Our initial inclination was not to blog about DiToto v. Nevro Corp., 2026 WL 1425041 (D. Md. May 21, 2026), given that it was an adverse, poorly reasoned trial court level decision. But then we received an updated citation indicating that – for reasons that totally escape us – Thompson-Reuters/West had decided to publish it in F. Supp. With that development, we’ve decided to write a critique after all.
Our waiting, however, has been serendipitous in one respect. DiToto involved a FDA premarket approved (“PMA”) device, the kind that our readers know is supposed to be protected by broad preemption, given Riegel v. Medtronic, Inc., 552 U. S. 312 (2008). As we recently discussed, the Supreme Court considered Riegel as the “dispositive” precedent in its new preemption decision, Monsanto Co. v. Durnell, 146 S. Ct. 2001 (
[W]e first address something that’s not found in the majority opinion at all – that is any reference to a “presumption,” or even an “assumption” against preemption. That’s important because a 20+-year-old FIFRA opinion, Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), had relied on such a presumption, despite the statute’s express preemption clause. Id. at 449-50. In the interim (as the Blog has repeatedly discussed), the Court abolished any such presumption in express preemption cases. Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115, 125 (2016). But in Durnell, despite what Bates had held about preemption presumptions, the majority opinion said not a word about it, even while discussing Bates itself. Instead, the “textual conclusion” in Durnell gave force to the literal meaning of §136v(b)’s language[. Block quote omitted]
Hence the title of this post, that “‘different from’ and ’ in addition to’ mean what they say”. . . . Durnell is further proof that, yes, the Supreme Court’s abolition of any presumption against express preemption applies to product liability litigation.
Contrast that with the first thing we wrote about DiToto when we added it to our Medical Device PMA Preemption Scorecard: “Incorrectly applies a presumption against preemption that does not exist in express preemption.”
That’s right. All of the dismal holdings in DiToto are based on this single basic false premise – that a presumption against preemption applied in what was a PMA express preemption case. As part of its purported “preemption background,” DiToto asserts, “the Supreme Court has repeatedly recognized, including in the context of the Medical Device Amendments, that there is a presumption against preemption.” DiToto, 2026 WL 1425041, at *6 (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996), and the aforementioned Bates decision). But that’s just plain wrong (or at minimum anachronistic; the judge in DiToto had senior status). In Franklin Trust, the Court held:
[B]ecause the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.
579 U.S. at 125 (citations and quotation marks omitted). As we’ve already mentioned, use of a presumption against preemption in Lohr and Bates has been superseded by Riegel and Durell, respectively – both of which considered such presumptions so irrelevant to express preemption that they did not even bother responding to dissents that asserted those purported presumptions.
Moreover, DiToto is a Maryland district court case, and Maryland is in the Fourth Circuit. The Fourth Circuit has also followed Franklin Trust in express preemption cases:
We think the best course is simply to follow as faithfully as we can the wording of the express preemption provision, without applying a presumption one way or the other. And in all events, we need not enter the great preemption presumption wars here because the text of the preemption provision . . . governs the disposition of this case.
Air Evac EMS, Inc. v. Cheatham, 910 F.3d 751, 762 n.1 (4th Cir. 2018) (citing Franklin). See Maryland Building Industry Ass’n, Inc. v. McIlwain, 2026 WL 946235, at *7 (D. Md. April 2, 2026); CSX Transportation, Inc. v. Bonsal American, Inc., 2024 WL 4597224, at *12 (W.D.N.C. Oct. 28, 2024); Mikos v. Abbott Laboratories, 2021 WL 5416534, at *3 (D. Md. Nov. 18, 2021) (following Franklin in FDCA case); In re Smith & Nephew Birmingham Hip Resurfacing (BHR) & R3 Hip Implant Products Liability Litigation, 300 F. Supp.3d 732, 742 n.8 (D. Md. 2018) (same in a PMA preemption case).
That’s the number one reason why DiToto isn’t worth the paper it was printed on and has no business being published – it applied a non-existent, indeed abolished, legal presumption to reach multiple incorrect legal results.
But that’s not all. Also, as part of its “preemption background,” DiToto states, “the Supreme Court in Riegel recognized that ‘§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case parallel, rather than add to, federal requirements.’” 2026 WL 1425041, at *6.
