New product liability lawsuits being filed in California against Fresenius
There’s a new type of product liability lawsuit being filed by injured California patients who have been treated for kidney failure at Fresenius and third-party dialysis clinics who choose to use GranuFlo® and NaturaLyte®.
How dialysis works
California patients suffering from end stage kidney failure are treated with dialysis at these clinics, which removes toxins and excess fluids from the blood. The patient is connected to a dialysis machine that removes blood from the patient’s body, runs it across a membrane, and returns it to the body. As the blood runs across the membrane, a fluid on the other side, called dialysate which consists of purified water, an acid concentrate and bicarbonate concentrate, draws out and carries away toxins and excess fluids and supplements the blood with necessary electrolytes, such as sodium, potassium, calcium and magnesium.
Dialysis and the blood’s pH balance
The goal of dialysis is to restore the pH balance in the patient’s blood. The body naturally produces acid which normally functioning kidneys neutralize to prevent metabolic acidosis, a condition in which the blood contains too much acid. Most dialysis treatments accomplish this by including bicarbonate concentrate, a base, in the dialysate to buffer the acid in the patient’s blood.
Too much bicarbonate can cause heart attacks, strokes, and death
Patients are prescribed a specific amount of bicarbonate by their physicians to be delivered during the dialysis process. If a patient undergoing dialysis receives an excess of bicarbonate, metabolic alkalosis can occur. Metabolic alkalosis is a medical condition in which there is too much bicarbonate or base in the blood. If left untreated, metabolic alkalosis can lead to serious adverse health consequences, including heart attacks, strokes, and even death.
Allegations being made against Fresenius regarding GranuFlo® and NaturaLyte®
The allegations being made in the GranuFlo® and NaturaLyte® lawsuits boils down to these products delivering too much bicarbonate, resulting in heart attacks, stokes, and death in patients who are treated with these substances during dialysis.
Did Fresenius know about the higher levels of bicarbonate in GranuFlo® and NaturaLyte®?
What makes these cases worse, if true, is the allegation that Fresenius—the manufacturer of GranuFlo® and NaturaLyte®—had knowledge that these products delivered too much bicarbonate, but chose not to warn anyone about the dangers and risks to patients using these during dialysis.
Fresenius Internal Memos
For example, an internal memoranda concerning GranuFlo® Concentrate from Fresenius executives and medical staff dated December 7, 2000, authored by Dr. J. Michael Lazarus, head of the Fresenius Bicarbonate Committee stated that Fresenius clinics were not accounting for the increased amount of bicarbonate in GranuFlo® and NaturaLyte®. Additionally, in a series of memos from 2005 to 2008, Fresenius acknowledged the increased risk of death with the use of GranuFlo® and NaturaLyte®, yet continued to manufacture, distribute, market and sell GranuFlo® and NaturaLyte® to third-party dialysis clinics. During this time, it is alleged, Fresenius chose not to warn of the defects and increased risk of injury and death for patients using GranuFlo® and NaturaLyte® during dialyses. Finally, in an internal memo dated November 4, 2011, Fresenius noted that its own patients’ serum pre-dialysis bicarbonate levels had steadily increased form 2004 to 2011 which was during the time Fresenius was increasing the use of GranuFlo® and NaturaLyte® in their own clinics.
The FDA issues a Class I recall of GranuFlo® and NaturaLyte®
In March 2012, the FDA issued a Class I recall of GranuFlo® and NaturaLyte®. A Class I recall is the most serious recall issued by the FDA. In its recall the FDA stated “This product may cause serous adverse health consequences, including death.”
Were any warnings given to patients?
It appears that Fresenius knew about the increased risks of using GranuFlo® and NaturaLyte® during dialysis, but chose not to warn doctors, clinics, and patients about these increased risks. We will report more on these cases as they are filed, and as we find out more during the discovery process.