Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse.  We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.

But a few more like Rieger, and maybe we won’t any longer.

Plaintiff brought suit against several manufacturer defendants for an allegedly defective insulin pump/infusion set.  After taking judicial notice of the defendants’ pre-market approvals and other FDA-generated documents, 2025 Cal. Super. Lexis 14, at *5-6,  Rieger agreed that all the plaintiff’s claims – for negligence, strict liability, and the now obligatory “unfair competition” (“UCL”) count – are preempted as “different from or in addition to” FDA-imposed PMA requirements.  Id. at 13-14.

A prior pump was cleared via an FDA pre-market approval supplement, as part of a complete glucose monitoring system. Id. at *15.  Significantly “the FDA specifically rejected a citizen petition (made by a prior plaintiff) that requested the approval of the . . . pump be limited to” its ability “to accept data from the sensor and the ability for the sensor to communicate directly to the pump.” Id.  That meant that “the FDA considered its [earlier] approval of the PMA supplement to include both the pump and the system as a whole.  Id.  When the current pump was substituted via another PMA supplement, it likewise went through full PMA scrutiny.  Id.

In response, plaintiff tried to split hairs – that the pump’s “insulin-delivering functionality” “should be considered separately from the glucose-monitoring functionalities.”  Id. at *16.  That argument would have allowed plaintiff to carve out the function that allegedly injured him from the otherwise comprehensive FDA PMA.  Id.

Didn’t work – indeed, it couldn’t work given the relevant regulatory history.  That distinction was exactly what the FDA’s rejected when it denied the earlier citizen petition.  That makes Rieger the latest of several cases where some pro-plaintiff group’s citizen petition produced an FDA denial that came back to strengthen the defendant’s later preemption argument.  Since the FDA employs the same scientific standards in evaluating both PMA approval and citizen petition, it should be obvious that the preemptive effect of both types of FDA review is the same.

Plaintiff’s argument that the insulin-dispensing apparatus never underwent the PMA process does not create a disputed issue of material fact.  The FDA expressly rejected a citizen petition that requested the FDA to take the position that its approval of the [earlier] pump, a predecessor to the [current] pump, was “limited solely to the ability of the pump to accept data from the sensor and the ability for the sensor to communicate directly to the pump” and “[did] not extend to the pump itself.”  In reliance on this position by the FDA, at least two courts have found similar claims involving the [earlier] to be preempted.

Id. at 22 (citing Duggan v. Medtronic, Inc. 840 F. Supp.2d 466, 472 (D. Mass. 2012) (discussed here), and Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443, 451 (E.D. Pa. 2011) (discussed here)).

Plaintiff’s attempted counter, relying on Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir. 2018), failed, as it should have.  Shuker involved an off-label use situation in no way comparable to the full FDA review that occurred in Rieger/Duggan/Bentzley.  As stated in Shuker:

[A]s the parties agree, because the [component’s] labeling reflected that the FDA had not approved [it] for use outside of [a particular s]ystem or in a total hip replacement system, . . . the [component’s] use in [plaintiff’s] total hip replacement system constituted an “off-label” use.

885 F.3d at 769 (citations omitted).  Unlike the combination of design features in Rieger (and the two earlier cases), the FDA had never evaluated the combination of components in Shuker at all.

That is precisely what Rieger held.  Unlike Shuker, where the targeted component “was not apparently separately approved” as part of the system in that case, the combination of features in Rieger had received full PMA review.  Rieger, 2025 Cal. Super. Lexis 14, at *24.  Even “[a]pplying Shuker’s reasoning, the [target] pump’s insulin-delivery functions . . . received PMA as part of the pump’s [supplemental]  approval process.”  Id. at *24-25.

Unable to avoid the FDA’s exercise of regulatory oversight, as a last resort plaintiff attacked the FDA review process itself, “contend[ing] that nonetheless, the [pertinent] functions of the [targeted] pump never received the rigorous scrutiny required for PMA.”  Id. at 25.  Plaintiff was just blowing smoke, and had zilch to back-up that attack, 

There is nothing the Court can rely on in determining what the minimum standard of PMA review ought to be, and whether the FDA’s review . . . fell below that level. . . .  The Court would simply be speculating were it to hold that the FDA did not sufficiently review the [approved] pumps.

Id. at *27-28.  Moreover, the plaintiff in Duggan tried the same thing, and got nowhere:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

840 F. Supp.2d at 472 (citations omitted).

With the PMA status of the device established, Rieger made quick work of the plaintiff’s claims.  Because “[p]laintiff does not dispute that the . . . pump Plaintiff was using when he was injured complied with the design and manufacturing requirements imposed by its PMA,” “necessarily” his claims “seek to impose different requirements than those imposed by the FDA.”  2025 Cal. Super. Lexis 14, at *29.  Nonspecific and factually unsupported violation claims could not create any fact issue on preemption.  Id.  Nor could plaintiff “seek[] enforce federal legal requirements.”  Id. (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and Glennen v. Allergan, Inc., 202 Cal. Rptr.3d 68 (Cal. App. 2016)).

PMA preemption – defendants can take it to the bank.