Eckhardt v. Qualitest Pharmaceuticals Inc.
2012 U.S. Dist. LEXIS 62202
S.D. Tex.2012Background
- Plaintiffs filed a complaint and two amendments alleging injury from long-term metoclopramide (Reglan) use by Eckhardt.
- Plaintiffs sue both brand-name and generic manufacturers for various theories, primarily failure to warn.
- Defendants Qualitest and Vintage move to dismiss under Rules 8, 9, 12, arguing preemption under Mensing.
- The case is treated as a Texas products liability claim under diversity jurisdiction; governing law is Texas law.
- Court analyzes Mensing and Texas law to determine preemption and which claims survive.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of failure-to-warn claims against generics | Mensing preemption does not apply to all claims; state law warnings differ from FDA labeling should be allowed. | Mensing preempts state-law failure-to-warn claims for generics because labeling must remain the same as brand-name. | Preempted; failure-to-warn claims against generics dismissed. |
| Survivability of non-preempted theories under Texas law | Some theories (e.g., manufacturing/design) could survive if not preempted. | Most theories are preempted or fail Rule 9(b) or causation requirements. | All theories except potentially limited ones dismissed; specific claims dismissed with prejudice. |
| Fraud, suppression, and DTPA claims viability | Fraud and suppression may survive independent of labeling issues. | Fraud and related claims lack particularity or are precluded by Mensing. | Fraud, suppression, and DTPA claims dismissed. |
| Rule 9(b) sufficiency of fraud allegations | Fraud claims should withstand heightened pleading. | Fraud claims fail to plead necessary particularity. | Fraud claims dismissed for lack of Rule 9(b) particularity. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (conflict preemption: generics cannot unilaterally change brand-equivalent labeling)
- Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) (fraud-on-the-FDA preemption; Lofton clarifies preemption scope)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling decisions and warnings interplay with state claims)