On March 25, 2025, a judge of the United States District Court for the Southern District of Texas Houston Division filed an Order accepting the Report and Recommendation prepared by a magistrate judge in which the federal judge stated, in part: “Judge Palermo correctly determined that the design-defect claims are preempted because Plaintiffs do not allege that the Filshie Clips were designed in violation of federal standards. (Dkt. No. 190 at 8). Instead, their theory essentially challenges an FDA-approved design as unreasonably dangerous, (see Dkt. No. 40 at 17–18)—precisely the type of claim the FDA’s preemption provision prohibits. See 21 U.S.C. § 379r(a). As Judge Palermo explained, permitting such a design-defect claim “would necessarily allow state law to impose requirements on the device that add to or differ from those imposed by federal law.” (Dkt. No. 190 at 8)”
“And although Plaintiffs argue that there is a causal connection between Defendants’ alleged violation of federal reporting requirements and the continued use of a defective design, (Dkt. No. 40 at 9–10, 17–18); (Dkt. No. 191 at 5), they don’t explain how this connection saves their design-defect claims from preemption, (see Dkt. No. 191 at 4–6). Their objections merely assert this connection without establishing how it creates a parallel claim under Texas law that is not subject to federal preemption. (See Dkt. No. 190 at 9) (explaining why “Plaintiffs’ attempt to connect their claim to the adverse event reporting requirement is also impliedly preempted under § 337(a)” (internal docket citations omitted)).”
“The Court also agrees with Judge Palermo’s assessment that Plaintiffs’ proposed alternative designs—cauterization of fallopian tubes and salpingectomy—are entirely different procedures rather than safer alternatives to the Filshie Clip itself. (Id. at 9–10). As the R&R notes, Texas law requires plaintiffs to propose a safer and feasible alternative design to the alleged defective design, not entirely different procedures. (Id. at 10) (citing Pizzitola v. Ethicon, Inc., No. 4:20-CV-02256, 2020 WL 6365545, at *4 (S.D. Tex. Aug. 31, 2020)). For that reason, the Court agrees that “even if Plaintiffs’ design defect claim was not preempted, Plaintiffs have failed to establish a genuine issue of material fact exists as to this claim.” (Id. at 9).”
“The Court finds that Judge Palermo correctly determined that no parallel duty exists under Texas law to report adverse events to the FDA. (Dkt. No. 190 at 13–17). While federal law requires manufacturers to report adverse events to the FDA, Texas law imposes a duty to warn consumers or prescribing physicians, not a federal regulatory agency. (Id. at 13–15). Judge Palermo properly concluded that Plaintiffs’ claims based on a failure to report adverse events to the FDA are “simply an attempt by private parties to enforce” FDA reporting requirements, which is “foreclosed under [21 U.S.C.] § 337(a).””
“The Court agrees with Judge Palermo that Plaintiffs have not identified an independent and parallel source of liability in Texas law for violating federal reporting requirements.”
“Without an independent basis for liability under state law, Plaintiffs’ failure-to-report claims are “‘simply an attempt by private parties to enforce’ FDA reporting requirements.””
The federal judge concluded: “Plaintiffs’ claims against Defendants are DISMISSED WITH PREJUDICE.”
Source Bulox v. Coopersurgical, Inc., Civil Action No. 4:21-CV-02320.
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