Fresenius Opposes GranuFlo Plaintiffs’ Motion to Turn over Docs Unrelated to Dialysis Drug

Published on August 13, 2014 by Sandy Liebhard

Plaintiffs involved in a federal GranuFlo litigation have asked Fresenius to turn over all documents pertaining to a corporate integrity agreement it entered more than a decade ago, whether or not they involved the dialysis medication, according to recent reports.

The agreement, which Fresenius Medical Care entered with the U.S. Department of Health and Human Services’ Office of Inspector General in 2000, related to a company it acquired in 1996 that filed false claims for reimbursement from healthcare programs.

Fresenius argued that producing all information related to the agreement, which expired in 2008, does not relate to NaturaLyte and GranuFlo lawsuits over two acid concentrates that have been associated with sudden cardiac death, cardiopulmonary arrest, strokes and other serious heart problems.

Request for Docs Not Related to GranuFlo Should Be Denied, Fresenius Says

According to court documents, Fresenius said the plaintiffs’ request “should be denied because those documents are wholly irrelevant to any issue in this case and will not lead to the discovery of admissible evidence.”

The defendant instead offered to produce all documents exchanged between Fresenius and the Office of Inspector Attorney General that involves GranuFlo, NaturaLyte and other acid concentrates.

In citing the reasons for its request, plaintiffs say any possible violation from the company in its past corporate integrity agreement may be grounds for punitive damages in their dialysis lawsuits.

Fresenius filed a separate motion on July 31st that opposed a request that they produce hard copies of all medical records for 941 patients that died after dialysis treatments aided by GranuFlo and NaturaLyte. These casualties were mentioned in an internal memo sent by Fresenius in November 2011 that warned doctors to adjust dosages of the medications, and was later discovered by the U.S. Food and Drug Administration (FDA).  These patient deaths were studied by Fresenius’ former chief medical officer, who found a link between cardiopulmonary arrest and their exposure to GranuFlo and NaturaLyte.

Following revelations related to GranuFlo and NaturaLyte, the FDA issued a Class I recall of the dialysis medications that warned of their alleged potential to cause serious heart problems.

A total of 1,942 lawsuits against Fresenius have now been filed in Massachusetts federal court, according to court documents.

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