903 F. Supp. 2d 143
S.D.N.Y.2012Background
- Pro se plaintiff Elizabeth Ohuche sues Merck Sharp & Dohme Corp. alleging injuries after ZOSTAVAX vaccination.
- Vaccination occurred March 12, 2009 by Dr. Ina Itzkovitz; plaintiff claims severe headaches, fever, rashes, facial symptoms, and partial vision loss.
- FDA labeling and 2009 resources warned of vaccine adverse effects; Itzkovitz did not review labeling before vaccinating.
- Medical records before Nov. 2010 largely show no rash; rash first documented Nov. 12, 2010, with later notes suggesting uncertainty about vaccine causation.
- Court treats the pleading as a potential product-liability failure-to-warn claim, but ultimately grants summary judgment for Merck on proximate-cause grounds, recognizing learned intermediary scope and potential malpractice liability.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Causation in fact between ZOSTAVAX and injuries | Ohuche | Merck | Disputed issue of material fact exists about causation |
| Proximate cause under learned intermediary doctrine | Ohuche | Merck | Merck protected; doctors' warning/prevention obligations limit liability for Merck |
| Whether claim fits product liability or malpractice | Ohuche | Merck | Claim dismissed as malpractice; product-liability claim inadequately supported |
Key Cases Cited
- Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980) (prescription-drug injury proof requires causation by drug)
- Saari v. Merck & Co., Inc., 961 F. Supp. 387 (N.D.N.Y. 1997) (temporal proximity inadequate for causation without proof)
- Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342 (E.D.N.Y. 1992) (no expert proof to establish causation against manufacturer)
- Plummer v. Lederle Labs. Div. of Am. Cyanamid Co., 819 F.2d 349 (2d Cir. 1987) (learned intermediary doctrine; warning to doctor, not patient)
- Fane v. Zimmer, Inc., 927 F.2d 124 (2d Cir. 1991) (direct causation from product characteristics and plaintiff's description)