Harden Manufacturing Corp. v. Pfizer, Inc.
2013 U.S. App. LEXIS 6797
| 1st Cir. | 2013Background
- MDL case on off-label Neurontin marketing by Pfizer; Harden plaintiffs are TPPs seeking class nationwide for bipolar off-label use (1994–2004).
- Court previously decided Kaiser and Aetna; Harden appeal focuses on off-label bipolar claims only.
- District court granted Pfizer summary judgment on causation for Harden; denied class certification for bipolar subclass.
- Rosenthal regression analysis used to prove aggregate causation; district court found reliance must be individual.
- Kaiser findings are integrated and guide proximate/but-for causation and class standards on appeal.
- We review summary judgment de novo and remand for state-law issues and class rulings based on Kaiser framework.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proximate causation under RICO for Harden claim | Harden shows direct, foreseeable injury from Pfizer's fraud. | Doctors’ independent judgments break causal chain; attenuation present. | Causation not too attenuated; facts support plausible proximate causation. |
| But-for causation with aggregate evidence | Rosenthal plus circumstantial evidence prove but-for causation without doctor-by-doctor reliance. | Need individualized doctor reliance; aggregate proof insufficient. | Rosenthal analysis can prove but-for causation at summary judgment. |
| Injury and injury causation under RICO | Clinical trial evidence shows Neurontin ineffective for bipolar; injury shown. | Injury depends on individual prescription effectiveness; contested. | Injury issue raises genuine fact for jury; not defeated by aggregation alone. |
| Class certification viability for bipolar subclass | Common evidence shows causation/damages; class manageable with aggregate data. | Granular doctor-by-doctor analysis required; class unmanageable. | Vacated denial of class certification; remanded for further proceedings. |
Key Cases Cited
- Bridge v. Phoenix Bond & Indem. Co., 553 U.S. 639 (2008) (proximate causation factors in RICO context)
- Holmes v. Securities Investor Protection Corp., 503 U.S. 258 (1992) (proximate causation and causal relation standard)
- Anza v. Ideal Steel Supply Corp., 547 U.S. 451 (2006) (direct relation and causation scope in RICO)
- Hemi Grp., LLC v. City of New York, 130 S. Ct. 983 (2010) (standing and causation considerations in RICO context)
- UFCW Local 1776 v. Eli Lilly & Co., 620 F.3d 121 (2d Cir. 2010) (quantity-effect vs. excess-price theory in pharmaceutical marketing)