621 F. App'x 401
9th Cir.2015Background
- Weber sued after silicone-gel breast implants allegedly caused symptoms and were removed; she filed a second amended complaint that the district court dismissed under Fed. R. Civ. P. 12(b)(6).
- The district court concluded Weber’s pleaded facts were not plausible under the Twombly/Iqbal standard.
- At oral argument Weber identified additional factual allegations she could plausibly plead (mass/volume loss, presence of manganese, symptoms inconsistent with mere idiosyncratic reaction).
- Weber also identified the manufacturing and FDA-related standards she contends were violated, invoking parallel state-law claims tied to federal device standards.
- The Ninth Circuit found amendment would not necessarily be futile and directed the district court to allow further leave to amend.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the complaint as pleaded met Rule 12(b)(6) plausibility standards | Weber contends facts (implant mass loss, manganese presence, symptom severity) support plausible design/manufacturing defect and excessive gel bleed | Allergan argued pleadings were too conclusory and did not plausibly show excessive gel bleed or manufacturing violations | Complaint as pleaded was insufficient under Twombly/Iqbal, but identified additional specific allegations that would make claims plausible |
| Whether amendment should be allowed or would be futile | Weber can allege specific facts (2.8% mass loss vs. 1% expected, manganese as manufacturing relic, symptoms inconsistent with idiosyncratic reaction) and the FDA-related standards she relied on | Allergan implied leave to amend would be futile because present allegations fail to state a claim | Court held amendment should be allowed; remanded for district court to consider further leave to amend (amendment not necessarily futile) |
Key Cases Cited
- Eclectic Props. E., LLC v. Marcus & Millichap Co., 751 F.3d 990 (9th Cir. 2014) (pleading must be plausible under Twombly/Iqbal)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (established plausibility standard for complaints)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (applied and clarified Twombly plausibility framework)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (discussed use of federal device-regulation standards in parallel state-law claims)
- Foman v. Davis, 371 U.S. 178 (1962) (standards governing leave to amend pleadings)