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GranuFlo Injury Overview

Millions of Americans suffer from advanced or chronic kidney disease. Many of these patients rely on kidney dialysis for treatment. GranuFlo is a prevalent dialysis drug manufactured by Fresenius Medical Care. The company also serves as the administrator of thousands of dialysis treatment centers nationwide. In recent years, health studies have revealed a link between the use of GranuFlo and severe heart problems. In some cases, these complications have been fatal.

Here, we'll explain GranuFlo and how it helps patients with kidney problems. We also discuss the risks and injuries you may suffer while using GranuFlo. Finally, we'll explain what to do if you or your loved one suffers an injury from GranuFlo or other dialysis products.

GranuFlo Used in Kidney Dialysis

People experiencing kidney failure rely on hemodialysis (dialysis) for treatment. During dialysis, the technician hooks the patient up to a dialysis machine. This machine takes the place of the patient's failing kidneys.

The dialysis machine filters various fluids, waste, and salt from a patient's blood.

GranuFlo is a bicarbonate additive medical professionals use during dialysis to prevent acid buildup in the patient's blood. Unfortunately, an improper dosage of this additive can cause serious side effects.

Research Links GranuFlo to Heart Attacks

Medical researchers first linked GranuFlo to serious heart problems in 2010.

In 2011, Fresenius conducted an internal study on GranuFlo to see if it caused an increased risk of heart attacks. The study found that improper doses of GranuFlo were responsible for cardiac arrest in 941 patients in 2010 alone.

The study also found that patients using GranuFlo were six times more likely to experience heart attacks or cardiac deaths than other dialysis patients. The internal memo instructed Fresenius dialysis centers to monitor each patient's bicarbonate prescription closely.

The company failed to notify other dialysis centers, clinics, or healthcare providers of this risk. Subsequent reports have also identified the side effects of GranuFlo.

These reports included the following adverse side effects of GranuFlo:

  • Heart attacks
  • Increased risk of cardiac arrest
  • Renal failure
  • Cardiopulmonary arrest
  • Irregular heartbeat
  • Stroke
  • Cardiac arrhythmia, which can cause sudden cardiac arrest
  • Low blood pressure

GranuFlo can also affect patients' blood content. When this happens, the patient may experience the following:

  • Low potassium levels
  • Low oxygen levels
  • High carbon dioxide levels

There have also been reports of patient deaths due to cardiac arrest after taking GranuFlo.

GranuFlo Recall

In March 2012, a person inside Fresenius leaked a copy of the company's GranuFlo internal memo to the U.S. Food and Drug Administration (FDA). The FDA learned that not only did Fresenius fail to warn doctors about the dangers of Granuflo, but the company continued to promote and market the drug after learning of the increased risk of heart attacks.

As a result of this report, the FDA issued a Class I recall of GranuFlo on March 29, 2012. The recall notice advised health professionals and the public that the "inappropriate prescription of [GranuFlo] can lead to a high serum bicarbonate level in patients undergoing hemodialysis."

The FDA alert concluded that "[GranuFlo] may cause serious adverse health consequences, including death."

GranuFlo Injury Lawsuits

As a result of Fresenius' failure to warn about the risks of GranuFlo, patients became ill. Some even died. When a manufacturer of a dangerous or defective consumer product fails to warn about risks, they may be liable for any resulting injuries. This type of liability falls under product liability law.

Product liability law applies when a product contains a defective design. It also applies when a company doesn't manufacture a medical device correctly. In the GranuFlo cases, the plaintiffs argued that the manufacturer, Fresenius, failed to warn the public about the health risks of GranuFlo.

Patients who suffered an injury after using GranuFlo sued Fresenius. So did family members of patients who died as a result of GranuFlo. Most plaintiffs alleged that Fresenius failed to warn doctors and patients about the side effects of GranuFlo. Their complaints also alleged that the defendant intentionally withheld information from healthcare providers.

These claims were widespread. Patients in 46 states filed suit against the medical device manufacturer.

Types of Damages in GranuFlo Lawsuits

If you or your loved one experienced cardiac arrest or any other injury from using GranuFlo, you can file suit as well. Your personal injury attorney will demand that the defendant compensate you for your injuries.

Depending on the facts of your case, your defective drug lawsuit may demand the following:

  • Medical bills and future medical expenses
  • Lost wages and lost future income
  • Pain and suffering
  • Punitive damages

Remember—judges rarely award punitive damages. But if your injury lawyer can prove that Fresenius withheld information about GranuFlo intentionally, you may be able to receive punitive damages. The courts reserve these damages for cases where they want to punish the defendant(s).

Why Is GranuFlo Dangerous?

Fresenius manufactures and distributes GranuFlo Acid Concentrate (GranuFlo). This powder form of dry acid concentrate helps patients suffering from kidney failure. The company designed the product so technicians can dilute them with purified water.

The technician combines GranuFlo with sodium bicarbonate. The medical professional uses this solution for delivery through hemodialysis machines to cleanse the patient's blood.

Healthcare professionals have used GranuFlo to treat more than half of all dialysis patients. Some patients had the liquid form of the GranuFlo called GranuFloNaturaLyte Liquid Acid Concentrate (NaturaLyte).

Unfortunately, patients have reported severe complications with the use of GranuFlo, including death. This led to thousands of Naturalyte lawsuits, including wrongful death lawsuits, against Fresenius.

Pursuing a GranuFlo Lawsuit

If you suffered an injury because of dangerous drugs, you have rights. You should contact an experienced product liability attorney so they can review your case. You may recover significant compensation depending on the nature and extent of your injuries.

Most personal injury law firms offer new clients a free case evaluation. Find out if you have a valid claim against Fresenius or other manufacturers.

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