Cody Laboratories, Inc. and Lannett Co., Inc. (collectively, "Cody") appealed a district court's dismissal of their action for declaratory judgment against the Food and Drug Administration (FDA). Cody has been manufacturing and distributing morphine sulfate since 2005. At the time Cody filed its complaint, the company had not received FDA approval for its morphine sulfate product. Cody contends that the product falls under the "grandfather clause" of the Food, Drug, and Cosmetic Act (FDCA). The FDA claims that the grandfather clause is exceedingly narrow and applies only to drugs that have been marketed in essentially identical form since 1938. The FDA sent Cody a warning letter in March 2009 stating that Cody's manufacture and distribution of morphine sulfate was in violation of the FDCA. Meanwhile, in August 2009, Roxane Laboratories, Inc., Cody's main competitor, submitted a New Drug Application ("NDA") for its own morphine sulfate product. Following its policy of granting expedited review of an NDA if no approved alternative drug exists, the FDA quickly reviewed and approved Roxane's NDA in January 2010. Cody submitted an NDA for its product the following month. The company's requests for expedited review were denied. Cody brought suit claiming the FDA acted arbitrarily, capriciously and contrary to law in violation of the Administrative Procedure Act by: (1) improperly determining that Cody's product was a "new drug" and thus not entitled to grandfathered status under the FDCA; and (2) treating Cody disparately from Roxane in processing the companies' respective NDAs. The court subsequently dismissed Cody's complaint for lack of jurisdiction, holding that the FDA had yet to complete "final agency action" under section 704 of the APA. Upon review of the record, the Tenth Circuit concluded that one of Cody's claims was mooted by post-judgment events and that Cody failed to exhaust available administrative remedies with respect to its remaining claim. The Court affirmed the district court's dismissal for lack of jurisdiction on the grandfathering claim, and dismissed Cody's disparate treatment claim as moot.
Justia U.S. 10th Circuit Court of Appeals Opinion Summaries
Shortly after Plaintiff Mark Rimbert's father began taking Prozac, he killed his wife and himself. Plaintiff brought a wrongful death action against Defendant Eli Lilly, the manufacturer of Prozac. Defendant moved for summary judgment on various grounds and to exclude the testimony of Plaintiff's sole expert witness on the question of causation. The motions were denied by the district judge initially assigned the case. Once the case was reassigned, Defendant moved for reconsideration. The second district judge granted Defendant's motion to exclude Plaintiff's expert witness. The court then entered summary judgment for Defendant, concluding that without the expert's testimony, Plaintiff had no case. Plaintiff brought this appeal to the Tenth Circuit, arguing that the district court erred by excluding the testimony of his expert. Upon review, the Tenth Circuit affirmed the district court's order excluding the testimony, but reversed the order granting summary judgment. The Court remanded the case for further proceedings.