Phares v. Actavis-Elizabeth LLC
892 F. Supp. 2d 835
S.D. Tex.2012Background
- Plaintiff Elidía Phares used Reglan/metoclopramide regularly (10 mg, 3–4 times daily) for about eight years through 2010.
- Plaintiff alleges tardive dyskinesia caused by Reglan/metoclopramide and sues multiple manufacturers (brand and generic) under Texas law.
- Plaintiff filed suit April 1, 2011; amended complaint dated August 26, 2011, asserting negligence, misrepresentation, fraud, suppression of evidence, strict liability, warranties, and DTPA claims.
- Actavis (generic Reglan) moves to dismiss under Rule 12(b)(6) and 12(c); Brand Defendants move for summary judgment.
- Court analyzes whether claims are failure-to-warn under Texas law, preemption under Mensing, and whether presumption of non-liability applies.
- Court grants Actavis’s motion to dismiss and Brand Defendants’ motion for summary judgment.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of failure-to-warn claims under Mensing | Mensing applies only to labeling; other theories viable. | Mensing preempts all state failure-to-warn claims for generics. | Mensing preempts all failure-to-warn claims. |
| Whether this is a Texas products liability action against Brand Defendants | Brand Defendants owe duty for negligent warnings. | Brand Defendants did not supply the product; Barajas/Aim limit liability. | Still a products liability action; Brand Defendants not liable. |
| Presumption of non-liability under Texas § 82.007 | Presumption rebuttable with fraud on FDA evidence. | Presumption applies; fraud-on-FDA preempted absent FDA finding. | Presumption applies; plaintiff cannot rebut due to lack of FDA finding. |
| Validity of fraud and suppression of evidence claims against Brand Defendants | Fraud supported by general allegations; suppression plausible. | 9(b) pleading standard and lack of authority for suppression claim. | Fraud dismissed for failure to plead with particularity; suppression claim dismissed. |
| Brand Defendants’ summary judgment on all claims | Claims against Brand Defendants valid under Texas law. | No duty owed by Brand Defendants; product liability limitations apply. | Brand Defendants granted summary judgment; claims dismissed. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (FDA labeling and preemption framework underpinning drug warning duties)
- Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (conflict impossibility preemption of generic-label strengthening under state law)
- Lofton v. McNeil Consumer & Specialty Pharm., 672 F.3d 372 (5th Cir. 2012) (fraud-on-the-FDA claim preempted unless FDA found fraud)
- Rozzell v. Security Services, Inc., 38 F.3d 819 (5th Cir. 1994) (substance of allegation controls whether claim is failure-to-warn)
- In re Great Lakes Dredge & Dock Co. LLC, 624 F.3d 201 (5th Cir. 2010) (standard for evaluating Rule 12(b)(6) and summary judgment overlap)
- Barajas v. Firestone Steel Prods. Co., 927 S.W.2d 608 (Tex. 1996) (manufacturer generally not liable for others' products; duty limits)