524 F.Supp.3d 1007
S.D. Cal.2021Background
- MDL over claims that incretin-based diabetes drugs (Byetta/exenatide; Januvia/Janumet/sitagliptin; Victoza/liraglutide) cause or increase risk of pancreatic cancer; plaintiffs are patients who took these drugs; defendants are Amylin/Lilly, Merck, and Novo.
- FDA monitored pancreatic safety for years, conducted extensive reviews (including a 2014 NEJM Assessment) and formally denied a citizen petition to withdraw Victoza, concluding evidence of a causal link was indeterminate and declining to require pancreatic-cancer labeling.
- After the Ninth Circuit remanded for supplemental discovery, defendants renewed a joint preemption motion and moved for summary judgment for lack of general causation; plaintiffs proffered multiple experts on statistical association, mechanism, and medical causation.
- The court found no “newly acquired information” sufficient to support a CBE label change and concluded defendants had fully informed the FDA and that the agency had effectively rejected adding a pancreatic-cancer warning.
- The court excluded plaintiffs’ key experts (statisticians Madigan and Wells; biological/causation experts Brown, Gale, Landolph, Woolf, Taylor) under Daubert for unreliable or speculative methodologies and failure to consider or update relevant data.
- Because plaintiffs lacked admissible expert evidence on general causation, the court granted summary judgment for defendants on preemption and on lack of general causation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Impossibility preemption / CBE "newly acquired information" | Plaintiffs: defendants did not show they lacked material new safety data; FDA review doesn't preclude state claims. | Defendants: no newly acquired information that would permit unilateral CBE label changes; FDA already evaluated issue. | Court: No newly acquired information; state failure-to-warn claims preempted. |
| Whether FDA clearly would have rejected label change (Albrecht "clear evidence") | Plaintiffs: no agency action carrying force of law; Albrecht limits preemption where manufacturer might seek CBE. | Defendants: FDA Assessment + denial of citizen petition + ongoing inaction after full review show FDA would not approve warning. | Court: FDA communicated it would not approve change; clear evidence supports preemption. |
| Admissibility of plaintiffs’ statisticians (Madigan, Wells) | Plaintiffs: experts show statistical signals/uncertainty supportive of causation theory. | Defendants: cherry-picking, inconsistent inclusion/exclusion criteria, failure to search/update literature -> unreliable. | Court: Excluded Madigan and Wells for unreliable, results-driven methods. |
| Admissibility of biological/medical experts & general causation (Brown, Gale, Landolph, Woolf, Taylor); summary judgment | Plaintiffs: experts provide biological plausibility, weight-of-evidence, latency, and pathological findings to support causation. | Defendants: experts failed to apply accepted methods, did not review/weight contrary data, relied on speculative animal/in vitro extrapolation. | Court: Excluded these experts; without admissible expert proof of general causation, summary judgment for defendants. |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state-law failure-to-warn claims preempted only if there is clear evidence FDA would have rejected proposed label change)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (judge decides “clear evidence” preemption and CBE availability ordinarily prevents impossibility preemption; manufacturers cannot propose changes not based on reasonable evidence)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (impossibility preemption arises when it is impossible to comply with both federal and state requirements)
- Celotex Corp. v. Catrett, 477 U.S. 317 (1986) (summary judgment standard and burdens of production)
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (1993) (district court gatekeeper role on admissibility and reliability of expert testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999) (Daubert gatekeeping applies to all expert testimony)
- Lust v. Merrell Dow Pharm., 89 F.3d 594 (9th Cir. 1996) (general causation in complex toxic tort/pharmaceutical cases requires expert proof)