It is hard to make sense of the Fresenius dialysis debacle. People have been hurt – the most vulnerable among us – and it could have been so easily prevented. What I try to do below is lay out what happened and explain what I believe the future of these lawsuits to be.
Fresenius Medical Care is the nation’s largest provider of dialysis treatments, with over 130,000 patients. Their dialysis facilities use GranuFlo and NaturaLyte acid dissolution products in treatments, which are products created by Fresenius. Countless non-Fresenius dialysis centers also use those products, which are sold by Fresenius. Defects in those products are terrifying not only because of the harm they could cause but because Fresenius has such a ridiculously high market share. This is not a product people want, it is a product they absolutely need.
Dialysis and Kidney Disorders: Background
Patients who are in kidney (renal) failure must go through a process called hemodialysis. Dialysis is the process of removing harmful products from the body, including excess waste, acid, and water. A dialysis patient’s kidney doctor (nephrologist) will set the parameters for dialysis, including how often the patient must go and solution flow rates. Dialysis patients typically go to a center about three times per week, with each treatment lasting about three to four hours.
GranuFlo and NaturaLyte are acid concentrates, which are important for dialysis. They are used to remove excess acid from the blood by helping the body to create bicarbonate, an acid neutralizer.
Defective GranuFlo & NaturaLyte Dialysis Drugs
Just as too much acid is dangerous to the body, so is too much bicarbonate. Acid dissolution solutions are supposed to help the body make more bicarbonate. The problem with GranuFlo and NaturaLyte is that some of the ingredients can be converted into bicarbonate—if the prescribing physician or technician doesn’t take this into account, the patient’s body might create too much bicarbonate, which can cause a number of injuries:
- 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)
Some studies are showing that patients using GranuFlo or NaturaLyte are four to six times as likely to suffer a heart attack within 48 hours of dialysis treatment. In 2010, there were 941 Fresenius patients who had heart attacks while at Fresenius dialysis clinics. There were certainly many more who were getting treatment at other dialysis centers.
What Fresenius Did Wrong
Where to begin? Fresenius knew about these problems, but decided to keep it quiet for far too long. When they realized there was a potential problem, they warned doctors at their own clinics, but didn’t tell any of the countless other clinics who use Fresenius products. It would be hard to find a more tailor-made “profits over people” example.
In fact, the way the FDA and other clinics found out was when an internal Fresenius memo was leaked. Fresenius then sent an official warning to those other clinics four months later. As a result, in June 2012 the FDA instituted a Class-I recall of NaturaLyte and GranuFlo. This is the highest level of recall, reserved for products which pose a serious concern of health problems or death.
Status of Fresenius Lawsuits
Our product liability lawyers are investigating potential Fresenius dialysis lawsuits. The most serious cases are those where patients have had a heart attack or death within two days of a dialysis treatment. Remember—patients treated at non-Fresenius dialysis centers may be at risk because other centers use Fresenius products.
If you or a family member is on dialysis, and believe you may have been treated with GranuFlo or NaturaLyte, contact our product liability lawyers at 1.800.553.8082, or send us some information about your case for a no charge, internet evaluation.