6 F. Supp. 3d 694
E.D. La.2014Background
- Keisha Hunt sued McNeil Consumer Healthcare/Johnson & Johnson under the Louisiana Products Liability Act after developing Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) allegedly from ingesting over‑the‑counter Children’s Motrin (ibuprofen).
- Plaintiff alleges defective design and inadequate warnings on the Children's Motrin label caused her injuries.
- Defendants asserted federal preemption (impossibility/conflict) under the FDCA as an affirmative defense; they bear the burden of proof.
- Defendants relied on Wyeth/Mensing/Bartlett line of Supreme Court preemption decisions and FDA materials (a 2006 FDA response to a 2005 citizen petition and a 2013 FDA letter) to argue clear evidence that the FDA would have rejected stronger warnings or redesign.
- The court focused on whether preemption applies to nonprescription (OTC) drugs given 21 U.S.C. § 379r’s express savings (non‑preemption) clause preserving state product‑liability actions.
Issues
| Issue | Hunt's Argument | McNeil's Argument | Held |
|---|---|---|---|
| Whether Hunt's inadequate‑warning claim is preempted by federal law | State LPLA warning duty valid; label was inadequate and could have been updated | Wyeth/Mensing principles preempt state claims unless clear evidence FDA would have rejected label changes | Not preempted: §379r(e) saves OTC product‑liability suits; defendants failed to show "clear evidence" FDA would have rejected the proposed warnings |
| Whether FDA’s 2006 citizen‑petition response is clear evidence FDA would reject stronger warnings | FDA did not expressly reject the broader warnings Hunt seeks | The FDA’s 2006 guidance shows agency preferred symptom‑based OTC wording, evidencing rejection of stronger terms | Not clear evidence: FDA did not categorically reject the broader, particular warnings Hunt alleges; subsequent adverse event reports changed the information landscape |
| Whether the FDA’s 2013 letter about acetaminophen constitutes clear evidence applicable to ibuprofen | Post‑2010 FDA action on a different drug is inapposite | FDA’s later action shows agency consistent preference for symptom‑based OTC warnings | Not persuasive: acetaminophen differs from ibuprofen; different data and context — not dispositive for ibuprofen labeling in 2010 |
| Whether Hunt’s design‑defect claim is preempted under Bartlett/Mensing | §379r(e) preserves state design‑defect claims for OTC drugs | Bartlett/Mensing preempt state design claims because federal law restricts unilateral labeling/composition changes | Not preempted: Bartlett/Mensing concern prescription/generic regimes; §379r(e) expressly preserves state product‑liability claims for OTC drugs, so defendants did not meet heavy preemption burden |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (brand‑name drug warning claims not preempted absent clear evidence FDA would have rejected label changes)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (held certain state design‑defect claims preempted in the prescription/generic context)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (generic drug regulations can create impossibility preemption due to duty‑of‑sameness labeling requirement)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (congressional intent is touchstone of preemption analysis)
- Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (federal law preempts conflicting state law; presumption against preemption for traditional state police powers)
- Fisher v. Halliburton, 667 F.3d 602 (5th Cir. 2012) (preemption is an affirmative defense; defendant bears burden of proof)
- Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (discusses OTC labeling and FDA response to citizen petition regarding SJS/TEN)