Dialysis Injury Lawsuits

According to the manufacturer, GranuFlo is "the most widely prescribed dry-acid product in the dialysis industry today." It is a "dry acid dissolution system," which is used to treat patients with kidney failure. NaturaLyte is a liquid solution. They help the body to get rid of acid, which people who have limited kidney function cannot do on their own. Fresenius Medical Care is the nation's largest dialysis provider, treating over 130,000 people. Of course, Fresenius dialysis centers use their own products, but they also supply those products to other dialysis centers.

Granuflo & Naturalyte Defects

The FDA is concerned that GranuFlo and NaturaLyte, when given to patients, contain too much bicarbonate (technically, that they contain too much other stuff that the body converts to bicarbonate), which is used to neutralize acid in the bloodstream. Doctors, not knowing the effects of GranuFlo or NaturaLyte, then prescribe too much bicarbonate. Too much bicarbonate is very likely the reason that patients using these products are experiencing heart attacks and cardiac problems at an excessive rate. Even the manufacturer is concerned, having sent a memo to its kidney dialysis clinics, warning that heart attacks were six times as likely with patients who used GranuFlo. The evidence indicates that these products are dangerous:

  • November 4, 2011: Fresenius warns its own employees of 941 cases of cardiac arrest in Fresenius clinics in 2010
  • March 29, 2012: Fresenius warns all of its patients
  • May 25, 2012: FDA Safety Communication
  • June 14, 2012: New York Times article "Dialysis Company's Failure to Warn of Product Risk Draws Inquiry

The defect could be a result of poor mixing by doctors and staff at dialysis centers, who were unaware that GranuFlo and NaturaLyte contain material that the body can convert into bicarbonate. The incredible part of this saga is that Fresenius warned its own doctors in November, 2011. It did not warn non-Fresenius dialysis clinics (many of which use the same products) until March 2012, when the FDA received a copy of the internal memo from an anonymous source.

Granuflo & Naturalyte Side Effects & Complications

GranuFlo and NaturaLyte appear to cause the following side effects and complications at a rate that is much higher than comparable products:

  • low blood pressure
  • hypoxemia (low levels of oxygen in the blood
  • cardiac arrhythmia (irregular heartbeat)
  • hypercapnia (excessive carbon dioxide in the blood)
  • cardiopulmonary arrest (heart attack

Again, this is likely because doctors did not realize that they had to compensate for bicarbonate created in the body by GranuFlo and NaturaLyte. To the extent that Fresenius did not warn doctors of these risks, they are guilty of defective or nonexistent warnings. At this point, there have been numerous articles and releases about the dangers, so future injuries may medical malpractice claims.

Contact Us

If you are on dialysis and had some sort of cardiac event, like a heart attack, contact our GranuFlo and NaturaLyte product defect lawyers at 1.800.553.8082, or online for a free consultation. We can help you to determine what product was used for your dialysis treatments, and whether that product likely caused your heart problems.

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