NaturaLyte and GranuFlo are two medications used in kidney dialysis, a medical treatment that helps people with kidney failure filter their blood mechanically. They are made by Fresenius, a German company that owns and operates the majority of dialysis centers in the U.S. and provides these and other, non-Fresenius centers with dialysis equipment and medications.
Controversy surrounds these Fresenius products because they have been found to increase the risk of sudden heart attacks and death in dialysis patients. GranuFlo and NaturaLyte lawsuits have been filed by many people who lost loved ones because of the medications. They claim that Fresenius did not make the risk clear to all dialysis centers and operators and instead only warned those centers operated by Fresenius.
Dialysis, NaturaLyte and GranuFlo
People with kidney failure no longer have functioning kidneys, the organs responsible for filtering out waste from the blood and sending that waste to the bladder to be excreted as urine. A person needs at least one functioning kidney to survive and without that will die soon. Kidney failure can be caused by many different conditions, including hypertension, but most people who have lost kidney function have been living with chronic diabetes.
When both kidneys fail to function adequately a person needs either a kidney transplant or dialysis. A dialysis machine takes blood out of the patient, filters it, and returns it to the body. People on dialysis require multiple treatments each week. While it can be done at home most people go to dialysis centers for treatment. These are medical facilities devoted to dialysis procedures for people in kidney failure.
Fresenius is a major player in dialysis with more centers in the U.S. than anyone else. They also make and sell most of the dialysis products used in the U.S., both in their own facilities and others. NaturaLyte and GranuFlo are drugs used in the dialysis process to neutralize excess acid in a patient’s blood. They are part of the filtering process and are the same formulations, but one is a liquid and the other comes in powder form.
Problems with NaturaLyte and GranuFlo
These dialysis drugs neutralize acid in the blood by a compound called sodium diacetate. Once in the blood this chances to bicarbonate, which can neutralize acidic blood. The problem with NaturaLyte and GranuFlo is that in addition to sodium diacetate, the also contain some bicarbonate. If a doctor or dialysis operator doesn’t realize that they also have bicarbonate, the dose could be wrong and a patient could end up with too much bicarbonate in the blood.
This problem came to light when some patients died of sudden cardiac arrest. The excess bicarbonate in the blood is known to increase the risk of fatal heart attacks. Patients were dosed incorrectly because it wasn’t clear that the medications contained bicarbonate in addition to sodium diacetate. NaturaLyte lawsuits have been filed blaming Fresenius for this mistake and for not warning about the possibility of incorrect dosing.
Fresenius Negligent in Failing to Warn
Several lawsuits have been started against Fresenius because plaintiffs believe that Fresenius was negligent in the deaths of many dialysis patients. The case is being made that the company knew about the risks of incorrectly dosing patients and the resulting fatal heart attacks. If Fresenius had better warned doctors and dialysis centers about the extra bicarbonate, lives could have been saved.
Fresenius has defended its actions in the cases against NaturaLyte and GranuFlo by pointing to a 2011 memo about the extra bicarbonate. They only sent this memo to Fresenius centers, though, leaving all of those non-Fresenius dialysis centers dangerously out of the loop. An anonymous person with access to that memo, who realized that the company was wrong to only send it internally, sent it to the FDA.
The FDA looked into the issue and made a warning statement about NaturaLyte and GranuFlo. The agency also issued a recall, considering them to be defective medical products that could cause more fatalities. Fresenius has defended its actions by saying that they did not have enough information about the risks to publish in a medical journal and that there was no other way to communicate the risks to non-Fresenius dialysis centers. Eventually, though, the company did send a warning out to other facilities.
NaturaLyte Lawsuits and Settlements
Because Fresenius so blatantly failed to warn all dialysis centers and operators about the risks of overdosing patients with NaturaLyte or GranuFlo, thousands of lawsuits have been filed against the companies by individuals who lost a loved one to a dialysis-induced heart attack. These were consolidated in a multidistrict litigation in Massachusetts, which eventually ended in a $250 settlement.
Although that set of cases was settled satisfactorily for the plaintiffs, there are still many more lawsuits pending. These are largely the loved ones of patients who died of a heart attack during or after dialysis. They are accusing Fresenius of negligence for the deaths and of committing fraud in presenting the drugs as safe when they actually came with serious risks. These outstanding cases are expected to be settled in favor of plaintiffs.
States Sue Fresenius
It hasn’t only been individuals and multidistrict cases coming after Fresenius for the NaturaLyte controversy. The state of Louisiana sued the company and accused it of violating the Unfair Trade Practices and Consumer Protection Law in the state on a number of counts. The state has made the case that the company defrauded Louisiana dialysis patients and their doctors by failing to warn of the risks of NaturaLyte. The prosecutor seeks $5,000 for each violation of the law, but is also asking for a return of profits Fresenius earned selling NaturaLyte and GranuFlo in the state.
You too may have a case against Fresenius and the legal battle against the company is far from over. Many more people are seeking compensation for the pain and suffering of losing a loved one too soon. Let a lawyer guide you through the process of starting a suit and help you fight the drug company to get what you deserve.