Lofton v. McNeil Consumer & Specialty Pharmaceuticals
2012 U.S. App. LEXIS 3496
5th Cir.2012Background
- Lofton died from Toxic Epidermal Necrolysis after taking Motrin; his family sued Motrin's manufacturers for failure to warn.
- The district court granted summary judgment preempting Texas § 82.007(b)(1), constraining failure-to-warn claims.
- Texas § 82.007 creates a presumption of non-liability if FDA-approved warnings accompany the product.
- § 82.007(b)(1) allows rebuttal by proving the defendant withheld or misrepresented information required by the FDA that was material and related to the injury.
- FDA had, in 2005, rejected a Citizen's Petition seeking broader labeling and alleged withholding; FDA found no evidence of undisclosed information.
- The core issue on appeal is whether § 82.007(b)(1) is preempted or can proceed as a fraud-on-the-FDA theory; the panel affirms summary judgment for preemption.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Is § 82.007(b)(1) preempted by the FDCA under Buckman? | Lofton argued Buckman does not preempt this statute's fraud-on-the-FDA theory. | McNeil contends Buckman preempts § 82.007(b)(1) because it conditions liability on fraud-on-the-FDA. | Yes; § 82.007(b)(1) is preempted unless FDA finds fraud. |
| Is § 82.007(b)(1) properly characterized as a fraud-on-the-FDA provision? | Lofton contends it is a traditional failure-to-warn claim, not fraud-on-the-FDA. | McNeil asserts § 82.007(b)(1) rests on fraud-on-the-FDA theory to rebut the presumption. | Yes; § 82.007(b)(1) is a fraud-on-the-FDA provision. |
| Does the Texas statute's severability affect preemption? | Lofton argues § 82.007(b)(1) can be severed from § 82.007(a). | McNeil argues severability is not necessary to resolve preemption. | Waived; court did not reach severability. |
Key Cases Cited
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA preemption; FDA enforcement powers)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (traditional failure-to-warn claims not preempted; agency-disclosure balance)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (parallel federal requirements allowed; damages remedy complements federal requirements)
- Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006) (Buckman-inspired view of fraud-on-the-FDA in separate context)
- Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) (Michigan statute preemption under Buckman in some applications)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (prescription generic-drug labeling preemption; presumption value questioned)