Seufert

Seufert v. Merck Sharp & Dohme Corp.

Good Law
187 F. Supp. 3d 1163·2016 WL 3369512·2016 U.S. Dist. LEXIS 91837
United States District Court, Southern District of CaliforniaMay 11, 2016Case No.: 13cv2169 AJB (MDD); Seufert: 13cv2169; Lara: 13cv2928; McDaniel: 13cv3191; Gaines: 14cv0056; Marble: 14cv0611; Stovall: 14cv1612; Heindl: 14cv1973; Blazer: 15cv1149; Gibson: 15cv1340; Deihl: 15cv1435; Copeland: 15cv1884; Matthews: 15cv2190; Elosegui: 15cv198California9,427 words

Opinion

Lead Opinion

Honbattaglia, J.

ORDER GRANTING DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT

I. INTRODUCTION

On February 27, 2014, the FDA published the following in the New England Journal of Medicine'.

The publication, titled “Pancreatic Safety of Incretin-Based Drugs—FDA and EMA 2 Assessment,” was prompted by claims that incretin mimetics commonly used to treat type 2 diabetes cause or increase the risk of pancreatic cancer. Plaintiffs raise the same claims in this litigation, alleging Defendants failed to warn of pancreatic cancer risk in product labeling. However, in addition to the FDA’s published assessment of pancreatic safety, the FDA has examined incretin mimetics and pancreatic ■ cancer risk on several occasions. Following each review, the FDA has concluded that evidence of a causal relationship between incretin mi-metics and pancreatic cancer is indeterminate, unsupported by current data, and inconclusive. In light of these findings, clear evidence exists that the FDA would have rejected a reference to pancreatic cancer in incretin mimetic labeling. Thus, it would have been impossible for Defendants to provide' the warning Plaintiffs seek, and" Plaintiffs’ claims are preempted under Wyeth v. Levine, 555…

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