Fresnius Medical Care is the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2.1 million individuals worldwide.
Not only does Fresnius manage over half the dialysis centers in the United States, but they are also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and the dialysis concentrates that are used in a dialysis treatment.
Information has surfaced recently indicating that Fresnius was aware of an increased risk of cardiac arrest and death as a result of their dialysis products. An internal memo from November 2011 indicates that Fresnius determined the risk needed urgent medical attention but instead of taking prompt action to warn all Fresnius product users, Fresnius chose to inform only the Fresnius managed clinics – allowing non-Fresnius clinics to continue to put their patients at risk for an additional 7 months.
Furthermore, more internal documents show that Fresnius has not effectively educated its own physicians and clinic personnel in the proper use of Fresnius dialysis machines and dialysate concentrate products for more than a decade.
As a result U.S. dialysis patients have been exposed to an increased risk of cardiac arrest – often unknowingly and unintentionally – since the 1990s. According to the Fresnius internal memo issued in November 2011, 941 patients suffered cardiac arrest in 2011.
If you are a loved one suffered a cardiac arrest during Dialysis, you have a right to hold the responsible party accountable.
Cardiac arrest is a devastating complication of hemodialysis treatments. This is not a new risk. However, as a result of changes to the top selling dialysis products on the market - Fresnius dialysis machines and Fresnius dialysate products - the risk of cardiac arrest increased and health care professionals were not made aware of the changes.
How could such a delicate patient population be put at an increased risk of harm?
In order to understand the increased risk, a general understanding of the science behind dialysis is needed. Kidneys remove wastes and water from the blood to form urine. Urine flows from the kidneys to the bladder through the ureters as shown in this picture.
Wastes in the blood come from the normal breakdown of active tissues, such as muscles, and from food. The body uses food for energy and self-repairs. After the body has taken what it needs from food, wastes are sent to the blood. If the kidneys did not remove them, these wastes would build up in the blood and damage the body. The kidneys regulate the body’s level of chemicals such as sodium, phosphorus and potassium and release them back to the blood to return to the body. The kidney’s regulation looks like this:
Dialysis is a medical process that is used when a person’s kidneys are damaged and can no longer filter toxins from the blood.
Hemodialysis is done at a dialysis center. In hemodialysis, your blood is allowed to flow, a few ounces at a time, through a special filter that removes wastes and extra fluids. A dialysis machine filters the blood and infuses it back into the body. Part of this process involves providing bicarbonate, an alkaline substance, to neutralize the acid that builds up in the blood. The clean blood is then returned to your body. This process looks like this:
Dialysate is the solution that passes through the artificial kidney to clean the blood during hemodialysis. The dialysate is continuously mixed and heated within the dialysis machine during a hemodialysis treatment. Dialysate is a mixture of three fluids: ultrapure water, bicarbonate concentrate, and acid concentrate. Bicarbonate concentrate contains sodium bicarbonate mixed in ultrapure water. Acid concentrate adds additional sodium, as well as the needed potassium, calcium, magnesium and the acid/acetate. Levels of all these components must be carefully controlled for the safety of the dialysis patient.
Plaintiffs charge that Fresnius knew of GranuFlo and Naturalyte Risks
Granuflo is the most widely prescribed dialysate in the dialysis industry today. While it received FDA approval in 1992, its formulation was changed in 2003 to a dry format that could be mixed at the dialysis clinic.
Naturalyte, another Fresnius product, also adds sodium acetate but at half the level that Granuflo does. It is in a liquid concentrate that is prepared prior to arriving at the dialysis clinic.
Prior to an FDA Safety Communication issued on May 25, 2012, many health care providers were not aware that Granuflo and Naturalyte contained an increased bicarbonate contribution and did not take it into account when deciding how much bicarbonate to prescribe separately.
As a result, healthcare providers may have subjected their dialysis patients to an overdose of bicarbonate, which in turn has been associated with a higher risk of cardiac arrest. Fresnius put dialysis patients at risk for a fatal disaster and, sadly, many have died as a result.
There are currently 11 GranuFlo lawsuits pending in eight different U.S. District Courts, but those numbers are expected to grow. In these lawsuits, plaintiffs charge that Fresnius knew or should have known of the risks posed by GranuFlow and NatrualLyte as a result of the November internal memo. On June 27, 2012, Fresnius announced an FDA issued Class 1 recall of their GranuFlow and NaturaLyte products as a result of the labeling changes needed for the safety of dialysis patients.
Motion Filed to Establish GranuFlo MDL
On December 12, 2012, a group of plaintiffs’ attorneys filed a petition to form a federal multidistrict litigation in the United States District Court for the District of Massachusetts and thereby consolidate wrongful death lawsuits against Fresnius, to which Fresnius responded with a brief on January 3rd agreeing to the Massachusetts venue.
As more plaintiffs are added to the case and as the case progresses through the courts, TorHoerman Law will continue to keep our clients updated through this website and our blog updates.