Utts v. Bristol-Myers Squibb Co.
251 F. Supp. 3d 644
S.D.N.Y.2017Background
- Plaintiffs Charlie and Ciara Utts sued Bristol‑Myers Squibb and Pfizer alleging Eliquis (apixaban) caused severe gastrointestinal bleeding and that labeling failed to warn adequately about bleeding, monitoring, dosing, and the absence of an antidote.
- Eliquis is a NOAC approved by the FDA in 2012; its FDA‑approved label repeatedly warns of serious bleeding, notes lack of a specific antidote, provides dosing guidance and cautions about concomitant therapies, and states routine coagulation tests are not useful for monitoring.
- The Second Amended Complaint (SAC) relied on nine external reports/articles (e.g., ISMP QuarterWatch, BMJ, Thrombosis Journal) to allege the label omitted material safety information; plaintiffs narrowed claims in opposition to focus on monitoring, reversal guidance, and dosing tailoring.
- Defendants moved to dismiss under Rules 12(b)(6) and 9(b), arguing state‑law failure‑to‑warn, warranty, fraud, consumer‑protection, negligence, and design claims are federally preempted or fail as a matter of law/pleading.
- The court held the SAC’s cited materials do not constitute “newly acquired information” under FDA CBE regulations, so plaintiffs cannot rely on a CBE‑based theory to avoid preemption; alternatively, the court found the FDA‑approved label adequate as a matter of law and fraud/consumer claims fail Rule 9(b).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of state failure‑to‑warn claims | Utts: secondary literature and adverse‑event data show undisclosed risks/new information justifying label changes (CBE) | BMS/Pfizer: cited materials are not "newly acquired information" under 21 C.F.R. § 314.3(b); thus state claims are preempted | Court: Plaintiffs failed to show newly acquired information; claims preempted and dismissed |
| Adequacy of FDA‑approved label (failure to warn) | Utts: label should require/advise closer monitoring, provide reversal strategy guidance, and offer individualized dosing | Defs: label already discloses bleeding risk, no antidote, dosing adjustments, and monitoring limits; literature does not identify concrete omitted warnings | Court: Label adequately and unambiguously warned of bleeding risks, lack of antidote, dosing, and monitoring limits; claims fail on merits |
| Fraud / fraudulent concealment / negligent misrepresentation (Rule 9(b)) | Utts: defendants misrepresented ARISTOTLE and omitted data in labels, dosing guidance, website, and ads | Defs: claims challenge FDA‑reviewed statements; allegations are conclusory and lack particularity required by Rule 9(b) | Court: Fraud‑based claims preempted where premised on fraud‑on‑FDA; otherwise dismissed for failure to plead with particularity |
| Consumer protection and warranty claims (California UCL, FAL, CLRA) | Utts: advertising and label omissions were misleading/false and breached warranties | Defs: advertising and label statements are consistent with FDA‑approved labeling and the cited literature does not contradict them; many claims amount to preempted design or failure‑to‑warn theories | Court: Consumer and warranty claims preempted or insufficiently pleaded; dismissed |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (manufacturer primarily responsible for labeling but preemption analysis allows CBE pathway)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (preemption principles re: labeling and manufacturer authority)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (state law fraud‑on‑FDA claims preempted)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading must state a plausible claim)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility standard for complaints)
- Galper v. JP Morgan Chase Bank, N.A., 802 F.3d 437 (on preemption at motion to dismiss stage; view facts favorably to plaintiff)