Teva Pharmaceuticals USA, Inc. v. Superior Court
158 Cal. Rptr. 3d 150
Cal. Ct. App.2013Background
- Pikerie suffered a left femur fracture allegedly related to Fosamax/alendronate use from 2006–2011.
- Brand-name Fosamax label was updated in 2010–2011, but the generic alendronate labels allegedly did not match those updates.
- Generics defendants Teva, Barr, Barr Labs, Mylan, Caraco, Sun, and NorthStar manufactured/allegedly marketed alendronate sodium.
- Trial court overruled demurrer, holding non-preempted claims could proceed; defendants sought writ relief.
- Court analyzes federal preemption, concluding the claims are not preempted because updating labels to match the brand label was possible and required by federal law.
- Petition denied; real party in interest to recover costs; the decision follows Mensing, Wyeth, Buckman, and Fulgenzi line of authority.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the complaint states non-preempted failure-to-update claims. | Pikerie alleges labels for generics did not match updated RLD labels. | Teva argues preemption under Mensing controls. | Not preempted; claims survive demurrer. |
| Whether failure-to-communicate warnings to professionals is preempted. | Warnings to physicians/Dear Doctor letters could be adequately provided. | Such communications would require sameness with RLD labels; preempted under Mensing. | Not preempted; summary considerations align with updating labels. |
| What is the controlling preemption framework for these claims (Mensing, Wyeth, Buckman)? | State tort duties can coexist with federal labeling requirements. | Some claims conflict with federal sameness requirements. | Court adopts Fulgenzi-like reasoning; Buckman inapplicable to these label-based claims. |
Key Cases Cited
- Mensing, Inc. v. PLIVA, Inc., 131 S. Ct. 2567 (Supreme Court 2011) (impossibility preemption where generic labels must match brand labels)
- Wyeth v. Levine, 555 U.S. 555 (Supreme Court 2009) (state tort warning duties not preempted when brand may comply with federal law)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (Supreme Court 2001) (fraud-on-the-FDA claims preempted; not applicable to pure labeling duties)
- Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013) (impossibility preemption not applicable where label updates could satisfy both duties)