Eleanor Fulgenzi v. PLIVA, Inc.
2013 U.S. App. LEXIS 4961
| 6th Cir. | 2013Background
- Fulgenzi sued PLIVA for failure-to-warn regarding tardive dyskinesia from long-term metoclopramide use.
- Plaintiff's prescriptions were filled with PLIVA's generic metoclopramide; branded Reglan had a stronger 2004 warning change.
- FDA updated labeling in 2004 to say therapy should not exceed 12 weeks; black-box warning issued in 2009.
- PLIVA did not update its labeling to reflect the 2004 warning change or inform physicians.
- Mensing held that generic manufacturers cannot unilaterally strengthen labels, creating potential impossibility preemption.
- District court dismissed Fulgenzi's claims as preempted; appeal challenged preemption and Ohio-law viability.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption: are state failure-to-warn claims precluded against generics? | Fulgenzi argues not preempted due to updated branded warnings and federal duty of sameness. | PLIVA contends Mensing forecloses any non-parallel state claims against generics. | No impossibility preemption; state claims survive to extent federal duty permits. |
| Purposes-and-objects preemption for generics under Hatch-Waxman | State tort relief aligns with congressional objectives; no intent to preempt remedies. | Preemption should follow federal policy to promote generic use and uniform labeling. | State tort remedies for inadequate warnings do not conflict with federal policy. |
| Buckman implied preemption via enforcement of federal regulations | Claim rests on state-law sufficiency of warnings, not fraud on FDA. | Buckman counsels implied preemption when litigation seeks to enforce federal regulatory violations. | Buckman does not require preemption here; claim relies on state duty of care, not solely federal violation. |
| Ohio-law adequacy and causation of warnings | 2004 updated warning was required; 2004 label omission proximately caused injury. | Sufficiency of the warning is a matter for federal labeling; not all aspects preempted. | Plaintiff plausibly alleges inadequate warning and causation; not preempted on merits. |
| Parallel claims and scope after Mensing | Actions were not limited to federal-duty violation; parallel state claim exists. | Mensing restricts to impossibility-based preemption; broader limitations may apply. | Claims survive to the extent not relying on federal-duty impossibility; state duty remains viable. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (failure-to-warn not preempted for branded drugs; no impossibility)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (impossibility preemption for generics when cannot update label unilaterally)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA preemption and federalism concerns)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (parallel remedies analysis; no express preemption for generic drugs)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (express preemption framework for medical devices; not directly controlling here)
- Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984) (preemption and regulatory compliance interplay; implied preemption context)