GranuFlo, along with a similar drug called NaturaLyte, are made by the German company Fresenius. They are used in kidney dialysis, the artificial filtering process used to treat people with kidney failure. GranuFlo is a powdered form of the drug, while NaturaLyte is a liquid. They both contain a compound used to neutralize acidic blood in patients undergoing dialysis.
Fresenius provides the majority of dialysis products used in the U.S. There are Fresenius dialysis centers, but their products are also used in other dialysis centers run by different organizations. Evidence that GranuFlo and NaturaLyte could cause sudden cardiac arrest and death in dialysis patients has put Fresenius in hot water. The company may have known about the risk and failed to warn patients and doctors. This is the basis for a number of lawsuits filed against Fresenius.
GranuFlo and NaturaLyte
The kidneys are organs that are responsible for filtering waste out of the body and excreting it in the form of urine. The functioning of at least one kidney is essential and kidney failure can quickly lead to death. Many things can cause kidney failure, but most common is chronic high blood pressure or diabetes. Kidney failure may occur slowly, but as it gets worse, a person will need dialysis.
Dialysis is an artificial process for filtering the blood when the kidneys can no longer do it. For end-stage kidney failure, most patients receive hemodialysis. The patient has blood removed, filtered by a machine, and returned into the body free of waste materials. While it can be done at home, most patients go to a dialysis center a few times a week for the process.
Fresenius operates more dialysis centers in the U.S. than any other company. It makes all of its products for operating the centers, including the drugs GranuFlo and NaturaLyte. These are drugs used as a part of the dialysis process to neutralize excess acid in the patient’s blood. They contain a compound called sodium diacetate. In the blood this is converted to bicarbonate, which neutralizes acid. The drugs also contain some bicarbonate.
Lawsuits against Fresenius
NaturaLyte and GranuFlo lawsuits have been filed against Fresenius because of the risk to patients of dying of sudden cardiac arrest while using the drugs during dialysis. The risk comes from too much bicarbonate in the blood. Excess bicarbonate can lead to a fatal heart attack. Because the two dialysis drugs contain both sodium diacetate, which is converted to bicarbonate in the blood, and bicarbonate, patients are at risk for getting a double dose of bicarbonate.
If the administering doctor or medical professional was not aware that the drugs contained both compounds, a patient may be given too much and be put at risk for a heart attack. Some patients did suffer this complication because of too-large doses of the medication. These incidents have spurred the lawsuits filed against Fresenius.
Fresenius and Negligence
The reason individuals and even state governments have been able to make cases against Fresenius is that they believe the company knew about the risks of overdosing bicarbonate. Plaintiffs have made the claim that Fresenius knew there was a risk that doctors would give patients too much of either NaturaLyte or GranuFlo because they were not aware of the extra bicarbonate in the drugs. The company should have made it clearer to medical professionals so they could dose correctly.
Fresenius claims that it did warn doctors, and they did send around a memo in 2011 warning about the risks of mis-dosing the drugs. However, they only sent that memo to doctors in their own dialysis centers, not to those working in other centers using GranuFlo and NaturaLyte. That internal memo was sent to the FDA by an anonymous whistle blower.
Fresenius has tried to deny negligence by claiming the only way to communicate the risk to other centers would have been to publish information in the journal. The company claimed it did not have adequate or complete data for publishing. Fresenius did eventually issue another warning that was sent to more dialysis centers and doctors. At the same time the FDA issued a warning about the risks of NaturaLyte and GranuFlo and also recalled the products.
Louisiana’s Case against Fresenius
The possible negligence of Fresenius in not adequately communicating the risks to dialysis patients is strong enough to have led to a number of lawsuits. In one case Louisiana sued the company for violating the state’s Unfair Trade Practices and Consumer Protection Law. The state claims the company tried to defraud dialysis patients, doctors and clinics by not warning all dialysis centers about the risks of heart attack and death. The state is seeking $5,000 for each violation as well as a return of profits that the company made selling the drugs in the state.
Individual and Multidistrict GranuFlo Lawsuits and Settlements
Thousands of cases against Fresenius were consolidated in a multidistrict case in Massachusetts. The company eventually agreed to a settlement in that case of $250 million, but there are still more cases to be heard and potentially settled.
There are also hundreds of individual NaturaLyte and GranuFlo lawsuits pending. These include a woman suing after her husband died of a heart attack a day after receiving dialysis with GranuFlo. In another case a woman who lost her husband the same way claims that the company was negligent and committed fraud in presenting the drugs as safe.
Many more similar cases have been field by the loved ones of people who died after being administered GranuFlo or NaturaLyte for dialysis. Because Fresenius did not warn every clinic, doctor, and patient of the risks of having a heart attack after using their drugs, the company is in a tight spot. More cases are expected to be resolved in favor of plaintiffs. If you lost a loved one to dialysis with Fresenius medications, you too could have a case to win justice for that loss. Speak with a lawyer to find out how you can start a lawsuit and what your options and chances are for a settlement win.