Johnson & Johnson, Inc. v. Brenda Fortenberry
2015-CA-01369-SCT
| Miss. | Oct 19, 2017Background
- Louise Taylor (through conservator Brenda Fortenberry) sued Janssen and Johnson & Johnson alleging Risperdal caused tardive dyskinesia after ~3 years' treatment; jury found for plaintiff on inadequate warning and negligent misrepresentation and awarded $1.95M.
- Taylor’s treating psychiatrist, Dr. Rhoden, had read the FDA-approved Risperdal label (which warned of tardive dyskinesia) and testified he warned Taylor; he prescribed Risperdal believing benefits outweighed risks and because he understood Risperdal as an "atypical" with lower EPS/TD risk.
- Plaintiff presented experts (neurology/psychiatry) and Janssen internal/promotional materials alleging marketing downplayed TD risk and promoted Risperdal as "atypical"/low-risk, which plaintiff argued diluted the label’s warning and influenced prescribing.
- Trial court submitted failure-to-warn and negligent marketing/misrepresentation theories to the jury; Janssen moved for JNOV and new trial—denied; Janssen appealed and Taylor cross-appealed on punitive damages.
- Supreme Court held as a matter of law that the FDA-approved Risperdal label adequately warned physicians and reversed and rendered judgment for Janssen on the failure-to-warn claim; it reversed and remanded the negligent misrepresentation claim for a new trial because key jury instructions were defective and clarified that standalone "negligent marketing" is not a cognizable claim apart from misrepresentation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Adequacy of Risperdal warning (failure-to-warn) | Labeling and marketing together failed to adequately warn physicians of TD risk; marketing diluted label | FDA-approved label explicitly warned of TD; physician (learned intermediary) was warned; no legal inadequacy or proximate causation | Warning was adequate as a matter of law; reversed and rendered for Janssen on failure-to-warn |
| Negligent misrepresentation / negligent marketing | Janssen’s promotional materials and internal docs misrepresented TD/EPS risk and influenced Dr. Rhoden to prescribe | No proof Dr. Rhoden saw or relied on any specific Janssen misrepresentation; learned intermediary doctrine bars patient-based claims | Jury questions existed on whether marketing misrepresentations were material and causative; negligent misrepresentation claim reversed and remanded for new trial due to defective jury instruction |
| Jury instructions (P-12, P-3, P-18, P-8) | Instructions fairly presented theories including negligent marketing/misrepresentation | Instructions omitted essential elements and conflated theories (e.g., negligent marketing vs misrepresentation) | Court found fatal defects (omitted elements of negligent misrepresentation); reversed and remanded that claim; failure-to-warn instruction issue moot after rendering |
| Punitive damages and closing argument misconduct | Plaintiff sought punitive phase based on internal documents and expert testimony; defendant objected to inflammatory closing remark | Trial court properly gatekept punitive phase; defendant contended counsel’s remark was prejudicial | Trial court did not abuse discretion denying punitive phase; closing argument remark was improper and should have been struck/admonished but remaining issues do not warrant reversal |
Key Cases Cited
- Wyeth Labs., Inc. v. Fortenberry, 530 So. 2d 688 (Miss. 1988) (learned-intermediary rule; adequacy of physician-directed warnings)
- Janssen Pharmaceutica, Inc. v. Bailey, 878 So. 2d 31 (Miss. 2004) (FDA-approved labeling adequacy is a factual question for the jury; marketing can be relevant)
- Union Carbide Corp. v. Nix, Jr., 142 So. 3d 374 (Miss. 2014) (MPLA elements for failure-to-warn claims)
- United Servs. Auto. Ass'n v. Lisanby, 47 So. 3d 1172 (Miss. 2010) (standard of review for JNOV/new-trial motions)