Gibbons v. Bristol-Myers Squibb Co.
919 F.3d 699
2d Cir.2019Background
- Bristol-Myers Squibb and Pfizer (both Delaware-incorporated with NY principal places of business) manufacture Eliquis, an FDA-approved anticoagulant that increases bleeding risk and bears warnings.
- Beginning in 2015 plaintiffs filed numerous state-law products-liability suits nationwide alleging excessive bleeding from Eliquis due to design defects and inadequate warnings; many were centralized in an MDL in SDNY (Judge Cote).
- The district court dismissed representative complaints (Utts I and Utts II) holding many failure-to-warn and design claims preempted by federal law or otherwise inadequately pleaded; that reasoning was applied to dismiss numerous other MDL cases.
- A subset of plaintiffs refiled in Delaware state court; defendants removed several of those actions to federal court in Delaware before any defendant had been served and sought transfer to the SDNY MDL. Plaintiffs moved to remand based on the forum-defendant rule.
- The district court denied remand and dismissed the transferred actions for failure to state non-preempted failure-to-warn claims. Plaintiffs appealed the denial of remand and the dismissals; the Second Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether pre-service removal by a home-state defendant is barred by 28 U.S.C. § 1441(b)(2) (forum-defendant rule) | Section 1441(b)(2) prohibits removal because defendants were sued in Delaware (their home state) | Section 1441(b)(2) only bars removal after a home-state defendant has been "properly joined and served," so pre-service removal is permitted | Affirmed: pre-service removal here was proper because §1441(b)(2) applies only after proper service |
| Whether plaintiffs pleaded "newly acquired information" sufficient to show defendants could have unilaterally revised the label under the CBE regulation (avoiding preemption) | Complaints alleged post-approval reports/studies of hemorrhaging, which plaintiffs say constitute newly acquired information | Allegations were conclusory; plaintiff failed to plead that reports revealed risks of different type, greater severity, or greater frequency than known to FDA | Affirmed dismissal: complaints lacked plausible allegations of newly acquired information and thus failure-to-warn claims are preempted |
| Whether the district court improperly relied on materials outside the operative complaints (Utts attachments) when dismissing Fortner and related pleadings | District court relied on Utts attachments not in Fortner, so dismissal was improper | Fortner dismissal rested on Fortner’s own insufficient factual allegations (not on Utts attachments) | Affirmed: dismissal stands because Fortner and related complaints lacked adequate factual pleading regardless |
| Whether other state-law claims (warranty, fraud, consumer-protection) were adequately pled | Plaintiffs contended all claims should survive | Defendants argued those claims were inadequately pleaded or preempted | Court declined to address in detail on appeal because plaintiffs did not meaningfully contest dismissal; lower-court dismissals were not reversed |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturers primarily responsible for labeling but may use CBE to strengthen warnings without prior FDA approval)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (Supremacy Clause preemption where compliance with both federal and state law is impossible)
- Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) (state-law design-defect claims preempted where federal law prohibited the required changes)
- Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147 (3d Cir. 2018) (statutory text of §1441(b)(2) is unambiguous; forum-defendant bar applies only after proper service)
- In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34 (1st Cir. 2015) (to avoid preemption plaintiff must plead a labeling deficiency that could be corrected via the CBE regulation)