364 F. Supp. 3d 343
D. Del.2019Background
- Plaintiffs Kathleen and Richard Freed sued St. Jude alleging injury from a Class III spinal cord stimulator (Protege Model 3789) implanted in Mrs. Freed, later explanted after painful shocks and burning.
- Device had prior recalls and complaints regarding batteries, heating during charging, and surges; Plaintiffs allege St. Jude failed to report or remedy these issues and failed to supplement labeling or submit required FDA reports.
- Plaintiffs filed a First Amended Complaint asserting: breach of express warranty (Count I), breach of implied warranties (Counts II–III), manufacture/sale of a dangerous/adulterated chattel (Count IV) (including failure-to-warn and negligent-manufacture theories), and loss of consortium (Count V).
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing MDA preemption (21 U.S.C. § 360k) and pleading failures under Twombly/Iqbal.
- The court (D. Del.) granted in part and denied in part: dismissed Counts I–III with prejudice; dismissed Count IV’s failure-to-warn claim without prejudice (allowing amendment to plead causation and Restatement § 388 basis); denied dismissal as to Count IV’s negligent-manufacture claim and Count V.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Plaintiffs' state-law claims are preempted by the MDA unless pleaded as "parallel" to federal requirements | Freed alleges violations of FDA reporting and GMP rules and that device/component was adulterated; thus claims mirror federal duties and avoid preemption | St. Jude contends Plaintiffs fail to plead specific FDA violations or facts showing claims are parallel; therefore claims are expressly preempted | Court: Preemption applies to many warranty claims; but properly pleaded parallel claims based on failure to report or GMP violations can survive. Allowed negligent-manufacture claim to proceed; dismissed warranty claims. |
| Breach of express warranty (Count I) | Plaintiffs rely on St. Jude reps and website statements promising safety/quality and a rep statement that Mrs. Freed would be “very happy” | St. Jude: statements are vague puffery/opinion and not specific affirmative promises; insufficient to plead an express warranty or avoid preemption | Court: statement was puffery/opinion and not a specific warranty; Count I dismissed with prejudice. |
| Breach of implied warranties (Counts II & III) | Plaintiffs allege implied merchantability/fitness based on marketing, website, reps, and that device was adulterated/nonconforming with GMPs | St. Jude: claims mirror original complaint and still fail to allege specific federal violations or factual bases to avoid preemption | Court: Plaintiffs did not plead specifics tying implied warranty breaches to particular federal violations; Counts II & III dismissed with prejudice. |
| Failure to warn based on failure to report adverse events to FDA (Count IV, § 388 theory) | Plaintiffs invoke Restatement § 388 (adopted in Delaware) and allege St. Jude failed to report adverse events/recalls and to supplement labeling under FDA rules, depriving physicians/patients of info | St. Jude: either no Delaware duty to report to FDA (so claim is FDCA-only), or Plaintiffs failed to plead which events were unreported and causal link showing reporting would have reached physicians and changed treatment | Held: Court allows a parallel failure-to-warn claim in principle but finds the FAC lacks allegations showing causation (that FDA reporting would have reached Mrs. Freed/physician and altered the decision). Claim dismissed without prejudice to amend to plead § 388 basis and causation. |
| Negligent manufacturing (Count IV) | Plaintiffs allege battery/component was adulterated, cite recalls and GMP violations, and claim device caused burns/shocks | St. Jude: Plaintiffs did not plead specific defect, cause, or federal violations sufficiently | Court: FAC now pleads recalls, component issues, and alleged GMP noncompliance enough to plausibly allege negligent manufacture and a parallel claim; motion to dismiss this theory denied. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (establishes MDA express preemption framework for PMA-approved Class III devices)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (private suits cannot be used to enforce FDCA requirements; Buckman implied-preemption concern)
- Shuker v. Smith & Nephew, PLC, 885 F.3d 760 (3d Cir.) (discusses applying § 360k to multi-component devices and parallel-claim limits)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir.) (holds failure-to-report-to-FDA-based state-law warning claim can be parallel to federal duties)
- Hughes v. Boston Sci. Corp., 631 F.3d 762 (5th Cir.) (similar; FDA reporting duties can form the basis of non-preempted state failure-to-warn claims)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading standard: factual plausibility)
- Ashcroft v. Iqbal, 556 U.S. 662 (applies Twombly plausibility standard to dismiss insufficient claims)