Bartoli v. APP Pharmaceuticals, Inc.
842 F. Supp. 2d 479
E.D.N.Y2012Background
- MDL involving generic pamidronate and ONJ was transferred to this court on December 2, 2009.
- Cases involve plaintiffs alleging ONJ or increased ONJ risk from generic pamidronate; claims span design defect, failure to warn, negligence, and warranties.
- By January 6, 2012, nine plaintiffs remained after 125 dismissed following Mensing's ruling and related stay.
- Defendants APP Pharmaceuticals, Ben Venue Laboratories, Hospira, Sandoz, and Teva moved to dismiss remaining claims under Rule 12(b)(6).
- Court applied Mensing to hold all remaining state-law claims preempted and granted dismissal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of failure to warn claims | Pls argue state law duty to warn survives federal sameness. | Mens ing requires sameness, preempts warnings claims. | Preempted; dismissed. |
| Preemption of design defect claims | Design defect independent of labeling duty exists. | Mensing extends to design; cannot alter design. | Preempted; dismissed. |
| Preemption of negligence claims | Negligence includes testing/manufacturing independent of labeling. | Negligence claims are essentially failure to warn under Mensing. | Preempted; dismissed. |
| Preemption of breach of express warranty | Express warranties stand apart from labeling changes. | Labels cannot be changed unilaterally; preempted by sameness. | Preempted; dismissed. |
| Preemption of breach of implied warranty | Implied warranties rely on design/safety benefits. | Design-related claims preempted under Mensing. | Preempted; dismissed. |
Key Cases Cited
- Mensing, Inc. v. plaintiff, 131 S. Ct. 2567 (2011) (failure to warn labels must be same as brand-name)
- Wyeth v. Levine, 555 U.S. 555 (2009) (federal duty to sameness preempts state-law warnings)
- Freightliner Corp. v. Myrick, 514 U.S. 280 (1995) (implied preemption when state and federal conflict)
- U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329 (S.D.N.Y. 2010) (preemption analysis for state tort claims against manufacturers)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (rejects threadbare pleadings; plausibility standard)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (heightened pleading standard; plausibility)