Phelps v. Wyeth, Inc.
938 F. Supp. 2d 1055
D. Or.2013Background
- Plaintiffs allege Betty Phelps sustained tardive dyskinesia from long-term use of a Pliva generic metoclopramide 2004–2007.
- FDCA requires generic labeling to match brand-name labeling; Pliva’s 2003–2004 inserts allegedly did not match Reglan.
- Judge Coffin previously held a failure-to-warn claim preempted; this action proceeds on a failure-to-update labeling claim.
- Pliva moved for summary judgment arguing preemption or lack of Oregon-law basis; district court adopted Coffin’s findings denying summary judgment.
- Court assesses Mensing-based preemption, Oregon-law viability, causation, and punitive damages, adopting Coffin’s recommendations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is the failure-to-update claim preempted by Mensing? | Mensing does not preclude updating-label claims; updating aligns with federal duties. | Mensing preempts state-law failure-to-update claims that conflict with FDA sameness requirements. | Not preempted; updating-label claim viable under state law |
| Does Oregon law provide a viable claim for failure to update labeling? | Oregon duty to exercise due care supports failure to update label claims independent of FDCA. | No Oregon-duty to mirror brand-name updates; claim improper under state law. | Viable under Oregon law |
| Is the FDCA preemption of the failure-to-update claim limited by Buckman/Medtronic principles? | Claims rest on traditional state tort duties informed by federal requirements, not mere FDCA violations. | FDCA preempts claims that enforce federal requirements or depend solely on FDCA violations. | FDCA does not bar these state-law negligence claims when grounded in traditional duties |
| Are there genuine issues of material fact on causation for updating-label failure? | Experts show a reasonable medical probability that updating would have prevented injuries. | No proof that doctors read or relied on Pliva’s label; causation uncertain. | Issues of general and specific causation survive |
| Do Oregon statutes permit punitive damages here based on FDA-label nonconformity? | Nonconforming labeling can support punitive damages under ORS 30.927. | FDA-approved labeling precludes punitive damages. | Sufficient evidence to permit punitive-damages inquiry; denial of summary judgment warranted |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (FDA sameness requires generic labels to match brand labels; state-law failure-to-warn claims preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (express preemption not to bar traditional state tort claims parallel to federal duties)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA claims impliedly preempted; private action grounded in FDCA violations)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (state-law negligence claims parallel to federal requirements not preempted; comparative framework to Medtronic)
- Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (Mensing preempts state failure-to-warn claims; labeling requirement context)