398 F.Supp.3d 700
E.D. Cal.2019Background
- Plaintiff Autumn Zetz received an Obtryx pelvic mesh sling (Boston Scientific) in 2008 for stress urinary incontinence and later suffered chronic pain, pudendal neuralgia, dyspareunia, bladder dysfunction, and loss of mobility.
- Plaintiffs allege the Obtryx contains polypropylene that is biologically incompatible, causing degradation, fragmentation, contraction/shrinkage, and adverse immune/inflammatory reactions, and that Boston Scientific knew, downplayed, and concealed risks while marketing the device as safe and effective.
- Plaintiffs sued alleging ten causes of action, including strict liability (failure to warn, manufacturing defect, design defect), negligence, breach of implied warranty, fraudulent and negligent misrepresentation, fraudulent concealment, and loss of consortium.
- Boston Scientific moved to dismiss under Rule 12(b)(6) as to seven causes of action (failure to warn claims limited by the learned intermediary doctrine; manufacturing defect; design defect (strict liability); breach of implied warranty; fraudulent/ negligent misrepresentation; fraudulent concealment).
- The court evaluated pleading sufficiency under Iqbal/Twombly and Rule 9(b) for fraud-based claims, and applied California doctrines (learned intermediary, privity for implied warranty, and limits on strict liability design-defect claims for prescription/implantable devices).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Failure to warn (strict liability & negligence) | Boston Scientific failed to warn physicians and/or concealed magnitude/frequency of risks | Learned intermediary doctrine limits duty to warn to physicians, not patients | Not dismissed: allegations suffice to show inadequate warnings to physicians; claims may be based only on warnings to physicians |
| Manufacturing defect (strict liability & negligence) | Device degraded/fragmented/contracted in vivo, so implanted product deviated from intended result | Plaintiffs failed to identify a manufacturing deviation from design or other units | Dismissed with leave to amend: allegations describe injury/performance but do not plead a specific manufacturing deviation |
| Design defect (strict liability) | Design caused harmful in‑vivo changes | Strict products‑liability design claim unavailable for prescription/implantable devices under California law | Dismissed with prejudice: strict liability design‑defect claim barred for prescription devices |
| Breach of implied warranty | Plaintiffs relied on Boston Scientific’s representations/skill and thus are in privity | No privity because patient relied on physician’s skill/judgment; allegations lack specific representations or personal reliance | Dismissed with leave to amend: privity/allegations of reliance are too vague; plaintiff may attempt to plead specific representations and reliance |
| Fraudulent / negligent misrepresentation & fraudulent concealment | Boston Scientific marketed and represented device as safe and concealed known risks | Pleading lacks specificity under Rule 9(b): fails to identify who said what, when, where, and how statements were false | Dismissed with leave to amend: fraud‑based claims fail Rule 9(b) but plaintiffs may replead with particularity |
Key Cases Cited
- Carlin v. Superior Court, 13 Cal.4th 1104 (learned intermediary doctrine applies to duty to warn)
- Brown v. Superior Court, 44 Cal.3d 1049 (manufacturer satisfies duty to warn by warning physician)
- Carmichael v. Reitz, 17 Cal.App.3d 958 (rationale for learned intermediary doctrine)
- Barker v. Lull Eng’g Co., 20 Cal.3d 413 (manufacturing defect defined as deviation from intended design)
- Garrett v. Howmedica Osteonics Corp., 214 Cal.App.4th 173 (strict liability design defect unavailable for prescription medical products)
- Blanco v. Baxter Healthcare Corp., 158 Cal.App.4th 1039 (privity and reliance on physician in implantable‑device context)
- Evraets v. Intermedics Intraocular, Inc., 29 Cal.App.4th 779 (implied warranty failed where plaintiff relied on physician’s judgment)
- Ashcroft v. Iqbal, 556 U.S. 662 (federal pleading plausibility standard)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading standard requiring plausibility)
- Kearns v. Ford Motor Co., 567 F.3d 1120 (Rule 9(b) applies to claims grounded in fraud)