Attempts to Outsmart the FDA Could Lead to Mass Torts.

The article discusses the court case United States v. Valor Medical, Inc. wherein the biomedical-device manufacturer Valor Medical Inc. and its officials are facing trial on alleged violations of the U.S. Federal Food, Drug, and Cosmetic Act in the U.S. District Court for the Southern District of California. It mentions that Valor withheld two animal studies from investigational device exemption (IDE) application of the U.S. Food and Drug Administration (FDA).