414 F.Supp.3d 1137
N.D. Ill.2019Background
- On June 15, 2012, Greager ingested two ibuprofen products: brand Motrin IB and a Walmart store-brand generic sold as Equate; she later developed Stevens–Johnson Syndrome/toxic epidermal necrolysis and alleges permanent injuries.
- Greager sued multiple manufacturers and sellers on state-law theories including defective design, failure to warn, negligence, consumer fraud, breach of implied warranty, and willful/wanton misconduct.
- Perrigo (manufacturer of Equate) and Walmart moved to dismiss, arguing the state-law claims against the Equate product are preempted by the FDCA and FDA regulations because Perrigo is an ANDA holder.
- Greager conceded she cannot state claims against Perrigo or Walmart based on ingestion of Motrin (the brand), focusing her response on claims tied to the Equate product.
- The court applied Supreme Court precedent (PLIVA/Mensing and Bartlett), finding ANDA holders have a federal “duty of sameness” and cannot independently change composition or labeling (no CBE authority), so state-law duties to redesign or relabel conflict with federal law.
- The court rejected Greager’s argument that nonprescription/OTC status and 21 U.S.C. § 379r(e) save her claims from preemption, concluding the savings clause does not avoid conflict preemption from other federal sources; it dismissed Perrigo’s and Walmart’s claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are state-law design/warning claims against an ANDA-holder generic preempted by federal law? | Greager contends her state-law claims against Equate are viable; federal law for OTC drugs differs so preemption should not apply. | Perrigo/Walmart: ANDA holders must match RLD labeling and cannot unilaterally change design/labeling, so conflict preemption bars state-law claims. | Held: Preempted. Mensing/Bartlett control; ANDA duty-of-sameness makes compliance with state law impossible. |
| Does OTC/nonprescription status prevent application of the duty-of-sameness preemption rule? | Greager: OTC drugs are governed by different statutes/regulations, so Mensing/Bartlett do not apply. | Defendants: The critical distinction is ANDA v. NDA status, not OTC v. prescription; CBE is available to NDA holders, not ANDA holders. | Held: OTC status does not change result; applicability depends on ANDA status (no CBE), so preemption applies. |
| Does 21 U.S.C. § 379r(e) (saving clause for product liability) preserve Greager’s state-law claims from preemption? | Greager: § 379r(e) expressly preserves product-liability claims for nonprescription drugs, so her claims survive. | Defendants: § 379r(e) only limits express preemption under § 379r(a); it does not shield claims from conflict preemption arising under other federal provisions. | Held: § 379r(e) does not defeat conflict preemption here; claims remain preempted. |
| Are Greager’s claims based on ingestion of Motrin viable against Perrigo/Walmart? | Greager effectively conceded she cannot maintain claims against Perrigo/Walmart based on Motrin ingestion. | Defendants argued dismissal as to Motrin-based claims. | Held: Greager conceded; Motrin-based claims against Perrigo/Walmart not pursued. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic-drug “duty of sameness” and conflict preemption of state-labeling/design claims)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (design-defect claims against generic manufacturers preempted where federal law forbids change)
- Wyeth v. Levine, 555 U.S. 555 (2009) (NDA holders may use CBE to strengthen warnings; non-preemption where label changes possible)
- Wagner v. Teva Pharmas. USA, Inc., 840 F.3d 355 (7th Cir. 2016) (state claims against ANDA holders preempted under Mensing/Bartlett)
- Guilbeau v. Pfizer Inc., 880 F.3d 304 (7th Cir. 2018) (examining conflict preemption in drug-label disputes)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (Rule 8 pleading standard)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard under Rule 8)