Redd v. DePuy Orthopaedics, Inc.
48 F. Supp. 3d 1261
E.D. Mo.2014Background
- Judith Redd received a DePuy AML Total Hip System (AML Small Stature femoral stem) in April 2008; about four years later the femoral stem fractured and the implant failed.
- Redd sued DePuy in Missouri state-law claims: strict liability (design defect and failure to warn) and negligence (design/manufacture and failure to warn).
- DePuy moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing (1) Redd’s claims are preempted by the Medical Device Amendments (MDA) to the FDCA and (2) Redd failed to plead plausible claims under Twombly/Iqbal.
- The Hip System was cleared via the FDA § 510(k) premarket notification pathway and is classified as a Class II device; DePuy pointed to a material-identification regulation and an FDA Class II Special Controls Guidance as device-specific federal requirements.
- The court found the regulation and the cited Special Controls guidance did not impose device-specific federal requirements applicable to Redd’s implanted device, and thus the MDA did not expressly preempt her state-law claims; the court also found Redd’s complaint met federal notice-pleading standards.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Redd’s state-law claims are preempted by the MDA (21 U.S.C. § 360k) | Redd: device entered via §510(k) and is subject only to general controls; no device-specific federal requirements exist, so state claims survive (Lohr controls). | DePuy: special controls and a regulation identifying stem material create federal device-specific requirements that preempt state-law claims (Riegel). | Court: Not preempted—device was cleared via §510(k) and DePuy failed to show any device-specific federal requirements applicable to this exact prosthesis. |
| Whether the referenced FDA regulation constitutes a preemptive federal requirement | Redd: the regulation is a generic identification/classification and does not impose specific manufacturing or annealing requirements relevant here. | DePuy: the regulation’s material description and classification impose federal requirements that differ from state law. | Court: The regulation is generic classification/identification, not a device-specific federal requirement; it does not trigger preemption. |
| Whether the Special Controls Guidance cited by DePuy applies to this device and preempts claims | Redd: the guidance covers a different hip device category and does not apply to the AML small-stature stem implanted in Redd. | DePuy: the guidance provides special controls for hip prostheses that govern this device. | Court: The Guidance covers a different classified device (§ 888.3310), not the device at issue (§ 888.3358); DePuy did not show it applied, so no preemption. |
| Whether Redd pleaded plausible state-law claims under Twombly/Iqbal | Redd: complaint alleges implantation, design/manufacturing defects (low fatigue strength, limited ductility, inadequate annealing), and failure to warn—enough to give notice and survive dismissal. | DePuy: allegations are conclusory, lack detail on warnings, causation, manufacturer knowledge, and fail to negate learned-intermediary defense. | Court: Pleading suffices—facts give fair notice and plausible basis; defendant’s arguments do not require dismissal at pleading stage. |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (U.S. 2008) (PMA-based federal requirements can preempt state-law claims)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (§510(k)/general controls do not necessarily create device-specific federal requirements for preemption)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (implied preemption bars state claims that are essentially enforcement actions to vindicate FDCA requirements)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (pleading must state a plausible claim beyond labels and conclusions)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (Twombly standard applied to all civil cases; factual allegations must allow reasonable inference of liability)
- In re Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (interpreting Lohr and Buckman; narrow gap for state-law claims to escape preemption)