Bledsoe v. Medtronic, Inc.

          OPINION AND ORDER

          THERESA L. SPRINGMANN CHIEF JUDGE

         This matter is before the Court on Defendant Medtronic, Inc.'s Motion to Dismiss [ECF No. 8], filed on April 12, 2018. For the reasons set forth below, the Court GRANTS in part and DENIES in part Defendant Medtronic, Inc.'s Motion to Dismiss.

         FACTUAL BACKGROUND

         The following facts are alleged in the Plaintiffs Complaint [ECF No. 4]. On June 14, 2011, Plaintiff Kirk J. Bledsoe was implanted with a SynchroMed II Programmable Implantable Drug Infusion System (“SynchroMed Infusion System”)^[1] to treat an unspecified medical condition. Compl. ¶ 16, ECF No. 5. The SynchroMed Infusion System is a medical device that is used to treat certain medical conditions by delivering medication via an implanted pump and catheter. Id. ¶ 2. Defendant Medtronic, Inc., a Minnesota corporation, designs, manufactures, and sells the SynchroMed Infusion System, including the system implanted in the Plaintiff. Id. ¶¶ 3, 6, 16, 31. Between March 2008 and March 2017, the Defendant issued ten recalls on the SynchroMed Infusion System. Id. ¶¶ 13-15, 17-23.

         In January 2015, the Plaintiff underwent a series of evaluations regarding his device at Methodist Hospital in Merrillville, Indiana. Id. ¶ 25. During each of the evaluations, a Medtronic representative was present. Id. At no point during the January 2015 evaluations was the Plaintiff informed of the recalls, and, based on the series of evaluations, the Plaintiff was led to believe that his device was in perfect working condition. Id. In November 2015, the Plaintiff underwent another series of implant evaluations at Methodist Hospital. Id. ¶ 26. At no point during the second series of evaluations was the Plaintiff informed of the recalls to his device, and he was, once more, led to believe his device was working properly. Id.

         On December 7, 2015, the Plaintiff's device malfunctioned. Id. ¶ 27. This malfunction resulted in the Plaintiff requiring an emergency trip to the hospital for immediate evaluation. Id. Again, a Medtronic representative was present during the December 7, 2015 evaluation. Id. For a third time, the Plaintiff was not informed of the recalls to his device and was led to believe his device was working properly. Id.

         On December 29, 2015, the Plaintiff's device once again malfunctioned. Id. ¶ 28. Due to the two malfunctions, the Plaintiff was hospitalized from December 20, 2015, through January 4, 2016. Id. During the Plaintiff's hospitalization, it was determined that the motor on his device had stalled. Id. Again the Plaintiff was evaluated by a Medtronic representative, who advised him that the device had restarted and that no further evaluation was needed. Id. The Plaintiff requested an additional evaluation from the Medtronic representative, but his request was denied. Id. At no point during his hospitalization was the Plaintiff informed of the recalls of his device. Id.

         Over the next several months, the Plaintiff's device continued to malfunction. Id. ¶ 29. Ultimately, the device's motor stalled completely, resulting in a failure of the Plaintiff's device. Id. On October 27, 2016, the Plaintiff's device was explanted. Id. ¶ 30. The Plaintiff claims that as a result of the malfunction and removal of the device he has suffered and continues to suffer substantial medical expenses, loss of quality of life, severe and permanent pain and suffering, a depreciated and impaired marital relationship, severe and permanent physical impairment, and other damages. Id. ¶ 33.

         PROCEDURAL HISTORY

         On November 3, 2017, the Plaintiff filed his Complaint [ECF No. 5] in Porter County, Indiana, Superior Court, bringing claims under the Indiana Products Liability Act and seeking relief for unspecified injuries he sustained as a result of a defective SynchroMed Infusion System. Id. ¶ 1. On April 5, 2018, the Defendant removed this case to federal court on the basis of diversity of citizenship.^[2] See Notice of Removal, ECF No. 1. On April 12, 2018, the Defendant filed the instant Motion to Dismiss [ECF No. 8] requesting that the Court dismiss the Complaint pursuant to Federal Rule of Civil Produce 12(b)(6) because it fails to state a claim upon which relief can be granted. The Plaintiff filed his Response in Opposition to Defendant's Motion to Dismiss [ECF No. 13] on April 26, 2018, and the Defendant filed its Reply Memorandum in Support of its Motion to Dismiss on May 3, 2018 [ECF No. 14]. On July 9, 2019, Defendant filed a supplement titled Additional Authorities Supporting Defendant Medtronic Inc.'s Motion to Dismiss [ECF No. 23].

