Tillman v. C.R. Bard, Inc.
2015 U.S. Dist. LEXIS 40338
| M.D. Fla. | 2015Background
- Plaintiff Lessie Tillman received a Bard G2® retrievable IVC filter in Feb. 2008; attempts to retrieve it in Mar. 2009 were aborted after imaging showed tilt and incorporation into the left renal vein, leaving the filter permanently implanted.
- Tillman sued Bard alleging negligence and strict liability (failure to warn, design defect, manufacturing defect) and seeks medical-monitoring damages because she claims an ongoing risk of fracture/embolization.
- Bard moved to exclude four expert witnesses (Ritchie; McMeeking & Begley; Hyman; Freeman) and moved for summary judgment; Tillman moved for partial summary judgment on certain affirmative defenses.
- Experts for plaintiff opined the G2/Recovery filters were prone to fatigue fracture due to design/manufacturing deficiencies (sharp inner rim, surface gouges, inadequate testing), and that Bard had early signals of elevated adverse-event rates. Bard challenged qualifications, methodology, relevance, and causation.
- The Court applied Daubert standards, admitted many expert opinions in part (denying several exclusion requests) but excluded portions that amounted to unsupported leaps, legal conclusions, or opinions outside an expert’s qualifications.
- On summary judgment the Court granted Bard judgment on failure-to-warn (no admissible expert showed IFU inadequacy to the treating physician) but denied summary judgment on design and manufacturing defect claims and punitive damages to the extent Tillman seeks medical-monitoring relief; it granted Tillman partial summary judgment eliminating Bard’s asserted implied-assumption-of-risk affirmative defense.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of experts under Daubert (qualification, methodology, fit) | Plaintiff: experts qualified and their methodologies reliable to show design/manufacturing defects and elevated failure rates | Bard: challenge qualifications, data sources, methodological gaps, legal conclusions, and that opinions do not fit facts | Court admitted fracture- and testing-related opinions (Ritchie, McMeeking/Begley, Freeman) but excluded unsupported causation leaps, manufacturing-process opinions beyond experts’ expertise, and legal-state-of-mind conclusions; Hyman limited/excluded on several topics |
| Failure-to-warn (strict liability & negligence) | Tillman: IFU minimized risks and omitted comparative failure rate information; learned intermediary doctrine should not preclude liability | Bard: IFU warned of fracture, migration, perforation and Stockland (implanting physician) read IFU and knew risks | Court: Granted summary judgment to Bard — plaintiff failed to present admissible medical expert evidence that the IFU was inadequate to inform the physician (learned intermediary controls) |
| Design defect / Comment k / risk-utility | Tillman: G2 design (geometry, lack of chamfer, inadequate testing) makes it unreasonably dangerous; benefits do not outweigh risks | Bard: Comment k (unavoidably unsafe product) and risk-benefit justify device; plaintiff must identify safer alternative design (Third Rest.) | Court: Denied summary judgment for Bard — factual disputes exist on design defects, adequacy of testing, comparative risks and whether Comment k protects Bard; court applied a risk-utility approach and rejected requirement that plaintiff identify an alternative design for medical-device context under Florida law |
| Manufacturing defect and causation (including medical-monitoring damages) | Tillman: surface gouges and variability constitute manufacturing defects; inability to remove filter plus increased fracture risk justify medical monitoring | Bard: No evidence plaintiff’s specific filter departed from design; MAUDE/other data unreliable for rate comparisons; plaintiff hasn’t proven causation of injury | Court: Cassisi inference inapplicable because tilt/migration/perforation are known risks; nevertheless material factual disputes exist about manufacturing defects (surface defects) and causation for medical-monitoring damages; summary judgment denied as to design/manufacturing claims and monitoring relief but damages for acute harms lacked admissible causation proof |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S. 1993) (trial court gatekeeper must assess relevance and reliability of expert testimony)
- United States v. Frazier, 387 F.3d 1244 (11th Cir. 2004) (three-part test for admissibility: qualification, reliability, helpfulness)
- McClain v. Metabolife Int'l, Inc., 401 F.3d 1233 (11th Cir. 2005) (burden on proponent to show expert reliability; courts may exclude insufficiently supported methodology)
- Allison v. McGhan Med. Corp., 184 F.3d 1300 (11th Cir. 1999) (warning against analytical leaps and reliance on anecdotal evidence)
- West v. Caterpillar Tractor Co., Inc., 336 So.2d 80 (Fla. 1976) (Florida adopted strict products liability under Restatement §402A; consumer negligence may be defense in limited circumstances)
- Upjohn Co. v. MacMurdo, 562 So.2d 680 (Fla. 1990) (adequacy of prescription-product warnings to physicians generally requires expert testimony)
- Cassisi v. Maytag Co., 396 So.2d 1140 (Fla. 1981) (risk-utility formulation and manufacturing-defect inference where product malfunctions during normal operation)