Bulox v. CooperSurgical, Inc.
4:21-cv-02320
S.D. Tex.Mar 25, 2025Background
- Plaintiffs (Bulox, Merlo families) brought Texas products-liability claims against device manufacturers (CooperSurgical, Femcare, Utah Medical Products) over post-implant complications involving the "Filshie Clip," a sterilization device.
- Plaintiffs alleged design defects and failure-to-warn, arguing that defendants violated federal reporting requirements and failed to propose safer design alternatives.
- Defendants argued that all state-law claims are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), which regulates the device and bars private enforcement actions.
- Magistrate Judge Palermo issued a Report & Recommendation (R&R) finding most of Plaintiffs' claims preempted by federal law.
- The district court, after a de novo review prompted by Plaintiffs' objections, adopted the R&R entirely, dismissed the claims with prejudice, and denied or mooted all summary judgment motions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of Design-Defect Claims | Filshie Clip's defective design and violation of federal reporting obligations defeats preemption. | Only challenges to FDA-approved design; no violation of federal design standards alleged. | State-law design claims are preempted under FDCA. |
| Safer Alternative Design | Cauterization/salpingectomy are safer, feasible alternatives. | Alternatives proposed are entirely different procedures, not device designs. | No valid alternative design; claim fails under Texas law. |
| Failure-to-Warn via FDA Reporting | Texas law imposes a parallel duty to report adverse events to FDA, so claim survives preemption. | Only federal law requires FDA reporting; Texas duty runs to users/physicians. | Claims are preempted; no parallel Texas duty to FDA exists. |
| Reliance on Hughes, Schouest | Precedent recognizes possible non-preempted state law claims for FDA reporting failures. | Cases do not establish such a duty under Texas law; no independent state claim. | No Texas precedent recognizing such claim; preempted. |
Key Cases Cited
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (analyzing preemption of failure-to-warn claims based on FDA reporting requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (holding that private state-law claims relying solely on FDCA disclosure requirements are impliedly preempted)