Dialysis Wrongful Death Lawsuit Filed Over Granuflo, Naturalyte Solutions

A Texas woman has filed a lawsuit against Fresenius USA, alleging that side effects of GranuFlo and NaturaLyte solutions caused her husband to die following hemodialysis. 

The complaint (PDF) was filed by Emma Hernandez, of Lubbock, Texas, in U.S. District Court for the District of Massachusetts on January 14, on behalf of herself and her deceased husband, Santos Pena Hernandez.

According to allegations raised in the dialysis solution wrongful death lawsuit, Hernandez died on January 17, 2011, after suffering a cardiac arrest following dialysis treatments involving the Granuflo or Naturalyte solutions manufactured and sold by Fresenius.

Hernandez, 68, underwent hemodialysis treatment involving the use NaturaLyte and GranuFlo solutions on January 16, 2011, at the Kidney Disease Associates Dialysis Center. The next day he complained that he felt bloated and did not feel well. Then on January 17, he awoke at 2:30 A.M. and tried to get dressed. He told his wife he had a headache and then clutched at his heart, the lawsuit claims.

Emma Hernandez began calling 911 after her husband began to spit up white saliva. However, by the time the ambulance arrived, Santos Hernandez was already dead.

Lawsuit Claims “Epidemic” of NaturaLyte, GranuFlo Wrongful Deaths

Fresenius medical care faces a growing number of similar wrongful death lawsuits over Granuflo and Naturalyte dialysis solutions, which have been linked to an increased risk of cardiac arrest when bicarbonate levels are not closely monitored during hemodialysis. The complaints allege that Fresenius failed to adequately warn about the risks associated with Granuflo and Naturalyte or inform doctors about the importance of closely monitoring bicarbonate levels while using the solutions.

“Mr. Hernandez’s injury and death, like those striking thousands of similarly situated victims across the country, were avoidable tragedies,” according to the complaint filed by Emma Hernandez. “GranuFlo and NaturaLyte have been implicated in a national epidemic of deaths of dialysis patients.”

The complaint accuses Fresenius of negligence, negligent misrepresentation, fraud, strict liability, failure to warn, breach of warranty, deceptive trade practices, and wrongful death. Emma Hernandez seeks compensation for mental anguish, economic losses, and the value of Santos Hernandez’s life, including expected income, services, protection, care, comfort and companionship.

Fresenius Dialysis Solution Problems

Fresenius is the largest provider of dialysis services and products in the world, owning thousands of dialysis clinics and manufacturing many of the products used during treatment at clinics owned by other companies, including machines, dialyzers, blood lines, needles and dialysis concentrates.

NaturaLyte is a liquid acid concentrate and GranuFlo is a dry acid concentrate.  Both products contain sodium acetate that allegedly converts to bicarbonate at higher-than-expected levels for most doctors, according to allegations raised in the Fresenius dialysis treatment lawsuits. 

Plaintiffs indicate that Fresenius’ failure to disclose the risks associated with their products have caused thousands of individuals to suffer a cardiac arrest during dialysis treatments in recent years.

In November 2011, Fresenius issued a detailed internal memo to their own clinics, warning about the risk of problems with Granuflo and NaturaLyte used during hemodialysis.  However, the same warnings and information about the risk of heart attacks among dialysis patients receiving the solutions was not provided to non-Fresenius clinics until March 2012.  The FDA has classified those warnings as a class I recall for Granuflo and NaturaLyte dialysate solutions.

In response to the mounting litigation against Fresenius, a motion was filed late last year to consolidate all federal lawsuits before one judge as part of an MDL, or multidistrict litigation. The U.S. Judicial Panel on Multidistrict Litigation is expected to hear oral arguments on the motion in March 2013.