226 F. Supp. 3d 166
S.D.N.Y.2016Background
- Plaintiffs Charlie and Ciara Utts (California residents) allege Mr. Utts suffered severe internal bleeding after taking Eliquis (apixaban), a branded anticoagulant manufactured by Bristol‑Myers Squibb and Pfizer.
- Eliquis was FDA‑approved in 2012 based on clinical trials including the international ARISTOTLE study; plaintiffs allege trial misconduct and undisclosed adverse events.
- The approved Eliquis label and Medication Guide warned of bleeding and stated there was no established antidote; the label cited ARISTOTLE safety data.
- Plaintiffs sued (12 causes of action) alleging design defect, manufacturing defect, failure to warn, negligence, breach of warranties, fraud/fraudulent concealment, consumer‑protection violations, and loss of consortium.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6) and 9(b), arguing federal preemption and pleading deficiencies; the court treated California law as controlling for the motion.
- Court dismissed design defect claims with prejudice (preempted), largely dismissed failure‑to‑warn and fraud/warranty/consumer claims (some with leave to amend), and allowed loss of consortium to remain pending amendment of underlying claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of failure‑to‑warn claims against brand manufacturer | Utts: label lacked multiple warnings (e.g., no reversal agent, boxed warning), ARISTOTLE concealed safety data, so state claims survive. | BMS/Pfizer: FDA approved label controls; state claims challenging pre‑approval label are preempted unless based on "newly acquired information" amendable via CBE. | Court: Most failure‑to‑warn claims appear preempted because complaint fails to plead "newly acquired information" permitting CBE; dismissed with leave to amend. |
| Design defect (strict and negligence) | Utts: Eliquis was defectively designed such that risks outweighed benefits. | Defendants: design choices were part of FDA‑approved NDA; altering design required FDA approval -> conflict/preemption. | Court: Strict liability design claim barred by CA law (dismissed with prejudice); negligent design claim preempted as it attacks FDA‑approved formulation -> dismissed with prejudice. |
| Manufacturing defect pleading sufficiency | Utts: product was defective at manufacture. | Defendants: allegations are conclusory; must identify how product deviated from specs. | Court: Manufacturing defect claim inadequately pled; dismissed with leave to amend to plead specific deviations. |
| Fraud / fraudulent concealment / negligent misrepresentation | Utts: defendants concealed safety data from FDA, physicians, and patients and made false representations about safety. | Defendants: fraud‑on‑the‑FDA claims are preempted (Buckman); other fraud claims fail Rule 9(b) specificity requirements. | Court: Fraud claims premised on FDA submissions are preempted and dismissed with prejudice; other fraud claims fail Rule 9(b) and are dismissed with leave to amend. |
| Warranties & consumer‑protection claim | Utts: breach of express and implied warranties; NY consumer‑protection claim alleged. | Defendants: warranty allegations are too vague and may be preempted; NY consumer law claim lacks standing for CA plaintiffs. | Court: Warranty and NY consumer‑protection claims dismissed for deficient pleading (leave to amend); NY consumer claim dismissed with leave to amend if plaintiffs elect to plead under CA law. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (explains CBE regulation and that brand manufacturers may be liable under state law unless changes were impossible under federal law)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (holds state failure‑to‑warn claims against generic manufacturers preempted due to ‘‘sameness’’ requirement)
- Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (holds state design‑defect claims against generic manufacturers preempted where federal law forbids independent design changes)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (preempts state law claims that effectively allege fraud on the FDA)
- Carlin v. Superior Court, 13 Cal.4th 1104 (California standard for prescription‑drug failure‑to‑warn: liability only for risks "known or knowable" at time of distribution)