Bell v. PLIVA, Inc.
2012 U.S. Dist. LEXIS 19859
E.D. Ark.2012Background
- Bell sued for personal injuries from metoclopramide; brand-name defendants moved for summary judgment showing Bell ingested only generic drug.
- Arkansas law required plaintiff prove injury caused by product actually manufactured or distributed by named defendant; summary judgment granted in 2011.
- Mensing held state-law failure-to-warn claims against generic manufacturers are preempted by federal law.
- Bell sought leave to amend after Mensing; amendment (Oct. 2011) asserted negligence, strict liability, warranties, misrepresentation, suppression of evidence, and fraud; brand-name defendants were dismissed from the action.
- Bell argues the 2004 label update not incorporated by PLIVA takes her case outside Mensing’s preemption; PLIVA argues learned intermediary doctrine and federal labeling controls make preemption unavoidable.
- Court concludes PLIVA’s preemption defense remains valid because Arkansas-law warnings to physicians and federal rules require communication through physicians, making simultaneous compliance impossible.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Bell's amended claims survive Mensing preemption. | Bell argues updated 2004 warning creates a non-preempted claim. | PLIVA asserts Mensing bars all failure-to-warn-style claims. | Preemption applies; claims barred. |
| Whether Bell’s 2004-label-update theory avoids preemption. | Bell contends failure to update warnings is outside Mensing. | PLIVA maintains impossibility to comply with both regimes. | Impossibility preemption stands; update does not defeat preemption. |
| Whether PLIVA could independently comply with federal law while Arkansas requires different warnings. | Plaintiff contends PLIVA could warn patients directly. | Warning to physicians only; brand-name labeling controls dissemination. | No; FE-compatibility impossible; learned intermediary doctrine preserves preemption. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (state-law failure-to-warn claims against generics preempted by federal labeling requirements)
- Wyeth v. Levine, 555 U.S. 555 (2009) (FDA labeling requirements and learned intermediary concepts)
- In re Prempro Prods. Liab. Litig., 514 F.3d 825 (8th Cir. 2008) (learned intermediary doctrine; warning adequacy under Arkansas law)