773 F. Supp. 2d 561
E.D. Pa.2011Background
- Plaintiff Kiley Wolfe, nine, ingested OTC Children's Motrin in 1996 after a physician's suggestion and subsequently developed Stevens-Johnson Syndrome (SJS) and later Vanishing Bile Duct Syndrome (VBDS) requiring a liver transplant.
- Defendants McNeil entities allegedly designed, manufactured, marketed and sold Children's Motrin in reliance on FDA-approved labels and warnings.
- At the time, the OTC Motrin label contained warnings such as seeking medical help for certain symptoms; in 2006 the FDA urged stronger warnings including skin reactions related to SJS.
- Plaintiff's mother initially did not read warnings, but later checked the box on the box/bottle; doses were administered over about three days before hospital admission.
- Plaintiff filed a multi-count federal products liability suit in the Eastern District of Pennsylvania (Civil Action No. 07-348); defendants moved for summary judgment.
- The court denied summary judgment on failure-to-warn and punitive damages, and granted it on all other negligence, strict liability, misrepresentation, warranty, and UTPCPL claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of failure-to-warn claims | Wolfe argues state-law warnings supplement FDA labeling, not preempted. | McNeil contends FDA label precludes state-law warnings where FDA would not approve changes. | Preemption not established; stronger warning urged by FDA supports denial of preemption. |
| Causation for failure-to-warn | A stronger warning could have prevented injury; presumption may apply that warnings would have been heeded. | No genuine issue of causation; medical guidance and other factors negate link to warnings. | Reasonable jury could find warning would have been heeded; summary judgment denied on failure-to-warn. |
| Negligent failure to test | There was a duty to test to ensure safety of Motrin for children. | No recognized tort for negligent failure to test; subsumed under design/manufacture. | Granted summary judgment on negligent failure-to-test claim. |
| Negligent marketing | Manner of promotion allegedly undermined warnings. | Pennsylvania does not recognize negligent marketing when the warning itself is insufficient; claim barred. | Granted summary judgment on negligent marketing claim. |
| Negligent defective design | Defendants owed a duty to design a safer product. | No duty to make ibuprofen safer given rarity of SJS and public interest. | Court found no duty; granted summary judgment on negligent defective design. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (Supreme Court, 2009) (FDA label preemption generally not automatic; state-law warnings supplement federal law)
- Donoughe v. Lincoln Elec. Co., 936 A.2d 52 (Pa. Super. Ct. 2007) (failure-to-warn and defect concepts in Pennsylvania courts)
- Schindler v. Sofamor, Inc., 774 A.2d 765 (Pa. Super. Ct. 2001) (restatement-of-torts prerequisites for strict liability)
- Viguers v. Philip Morris USA, Inc., 837 A.2d 534 (Pa. Super. Ct. 2003) (heeding presumption in warning cases; enunciates considerations)
- Pavlik v. Lane Ltd./Tobacco Exps. Int'l, 135 F.3d 876 (3d Cir. 1998) (predicted adoption of rebuttable heeding presumption in PA)
- Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (warn- and warranty-related analyses in drug product cases)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (Supreme Court, 2001) (Buckman preemption concerns for fraud-on-FDA claims; not dispositive here)