Fresenius Granuflo and Naturalyte Recall

Heart attack recallJohn Maher:  Hi, I’m John Maher, and I’m here with Jeff Bowersox of Bowersox Law. Jeff is an attorney with special expertise in defective products and medical devices. Today, we’re talking about the Fresenius GranuFlo and NaturaLyte recall due to the potential risk of heart attack. Welcome, Jeff.

Jeff Bowersox:  Hi, John. Thanks for asking me to participate in the program today.

John:  Sure. Jeff, what is the Fresenius GranuFlo and NaturaLyte recall, and how would I determine if I have a potential claim from a Fresenius GranuFlo lawsuit?

Jeff:  John, Fresenius is one of the largest dialysis companies in the entire world. It controls a huge part of the United States market for all of the people in the United States who need to undergo dialysis.

Dialysis, as many of our listeners will know, is a process whereby there is an artificial cleansing of our blood to take the place of the natural body cleansing of our blood that would occur from our kidneys. If there’s kidney injury or kidney damage, then a patient undergoes a mechanical process of dialysis to clean their blood and keep them healthy. They have to undergo this dialysis approximately three times a week.

What happens is a person goes to a clinic. Most often, in the circumstances that are of concern to us here today, it would be a Fresenius clinic. However, it’s important to know that people could have been injured and could have been affected by the Fresenius GranuFlo or NaturaLyte product even if they were having their hemodialysis performed at a different clinic.

For example, a DaVita clinic or a Baxter clinic may well have purchased GranuFlo or NaturaLyte and used that product in their clinic to use as a dialysate for the hemodialysis that the patient had and was injured by. Almost certainly, the product would have been used in a Fresenius clinic and could well have been used in a DaVita or Baxter clinic.

If in fact the patient was having hemodialysis and sustained what is commonly called a “heart attack” while undergoing the dialysis. There is a great cause for concern that NaturaLyte or GranuFlo was used and is implicated in, may have actually caused, the heart injury, which could have led to hospitalization and unfortunately, more often than not, led to immediate death.

When we talk about a GranuFlo heart attack case, we need to make a couple of important distinctions. A GranuFlo heart attack case is not a heart attack that occurs. For example, middle of January, you live in Buffalo. There’s three feet of wet snow that’s dumped down. You’re out shoveling it. All of a sudden, you have a heart attack.

That heart attack is called a “myocardial infarction.” It’s a blockage. It is a circumstance where your blood flow to your heart is blocked. As all of us know from many years of health education press, it can be caused by stress. It could be caused by eating too much fat, high cholesterol, all sorts of things, genetics.

If the heart attack is a myocardial infarction, it was not a GranuFlo heart attack. A GranuFlo heart attack is more properly called “sudden cardiac death.” It’s an electrical disturbance of the heart that causes the heart not to properly beat. It disrupts the electrical functions of the heart.

This is when you see someone being shocked back using the paddles. If you’re watching a TV show, everybody yells, “Clear.” They put the paddles on the patient’s chest, and he’s electrically shocked.

That’s because the person has had a disruption of the electrical rhythms of their heart, and they’ve had a sudden cardiac event. The problem is that if the person dies, the patient dies while having dialysis. They’re transported urgently to the hospital or directly to a funeral home, the death certificate may list the cause of death as heart attack. When in fact it’s not, as I said, it’s not a common heart attack.

This presents a difficult problem for the survivors. They’ve lost a loved one, they’re grieving, the situation is one that everyone is upset about, and maybe someone is suspicious about why did this happen. But it’s very difficult to determine why the heart attack occurred. If in fact you are a family member of a loved one who had a heart attack while undergoing dialysis, or sometime say 12 even 24 hours after dialysis.

Especially if they were at a Fresenius clinic you need to investigate this matter. You need to investigate why your loved one had this sudden cardiac event that led to their death.

John:  Jeff, why did the FDA recall GranuFlo?

Jeff:  GranuFlo was ultimately voluntarily recalled by Fresenius amazingly enough. They eventually gave public notice of the problem that is now well understood by attorneys representing family members and injured victims of this dialysis product. The reason it was recalled is that the way the product was formulated caused a significant increase in blood level potassium.

This gets into a very technical issue and if there was a physician listening, that person would understand immediately the significance of high levels of potassium or on the other hand, extremely low levels of potassium in a patient’s blood level. For you and I John, and for the listeners, most of our listeners, this is very complex stuff. Suffice it to say that potassium in either severe deprivation, so small amounts in your blood, or in excess in your blood causes electrical disturbances in the way your heart operates.

Our hearts actually what causes them to beat is an electrical current. Probably all of us have heard of a pacemaker. A pacemaker is designed to make sure that the electrical current comes and goes to the heart in a proper beat, beat, beat system. If there’s too much potassium as a result of an improperly formulated GranuFlo or NaturaLyte product from Fresenius, the electrical system of the heart gets disrupted and the heart beats wildly and does not properly pump blood and the patient can promptly die.

John:  OK. So is there potential for litigation if I or a family member suffered a heart attack and GranuFlo or NaturaLyte was used as part of my Fresenius dialysis?

Jeff:  Yes. Two cautions. You need to promptly contact an experienced attorney about this because even in the circumstance that we’ve described of a patient having this event while they’re having the dialysis. There are many complicated medical issues that have to be examined to determine how the patient or the patient’s family if that person died, can properly present their claim to the court and receive fair compensation.

A competent attorney who is experienced in this knows what questions to ask of the family, knows what medical records need to be sought, and has retained already experts who can examine the records and determine whether the Fresenius GranuFlo or NaturaLyte product more likely than not caused the injury and/or unfortunately often times death.

John:  OK, with Jeff Bowersox. Thanks very much for speaking with me today.

Jeff:  Thank you John.

John:  For more information, you can visit or call Jeff at 1‑800‑255‑1996.

Photo credit: Garrett Ammon / Foter / CC BY-SA