GranuFlo and NaturaLyte lawsuits are being filed in courts around the country, after hundreds of patients suffered cardiac arrest, sudden cardiac death, and other serious heart problems following administration of the drugs during dialysis treatments.   While Fresenius Medical, the manufacturer of GranuFlo and NaturaLyte, learned of the risks associated with the dialysis drugs in 2011, a GranuFlo and NaturaLyte recall was not announced until months later. GranuFlo and NaturaLyte lawsuits are now being filed on behalf of people who suffered serious heart side effects within 48 hours of a dialysis treatment with these drugs, including:

  • cardiovascular death
  • sudden cardiac death
  • cardiopulmonary arrest
  • heart attack
  • other catastrophic heart injuries

If you or someone you love suffered one of the above side effects within 48 hours of undergoing a  dialysis treatment with either of these products, you may be eligible to file a GranuFlo or NaturaLyte lawsuit seeking compensation for your medical expenses, pain and suffering, and other damages.

GranuFlo and NaturaLyte Recall

GranuFlo and NaturaLyte are acid concentrates used to neutralize the acid that builds up in the blood during dialysis.  GranuFlo is an acid concentrate powder, while NaturaLyte is a liquid.  Both products were widely used at Fresenius dialysis clinics, and at over 125,000 facilities supplied by the company. Fresenius is the largest dialysis services and products company in both the U.S. and the world.  The company operates over 1,800 kidney dialysis clinics in the U.S., and treats more than one third of this country’s dialysis patients.

Both GranuFlo and NaturaLyte contain an ingredient that the body converts to bicarbonate.  While rival dialysis drugs also contain this ingredient, GranuFlo contains more.  Both products have been linked to alkalosis, a condition associated with an increase in cardiovascular death and catastrophic cardiovascular injuries in patients undergoing dialysis treatment. On March 29, 2012, Fresenius issued an “Urgent Product Notification”  to warn of the heart risks associated with GranuFlo and NaturaLyte.  In June, the U.S. Food & Drug Administration (FDA) announced a Class I GranuFlo and NaturaLyte recall.  Class I recalls are the agency’s most serious type of recall, and are issued when there is a reasonable chance that use of a product will cause serious side effects or death.

Before the GranuFlo and NaturaLyte Recall:  Fresenius’ Failure to Warn

Fresenius is now being investigated by the FDA over its delay in warning thousands of doctors and clinics of the risks associated with GranuFlo and NaturaLyte.  According to GranuFlo and NaturaLyte lawsuits, an internal company memo dated November 4, 2011 – months before the GranuFlo and NaturaLyte recall was announced — warned of more than 900 deaths that had occurred following administration of GranuFlo.  The document had been prepared in response to the high rate of cardiac arrests that occurred in Fresenius dialysis clinics in 2010.  According to the memo, doctors had not been accounting for the fact that GranuFlo would result in higher levels of bicarbonate in patients.  Fresenius’ own medical staff concluded that patients with high levels of bicarbonate in their blood had about six times the risk of cardiac arrest as those with lower levels.

While the November 2011 Fresenius memo was distributed to the company’s own dialysis clinics, its customer clinics were not warned until March of 2012, when Fresenius issued an Urgent Product Notification.  During that time, its customer clinics continued to use GranuFlo and NaturaLyte, placing an untold number of patients at risk for cardiac arrest, sudden cardiac death and other catastrophic heart problems.    The FDA announced the GranuFlo and NaturaLyte recall in June 2012 and issued a warning to dialysis clinics after it received a copy of the November 2011 Fresenius memo from an anonymous source.

How to File a GranuFlo or NaturaLyte Lawsuit

If you or a loved one suffered cardiac arrest, sudden cardiac death or another catastrophic heart problem within 48 hours of a dialysis treatment with one of these medications, you could be eligible to pursue a GranuFlo or NaturaLyte lawsuit.  By filing a GranuFlo or NaturaLyte lawsuit, you may be able to obtain compensation for any medical expenses, lost wages and pain and suffering these dialysis drugs have caused you. Call the lawyers at Bernstein Liebhard LLP at (877) 779-1414. We will be happy to answer any questions you may have regarding the legal process for filing a GranuFlo and NaturaLyte lawsuit.

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Published October 10, 2012 by