Andrew Schmidt v. Dexcom, Inc.

District Court, E.D. Michigan·Decided August 4, 2026·No. 2:25-cv-13258·Unknown

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION ANDREW SCHMIDT, Plaintiff, Case No.: 2:25-cv-13258 Hon. Gershwin A. Drain

DEXCOM, INC., Defendant. eee OPINION AND ORDER GRANTING DEFENDANT’S MOTION TO DISMISS [ECF No. 9] On October 15, 2025, Plaintiff Andrew Schmidt filed the instant action against Defendant Dexcom, Inc. Plaintiff alleges that he was injured while using Defendant’s “Dexcom G6 Continuous Glucose Monitoring System” and asserts various theories of liability against Defendant. Presently before the Court is Defendant’s Motion to Dismiss or, in the alternative, Motion to Compel Arbitration. Plaintiff opposes the motion. The Court concludes that a hearing will not aid in the disposition of this motion and will determine the outcome on the briefs. E.D. Mich. L.R. 7.1(f)(2). For the reasons that follow, Defendant’s Motion to Dismiss [ECF No. 9] is GRANTED and this case DISMISSED for failure to demonstrate the existence of personal jurisdiction.

I. BACKGROUND

Plaintiff Andrew Schmidt lives in Davisburg, Michigan. ECF No. 1, PageID.3. Defendant Dexcom, Inc. is a Delaware corporation with its principal place of business in California. ECF No. 9, PageID.65. Defendant produces the “Dexcom G6 Continuous Glucose Monitoring System” (“G6”), which is a “real-time continuous glucose monitoring system authorized for marketing by the FDA and indicated for the management of diabetes in persons two years and older.” /d. at PageID.59. The G6 deploys a needle and sensor under the skin, and the needle retracts back into the applicator. /d. Once the sensor is under the skin, it transmits the user’s glucose data to a display device, such as the Dexcom receiver or an app on the user’s smartphone. /d. at PageID.60—61. A user can use the G6 with or without

a Dexcom account, but if he chooses to create a Dexcom account, he is required to

agree to the Terms of Use which include an arbitration clause. /d. at PageID.61; ECF No. 9-3, PageID.131, 143-44. According to Defendant, Plaintiff created a Dexcom account and accepted Defendant’s Terms of Use and arbitration clause. ECF No. 9- 4, PageID.173. The G6 is considered a Class II medical device! under the Medical Device Amendments (“MDA”) of the Food, Drug, & Cosmetic Act. /d. at PageID.62. The

' The MDA divides medical devices into three classes according to risk, with Class I posing the least risk and Class HI posing the most risk. See Higginbottom vy. Dexcom, Inc., 744 F. Supp. 3d 1058, 1079-80 (S.D. Cal. 2024).

G6 was approved for marketing by the Food & Drug Administration (“FDA”) through the FDA’s De Novo review process, which is a robust review process for approving a medical device which has no predicates. See Dickson v. Dexcom, Inc., No. 2:24-cv-00121, 2024 WL 3417392, at *1, *1 n.1, *5 (W.D. La. July 15, 2024).? To obtain De Novo approval of a medical device from the FDA, the FDA must find that general or special controls? would provide reasonable assurance of the device’s safety and effectiveness. See 21 U.S.C. § 360c(a)(1)(B); 21 C.F.R. § 860.260(c). The FDA approved the G6 pursuant to its De Novo review process and established regulations governing the special controls necessary for the G6 and for future integrated continuous glucose monitoring systems. See 21 C.F.R. § 862.1355.

If a medical device has predicates, it is reviewed for equivalence with those predicate devices rather than under heightened “De Novo” review. See Dickson, 2024 WL 3417392, at *5. 3 General controls are universal baseline provisions that apply to all medical device classes, and include labeling, device listing, registration requirements, quality systems, good manufacturing practices, post-market surveillance, data requirements, and performance standards. See FDA, General Controls for Medical Devices, https://www.fda.gov/medical-devices/regulatory-controls/general-controls- medical-devices. Special controls are device-specific requirements for Class II devices where the FDA has deemed general controls alone to be insufficient to provide reasonable assurance of their safety and effectiveness, and for which there is sufficient information to establish special controls to provide such assurance. These may include additional performance standards, post-market surveillance, patient registries, special labeling requirements, premarket data requirements, and guidelines. See FDA, Regulatory Controls, https://(www.fda.gov/medical- devices/overview-device-regulation/regulatory-controls#special; see also Higginbottom, 744 F. Supp. at 1079-80.

Plaintiff alleges that on December 1, 2022, he was attempting to put the G6 needle into his arm when the needle detached from the system into his arm. ECF No. 1, PageID.3. Plaintiff underwent surgery in an attempt to remove the needle, which left permanent scarring and disfigurement. /d. Plaintiff alleges that a second needle

was also lost in his arm at some later time. /d.4 Plaintiff filed the instant action against Defendant on October 15, 2025. See ECF No. 1. Plaintiff brings claims for negligence, strict liability, failure to warn, negligent design, negligent manufacturing, breach of implied warranty, breach of

express warranty, and breach of the Michigan Consumer Protection Act. See ECF No. 1. In lieu of an answer, Defendant filed a Motion to Dismiss or, in the alternative, to Compel Arbitration. See ECF No. 9. First, Defendant argues that Plaintiff has failed to establish personal jurisdiction. Defendant notes that the Court has no general personal jurisdiction because, being a Delaware corporation with its principal place of business in California, Defendant is not “at home” in Michigan. Id. at PageID.65. Defendant further asserts that Plaintiff has alleged no facts to

* Although not relevant to the disposition of this motion, Defendant states that the G6 is only approved for an adult user to wear on the abdomen and is not approved for wear on the arm. See ECF No. 9-2, PageID.89 (FDA’s Decision Summary regarding the G6). In other words, Defendant claims that Plaintiff was misusing the G6 when he was injured. See ECF No. 9, PageID.60. Plaintiff stated in his reply that Dexcom’s website suggests the arm is a proper location to use the G6. ECF No. 10, PageID.359.

establish specific personal jurisdiction, i.e., that Defendant purposefully availed itself of conducting business within Michigan. /d. at PageID.66. In the alternative, Defendant argues that the Court should compel arbitration because Plaintiff is subject to the arbitration clause contained in Defendant’s Terms of Use, which he necessarily accepted when he registered a Dexcom account. /d. at PageID.68. Finally, Defendant argues that Plaintiff has failed to state a claim because his claims

are expressly or impliedly preempted by the MDA and because his claims are insufficient or otherwise conclusory. /d. at PageID.71—81. In response, Plaintiff alleges that Defendant is subject to general personal jurisdiction in Michigan because he marketed, sold, and procured for use the G6 in Michigan. ECF No. 10, PageID.361. Plaintiff also alleges that Defendant is subject to specific personal jurisdiction in Michigan for the same reason. /d. at PageID.364. Next, Plaintiff alleges that Defendant proffered no evidence of Plaintiff's agreement to arbitrate except for “self-serving affidavits.” /d. at PagelD.364—65. Finally, Plaintiff alleges that the complaint “contains sufficient factual information [to] state

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Andrew Schmidt v. Dexcom, Inc., (E.D. Mich. 2026).

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