Oden v. Bos. Scientific Corp.
330 F. Supp. 3d 877
E.D.N.Y2018Background
- Plaintiff Furnie Oden underwent implantation of a Boston Scientific Greenfield permanent IVC filter in January 2008 and later experienced chronic pain and alleged risks associated with the device (migration, fracture, perforation, thrombosis).
- Complaint asserted negligence, strict products liability (design, manufacturing, failure to warn), breach of express and implied warranties, fraudulent misrepresentation and concealment, negligent misrepresentation, violations of N.Y. Gen. Bus. Law §§ 349 & 350, and a demand for punitive damages.
- Defendant moved to dismiss under Fed. R. Civ. P. 12(b)(6); Court treated Complaint allegations as true for pleading purposes and considered product materials and marketing documents incorporated by reference.
- Plaintiff relied on general allegations that the filter was defective and that Boston Scientific concealed/failed to disclose known risks; plaintiff pointed to marketing materials (brochure, website) and contrasted permanent Greenfield filters with retrievable filters.
- Court evaluated claims under New York law for product liability (design, manufacturing, failure to warn), warranty law, fraud-related claims (subject to Rule 9(b) where applicable), GBL §§ 349/350 consumer-protection standards, and doctrine of the learned intermediary for medical devices.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Design defect (strict liability/negligence) | Greenfield filter was defectively designed and posed unreasonable risks; retrievable filters show feasible alternatives | Plaintiff failed to identify a specific design problem or plausible alternative design comparable to a permanent filter | Dismissed – plaintiff did not plead particularized design defect or feasible alternative design |
| Manufacturing defect | The specific unit implanted malfunctioned and deviated from intended product | Complaint lacks factual allegations showing the implanted unit deviated from other units or that a manufacturing mishap occurred | Dismissed – no specific facts showing a manufacturing deviation for the product unit |
| Failure to warn | Warnings and marketing omitted or understated serious risks; consumers and physicians were not adequately warned | Instructions for Use and brochure contained many of the listed risks; plaintiff fails to plead how warnings were inadequate or that physician (learned intermediary) was not informed | Dismissed – warnings as pleaded were insufficiently particular and plaintiff failed to plead causation or inadequacy vs. provided materials |
| GBL §§ 349/350 and fraud claims | Marketing statements were deceptive/false and induced reliance by plaintiff and medical community | Plaintiff did not plausibly allege exposure to or justifiable reliance on specific statements; fraud claims also fail Rule 9(b) particularity | Dismissed – no particularized allegations of when/where statements were seen or relied upon; GBL claims lack causation showing exposure |
Key Cases Cited
- LaFaro v. N.Y. Cardiothoracic Grp., 570 F.3d 471 (2d Cir. 2009) (complaint allegations are accepted as true on a motion to dismiss)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (pleading must state a claim that is plausible on its face)
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (two‑pronged plausibility framework; courts disregard conclusory legal statements)
- Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102 (N.Y. 1983) (New York recognizes design, manufacturing, and warning defects as products liability theories)
- Scarangella v. Thomas Built Buses, Inc., 93 N.Y.2d 655 (N.Y. 1999) (definition of defectively designed product and utility-risk balancing)