That mat makes DiToto 0-2. As the Supreme Court recently reiterated in Durnell, Reigel did not “recognize” parallel claims at all – rather the plaintiff in Riegel waived them.
Riegel did not consider state-law claims that were parallel to an applicable federal requirement, apart from the FDA’s premarket approval process. . . . It is true that Riegel did not assess whether the state-law claims at issue were “different from, or in addition to” the relevant federal-law requirements.
Durnell, 146 S. Ct. at 2015-16 n.9 (emphasis added).
Thus, DiToto’s “preemption background” was entirely bogus. In that light, that DiToto would come to erroneous conclusions as to the particular claims that the plaintiff asserted is hardly surprising.
First up were “manufacturing” defects, which we have to concede, have historically been the category of claims with the highest potential to avoid preemption as so-called “parallel” claims. But binding Fourth Circuit precedent, specifically Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012), rejects purportedly “parallel” manufacturing defect claims. “[W]e agree . . . that an alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations.” Id. at 580 (citation and quotation marks omitted). But DiToto did not cite Walker in its discussion of manufacturing defect claims – or, for that matter, Riegel. 2026 WL 1425041, at *6-7. Instead DiToto relied on the notorious, and nonbinding, Bausch decision from the Seventh Circuit, and Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which of course is superseded for PMA devices by Riegel. The pro-plaintiff discussion of manufacturing defect ignores binding precedent as blatantly as we have ever seen (and some of us practice in Philadelphia).
And what was the supposed FDCA-violating “manufacturing defect” in DiToto anyway?
We don’t know. This was all the plaintiff alleged:
The First Amended Complaint does not merely allege that [plaintiff’s] . . . device failed on a given date, however. Instead, [plaintiff] alleges that the device was manufactured as defective, with the evidence of that defect being the fact that the device failed.
2026 WL 1425041, at *7. DiToto recites that that this is enough “at the motion-to-dismiss stage” to be “plausible.” Id. But that’s simply wrong. A purported malfunction isn’t enough to infer a FDCA violation. Here is one of many decisions so holding:
There is no allegation that the manufacturing of [defendant’s device] deviated in any way from the process approved by the FDA, other than the conclusory allegation that [defendant] negligently failed “to manufacture a pacemaker that met FDA specifications . . . .” Such an allegation is insufficient. Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption. The fact that the [device] allegedly failed does not itself establish a deviation from the FDA-approved standards.
Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. Mar. 13, 2013). For numerous other decisions for the same proposition, see our TwIqbal cheat sheet and search for “manufacturing.” The allegation allowed to survive in DiToto – that the device “was manufactured such that it was defective when sold,” 2026 WL 1425041, at *7, says nothing at all.
Next, DiToto waves through “duty to warn” claims under the guise of “duty to report.” The allegations were that the defendants “consistently” under-reported adverse events over a six-year period. But that’s just repackaging a fraud on the FDA claim that is preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). That didn’t matter in DiToto, though. DiToto cited, 2026 WL 1425041, at *8, one case, Williams v. Smith & Nephew, Inc., 123 F. Supp.3d 733, 742-43 (D. Md. 2015), that in turn cited no Maryland cases at all, for the proposition that, because Maryland generally “recognizes that a duty to warn can undergird a negligence case,” that this means Maryland would allow claims indirect warning claims involving governmental notification. No Maryland court has ever allowed anything like that. See Lamb v. Hopkins, 492 A.2d 1297, 1306 (Md. 1985) (probation officers’ statutory duty to report drunk driving offenses ran only to the government, no common-law duty owed to third persons); Lemon v. Stewart, 682 A.2d 1177, 1185 (Md. App.1996) (affirming dismissal of claim that health care providers could be liable for not reporting a patient’s HIV status to a local government agency); Sheridan v. United States, 969 F.2d 72, 73 (4th Cir. 1992) (military regulation requiring internal reporting of “infractions” by servicemen did not create any Maryland common-law duty to members of the general public).
Until DiToto, no Maryland law case in the last decade had allowed any FDCA-based failure to report claim to proceed. See Merkle v. Medtronic, Inc., 2026 WL 1361491, at *7 (D. Md. May 15, 2026) (failure to report claims did not exist under Maryland law and are preempted under Buckman); Chiapello v. Corin USA Ltd., 2024 WL 3548726, at *5 (D. Md. July 23, 2024) (same); Mikos v. Abbott Laboratories, 2021 WL 5416534, at *8 (D. Md. Nov. 18, 2021) (failure to report claims preempted under Buckman). None of these cases was mentioned, let alone distinguished, in DeToto).
