Karina Basso  |  June 11, 2014

Category: Legal News

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GranuFlo heart attackAlabama resident Olivia Carolyn Carr has filed a GranuFlo lawsuit against Fresenius Medical Care and its subsidiaries for producing and selling the product that allegedly caused her husband, Benny Douglas Carr, severe cardiac problems leading to his death.

Mr. Carr was a dialysis patient who had been given GranuFlo by his healthcare provider as part of his kidney dialysis treatment. On May 22, 2008, Mr. Carr allegedly experienced adverse cardiovascular activity following his dialysis treatment. Mr. Carr is survived by his wife who is pursuing this GranuFlo lawsuit and monetary compensation for her husband’s sudden and allegedly preventable death.

On behalf of her husband and his estate, Mrs. Carr alleges in her GranuFlo lawsuit that Fresenius is guilty of negligence, misrepresentation, fraud, breach of warranty, and the wrongful death of Mr. Carr.

The GranuFlo lawsuit is Olivia Carolyn Carr v. Fresenius Medical Care Holdings Inc., et al., Case No. 1:14-cv-12228-DPW in the U.S. District Court, District of Massachusetts. It has been added to the GranuFlo multidistrict litigation (MDL) In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, Case No. 1:13-MD-2428-DPW, in the U.S. District Court, District of Massachusetts.

History of GranuFlo

In 2003, GranuFlo was approved by the U.S. Food and Drug Administration (FDA) as a treatment for acute renal failure and chronic kidney disease. It was manufactured, marketed, and distributed to hospitals and clinics by Fresenius Medical Care from January 2008 until June 2012. More than 400,000 Americans undergo dialysis treatment for kidney issues several times each month and about half of them have used GranuFlo or its sister drug NaturaLyte.

GranuFlo is a powdered drug  composed of acetate and sodium diacetate, which when mixed produce bicarbonate. The resulting bicarbonate compound is used to filter and clean a dialysis patient’s blood during treatment. In many cases, patients using GranuFlo or NaturaLyte have an excess amount of bicarbonate present in the blood stream after dialysis treatment which can lead to serious health complications.

On March 29, 2012, the FDA issued a Class I recall (the highest recall possible) for GranuFlo and NaturaLyte because of the high number of incidences linked to the heart problems, heart failure, and sudden death.

Granuflo Side Effects

Fresenius Medical Care officials became aware of the possible dangers of GranuFlo in 2011 when reports were issued of 941 GranuFlo patients who experienced severe cardiac arrest during the previous year. Fresenius Medical Care informed their clinics on Nov. 4, 2011 about the need for proper administration and monitoring of the dialysis product, but did not issue the same warning to clinics not owned by Fresenius Medical Care, who also bought and administered the drug.

While not explicitly stated on the marketing or packaging, recent studies and reports have linked the use of GranuFlo and Naturalyte in kidney dialysis with the following side effects:

  • Cardiac arrhythmia
  • Low blood Pressure
  • Low blood oxygen (hypoxemia)
  • Low blood potassium (hypokalemia)
  • Excessive carbon dioxide present in the blood

 

These GranuFlo side effects are likely to lead to the following medical conditions:

  • Heart Attack
  • Stroke
  • Cardiovascular Problems
  • Sudden Death

Join a Free GranuFlo Class Action Lawsuit Investigation

If you or someone you know suffered a heart attack or similar complication and were undergoing dialysis treatment, you may be eligible to pursue compensation for your injuries. Obtain a free legal review of your case by submitting your information now:

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