Drug & Device News

A U.S. District Court judge sitting in Los Angeles dismissed an off-label drug promotion multi-district litigation on Dec. 17, 2008. The suit claimed that Amgen Inc., Da Vita Inc. and Fresenius Medical Care Holdings Inc. pushed doctors to use the anemia drugs Epogen and Aranesp to treat people with kidney disease, cancer and HIV even though the drugs are not approved for those uses. Judge Pillip Gutierrez ruled in In re Epogen & Aranesp Off-Label Mktg. and Sales Practices Litig., MDL08-1934 (ARG) (C.D. Calif.), that the seven plaintiff health-benefits plans could not sue the defendant drug companies using federal racketeering laws or state unfair business practices laws. The court determined the suit was barred because the Federal Food and Drug Administration has exclusive jurisdiction over enforcement of the rules against promoting off-label drug uses. “Allowing plaintiffs to proceed on a theory that defendants violated RICO by engaging in off-label promotion, without specific allegations that defendants made false or misleading statements, would, in effect, permit plaintiffs to use RICO as a vehicle to enforce the FDCA [Food, Drug and Cosmetic Act] and the regulations promulgated thereunder,” wrote the court. Justice Gutierrez did, however, leave it open for the plaintiffs to amend their suit to keep it alive, although it was not clear on what basis this could be done.

Following the dismissal, Amgen attorney Mark Cheffo, of Skadden Arps Slate Meagher & Flom in New York, said, “The judge is not letting insurers second-guess medical providers across the country. I think he also respected the FDA's role and was not going to allow judges and juries to make decisions around the United States that are inconsistent with the FDA.”