Here Come the Feds: Fresenius Subpoenaed Over GranuFlo and NaturaLyte

Fresenius Medical Care has acknowledged receiving a subpoena over its dialysate concentrate products NaturaLyte and Granuflo. Hundreds of plaintiffs are filing lawsuits against the company alleging that these products caused serious harm to patients, specifically by inducing cardiac arrest.

But civil lawsuits are not the only aspect of Fresenius’ problems; the United States Attorney’s Office for the District of Massachusetts has subpoenaed the company requesting all documents related to GraunFlo and its recall. The subpoena was served to Fresenius on December 7, 2012.

Notably, this isn’t Fresenius’ first encounter with the federal government. The company was subpoenaed back in April 2005 by the United States Attorney for the Eastern District of Missouri, requesting documents relating to a drug called Epogen. The company fought the subpoena tooth and nail, moving to quash the subpoenas in the district court. Fresenius then appealed when the district court refused to quash the subpoenas. It lost again in the appellate court. The company was also subpoenaed by the U.S. Attorney’s Office for the Eastern District of New York in October 2004.

It will be interesting to see whether Fresenius can justify its claim that they are “cooperating fully” with the subpoena request from the U.S. Attorney’s Office. One thing is clear; the company has quite the history of getting the Department of Justice’s attention and scrutiny.