METX, LLC v. Wal-Mart Stores Texas, LLC
2014 U.S. Dist. LEXIS 102979
| E.D. Tex. | 2014Background
- Plaintiffs are Texas-licensed hearing aid fitters/dispensers asserting violations of Texas Hearing Aid Statute (Tex. Admin. Code § 141.16) and related licensing provisions against Wal-Mart Defendants.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6) arguing federal preemption under the Medical Device Amendments (MDA) and FDCA/FDA regulations.
- Magistrate Craven recommended partial dismissal—preempting Texas statutory claims but allowing amended claims for tortious interference and unjust enrichment based on fraud.
- Plaintiffs objected, contending Texas regs are substantially identical to federal regs and not preempted; AG opinion and case law cited.
- The district court adopted the magistrate’s recommendation, granting in part/denying in part; Texas Hearing Aid Statute claims dismissed with prejudice; plaintiffs to amend related fraud-based claims within 20 days.
- The opinion includes de novo review of magistrate findings and extensive preemption analysis under 21 U.S.C. § 360k(a).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is the Texas Hearing Aid Statute preempted by federal law? | Plaintiffs argue Texas regs are identical to federal rules. | Wal-Mart argues Texas rules impose additional requirements and licensees, thus differ from federal regs. | Yes; preemption established for the Texas statute's fitting/dispensing/licensure provisions. |
| Do Texas licensing/fitting requirements relate to device safety and effectiveness? | Texas requirements mirror federal aims and are not preempted. | Texas provisions add non-identical duties (audiological eval, waivers) affecting safety/efficacy. | Yes; Texas requirements relate to safety/effectiveness and are expressively preempted. |
| Should tortious interference claim survive given preemption of Texas statute? | Claim based on preempted Texas statute; may plead under federal law. | Interference claim lacks independent factual support and rests on preempted conduct. | Tortious interference can proceed; preemption not fatal yet; amendment ordered for clarity. |
| Should unjust enrichment based on fraud be dismissed? | Fraud-based unjust enrichment remains viable. | Must plead fraud with particularity; unjust enrichment predicated on preempted conduct. | Denied-in-part; require particularity for fraud; allow amendment; dismissal not sworn. |
| What amendments are required after ruling? | Amend for detail on federal regulation violations and fraud theory. | Such amendments will clarify scope and ensure non-preempted claims are viable. | Plaintiffs to amend with more detail; preempted Texas claims dismissed with prejudice; fraud-based claims to be refined. |
Key Cases Cited
- Massachusetts v. Hayes, 691 F.2d 57 (1st Cir. 1982) (preemption of stricter state requirements in medical devices)
- Hearing Help Express, Inc. v. Missouri Bd. of Exam’rs for Hearing Instrument Specialists, 447 F.3d 1033 (8th Cir. 2006) (federal preemption where state requires audiological evals not in federal scheme)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (1996) (FDA regulation of medical devices; preemption framework)
- In re Medtronic, Inc. Implantable Defibrillators Litig., 465 F. Supp. 2d 886 (D. Minn. 2006) (state law claims for compliance with federal regulations not preempted per se)
- Massachusetts v. Hayes, 691 F.2d 57 (1st Cir. 1982) (quoted for policy on preemption of stricter state requirements)