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# California Appeals Court Reverses Drug Preemption Case
- URL: https://www.fdaweb.com/california-appeals-court-reverses-drug-preemption-case/
- Published: 2018-11-14T12:00:00.000Z
- Updated: 2026-09-15T00:44:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142823

A California Court of Appeals has [reversed](https://scholar.google.com/scholar%5Fcase?case=5365735435581567254&hl=en&as%5Fsdt=6&as%5Fvis=1&oi=scholarr&ref=fdaweb.com) a lower court ruling that cases claiming that manufacturers of incretin-based drugs failed to warn consumers that the drugs increase the risk of developing pancreatic cancer were preempted. The lower court had agreed with the manufacturers (Amylin Pharmaceuticals for its Byetta, Lilly for its Victoza, and Merck for its Januvia and Janumet) that the plaintiffs’ failure-to-warn claims were preempted by federal law.

But the appeals court said it agreed with the 9th Circuit Court of Appeals, which heard federal cases on the same issue, that the trial court erroneously interpreted the Supreme Court’s decision in *Buckman* to preclude consideration of scientific evidence that FDA had not previously evaluated.

The state court said the plaintiffs raised the same two arguments that the federal plaintiffs asserted in their appeal to the 9th Circuit: **(1)** the companies failed to present clear evidence that FDA would have rejected a changes being effected application seeking to add a warning for pancreatic cancer, and **(2)** *Buckman* does not preclude consideration of the plaintiffs’ new safety evidence.

The state appeals court says it agrees with the 9th Circuit that *Buckman* does not preclude consideration of the plaintiffs’ new safety evidence. It sent the case back to the lower court for further proceedings.