump is implanted in the abdomen and connects to a thin catheter that extends back to the spine, where it delivers the medication. The device initially worked well for Ms. Fisk. In 2008, she underwent surgery to replace the pump with a new model, but the original catheter remained in place and was connected to the new pump. The new device began leaking its medication, though, which caused painful granulomas (inflammations). Ms. Fisk was thus weaned off of the medication and stopped using the device by the end of 2012.

         In December 2013, Ms. Fisk underwent surgery to remove the device. She alleges that, on the recommendation of Medtronic, which manufactured the device, only the pump was removed, and the catheter was left implanted. About a year later, she began experiencing rubbing and poking sensations in her abdomen, before the catheter finally pierced through her skin and became exposed. Ms. Fisk thus had to undergo another procedure on January 7, 2015, to remove the catheter, which had developed infections on both ends. Ms. Fisk alleges in this action that the catheter was defective and was not safe to have remained implanted.

         The SynchroMed II device is a Class III medical device that was approved by the FDA through its Pre-Market Approval process in 1988. As discussed below, Class III medical devices are subject to a rigorous approval process, after which they are subject to continuing requirements that regulate their manufacture and labeling and that require the manufacturer to report incidents or malfunctions in which the device caused or contributed to death or serious injury. Ms. Fisk alleges that Medtronic committed numerous violations of its various obligations over a number of years relative to the SynchroMed II device. She cites a series of warning letters issued to Medtronic by the FDA finding, among other things, that certain of these devices were “adulterated, ” in that they were not manufactured in compliance with applicable standards, and that Medtronic failed to implement proper complaint handling procedures and to timely notify the FDA of adverse events. She also alleges that the FDA issued a number of recalls for SynchroMed II devices, and that most recently, the FDA entered a consent decree with Medtronic that barred Medtronic from continuing to manufacture these devices until it meets certain conditions.

         Drawing in part on this pattern of conduct, Ms. Fisk alleges that the device that was implanted in her was defective and was not manufactured in compliance with the applicable regulations. She further alleges that Medtronic failed to report adverse events and known problems with the devices to the FDA, and that if the FDA had been properly informed of those issues, she and her doctors would have learned of them in turn and would have removed the catheter when the pump was removed instead of leaving it implanted. Accordingly, she filed a complaint against Medtronic in state court on December 12, 2016, asserting six claims under the Indiana Product Liability Act. Medtronic removed the action to federal court on the basis of diversity of citizenship, [1] and has now moved to dismiss the complaint.


         In reviewing a motion to dismiss for failure to state a claim upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6), the Court construes the complaint in the light most favorable to the plaintiff, accepts the factual allegations as true, and draws all reasonable inferences in the plaintiff's favor. Reynolds v. CB Sports Bar, Inc., 623 F.3d 1143, 1146 (7th Cir. 2010). A complaint must contain only a “short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2). That statement must contain sufficient factual matter, accepted as true, to state a claim for relief that is plausible on its face, Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), and raise a right to relief above the speculative level. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). However, a plaintiff's claim need only be plausible, not probable. Indep. Trust Corp. v. Stewart Info. Servs. Corp., 665 F.3d 930, 935 (7th Cir. 2012). Evaluating whether a plaintiff's claim is sufficiently plausible to survive a motion to dismiss is “‘a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.'” McCauley v. City of Chicago, 671 F.3d 611, 616 (7th Cir. 2011) (quoting Iqbal, 556 U.S. at 678).


         Ms. Fisk asserts six counts against Medtronic, all arising under Indiana law. Though all of the claims are based on the Indiana Product Liability Act, Ms. Fisk set them forth in six counts, which she labeled as follows: (1) manufacturing defect; (2) failure to warn; (3) negligence; (4) breach of express warranty; (5) breach of implied warranty; and (6) negligent misrepresentation. Medtronic moved to dismiss the complaint in its entirety, offering a number of arguments. It first argues that Ms. Fisk's claims are barred by the statute of limitations. It also argues that some of Ms. Fisk's claims do not allege valid theories under state law. Finally, it argues that her claims are preempted by federal law to the extent they would impose requirements beyond those imposed by federal law, and that Ms. Fisk has not adequately pleaded that Medtronic violated its obligations under federal law and that she was injured as a result. After first addressing the statute of limitations, the Court addresses the remaining arguments together, as the pleading and scope of the state law claims and the question of whether those claims are preempted are interrelated.

         A. Statute of Limitations

         Medtronic argues that Ms. Fisk's claims are barred by the two-year statute of limitations under the Indiana Product Liability Act. Ind. Code § 34-20-3-1(b)(1). Ms. Fisk filed her complaint on December 12, 2016, so any claims that accrued more than two years before that date are barred. Medtronic first notes that Ms. Fisk had her first pump replaced in 2008 (the complaint does not specify why), and that her second pump began leaking before 2010 and was removed in December 2013, all of which occurred more than two years before Ms. Fisk filed the complaint. Thus, Medtronic argues that any claim based on the first pump, the device's failure, or removal of the second pump is barred by the statute of limitations. Ms. Fisk does not take issue with that analysis, but instead argues that her claims are based solely on the catheter that was left implanted after her surgery in 2013, and that later protruded through her skin and had to be removed in January 2015. Accordingly, any claim that may have been asserted other than for the catheter that remained implanted is dismissed.

         Medtronic further argues that any claim related to the catheter is barred by the statute of limitations as well. It notes that the complaint alleges that Ms. Fisk first noticed the rubbing and poking sensations in her abdomen in “late 2014.” [DE 6 ¶ 16]. Because any claim that accrued before December 12, 2014 is barred, Medtronic asserts that a claim based on the catheter is “likely” barred, and it objects in its reply brief that Ms. Fisk provided “no evidence” of when she first discovered the problem with the catheter. However, the statute of limitations is an affirmative defense, and “‘complaints need not anticipate and attempt to plead around defenses.'” Chicago Bldg. Design, P.C. v. Mongolian House, Inc., 770 F.3d 610, 613 (7th Cir. 2014) (quoting United States v. N. Trust Co., 372 F.3d 886, 888 (7th Cir. 2004)). Accordingly, “a motion to dismiss based on failure to comply with the statute of limitations should be granted only where ‘the allegations of the complaint itself set forth everything necessary to satisfy the affirmative defense.'” Id. (quoting United States v. Lewis, 411 F.3d 838, 842 (7th Cir. 2005)). In other words, dismissal on this ground at the pleading stage is only appropriate when the plaintiff “affirmatively plead[s] [her]self out of court.” Id.; see also Vinson v. Vermilion Cty., Ill., 776 F.3d 924, 929 (7th Cir. 2015) (“[A] plaintiff may plead herself out of court when she includes in her complaint facts that establish an impenetrable defense to her claims.”).

         Here, the complaint is ambiguous as to when Ms. Fisk discovered the problem with the catheter-“late 2014” could mean either before or after December 12, 2014. Ms. Fisk thus has not plead herself out of court, as the complaint does not establish that this aspect of her claims is untimely. A plaintiff need not submit evidence at the pleading stage or plead around affirmative defenses, either, so dismissal of this aspect of Ms. Fisk's complaint on statute of limitations grounds is unwarranted. Therefore, Ms. Fisk may proceed on her claims to the extent they are based on the catheter and the problems that led to her injury in late 2014 and the catheter's subsequent removal in 2015.

         B. Pleading ...

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