207 F. Supp. 3d 1133
S.D. Cal.2016Background
- Plaintiffs Dina Andren and Sidney Bludman sued Alere entities over INRatio and INRatio2 home INR testing kits, alleging the devices produced clinically significant inaccurate INR results that caused injuries.
- Plaintiffs contend Alere advertised the devices as “accurate,” “reliable,” and “safe,” but omitted that the devices produced erroneous INR values; they allege FDA inspections, warning letters, and later Class I recalls.
- Plaintiffs bring claims under the CLRA, California UCL, common-law fraud (fraudulent omissions/misrepresentations), and unjust enrichment; all claims are premised on a uniform course of fraudulent conduct.
- Defendants moved to dismiss for failure to plead fraud with particularity under Fed. R. Civ. P. 9(b), and sought judicial notice of several documents (including a User Guide and a 510(k) summary).
- The court denied judicial notice for the User Guide and 510(k) contents (but took notice of other public records), held Plaintiffs’ fraud-based claims failed Rule 9(b) particularity requirements for both affirmative misrepresentations and omissions, dismissed all claims with leave to amend, and discussed the learned-intermediary doctrine and unjust enrichment.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Judicial notice of User Guide and 510(k) contents | Defendants may rely on these documents to show disclosures and negate omissions | Documents are outside the complaint and contents are disputed; User Guide not authenticated | Denied as to User Guide and 510(k) contents; other public records judicially noticed |
| Sufficiency of misrepresentation allegations under Rule 9(b) | Plaintiffs alleged they relied on Alere’s marketing/packaging stating devices are accurate/reliable and cited web material | Plaintiffs fail to specify who made what statement, when/where Plaintiffs saw it, and which statements they relied on | Dismissed: misrepresentation-based claims fail Rule 9(b) for lack of particularity |
| Fraudulent-omission duty to disclose | Plaintiffs allege Alere had exclusive knowledge and actively concealed discrepant results | Defendants say there was no duty because facts were public (FDA letters, publications, recalls) and no specific concealment pleaded | Dismissed: omissions claims fail Rule 9(b) because no pleaded duty to disclose or specific active concealment |
| Unjust enrichment and remedy posture | Plaintiffs seek restitution | Defendants contend other claims fail so unjust enrichment cannot stand alone | Dismissed (unjust enrichment dependent on viable underlying claims); court grants leave to amend |
| Learned intermediary doctrine (duty to warn) | Plaintiffs argue devices may be available without prescription so doctrine may not apply | Defendants invoke learned-intermediary defense for medical device warnings to physicians | Court: issue depends on pleadings—Plaintiffs should clarify prescription status; doctrine may bar claims if physician was the intermediary |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for pleadings)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must be plausible, not merely conceivable)
- Lee v. City of Los Angeles, 250 F.3d 668 (9th Cir. 2001) (limits on considering materials outside the complaint; judicial notice of public records)
- Kearns v. Ford Motor Co., 567 F.3d 1120 (9th Cir. 2009) (Rule 9(b) applies to CLRA and UCL claims grounded in fraud; must plead who, what, when, where, how)
- Vess v. Ciba-Geigy Corp., 317 F.3d 1097 (9th Cir. 2003) (claims sounding in fraud require Rule 9(b) particularity)
- Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004) (learned intermediary doctrine and causation for failure-to-warn claims)
- Plenger v. Alza Corp., 11 Cal.App.4th 349 (1992) (California application of learned intermediary for medical devices)
- Mirkin v. Wasserman, 5 Cal.4th 1082 (1993) (limits on presumption of reliance from securities law in California fraud law)