GranuFlo Lawsuit

Many men and women have suffered cardiac arrest or even died during or after dialysis involving GranuFlo, a popular component of dialysis treatments at Fresenius and other dialysis centers across the country. Sometimes the cardiac arrests occurred during the dialysis; other times they came 24 to 48 hours after treatments.

Baron & Budd’s leadership role in the GranuFlo litigation

In 2013, firm shareholder Burton LeBlanc was appointed to the leadership committee in the GranuFlo/NaturaLyte litigation, known as the Plaintiffs’ Steering Committee (PSC). This team of lawyers oversees all of the activity in the lawsuit and works on behalf of all consumers represented in the litigation. In this capacity, LeBlanc, along with Baron & Budd, represents thousands of people who have been allegedly harmed by GranuFlo use.

How can you be a part of the GranuFlo lawsuit?

If you or someone you know suffered from cardiac arrest after receiving dialysis, please contact us. It is possible that GranuFlo was used during the dialysis process and may be the cause of the health effects.

There is a limited window of opportunity to file a pharmaceutical-related lawsuit and we do not want you to miss your chance. We also understand that those who may be suffering from GranuFlo-related health complications and their loved ones are under stress, be it time, money, physical or emotional pain – not to mention the sheer confusion of having to know everything you can about GranuFlo, dialysis and the GranuFlo lawsuit. That is why our GranuFlo lawyers are here. We can help you figure out whether or not you have a case – so let’s get started. Call us at 866-520-2755 or complete our contact form. Our law firm has been taking on cases of wrongful exposure and dangerous medical drugs for over thirty-five years – your health and safety matters to us, and we do everything we can to protect your rights.

Want to learn more about what went wrong?

Each year, over four hundred thousand Americans receive dialysis, a long-term medical treatment that helps people with impaired kidneys by copying the kidney’s natural cleaning function to filter waste from the blood.

Dialysis treatment works by using two fluids — one is a drug known as a dialysate and the other is the patient’s own blood that is filtered with the dialysis treatment. With dialysis, the dialysate is used to help cleanse and remove waste products from the blood before the blood is pumped back into the patient. Typically, dialysis is performed three times a week.

A large role of the dialysis treatment is to maintain the acid/alkali balance in the bloodstream. This is done by using bicarbonate, or an alkaline substance, that the body can use to help neutralize acid buildup in the bloodstream.

However, when the bicarbonate levels are not properly maintained, a condition called metabolic alkalis can occur, meaning the blood pH level becomes overly alkaline, putting patients at a six times higher risk of cardiovascular harm including heart attacks.

If you or someone you know suffered cardiac arrest after receiving dialysis you may be able to get help from a GranuFlo lawyer.

The GranuFlo dialysate is a compound that creates bicarbonate, manufactured in a powdered form; another dialysate known as NaturaLyte works in a similar way but is manufactured in a liquid form. Both of these drugs have been identified by RenalWEB, a site that keeps track of the dialysis industry, as distinctive in that they use sodium diacetate instead of the commonly used sodium (mono)acetate. This specific NaturaLyte and GranuFlo dialysate composition may lead to the production of increased bicarbonate levels when it is administered at the same dosage levels as the more common (mono)acetate dialysate drugs.

However, the GranuFlo lawsuit dialysate’s manufacturer, Fresenius, allegedly did not properly label the drug’s warning labels – in turn causing doctors to accidentally prescribe their patients an overdose of bicarbonate.

This is what allegedly happened to patients who suffered cardiac arrest or other serious injuries after receiving dialysis that included the GranuFlo lawsuit dialysate. And this is the reason for the GranuFlo lawsuit now.

On March 29th, 2012, the Food and Drug Administration (FDA) issued a Class 1 GranuFlo recall to revise prescribing instructions of GranuFlo, the drug that is now the subject of a GranuFlo lawsuit. According to the GranuFlo recall, the use of GranuFlo, as well as the similar drug NaturaLyte, can lead to heart problems such as low blood pressure and cardiac arrhythmia, which can cause cardio-pulmonary arrest or even death.

Class 1 recalls are the most severe form of recall that the FDA issues, initiated only when there is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The GranuFlo lawsuit drug was made by Fresenius Medical Care, the world’s largest provider of dialysis products and services. Fresenius is the world’s largest provider of all things dialysis. That means that more than one-third of the 400,000 Americans who receive dialysis each year go to Fresenius clinics for their treatment.

