Seufert
Seufert v. Merck Sharp & Dohme Corp.
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…