314 F. Supp. 3d 1251
M.D. Fla.2018Background
- Douse had a Greenfield permanent inferior vena cava (IVC) filter implanted after a 2003 pulmonary embolism; by 2017 the filter had perforated the vein and caused complications.
- Douse sued Boston Scientific alleging defective design and manufacture, inadequate testing and warnings, breach of warranties, fraud, negligent misrepresentation, FDUTPA violations, and sought punitive damages; original complaint was removed and dismissed as a shotgun pleading, leading to an Amended Complaint.
- The Amended Complaint alleges the Greenfield Filter was prone to breakage, migration, collapse, perforation, and thrombus formation, and that Boston Scientific continued to market it for long-term use despite knowledge of risks and FDA warnings about long-term IVC filter implantation.
- Boston Scientific moved to dismiss on multiple grounds: shotgun pleading, failure to state plausible claims (including Rule 9(b) for fraud), lack of privity for warranty claims, FDUTPA inapplicability, and insufficient punitive-damages pleading.
- The court sustained negligence, strict liability (design, manufacturing, failure to warn) and punitive-damages allegations at the pleading stage, but dismissed breach-of-warranty, fraud-based claims, FDUTPA, and negligent misrepresentation counts for pleading deficiencies or legal inapplicability.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Shotgun pleading | Amended Complaint cures prior defects and gives adequate notice | Still a shotgun because counts are vague and overlapping | Not a shotgun pleading; Amended Complaint survives on this ground |
| Negligence (Count I) | Boston Scientific breached duties in design, manufacture, testing, marketing and warnings, causing injury | Insufficiently pleaded duty/breach | Negligence claim plausible; Count I survives |
| Strict liability — design & manufacturing (Counts II-III) | Filter was unreasonably dangerous (consumer-expectations and risk-utility theories); long-term use correlates with perforation | Complaint fails to identify specific defective components or design flaws | Design and manufacturing claims plausibly pleaded; Counts II–III survive |
| Strict liability — failure to warn (Count IV) | Company failed to warn doctors/learned intermediaries of known risks and downplayed complications | Warnings were adequate; learned intermediary breaks causation | Adequately pleaded; learned-intermediary doctrine satisfied; Count IV survives |
| Breach of warranties (Counts V–VII) | Douse relied on manufacturer's brochures/website/ads | No privity between manufacturer and patient | Dismissed for lack of privity; marketing materials insufficient to establish privity |
| Fraud (fraudulent misrepresentation and concealment, Counts VIII–IX) | Manufacturer made false factual statements and concealed material risks | Fails Rule 9(b): lacks particularity as to who/what/when and many statements are opinion | Fraud and concealment claims dismissed for failure to plead with required particularity |
| Negligent misrepresentation (Count X) | Manufacturer negligently misrepresented that filter was tested and safe | Pled conclusorily and fails Rule 9(b); reliance/inquiry issues | Dismissed for failure to plead particulars and reliance sufficiently |
| FDUTPA (Count XI) | Deceptive marketing concealed risks and injured consumer | FDUTPA does not apply to personal-injury claims | Dismissed: FDUTPA excludes personal injury/death claims |
| Punitive damages | Allegations show knowledge or reckless indifference to risks | Insufficient specific acts alleged | Survives at pleading stage; specific allegations of knowledge/recklessness are adequate for now |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility standard for pleadings)
- Ashcroft v. Iqbal, 556 U.S. 662 (limits on conclusory allegations in pleadings)
- Weiland v. Palm Beach Cty. Sheriff's Office, 792 F.3d 1313 (shotgun-pleading doctrine)
- Felix v. Hoffmann‑LaRoche, Inc., 540 So.2d 102 (learned intermediary doctrine in medical products cases)
- Aubin v. Union Carbide Corp., 177 So.3d 489 (consumer-expectations and risk-utility tests under Florida law)
- Cintron v. Osmose Wood Preserving, Inc., 681 So.2d 859 (elements of Florida strict products liability)
- Butler v. Yusem, 44 So.3d 102 (elements of fraud under Florida law and reliance principles)