Lawsuits Filed Over Heart Problems, Deaths Following Dialysis Treatments

An influx of Fresenius dialysis treatment lawsuits have been filed in the federal court system over the past week, following a decision by a panel of judges to centralize and consolidate the litigation before one judge.

On Thursday and Friday of last week, at least 12 new lawsuits were filed over injuries and wrongful death caused by Fresnius’ Granuflo and Naturalyte dialysis treatments.

The complaints involve nearly identical allegations to those raised in more than 100 other lawsuits filed throughout the country, indicating that plaintiffs or their family members suffered cardiac arrest, heart attacks and other heart problems following hemodialysis where Granuflo or NaturaLyte were used.

Some of the recently filed complaints involve dialysis treatment deaths occurred as far back as 2005, which highlights the far-reaching scope of the litigation that may eventually be filed against Fresenius Medical Care as families learn that the death of a loved one may have been caused by the use of the now recalled Granuflo and NaturaLyte dialysate solutions.

Fresnius Dialysis Litigation

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.

Over the past decade, many individuals undergoing hemodialysis treatment received NaturaLyte, a liquid acid concentrate, or GranuFlo, a dry acid concentrate.  Both products were recalled last year amid warnings that individuals were suffering sudden cardiac arrest or death during treatments involving the products.

Granuflo and Naturalyte both contain sodium acetate, which converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in lawsuits filed throughout the United States. Plaintiffs claim that Fresenius knew or should have known about the importance of doctors monitoring patients’ bicarbonate levels during dialysis treatments, but withheld that information and continued to sell the products.

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.

According to an internal analysis of patients treated at 667 Fresenius dialysis clinics in 2010, the company found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment. 

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.

Following a hearing late last month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued an order consolidating all Fresenius GranuFlo and NaturaLyte lawsuits under U.S. District Judge Douglas P. Woodlock in federal court in Massachusetts. Such consolidation is designed to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of the witnesses, parties and the courts.

At the time the Fresenius dialysis litigation was centralized, there were 119 complaints filed in 16 different U.S. District Courts throughout the United States. However, lawyers reviewing potential claims expect that the number of lawsuits will increase dramatically over the coming months, as additional lawsuits are reviewed and filed in the federal court system.