Rita McDaniel v. Upsher-Smith Laboratories, Inc.
893 F.3d 941
| 6th Cir. | 2018Background
- Upsher-Smith manufactured generic amiodarone; FDA regulations require manufacturers to ensure Medication Guides are available to patients with each prescription.
- Medication Guides warn that amiodarone is for life‑threatening ventricular arrhythmias and list serious side effects (e.g., lung damage).
- Rita McDaniel sued after her husband, prescribed amiodarone for non‑life‑threatening atrial fibrillation, allegedly did not receive the Medication Guide and later died from drug toxicity.
- McDaniel pleaded Tennessee strict‑liability and negligent failure‑to‑warn claims premised solely on Upsher‑Smith’s alleged failure to provide the Medication Guide.
- The district court dismissed those claims as impliedly preempted by the FDCA; McDaniel appealed.
- The Sixth Circuit affirmed, holding claims that depend on enforcement of the federal Medication Guide requirement are preempted (and McDaniel waived any separate negligence‑per‑se argument).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Tennessee failure‑to‑warn claims premised solely on failure to provide an FDA Medication Guide are impliedly preempted by the FDCA | McDaniel: claim alleges Upsher‑Smith failed to provide federally required Medication Guides; state tort enforces a separate duty to warn and challenges adequacy of warnings | Upsher‑Smith: the claim seeks to enforce federal regulation (Medication Guide requirement) that only the federal government may enforce; no parallel state duty exists | Held: Preempted — claims depend on violation of federal regulation and therefore are impliedly preempted under Buckman and §337(a) |
| Whether the case is controlled by Fulgenzi (permitting state failure‑to‑warn claims) | McDaniel: analogous to Fulgenzi; she challenges adequacy of warnings caused by lack of a guide and pleaded federal violation to avoid Mensing impossibility preemption | Upsher‑Smith: unlike Fulgenzi, McDaniel’s claim depends on a federal‑regulation violation as a critical element (not merely background) | Held: Distinguished Fulgenzi — here the federal duty to provide Medication Guides is a critical element, so Buckman preemption applies |
| Whether Mensing impossibility preemption bars the claim | McDaniel: invoked federal duty in complaint to avoid Mensing — not seeking to enforce federal law but to preserve the claim from impossibility preemption | Upsher‑Smith: claim enforces federal regulation; private enforcement is barred by §337(a) and Buckman | Held: Mensing inapplicable as the court found obstacle/Buckman preemption rather than impossibility; the complaint’s reliance on the federal regulation means the claim is effectively an attempt to enforce the FDCA |
| Whether negligence per se (relying on FDA/regulatory violation) survives | McDaniel: asserted negligence per se in complaint (but chiefly for off‑label claim) | Upsher‑Smith: procedural/pleading deficiencies; Tennessee requires a separately pleaded negligence‑per‑se claim | Held: Waived — McDaniel failed to properly pursue negligence per se below and the argument is waived on appeal |
Key Cases Cited
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (private litigants cannot create causes of action that would effectively enforce the FDCA; claims that rest on federal‑law violations are preempted)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (impossibility preemption where federal duty of sameness prevents generic manufacturer from complying simultaneously with state law requiring different warnings)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (state failure‑to‑warn claim against generic manufacturer not preempted where claim focuses on adequacy of warnings under state law and does not make federal violation a critical element)
- Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (1982) (conflict preemption principles)