The daughter of an Oregon woman who suffered a fatal cardiac arrest following hemodialysis has filed a wrongful death lawsuit against Fresenius Medical Care, alleging that the company’s GranuFlo and NaturaLyte dialysis treatments caused the sudden heart problems.
The complaint (PDF) was filed by Colleen Coultas in the U.S. District Court for the District of Massachusetts on May 17, indicating that her mother, Shannon Giltner, died in May 2010 due to a cardiovascular event following hemodialysis treatment involving the use of Granuflo and NaturaLyte, which were recalled last year amid reports of hundreds of similar heart attacks and deaths.
Fresenius Medical Care is one of the largest providers of dialysis treatments in the world, not only owning thousands of dialysis clinics but also manufacturing many of the products used at other clinics throughout the United States, including Granuflo and NaturaLyte.
According to allegations raised in the hemodialysis wrongful death lawsuit, Fresenius withheld information about the importance of monitoring patient bicarbonate levels during dialysis treatments involving Granuflo and NaturaLyte, which could increase the risk of hemodialysis patients suffering fatal heart problems, including cardiac arrest, electrolyte imbalances, hypokalemia, hypoxemia, hypercapnia, hypotension, cardiac arrhythmias, stroke, coma or death.
GranuFlo and NaturaLyte Recalls
NaturaLyte and Granuflo are acid concentrates commonly used during hemodialysis at clinics throughout the United States. The products are used along with bicarbonate concentrate to create a bicarbonate dialysate.
According to allegations raised in Coultas’ complaint and dozens of other Fresenius hemodialysis treatment lawsuits filed on behalf of individuals throughout the United States, Granuflo and NaturaLyte convert to bicarbonate at higher-than-expected levels because they contain sodium acetate. However, lawsuits claim that Fresenius withheld this information from doctors and continued to sell the products as safe and effective.
In November 2011, Fresenius issued an internal memo to doctors at their own clinics about the risk of problems with Granuflo and NaturaLyte. However, that same information was not provided to other clinics that used the products and it was not disclosed to consumers or federal health regulators.
According to the memo, an internal analysis of patients treated at 667 Fresenius dialysis clinics in 2010 found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment, often resulting in death.
After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers, which the FDA has classified as a NaturaLyte and Granuflo recall.
Fresenius Hemodialysis Lawsuits
Coultas joins a growing number of families nationwide who are pursuing a wrongful death or heart attack lawsuit against Fresenius over use of Granuflo or NaturaLyte during hemodialysis treatment.
In March, the U.S. Judicial Panel on Multidistrict Litigation issued an order consolidating the federal court Fresenius litigation before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, where the cases will be coordinated during pretrial proceedings as part of an MDL or multidistrict litigation.
According to the latest case list (PDF) released by the U.S. JPML, there were already at least 161 complaints filed in U.S. District Courts throughout the United States that have been transferred into the MDL. In addition, a large number of lawsuits have been filed against Fresenius in Massachusetts state court, which is where the company is headquartered in the U.S.
Fresenius hemodialysis lawyers reviewing potential lawsuits for families throughout the U.S. have indicated that the number of complaints is expected to increase dramatically over the coming months and hundreds, if not thousands, of cases are likely to be filed over problems with Granuflo or NaturaLyte.