A mere two weeks ago, we praised a California federal court for dismissing preempted claims against a prescription drug manufacturer and not giving the plaintiff a third chance to plead a non-preempted claim.  We noted that allowing three strikes seems to be the default rule on serial amendments in response to motions to dismiss or orders granting them, but that some courts have allowed a fourth complaint rather than dismiss all the claims with prejudice on the failed third try.  This week, we have a different California federal court dispensing a well-reasoned dismissal of all the claims in the third complaint against the manufacturer of a prescription blood glucose monitoring system, but the dismissal was somewhat sullied by the unexplained decision to give the plaintiffs a chance to file a fourth complaint.  The fourth strike, much like the fifth down that the Chiefs were afforded in the 2023 AFC Championship Game, is hard to justify, inviting speculation about possible undue bias or sympathy.  In Higginbottom v. Dexcom, Inc., No. 24-cv-0195-WQH-BLM, 2026 WL 2658079 (S.D. Cal. Sept. 9, 2026), the plaintiffs were the representatives and heirs of their deceased teenage son, so some sympathy is understandable.  In this case, however, another amendment seems patently futile and it is time for finality.  The case has been around for more than two and a half years without getting past pleadings; it has been more than two years since the claims against the manufacturer in the second complaint were dismissed without prejudice as expressly preempted and plaintiffs were permitted to file a third complaint. We discuss that dismissal here, along with other issues decided at the same time.  When the plaintiffs amended, the manufacturer moved to dismiss again.  After a stay and unsuccessful mediation, the manufacturer refiled its motion in October 2025 and the motion was ripe in early December 2025.  There are multiple cases around the country involving the device at issue that have not been consistent on preemption.  See here for a notable early preemption win with the same device.  Based on the two preemption decisions in Higginbottom it seems that the only way plaintiffs could plead around preemption would be to add completely new claims, which should not be happening at this stage.  The 2024 decision finding plaintiffs’ claims to be expressly preempted clearly put plaintiffs on notice of what their third complaint needed to accomplish but it fell short.  We would have expected that to be the end of the case.

Otherwise, Higginbottom is pretty good on the merits.  Plaintiffs’ minor son was diagnosed with type 1 diabetes and prescribed defendant’s glucose monitor and another company’s insulin pump.  After almost two years of successful control of his diabetes with the aid of these devices, the decedent changed a sensor in glucose monitor.  2026 WL 2658079, *3.  Within a day, it allegedly began to malfunction, registering high readings that led to the over-administration of insulin by the pump and decedent’s own hand.  He then drove himself on a rural road, allegedly experienced hypoglycemia from the excess insulin, passed out, and suffered a fatal automobile accident.  His estate initially sued both manufacturers, but ultimately settled with the pump manufacturer.  We infer that the allegations in the complaints shifted over time to focus on the alleged malfunction of the remaining defendant’s glucose monitor as being solely responsible for the hypoglycemia.  Although there were four counts in the third complaint, there was really a single theory that the defendant had failed to warn FDA of adverse events suggesting the monitor could lead to the over-administration of insulin.  It appears that plaintiffs must not have ever tried to articulate a potentially non-preempted warnings claim that the Instructions for Use failed to inform prescribing physicians of the device’s risk of contributing to hyperglycemia.  That was probably because they thought that the dubious judicial creation of a state law duty to warn FDA would carry the day.

As we have said before, ascertaining if the state law claims asserted actually exist and have been pleaded properly is a good starting point for deciding express and implied preemption.  Sometimes, that requires a choice of law analysis.  Plaintiffs wanted California law.  They sued there, presumably both because the glucose monitor’s manufacturer is based there and because California is one of the few states whose courts have made up a nonsensical state law duty to report adverse events to FDA.  The plaintiffs were from Wyoming, which is also where the prescription, use, and alleged malfunction of the device occurred and where their decedent’s fatal accident occurred.  Under California choice of law rules, Wyoming law was clearly the one to apply.  We will not dwell much on that analysis, but it did involve an Erie prediction as to whether Wyoming would adopt the same state law duty as California.  Although it did not cite Erie, Higginbottom cited cases that cited Erie and discussed the concept of Erie deference.  (Yes, we did mention Erie three times in one sentence.)  Citing an MDL’s survey of state law on the discussed here that found no support for Wyoming adopting the relatively novel duty, Higginbottom found no authority either and noted plaintiffs’ admission that Wyoming has made a “decision not to recognize a failure warn claim[ ] based on a failure to report adverse events.”  Id. at *8.  (Had the court looked to our surveys on the issue, it would have gotten the same absence of support in Wyoming.)  Thus, the court “decline[d] to recognize such a claim under Wyoming law at this stage of the proceedings.”  Id.  That established the conflict between California and Wyoming law, but it also mattered to the express preemption analysis.

As we discussed at length with the Dickson case that involved the same defendant’s glucose monitors, see here, here, and #6 in our list here, there is a middle ground between Lohr and Riegel that includes Class II devices cleared under de novo 510(k) applications that have special controls codified in a regulation.  Without diving into the issues with broadly applying Lohr to much more recently cleared Class II devices, it is obvious that the glucose monitor was not a “regular” Class II device.  Back in 2024, the first Higginbottom decision had relied heavily on Dickson in finding that the device’s specific regulatory history meant that express preemption applied to plaintiffs’ claims.  Id. at *13.  Plaintiffs urged a different result in 2026 based on the timing of the Final Rule (that is, the CFR section for this kind of device) in relation to the death of plaintiffs’ son.  However, the third complaint actually alleged that the same special controls applied when the device was cleared:

Unlike general requirements, which may be imposed through substantial-equivalence review, the SAC supports the inference that the FDA classified the G6 System subject to device-specific special controls for the purpose of assuring the safety of the medical device.  The allegations that the G6 System underwent subsequent § 510(k) reviews for various aspects of its system—including new interfaces for elements, such as its mobile application and an adhesive patch—do not indicate that the special controls reflected in its initial classification no longer applied.

Id. at *14.  That meant the FDCA’s express preemption provision applied. 

Because Wyoming does not have a state law claim for failure to warn the FDA, plaintiffs could not utilize the largely fictitious parallel claim under Stengel.  Id. at *15.  We have had too many posts on Stengel and parallel claims to link them here.  Many of those posts have talked about how claims that were held not to be expressly preempted could still be impliedly preempted under Buckman.  Higginbottom did not analyze implied preemption.  Maybe that will come up in the inevitable ruling on the motion to dismiss plaintiffs’ fourth complaint that tries to plead a single non-preempted claim.