Reckis v. Johnson & Johnson
471 Mass. 272
| Mass. | 2015Background
- In 2003 seven-year-old Samantha Reckis developed toxic epidermal necrolysis (TEN) after receiving multiple doses of OTC Children’s Motrin (ibuprofen) manufactured by McNeil-PPC/Johnson & Johnson; plaintiffs sued for defective warning, negligence, and related claims.
- Label at the time contained a generic allergy alert (hives, facial swelling, asthma, shock) but did not mention SJS/TEN, rash/blisters, or that such symptoms could progress to a life‑threatening disease.
- Plaintiffs presented expert pharmacologist Randall Tackett and treating physicians who testified ibuprofen caused Samantha’s TEN; defendants presented experts disputing causation.
- FDA received a 2005 citizen petition asking for SJS/TEN warnings; in 2006 FDA required listing of symptoms (skin reddening, rash, blisters) but explicitly declined to require the disease names SJS/TEN on OTC labels.
- Jury returned verdicts for plaintiffs: $50 million to Samantha and $6.5 million each to her parents for loss of consortium; trial court denied defendants’ motions for JMOL, new trial, and remittitur; defendants appealed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Federal preemption of failure‑to‑warn claim | Reckis: state tort not preempted; §379r(e) preserves product‑liability suits and FDA did not clearly forbid the warning plaintiffs sought | McNeil: conflict preemption — FDA rejected including SJS/TEN by name and citizen‑petition response is "clear evidence" FDA would reject the requested warning, making compliance impossible | Court: §379r(e) does not bar conflict preemption; FDA response provides clear evidence only as to disease names (SJS/TEN) but not as to a warning that rash/blisters may lead to life‑threatening disease; verdict not overturned on preemption grounds |
| Expert qualification & causation (Tackett) | Reckis: Tackett, a pharmacologist/toxicologist, is qualified to opine on specific causation based on training, literature, and medical‑record review | McNeil: Tackett lacked medical qualifications/foundation for specific causation and for the opinion that stopping after earlier doses would have prevented TEN | Court: trial judge did not abuse discretion; Tackett was qualified and his dose‑opinion went to weight, not admissibility |
| Jury reliance on preempted theory (warning naming SJS/TEN) | Reckis: primary theory was failure to warn that rash/blisters could lead to life‑threatening disease, not requirement to name SJS/TEN | McNeil: jury could have relied on the preempted theory (disease names) and verdict must be vacated | Court: record (plaintiffs’ counsel’s closing, parents’ testimony) strongly indicates jury relied on non‑preempted symptom/life‑threatening warning; no new trial required |
| Excessiveness of damages (past/future med, pain, loss of consortium) | Reckis: awards supported by severe, lifelong injuries, treating‑physician testimony, and jury’s fact‑finding discretion | McNeil: awards are grossly excessive and unsupported (insufficient evidence for future costs/earning loss; possible passion/prejudice) | Court: damages not so disproportionate as to be a miscarriage of justice; trial judge did not abuse discretion; parental consortium awards supported by evidence |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state failure‑to‑warn claims not preempted absent "clear evidence" FDA would have rejected the warning; CBE regulation allows unilateral strengthening of warnings)
- Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (conflict preemption principles and that a federal regulation can preempt state law that stands as an obstacle to federal objectives)
- Canavan's Case, 432 Mass. 304 (2000) (expert causation testimony standards under Massachusetts law; admissibility requires sufficient education, training, experience and reliable methodology)
- Labonte v. Hutchins & Wheeler, 424 Mass. 813 (1997) (standard for reviewing alleged excessive damages; reversal for excess is rare and requires abuse of discretion)
- Monahan v. Methuen, 408 Mass. 381 (1990) (standards for parental recovery for loss of filial society/consortium)