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GranuFlo Lawsuit Filed Over Dialysis-Related Death

Granuflo DialysisAnother GranuFlo lawsuit has been filed over a death allegedly related to recalled dialysis products. The recent case (# 15-cv-11668) was filed on April 22, 2015 in the U.S. District Court, District of Massachusetts. The complaint names “Debra Phelps, personal representative of Estate of William Cox, Deceased” as the plaintiff. Mr. Cox, an Arizona resident, died on April 23, 2013, purportedly in connection to the dialysis treatment he was receiving at Banner Boswell Medical Center in Sun City.

The lawsuit was filed using the short-form complaint that allows for direct inclusion into the multidistrict litigation (MDL No. 1:13-MD-2428-DPW, In Re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation) now taking place in Massachusetts. It does not name a specific cause of death; however, the hundreds of lawsuits filed against defendants Fresenius Usa, Inc., et al that have been consolidated as part of the MDL related to plaintiffs who suffered heart attacks in connection with GranuFlo or NaturaLyte products, as detailed in the master complaint form which the short form references.

Recent GranuFlo lawsuit is one of close to 3,000

More than 2,700 GranuFlo or NaturaLyte lawsuits have been consolidated as part of the Massachusetts MDL over which U.S. District Judge Douglas P. Whitlock presides. The Granuflo MDL was created following a class I FDA recall for the products in 2012 and the filing of multiple lawsuits over the products that shared similar allegations.

Fresenius, a company based in Germany, also supplies several medical centers in the U.S. responsible for the treatment of over one third of the approximately 400,000 dialysis patients in this country, with their dialysis products. Complaints allege that patients suffered cardiac arrest, and sometimes death (as in the case of Mr. Cox) during kidney dialysis because the use of Fresenius brand products resulted in excess bicarbonate production during treatment, a problem which the defendants did not disclose.

An internal memo circulated in 2012 indicated that officials in the company were aware of the problems with disproportionate bicarbonate production, noting 941 cases in which patients suffered heart attacks while receiving dialysis treatment at their medical centers. However, although they informed their own centers of the problem, they did not alert U.S. users of the elevated risks involved with their products if used as directed. The FDA issued their recall after the memo was leaked.

Preliminary bellwether trials to begin in 2016

Preliminary (or “bellwether”) lawsuits involving GranuFlo and NaturaLyte products are slated to begin in 2016. Currently, representative parties are meeting to discuss the discovery phase for the trials, a representative choice of lawsuits, and other procedural matters. Ten bellwether lawsuits will be chosen.

The bellwether trials are meant to serve as indications of how juries might respond to the evidence presented in hundreds of other similar cases. Such lawsuits are intended to avoid duplication or conflicts and to push the parties toward resolution of all pending claims through large scale settlements.

All lawsuits that are part of the MDL claim that Fresenius’ products were directly responsible for the heart attacks and deaths suffered by patients during dialysis and that, furthermore, the company provided insufficient warning regarding their products’ risks. The company only provided information about such risks to non-Fresenius clinics using their products in March of 2012, following the leak of the memo.

  1. US District Court, District of Mass, MDL2428: In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation

  2. NY Times, Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry