Fulgenzi v. Pliva, Inc.
2012 WL 1110009
N.D. Ohio2012Background
- PLIVA moves to dismiss all claims as federally preempted under Mensing.
- Fulgenzi’s SAC asserts state-law claims related to warnings for generic metoclopramide (Reglan).
- FDA labeling rules require generic labeling to match the reference-listed drug; changing labels by generics is federally regulated.
- Mensing held state-law failure-to-warn claims against generic manufacturers are preempted when labels must mirror brand-name labeling.
- The Ohio Product Liability Act (OPLA) abrogates most common-law product-liability claims, leaving pleading gaps in design/manufacturing theories.
- Court grants PLIVA’s motion to dismiss as preempted by federal law and precluded by Mensing.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Mensing preempts Fulgenzi’s claims | Fulgenzi argues state-law warnings are independent of FDA labeling. | Mensing preempts claims predicated on inadequate warnings of generics. | Yes, preempted by Mensing. |
| Whether OPLA abrogates the common-law claims | OPLA does not bar all common-law product claims. | OPLA displaces common-law product liability claims. | OPLA abrogates most common-law claims; remaining claims insufficiently pleaded. |
| Whether the pleading suffices for design/manufacturing claims | Claims allege design/manufacturing defects. | Pleading is conclusory and fails to state a manufacturing/design defect. | Dismissed for pleading deficiencies and preemption. |
| Whether there is a private right of action to enforce FDA regulations | Plaintiff may enforce FDA labeling requirements via state-law claims. | No private cause of action under FDA regulations; enforcement reserved to FDA. | No private right of action; claims preempted. |
Key Cases Cited
- Mensing v. Wyeth, Inc., 131 S. Ct. 2567 (U.S. 2011) (state-law warnings preempted for generic labels when mirroring brand labeling)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling changes by brand-name permitted; related private actions discussed)
- Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) (post-Mensing preemption of state-law failure-to-warn claims)
- Gross v. Pfizer, Inc., 825 F. Supp. 2d 654 (D. Md. 2011) (warnings-focus claims treated as preempted)
- Levine (Wyeth v. Levine), 555 U.S. 555 (Supreme Court 2009) (preemption/ CBE labeling considerations in FDA regime)
- Grinage v. Mylan Pharms., Inc., 840 F. Supp. 2d 862 (D. Md. 2011) (preemption of failure-to-warn-based claims)