Fresenius Medical Care Facing Hundreds of GranuFlo Lawsuits

Fresenius Medical Care Facing Hundreds of GranuFlo Lawsuits

By Amanda Antell

Fresenius Medical Care continues to be hit with wrongful death lawsuits as more people find out their loved one’s death was caused by the company’s dialysis product GranuFlo.

Fresenius Medical Care is the largest dialysis company in the world, treating more than a quarter of a million kidney failure patients with its dialysis product GranuFlo. There are 1,080 Fresenius clinics in the United States, and 3,300 Fresenius GranuFlo suppliers.

GranuFlo is a dry dialysis substance that is mixed into the dialysis treatment liquid, and is meant to help stabilize and prevent kidney failure. The product works by concentrating certain acids in the body by producing alkaline, which is associated with causing high levels of bicarbonate in the blood. Many legal and medical experts believe that these high bicarbonate levels are directly linked to the sudden cardiac deaths and strokes associated with GranuFlo.

Fresenius knew of the potential occurrence of sudden heart attack and death from using GranuFlo, but failed to notify the public or the U.S. Food and Drug Administration. Some Fresenius Medical Care lawsuits allege the company knew about these GranuFlo side effects as early as October 2004, after a report about the company published in the American Journal of Kidney Diseases showed patients with higher pre-dialysis metabolic alkalosis levels were more likely to experience sudden heart attack or cardiac death if they were exposed to high bicarbonate levels. The known side effects of a bicarbonate overdose include:

• Cardiac arrhythmia
• Low blood pressure
• Low potassium
• Low blood oxygen
• Hypercapnia (too much carbon dioxide in the bloodstream)

Fresenius Medical Care Hid Dialysis Deaths

GranuFlo was approved for use in 1994, while its liquid cousin, NaturaLyte, was approved in 2003 in 2007. Both of these dialysate mixtures were approved through the FDA’s 510k Premarket Notification process, which only requires companies to prove products work at an equivalent level of a product already released on the market.

Despite discovering that their products are six times more likely to cause sudden cardiac arrest than other dialysis products, Fresenius did not recall GranuFlo or NaturaLyte until 2012. Fresenius also failed to tell the FDA about the hundreds of deaths that occurred at Fresenius clinics until an internal memo was leaked to the FDA earlier in the same year.

The internal memo stated that the company had conducted its own study on their products, which found the increased likelihood of NaturaLyte and GranuFlo causing fatal problems. While the internal memo was sent to several Fresenius-owned clinics and physicians, it was not sent out to non-Fresenius clinics or all physicians.

Even to the clinics they did sent the notice to, Fresenius did not go into full detail about how likely it was for patients to die from GranuFlo and NaturaLyte. In light of the internal memo, the FDA issued a Class I recall for both NaturaLyte and GranuFlo on March 29, 2012.

Did Your Loved One Die from a Dialysis Heart Attack?

If you believe that you or a loved one has been the victim of a GranuFlo cardiac injury, you have legal options. Please visit the Kidney Dialysis Heart Attack GranuFlo and NaturaLyte Recall Class Action Lawsuit Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned NaturaLyte or GranuFlo lawsuit lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process at no out-of-pocket expenses or hidden fees. The product liability lawyers working this investigation do not get paid until you do.