Even Americans who receive dialysis from places outside of the Fresenius treatment centers still come across Fresenius often by way of the many Fresenius machines, disposable products and prescription drugs used in even non-Fresenius dialysis clinics.

Before the FDA issued a Class 1 GranuFlo lawsuit dialysate recall, GranuFlo was used in thousands of dialysis treatment centers in the United States.

The GranuFlo lawsuit drug’s manufacturer, Fresenius Medical Care, knew of the product’s dangers many months before the GranuFlo recall.

In fact, an internal company memo dated November 4th, 2011, shows that Fresenius was aware of the risks and complications in the use of GranuFlo. The internal memo cites 900 patients who suffered heart attacks within Fresenius clinics during the previous year.

Actual Fresenius internal memo showing concern about Granuflo

Here is the actual Fresenius internal memo showing the company’s awareness of the dangers of GranuFlo.

The memo says that the company’s own medical staff had found that patients with excess levels of bicarbonate in their blood were six times more likely to have cardiac arrest that those with normal levels of bicarbonate.

The link between GranuFlo, increased bicarbonate levels and increased cardiac arrest risk is also made. Fresenius knew what they were doing.

Not exactly. While the internal memo is dated November 4th, 2011, the FDA’s Class 1 recall was issued on March 29th, 2012. Meaning almost five months, or 146 days, passed before significant effort was taken to ensure dialysis patient safety. 146 days is a lot of time when it comes to serious risks like cardiac arrest and has led to the GranuFlo lawsuit. So, why the delay?

Well, it was an internal company memo, and Fresenius Medical Center apparently had no interest in making their life-saving news public. After all, alerting patients and the medical field to their faulty product would have resulted in a loss of sales.

Sadly, the patient and medical world only became aware of the danger when the internal company memo above was leaked anonymously to the FDA.

When you manufacture a medical product that acts differently than the other medical products in its category it makes sense to properly explain what this new product is, how it acts differently and how doctors should prescribe the product – and adjust any additional drug prescriptions – in a manner that is specific to the individual formula, right?

After all, if a warning label is not clear, then doctors cannot do their jobs treating their patients – nor can patients be expected to do their own jobs of looking after their health needs, too. Instead, in order for doctors and patients to look after patient health, drug manufacturers must comply with a basic level of truthfulness and caution when writing their drug warning labels.

Since Fresenius Medical Care knew that their GranuFlo product led to higher levels of bicarbonate in the bloodstream, they should have included this information on the drug label so that doctors could factor this into the additional bicarbonate prescription that is typically prescribed to dialysis patients! It would have been one thing if Fresenius did not know about the GranuFlo lawsuit dialysate’s dangers, but they did, and so it should have been on the label.

Fresenius Medical Care should have followed their internal company memo with an immediate outreach to all of the Fresenius and non-Fresenius dialysis providers and doctors with information about the increased bicarbonate levels. That did not happen.

Instead, dialysis treatment centers and doctors at non-Fresenius dialysis centers were left in the dark – as were all patients, whether they were receiving dialysis from Fresenius dialysis treatment centers or non-Fresenius dialysis treatment centers.

In addition, the warning label should have been properly modified to aid doctor and patient ability to look after patient acid/alkali bloodstream balance.

These are issues that the GranuFlo lawsuit has put on the table – both to fight for the injured patients so that they may receive financial compensation for their injuries and to decrease the chance that companies like Fresenius Medical Care will chose to knowingly hide information from their patients again.

Sometimes law firms get a bad rap for handling cases involving a person’s physical harm, or for working to use lawsuits involving large corporations as examples so that other companies will not follow down the same, dishonest path. However, the truth is, if law firms and the people they seek to protect as clients do not stand up, companies like Fresenius Medical Care can have free reign. We’ve seen whom that hurts most. You, the patient.

GranuFlo is a dialysate sometimes used in dialysis that may cause cardiac arrest in some patients. Unfortunately, the drug manufacturer of GranuFlo, Fresenius, allegedly did not properly label the drug, causing doctors to accidentally prescribe doses that were too high. This led to the GranuFlo lawsuit, the way for injured patients and their loved ones to work with a GranuFlo lawyer, to fight back and seek significant compensation for costs related to the health issues caused by GranuFlo use.

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