187 F. Supp. 3d 1163
S.D. Cal.2016Background
- Plaintiffs sued manufacturers of Onglyza and Kombiglyze (DPP‑4 inhibitors) alleging failure to warn that incretin‑based drugs cause or increase pancreatic cancer risk.
- FDA repeatedly reviewed pancreatic safety for the incretin class (2009, 2012–2014), issued a 2013 safety communication, and published a joint FDA/EMA Assessment in the New England Journal of Medicine (Feb. 27, 2014) concluding current data do not support a causal link and labeling is adequate.
- Defendants moved for summary judgment asserting conflict preemption under Wyeth v. Levine: it would have been impossible to add the pancreatic cancer warning because the FDA would have rejected it.
- Court applied the Wyeth “clear evidence” standard (whether FDA would have rejected a proposed labeling change) and considered the regulatory history, FDA reviews, citizen petition response, and available scientific data through Feb. 27, 2014 (discovery cutoff).
- Court found the FDA’s repeated independent reviews and public statements showing an indeterminate causal link constituted clear evidence the FDA would have rejected a pancreatic cancer label change; summary judgment for defendants granted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Plaintiffs’ failure‑to‑warn claims are conflict preempted under Wyeth’s “clear evidence” test | Wyeth requires a manufacturer to have submitted a proposed warning and an express FDA rejection; absence of such submission defeats preemption | FDA’s repeated independent reviews and public conclusions that evidence is indeterminate show clear evidence FDA would have rejected a pancreatic cancer labeling change, so preemption applies | Held: Conflict preemption applies; defendants met clear evidence standard without having submitted a CBE because the FDA repeatedly concluded data were insufficient and labeling was adequate |
| Whether FDA consideration of the general risk (vs. specific proposed warning language) suffices for clear evidence | FDA must have considered and rejected the specific warning language sought by plaintiffs | Where FDA has directly and repeatedly considered the exact risk alleged (pancreatic cancer) and publicly concluded evidence insufficient, specific proposed language submission is not necessary | Held: FDA considered the exact risk; specific language submission not required to establish clear evidence |
| Whether reference to pancreatitis in labeling undermines preemption for pancreatic cancer warnings | Plaintiffs: presence of pancreatitis warnings suggests FDA would allow pancreatic cancer reference | Defendants: pancreatitis and pancreatic cancer are distinct; FDA treated them separately and found stronger evidence for pancreatitis than cancer | Held: Distinction supports preemption; pancreatitis labeling does not imply FDA would permit cancer labeling |
| Whether plaintiffs should get additional discovery past Feb 27, 2014 | Plaintiffs seek more discovery to rebut preemption and to investigate alleged withholding/misrepresentation | Defendants argue date was set for assessing FDA position at time claims accrued; post‑cutoff data largely irrelevant and Buckman bars using discovery to relitigate FDA conclusions | Held: Denied; cutoff upheld and Buckman/precedent limit the relevance of discovery aimed at undermining FDA’s public conclusions |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (establishes "clear evidence" standard for FDA rejection in conflict preemption of failure‑to‑warn claims)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (presumption against preemption in areas of traditional state regulation)
- Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011) (analyzing scope of FDA consideration required for preemption defense)
- Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (FDA decision not to require a warning weighs in favor of preemption)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (summary judgment standard)