Hughes v. Boston Scientific Corp.
2011 U.S. App. LEXIS 1376
| 5th Cir. | 2011Background
- Hughes sues Boston Scientific for injuries from the HTA, a Class III device approved via FDA PMA in 2001 and marketed 2002–2009.
- HTA uses hot saline to treat menorrhagia and is subject to FDA post-approval MDR reporting requirements.
- Hughes alleges inadequate warnings/instructions and FDA reporting violations, including failure to report serious injuries and malfunctions.
- Hughes points to an internal FDA-directed reporting algorithm for burns and a 2008 FDA directive to abandon it and report all burns.
- District court granted summary judgment, holding all state claims preempted by the MDA; court remanded only the failure-to-warn theory tied to FDA regulations.
- The Fifth Circuit affirms preemption for most claims but remands Hughes’s failure-to-warn claim tied to FDA reporting for further proceedings on the merits.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are expressly preempted under §360k. | Hughes argues some claims parallel FDA requirements and are not preempted. | Boston Scientific contends all claims are preempted as they seek to impose different/additional requirements. | Express preemption applies to traditional duties; some parallel claims survive. |
| Whether failure-to-warn based on FDA MDR reporting isn't preempted if it alleges FDA regulations were violated. | Hughes maintains MDR reporting violations are parallel to federal requirements. | Boston Scientific argues such claims add requirements beyond federal ones. | Not preempted to the extent based on FDA regulatory violations; parallel claim allowed. |
| Whether negligence per se claims are preempted as a matter of Buckman-type implied preemption. | Hughes asserts negligence per se aids proving breach of state duty to warn. | Buckman bars fraud-on-FDA claims but not parallel state duties. | Negligence per se not impliedly preempted; can be used to prove breach when grounded in state law. |
| Whether Buckman preemption bars a parallel claim premised on FDA regulation violations. | Hughes's suit based on FDA rule violations should survive as parallel. | Buckman precludes fraud-based or purely FDCA-disclosure schemes. | Buckman does not bar parallel claims here; Riegel Gomez framework controls. |
| Whether causation issues should be resolved on remand given remand for the failure-to-warn claim. | Hughes argues causation may be proven if reporting was accurate. | Motions on causation should be resolved on remand. | Causation remand proper; district court to address on remand. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (two-prong express preemption test; parallel claims allowed if consistent with FDA requirements)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (parallel claims concept; not preempted if grounding is a state duty aligned with federal regs)
- Gomez v. St. Jude Med. Daig. Div., Inc., 442 F.3d 919 (5th Cir. 2006) (premised on FDA requirements; some claims preempted; others allowed as parallel)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 347 (U.S. 2001) (fraud-on-the-FDA theory; implied preemption for claims purely about FDCA disclosures)
- Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806 (5th Cir. 1992) (Mississippi duty to warn; negligence per se considerations in state law)
- Howard v. Sulzer Orthopedics, Inc., 382 F. App’x 436 (6th Cir. 2010) (not preempted when based on GMP/FDAs manufacturing specs; parallel reasoning)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (negligence claims premised on FDA specifications survive preemption)