After that, DiToto held that “failure to train” claims were not preempted, citing only Lohr and Bausch, neither of which even involved such claims. Worse, DiToto did not even discuss whether the FDA imposed any training requirements on users of this device, which seems pretty basic, given the applicable “different from or in addition to” preemption clause. DiToto viewed such claims as “allegations that . . . Defendants failed to use reasonable care in the sale of their [device].” Id. at *9. That’s squarely preempted under Riegel, which extended preemption to “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the [device]. 552 U.S. at 321 (emphasis added). See also Walker, 670 F.3d at 580-81 (“common law tort claims based on the failure of devices that were designed, manufactured, and sold in accordance with the terms of their premarket approval [are] preempted under Riegel”) (emphasis added).
DiToto’s parade of errors continues with rulings about fraud, consumer fraud, and negligent misrepresentation. DiToto lumped all these informationally-based claims together and held them not preempted “because each addresses the manner in which . . . Defendants allegedly marketed and sold the [device].” That reasoning is bogus for the same reason that the duty to train claim should have been preempted. Riegel − which DiToto again fails to mention – expressly held that all claims attacking a PMA device’s “design, testing, inspection, distribution, labeling, marketing, and sale” were preempted. 552 U.S. at 321 (emphasis added). Moreover, the recent Durnell decision doubled down on Riegel holding that the same preemptive language (“in addition to”/”different from”) expressly preempted attacks on the information that the defendant provided with the product. “Riegel is dispositive here. If FDA’s premarket approval of medical devices preempted additional state-law requirements, so too must EPA’s registration of pesticides and approval of pesticide labels.” 2026 WL 1425041, at *9.
Continuing with DiToto’s pro-plaintiff hit parade, the plaintiff’s express warranty claim also survived preemption. To us, this is the only plausible piece of the opinion, because significant precedent, including a Maryland appellate decision, considers voluntary statements beyond anything that the FDA approved not to be subject to preemption. See DiToto, 2026 WL 1425041, at *10 (citing McCormick v. Medtronic, Inc., 101 A.3d 467, 492 (Md. App. 2014)). Since Riegel, a lot of purported “express warranty” have been dismissed for a variety of reasons (from preemption to pleading to disclaimer), but the peculiar sales-representative-based statements apparently alleged in DiToto could fall through the cracks.
Last, and probably least, DiToto allowed what looks like an FDCA-based negligence per se claim to survive, again citing only Lohr and Bausch as preemption decisions. “It is not preempted by §360k.” 2026 WL 1425041, at *11. The only basis for a negligence per se claim offered in DiToto is the allegation that the device “deviated from the FDA’s premarket approval when it was manufactured.” Id. That’s wrong for all the reasons that we discussed above in connection with the manufacturing defect claim (barred by Riegel and Walker; malfunction insufficient to support a violation claim; no facts supporting any particular violation). But not only that, the negligence per se claim is barred both by implied preemption (which DiToto apparently did not consider) as a private attempt to enforce the FDCA under Buckman, and under Maryland law since negligence per se will not lie where contrary to the intent of the underlying statute. See Latz v. Parr, 254 A.3d 509, 519 (Md. App. 2021) (“in light of the ‘stated intent,’ we are not persuaded that the legislation was intended to change the common law” in the way that plaintiff’s negligence per se claim would). In the FDCA, of course, Congress expressly barred private enforcement. Buckman, 531 U.S. at 352 (“we have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government”) (citing 21 U.S.C. §337(a)). So even if an FDCA-based negligence per se could survive express preemption as a purported “parallel” claim, it neither exists in the first instance under Maryland law, and it would be impliedly preempted under Buckman.
In sum, DiToto relied exclusively on Lohr, which has been entirely superseded in the PMA preemption context by Riegel (and now Durnell), and on Bausch, which is incompatible with the controlling Fourth Circuit Walker decision. The result is an erroneous mess, which unfortunately now has been amplified by an ill-considered decision to publish DiToto. Rather than published, DiToto should be reconsidered and vacated under binding preemption precedent.
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