308 F.R.D. 360
D. Colo.2015Background
- Plaintiffs are former DaVita dialysis patients (or relatives) who allege cardiac events (heart attacks, strokes) occurred during or soon after treatments using GranuFlo/NaturaLyte dialysate, which contains higher acetate (converted to bicarbonate) than standard solutions.
- Plaintiffs contend DaVita failed to account for the extra acetate, causing excess bicarbonate, metabolic alkalosis, and increased risk of cardiac events; experts estimated ~1–2% of exposed patients suffered such outcomes.
- FDA issued a Class I recall in March 2012 warning physicians to account for acetate concentration but did not remove the product from the market.
- Plaintiffs moved to certify nationwide classes under Rule 23(b)(2) (injunctive relief) and 23(b)(3) (damages and CCPA), and sought issue certification under Rule 23(c)(4); DaVita opposed certification and challenged standing.
- The court held a two-day evidentiary hearing, found Article III standing problems as to the (b)(2) injunctive class representatives, and concluded class treatment under (b)(3)/(c)(4) was not appropriate because individualized causation issues and choice-of-law differences made class litigation unmanageable and not superior to individual actions.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing for absent class members | Only named plaintiffs must show standing at certification; absent members need not show individual injury | Majority of putative class suffered no injury, so class lacks Article III standing | Court: Only named plaintiffs must show standing; DaVita’s argument about absent members fails as a matter of law |
| Standing for (b)(2) injunctive relief | Plaintiffs sought injunctive relief to obtain patient records/notice; alleged injury: concealment of medical information | Named plaintiffs already know they received GranuFlo, so they lack a continuing or imminent injury required for prospective relief | Court: Named plaintiffs lack standing for (b)(2); denies certification of injunctive class |
| Rule 23(a) prerequisites for (b)(3)/(c)(4) issue class | Common issues (GranuFlo’s effects, DaVita practices, concealment) exist and typicality/adequacy met for those issues | DaVita contends differences in exposure, effect, and individual medical histories defeat commonality/typicality | Court: Finds numerosity, and (for 11 narrowed issues) commonality, typicality, and adequacy are satisfied under Rule 23(a) when limited to (c)(4) issues |
| Predominance / Superiority for (b)(3)/(c)(4) class | Isolate common issues under (c)(4) to materially advance the case and satisfy predominance; class-wide proof available on corporate conduct and GranuFlo properties | Individualized causation, state-law choice-of-law differences, and manageability problems predominate; class litigation would require thousands of mini-trials and multi-state law parsing | Court: Although predominance for the isolated issues could be met, superiority and manageability fail; (c)(4) certification would not materially advance litigation. Denies (b)(3) class certification |
Key Cases Cited
- Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338 (Sup. Ct. 2011) (rigorous Rule 23 commonality analysis requiring common answers)
- Amgen Inc. v. Conn. Retirement Plans & Trust Funds, 568 U.S. 455 (Sup. Ct. 2013) (limits on merits inquiries at certification)
- DG ex rel. Stricklin v. Devaughn, 594 F.3d 1188 (10th Cir. 2010) (standing for named plaintiffs required for prospective relief)
- In re Deepwater Horizon, 739 F.3d 790 (5th Cir. 2014) (discussion of standing at class certification and approaches to absent-members standing)
- Valentino v. Carter-Wallace, Inc., 97 F.3d 1227 (9th Cir. 1996) (Rule 23(c)(4) permits isolation of common issues)
- Garcia v. Medved Chevrolet, Inc., 263 P.3d 92 (Colo. 2011) (CCPA requires causation/reliance analysis; court must rigorously assess whether reliance can be inferred classwide)