167 F. Supp. 3d 296
D. Conn.2016Background
- Kyle Kimball took one dose of OTC Motrin (ibuprofen) in Oct. 2010, developed SJS/TEN, suffered permanent injuries, and died by suicide in Dec. 2011; his mother Amy Batoh sued McNeil-PPC and J&J under the Connecticut Product Liability Act (CPLA).
- Motrin is an FDA-approved OTC ibuprofen product; FDA-guided “Allergy Alert” language (including “skin reddening,” “rash,” “blisters”) was on the label in 2010 after agency-directed revisions in 2005–2006.
- Plaintiff alleged defective labeling (failure to warn of severe cutaneous adverse reactions and related consequences) and a design defect (that the product’s active ingredient should have been changed to dexibuprofen), plus related common-law claims.
- Critical evidentiary facts: (a) decedent reportedly told family he would not have taken Motrin if warnings were more specific, but those out-of-court statements were not sworn and were made months after hospitalization; (b) no direct evidence decedent read or relied on the Motrin label before ingestion.
- Defendants moved for summary judgment on multiple grounds including lack of admissible evidence of causation for failure-to-warn and impossibility (conflict) preemption for design-defect claims requiring altering the active ingredient; court applied Connecticut law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure-to-warn causation: Would decedent have avoided Motrin if label were more explicit? | Batoh: family testimony and decedent’s statements show he was cautious and said he would not have taken Motrin with stronger warnings. | McNeil: statements are inadmissible hearsay or character evidence; no proof decedent read or relied on label. | Held for Defendants — no admissible evidence that decedent would have heeded a different label; failure-to-warn causation fails. |
| Residual-hearsay admissibility of decedent’s post‑event statements | Batoh: Rule 807 permits admission because statements are material, probative, and trustworthiness exists. | Defendants: statements lack sufficient circumstantial guarantees of trustworthiness; were self-serving and possibly made in context of litigation. | Held for Defendants — statements inadmissible under Rule 807; plaintiff failed to meet trustworthiness requirement. |
| Preemption of failure-to-warn claim under FDCA (impossibility) | Batoh: FDA review and prior agency rejections do not show it would have prevented McNeil from strengthening label under CBE regulation. | Defendants: FDA controls labeling; company couldn’t unilaterally change OTC labeling without FDA approval, so compliance with state law was impossible. | Held for Plaintiff on preemption — failure-to-warn claim is NOT preempted because defendant failed to show clear evidence FDA would have forbidden the labeling change; CBE route plausibly available. |
| Preemption of design-defect claim (change active ingredient) | Batoh: defendants could have adopted dexibuprofen (allegedly safer). | Defendants: switching active ingredient is a ‘‘major change’’ requiring prior FDA approval; impossible to satisfy state duty to redesign absent FDA action. | Held for Defendants — design-defect claim based on altering chemical composition is preempted by federal law (impossibility preemption). |
Key Cases Cited
- Celotex Corp. v. Catrett, 477 U.S. 317 (summary judgment standard)
- Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (jury evidence standard on summary judgment)
- Wyeth v. Levine, 555 U.S. 555 (2009) (impossibility preemption is demanding; manufacturer may use CBE to strengthen warnings)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (preemption where manufacturer cannot independently satisfy conflicting state duties without FDA permission)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013) (state-law design-defect duties that would require altering drug composition conflict with federal law)
- Potter v. Chicago Pneumatic Tool Co., 241 Conn. 199 (Conn. law on consumer-expectations/risk-utility for design defect)