929 F. Supp. 2d 670
W.D. Ky.2013Background
- Breanna Sadler received a cochlear implant (HiRes 90k) in 2006; device failed due to a feedthru leak allowing moisture ingress.
- The Vendor B HiRes 90k used AstroSeal feedthru and lacked PMA Supplement approval, though the device had FDA regulation and PMA oversight.
- Breanna experienced three electrical shocks from the implant after the December 2009 feedthru issue; replacement with a competitor device followed in 2010.
- Plaintiffs allege negligence, products liability, negligence per se, and fraud (with implied warranty withdrawn) related to device design, manufacture, labeling, and testing.
- The FDCA and MDA impose PMA requirements and CGMPs; the court must determine express and implied preemption scope under Lohr, Riegel, and Buckman; the Sixth Circuit has recognized a narrow gap for parallel claims.
- The court preliminarily notes previous district decisions (Purcel, Purchase, Purcel II, Purchase) as persuasive but not controlling in the present Ky-based dispute.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether express preemption bars Plaintiffs' claims. | Plaintiffs contend FDA PMA/regulatory requirements preempt state claims. | Advanced Bionics argues § 360k preempts state tort claims. | Partially the claims survive where parallel requirements exist. |
| Whether implied preemption bars fraud-related claims (Buckman). | Fraud-based claims arise independently of FDA regulation. | Buckman preempts claims that enforce FDCA provisions via state law. | Fraud claims largely preempted; some omissions claims expressly preempted. |
| Whether manufacturing/design defect and CGMP-based claims are preempted. | CGMP violations and PMA deviations constitute state duties parallel to federal requirements. | Such duties are preempted if they add/differ from federal requirements. | Two parallel strict-liability claims survive (PMA deviation and CGMP testing). |
| Whether Kentucky negligence and damages claims survive preemption and how to handle emotional damages. | Negligence claims grounded in federal mandates may survive as parallel. | Many negligence theories are preempted; emotional damages governed by Osborne standard. | Some negligence theories survive; emotional damages denied expansion but Osborne issue unresolved at time. |
| Whether Plaintiff's fraud omission claims are preempted. | Omissions alleged independent of FDA labeling decisions. | Buckman preempts fraud-on-FDA; omissions to public preempted. | Fraudulent omissions claims are expressly preempted. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (set framework for MDA preemption ignoring parallel state remedies)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (two-step test for § 360k preemption; PMA vs. state requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (implied preemption; fraud-on-FDA claims preempted)
- Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000) (PMAs and device-specific requirements; parallel claims survive)
- Purchase v. Advanced Bionics, LLC, 896 F. Supp. 2d 694 (W.D. Tenn. 2011) (CGMPs as potential federal requirements; some CGMPs too vague to impose duty)
- Howard v. Sulzer Orthopedics, Inc., 382 F. App’x 436 (6th Cir. 2010) (CGMPs can impose concrete federal requirements beyond PMA when specific)
- Giddings & Lewis, Inc. v. Indus. Risk Insurers, 348 S.W.3d 729 (Ky. 2011) (fraud elements under Kentucky law for misrepresentation/omission)
- St. Luke Hosp., Inc. v. Straub, 354 S.W.3d 529 (Ky. 2011) (negligence per se labeling concerning federal laws; limits in KY)
- T&M Jewelry, Inc. v. Hicks, 189 S.W.3d 526 (Ky. 2006) (federal law can create duty in negligence actions)
- Yeager v. Dickerson, 391 S.W.3d 388 (Ky. Ct. App. 2013) (federal law used to establish duty; no wholesale federal preemption)