In re: Avandia Marketing v., 945 F.3d 749

Background

FDA approved Avandia (rosiglitazone) in 1999; GSK marketed it as controlling blood sugar and as having cardiovascular benefits vs. older, cheaper drugs, prompting health plans to cover its higher cost.
Meta-analyses and the Nissen study (2006–2007) raised signals of increased myocardial ischemic events; GSK submitted a Prior Approval Supplement to change labeling.
In June 2007 the FDA found GSK’s supplement “not approvable” as submitted, requested more data, and later directed GSK to add black‑box warnings for congestive heart failure and myocardial ischemic risk; label text was revised again in 2011 and 2014.
Plaintiffs (two health benefit plans) sued claiming GSK fraudulently marketed Avandia and concealed cardiovascular risks, violating state consumer‑protection laws and RICO; they alleged they paid more to cover Avandia because of claimed cardiovascular benefits.
The District Court granted summary judgment for GSK, holding state‑law claims preempted by the FDCA (impossibility), finding no distinct RICO enterprise, and refusing to consider plaintiffs’ "benefits" theory as belated.
The Third Circuit reversed (as to state‑law claims), vacated (as to RICO), and remanded: preemption was not established under Merck; RICO judgment was premature without discovery; and the benefits theory was timely.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
FDCA impossibility preemption (Wyeth/Merck)	State consumer‑protection claims are not preempted because GSK cannot show FDA would have forbidden the label change.	FDA rejected GSK’s supplement, advised against CBE, and later concluded no increased CV risk—so federal law preempts.	Reversed: GSK failed Merck’s two‑prong test—did not show it "fully informed" the FDA and that the FDA affirmatively told it the warning would be disapproved.
Availability/effect of CBE and timing of data	GSK could have warned earlier (or at least the CBE was not barred); plaintiffs allege omissions perpetuated marketing of CV benefits.	GSK lacked necessary new data before mid‑2006 and was effectively advised not to use CBE.	GSK’s CBE/CBE‑advice arguments insufficient; informal FDA calls and boilerplate in the Letter do not satisfy Merck preemption standard.
RICO — distinct enterprise & discovery	Plaintiffs needed discovery to prove an enterprise distinct from GSK and other RICO elements; denied discovery under Rule 56(d) was reversible error.	No distinct enterprise: GSK itself was both person and enterprise; summary judgment appropriate.	Vacated: district court abused discretion by granting summary judgment without addressing plaintiffs’ Rule 56(d) declarations and denying discovery on enterprise.
Timeliness of marketing‑as‑benefit theory	Plaintiffs consistently alleged GSK marketed Avandia as providing superior cardiovascular outcomes; the theory is part of the original pleadings.	District Court deemed the benefits theory belated and refused to consider it at summary judgment.	Reversed: the benefits theory was timely and must be considered on remand.

Key Cases Cited

Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (clarified Wyeth: "clear evidence" requires manufacturer fully informed FDA and FDA informed manufacturer it would not approve label change)
Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturer has duty to warn; FDCA does not preempt state‑law failure‑to‑warn claims absent clear evidence)
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (possibility of impossibility is insufficient to establish federal preemption)
Reeves v. Ernst & Young, 507 U.S. 170 (1993) (RICO requires a distinct enterprise separate from the defendant)
Shelton v. Bledsoe, 775 F.3d 554 (3d Cir. 2015) (district court must consider properly filed Rule 56(d) declarations before granting summary judgment)
In re Avandia Mktg., Sales Practices & Prod. Liab. Litig. (Avandia I), 804 F.3d 633 (3d Cir. 2015) (prior interlocutory decision on standing and Rule 12(b)(6) survival)