         LEGAL STANDARD

         A motion to dismiss brought under Rule 12(b)(6) “challenges the viability of a complaint by arguing that it fails to state a claim upon which relief may be granted.” Camasta v. Jos. A. Bank Clothiers, Inc., 761 F.3d 732, 736 (7th Cir. 2014) (citing Fed.R.Civ.P. 12(b)(6); Gen. Elec. Capital Corp. v. Lease Resolution Corp., 128 F.3d 1074, 1080 (7th Cir.1997)). The Court presumes that all well-pleaded allegations are true, views these well-pleaded allegations in the light most favorable to the Plaintiff, and accepts as true all reasonable inferences that may be drawn from the allegations. Reynolds v. CB Sports Bar, Inc., 623 F.3d 1143, 1146 (7th Cir. 2010). Surviving a Rule 12(b)(6) motion “requires more than labels and conclusions . . . [f]actual allegations must be enough to raise a right to relief above the speculative level.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). “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.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 556).

         ANALYSIS

         The Plaintiff asserts three counts against the Defendant, all of which arise under Indiana law. Although not specified in each count, the counts are necessarily brought pursuant to the Indiana Products Liability Act (“IPLA”). See Dague v. Piper Aircraft Corp., 418 N.E.2d 207, 212 (Ind. 1981) (“[I]t seems clear the legislature intended that the [IPLA] govern all product liability actions, whether the theory of liability is negligence or strict liability in tort.”). Count 1 and Count 2 are both titled “Negligence”; however, the counts are more aptly described as a failure to warn claim (Count 1) and a design and manufacturing defect claim (Count 2). Count 3 is a strict liability claim.

         The Defendant, in the instant Motion, sets forth several reasons why the Complaint should be dismissed: (A) the form of the Complaint is improper under the IPLA; (B) the Complaint fails to meet the Federal Rule of Civil Procedure 8(a) pleading requirements; and (C) the Plaintiff's claims are preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act. The Court will address each argument in turn.

         A. Consolidation of Claims under the IPLA

         The Defendant contends that the Plaintiff's Complaint is inconsistent with Indiana law because it details three distinct counts, while the IPLA, regardless of the legal theory, provides for a single cause of action. The IPLA “governs all actions that are: (1) brought by a user or consumer; (2) against a manufacturer or seller; and (3) for physical harm caused by a product.” Ind. Code § 34-20-1-1. It is well established that the IPLA “govern[s] all product liability actions, whether the theory of liability is negligence or strict liability in tort.” Dague, 418 N.E.2d at 212. Therefore, an IPLA claim is properly brought under a single count in one cause of action. Atkinson v. P&G-Clairol, Inc., 813 F.Supp.2d 1021, 1023-24 (N.D. Ind. 2011) (citing cases).

         The Plaintiff agrees with the Defendant but contends that it is sufficient that the Court “treat the claims as a single, merged cause of action under [the] IPLA for [purposes] of Defendant's motion to dismiss.” Pl.'s Mem. in Supp. of Resp. in Opp'n to Def.'s Mot. to Dismiss 6. The Plaintiff is correct. In cases where a plaintiff has brought multiple claims under the IPLA-such as the instant case-courts generally allow for the claims to be merged into a single count. See, e.g., Atkinson, 813 F.Supp.2d at 1024; Am. Int'l Ins. Co. v. Gastite, No. 1:08-CV-1360, 2009 WL 1383277, at *4 (S.D. Ind. May 14, 2009). Considering that merging the claims is more efficient than dismissing the Complaint and waiting for the Plaintiff to file an amended pleading, the Court will consider the Complaint to contain one count alleging a cause of action under the IPLA.

         B. Federal Rule of Civil Procedure 8(a) Pleading Standard

         The Defendant next argues that the Complaint does not satisfy the pleading requirements mandated by Federal Rule of Civil Procedure 8(a)(2). Rule 8(a)(2) requires that a complaint contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed.R.Civ.P. 8(a)(2).

         Although Plaintiff does not detail the facts of how his system malfunctioned, the Complaint nevertheless alleges the following: the Plaintiff was implanted with the SynchroMed Infusion System; the Defendant designed, manufactured, and sold the SynchroMed Infusion System; the Plaintiff's SynchroMed Infusion System repeatedly malfunctioned; the Plaintiff's SynchroMed Infusion System malfunctioned because the Defendant negligently failed to comply with applicable laws and regulations; the Plaintiff's SynchroMed Infusion System was eventually removed due to repeated malfunctions; the Plaintiff suffered injuries due to the malfunction and removal of his SynchroMed Infusion System; and the Plaintiff's injuries are the direct and proximate ...