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Granuflo Recall Lawsuits

patient helped during dialysis session in hospital

GranuFlo and Naturalyte

GranuFlo and Naturalyte are medical products used during dialysis treatment. Patients undergo dialysis when their kidneys no long function properly, with the treatment removing toxins built up in their blood. GranuFlo is a dry acid concentrate used to neutralize acid buildup during dialysis treatment. Until recently, it was considered an effective and affordable option for dialysis. Unfortunately, many patients have experienced negative side effects from GranuFlo use and the company responsible for producing and distributing GranuFlo is being investigated by the FDA. Have you or a loved one been affected by GranuFlo? Here is what you should know:

Unusual or Dangerous Side Effects

According to FDA warnings, GranuFlo is known to produce certain negative side effects in some patients. These are mainly related to heart health and include:

  • Low blood pressure
  • Heart arrhythmia
  • Heart attack
  • Cardiac arrest
  • Sudden cardiac death

The problems are believed to be caused when excess biocarbonate levels are heightened in the patient’s system. This leads to a medical issue known as metabolic alkalosis. It does not happen for everyone using Granuflo, but it occurred in enough patients that the company issued an Urgent Product Notification warning in March 2012.

Fresenius Medical Care, Makers of Granuflo, is Under Investigation

Within months of the notification, the FDA determined that the danger was severe enough to issue a Class 1 recall of GranuFlo. This level indicates the most serious type of danger associated with a product.

Unfortunately, the FDA also learned that Fresenius Medical Care waited a significant period of time before issuing their warning. The company had previously issued a memo to only a few dialysis clinics warning of potential medical risks when using Granuflo. Furthermore, the memo insinuated that the clinics were responsible for the medical emergencies because they were using GranuFlo improperly. Some believe this memo is proof that the company knowingly withheld information that led to serious injury and death for some patients.

There is also some concern over the fact that Fresenius Medical Care only notified clinics within its own system. Fresenius operates clinics around the world and treats approximately 400,000 dialysis patients in the United States. However, the Granuflo products were also used by independent dialysis clinics and continued to be used until the official FDA recall was issued. This meant for several months, patients within and outside of the Fresenius system continued to be exposed to Granuflo, despite the company’s awareness of the product’s risks.

I’ve Used GranFlo, Am I At Risk?

Patients currently undergoing dialysis are likely no longer at risk. Check with your clinic to ensure they followed the instructions of the recall notice, but GranuFlo is likely no longer in use.

If you have undergone dialysis in the last three years or so and were exposed to GranuFlo, your risk has likely passed. Most patients experienced side effects within 48 hours of their dialysis treatment, so those exposed to GranuFlo in the past are probably fine now. However, if you were undergoing dialysis treatment and suffered a cardiac event, you need to speak to your doctor about a potential connection with your treatment. If your treatments included GranuFlo, you may be due compensation for your injuries.

GranuFlo Recall Lawsuits

Lawsuit filings have begun for patients injured or killed by exposure to GranuFlo. As more and more people learn about the connection between cardiac events and GranuFlo, and become aware of the company’s efforts to hide the danger, they are requesting compensation. There is an expectation that many lawsuits will be filed, so the US Judicial Panel on Multidistrict Litigation has centralized the issue in the Massachusetts court system. Fresenius is based in Massachusetts, so it is believed the majority of documents related to the case and the witnesses expected to be called will be in the area.

As of June 2013, there were more than 300 pending cases related to the use of GranuFlo.

What Compensation Might I Receive if I File a Lawsuit?

Patients who suffered medical emergencies because of their exposure to GranuFlo might be eligible to receive compensation for their own injuries or the injuries of a loved one, if these injuries resulted in death. Possible compensation might be available for:

  • The cost of medical care
  • Reduced wages
  • Permanent disability
  • Reduced quality of life
  • Emotional distress
  • Pain and suffering

How Do I File a Lawsuit?

Many patients injured by GranuFlo have never filed a lawsuit before and are unfamiliar with the process. An experienced GranuFlo lawsuit attorney can make the process easier and more understandable. If you were injured by a medical product, you deserve compensation. If the manufacturers of GranuFlo knew of the danger and still allowed patients to be exposed to their product, they are guilty of negligence. Your injuries or the injuries of a loved one could have been prevented.

If you are interested in discussing your exposure to GranuFlo, or you would like more information, contact one of our attorneys today for a free consultation. We can provide the necessary support and information, and help you determine the right course of action for you. Contact an experienced GranuFlo lawsuit attorney today for a free consultation by calling 855-477-4900, filling out our contact form, or click the Live Chat link on the top of your screen for 24/7 live access.

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