987 F. Supp. 2d 795
N.D. Ill.2013Background
- Plaintiff Klaus Rosenstern, as executor of Janet Rosenstern’s estate, sues Allergan and Allergan USA for injuries and death linked to Botox.
- Plaintiff alleges Botox can migrate, cause brain damage and autoimmune reactions, and was promoted for off-label TMJ treatment.
- Plaintiff claims Allergan marketed, funded organizations, trained sales reps, and encouraged off-label use despite known risks; Allergan pled guilty to off-label promotion.
- Rosenstern received Botox (75 units) for TMJ on May 25, 2011; treatment relied on Allergan’s representations of safety and appropriate use.
- Decedent’s death in 2013 is alleged to have resulted from Botox treatment; Sarasota ME lists suicide, but Plaintiff contends Botox poisoning precipitated it.
- Nine substantive counts are pleaded: I–Warning; II–Manufacturing defect; III–Negligence; IV–Implied warranty; V–Express warranty; VI–Negligent misrepresentation; VII–Wrongful death; VIII–Survival; IX–Punitive damages disavowed and dismissed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Count I survives under the learned intermediary doctrine | Rosenstern and providers were warned; doctrine inapplicable | Learned intermediary bars consumer warnings | Count I survives (learned intermediary not applicable) |
| Whether Count II adequately pleads a manufacturing defect | Defect existed when Botox left control and caused injuries | Lacks specific defect details | Count II survives (sufficient notice under pleading standards) |
| Whether Count III states a negligence claim including marketing/design | Allergan breached duty by marketing and design problems | Design preemption concerns; FDA-approved design possible | Count III survives (negligence claims proceed) |
| Whether Count IV may be maintained as an implied warranty | Allergan knew TMJ use and relied on marketing | Privity and reliance questions; narrowed | Count IV survives (implied warranty possible) |
| Whether Count VI may proceed as negligent misrepresentation (fraud standard) | Allergan knowingly misrepresented risks; relied upon | Claims amount to fraud; must plead with particularity under Rule 9(b) | Count VI dismissed without prejudice for lack of particularity (fraud standard) |
Key Cases Cited
- Sollami v. Eaton, 200 Ill.2d 1 (Ill. 2002) (unreasonably dangerous product defect can be failure to warn, design, or flaw in product)
- Walton v. Bayer Corp., 643 F.3d 994 (7th Cir.2011) (learned intermediary doctrine governs warning to physicians)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.2010) (preemption and off-label marketing evidence; informs design/approval analysis)
- Reid v. Unilever U.S., Inc., 964 F.Supp.2d 893 (N.D.Ill.2013) (privity not required for personal injury implied warranties)
- Johnson v. Wal-Mart Stores, Inc., 588 F.3d 439 (7th Cir.2009) (causation in tort and foreseeability in injury-related claims (suicide reference))
- Advincula v. United Blood Servs., 176 Ill.2d 1 (Ill. 1996) (Survival Act scope and accrual of claims)
- Advincula v. United Blood Servs., 678 N.E.2d 1009 (Ill. 1996) ()
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liability Litig., 623 F.3d 1200 (8th Cir.2010) (contextual pleading standards for product liability)