We recently returned from our summer vacation in a small European country with a tiny but charming coastline, formidable mountains, abundant vineyards, and relentlessly friendly service.  That last bit serves as a clumsy segue into today’s case, Aguila v. RQM+LLC, 2025 U.S. Dist. LEXIS 155232 (S.D. Fla. Aug. 12, 2025), which is mostly about service of process.

Aguila continues this particular author’s run of Sunshine State cases (three in a row).  That is not on purpose, unless you want to chalk it up to our predilection for weird cases.  Call it a confounding factor.

This dismissal of a case would not ordinarily be bloggable, except that the plaintiff’s bizarre argument culminated in a judicial decision on a service of process issue that might be of general interest to our clients, particularly those based in other countries.  

The plaintiffs in Aguila included Mr. Aguila and the sole proprietorship that he owned. Both were Florida citizens. The sole proprietorship was “in the business of medical device evaluations.”  It operated as a third party review organization accredited by the Center for Devices and Radiological Health (CDRH), a branch of the Food and Drug Administration (FDA). In that role, the plaintiff entity was primarily responsible for reviewing new medical device applications, including the review of 510(k) submissions, and recommending to CDRH whether the subject medical devices should be cleared/approved or not. 

The defendants included Australian corporations and a Pennsylvania limited liability company.  We will get to the Pennsylvania LLC in a bit.  The Australian companies developed a medical device used for electroencephalogram analysis. The plaintiffs alleged that they contracted with the defendants to provide third-party medical device review services in connection with CDRH’s review of a 510(k) submission for the device. 

Things apparently did not go well.  The plaintiff sued the defendants, alleging that, during the course of the regulatory review process, the defendants made false representations to CDRH about the plaintiffs’ business conduct. According to the plaintiffs, such misrepresentations “were a significant factor in the CDRH’s eventual decision to withdraw [the defendants’] accreditation as a third-party review organization.”  We presume that loss of such accreditation was injurious to the plaintiffs’ business.

The plaintiff ended up suing the manufacturer on a variety of legal theories, including racial discrimination in medical device safety testing in violation of a couple of Florida statutes, fraudulent misrepresentation, breach of contract, tortious interference with business relations, and violation of the Florida Security of Communications Act.  The Aguila decision does not address the substantive merit of any of these causes of action, which is sort of a pity because we all could have been treated to more Florida weirdness. Did we mention that the plaintiffs were proceeding pro se?

The case was initially filed in Florida state court, and then the defendants removed the case to federal court.  Rather than follow the foreign service rules, (Federal Rule of Civil Procedure 4), the plaintiff purported to serve that company’s “U.S. agent designated for FDA purposes” with process.  That U.S. agent was the Pennsylvania LLC. The defendants moved to quash service of process per Fed. R. Civ. P. 12(b)(5) and to dismiss for failure to serve properly and for lack of personal jurisdiction per Rule 12(b)(2). 

The court granted the motion to quash service of process. The procedural requirements for service of process on individuals and corporations not located in the United States are set forth in Fed. R. Civ. P. 4(f) and 4(h).  The defendants did a good job of providing evidence showing that the Australian defendants were, well, Australian, and that the Pennsylvania LLC was an agent only for FDA purposes (see 21 U.S.C. 360(i)(1)) and was not empowered to accept service of process. The burden was squarely on the plaintiffs to demonstrate proper service. (Yes, Rule 4 is “flexible” and yes, some leniency is afforded to pro se litigants, but the relevant law and rules of court still actually apply.) The plaintiffs  could not meet their burden.

A U.S. agent for FDA purposes “shall assist the FDA in communicating with the foreign establishment, respond to questions concerning the foreign establishment’s products that are imported or offered for import into the United States, and assist FDA in scheduling inspections of the foreign establishment.”  21 CFR 807.40(b)(2)) The Aguila court read the regulation to “make clear that designation of the U.S. agent pursuant to 21 U.S.C. 360(i)(1) is for FDA’s purposes only.”  The plaintiffs, unsurprisingly, argued that the FDA “U.S. agent” designation is not limited to facilitating communications with the FDA.  But the plaintiffs “cite no authority for their argument that a U.S. agent designated for FDA purposes is also authorized by law to receive service of process under Rule 4(h).”

The Aguila court generally referred to cases cited by the defendants in their motion to quash, but did not cite such case law in its opinion.  As far as we can tell, Aguila looks like the first decision definitively holding that the FDA agent of an overseas entity regulated by the FDA and required to designate a US agent for regulatory purposes is not also an agent for service of process. Further, even if the defendants could be said to have actual notice of the lawsuit, such actual notice is not sufficient to cure defectively executed service.   

The Aguila court did not need to address the personal jurisdiction argument, but did go on to make the point that the defendants’ notice of removal was neither a responsive pleading nor a motion made under Rule 12, and thus did not operate as a waiver of the defense of lack of personal jurisdiction under Rule 12(h).