Every week Bexis circulates an email with new, bloggable cases, but sometimes there are more new decisions than blogging days, and cases get passed over.
Here are three (relatively) recent examples
Gonzalez v. International Medical Devices, Inc., ___ F. Supp.3d ___, 2025 WL 2054361 (W.D. Tex. June 20, 2025), arose from the plaintiff’s apparent off-label use of a penile implant for “cosmetic enhancement” rather than its intended therapeutic purpose. Id. at *6. Needless to say, since Gonzalez is a product liability action, there were complications. The first significant issue in Gonzalez was personal jurisdiction over the out-of-state alleged inventor of the device and his corporation. Plaintiff succeeded on specific personal jurisdiction based on allegations that, beyond maintaining a website, which wasn’t enough, id. at *5, he “purposefully” targeted the jurisdiction (Texas) by providing device-related training to in-state surgeons and “licensing” them to use his invention. Id. at *5-6. That’s a point that is important for inventors and smaller companies to realize. Licensing and training physicians in use of a product has the potential to support specific personal jurisdiction in the forum where the physicians who were so instructed practice.
A Texas consumer fraud claim also survived (for the time being) in Gonzalez. The allegation was that the defendants’ website affirmatively misrepresented that the device was “FDA-cleared” for a particular intended use when the actual clearance was for something else. Id. at *6. Potential allegations that defendants have some sort of heightened duty to disclose FDA intended uses in off-label use cases always catches our eye because we reject that FDA regulatory status – as opposed to medical risks and benefits – are relevant to anything plaintiffs must be told in such litigation. However, Gonzalez appears to be different, alleging an actual misrepresentation, as opposed to some unmet duty to disclose. Id. Moreover, the Gonzalez allegations are probably factually incorrect and thus unlikely to survive once the pleadings are pierced. Id. (refusing, on the pleadings, to entertain an argument that the plaintiff’s allegation was simply “wrong” as to “which iteration” of the device had been implanted).
Finally, Gonzalez held that causation under the Texas learned intermediary rule was adequately pleaded, given allegations that the implanter “opined the older model of the . . . Device was defective and that he no longer provides [that kind of] implant surgery due to his patients’ dissatisfaction.” Id. at *8. Ouch. Again, these are pleadings, the veracity of which is questionable, but to us they demonstrate what TwIqbal really requires for learned intermediary causation. We don’t see this sort of specific and detailed allegation often, if at all, from plaintiffs.
Case #2 is Morrison v. Family Dollar Stores, LLC, 2025 WL 1368839 (Mag. S.D. Fla. May 5, 2025), which dismissed another of these all-too-common OTC drug economic loss class actions. Plaintiffs alleged they “purchased numerous different over-the-counter (“OTC”) drugs and medical devices” from the defendant’s “stores in twenty states” and mentioned several recalls for improper storage in their complaint. Id. at *1. They alleged “adulteration,” attempting to take advantage of precedent that gave such claims a free pass on alleging injury-in-fact. Id. at *4-5.
Not enough – not nearly. Their other allegations made clear that “adulteration” could not be decided across the board:
[T]his case is not about whether a product contains an ingredient that renders it (every single unit of it) adulterated at the outset. Rather, Plaintiffs allege that the products they purchased became adulterated because they were stored outside of labeled temperature requirements. And while it is plausible, based on Plaintiffs’ allegations, that some [of these] products were stored outside of labeled temperature requirements, Plaintiffs’ allegations that they themselves purchased such products are speculative, not plausible.
Morrison, 2025 WL 1368839, at *6 (footnote omitted). Plaintiffs alleged no facts that products they purchased had the claimed storage problems. Their broad-brush allegations that everything was “adulterated” were “a conclusory label that is not entitled to the assumption of truth.” Id. (citations omitted). The complaint “beg[ged] the question of how one could conclude that the products Plaintiffs purchased were ‘Adulterated Products.’” Id.
Transportation and storage-related conditions are inherently individualized (which should also eventually kill class certification, if Morrison ever got that far). The various recalls couldn’t provide the essential inference. Id. at *7. For this proposition, Morrison cited what we called the “silver lining” in the otherwise adverse Huertas v. Bayer US LLC, 120 F.4th 1169 (3d Cir. 2024), decision: “The mere fact that a product was recalled would not nudge Plaintiffs’ claims across the line from conceivable to plausible.” Morrison, 2025 WL 1368839, at *7 (quoting Huertas, 120 F.4th at 1178). Nor are recalls any sort of “admission” that every unit of every recalled product necessarily had the recalled attribute. Id. (that was “not a reasonable inference”).
Further, plaintiffs did not allege any facts to establish that they actually bought recalled products:
Plaintiffs merely allege that they purchased those products during the Class Period, without alleging facts showing that they purchased the products during the relevant recall period, much less from the affected stores or in the affected states. But the Class Period exceeds 28 months. And for more than 19 of those 28 months, no recalls were in effect.
Id. The complaint established only the “possibility” that plaintiffs could have bought recalled products, not that they actually did. Id. Nor could potential testimony from a “handful of former employees” suffice to create some overarching presumption that every product everywhere was “adulterated.” Id. at *9. Again, the Huertas silver lining came to the defendant’s rescue, since the recalls “had no relevance to the plaintiffs who did not allege they purchased spray products with the lot numbers in the recall,” and these plaintiffs pleaded no facts supporting any purchase of recalled products. Id. at *11. In sum:
Plaintiffs have failed to plausibly allege that any of the drugs or devices they purchased from [defendant] were adulterated. Nor have they plausibly alleged such widespread adulteration to the degree that every single OTC drug and device sold . . . at any store in the United States during the 28-plus month Class Period (including Plaintiffs’ products) was adulterated.
Id. Case dismissed for lack of standing. Even with an “adulteration” free pass on injury-in-fact, the Morrison plaintiffs could not get to first base under TwIqbal.
The third and final case, In re Johnson & Johnson Talcum Powder Products Marketing, Sales Practices & Products Liability Litigation, 2025 WL 1334619 (D.N.J. May 7, 2025), involved talc (obviously), rather than prescription medical products. The proposition it established, however – that mere unenacted FDA “proposals” are not admissible in product liability litigation – is more likely to recur in our sandbox than anywhere else.
This ruling is short and sweet. In Talcum, plaintiffs sought either to “supplement the record” or have “judicial notice” taken of a pending – not final − FDA proposed rule concerning testing of talc-containing products generally. Id. at *1. Both requests were denied because “the FDA has not completed its formal rulemaking process.” Id. Plainly the proposal was “not final,” so it could not possibly “represent final agency action.” Id. “Because current regulations govern until the Proposed Rule becomes final, the Court ‘decline[s] to take cognizance of the proposed regulation.’” Id. (quoting Depenbrock v. Cigna Corp., 389 F.3d 78, 85 (3d Cir. 2004)). The FDA proposal was not yet in effect (in contrast to non-binding, but current, FDA guidance) and thus could not have any retroactive relevance to the litigation.
Given the current management of the FDA, we have no idea what unusual (or worse) proposals may be coming down the pike. This Talcum order will be directly on point, should plaintiffs try to influence judges or juries with some off-the-wall future FDA proposal.