Tapia v. Davol, Inc.
116 F. Supp. 3d 1149
S.D. Cal.2015Background
- Plaintiff Jesus Tapia sued Davol, Inc. (and related Bard entities) claiming injuries from a Bard Composix Kugel hernia repair patch implanted in 2005; he alleges the patch’s internal polymer memory recoil ring fractured, caused an enterotomy and infection, and required removal in 2013.
- The Kugel Patch was cleared by the FDA as a Class II device in 2001; Defendants later received adverse-event reports of ring breaks, bowel perforations, adhesions, deformity, and at least one death-related report.
- FDA inspections (2006, 2007) identified post‑market surveillance failures and quality‑system violations; Defendants issued a Class I recall beginning December 2005 and expanded in 2006–2007.
- Complaint asserts manufacturing and post‑market weld process defects with the memory recoil ring, concealment of adverse information, inadequate testing, regulatory noncompliance, and misleading warranties/labels.
- Procedural posture: Davol moved to dismiss under Rule 12(b)(6). Plaintiff withdrew two claims; the court granted dismissal of several claims (some with leave to amend) and denied dismissal of the manufacturing‑defect claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Manufacturing defect (strict liability) | Alleged weld/process problems caused ring breaks; Patch implanted in ordinary use and ring broke causing injury | Complaint lacks specific factual showing that plaintiff’s unit deviated from design or caused injury | Denied — complaint sufficiently alleges a manufacturing defect causally linked to injury |
| Failure to warn (strict liability) | Defendants knew of ring weakness, recall, and FDA findings but failed to warn physicians/healthcare community or include warnings in labeling | Complaint fails to allege what warnings were omitted vis‑à‑vis plaintiff’s treating physician and fails to plead causation under learned intermediary rule | Granted with leave to amend — plaintiff must plead failure to warn to his treating physician and causation |
| Breach of implied warranty of merchantability | Exception to privity should apply to implanted medical devices (like drugs/food) | Privity required for implied warranty claims involving implants; no authority distinguishing merchantability from fitness re: privity | Granted dismissal with prejudice — privity required, amendment futile |
| Breach of express warranty | Manufacturer’s labels/ads warranted safety and fitness; express warranty exception to privity applies | Plaintiff fails to allege physician reliance and does not identify specific representations/which defendant made them | Granted with leave to amend — express‑warranty allegations insufficient (must plead physician/learned intermediary reliance and particularized warranty statements) |
| Fraud / negligent misrepresentation and fraudulent concealment | Defendants actively concealed known defects and adverse events; plaintiff pleads concealment facts | Claims fail Rule 9(b): allegations lump defendants, lack particularity as to who said what, when, where; no allegation that plaintiff’s physician would have acted differently | Granted with leave to amend — concealment facts pleadable but must identify each defendant’s role, particularize affirmative misrepresentations, and plead causation (physician reliance) |
Key Cases Cited
- Balistreri v. Pacifica Police Dep’t, 901 F.2d 696 (9th Cir. 1990) (12(b)(6) dismissal standard where complaint lacks cognizable theory)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility standard for pleadings)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (non‑conclusory factual allegations required to survive dismissal)
- Anderson v. Owens‑Corning Fiberglas Corp., 53 Cal.3d 987 (Cal. 1991) (strict products liability principles)
- Greenman v. Yuba Power Prods., 59 Cal.2d 57 (Cal. 1963) (manufacturer strict liability foundational case)
- Barker v. Lull Eng’g Co., 20 Cal.3d 413 (Cal. 1978) (definition of manufacturing defect)
- Carlin v. Superior Court, 13 Cal.4th 1104 (Cal. 1996) (failure‑to‑warn standard for known or knowable risks; learned intermediary doctrine context)
- Plenger v. Alza Corp., 11 Cal.App.4th 349 (Cal. Ct. App. 1992) (learned intermediary rule for implanted devices)
- Burr v. Sherwin‑Williams Co., 42 Cal.2d 682 (Cal. 1954) (privity rule and exceptions for warranty claims)
- Seely v. White Motor Co., 68 Cal.2d 9 (Cal. 1968) (express‑warranty/privity discussion)
- Hauter v. Zogarts, 14 Cal.3d 104 (Cal. 1975) (express warranty and privity principles)
- Daugherty v. American Honda Motor Co., 144 Cal.App.4th 824 (Cal. Ct. App. 2006) (elements of express warranty claim)