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Lawsuit Alleges Heart Injury Death from Naturalyte

Fresenius Medical Care logoA NaturaLyte lawsuit alleging heart injury was filed on July 1 of this year on behalf of a decedent who experienced a “severe adverse cardiovascular event” while receiving dialysis treatment at a Fresenius clinic.

According to the complaint, Marshall Russell Phillips was stricken on July 7, 2012 while undergoing treatment at a clinic in Brandon, MS that used NaturaLyte and/or GranuFlo dialysis products. The complaint alleges that the heart injury resulted from the use of these products, which have been implicated in heart attack deaths in hundreds of other lawsuits.

Case 1:15-cv-12872 was filed using the short complaint form and will join the previously established multidistrict litigation (MDL No. 2428, In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation) which is designed to expedite trials for the growing number of related lawsuits. While Mr. Phillips and his wife Nellie, who survives him, were residents of Mississippi, the MDL has been established in a Massachusetts court.

NaturaLyte heart injury lawsuit

The lawsuit filed on behalf of the Phillips estate joins a growing number of complaints concerning the allegedly undisclosed heart heart attack risks posed by NaturaLyte and GranuFlo dialysis products as they were used during the treatment of thousands of patients in the U.S.

As early as 2012, officials for the German company Fresenius (manufacturers of the products who also run hundreds of dialysis clinics) were aware that there were potentially fatal problems with NaturaLyte and GranuFlo when used as directed. The products produced a disproportionately high amount of bicarbonate, a feature linked to higher rates of cardiac arrest and sometimes resultant death. A memo circulated within the company that year reported 941 heart attack reports associated with patients receiving treatment at Fresenius centers.

While the company alerted their own clinics regarding the problem, they did not disclose the risks to other clinics which also used their products. A whistle-blower leaked the contents of the memo, however, and the FDA subsequently issued a Granuflo and Naturalyte recall upon learning of the heart risks.

Fresenius responsible for thousands of dialysis patients

Fresenius Medical Care is responsible for over one third of the approximately 400,000 dialysis patients in the U.S., either through their own clinics or through the products they supply to other clinics. The number of lawsuits filed concerning their products, which allegedly resulted in heart attack deaths, has climbed steadily since the FDA recall in 2012 to the point where the court system approved the creation of the Massachusetts MDL. The close to 3,000 currently pending complaints to be heard in the District Court of Massachusetts, in Boston, will be processed together as part of the MDL in hopes of encouraging a large-scale settlement.

U.S. District Judge Douglas P. Whitlock presides over the Granuflo MDL and has initiated the process for choosing preliminary (or “bellwether”) lawsuits that will serve as representative cases to determine potential jury reactions to the evidence presented. Such trials are expected to begin in 2016.

  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