Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)–S.D. Cal.: Diabetic consumer’s state-law failure-to-warn tort claims against medical device manufacturer are preempted by the MDA, (Sep 15, 2026)

By Nadine E. Roddy, J.D.

But dismissal of the consumer’s claims was without prejudice to replead.

Wyoming law does not recognize a cause of action for failure to warn under negligence or strict products liability theories, and thus such claims are not “parallel” to a federal failure-to-warn claim under the Food, Drug, and Cosmetic Act (FDC Act), a federal district court in California has ruled. Thus, the consumer’s state-law claims were expressly preempted by the Medical Device Amendments (MDA). Accordingly, the court granted the motion to dismiss the second amended complaint (Higginbottom v. Dexcom, Inc., No. 3:24-cv-00195-WQH-JAC (S.D. Cal. Sept. 9, 2026)).

The parents and personal representatives of the estate of a consumer, a minor who died in a vehicle crash, brought suit in California superior court, asserting failure-to-warn claims based on negligence and strict products liability against two corporate defendants. The first defendant (M1) was a Delaware corporation with its principal place of business in San Diego, California, that manufactured and distributed the “Dexcom G6 Integrated Continuous Glucose Monitoring System (G6 System).” The G6 System is a prescribed medical device for use by diabetic patients that scans, detects, and provides alerts for dangerous glucose levels. The second defendant (M2) was a Delaware corporation that manufactured and distributed the “Tandem t:slim X2 Insulin Pump (the t:slim pump),” a prescribed medical device that operates as an automated insulin delivery system for the management of diabetes. The t:slim pump “integrates” with the G6 System to create a diabetes therapy system for patients who require regular insulin doses, including corrective dosing based on detection of hyperglycemia/hypoglycemia by the G6 System. The defendants successfully removed the case to federal district court.

The second amended complaint (SAC) alleged that the G6 System had a “propensity to obtain inaccurate glucose readings, fail to transmit glucose readings, and/or notify and alert its users of potential hyperglycemic and hypoglycemic events.” When used in connected with the t:slim pump, the G6 System could increase the risk of “insulin stacking,” which means “taking multiple doses of insulin at close intervals” and “caus[ing] a rapid drop in blood sugar levels.” According to the SAC, this is what happened to the consumer, who was using both products for his Type I diabetes, when he was driving his vehicle, lost consciousness, and crashed into a truck, sustaining fatal injuries. The accident occurred in Wyoming, where the consumer and the representatives lived.

The SAC further alleged that on March 27, 2018, the G6 System was granted clearance by the FDA as a Class II device via a De Novo classification request. On February 18, 2022, the FDA issued a Final Rule [21 C.F.R. § 862.1355] describing special controls for all “integrated continuous glucose monitoring system[s].” The Final Rule states that, “[a]fter review of the information submitted” in M1’s De Novo classification request, the agency determined that the G6 System could be classified into Class II with the establishment of special controls. After the FDA approved the G6 System, M1 had a continuing responsibility to “maintain[] the labeling of [the G6 System] in light of the most current risk information obtained from the real-world clinical experience” with the device and to report any information to the FDA suggesting that the device may have caused/contributed to a death or serious injury.

Before the court was M1’s Rule 12(b)(6) motion to dismiss the SAC.

Choice-of-law-issue. Applying the law of the forum (that is, California’s choice-of-law rules), the court determined that Wyoming law, rather than California law, governed the tort claims. Under California’s “governmental interest” test, Wyoming’s interest in having its law applied to its own residents, and to conduct occurring within its borders, would be more seriously impaired by the application of California law than would California’s interest in regulating companies based within its boundaries by application of Wyoming law.

Preemption. M1 contended that the representatives’ claims were expressly or impliedly preempted by the MDA because the FDA had established specific requirements for the G6 System, and the state law requirements would impose different or additional requirements. The court noted that the MDA includes an express preemption provision applicable to state regulation of all classes of medical devices, which the FDA interprets to mean that state requirements are preempted when (1) the agency has established specific counterpart regulations, or (2) there are other specific requirements applicable to a particular device that render any divergent state requirements “different from, or in addition to” the specific FDA requirements. [21 C.F.R. § 808.1(d)]

Further, the Supreme Court has held that common-law causes of action for negligence and strict liability impose requirements that may be preempted by the MDA, but the MDA does not prevent a state from providing a damages remedy for claims premised on a violation of FDA regulations. In such a case, the state duties “parallel,” rather than “add to,” the federal requirements. M1 argued that the representatives’ claims based on M1’s alleged failure to warn the FDA about subsequent adverse events would impose requirements different from those imposed by the FDC Act, which meant that the MDA preempted those claims. The representatives, on the other hand, contended that their state law claims were “viable parallel claims.”

The question became whether Wyoming recognizes a parallel state-law duty for failure to report adverse events as required by law. The court determined that—at least at this stage of the proceedings—the state does not. Although it recognizes tort claims based on strict liability, the state does not recognize claims based on a failure to report adverse events to the FDA. The representatives did not contend that, even in the absence of relevant authority, the court should interpret general tort principles of Wyoming to support a negligence and/or strict products liability claim based on a failure-to-warn theory. Thus, the SAC did not adequately state a parallel cause of action such that their claims could avoid express preemption by the MDA.

Having found that the claims for negligence and strict products liability had to be dismissed, the court also dismissed the derivative claims for punitive damages and wrongful death. The dismissal was without prejudice.

The case is No. 3:24-cv-00195-WQH-JAC.

Judge: Hayes, W.

Attorneys: Jason Edward Ochs (Ochs Law Firm) for Joseph Higginbottom. Renata Ortiz Bloom (Gordon & Rees LLP) for Dexcom, Inc.

Companies: Dexcom, Inc.

Cases: CaseDecisions GCNNews MDeviceNews PreemptionNews PLDeviceNews CaliforniaNews